• Don’t Miss This! Watch the Vaccines Revealed Series for Free Now!

    November 30, 2017



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  • Mark Blaxill: My Hanging Offense

    September 5, 2017

    On May 8, The Boston Herald published an editorial calling for my execution. They didn’t know much about me, but had heard about an event in Minneapolis at which I spoke. I learned subsequently the piece was written by Rachelle Cohen, editor of the newspaper’s editorial page. Her brief essay didn’t refer to me by name, but cited a Washington Postarticle from May 5th that did, describing me as “a Boston businessman” and “anti-vaccine activist.”

    Cohen wrote that during “this latest outbreak [of measles in Minnesota], anti-vaccine groups have fanned the flames, making it hard for public health officials and doctors to be heard above the noise. These are the facts: Vaccines don’t cause autism. Measles can kill. And lying to vulnerable people about the health and safety of their children ought to be a hanging offense.” [emphasis added]

    Four months later, the much-hyped Minnesota measles outbreak has passed with little notice, but there are important lessons to be learned from the events surrounding it. What really happened? Why all the fuss? What are the salient facts about measles, vaccines and autism? What was my role in the process? Most importantly, what does this episode teach us about the state of public health policy and the ongoing concern for vaccine safety and parental rights. To explore those questions, let’s first take a look at the outbreak itself.

    The Minnesota measles outbreak of 2017

    On April 13, the first news report of three measles cases among “toddlers” in Minneapolis was published (see HERE). The next day, confirming five more cases, the Minnesota Department of Health (MDH) issued a press release with additional information. Of the then eight confirmed cases, all were unvaccinated children living in Hennepin County. Seven of the eight were “Somali Minnesotans.” Six of these children were hospitalized.

    Over the next three months, as the count of confirmed cases rose to 79, the initial pattern continued. The outbreak was largely confined to children (73 were under 10 years old) who were Somali-American (64 of 79) residents of Hennepin County (70 of 79), most of whom (71 of 79) were unvaccinated. The case count rose quickly to reach 73 by the end of May and then leveled off sharply. Six additional cases were confirmed, until the last case report on July 13.


    By late April, MDH was posting daily case updates on their web-site (see HERE). This was both a response to and a stimulus for widespread media coverage, first in local news outlets and then nationally. At the outset, these were brief, factual reports, but it didn’t take long for the MDH to start pointing fingers. On May 5, The Washington Post published the article that caught Rachelle Cohen’s attention, “Anti-vaccine activists spark a state’s worst measles outbreak in decades.” (see HERE). Health officials complained specifically that the Vaccine Safety Council of Minnesota (VSCM) “in the middle of their crisis” was informing Somali-Americans that they had the right according to Minnesota law to opt out of vaccination based on conscientiously held beliefs. Reminding parents of their rights was a message these officials felt was “exactly the opposite of what clinicians and public health officials are urging, which is to get vaccinated as soon as possible.”

    On August 25, the MDH officially “declared an end to the measles outbreak of spring and summer 2017.” Their news release, which was not widely reported, described why they waited so long to announce something that had been clear for weeks.

    “The outbreak that eventually sickened 79 people, mostly children under 10 years of age, began when the first case was identified April 11. The last case was identified on July 13. Under standard public health practice, the outbreak can be declared over if there are no new cases identified for 42 days. The incubation period for measles is 21 days, meaning that’s how long it can take for someone who has been infected with measles to show symptoms. Health officials wait two incubation periods (42 days) out of an abundance of caution.”

    Despite the often-hysterical treatment the outbreak received from the press, it was a relatively modest event. Although measles no longer circulates freely in the U.S., minor outbreaks like this one remain common. Since 2000, measles cases in the U.S. have averaged close to 130 per year, typically sparked by infected travelers entering the country. When larger outbreaks take place, they often occur in communities that have low vaccination rates: an Amish community in Ohio saw nearly 400 cases in 2014; the year before saw two smaller outbreaks, one in an orthodox Jewish community in New York, another in a church community from Texas.  Most notorious among recent outbreaks is the one that began in Disneyland in December 2014. By the time it subsided in mid-February, the Disneyland outbreak totaled 147 cases.

    By comparison, the Minnesota measles outbreak was a small one. It also appears to have had no lasting health consequences for those infected. According to MDH, 22 of the 79 cases were hospitalized, at first blush a large number. But according to Patti Carroll, a board member of the VSCM, none of these cases were ever in intensive care and all recovered with no known lasting health effects. The hospitalization rate appears to reflect an aggressive response to the initial problem since 6 of the first 8 confirmed cases were taken to the hospital. Of the subsequent 71 cases, MDH data suggest only 16 were hospitalized.

    The Vaccine Safety Council of Minnesota event

    As MDH began targeting the Somali-American community in mid-April, concerns arose among those families who were targeted. Parents who had made the decision to avoid or delay administering the Merck measles-mumps-rubella vaccine (MMR II) to their children reported intense pressure to vaccinate these children against their wishes. According to the VSCM, “the concerns we hear are based on the bullying and overreach of MDH and doctors lying to parents that they have no options or choice on medical decisions for their children.”

    Eager to provide a counterbalance to this pressure, a group of Somali parents reached out to the VSCM and asked them to hold an information session for the Somali community. The VSCM agreed to arrange the session, which was scheduled for April 30th. Originally planned for a community center in Minneapolis, the venue had to be changed after the MDH prevailed on the center to renege on their agreement to host it.

    On Sunday April 30th, I was the main speaker at the relocated VSCM briefing session. Although the last-minute change of venue had reduced the audience somewhat, there was a large turnout of Somali families. A number of media outlets attended as well. The room was smaller than the original community center, but it was fairly full.

    At the outset of my talk, I asked the audience for a show of hands. First, I asked how many knew a child with a measles infection? Almost no one raised their hands, excepting three white doctors sitting together in the center of the room. They were clearly there to represent the public health side of the issue. Next, I asked how many knew a child with autism? Virtually the entire room raised their hands.

    The autism issue was the elephant in the room. The Minnesota Somali community, America’s largest, has been devastated by autism. A 2013 study conducted by University of Minnesota researchers, following the method of the CDC’s Autism and Developmental Disabilities (ADDM) network, analyzed autism prevalence in Minneapolis children, including residents of Somali descent. The study reported an overall prevalence rate in Minneapolis children of 1 in 48, a rate nearly as high as the record-setting rate of 1 in 46 reported by the New Jersey ADDM site. But the rate in the Somali community was 1 in 32, higher than any rate ever reported in America. Parents in the audience told me they believe that rate is an underestimate.


    So many parents of Somali children with autism have seen a regression following the MMR II vaccine that they call it “the autism shot.” And the concern over autism has led to lower vaccination rates among Somali Minnesotans, making them—like the Amish in Ohio and the orthodox Jews in New York– more susceptible to measles outbreaks. The chart below from the CDC’s Morbidity and Mortality Weekly Review illustrates the trend: the MDH would call it a “crisis”; others might call it a rational response from informed parents to an urgent childhood health problem.


    With the elephant—not to mention three hostile doctors—firmly placed in the room, I proceeded with my talk. I broke the presentation into five sections.

    1. An overview of American vaccine policy. I contrasted the positions of government officials and “anti-vaxxers” and stated quite clearly that I was not anti-vaccine, but rather a critic of the dramatic expansion in the CDC’s recommended childhood vaccine schedule. I argued that vaccines have both risks and benefits and that public health officials routinely overemphasize the risks of infectious disease while underplaying the risks of vaccine injury.
    2. Measles risk. I showed CDC data on measles morbidity and mortality in America since 1900. I showed that the risk of death from a measles infection had plummeted throughout the 20th century, but took pains to point out that risk from measles infection remained and that parents should understand that. I shared CDC data on 11 reported deaths from measles since 2000, two of them “verified.” Cancer patients and the immune-suppressed carry the greatest risk.
    3. Autism in Minnesota. I argued, as I have for years, that the dramatic rise in autism rates is real and an urgent public health crisis. I showed the audience how the Somali autism rate dwarfs rates measured in other parts of the country.
    4. Research fraud from the CDC in MMR-autism study. I shared publicly released working documents from CDC scientist William Thompson showing that the CDC had found an increased risk of autism in African American children who had received the MMR vaccine early. Their concealment of those findings is described extensively in the movie Vaxxed and provides key evidence casting doubt on the oft-repeated claim that there is no link between vaccines like the MMR II and autism.
    5. Exemption rights. Finally, I made the point to the Somali parents that it was their right and responsibility to weigh all the information they received and make the decision they felt was best for their child. If, based on their “conscientiously held belief”, they decided to forego or delay vaccination, then they had that right under Minnesota state law.

    So that was my hanging offense. Although some journalists reported fairly on the briefing session, others misrepresented what they heard. Emily Sohn, an NPR reporter who attended the meeting also contributed to The Washington Post article that described me as an “anti-vaccine activist.” Soon thereafter, Rachelle Cohen was literally calling for a lynch mob.

    Lessons from the outbreak

    When your hometown newspaper calls for your execution, it’s an occasion for self-reflection. Was Rachelle Cohen correct? Was I “fanning the flames” of dangerous “anti-vaxxer” sentiment and putting children’s lives at risk? Or was I acting heroically and saving the poor Somali families from the evil clutches of the CDC and their minions at MDH?

    Needless to say, neither of these extremes bear much resemblance to the reality I witnessed. While I’m both bemused and a little alarmed by the media backlash, I can honestly say that I’ve never had a moment of regret about the event. Quite the contrary, I believe that when important rights are under attack it’s important to stand up and defend them. So I was proud to stand with my VSCM friends and their colleagues in the Minnesota Somali community. I hope the information I shared that night was useful to some of them.

    But my overwhelming impression is that the hysterical government and media reaction–one that Rachelle Cohen carried to an alarming extreme–missed three critical points. First and most importantly, it was hugely disrespectful to the Somali families involved. The racist undertone to the official response was hard to ignore. Instead of the educated, informed and caring Somali parents I met that night, the press would have you believe they were ignorant and uncritical victims easily swayed by charlatans and frauds, including me. Far from me educating them, however, I may have learned more from the attendees at the event than they learned from me. Several of the Somali women I spoke to knew a great deal more about the local prevalence study I cited than I did. I took notes!

    Second, what the media response showed most clearly is how complex phenomena like an isolated measles outbreak is made meaningful only to the degree it can be twisted to fit some other pre-existing narrative. As Chicago politician Rahm Emmanuel famously said, “never let a serious crisis go to waste.” And as public health officials have learned with the Disneyland outbreak, measles outbreaks provide a golden opportunity to advance their policy agenda of mandatory vaccination. Friendly partners in the media are only too happy to oblige. As the friendly media has also learned, the threat of a plague makes great television.

    So, the VSCM event became less about the facts and a few dozen Somali children who had to stay home for a few days. Instead, it was quickly turned to familiar themes and characters. The Washington Post went on at length about a visit Andrew Wakefield made to Minneapolis many years ago, pinning blame on him for the decline in vaccine compliance instead of valid concerns about vaccine injury that Somali families have witnessed firsthand.

    But in our increasingly polarized media environment, a serious crisis can be twisted to fit multiple narratives. On another edge of the political spectrum, Michael Patrick Leahy of Breitbart (see HERE) sought to turn the outbreak into a story about the dangers of too many (and disease-carrying), illegal, Islamic immigrants. But there’s a problem with that narrative too. Somali Minnesotans are legal immigrants, invited by the State of Minnesota as part of a deliberate policy. Whether or not one agrees with that policy or the extent of immigration involved, there is no denying that the Somalis I encountered were affluent, educated and well connected to Minnesota society. Like so many of us in the autism parent community, they are simply worried about the health of their children and their right to make their own decisions about vaccination.

    Third, the real public health issues end up subordinated by the official narrative on vaccines and autism, which reared its ugly head again here: Wakefield! Anti-vaxxers! Vaccines never ever cause autism! Measles!  Crazy parents are dangerous!

    But there’s an odd issue when it comes to measles outbreaks, which have been exploited while other more worrisome public health issues are ignored. Measles is the news, but the most serious issues of infectious disease in “vaccine-preventable diseases” aren’t measles. In the last couple of years, a serious mumps epidemic has been sweeping through the country, including Minnesota, with over 3000 cases reported so far this year.  While mumps is usually harmless in children, a mumps infection is far more serious in adults (according to CDC statistics, between 2000 and 2014, the number of “reported” deaths from mumps were exactly same as measles). Why is there no publicity on the very real dangers of our current mumps epidemic? Because the vast majority of mumps infections occur in the vaccinated. The mumps epidemic is evidence of a widespread failure of the mumps component of the MMR II vaccine (a whistleblower lawsuit filed by two Merck scientists argues that Merck covered up evidence of this problem  (see HERE )). Like the mumps epidemic, there’s little mention of an even more pervasive problem, the widespread incidence of whooping cough, which has shown up in hundreds of thousands of reported cases since 2000. But again, like the mumps problem, whooping cough (aka pertussis) overwhelmingly infects those who have already been vaccinated.

    Since these are crises that can’t be put to use, we hear little about them. And the Minnesota measles outbreak received widespread attention because public health officials want to abolish vaccine exemption rights. They have chosen to use recent measles outbreaks to go on the political offensive and attack groups like VSCM that defend exemption rights. Which led Rachelle Cohen, perhaps unwittingly, to me.

    It’s possible, however, that this time these forced narratives backfired, or at least failed to have their desired effect. Did the prospect of a made-for-Breitbart narrative (unclean, disease-carrying, Islamic immigrants!) neutralize the pharma-friendly narrative we saw on outlets like The Washington Post and NPR? Perhaps so, since unlike the Disneyland outbreak, the Minnesota measles outbreak hasn’t yet spawned a new attack on exemption rights. At least not in Minnesota, where the VSCM stands guard. Will that change soon? Only time will tell.

    In the meantime, I still walk the streets of Boston safely. No lynch mobs have been sighted. And if Rachelle Cohen or her colleagues ever want to sit down and have a civil conversation about public policy, I’d welcome the opportunity. Denial

    Mark Blaxill is Editor-At-Large for Age of Autism. His new book, co-authored with Dan Olmsted, is called Denial How Refusing to Face the Facts about Our Autism Epidemic Hurts Children, Families, and Our Future and is available now.

  • Putting Measles and the MMR Vaccine into Perspective

    April 20, 2017

    Despite assurances of the safety of the measles vaccine (MMR), some children suffer permanent brain damage from the vaccine, and some die from it.

    Vaccine manufacturers were paying out large settlements for successful lawsuits filed after devastating vaccine injuries occurred.  This led them to heavily lobby the federal government to pass the National Childhood Vaccine Injury Act (NCVIA) of 1986.  Through this legislation, congress granted doctors and pharmaceutical companies freedom from liability when vaccines disable or kill people, and established the National Vaccine Injury Compensation Program (NVICP).(1)  This administrative program, funded completely by vaccine consumers, became the only method of receiving compensation for vaccine injuries and deaths in the United States.

    Measles vaccine injuries have been compensated through the NVICP

    • 469 families have been compensated through the NVICP for death, brain damage or disability from the MMR vaccine alone.
    • 59 families have been compensated for death from a measles vaccine.
    • So far, the NVICP has awarded over $3.4 billion to over 5,250 victims of vaccine injury, nearly half of whom suffered permanent brain damage.  An analysis of a sampling of those compensated for vaccine-induced brain damage (encephalopathy or seizure disorders) shows that nearly 50% of them have autism.(2)

    Vaccine Adverse Events Reporting System (VAERS)

    VAERS is a federal database established through the NCVIA of 1986 to track reports of adverse reactions following vaccines.  Although federal law states doctors are required to report any suspected vaccine injuries, the law is not enforced.  Even when parents report immediate, severe, and well-acknowledged vaccine reactions like seizures or death, they are often told it was purely coincidental, and unrelated to the vaccine.  As a result, injuries from vaccines are vastly underreported.  Even with these limitations, there have been over 593,000 reports of harm from vaccines, including 6,469 deaths.

    How many Minnesotans are dying of measles?

    Minnesota Department of Health Commissioner Ed Ehlinger falsely stated in a radio interview that “we would have thousands of children dying in our community each year” if people chose to let their children get the measles rather than take the risk of them getting autism from the MMR vaccine.(3)

    • In actuality, deaths from the measles had become extremely rare (averaging less than 5 per year in the entire state – not just in “our community”) BEFORE a vaccine for the measles was even licensed in Minnesota.

    Cochrane Collaboration questions safety of MMR vaccine

    The Cochrane Collaboration, an international review system for scientific evidence on the safety and effectiveness of medical interventions, (often referred to as the “Gold Standard” for evidence-based health) examined published studies on MMR vaccine safety and concluded that: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The evidence of adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases.” (4)

    “Pediatrics” published study acknowledges encephalopathy

    (Brain damage) following measles vaccine

    “Acute Encephalopathy Followed by Permanent Brain Injury or Death Associated With Further Attenuated Measles Vaccines: A Review of Claims Submitted to the National Vaccine Injury Compensation Program” (5)

    After studying the cases of 48 children compensated by the NVICP for injury from the measles vaccine, results showed: “Eight children died, and the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders”

    “CONCLUSIONS: This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.”                                                                 

    CDC scientist reveals deliberate research fraud in MMR/autism study                                     Senior CDC scientist Dr. William Thompson revealed in August 2014 that he and his CDC co-authors committed intentional research fraud in a study on the relationship between the MMR vaccine and autism.(6) A congressional investigation into this and other CDC malfeasance during vaccine safety studies is pending.


    Educated consumers are justified in rejecting hyperbole about the risks of measles, and are wise to question the safety of the MMR vaccine.

    Because there is enormous risk, there must be choice.

    1. https://www.hrsa.gov/vaccinecompensation/index.html
    2. http://digitalcommons.pace.edu/pelr/vol28/iss2/6/
    3. http://www.mprnews.org/story/2011/03/28/midday1 (9:33-9:40)
    4. http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/frame.html
    5. http://pediatrics.aappublications.org/content/101/3/383.abstract
    6. http://www.rescuepost.com/files/william-thompson-statement-27-august-2014-3.pdf



  • Vaccines Revealed

    January 10, 2017



    This exclusive documentary series is about to be unveiled for FREE viewing on January 10th – 18th.

    You’ll discover the most cutting edge news and just released evidence  — from over twenty of the world’s authorities and experts.


    You’ll be on the forefront of the latest discoveries and get released evidence from over a dozen of the world’s authorities and experts.

    Watch this exclusive release in its entirety – just sign up below today.


  • Keeping Your Children Safe at Back to School Time

    September 3, 2016

    back-to-school-183533_1280It’s that time of year again. As our beautiful Minnesota summer winds down and busy parents send their children back to school, the Vaccine Safety Council of Minnesota wants to remind parents of their rights when it comes to vaccines and school.

    Unfortunately, VSCM has been flooded with parental reports of school districts that are making false claims regarding the vaccination rules for students.

    Parents are receiving statements similar to these:

    “If your student has not received such and such a vaccine, he/she will be excluded from school”

    “Your child is missing/needs the following vaccines”

    “Our records show your child is non-compliant”

    “The following vaccines are required before your child can begin school”

    But rest assured – in Minnesota, YOU (the parents) are in complete control over which vaccines your child receives, and when! Blanket statements such as “No Shots, No School” are false, and appear to be an intentionally misleading representation of parental rights.

    Children who are medically contraindicated for receiving certain vaccines may have medical exemptions signed by their doctor.

    To otherwise obtain an exemption from any or all vaccines in Minnesota, you need only write a statement of your conscientious objection, sign it, and have it notarized. The Minnesota Department of Health (MDH) has an exemption form that you can use. BUT – be aware that Vaccine Safety Council of Minnesota strongly objects to some wording that was slipped in to this exemption form recently, possibly without authorization.

    MDH’s exemption statement now includes the following line: “However, not following vaccine recommendations may endanger the health or life of the child or others they come in contact with”

    The problem with this statement is that it can just as easily be stated (and with more actual evidence) “I understand that by following vaccine recommendations, I may endanger the health or life of my child and others they may come in contact with”

    MDH does not require people to sign such a statement whenever a vaccine is administered, despite knowing each and every vaccine has the potential to cause death or permanent brain damage. MDH is well aware that pertussis-containing vaccines do not prevent recipients from carrying and transmitting the pertussis bacteria to others. They also know that for live virus vaccines (measles, mumps, rubella, and chicken pox) vaccinated people can endanger others because they shed the virus for weeks after being vaccinated. And of course, there is no guarantee whatsoever of vaccine efficacy, so even the vaccinated often become ill with the very diseases they were vaccinated against.

    So it is the recommendation of the Vaccine Safety Council of Minnesota that the MDH vaccine exemption form NOT be used. Create your own statement and have it notarized. If you do choose to use the MDH exemption form, boldly cross out the offensive language and initial the form.

    Here is a template if you choose to create your own exemption statement:

    To Whom It May Concern At __________________ School District;

    (Parent) and (Parent), as the Parents of (Child’s name) are exercising our rights under the First Amendment of the US Constitution and Minnesota Statutes: 121A.15 Health Standards; Immunizations; School Children; Subd. 3 (d) to file a Religious/Conscientious Exemption to all vaccinations.


    Parent(s) Names ____________________________

    Parent(s) of ________________________________



    State of _________________________________, ________________________ County

    I,_________________________________, a Notary Public for said County and State, do hereby certify that ____________________________ and

    _________________________________personally appeared before me this day and acknowledged the due execution of the foregoing instrument.

    Witness my hand and official seal, this the ______ day of ______________, 20 ____.

    Notary Signature:_______________________________________________


    We wish you a safe and healthy school year!

  • Examining the Possibility of a Relationship Between MMR Vaccine and Autism

    February 8, 2015




    My name is William Thompson. I am a Senior Scientist with the Centers for Disease Control and Prevention, where I have worked since 1998.

    I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed.

    I want to be absolutely clear that I believe vaccines have saved and continue to save countless lives. I would never suggest that any parent avoid vaccinating children of any race. Vaccines prevent serious diseases, and the risks associated with their administration are vastly outweighed by their individual and societal benefits.

    My concern has been the decision to omit relevant findings in a particular study for a particular sub-group for a particular vaccine. There have always been recognized risks for vaccination and I believe it is the responsibility of the CDC to properly convey the risks associated with receipt of those vaccines.

    I have had many discussions with Dr. Brian Hooker over the last 10 months regarding studies the CDC has carried out regarding vaccines and neurodevelopmental outcomes including autism spectrum disorders. I share his belief that CDC decision-making and analyses should be transparent. I was not, however, aware that he was recording any of our conversations, nor was I given any choice regarding whether my name would be made public or my voice would be put on the Internet.

    I am grateful for the many supportive e-mails that I have received over the last several days. I will not be answering further questions at this time. I am providing information to Congressman William Posey, and of course will continue to cooperate with Congress. I have also offered to assist with reanalysis of the study data or development of further studies. For the time being, however, I am focused on my job and my family.

    Reasonable scientists can and do differ in their interpretation of information. I will do everything I can to assist any unbiased and objective scientists inside or outside the CDC to analyze data collected by the CDC or other public organizations for the purpose of understanding whether vaccines are associated with an increased risk of autism. There are still more questions than answers, and I appreciate that so many families are looking for answers from the scientific community.

    My colleagues and supervisors at the CDC have been entirely professional since this matter became public. In fact, I received a performance-based award after this story came out. I have experienced no pressure or retaliation and certainly was not escorted from the building, as some have stated.

    Dr. Thompson is represented by Frederick M. Morgan, Jr., Morgan Verkamp, LLC, Cincinnati, Ohio,



    * The article above is a representation of the text of the original press release. The font was changed to improve readability. The orginal press release can be found here.


  • Herd Immunity and Compulsory Childhood Vaccination: Does the Theory Justify the Law?

    February 8, 2015

    Oregon Law Review

    2014 Volume 93 Number 1


    Compulsory childhood vaccination is a cornerstone of U.S. public health  policy.  All  fifty  states  compel  children  to  vaccinate  against many  infectious  diseases  to  achieve  so-called  herd  immunity,  a scientific  theory  that  attempts  to  explain  how  societies  protect themselves against infectious disease.

    This  Article  explores  both  the  theory  and  practice  of  herd immunity. The authors evaluate the scientific assumptions underlying the theory, how the theory applies in law, a game theory approach to herd immunity, and a possible framework for rational policymaking. The  Article  argues  that herd  immunityis unattainable for most diseases  and  is  therefore  an  irrational  goal. Instead,  the  authors conclude that herd effect is attainable and that a voluntary vaccination marketplace,  not  command-and-control  compulsion,  would  most efficiently achieve that goal.

    The Article takes on the bugaboo of the citizen “free rider” who is out to game the system, how a vaccination marketplace might work, and what factors policymakers must take into account in developing sound policies. The Article concludes that it is time for states to adopt more realistic and cost-efficient laws to achieve attainable herd effect, not illusory herd immunity.


    *Mary Holland is a Research Scholar and Director of the Graduate Lawyering Program at  New  York  University  School  of  Law. Chase  Zachary  received  his  J.D.  degree  from NYU School of Law in 2014, and he has a Ph.D. in Chemistry from Princeton University.

    Read Paper Here

  • Measles and the MMR Vaccine – Setting the Record Straight

    February 3, 2015

    With the current media frenzy and fear mongering over a few dozen cases of the measles, it is astonishing to note that very few mainstream reports provide balance by also reporting on the damage being done by the MMR vaccine.

    The CDC continues to brazenly lie about the MMR, as evidenced in a media teleconference held on 1/29/15 where CDC representative Ann Schuchat stated: “MMR vaccine is safe and effective”.

    But facts show the MMR is not safe or effective. Frankly, we have no idea how many people are harmed or killed by the vaccine, nor do we know which people the vaccine may provide temporary disease protection for. The “authorities” don’t know, either – despite their claims.


    The Cochrane Collaboration, which evaluates the strength of scientific evidence for the safety and effectiveness of medical interventions, examined published studies about MMR vaccine safety and concluded that  “The design and reporting of safety outcomes in MMR vaccine studies …, are largely inadequate. The evidence of adverse events following immunisation with MMR cannot be separated from its role in preventing the target diseases.” [i]

    17 years ago, a study published in the journal of the American Academy of Pediatrics showed that measles-containing vaccines were definitely NOT safe for every child.

    Acute encephalopathy followed by permanent brain injury or death associated with further attenuated measles vaccines: a review of claims submitted to the National Vaccine Injury Compensation Program.

    RESULTS: A total of 48 children, ages 10 to 49 months, met the inclusion criteria after receiving measles vaccine, alone or in combination. Eight children died, and the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders. The onset of neurologic signs or symptoms occurred with a nonrandom, statistically significant distribution of cases on days 8 and 9. No cases were identified after the administration of monovalent mumps or rubella vaccine.

    CONCLUSIONS: This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.

    Pediatrics, Vol. 101 No. 3 March 1, 1998 pp. 383 -387 http://pediatrics.aappublications.org/content/101/3/383.abstract

    (Although the authors of this paper use the term “rare complication” there is no way to know how many individuals were harmed or killed by the vaccine, as the study only looked at claims that were filed in the NVICP)

    In a 10-year study of adverse reactions from MMR in adults, VAERS (the Vaccine Adverse Events Reporting System) received 3,175 US reports after MMR vaccine in adults. Of these, 168 (5%) were classified as serious, including 7 reports of death.


    This study also identified 131 reports of MMR vaccine administered to pregnant women, of which 38% experienced an adverse reaction.

    One Canadian study found “There are significantly elevated risks of emergency room visits” following the MMR vaccination. [ii]

    The package insert is seldom presented to consumers, so here is a link to the package insert for the M-M-R® II vaccine:


    Among the list of side effects are:

    Panniculitis; atypical measles; fever; syncope; Vasculitis ; Pancreatitis; diarrhea; vomiting; parotitis; nausea; Diabetes mellitus; Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis; Anaphylaxis; Arthritis; arthralgia; myalgia; Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE); subacute sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia; Pneumonia; pneumonitis; sore throat; cough; rhinitis; Stevens-Johnson syndrome; erythema multiforme; urticaria; rash; measles-like rash; pruritis; Nerve deafness; otitis media; Retinitis; optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis; Epididymitis; orchitis; Death.

    Senior CDC scientist-turned whistleblower William Thompson revealed in August 2014 that he and his co-authors intentionally omitted a subset of children in a 2004 study on the MMR vaccine. http://www.rescuepost.com/files/william-thompson-statement-27-august-2014-3.pdf

    The study was designed to determine if earlier administration of the MMR vaccine resulted in a higher rate of autism. Original study results showed a significantly higher rate of autism in children who got the MMR before 36 months of age, and the association was highest among African-American boys. After Thompson and his co-authors deliberately removed a subset of African-American boys from the dataset (which completely defied study protocol), the statistical significance of an increased rate of autism was removed. And that altered study is what the CDC submitted for publication.

    With William Thompson finally achieving whistleblower status and protection, the congressional investigation into CDC malfeasance related to MMR vaccine safety studies will be moving forward soon. But even in the absence of confirmed fraud at the CDC, it simply cannot be said that the MMR vaccine is “safe”.

    In 1986, Congress passed the National Childhood Vaccine Injury Act, which shielded drug companies selling vaccines, and doctors giving them, from most vaccine injury lawsuits. The law set up a federal Vaccine Injury Compensation Program (VICP), and so far nearly $3 billion dollars has been awarded to victims of vaccine injury. To date, 357 families have been compensated by the federal court for death, brain damage or permanent disability from the MMR vaccine alone, and this continues, averaging fourteen families every year.

    In the years 2009 through 2014 there were zero measles deaths in the U.S. but the National Vaccine Injury Compensation Program compensated five families when their children died after receiving vaccines that included the live measles vaccine*.

    2009 – Natural Parents of ERICK SANTIAGO, JR., Decedent, Petitioners ADEENA SANTIAGO and ERICK SANTIAGO, SR., allege that the measles-mumps-rubella (“MMR”) and varicella vaccines administered to Erick on November 20, 2008, and the diphtheria-tetanus acellular-pertussis (“DTap”) and pneumococcal conjugate (“PCV7”) vaccines administered to Erick on May 21, 2009, exacerbated his pre-existing reactive airway disease and asthma, resulting in, or substantially contributing to his death on May 29, 2009. A lump sum of $25,000.00, in the form of a check payable to petitioners, as administrators/executors of Erick’s estate…http://www.uscfc.uscourts.gov/sites/default/files/opinions/CAMPBELL-SMITH.SANTIAGO.7.19.2012.pdf

    2009 – (Attachment) KRISTEN RIDL, parent of S.M., deceased, Kristen Murdock (petitioner) filed a petition on behalf of her daughter, S.M., pursuant to the National Vaccine Injury Compensation Program.2 42 U.S.C. §§ 300aa-1 to -34 (2006). Petitioner alleged that S.M. suffered an encephalopathy and later died as a result of her receipt of Hepatitis A, Varicella, and Measles-Mumps-Rubella (“MMR”) vaccines on January 21, 2009. A lump sum of $170,000.00 in the form of a check payable to petitioner as guardian/conservator of S.M.’s estate. This amount represents compensation for all damages that would be available under 42 U.S.C. § 300aa-15(a).

    2010 11-356V • APRIL L. GARTON and JEREMIAH R. CASMIRE, SR., natural parents of Jeremiah R. Casmire, Jr., deceased V. SECRETARY OF HEALTH AND HUMAN SERVICES April L. Garton and Jeremiah R. Casmire, Sr., filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that their son, Jeremiah Casmire, Jr., suffered a hypoxic/ischemic insult encephalopathy, which was caused-in-fact by the MMR vaccine he received on April 19, 2010, and died as a sequelae of the encephalopathy. I award petitioners a lump sum payment of $250,000.00 in the form of a check payable to petitioners, April L. Garton and Jeremiah R. Casmire, Sr. This amount represents compensation for all damages that would be available under § 300aa-15(a). http://www.uscfc.uscourts.gov/sites/default/files/opinions/VOWELL.GARTON102611_0.pdf

    20111:13-vv-00409 • DAHL et al v. SECRETARY OF HEALTH AND HUMAN SERVICES Dalan and Elizabeth Dahl (petitioners) filed a petition on behalf oftheir daughter, LD, pursuant to the National Vaccine Injury Compensation Program.. Petitioners alleged that LD received a measles, mumps, and rubella (“MMR”) vaccine on June 6, 2011, and thereafter developed symptoms that led to her death on June 18, 2011. Informed by respondent’s concession that an award of damages is appropriate, the undersigned finds that petitioners are entitled to compensation under the Vaccine Act. A lump sum of $250,000.00, in the form of a check payable to petitioners. https://ecf.cofc.uscourts.gov/cgi-bin/show_public_doc?2013vv0409-25-0

    2013 14-683 • R.T., et al v. SECRETARY OF HEALTH AND HUMAN SERVICES Filed 11/21/2014 Public Decision – Damages Decision Based on Proffer, conceded entitled to compensation. MMR, Varicella, Hib, and pneumococcal vaccines received on July 10, 2013; Death, payment of $500,000.00 and $600,394.22 to NM Medicaid lien https://ecf.cofc.uscourts.gov/cgi-bin/show_public_doc?2014vv0683-40-0

    • The last death in the state of Minnesota with any relation to the measles was a toddler who perished from the measles VACCINE – and that was 24 years ago!

    *This is likely only a fraction of the actual number of deaths, as very few claims are successful in proving causation in the NVICP. Many infant deaths are ruled as “SIDS”, without proper investigation into parental claims. When you also factor in the hundreds of compensated claims for permanent vaccine-induced brain damage, and the additional thousands of parental reports of such, ask yourself:

    What is an acceptable price for preventing measles?

    Death from a disease or a vaccine is devastating for any family.

    First, do no harm


    “As for any vaccine, vaccination with M-M-R II may not result in protection in 100% of vaccinees.”

    From package insert: http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf

    In 2014, “…About 17 percent of U.S. (measles) cases this year (2014) were vaccinated. Health officials say that although the vaccine is very effective, it’s not perfect. “


    • In fact, in every measles outbreak in recent years, there have been cases confirmed in vaccinated individuals. And in the recent mumps outbreaks, the majority of the cases had been vaccinated with MMR.
    • Merck, the manufacturer of the MMR, is in the middle of a controversy following disturbing allegations of wrongdoing. In the case of United States v. Merck & Co., claims have been made by two former Merck scientists that Merck “fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act].”  The whistleblowers claim the fraud was committed in order to produce test results that would meet the FDA’s requirement that the mumps vaccine was 95% effective. Although Merck attempted to get the case thrown out, a judge dismissed Merck’s objections to the case proceeding, and determined the whistleblowers had plausible grounds on all of the claims lodged against Merck.  The situation and charges are outlined in more detail here:


    Vaccine Safety Council of Minnesota encourages consumers to educate themselves rather than blindly accepting the cavalier statements of public health officials who disregard and downplay the horrific, well-documented vaccine injuries. There is no informed consent when one is not fully informed.

    [1] Adverse Events following 12 and 18 Month Vaccinations: a Population-Based, Self-Controlled Case Series Analysis

    Kumanan Wilson1,2,3,4*, Steven Hawken2, Jeffrey C. Kwong5, Shelley Deeks6, Natasha S. Crowcroft6, Carl

    Van Walraven1,2,3, Beth K. Potter2,3, Pranesh Chakraborty4,8, Jennifer Keelan7, Michael Pluscauskas4,

    Doug Manuel2,3,9

    [i] http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/frame.html
    Cochrane Database of Systematic Reviews 2005, Issue 4  “Vaccines for Measles, Mumps and Rubella in Children”  Demicheli V,  Jefferson T,  Rivetti A,  Price D

    [ii] Adverse Events following 12 and 18 Month Vaccinations: a Population-Based, Self-Controlled Case Series Analysis

    Kumanan Wilson1,2,3,4*, Steven Hawken2, Jeffrey C. Kwong5, Shelley Deeks6, Natasha S. Crowcroft6, Carl

    Van Walraven1,2,3, Beth K. Potter2,3, Pranesh Chakraborty4,8, Jennifer Keelan7, Michael Pluscauskas4,

    Doug Manuel2,3,9

    1 Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada, 2 Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada, 3 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada, 4 Newborn Screening Ontario, Children’s Hospital of Eastern Ontario, Ottawa, Canada, 5 Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada, 6 Ontario Agency for Health Protection and Promotion, Toronto, Ontario, Canada, 7 Dalla Lana School of Public Health, University of Toronto, Toronto, Canada, 8 Department of Pediatrics, University of Ottawa, Ottawa, Canada, 9 Department of Family Medicine, University of Ottawa, Ottawa, Canada

    Results: Four to 12 days post 12 month vaccination, children had a 1.33 (1.29–1.38) increased relative incidence of the combined endpoint compared to the control period, or at least one event during the risk interval for every 168 children vaccinated. Ten to 12 days post 18 month vaccination, the relative incidence was 1.25 (95%, 1.17–1.33) which represented at least one excess event for every 730 children vaccinated. The primary reason for increased events was statistically significant elevations in emergency room visits following all vaccinations. There were non-significant increases in hospital admissions. There were an additional 20 febrile seizures for every 100,000 vaccinated at 12 months. Conclusions: There are significantly elevated risks of primarily emergency room visits approximately one to two weeks following 12 and 18 month vaccination. Future studies should examine whether these events could be predicted or prevented.


  • “Questioning the Vaccine Program? Come hear the critics!”

    November 25, 2014

    Vaccine Program Flaws Exposed by Experts on Jan. 24

    MINNEAPOLIS, MN — Why are fewer children vaccinated according to the U.S. Centers for Disease Control’s (CDC) schedule? What evidence is behind media reports that increasing numbers of highly educated parents are questioning CDC vaccination policies and science?

    The hard facts explaining vaccine hesitancy are the focus of an event, Questioning the Vaccine Program? Come Hear the Critics, on January 24 at the University of Minnesota’s Cowles Auditorium in Minneapolis. This all-day event, hosted by Skyhorse Publishing and the nonprofit organization Health Choice, is intended to educate the public about a variety of urgent vaccination topics.

    Ten expert authors from the fields of science, law, business, education and journalism will shed light on public health data that is often overlooked. Discussions will explore scientific evidence on illnesses associated with vaccine injuries (e.g. autism), legal recourse for vaccine injury, ingredients, contaminants, and safer vaccination choices that accommodate individual biological predispositions.

    “The health experiences of many U.S. consumers don’t match what the CDC’s public relations claims; our nation’s children are the sickest in history,” said Jennifer Larson of Health Choice. “This group of parent experts provide a strong voice to vaccine injury victims and exposes a very cozy relationship between government and industry. ”

    These ten authors will discuss their seven books:
    Science for Sale: How the U.S. Government Uses Powerful Corporations and Leading Universities to Support Government Policies, Silence Top Scientists, Jeopardize Our Health, and Protect Corporate Profits by Dr. David Lewis, a former EPA microbiologist now with the National Whistleblowers Center;
    • Plague: One Scientist’s Intrepid Search for the Truth about Retroviruses, Chronic Fatigue Syndrome, Autism, and Other Diseases by Kent Heckenlively, J.D. & Dr. Judy Mikovits;
    • Vaccines 2.0: The Careful Parent’s Guide to Making Safe Vaccination Choices for Your Family by Mark Blaxill & Dan Olmsted, a former UPI investigative reporter;
    • The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program by Wayne Rohde;
    • The Autism War and Vaccine Injuries: Documented Adverse Reactions to Vaccines by Louis Conte, a law enforcement officer and independent investigator with the Westchester County, NY Department of Probation;
    • The Big Autism Cover-Up: How and Why the Media Is Lying to the American Public by Anne Dachel, a teacher and contributing editor at the Age of Autism blog; and
    • Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children by contributing writers Mary Holland, J.D. & Kim Mack Rosenberg, J.D.

    Reserve your tickets now; space is limited. Tickets are available through the Health Choice website:


    Health Choice is a non-profit organization focusing on awareness of health choices, education on nutrition, healing, and prevention of chronic illnesses for children and adults. A study in Academic Pediatrics says 43% of U.S. children (32 million) now suffer from a chronic health condition. Health Choice’s volunteer advocates are working to protect everyone’s right to a healthy life.

  • Vaccines – Your Child, Your Choice

    August 4, 2014

    The state of Minnesota protects parental decision-making regarding vaccines.

    At back-to-school time, most parents are given information suggesting that their children must receive vaccinations before they go to school.  But that is not correct; Minnesota parents are free to choose to vaccinate their child if and when they decide their child is ready, and only with the vaccines that they have thoroughly investigated and found necessary for their child.

    It is your right to choose NOT to vaccinate your children before they go to school or day care.  Many Minnesota parents do extensive research, and allow only the vaccines they have determined are safe and necessary for their unique child – and only when those vaccines are appropriate.

    The law in Minnesota simply requires that parents report to schools or day care centers whether or not their child is vaccinated.  If you choose not to follow the “one size fits all” schedule for your child, the only requirement is your statement with a notarized signature.  The Department of Health has a form you can use, or you can create your own form, indicating that you are conscientiously choosing to follow a schedule best suited to your child’s health status, or exempt them completely from vaccines.  The MN Department of Health website has information on how to obtain exemptions, including where you can find notary services at little or no cost.


    If you are concerned about the safety of vaccines, the majority of parents agree with you.  Recent research shows that 89% of U.S. parents identified vaccine safety as the top research priority for them in managing their child’s health care. http://www.fiercebiotech.com/press-releases/vaccine-and-medication-safety-are-parents-top-research-priorities


  • Vaccines – Your Child, Your Choice!

    August 14, 2013

    The state of Minnesota protects parental decision-making regarding vaccines.

    It is your right to choose NOT to vaccinate your children before they go to school or day care.  Many Minnesota parents do extensive research, and allow only the vaccines they have determined are safe and necessary for their unique child – and only when those vaccines are appropriate.

    The law in Minnesota simply requires that parents report to schools or day care centers whether or not their child is vaccinated.  If you choose not to follow the “one size fits all” schedule for your child, the only requirement is a notarized signature.  The Department of Health has a form you can use, or you can create your own form indicating that you are conscientiously choosing to follow a schedule best suited to your child’s health status, or exempt them completely from vaccines. (http://www.health.state.mn.us/divs/idepc/immunize/laws/notary.html)

    Also listed at the MDH website are locations where you can find notary services at little or no cost.

    At back-to-school time, most parents are given information suggesting that their children must receive vaccinations before they go to school.  But that is not correct; Minnesota parents are free to choose to vaccinate their child if and when they decide their child is ready, and only with the vaccines that they have thoroughly investigated and found necessary for their child.

    If you are concerned about the safety of vaccines, the majority of parents agree with you.  Recent research shows that 89% of U.S. parents identified vaccine safety as a top research priority for them in managing their child’s health care. http://www.fiercebiotech.com/press-releases/vaccine-and-medication-safety-are-parents-top-research-priorities

    Here are some excerpts from the Minnesota law on childhood vaccines that show the different categories of exemptions that parents use to tell the school why they have not vaccinated their child:

    “(d) If a notarized statement signed by the minor child’s parent or by the emancipated person is submitted to the person having supervision of the school or child care facility stating that the person has not been immunized as prescribed because of the conscientiously held beliefs [bold added] of the parent of the minor child or of the emancipated person, the immunizations specified in the statement shall not be required. “ (Minn Stat. 121A.15 Subd 3(d) 2012)

    “(c) If a statement, signed by a physician, is submitted to the administrator or other person having general control and supervision of the school or child care facility stating that an immunization is contraindicated for medical reasons or that laboratory confirmation of the presence of adequate immunity exists, the immunization specified in the statement need not be required.” (Minn. Stat. 121A.15 Subd. 3(c) 2012)

    “(a) If a person is at least seven years old and has not been immunized against pertussis, the person must not be required to be immunized against pertussis.

    (b) If a person is at least 18 years old and has not completed a series of immunizations against poliomyelitis, the person must not be required to be immunized against poliomyelitis….

    (e) If the person is under 15 months, the person is not required to be immunized against measles, rubella, or mumps.

    (f) If a person is at least five years old and has not been immunized against haemophilus influenzae type b, the person is not required to be immunized against haemophilus influenzae type b.

    (g) If a person who is not a Minnesota resident enrolls in a Minnesota school online learning course or program that delivers instruction to the person only by computer and does not provide any teacher or instructor contact time or require classroom attendance, the person is not subject to the immunization, statement, and other requirements of this section. (Minn. Stat. 121a.15 Subd. 3(a),(b)(e)(f) and (g)

    Here is more information on Minnesota’s vaccination law:


    If you would like to report to the school or day care that you are exempting your child from any or all vaccines required for entrance to school or child care, fill out a statement, have it notarized, and give it to your school or child care provider.  You may use this form for your statement if you wish:

    For children in child care:


    For school:


    Note: Minnesota law states that any written information on vaccine requirements from your school or child care facility or from your medical facility must also give you information on your options for exemptions! If you have received written information that does not include exemption information, please contact Patti Carroll of VSCM at (651) 785-5716 to report this, and notify Patti Segal Freeman of the Minnesota Department of Health at (651) 201-5520.

    The Vaccine Safety Council of Minnesota opposed recent proposed rule changes by MN Department of Health to add more vaccines: Recently the Vaccine Safety Council of Minnesota, together with other consumer groups including Vaccine Awareness Minnesota, Dental Amalgam Mercury Solutions, Canary Party, National Health Freedom Action, and The Organic Consumers Association opposed a proposed rule by the Minnesota Department of Health to add more vaccines to the child school and day care schedule.  We opposed a new requirement for hepatitis A and hepatitis B vaccines for infants in child care, and meningococcal vaccines for seventh graders.  VSCM believes these vaccines are not needed due to the extremely low incidence of these diseases in Minnesota children, and because they pose an additional risk of vaccine injury.

    A hearing was held before an Administrative Law Judge on June 27 to present evidence for and against the proposed rules; 200 comments were submitted after the hearing, the majority against the proposed rule changes.  If you sent in testimony or comments, thank you!  Judge Eric Lipman has not yet handed down his ruling on this proceeding.  VSCM will post the ruling as soon as it is available.


    The Vaccine Safety Council of Minnesota’s purpose is to inform and educate.  We offer research, news, and vaccine safety information not often available through mainstream media or public health outlets.  We encourage parents to do their own research, in order to make fully informed vaccine choices based on their unique child’s circumstances.  VSCM provides general information regarding vaccines and vaccine policy.  Our information comes from a variety of sources and should not be misconstrued as official medical or legal advice.  Please consult with trusted practitioners regarding any actions you implement for yourself or your child.  We hope this information inspires consumers to make truly educated decisions for the health and well-being of their families.


  • Vaccine bombshell: Baby monkeys develop autism symptoms after obtaining doses of popular vaccines

    November 8, 2012

    By Sola Ogundipe

    Following a recent study conducted by scientists at the University of Pittsburgh, Pennsylvania which revealed that many infant monkeys given standard doses of childhood vaccines as part of the new research,developed autism symptoms, question marks over the ultimate safety of vaccines have come to the fore.

    The groundbreaking research findings presented at the International Meeting for Autism Research (IMFAR) in London, England, have revealed that young macaque monkeys given the typical CDC-recommended vaccination schedule from the 1990s, and in appropriate doses for the monkeys’ sizes and ages, tended to develop autism symptoms. Their non vaccinated counterparts, on the other hand, developed no such symptoms, which points to a strong connection between vaccines and autism spectrum disorders.

    This development which deconstructs mainstream myth that vaccines are safe and pose no risk of autism, was brought on by after studies on the type of proper safety research on typical childhood vaccination schedules that the U.S. Centers for Disease Control and Prevention (CDC) should have conducted — but never has — for such regimens.

    Read full article click HERE

  • Vaccines: Towards Removing Additives Containing Aluminum

    October 29, 2012

    By www.20min.fr

    Faced with a growing distrust towards vaccines and return of infectious diseases once thought extinct, the study group on immunization of the National Assembly, chaired by MP Olivier Jardé New Center, was created . After a year of hearings, eleven recommendations were made ??public Tuesday. Read full article click HERE.

    To read the study group click HERE.

  • Merck sued over mumps vaccine research

    June 25, 2012

    FOR IMMEDIATE RELEASE: Monday, June 25, 2012
    Contact: Vaccine Safety Council of Minnesota – Wayne Rohde 651-705-5030 / 405-973-7049

    Merck sued over mumps vaccine research

    Virologists claim “improper testing and data falsification”;
    $$ cost to U.S. for fraud could be in hundreds of millions

    ST. PAUL, MINN. – Two virologists have filed a federal lawsuit against pharmaceutical giant Merck, claiming the corporation exaggerated the effectiveness of its mumps vaccine. Merck has held a monopoly on mumps vaccine sales to the federal government for more than four decades.

    The plaintiffs, or “Relators,” are former Merck employees Stephen A. Krahling and Joan A. Wlochowski. They filed a civil action April 27 in United States District Court for the Eastern District of Pennsylvania, citing violations of the Federal False Claims Act. They demand a jury trial.


    According to the 55-page filing, the virologists “witnessed firsthand the improper testing and data falsification in which Merck engaged to conceal what Merck knew about the vaccine’s diminished efficacy. In fact, their Merck superiors and senior Merck management pressured them to participate in the fraud and subsequent cover-up when Relators objected to and tried to stop it.”

    • “Merck predicted the resurgence of outbreaks given the diminished effectiveness of its mumps vaccine. … Merck knows that the vaccine’s efficacy is significantly less than that now. … Merck set out to conduct testing of its mumps vaccine that would support its original efficacy finding. … The only way Merck could accomplish this was through manipulating its testing procedures and falsifying the test results.”
    • “As a result of Merck’s fraudulent scheme, the United States has over the last decade paid Merck hundreds of millions of dollars for a vaccine that does not provide the efficacy Merck claims it provides and does not provide the public with adequate immunization.”

    Merck scientists are accused of rigging a study using animal antibodies to boost seroconversion levels, unethically counting those as human antibodies. Since 1971 Merck has claimed its mumps vaccine efficacy rate was 95 percent, but that experiment boosted results to an unrealistic 100%.

    “If found guilty, Merck defrauded tens of millions of people out of hundreds of millions of dollars, failed to protect our nation’s health, and destroyed our trust,” said Patti Carroll of the Vaccine Safety Council of Minnesota. “The U.S. Senate and journalists should be investigating Merck.”

    The plaintiffs have requested that the Court “enter judgment against Merck in an amount equal to three times the damages suffered by the United States due to Merck’s unlawful conduct.”


    Questions journalists should ask:

    1. How many vaccinated people have had mumps (e.g. Iowa 2006, New York/New Jersey 2009)?

    2. Why aren’t these reports of falsified data and vaccine failure being policed by the FDA?

    3. Why did Merck pull individual measles, mumps and rubella vaccines off the market after public outcry about MMR adverse reactions increased consumer demand for individual shots?

    4. Why do former Merck employees have far more legal recourse than vaccine consumers?

    5. Does the government/industry revolving door inhibit free market competition of better vendors?

    6. If Merck is found guilty, are other vaccine manufacturing divisions there and at other companies operating under a similarly dishonest corporate culture to enhance profitmaking?




  • CDC Mandatory Vaccine Schedule 1983 vs 2010

    March 7, 2012

    By drmomma.org

  • Conflicts of Interest in Vaccine Safety Research

    March 5, 2012

    By Gayle Delong, Accountability in Research, 19:65-88, 2012
    Click Here to Read

  • The Refusers

    February 20, 2012


    MB Comment: Here is a proposal from a CDC-associated stooge to have public health departments and vaccine fanatics sue vaccine refusers as public nuisances – before any outbreak of disease.

    This masterpiece of vaccine fanatacism was recently published in the Michigan Law Review. This proposal represents a new escalation in the rhetoric coming from the drug industry-dominated CDC and public health establishment (The former head of the CDC, Dr. Julie Gerberding is now head of Merck’s vaccine division).

    Left unsaid in this article is the vaccine establishment’s responsibility for creating the one and only epidemic currently raging in the US – neurological damage from vaccine adverse reactions. Who is going to hold them accountable?

    This magnum opus does not bother with any definition of disease causation or specific evidence of disease transmission. Courts are simply supposed to assume that diseases are spontaneously generated and transmitted only by vaccine refusers.

    Proposals like this betray the medical fascism that is at the heart of the public health profession and its puppetmasters in the CDC and pharmaceutical industry.

    ‘There is a strong public health argument in favor of strengthening existing measures to obtain the highest vaccination coverage rates to ensure community protection. It is possible for communities to confront personal belief exemptors—if they have the collective will …

    Read full article HERE

  • How the Medical Profession Covered Up Vaccine Injuries and Called it ‘Child Abuse’

    February 14, 2012

    By Christina England, Vactruth.com

    A short while ago I exposed a series of thirteen papers which unequivocally proved that Prof Roy Meadow the UK’s most famous Munchausen Syndrome by Proxy (MSBP) expert, attended thirteen meetings on adverse reactions to vaccines just about the time MSBP rates rocketed. [1] Up to this time most people researching Meadow were only aware of him attending four meetings with the ARVI (Adverse Reactions to Vaccination and Immunizations) and a few with the CSM (Committee for the Safety of Medicine).

    As exciting as the discovery of these new papers were, especially for those parents falsely accused of Munchausen by Proxy (MSBP) or Shaken Baby Syndrome (SBS) after a vaccine injury had affected their children, they only proved that Prof Roy Meadow had attended meetings discussing adverse reactions to vaccines; they did not prove that he actually participated in them. This is because the papers had all the professionals names blacked out by Freedom of Information (FOI). This made it impossible for the public to determine which comments were said by which professional.

    Since I published my last paper however, I have received the cleaned up versions of four of those papers revealing exactly what was said and by whom. This is a breakthrough and enables parents of vaccine damaged children, accused of MSBP or SBS by Meadow, to finally have proof that Meadow not only attended these meetings but actually participated, advised and commented on the topics of cot death, seizures, anaphylaxis, and the yellow card reporting system (UK reporting system for adverse reactions to vaccines.)

    Read full article HERE

  • HPV Vaccine Policy: At Odds With Evidence-Based Medicine?

    January 31, 2012

    Roxanne Nelson/From Medscape Medical News

    January 31, 2012 — Is the policy for the human papillomavirus (HPV) vaccine at odds with evidence-based medicine?

    Yes, according to an essay published online December 22, 2011, in the Annals of Medicine.

    Canadian researchers Lucija Tomljenovic, PhD, and Christopher Shaw, PhD, from the Neural Dynamics Research Group, University of British Columbia, in Vancouver, point out that there is a major discrepancy in claims regarding the safety and efficacy of Gardasil (Merck & Co) and Cervarix (GlaxoSmithKline) — the 2 HPV vaccines that are currently on the market.

    The vaccines have been heavily promoted in the United States by their respective manufacturers, the essayists report. In addition, the vaccines are backed by government agencies in the United States, including the Center for Disease Control and Prevention and the US Food and Drug Administration, and by medical authorities in a number of other countries.

    HPV vaccination has been mired in controversy since the first vaccine was approved in the United States in 2006. There have been clashes among politicians, parents, professional and advocacy organizations, and public health officials, with heated exchanges over issues ranging from safety, the premise that vaccination will promote sexual activity in teens, cost, and concerns about aggressive lobbying by Merck to make the vaccine mandatory for girls.

    Drs. Tomljenovic and Shaw note that skepticism about the vaccine has been increasing for a number of reasons, despite reassurances from the public-health sector. In their essay, they examine the current evidence to answer a key question: “Is it possible that HPV vaccines have been promoted to women based on inaccurate information?”

    Does it Prevent Cancer?

    Read the full article here

  • GSK lab fined over vaccine tests that killed 14 babies

    January 4, 2012

    January 4, 2012

    Buenos Aires Herald

    GlaxoSmithKline Argentina Laboratories company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for the killing of 14 babies during illegal lab vaccine trials conducted between 2007 and 2008.

    Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined with 300,000 pesos each for irregularities during the studies.

    The charges included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

    Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.

    A total of 7 babies died in Santiago del Estero; 5 in Mendoza; and 2 in San Juan.

    Pediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals (FESPROSA in Spanish), and was working at the Eva Perón children’s public hospital in Santiago del Estero when the studies wee being conducted, said this morning in conversations with Continental AM radio that “GSK Argentina set an protocol at the hospital, and recruited several doctors working there.”

    To read the full article click here

  • Minnesota School Immunization Law Exemption Provision

    December 7, 2011

    Minnesota School Immunization Law Exemption Provision

    -Minnesota Department of Health

    Minnesota’s School Immunization Law allows the parent or guardian of a minor child (or the emancipated student) to file for a legal exemption to the school immunization requirements. The law allows for two types of legal exemptions: medical and conscientious. Below is a summary of how to obtain these exemptions.

    Read the full piece online here:



  • Parent of Autistic Child in Wakefield Study Says Key Journalist Got Facts Wrong

    November 4, 2011

    FALLS CHURCH, Va., Nov. 3, 2011 /PRNewswire/ —  When reporter Dan Olmsted met with the father of an autistic boy whose medical history is central to a British Medical Journal article refuting the vaccine/autism link, Olmsted never expected to be shown a letter written by the boy’s father that would reveal the facts of the BMJ article to be flagrantly false. In contrast to the article, the letter clearly reveals the plausibility of the boy’s autism being caused by his MMR (combined measles, mumps, rubella live virus vaccination) as well as the father’s belief that the shot caused his son’s autism.

    Today in Age of Autism, Olmsted’s interview with this father of a boy with autism known only as “child 11” appears in Part 7 of the Elaborate Fraud series by Olmsted and Mark Blaxill, Age of Autism’s Editor-At-Large. The contents of the letter mark another revelation in the controversy over the British Medical Journal’s published report by freelance journalist Brian Deer who has received support from  MedicoLegal Investigations (MLI), a bureau affiliated with the Association of the British Pharmaceutical Industry (ABPI) which specializes in bringing doctors before the General Medical Council, the UK’s disciplinary body.

    The father’s 1997 letter was written to Dr. Wakefield, who had led a team of researchers in the controversial case study of 12 children with autism. Contrary to Deer’s January report in the British Medical Journal, the chronology of Child 11’s MMR shot and his subsequent autism diagnosis was inaccurately reported.  From Olmsted’s article:

    “When I showed Father 11 what Deer had written about the shot-and-symptoms sequence, he said, emphatically, ‘That’s not correct.'”

    BMJ’s fraud allegations against Wakefield derive from 2009 and were published in the Sunday Times six days after proprietor James Murdoch was appointed to the board of MMR manufacturer GlaxoSmithKline with a brief “to review…external issues that might have the potential for serious impact upon the group’s  ‘reputation.'”

    Dr Peter Fletcher, former Chief Scientific Officer at the UK Department of Health, said if it is proven that the jab causes autism, “the refusal by governments to evaluate the risks properly will make this one of the greatest scandals in medical history“.

    Contact: Ginger Taylor
    Phone: (855) 711-5282
    Email mail:media@canaryparty.org

    SOURCE Age of Autism

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  • Scandal Exposed in Major Study of Autism and Mercury

    October 31, 2011

    Oct. 25, 2011

    By: Coalition for Mercury Free Drugs (CoMed)

    SILVER SPRING, Md., Oct. 25, 2011 — /PRNewswire-USNewswire/ — The Coalition for Mercury-free Drugs (CoMeD) exposes communications between Centers for Disease Control (CDC) personnel and vaccine researchers revealing U.S. officials apparently colluded in covering-up the decline in Denmark’s autism rates following the removal of mercury from vaccines.

    Documents obtained via the Freedom of Information Act (FOIA) show that CDC officials were aware of Danish data indicating a connection between removing Thimerosal (49.55% mercury) and a decline in autism rates.  Despite this knowledge, these officials allowed a 2003 article to be published in Pediatrics that excluded this information, misrepresented the decline as an increase, and led to the mistaken conclusion that Thimerosal in vaccines does not cause autism.

    In Denmark, Thimerosal, a controversial mercury compound used as a preservative in certain vaccines, was removed from all Danish vaccines in 1992.  The well-publicized Danish study published in Pediatrics 2003 claimed that autism rates actually increased after Thimerosal was phased out.  This study subsequently became a cornerstone for the notion that mercury does not cause autism.  However, one of the FOIA documents obtained from CDC clearly indicates that this study omitted large amounts of data showing autism rates actually dropping after mercury was removed from Danish vaccines.

    Read more: http://www.sacbee.com/2011/10/25/4005040/scandal-exposed-in-major-study.html#ixzz1cN2b82Ly

  • Flu Shots Have More Than 250x EPA Mercury Safety Limit

    October 13, 2011

    October 10, 2011

    By Anthony Gucciardi, Health Freedom Alliance

    Thimerosal is a widely used vaccine preservative that is present in the majority of flu shots and other vaccines. Thimerosal is 49% mercury by volume, an extremely toxic chemical element that wreaks havoc on the nervous system, neurological function, and overall biological function [1]. Each dose of flu vaccine contains around 25 micrograms of thimerosalover 250 times the Environmental Protection Agency’s safety limit of exposure.

    Mercury, a neurotoxin, is especially damaging to undeveloped brains. Considering that 25 micrograms of mercury is considered unsafe by the EPA for any human under 550 pounds, the devastating health effects of mercury on a developing fetus are truly concerning.

    Though thimerasol is not entirely mercury, the mercury content is still extremely high, making it very toxic to the human body. Despite highly exceeding the EPA safety standards for mercury content by over 250 times, flu shots are still recommended for children over 6 months and pregnant women.

    It seems that the age groups that are urged to receive the flu shot are actually most affected by mercury exposure. Young children, pregnant women, and elderly are the ‘targeted’ demographic of flu shot manufacturers, and these individuals also happen to have the least defense against the elemental neurotoxin mercury.

    Dr. Russel Blaylock, a leading neurologist, explains:

    Read the full piece online here:


  • California Parents’ Health Rights Taken By Government

    October 11, 2011

    FOR IMMEDIATE RELEASE: Tuesday, October 11, 2011
    Contact: Vaccine Safety Council of Minnesota – Wayne Rohde 651-705-5030 / 405-973-7049

    On October 9 California?s Governor Jerry Brown signed into law a bill that allows children as young as twelve to have themselves injected with unproven, risky and costly HPV vaccines – without the knowledge or permission of that child?s parents, and without a product warranty.

    Assembly Bill 499 was opposed by parents? rights advocates, religious groups and vaccine safety advocates, but lobbying by pharma-funded groups pushed the bill through regardless. Ironically this week Gov. Brown also signed a bill banning teenagers from using tanning beds; previously teens could get parental permission to tan.

    So far more than 18,000 reports of adverse events following injection with HPV vaccines have been reported to the Vaccine Adverse Events Reporting System, including more than 100 deaths.

    “Parents know their children?s health better than anyone,” said Wayne Rohde of the Vaccine Safety Council of Minnesota. “It?s bad enough that government is taking away parents? rights, but now they and pharma are giving that medical authority to pre-teen children. It?s frightening.”

    U.S. laws are supposed to protect children from predatory influences, prohibiting alcohol and tobacco marketing due to kids? vulnerability to psychological manipulation and peer pressures. Advertising agencies craft messages targeted to coerce children into believing they cannot live without having the latest thing. In this case it?s a $360 product with no efficacy guarantee for results that won?t be known for decades, and no warranty protection if it causes health problems.

    “A twelve-year-old child is not intellectually ready to assess risks versus benefits data, or research vaccine manufacturers? use of an aluminum adjuvant as a placebo instead of saline,” said Jennifer Larson, Board Member of Vaccine Safety Council of Minnesota. Preteens don?t understand terms like disseminated encephalomyelitis, encephalitis, demyelination, or myelitis – injuries reported to VAERS. Nor are they aware that recombinant DNA has been found in HPV vaccines, the adverse effects of which are yet to be determined.

    The HPV vaccine Gardasil has a 30-page package insert. “If an impulsive child can?t be depended on to buy a healthful lunch from the school cafeteria, how can that child possibly make their own medical decisions?” said Patti Carroll, mother of a vaccine injured child. “The California bill opens the doors for pharma marketing directly to kids, bypassing parental screening. What?s next, a free pink iPod with every shot?”

    The CDC and vaccine manufacturers have shown no accountability to consumers. Vaccine injury reports are ignored or denied, vaccine injury research is minimal and medical treatments are few. If a vaccine causes harm, victims have almost no recourse and are left to struggle with lifelong disabilities and health problems. Next year a documentary on HPV vaccine injury will be released.

    “California?s Assembly Bill 499 is a self-serving breach of ethics that amounts to medical tyranny,” said Rohde. “These influence-peddling government/pharmaceutical partners are eager to sell products, but they avoid any post-market follow-up helpful to consumers. Our hit-and-run vaccine delivery system rolls forward faster and faster, never looking back to learn from mistakes.”

    “Public health policymakers say that they?re „protecting? teenagers, but good intentions are no guarantee of good outcomes,” said Rohde. “There?s no accountability to damaged kids and their families. Vaccine injuries and denial are pushing American parents to the boiling point.”

  • Conclusive Link Now Admitted: Swine Flu Vaccine Causes Chronic Nervous System Disorders

    October 10, 2011

    October 10, 2011 10:11 AM EST

    (NaturalNews) The nation of Finland has now openly admitted that the swine flu vaccine “conclusively” causes narcolepsy, a chronic nervous system disorder that makes people uncontrollably fall asleep. The Finnish government, in acknowledging this link, says it will pay for “lifetime medical care” for 79 children who have been irreparably damaged by the swine flu vaccine. (http://news.yahoo.com/finland-vows-…)

    Narcolepsy isn’t the only side effect now admitted to be caused by swine flu vaccines: 76 of the 79 children also suffered hallucinations and “paralyzing physical collapses,” say Finnish researchers.

    Remarkably, even though the link between swine flu vaccines and permanent neurological damage in children is now openly admitted by the Finnish government, there is absolutely no talk about halting the utterly unscientific ritual of injecting children with flu vaccines in the first place. Not only are flu vaccines harmful to children (as is now admitted), but flu vaccines don’t even work! A simple daily dose of vitamin D would do far more to halt influenza than any vaccine (http://www.naturalnews.com/029760_v…).

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    The U.S. government, of course, still refuses to admit vaccines cause any harm whatsoever. Both the government and the vaccine industry continue to push the fabricated fairy tale that “vaccines are safe and effective,” meaning they harm no one but help everyone. Yet the truth is practically the polar opposite: Vaccines harm countless millions of children each year in ways that are usually never linked to vaccines (mild mental retardation, suppressed immune function, learning disabilities, etc.). At the same time, vaccines are all but worthless at preventing infections. Even the vaccine industry’s own research shows that flu shots only work on 1 out of 100 people, meaning they’re completely useless for 99 percent of those who take them (http://www.naturalnews.com/029641_v…).

    Instead of admitting the truth that vaccines cause autism, the U.S. government has conspired with vaccine manufacturers to create a Vaccine Injury Compensation Program which essentially pays “hush money” to parents of permanently harmed children to make sure they cannot bring their claims of harm to federal courts (http://www.naturalnews.com/033635_v…).

    Even worse, the medical establishment — which is heavily influenced if not downright dominated by pharmaceutical interests — absolutely refuses to advocate vitamin D as a flu prevention nutrient. Vitamin D is safe, effective and affordable. It’s available without a prescription and could save literally billions of dollars in national health care costs for just pennies per day per person. So why won’t the medical establishment promote vitamin D? Precisely because it would cost the industry billions of dollars in lost profits from all the sickness and degenerative disease that is prevented by vitamin D.

    There is absolutely no question in the mind of any reasonably informed person that vaccines cause neurological damage, including (but not limited to) autism. Only the corporate-whore scientists around the world continue their charade that vaccines are not linked to autism; or that vaccines even work in the first place. Most Americans haven’t yet heard the secret interview with Merck vaccine scientist Dr. Maurice Hilleman where he openly admits vaccines carry dozens of strains of cancer-causing “stealth” viruses. Read the transcript here:

    Read the full piece online here:


  • New Study: Vaccinated Children Have 2 to 5 Times More Diseases and Disorders Than Unvaccinated Children

    October 10, 2011

    October 9, 2011

    From David Michael Augenstein, Journal of Natural Food & Health

    Preventable Vaccine-induced Diseases

    A German study released in September 2011 of about 8000 UNVACCINATED children, newborn to 19 years, show vaccinated children have at least 2 to 5 times more diseases and disorders than unvaccinated children.

    The results are presented in the bar chart below; the complete data and study results are here. The data is compared to the national German KIGGS health study of the children in the general population. Most of the respondents to the survey were from the U.S.

    The data was collected from parents with vaccine-free children via an internet questionnaire by vaccineinjury.info and Andreas Bachmair, a German classical homeopathic practitioner. The website is not a pretty one (including Google ads for vaccines) but the actual data is what counts. The independent study is self-funded and is not sponsored by a large “credible” non-profit or government health organization with political and financial conflicts of interest. Each one of the 8000 cases are actual cases with medical documentation. Three other studies had similar results according to Bachmair and are reported below.

    No study of health outcomes of vaccinated people versus unvaccinated has ever been conducted in the U.S. by CDC or any other agency in the 50 years or more of an accelerating schedule of vaccinations (now over 50 doses of 14 vaccines given before kindergarten, 26 doses in the first year). Most data collected by CDC is contained in the Vaccine Adverse Event Reporting System (VAERS) database. The VAERS is generally thought to contain only 3 to 5 percent of reportable incidents. This is simply because only some immediate reactions are reported by doctors; but many are not admitted to be reactions to the vaccine. Most importantly, the VAERS numbers are only immediate reactions, which I would place with a few hours to a few weeks. Long-term vaccine-induced diseases and disorders are not recognized by parents or doctors when these conditions develop perhaps a few months to five years or more and would never be realized to come from multiple vaccinations. In other words, many children and adults have diseases and disorders that are vaccine induced and they never suspect they are from the vaccines, as this study indicates.

    The comparisons of the health of vaccine-free children with the health statistics of the general population are the same as comparing unvaccinated with vaccinated. This is simply because the general population of U.S. children are nearly 100 percent vaccinated.

    Only four of the unvaccinated 8000 responded with severe autism (0.05%) and these were said to be high mercury cases. On the other hand, I had noticed the results show about a 1% rate for autism in the unvaccinated over 3 years old–about the same as vaccinated children. So I asked Bachmair why the data does not show significantly less. He told me he had invited many autism groups and internet autism lists to participate and thus skewed the results accordingly. If the true rate is 0.5%, I calculated that only 40 extra respondents (above the true average number) responded yes to autism, it would skew the results by a factor of 2. If the true rate is 0.25%, only 60 additional respondents (above the true average number) of the 8000 responded yes to autism, it would skew the results by a factor of 4. So it would not take many respondents from these lists to skew the results significantly.

    The only other bias in this study may include the fact that parents of unvaccinated children are obviously concerned about the health risks of vaccines, and are more likely to make other healthier choices such as feeding their children a much better diet and using more natural remedies and using fewer pharmaceuticals.

    Now half the U.S. children suffer from chronic diseases and disorders and 21% are developmentally disabled. Yet the public health system always uses the sacred mantra “vaccine-preventable diseases” when referring to their top public health achievement of mass vaccinations. I think we should be talking more in terms of preventable vaccine-induced diseases.

    Read the full piece online here:


  • Journalist Greg Dobbs on The “Sausage Making” of His WorldNet Autism Vaccine Story

    October 10, 2011

    August 2011

    From Greg Dobbs, The Age of Autism

    Dear Family and Friends,

    Although the piece that just ran on our program World Report was my swan song on HDNet, it was satisfying, because while everyone surely won’t agree with the conclusions I reached, it’s on an important topic that is terribly complex and equally controversial: childhood vaccinations and autism, not only the long-running debate about cause-and-effect, but the federal government’s inconsistency dealing with it.

    For starters, for the sake of those of you who don’t know much of anything about autism, I should define it.  The only trouble is, each definition is presented differently.  The first website that comes up when you Google “autism” is an agency within the National Institutes of Health and it describes autism this way: “A pervasive developmental disorder… that appears in the first 3 years of life, and affects the brain’s normal development of social and communication skills.”  The site goes on to say, “Autism is a physical condition linked to abnormal biology and chemistry in the brain.  The exact causes of these abnormalities remain unknown, but this is a very active area of research.  There are probably a combination of factors that lead to autism.”

    Wikipedia gives this description: “Autism is a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior.  These signs all begin before a child is three years old.  Autism affects information processing in the brain by altering how nerve cells and their synapses connect and organize; how this occurs is not well understood.”

    Then there’s the website of the United States Surgeon General: “Autism, the most common of the pervasive developmental disorders (with a prevalence of 10 to 12 children per 10,000), is characterized by severely compromised ability to engage in, and by a lack of interest in, social interactions. It has roots in both structural brain abnormalities and genetic predispositions, according to family studies and studies of brain anatomy.”

    Or you can just take it the way I described it in the program as I introduced two young women who I’ll tell you more about later in this letter.  What you need to know now is, both of them are autistic, but each was treated in a different way when it came to making a claim for lifetime care: “Both girls are brain-damaged, and both have limited language and socialization, lots of repetitive movement, no eye contact, no tolerance for change.”  One thing I left out, but a common trait according to parents of autistic children, is tantrums.  Severe tantrums, sometimes with no discernable catalyst.

    In short, autism, no matter what words we use to describe it, is the result of some kind of disorder in the brain.  And that is a key word: it is a disorder, not a disease.  What this means is, it’s not something you can detect by testing someone’s blood.  Or mapping their genome; so far, although scientists have been searching for an “autism gene,” (which in fact the Surgeon General declares a high priority), they haven’t found one.  You wouldn’t even find autism in an autopsy.  It doesn’t have a physical component; it is a set of behaviors.  In other words, if someone exhibits the symptoms of autism, they are autistic.  Or, to use the medical lingo, they are on the “spectrum of autism.”

    Read the full piece online here: http://www.ageofautism.com/2011/10/journalist-greg-dobbs-on-the-sausage-making-of-his-worldnet-autism-vaccine-story.html

  • HPV Vaccine Injury Victims Deserve Help, Not Media Abuse

    September 24, 2011

    To: Opinion Editor, Minneapolis Star Tribune
    From: Nancy Hokkanen, Vaccine Safety Council of Minnesota
    Date: Thursday, September 22, 2011
    Re: Commentary (604 words)

    Whatever one’s opinion of Rep. Michele Bachmann, she spotlighted a dirty little secret: the silent epidemic of vaccine injury, and its ongoing dismissal by government, industry, medical trade unions and media.

    Journalists have adopted public health administrators’ utilitarian “more is better” attitude toward vaccines. Commentators tout lives theoretically saved by vaccines, then fail to express concern for people paradoxically disabled or killed by vaccines.

    According to the U.S. Centers for Disease Control, as of June 22, 2011, VAERS [the Food and Drug Administration’s Vaccine Adverse Events Reporting System] received 18,727 reports of adverse events following Gardasil® vaccination. A total of 2,799 adverse events were classified as “Serious,” including encephalopathy (brain damage); 98 deaths have been reported.

    Dr. Scott Ratner, M.D., whose wife is also a physician, told CBS-TV that their daughter Amanda became severely ill after a shot of Gardasil. She changed from “a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis.”

    The CDC and medical groups deny evidence of mental retardation from Gardasil, yet the VAERS database contains 27 reported cases of encephalitis (brain inflammation) and seven cases of Acute Disseminated Encephalomyelitis – demyelinating brain and spinal cord disease – following the HPV vaccine.

    Among the health problems that HPV vaccine recipients have reported to VAERS include seizures, autoimmune disorders such as lupus, thrombosis, stroke, and death. Some developed Guillain-Barré syndrome (GBS), a neurologic disorder causing muscle weakness and paralysis.

    An Indiana girl, Zeda Pingel, suffered an adverse reaction to Gardasil and went from being a cheerleader and a bright student to being strapped to a wheelchair, eyes wandering, unable to walk, talk, or eat.
    Unfortunately the many girls injured by HPV vaccines have little recourse, largely because their vaccine injuries are not investigated by the CDC. In addition, the National Vaccine Injury Compensation Program is slow, contentious, and rejects most claims.

    The 2,799 people who were reported to VAERS to have had serious adverse events following HPV vaccination are equivalent in number to the population of a large high school. Factor in estimated underreporting to this passive surveillance system, then consider the impact of the CDC’s inaction: no studying of vaccine injuries to help treat victims, or to prevent future damaged lives. The costly social consequences of this ethical void are enormous.

    Despite so many consumer concerns, a bill to allow 12-year-olds to get the HPV vaccine without parents’ consent is on the desk of California Governor Jerry Brown. However few media outlets have reported on the myriad negative implications of this usurping of parental health care rights.

    With global vaccine revenues expected to grow from $30 billion in 2010 to $52 billion in 2016 and almost no product protections available for vaccine consumers, aggressive media scrutiny of vaccines and public health administration is urgently needed more than ever.

    Journalism professor Alison Bass, a science writer and Pulitzer Prize nominee, summarized these issues: “I wish the media would use this opportunity to explore the public health ramifications of allowing a drug manufacturer to aggressively target the wrong population for an expensive and possibly unnecessary vaccine.”

    The CDC, AAP and media must stop blaming “coincidence” and start investigating vaccine injuries – to put an end to adverse events, diminish consumer skepticism, and demonstrate a humane care ethic.

    Parents must be able to make informed choices on all medical decisions for their children, including vaccines. The medical community must be honest with the public about vaccine risks. The statements by recent health leaders that there is “absolutely no scientific evidence of harm from the HPV vaccine” are simply false. Consumers deserve far better from the people charged with protecting public health.


  • A License to Kill? Part 1: How A Public-Private Partnership Made the Government Merck’s Gardasil Partner

    September 24, 2011

    By Mark Blaxill

    “Perhaps no other recent product on the market demonstrates successful health care technology transfer better than the human papillomavirus (HPV) vaccine, Gardasil, produced by Merck & Co. and approved by the FDA in June 2006,” proclaimed a recent National Institutes of Health (NIH) newsletter. In a February 23, 2007 article entitled “From Lab to Market: The HPV Vaccine”, the NIH Record celebrated the pivotal role of government researchers in developing Merck’s Gardasil product. “Based largely on technology developed at NIH,” the newsletter reported, “the vaccine works to prevent four types of the sexually transmitted HPV that together cause 70 percent of all cervical cancer and 90 percent of genital warts (HERE).

    The occasion motivating this celebratory article was the “Philip S. Chen, Jr. Distinguished Lecture on Innovation and Technology Transfer” given by Douglas T. Lowy, one of the NIH scientists involved in developing the HPV vaccine. In the ceremony pictured above, Lowy is receiving an honorary poster from the head of NIH at the time, Elias Zerhouni, who took advantage of the occasion to shower praise on his team’s work, one he viewed as a model for future efforts. “It’s a ‘heroic’ story about the effort to fight cervical cancer, the second most deadly cancer for women worldwide, said NIH director Dr. Elias Zerhouni,” in the NIH Record’s account. “He noted that he has talked about the vaccine’s creation to Congress and with the President on his recent visit to NIH. How researchers took the technology ‘from the lab to the marketplace is a journey we can learn from,’ Zerhouni said.”

    While Zerhouni was bragging to anyone in Washington D.C. who would listen about the NIH team’s role in this historic accomplishment, the vaccine’s developers were actively spreading the news of their achievement in scientific circles. It’s hard to blame them, because at the time Lowy and his colleague John T. Schiller, leaders of the team that had invented the technology for the “virus-like particles” (or VLPs) that made Gardasil possible, were in some pretty heady company. In 2008, Harald zur Hausen, the scientist who discovered the role of human papillomavirus (HPV) in cervical cancer during the 1980s, received one half of the Nobel Prize in Medicine; the two researchers at the Pasteur Institute who had discovered the human immunodeficiency virus (HIV) had to share the other half.

    Perhaps campaigning for their own place in the pantheon of medical heroes, Lowy and Schiller described their VLP technology in several review articles on the history and development of the Merck vaccine. These treatments were studiously scientific in tone and at points openly critical of their commercial partner, as the authors commented with disapproval on the high price Merck was charging for Gardasil. But in one May 2006 review in The Journal of Clinical Investigation, the pair also made the following disclosure about their own commercial interests:

    “Conflict of interest: The authors, as employees of the National Cancer Institute, NIH, are inventors of the HPV VLP vaccine technology described in this Review. The technology has been licensed by the NIH to the 2 companies, Merck and GlaxoSmithKline, that are developing the commercial HPV vaccines described herein.”

    Attached to an otherwise heroic narrative of the triumph of technology over cancer, this disclosure struck a discordant note. Conflict of interest? Inventors? Vaccine technology? Licenses? Pharmaceutical companies? Commercial vaccines? This isn’t scientific language, but rather the language of money and commerce. What was this unusual concession doing there in the fine print?

    This is not an idle question, for Lowy and Schiller’s conflict disclosure forms the basis for an alternative to Zerhouni’s narrative, one that spotlights the unusually self-contained set of Department of Health and Human Services (DHHS) activities that surrounded HPV vaccine development. This alternative narrative is more of a business story than a scientific one, a narrative in which commercial interests were inextricably linked to matters of life and death. In this narrative, Gardasil is perhaps the leading example of a new form of unconstrained government self-dealing, in arrangements whereby DHHS can transfer technology to pharmaceutical partners, simultaneously both approve and protect their partners’ technology licenses while also taking a cut of the profits. Literally and figuratively, DHHS has the authority in such situations to allow its business partners to get away with murder for the greater good, effectively granting its private business partners a license to kill.

    DHHS officials have their own language for such arrangements. They call them public-private partnerships, and DHHS agencies have gotten progressively more aggressive about pursuing them. NIH, for example, launched its own “Program on Public-Private Partnerships” in 2005, shortly before Gardasil’s launch. On the web-site describing this program, the NIH program managers concede that the kind of technology transfer involved with Gardasil carries unavoidable ethical risks, acknowledging that “The potential for conflict of interest exists any time the NIH and NIH staff engage with non-Federal entities to achieve mutual goals.” They provide little more than a pro forma solution for such conflicts, however: any concerned NIH staffers are encouraged to “contact their Deputy Ethics Counselor.”

    It’s important to shed light on this alternative narrative as a counterpoint to the heroic story promoted by Gardasil’s many sponsors. An uninformed observer might like to assume that the responsible agencies of DHHS care not at all about commercial opportunities and exclusively attend in a disinterested fashion to the issues of health and safety that would naturally concern any consumer of vaccine products.

    But that assumption would be incorrect. By taking a commercial perspective on Gardasil’s development and regulation, one is forced to confront a new and disturbing question. How is disinterested vaccine safety governance even remotely possible when DHHS employees stand as heroes at the head of the parade when a new vaccine is invented within its walls, while agency leaders are leading the cheering section, approving the new product’s launch, making the market for the product with its recommendations and then turning around to cash multi-million dollar checks? In order to better understand the real lessons of Gardasil under the harsh light of the business interests at work, let’s take a closer look at how the Merck-NIH partnership on Gardasil was forged.

    Conflicts of interest in vaccine development and regulation

    As the world’s largest single sponsor of biological research, NIH frequently funds research with commercially valuable outcomes. When that R&D generates potentially valuable inventions, NIH submits patent applications to the U.S. Patent and Trademark Office (USPTO) and actively pursues the approval of those patents, which when granted become valuable commercial property for DHHS, the patents’ owner. Since NIH has neither the authority nor the capability to pursue product commercialization efforts, in order to encourage private companies to invest in conducting the necessary clinical trials, NIH’s Office of Technology Transfer (OTT) was created to grant commercial licenses for such DHHS patents to commercial partners, including vaccine manufacturers. When new products invented at NIH clear the requisite regulatory hurdles at the Food and Drug Administration (FDA) and reach the market, OTT then shares in the profits. They also distribute the rewards back to the scientific teams whose products have succeeded in reaching the commercial stage: when license fees flow into OTT’s coffers, the Federal employees who invented the technology are entitled by NIH policy to a share of the royalties.

    From a technology development standpoint, such commercial arrangements are the result of an intentional public policy; in fact they resulted from an Act of Congress. The Bayh-Dole Act of 1980 was written with the express purpose of making it easier for federally-funded academic research to receive patent protection that would allow the ready licensing of the fruits of commercially valuable R&D to private businesses. At the time, the concern of Congress was that federally funded inventions too often languished within the academy because businesses had insufficient incentive to invest in clinical trials, since these inventions were often unsupported by the powerful competitive protection afforded by an exclusive patent license.

    The policy worked. Within the research universities that receive the vast majority of federal funding, Bayh-Dole has had the desired effect and has enabled university technology transfer offices all over the world to generate billions of dollars of licensing revenue in the last few decades–especially in the life sciences–by licensing patents from federally-funded university research to corporate partners. Bayh-Dole has effectively turned research into big business for many universities and transformed technology transfer offices into important profit centers at academic institutions all over the world.

    But when technology licensing takes place within federal agencies, Bayh-Dole creates an entirely different problem: an unprecedented web of conflict, one in which the same departments that are tasked with regulating the health and safety of medical products are also profiting from them. As Lowy and Schiller conceded in their review article disclosure, this conflict of interest came into play directly on Gardasil: both men are named inventors on the technology that makes Gardasil possible; NIH filed for and received patents on their invention of the VLP technology; DHHS is the owner of the patent family that protects the commercial rights to the invention; in order to bring the product to market, OTT licensed the vaccine technology to Merck; and as Merck has generated billions in Gardasil revenue, OTT has received millions in Gardasil profits.

    But DHHS is also responsible for regulating Gardasil in numerous ways. The FDA reviewed the clinical trials in which Gardasil was tested in human populations and passed judgment on Gardasil’s safety. An Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) decided whether or not to recommend Gardasil for young women and children. The FDA and CDC together now conduct the surveillance to decide whether or not Gardasil is proving safe in larger populations. And as some families are now beginning to seek compensation based on claims that Gardasil caused injury in some of its recipients, the division of the Health Resources and Services Administration (HRSA) that oversees the Vaccine Injury Compensation Program (VICP) will soon sit in judgment as to whether, to whom, and how much compensation will be provided to Gardasil’s victims.

    As you can see in the chart below, all of this activity is supervised in a single department by one Cabinet official, the Secretary of Health and Human Services. The sole non-governmental agency involved in this commercial enterprise is Merck’s Vaccine Division. In effect, the Merck-DHHS partnership leaves the business side to Merck while DHHS is solely responsible for

    • Creating the market for Gardasil by funding commercial research, supervising the conduct of clinical trials, judging the outcome of those trials and promoting a policy of universal vaccination
    • Collecting the license fees that result from Gardasil revenues from Merck and other vaccine manufacturers and then distributing these financial benefits to Federal employees and
    • Deciding whether or not to protect the policy decisions and profit streams of their sister DHHS agencies through postlicensure safety monitoring and vaccine injury compensation rulings.

    Is this good government at work or an example of the medical-industrial complex run amok? In this investigative series, Age of Autism will take a look at how DHHS agencies have managed Gardasil in all three of these sequences. We’ll start by taking a closer look at the NIH patent portfolio and the associated license fees that have been flowing into NIH coffers since 2006. (Click chart to see original slide.)

    Celebrating the invention of a new market

    Lowy and Schiller are both employed by the National Cancer Institute (NCI). One of the largest of the NIH institutes, NCI was established in 1937 by Franklin Delano Roosevelt. For many decades, NCI has been the agency at the forefront of the so-called “War on Cancer.” Perhaps the earliest inspiration for the both the Cancer War and the Gardasil program began during the 1960s, when NCI researchers first began looking in earnest at viruses as a potential cause for cancer. In 1961, NCI leaders created the Laboratory of Viral Oncology to begin the search for cancer-causing viruses; in 1962 the Human Cancer Virus Task Force was first convened; and by the end of the decade, enthusiasm over this research was part of the scientific momentum that persuaded President Richard Nixon to launch the War on Cancer in 1971. Unfortunately for Nixon’s legacy, and for most subsequent cancer victims, the War on Cancer has famously failed to find a cure for cancer or to validate theories of viral causation in the vast majority of human cancers.

    But starting in the 1980s, the two exceptions to this litany of failure—hepatitis B virus and the human papillomavirus–led to the launch of two blockbuster new vaccine products. The infant hepatitis B vaccine was developed in the 1980s and launched in 1991 with an ACIP recommendation that all American infants be vaccinated on the first day of life. And after 1984, when Harald zur Hausen first pinpointed the role of certain strains of human papillomavirus in cervical cancer, the work on another anti-cancer vaccine could begin. By the early 1990s, laboratories all over the world were racing to develop the first HPV vaccine.

    Lowy and Schiller’s NCI team were among the four most active research teams in this race, all of whom were aggressively filing patents on their HPV inventions. Along with a third NCI colleague, Reinhard Kirnbauer, Lowy and Schiller filed their first application for a patent entitled “Self-assembling recombinant papillomavirus capsid proteins” on September 3, 1992. Since then–and after splitting the original application into 29 “children” in the form of numerous “divisionals”, “continuations” and “continuations-in-part”–nine patents from that family have been granted, as well as four from a branch of the family tree entitled “chimeric papillomavirus-like particles.” The ability of the novel “L1 proteins” described in their patent to “self-assemble” into virus-like structures, which when deployed in a vaccine solution could stimulate a protective immune response against HPV, formed the essence of their invention. Although OTT doesn’t specify the royalty-bearing patents, the commercially valuable technology that Merck has licensed likely comes from this group of nine “self-assembling recombinant papillomavirus capsid proteins” patents: US5437951, US5709996, US5716620, US5744142, US5756284, US5871998, US5985610, US7220419, and US7361356.

    The NCI team was among the leaders in HPV technology, but the race to make a commercially viable HPV vaccine involved several other research teams from all over the world. Most notable among these were the University of Queensland in Australia, Georgetown University and the University of Rochester. In addition to NCI’s filings, each of these university-based research teams filed their own patents; eventually, Merck and GSK got into the act as well. Like many promising areas of technology, the HPV patent landscape became large and crowded in a short period of time.

    Amid this blizzard of activity, the USPTO’s Bureau of Patent Appeals and Interferences (BPAI) had to step in to sort out whether these competing patent applications interfered with each other and to distribute the credit, making a series of hotly contested decisions that were ultimately appealed to the Court of Appeals for the Federal Circuit (CAFC), the nation’s most powerful patent court. By 2007, all the BPAI and CAFC rulings had come in and the respective contributions of all four groups were conclusively allocated for commercial purposes. The team led by Ian Frazer at the University of Queensland received credit for the being the first to propose the idea of using VLP technology for a vaccine, since their application was filed on July 20, 1992, just six weeks earlier than the NCI team’s. But thanks to their unique technology of “self-assembly,” most of the invention claims of the NCI patent family remained intact as well; Lowy and Schiller’s invention has since been generally accepted as a critical advance in the wave of new technology that made Gardasil possible. In terms of the distribution of financial reward, both Rochester and Queensland have reported receiving royalty income for their HPV inventions (in undisclosed amounts) in addition to the revenues reported by OTT.

    As the technology transfer officials at OTT were paving the way for the financial benefits from Gardasil to flow back to NIH, Lowy and Schiller were benefiting in other ways as well, especially when it came to scientific credit. Throughout much of 2006 and 2007, they received awards from many quarters for their role in developing Gardasil’s “virus-like particles.” Their joint awards included the Dorothy P. Landon-AACR Prize for Translational Cancer Research in April 2007 and the 2007 Novartis Prize for Clinical Immunology. In addition, Lowy by himself received the Daniel Nathans Memorial Award in September 2007 and the American Cancer Society’s Medal of Honor for Basic Research in October 2007.

    In addition to these awards, on September 19, 2007, Lowy and Schiller received what was perhaps their crowning honor. That’s when the Partnership for Public Service awarded the pair the “Federal Employees of the Year Service to America Medal.” According to its sponsors, “The Service to America Medals have earned a reputation as one of the most prestigious awards dedicated to celebrating America’s civil servants. Often referred to as the ‘Oscars’ of government service,” they are more commonly known in government circles as the “Sammies.” Upon receiving his crowning honor, Lowy was interviewed for the NIH Record and professed the requisite modesty in its October 2007 edition, saying “We are simply symbols of the many people who have made critical contributions to understanding the relationship between papillomavirus infection and cervical cancer.”

    If Lowy was modest, the top brass at NIH could barely conceal their pride over their employees’ accomplishments. According to the Partnership for Public Service, “Lowy and Schiller’s 20-year partnership has been a boon to the nation’s health and for the advancement of scientific discovery.”

    Collecting the licensing fees

    Alongside the science and policy celebrations, the business side of the Merck-NIH partnership proceeded with a bit less fanfare and with a different kind of currency. Once their patent was approved, OTT could then turn to extracting their share of the benefits from their commercial partners’ new products, which in the case of HPV vaccine included sales first from Merck’s Gardasil product and later from GlaxoSmithKline’s Cervarix. Merck reached the market first in 2006, but GSK followed shortly thereafter in 2007. As each company began collecting revenue from their new vaccines, OTT began collecting royalties. The table below shows Age of Autism’s analysis of how Merck and GSK’s revenues may have flowed into OTT’s coffers.

    Both Merck and GSK itemize revenue for Gardasil and Cervarix in their quarterly and annual earnings statements. Their annual results are summarized in the first two columns of the table. For Merck, Gardasil has been a blockbuster success, yielding a cumulative total of over $4 billion in revenue through year end 2009. By contrast, GSK’s revenues have been growing more slowly and have not yet reached a cumulative total of half a billion dollars.

    For their part, OTT does not itemize their HPV license revenues. However, they do report their total royalty revenue as well as the cumulative revenue from their “top 20” technology licenses since 2007. These top 20 licenses have been worth over $70 million annually in profits for NIH in the last three years, and HPV licenses have soared to the top of those rankings quickly. Last year, OTT reported that HPV licensing was its top revenue generator. OTT doesn’t disclose exactly how much the Gardasil and Cervarix royalties contribute to NIH, but if we make the assumption that their patent licenses entitle them to 1% of the HPV vaccine revenues of their partners (an assumption that appears reasonable based on the available data), then we can safely estimate that OTT has been collecting somewhere in the range of $15 million per year from Lowy and Schiller’s invention.

    In addition to their numerous scientific awards for their discoveries, Lowy and Schiller have received cash distributions from NIH based on their patents. As Federal employees, they are each eligible to receive a share of patent royalties up to $150,000 per year and Gardasil’s success has guaranteed that they would receive the maximum reward. That means that since FDA’s approval in 2006, each man has earned roughly a half million dollars in royalty revenue.

    * * *
    This is the DHHS vision of public private partnership at work. Contrary to the rhetoric, these partnerships aren’t simply a high-minded collaboration of scientific visionaries, but rather a large commercial enterprise with extraordinary profits at stake: an enterprise from which NIH receives credit and money and based on which its corporate partners build multi-billion dollar businesses.

    How does such a partnership affect the incentives of regulators whose job it is to make sure the products are safe? It’s not obvious that they do. Just because DHHS has a financial stake in Gardasil doesn’t necessarily mean that every subsequent decision its employees make is corrupt, part of some nefarious conspiracy to kill young women for money. Indeed, HPV royalty revenues of $15 million represent just a small fraction of a DHHS budget that rose to well over $700 billion in 2009. In the larger scheme of things, DHHS revenues on Gardasil are just a small drop in a very large bucket.

    Far more likely to play a role, however, in public-private paternerships like the Gardasil vaccine are the insidious cultural pressures that emerge in a supremely political organization like DHHS. Can we really expect the Secretary of HHS to take his or her FDA Director to task for implementing lax standards on vaccine approval when the Director of NIH is simultaneously praising the “heroic” researchers who invented the product in the first place? Is it more likely that CDC will apply extra caution in their vaccine policy recommendations when its sister agency is involved or will they be more likely to activate the fast track in their process of making recommendations for Gardasil? What we have observed so far merely suggests the potential for bias in the regulation of products in which DHHS holds a direct stake. In the next part of our series, Age of Autism will investigate the question of whether or not there have been actual patterns of bias in the ways in which regulators at FDA and CDC have conducted their duties with respect to Gardasil.

    SOURCE: http://www.ageofautism.com/2010/05/a-license-to-kill-part-1-how-a-publicprivate-partnership-made-the-government-mercks-gardasil-partner.html


  • A License to Kill? Part 2: Who Guards Gardasil’s Guardians?

    September 24, 2011

    By Mark Blaxill

    In the first part of this report (HERE), Age of Autism identified a pattern of conflict of interest at the Department of Health and Human Services (DHHS) involving Merck’s Gardasil vaccine. Researchers at the National Cancer Institute (NCI) invented critical technology for the “virus-like particles” (or VLPs) that were used in the Gardasil vaccine. As the invention reached the commercial marketplace, these researchers’ bosses at the National Institutes for Health (NIH) celebrated their work as “heroic” and “a journey we can learn from.” Meanwhile, officials in the NIH Office for Technology Transfer (OTT) filed for patents on the VLP technology invented at NCI, licensed those patent rights to vaccine manufacturers and eventually received royalties from Merck, Gardasil’s manufacturer, and GlaxoSmithKline (GSK).

    In the second part of the series, Age of Autism will follow the Merck-DHHS “public-private partnership” as it moved beyond NIH to its sister agencies. In a subsequent process at the Food and Drug Administration (FDA), officials in the Center for Biologics Evaluation and Research (CBER) supervised the clinical trials and granted Merck the first “Biologics License Application” (BLA) for a human papillomavirus (HPV) vaccine. Three weeks later, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommended universal HPV vaccination for women from nine to twenty-six years of age, guaranteeing in one series of votes that Gardasil would reach blockbuster status for Merck: annual revenues of well over $1 billion. Subsequently, agencies within FDA and CDC have been responsible for monitoring Gardasil’s safety in the field, as officials within the Health Resources Services Administration (HRSA) brace themselves to sit in judgment over a new wave of vaccine injury claims. As we pointed out in the first part of this series, this conflict of interest is both extraordinary in scope and poorly understood by the general public.

    At the same time, simply observing the possibility of conflict between the commercial activities of NIH and the regulatory roles of other agencies doesn’t necessarily mean that there will be bias, negligence or lack of diligence on the part of DHHS regulators. Nevertheless, the proclamation of great victory for a vaccine against cervical cancer—one that prompted the NIH Director to single out the invention for praise to both Congress and the President and won its inventors recognition as Federal Employees of the Year—could certainly have created pressure to usher Gardasil through the BLA approval and ACIP recommendation processes with special attention and unusual dispatch. As a result, one might argue that the potential for bias on the part of CBER and ACIP regulators–regulators who would have had a dangerous temptation to relax their required skepticism and hold the favored new product to lower standards of safety—gave them a responsibility for unusual diligence and extra care. But what does the evidence really say about their actual level of diligence? Did CBER and ACIP officials betray their eagerness to enable the celebration of a new “anti-cancer vaccine” or did they hold Gardasil to even more exacting standards of safety? Let’s take a closer look at how FDA and CDC approached their respective responsibilities for Gardasil.

    How stringent was FDA’s safety review for Gardasil?

    When the FDA issued its approval of Merck’s BLA for Gardasil on June 8, 2006, its decision was based on a review of Merck’s data from five separate clinical trials, each of which included efficacy and safety assessments for Gardasil. Four of the five trials approached their efficacy and safety studies in similar fashion, comparing Gardasil against a “placebo” that contained an active ingredient, with one trial comparing Gardasil against what the CBER reviewers described as a “saline placebo.” All together, these five trials examined a total of close 12,000 subjects who received at least one dose of Gardasil and compared their outcomes to roughly 10,000 subjects who received up to three injections of what Merck and CBER officials agreed to describe as a “placebo.”

    But what is a placebo, really? One definition describes a placebo as “an innocuous or inert medication; given as a pacifier or to the control group in experiments on the efficacy of a drug.” The operative term here is the word inert. But in four of the five trials, Gardasil placebos contained a substance called an adjuvant, “a substance which enhances the body’s immune response to an antigen.” According to one of the trial publications, most of the Gardasil trial placebos actually contained an “amorphous aluminium hydroxyphosphate sulfate adjuvant… and was visually indistinguishable from vaccine.” So although the majority of the placebo treatments in the Gardasil trials did not include Gardasil VLPs, they were by no means inert. In control populations representing nearly 95% of all “placebo” recipients, the study subjects received a formulation that actually included an immunologically active (and potentially harmful) aluminum adjuvant.

    One of the five trials, however, was different. In this trial, the only one that examined a younger population of nine-to-fifteen year olds, the placebo recipients did not receive an aluminum adjuvant. By contrast, and according to most of the FDA documentation, the nearly 600 control subjects in this trial received a formulation most commonly described as either a “non-alum placebo” or a “saline placebo.” The safety results of this trial deserve special notice, since it’s the only trial that compared Gardasil to a solution that could reasonably be described as “inert.”

    But even that assumption would overstate the case. Although the “saline placebo” did contain water and sodium chloride (ordinary table salt), the FDA was incorrect to suggest that there were no other active ingredients. According to the published description of this trial’s methods, “The placebo used in this study contained identical components to those in the vaccine, with the exception of HPV L1 VLPs and aluminum adjuvant, in a total carrier volume of 0.5 mL.” Formulations like this, which are made up of everything in the vaccine except its immunologically active components, are sometimes called a “carrier solution.” The correct description of the placebo as a “carrier solution” rather than a “saline placebo” was provided only once in the CBER review, buried in a table on page 301. Nowhere in either the CBER review or the published account of the trial can one find any description of this placebo’s ingredients.

    It is possible, however, to infer the composition of the carrier solution from Merck’s Gardasil package insert, which lists the vaccine’s immunologically inactive ingredients. These include: “yeast protein, sodium chloride [table salt], L-histidine [an amino acid], polysorbate 80 [an emulsifier], sodium borate, and water for injection.” At least one of these chemicals, sodium borate, is a chemically reactive toxin, one that has many industrial uses as an active ingredient. These include applications as: a replacement for mercury in gold mining; an insecticide and fungicide; and a food additive that is now banned in the United States.

    Is there any defense for the FDA to allow this approach to placebo selection in the Gardasil trials? From an efficacy standpoint, one can reasonably argue that yes, using an adjuvant in a placebo makes sense, since it will provide the most rigorous test of the value of the active ingredient under review, in this case the VLPs invented at NCI. And in fact, the returns from all five clinical trials provided convincing evidence that when the VLPs were added to a vaccine formulation containing the aluminum adjuvant, a strong immune response resulted. CBER therefore drew the reasonable conclusion that Gardasil works, at least against the endpoints it was able to measure.

    But is it safe? When it comes to the accurate measurement of adverse effects of Gardasil, there is little justification for reliance on a placebo with ingredients that are not inert. There is some limited value, perhaps, in comparing adverse events that are introduced solely by the addition of VLPs to the vaccine solution. But a truly rigorous safety assessment would investigate the full safety profile of the VLPs in combination with the aluminum adjuvant and compare that profile to the profile of an inert solution. After all, the adjuvant is present precisely because it is not inert.

    If the FDA trial standards were truly to enforce a high standard of safety, they would require the comparison of Gardasil’s safety profile to a true saline placebo. But Merck performed no such analysis and CBER permitted them to apply a lesser safety standard of safety analysis. As a result, CBER issued its BLA approval without any idea whatsoever of the true risks of Gardasil. Not surprisingly, most of the comparisons between adverse outcomes for those receiving doses of Gardasil and those exposed to an aluminum adjuvant “placebo” showed little evidence of injury risk from Gardasil.

    Unfortunately, the conclusion that Gardasil was therefore safe was horribly wrong.

    A different view of the Gardasil trial data

    Based on the data provided in CBER’s review of the Gardasil trials, it is possible to piece together an alternative view of Gardasil’s adverse event profile by examining three separate populations: 1) the subjects who received actual doses of Gardasil (over 96% got all three doses); 2) the subjects who received a “placebo” containing an aluminum adjuvant (over 98% got 225 micrograms of amorphous aluminum hydroxide sulfate) formulated in a carrier solution that made it visually indistinguishable from the full vaccine; and 3) the subjects who received only doses of a carrier solution. For the Gardasil and aluminum adjuvant groups, safety results were collected in two ways: a smaller set of reported outcomes was measured for the entire trial group (the “general safety population”) and a smaller group (the “detailed safety population”), including the entire carrier solution group, followed a more detailed protocol. The respective sizes of these safety assessment groups are shown below. Unfortunately, the small relative size and somewhat unmatched profile of the carrier solution group reduces the statistical power of a comparative analysis across the three groups: the age profile of this carrier solution trial was younger (9-15 years of age) than the other four trials (10-26 years of age, with the bulk falling between 16-23 years old); and less female (54%) than the Gardasil recipients (over 90%) and the aluminum adjuvant recipients (100% female). Nevertheless, the results of this three way comparison are the closest thing we have to a valid, non-passive safety analysis; and they show striking differences in safety profiles, none of which can be attributed to sample bias.

    There are several ways in which the CBER trial review permits a comparative safety analysis across all three groups. The first is by comparing immediate adverse events at the injection site: events such as pain, swelling, “erythema” (redness of the skin), hemorrhage and pruritis (itching). These events are highly specific and show up in the first few days; they can, however, vary quite a bit in terms of severity. The Gardasil trials reported their results for these injection site adverse events in the “detailed study population” within five days after any vaccination visit. The comparison of these outcomes is shown below (using a scale that keeps the ratios between the rates of the adverse events constant).

    As the chart shows, the vast majority of the Gardasil (81%) and aluminum adjuvant (75%) groups reported some kind of adverse event, most of which involved some kind of pain. By contrast, less than half of the carrier solution group (45%) reported an adverse event. This pattern continues in almost all of the individual categories, with the Gardasil group showing the largest rate of local reactions, followed closely by the aluminum adjuvant group and then with a clear drop off in the frequency of adverse events in the carrier solution group. On a retrospective basis, all but one of the reduced risks for the carrier solution group were statistically significant.

    The most striking difference between the three groups is in the area of “serious adverse events.” Although less frequent than minor instances of pain or swelling at the injection site, these serious events were disturbingly common in the groups exposed to active substances. Nearly 5% of the Gardasil recipients had a serious adverse event, well over six times the rate of the carrier solution group. And more than 2% of the aluminum “placebo” recipients had severe reactions, more than three times the rate of adverse events in the carrier solution group. Based on this finding alone, it’s hard to defend the choice to classify Merck’s adjuvant as an “inert” placebo.

    A second approach to comparative safety analysis involves examining the adverse events that caused the participants to withdraw from the trial in a two week period after any vaccine visit. These withdrawals included a range of adverse reactions, only a small fraction of which the investigators designated as “severe.” But sudden deaths (which need not be specific to the vaccine) were also included. The comparison of the discontinuation rates in the three groups is shown below.

    Overall, the rate of discontinuation was low, at less than half a percent. But in the carrier solution group not a single recipient chose to drop out of the trial. In addition, there were three discontinuations after two weeks due to deaths in the Gardasil group and one such death in the aluminum adjuvant groups, whereas there were zero deaths at any point in the carrier solution group. Seven discontinuations (four in the Gardasil group and three in the aluminum adjuvant group) were due to other severe adverse events. These are obviously small numbers, and the deaths were dismissed by the reviewers as unrelated to vaccination. And in fact, the rate of discontinuation in the Gardasil and aluminum adjuvant groups was nearly identical. As a result of this similarity on outcomes, the CBER reviewers dismissed any effect of vaccination on withdrawal decisions, in all likelihood because the vast majority of the officially designated “placebo” group was exposed to the aluminum adjuvant.

    A third approach to a comparative safety analysis takes a longer view of adverse events, using data for serious adverse events over a twelve month period after the beginning of the trial. The FDA review includes voluminous data on these events, but one of the easiest to measure is simply the overall rate of serious adverse events. The trial data show rates for such serious events that were similar between the Gardasil and placebo group. Indeed the rate of serious adverse events in the Gardasil group (1%) was actually lower than the placebo group as a whole (1.1%). Not surprisingly, however, this result was driven entirely by a high rate of serious adverse events in the aluminum adjuvant group. When one examines the rate of serious adverse events in two distinct placebo groups, the rate of serious adverse events in the aluminum adjuvant group rises even higher, to 1.27%, while the rate in the carrier solution group comes out at zero. This comparison is shown below.

    A final approach to safety assessment takes the extensive twelve-month data on the medical conditions in all trial subjects and examines the longer term adverse events in specific categories of interest. Several such categories show disturbing patterns. Autoimmune conditions like arthritis, lupus and thyroiditis were sharply higher in the Gardasil group when compared to the overall “placebo” group and were even noted by the FDA reviewer as a source of concern. These occurred at a rate of over 1 in 1000 in the Gardasil group; there were, however, zero reported cases of autoimmune disorders in the carrier solution group. As in the two week analysis, death rates over twelve months were higher in the Gardasil and aluminum groups. By contrast, the carrier solution group had no deaths in the longer period. The chart below shows the results for the twelve month analysis.

    How much of the low rate of adverse events in the carrier solution group (officially designated the “018 Protocol”) was due not to real differences in outcome but rather to sample bias, the fact that the population for the 018 Protocol was younger and less purely female than the other four trial populations? The short answer is, not very much. There are several ways to test the effect of sample bias. These include: comparing the adverse event rate in the 018 Gardasil group to the Gardasil groups in the other four protocols (higher adverse events show the 018 population was more vulnerable); comparing differences in adverse event rates between boys and girls in the 018 Gardasil group (higher adverse events in boys also show the 018 population was more vulnerable); and comparing differences in rates between the 9-12 year olds and the 13-15 year olds in the 018 Gardasil groups (higher adverse events in younger subjects show the 018 group was more vulnerable). If anything, most of these comparisons suggest the use of the carrier solution group understates the adverse event rate for Gardasil. For example, the younger subjects in both 018 groups had a higher rate of injection site adverse events and the 018 Gardasil group also had a higher rate of severe adverse events than the other groups. Only the findings on deaths and discontinuations (which were most frequent in the Protocol 018 Gardasil boys and 13-15 year olds) might have been influenced by sample bias.

    The FDA downplayed deaths during the clinical trial

    When it came to the most serious adverse event of all, death, the FDA review effectively gave Gardasil a free pass. They failed to mention, of course, that the deaths in their “placebo” group actually received the entirety of the vaccine’s contents excepting the VLPs. Nevertheless, they did report briefly on each individual case of death. In cases of death due to traumatic events like motor vehicle accidents, however, no details were reported (could a seizure or heart attack while driving have caused some traumatic events?). In most of the biologically-related deaths, they found reasons not to make any connection to Gardasil or to blame the victims’ behavior (“they were on birth control pills”) or family history (“the family had a history of arrhythmia”). Here is the FDA reviewer’s summary of the deaths in the trial.

    There were 10 deaths in the Gardasil recipients (0.8%), and 7 deaths in the placebo group (0.7%). The majority of the deaths were due to trauma in both groups. These deaths did not appear related to vaccine administration.

    In each treatment group, there was a death related to a deep vein thrombosis and/or pulmonary embolism, and both subjects were on hormonal contraceptives. The Gardasil recipient with this event had symptoms of leg pain prior to the first vaccination. The other Gardasil recipients who died included one subject with pancreatic cancer 578 days after dose 3, and one young male who died of arrhythmia 27 days after dose 1. This latter subject had a strong family history for arrhythmia. These events did not appear related to administration of the vaccine.

    Even if all of these deaths could be explained away one way or another, this certainly sounds like a lot of deaths for such a young, and overwhelmingly female, group (16 of the 17 deaths were in females; one 15 year-old male Gardasil recipient died of a heart attack). What kind of death rate is normal for young women? The trials provide no such reference rate, but such statistics are readily available. Carnegie Mellon has a web-site called “Death Risk Rankings” (see HERE) that provides an interactive tool for calculating death rates within a wide range of demographic categories. For American females in the age range of the Gardasil trials (9-26 years of age), the rates are as follows: 2.75 per 10,000 in 10-19 year olds and 5.03 per 10,000 in 20-29 year olds. [Note: the majority of trial subjects were from the U.S. and Europe. European deaths rates from young women are 30% lower than American death rates, making this a conservative comparison].

    Out of 11,778 Gardasil recipients, over 90% of them young women between the ages of 9 and 23, one would expect an annual death rate to be a mix of the rates for the two reference groups, or less than 4 per 10,000 in an entire year. But in the trials, there were three “sudden deaths”, i.e. deaths that occurred within just the two weeks of the Gardasil injections, in a review period of less than forty-five days. That’s a death rate close to ten times higher than would be expected such a short period. And the overall Gardasil death rate of 8.5 per 10,000 (10 deaths out of 11,778) for the 12 month period of the trial is more than twice what one would expect. The FDA review evinced little concern over this high death rate, preferring instead to compare the deaths in the Gardasil group to that of the “placebo” group. But as one can see from the chart below, the death rate in the aluminum adjuvant group was higher than the reference groups as well.

    In short, the CBER review of Gardasil condoned the use of an immunologically active placebo and not an inert solution. So instead of a adopting an increased measure of diligence in light of the potential for bias due to the DHHS conflict of interest in Gardasil, it appears that FDA permitted Merck to use a lower standard of safety. Only by using the single set of trial data in which the placebo solution was relatively (although not entirely) inert, can one assess the impact of this relaxed standard. Based on an analysis of this data, one is drawn to an inescapable conclusion.

    Gardasil was not safe.

    ACIP’s recommendation for universal vaccination of young females

    If the FDA was less than diligent in its review of safety profile of the anti-cancer vaccine invented at its sister agency at NIH, how did its counterparts at CDC compare in terms of their own decision processes? Faced with a choice either to take a deliberate course, allowing a period of observation to follow Gardasil’s BLA approval, or to rush Gardasil into widespread use, CDC’s approach provides another standard of comparison for DHHS’s conduct. Would their key decision-making group, the Advisory Committee on Immunization Practices (ACIP) choose the deliberate or the hasty path?

    There is very little ambiguity in this answer. ACIP wasted absolutely no time in recommending Gardasil for universal use among young women. Indeed, it would have been hard for them to move any faster. In June 2006, almost immediately after FDA approval, ACIP recommended the HPV vaccination. An account in the March 23, 2007 edition of the CDC publication, Morbidity and Mortality Weekly Report (MMWR) showed that ACIP was preparing for near instantaneous approval even before the FDA’s final reviews were completed.

    The Advisory Committee on Immunization Practices (ACIP) HPV vaccine workgroup first met in February 2004 to begin reviewing data related to the quadrivalent HPV vaccine. The workgroup held monthly teleconferences and meetings three times a year to review published and unpublished data from the HPV vaccine clinical trials, including data on safety, immunogenicity, and efficacy. Data on epidemiology and natural history of HPV, vaccine acceptability, and sexual behavior in the United States also were reviewed. Several economic and cost effectiveness analyses were considered. Presentations on these topics were made to ACIP during meetings in June 2005, October 2005, and February 2006. Recommendation options were developed and discussed by the ACIP HPV vaccine workgroup. When evidence was lacking, the recommendations incorporated expert opinion of the workgroup members. Options being considered by the workgroup were presented to ACIP in February 2006. The final recommendations were presented to ACIP at the June 2006 ACIP meeting. After discussions, minor modifications were made and the recommendations were approved at the June 2006 meeting.

    The date of the BLA approval for Gardasil was June 6, 2006. In the June 29 ACIP meeting, just 23 days after the FDA’s decision, ACIP gave Gardasil its formal support. The vote was unanimous, with two of the fifteen members abstaining due to their financial involvements with Merck.

    But not only was the vote unanimous, the mood in the meeting was celebratory. Numerous vaccine safety advocates attended the June meeting due to their concerns over the influenza vaccines. One attendee recounted the reaction to the Gardasil decision. “After the vote the place erupted in applause. There was hand-shaking and back-slapping. It seemed kind of odd and inappropriate to us.” Asked why it seemed inappropriate, the observer explained that the concern arose, “because they were so clearly cheering the recommendation. It was clear and absolutely a celebratory reaction.”

    The safety discussion was almost exclusively informed, of course, by the FDA’s flawed trial data. Not surprisingly, few concerns were raised. Here’s what the ACIP minutes had to say about Gardasil’s safety profile.

    The clinical trial program places strong emphasis on evaluating the safety profile of GARDASIL®. Of ~21,464 subjects, ~11,000 received detailed safety follow-up and the remainder received serious adverse experiences in medical history and pregnancy follow-up. The incidence of overall adverse events (AEs), injection-site AEs, and low-grade fevers >100°F was slightly higher in the GARDASIL® group compared to the placebo group. Systemic AEs were comparable between the two groups. Serious AEs and discontinuation due to adverse experiences were extremely rare. [emphasis added]

    As a result of this accelerated process, ACIP made a series of recommendations. The first placed Gardasil on the recommended list of childhood vaccines. “ACIP recommends routine vaccination of females 11-12 years of age, with three doses of the quadrivalent HPV vaccine. The vaccine series can be started as young as nine years of age at the discretion of the provider.” In the context of the clinical trials, this was an extremely aggressive recommendation. A scant 85 pre-pubescent girls, nine years of age or younger had received Gardasil in any trial (matched with only 48 controls) and only three percent of the Gardasil trail recipients were in the range of ACIP’s target population of 11-12 year olds. Not only was ACIP basing its recommendation on flawed safety analysis, it was extending its recommendations to include groups who lay outside of even this biased assessment.

    But ACIP didn’t stop there. They also recommended a catch-up vaccine for all young women, even those who would have been sexually active for many years, who had contracted at least one strain of the virus, cleared it, and therefore received diminished benefit from vaccination. “ACIP recommends vaccination for females 13-26 years of age who have not been previously vaccinated. Ideally, vaccine should be administered before onset of sexual activity, but females who are sexually active should still be vaccinated.” From a commercial perspective, this recommendation multiplied Gardasil’s profit potential for Merck and its NIH partners, creating a near term target market that was seven times larger than just the routine market of 11-12 year- olds.

    There was little effective restriction placed on Gardasil’s market potential. And only the yeast protein in the carrier solution was cited as a safety concern. “Vaccination should be deferred until after moderate or severe acute illnesses improve,” read the ACIP recommendation. “A history of hypersensitivity or severe allergic reaction to yeast or any other vaccine component should be classified as a contraindication. Initiation of the vaccine series should be delayed until after completion of the pregnancy.”

    The momentum for an aggressive roll-out was strong. Representatives from nine different organizations gave formal statements in support of Gardasil during the public comment period. In the meantime, and with a strong push from Merck, some state officials stood in line to move even faster than ACIP. In February of 2007, Republican Texas Gov. Rick Perry bypassed the legislature and mandated Gardasil for all 11- and 12-year-old girls in the state.

    The commercial results were powerful and immediate. Merck reported its first revenues from Gardasil in the second quarter of 2006 (presumably from sales after the June BLA approval), and its revenues began to climb rapidly: $70 million in the third quarter, $155 million in the fourth quarter, all leading to a blockbuster year of 2007 in which Gardasil recorded revenues of $1.5 billion. The financial bonanza had begun in earnest.

    A few years later, Merck would attract criticism for its aggressive marketing of Gardasil during this period. Sheila and David Rothman wrote a sharp critique in the Journal of the American Medical Association (hardly a radical hotbed of vaccine consumerism) in which they neglected the conflicts described here but noted the extreme measures that Merck adopted.

    The marketing of this vaccine broke with traditional practices. Heretofore, vaccines had been identified by the disease they were preventing (measles, mumps) or by their creators (Salk or Sabin). This HPV vaccine followed a different model. It was identified by a trade name, Gardasil, and promoted primarily to “guard” not against HPV viruses or sexually transmitted diseases but against cervical cancer. The marketing campaign that followed, according to Merck’s chief executive officer, proceeded “flawlessly.” In 2006, Gardasil was named the pharmaceutical “brand of the year” for building “a market out of thin air.”

    But the Rothmans’ critique would do little to delay or disrupt the launch. At the time of the DHHS rush to market there were few dissenting voices and none of them were heard at ACIP.

    One lone voice stood out. In March 2007, just as the vaccine was reaching its peak revenue numbers, one of the doctors who had guided the clinical trials voiced an objection. On March 14, 2007, an article in a small newspaper in Fort Wayne, Indiana reported on an interview with one of the scientists involved in the clinical trials. The scientist was named Diane Harper and she expressed dismay at the ACIP recommendation.

    “Giving it to 11-year-olds is a great big public health experiment,” said Diane M. Harper, who is a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire.

    “It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue.”

    Harper didn’t have much to gain from the commercial success of Gardasil, but she also was taking considerable risks by breaking ranks with her colleagues. One can only imagine how things would have been different if she had been in charge of the review process at FDA rather than running one branch of the clinical trial. In the midst of such a widespread degradation in regulatory ethics and standards, it’s interesting to consider why she made that choice.

    The Fort Wayne reporter, Cindy Bevington, was frank as to why Harper was telling her story to them rather than a larger media outlet. “For months, Harper said, she’s been trying to convince major television and print media to listen to her and tell the facts about the usefulness and effectiveness of this vaccine.” Why was an inside critique of the Gardasil promotion campaign not already big news? “No one will print it,” Harper said.

    Over the coming months, the assessment of adverse effects of Gardasil would be transferred to a different group within DHHS, from CBER and ACIP to the “postlicensure safety surveillance” groups within FDA and CDC. At this point, the deaths and serious adverse events would leave the realm of closely held statistics within a vaccine manufacturer’s actively monitored trial sample and into the realm of passive surveillance in the general population; soon watchdog and vaccine safety groups like National Vaccine Information Center and Judicial Watch issued critical analyses, see HERE and HERE. And Harper’s concerns over the inadequate safety data would prove prophetic. Why had Harper broken ranks so early? When Bevington asked Harper why she was speaking out despite the momentum to the contrary, her answer was refreshingly simple.

    “I want to be able to sleep with myself when I go to bed at night.”

    SOURCE: http://www.ageofautism.com/2010/05/a-license-to-kill-part-2-who-guards-gardasils-guardians.html



  • A License to Kill? Part 3: After Gardasil’s Launch, More Victims, More Bad Safety Analysis and a Revolving Door Culture

    September 24, 2011

    By Mark Blaxill

    In parts 1 (HERE) and 2 (HERE) of this series, Age of Autism identified a disturbing pattern of conflicts within the Department of Health and Human Services (DHHS) regarding Merck’s Gardasil vaccine. In an unprecedented “public-private partnership,” researchers at the National Institutes of Health (NIH) patented the technology for the “virus-like particles” (VLPs) that provoke Gardasil’s immune response to the human papillomavirus (HPV) and licensed their VLP technology to Merck. The terms of the patent license effectively made DHHS Merck’s financial partner on Gardasil, giving DHHS a clear conflict of interest on decisions regarding Gardasil.

    This partnership gave Gardasil favorable treatment at key decision points, treatment that was financially rewarding to both parties. While the NIH Director celebrated his researchers’ “heroic” achievement and the researchers received numerous awards, including “Federal Employees of the Year,” officials at NIH’s sister agency, the Center for Biologic Research and Evaluation (CBER) of the Food and Drug Administration (FDA), stood watch over the Gardasil clinical trials. CBER’s review failed to hold Gardasil to a high standard of safety. Instead of comparing Gardasil to an inert placebo, as they should have, CBER based its entire safety assessment on a comparison of Gardasil’s adverse event profile with the adverse events associated with a “placebo” that was actually an immunologically active aluminum-based adjuvant. Despite the fact that an alternative comparison, pitting Gardasil against a relatively inert “carrier solution,” should have warned them of clear evidence of harm to Gardasil recipients, CBER approved Merck’s Gardasil Biologics License Application (BLA) anyway. In the meantime, following CBER’s approval of Merck’s BLA a key committee at the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP), put Gardasil on a fast track and immediately recommended three doses of the Gardasil vaccine to all American women between nine and twenty-six years of age. In a matter of days, Merck was guaranteed a blockbuster launch for Gardasil and within months Gardasil had reached annual revenue levels of well over $1 billion. Soon, Gardasil would become the #1 royalty generator for NIH’s technology licensing group, completing the partnership circle.

    As a result of this favorable treatment at the hands of it regulatory partners at DHHS, by late 2006, Merck’s Gardasil was reaching a mass market of young American women. FDA had downplayed the fatalities associated with Gardasil in the clinical trials, but in a population of less than 12,000 young people, three sudden deaths following Gardasil and ten deaths within a year were a clear cause for concern. And as Gardasil’s reach was extending to a population numbering in the millions, the body count would soon rise. At this point in the process, the locus of DHHS conflict of interest would shift from agencies responsible for prelicensing activities such as clinical trial review and public health policy assessments to the agencies responsible for what insiders call “postlicensure surveillance” activities. The events the follow Gardasil’s launch is where part 3 of this series begins.

    The body count rises

    On July 20, 2008, the New York Post reported the vivid account of a mother who claimed her daughter was killed by Gardasil. In a story titled “My Girl Died As ‘Guinea Pig’ For Gardasil,” Lisa Ericzon’s description of her daughter’s tragic death was both detailed and disturbing. As told by the Post’s reporter, the story began like this:

    “She loved SpaghettiO’s, pepperoni, lilies, listening to her iPod and making her pals laugh. In her senior yearbook, she wrote, “The best things in life aren’t things, they’re friends.” Now that’s the quote chiseled into her gravestone.

    Jessica Ericzon, 17, was “an all-American teenager,” as described by one of her upstate LaFargeville teachers. Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother. Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom. It started with a pain in the back of her head.

    On the advice of her family doctor, Jessie had taken a series of three Gardasil shots.

    Sadly, Jessica Ericzon’s death was not an isolated incident. Since Gardasil’s launch in late 2006, a rising number of parents have stepped forward to report the deaths of their daughters at the hands of the vaccine. Gardasil has now become a global product, so these reports have come from around the world; but the United States is by far Merck’s largest market, so most of the reported fatalities have come from closer to home. Jessica Ericzon came from upstate New York, about a mile south of the Canadian border, and her parents were among the first to go public about Gardasil. But they haven’t been the last. There are at least ten public reports of young women allegedly killed by Gardasil in the months since FDA approved Merck’s BLA on June 8, 2006. Many more have been reported privately to the CDC.

    In contrast to Jessica’s sudden death, and just a few weeks before the New York Post headline and article, another family went public with their daughter’s plight, in a blog named “Jenny’s Journey.” In their introductory blog post, Jennifer Tetlock’s parents relayed an urgent request. Their daughter wasn’t dead, but she was dying from what Jenny’s doctors had theorized was a rare degenerative neurological condition, an unusual form of early onset amyotrophic lateral sclerosis (or ALS, popularly known as Lou Gehrig’s disease). The bloggers, Barbara Mellers, Philip Tetlock, and Barbara Shapiro, were in no sense activists, and weren’t eager to join what they later termed the “anti-Gardasil movement.” What they wanted most of all was to find a way to save their daughter’s life. “One of the major things that would help her doctors figure out what to do”, they wrote on June 6, 2008, “is to find other people like Jenny (called “comparables”)–people that share her medical condition and perhaps have had luck with certain treatments.”

    The list of Gardasil victims who have gone public–parents of young women like Jessica Ericzon and Jennifer Tetlock–provides only a fragmentary view of the death toll associated with Gardasil. Many more deaths have been reported to the Vaccine Adverse Events Reporting System (VAERS) in cases where the family has chosen not to go public with their tragic loss. Among the short list of publicized cases, most simply dropped dead like Jessica Ericzon within days of receiving a dose of the vaccine; these cases most closely resembled the three cases of sudden death from Gardasil reported during the clinical trials. Cases of clear “comparables” to Jenny Tetlock, young women who could satisfy Jenny’s parents’ quest, were less common. Nevertheless, there were a number of these publicly reported cases in which a Gardasil shot seemed to trigger a downward spiral of ill health– encompassing a diverse range of symptoms–that would culminate in death (many of which came on suddenly as well).

    The table below summarizes the connection between Gardasil and ten deaths that have been publicly associated with the vaccine. All of these stories have been reported elsewhere, most of them assembled in a memorial web-site called “The Truth About Gardasil.” You can find go to this web-site to read more about the stories of many of these young women (see HERE).

    These public reports provide varying degrees of detail regarding cause of death. In one case (one where substantial detail has been reported), a young woman named Brooke Petkevicius who died suddenly after her first dose of Gardasil showed symptoms remarkably similar to a case report detailed in CBER’s clinical trial review. The February 6, 2008 edition of East Bay Express (see HERE), a San Francisco Bay Area newspaper, provided the following account.

    In early 2007, as the pharmaceutical giant Merck began promoting its new vaccine Gardasil as protection against cervical cancer, Brooke Petkevicius was a nineteen-year-old freshman at UC Berkeley. She had seen the ads for the vaccine, and discussed getting it with her mother, whose gynecologist also had recommended it. On March 12, Brooke received the first of three doses. Two weeks later, she dressed to go running with a friend. As they reached the elevator, Brooke suddenly collapsed against the wall and had a seizure.

    “She started shaking a lot,” recalled the friend, Kristin Bietsch. “And her eyes went glazy a little bit.” An ambulance rushed Petkevicius to the hospital, but doctors couldn’t save her. Her autopsy indicated that she was killed by a pulmonary embolism, or blood clot, which had blocked the artery between her heart and lungs. “She had a whole bunch of little floating clots in her system,” said her mother, Debra Sonner, recalling what doctors told her at the time.

    Was Brooke’s death just a random coincidence or were there clues from the early safety reviews that anticipated her tragic death? One needn’t look far for comparable stories: the following account comes from one of the three sudden deaths after Gardasil reported in the clinical trials.

    This 22 year old non-smoking white female subject had symptoms of leg pain prior to the vaccination (11/15/02), and was seeing a masseur for this complaint. She was also on hormonal contraceptives. The subject was vaccinated with her first dose of Gardasil on ——-. On ——–, Day 19 Postdose 1, the subject experienced suspected deep vein thrombophlebitis (DVT) of the left leg and consulted her own general practitioner. On ——–, Day 20 Postdose 1, the subject experienced severe chest pain and was taken to the emergency room (ER). The subject subsequently experienced a suspected acute massive pulmonary embolism of severe intensity and was admitted to the intensive care unit (ICU). Echocardiography was performed and showed normal aorta and no thrombosis in the vena cava. Abdominal ultrasound was performed with no abnormal findings. On the same day, the subject died of acute massive pulmonary embolism and deep vein thrombosis of the left leg. The autopsy report confirmed the diagnosis of acute massive pulmonary embolism and deep thrombophlebitis of the left leg and also revealed an incidental finding of acute ischemic renal failure.

    As this account suggests, the CBER review eventually explained away this death as a coincidence, an unfortunate side effect of taking birth control pills in a situation where the victim suffered from a pre-existing condition. So as soon as reports of similar deaths began entering the VAERS system, the CDC found ways to dismiss comparable cases such as Brooke Petkevicius by pointing a finger at birth-control pills as well. In a June 2007 report on the early deaths from Gardasil that were reported to the Vaccine Adverse Event Reporting System (VAERS), CDC dismissed Brooke’s death as yet another coincidence. “Preliminary data indicate that the two women [including Brooke], who died of blood clots were taking birth-control pills, and blood clots are a known risk associated with birth-control pills. All four deaths are being fully investigated but none appear to be caused by vaccination,” claimed CDC. With regard to Gardasil, CDC wrote in its defense, “Since more than 5 million doses have been distributed, some deaths will occur coincidentally following vaccination (but not due to vaccination).”

    Blaming the victim and citing coincidental death following vaccination are two well-known tactics that long ago became part of the DHHS playbook and CDC is not alone in deploying this tactic. In addition to the pulmonary embolism described above, the CBER review dismissed the two other cases of sudden death following Gardasil. One such case was a 15-year old boy who died of a heart attack less than a month after his first dose of Gardasil; yet CBER reported “the autopsy was inconclusive, but there was a strong family history of arrhythmia.” The other case was a 21 year-old woman who died with a convulsion four days after her third Gardasil dose; the CBER review again blamed this victim for her death, reporting that “this subject had a history of seizure disorder and anxiety. She suffered a seizure 4 days after dose 3, and was noted to have cocaine in her urine.”

    Natural skepticism aside, making sense of individual cases like the ten public death reports and the three sudden deaths in the Gardasil trials is tricky business. Without intensive medical investigations one may never find definitive proof of harm from Gardasil. And, of course, the vast majority of Gardasil recipients have survived their vaccination series with no discernible lasting effects. There can be little dispute, however, that Merck has an enormous incentive to downplay obstacles to a profitable new product like Gardasil. And unfortunately, as we’ve seen in the clinical trial cases, FDA appears to have shared Merck’s bias, acting more like an equity participant in a DHHS “public-private partnership” than a conscientious guardian of the public trust; Its CBER reviewers effectively turned a blind eye to troubling signals as they granted Merck its BLA for Gardasil. Inevitably, however, a persuasive critique of vaccine safety monitoring for a blockbuster vaccine like Gardasil needs to move away from the realm of anecdote and into the realm of statistics. As we move beyond the review of individual cases, we’ll take a closer look at whether or not DHHS officials displayed notable biases in their analyses of Gardasil’s adverse effects in larger populations and how those analyses have been criticized by others.

    Lack of diligence in postlicensure safety surveillance

    Responsibility for what public health officials call “postlicensure safety surveillance” falls to a small set of DHHS departments. Two of these are the FDA’s Vaccine Safety Branch (VSB) and the CDC’s Immunization Safety Office (ISO). After CBER approves a vaccine and ACIP recommends it, the baton within DHHS passes next to VSB and ISO. In the passing of this baton, as stipulated previously, the presence of a conflict of interest does not mean that regulatory activity will necessarily reflect bias, negligence or lack of diligence on the part of the next group of regulators: Each department’s work deserves to be judged on its own merits. But in light of what appears to be a clear pattern of bias in the prelicensure activities of DHHS, it’s reasonable to approach an assessment of postlicensure activities with some skepticism. What, then, does the public record of postlicensure surveillance activity say about the presence of absence of bias and how VSB and ISO have done their jobs in assessing Gardasil’s safety?

    The main public output of the FDA and CDC groups’ work has so far come in a single report published in the August 19, 2009 issue of the Journal of the American Medical Association (JAMA). In that paper, ISO’s Barbara Slade and four of her colleagues from CDC joined together with seven FDA colleagues to publish the first-ever analysis of the VAERS data on Gardasil. Not surprisingly, the JAMA paper gave Gardasil a free pass; in the process the authors joined the chorus of DHHS celebration for the breakthrough of its home-grown anti-cancer vaccine. “Vaccination with [Gardasil] has the potential to decrease the global morbidity and mortality of HPV-associated diseases, including cervical cancer. After hepatitis B vaccine, which can prevent liver cancer, [Gardasil] is only the second vaccine licensed with an indication to prevent cancer.” And although they acknowledged the possibility of injury due to blood clots like those that killed Brooke Petkevicius, Slade et al argued that the data from VAERS led to the same conclusion as the positive review from their colleagues at CBER. “The postlicensure safety profile presented here is broadly consistent with safety data from prelicensure trials.”

    As for the specific question of Gardasil deaths, Slade et al acknowledged that there had been deaths associated with Gardasil. But they dismissed the VAERS death reports as not frequent enough to worry about.

    Causes of death included 4 unexplained deaths, 2 cases of diabetic ketoacidosis (1 complicated by pulmonary embolism), 1 case related to prescription drug abuse, 1 case of juvenile amyotropic lateral sclerosis, 1 case of meningoencephalitis (Neisseria meningitidis serogroup B), 1 case of influenza B viral sepsis, 3 cases of pulmonary embolism (1 associated with hyperviscosity due to diabetic ketoacidosis), 6 cardiac-related deaths (4 arrhythmias and 2 cases of myocarditis), and 2 cases due to idiopathic seizure disorder. The PRR [statistics speak for “proportional reporting ratio”, or the VAERS death rate relative to the “background” expected death rate] for deaths in 6- to 17-yearolds was 1.4 (?2=0.42, P=.52). The PRR for deaths in 8- to 29-year-olds was 1.2 (?2=0.01, P=.92). Neither of these met the screening criteria for signal detection. [emphasis added]

    Criticism of the JAMA analysis came quickly (some preceded the paper’s publication) and from several different quarters. One of the most trenchant attacked the relevance of the VAERS case data itself and came from the parents of a Gardasil victim. Like so many parents of vaccine injured children, Jennifer Tetlock’s parents had become deeply dissatisfied by the diligence of federal officials in evaluating Gardasil’s safety. Jennifer’s adverse reaction, as originally diagnosed, was among the least common adverse events; Slade et al reported it as an isolated case. But in April 2009, Jenny’s parents publicly voiced their suspicion that their doctor’s original diagnosis of juvenile amyotrophic lateral sclerosis may have been misleadingly narrow. They argued that “world-class immunologists suspect that Jenny had a potentially treatable autoimmune disorder mimicking ALS, possibly triggered by the Gardasil vaccination.” If true, this interpretation of her reaction placed Jenny’s death in a broader category of a severe autoimmune reactions from Gardasil. As reported previously in part 2, this kind of autoimmune reaction was a risk that the clinical trials showed to be quite common.

    More broadly, Jenny’s parents struck out at CDC’s failure of postlicensure diligence.

    The CDC does not inspire confidence, so we conducted our own shoestring search to determine whether Jenny was alone. We created a website (jenjensfamilyblogspot.com). Although this website has only drawn 40,000 visitors, it has out-performed the federal government in finding girls ominously similar to Jenny (current score is: Jenny site 2; CDC’s VAERS: 0).

    One does not need to be a statistician to see how unlikely it is that these two other girls are the only cases out there—or how frightening it is that we already know of three documented cases of girls (those two plus Jenny) who developed ALS within several months after their vaccinations. After all, if the odds of ALS in teenaged girls are 1 in 3 million and we found 3 in only 40,000, it is very possible that many other of the 6 million girls vaccinated have already developed severe neurological collapse, like Jenny.

    Jenny’s parents may have been uncertain about the proper diagnosis of Jenny’s reaction, but they were not alone in their criticism of the statistics underlying the FDA/CDC analysis. In a December 2009 letter to JAMA, Drs. Vicky Debold (Full disclosure: Debold is a director of the Age of Autism sponsor SafeMinds) and Eric Hurwitz criticized the Slade analysis. Debold and Hurwitz identified numerous flaws in the CDC/FDA report, arguing that: a) cases of autoimmune diseases such as Guillain-Barré syndrome were systematically underreported; b) the method for obtaining background rates of disease could include vaccine injury and were thus inappropriate to use in comparisons; and c) the denominator for the case population used to generate the PRRs was grossly overstated. On the last point, Debold and Hurwitz noted that Slade et al had mistakenly used “total vaccine doses distributed” as the denominator for disease rates instead of doses administered (or for that matter the number of women receiving doses), a choice that “systematically inflates the ratio’s denominator.”

    Debold and Hurwitz noted the larger policy problem created by these failures in postlicensure surveillance and by Slade et al’s low standard of diligence. “Federal officials have cited this study as evidence that [Gardasil] ‘is a safe and effective vaccine,’” they noted. “However, we consider that conclusion to be unwarranted because the study draws inferences from data likely to be systematically biased.”

    Diane Harper, one of the researchers involved in the Gardasil trials, agreed with Debold and Hurwitz. In an August 2009 interview with CBS News reporter Sharyl Attkisson, she also criticized Slade et al, arguing to Attkisson that “the risks of vaccination are underreported in Slade’s article, as they are based on a denominator of doses distributed from Merck’s warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade’s work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold” [emphasis added].

    Harper also agreed with Jenny Tetlock’s parents’ suggestion that Slade et al were understating the number of deaths in their risk assessment, the numerator. Harper told Attkisson, “Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in Dr. Slade’s work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil.”

    So how should one weigh the net impact of all these claims and criticisms? Certainly, although there are serious health risks, including death, associated with Gardasil, there are also potential benefits, including reduced rates of cervical cancer. Slade’s analysis doesn’t provide the number of individuals receiving vaccine in the first two years after the Merck vaccine’s introduction, but based on the statistics she provides, it’s reasonable to assume that something less than 10 million young women received doses of Gardasil (23 million doses distributed with a target of 3 doses per subject). A balanced review of the overall benefits of Gardasil would compare the frequency and consequences of vaccine injury in this population, based on the most objective rate of adverse events, with the vaccine’s purported benefits.

    If we compare the death rate (these rates were calculated in part 2 of this series) in the Gardasil trial group of 8.5 per 10,000 to an expected death rate in young women of 3.9 per 10,000, we get an extra death risk from Gardasil of roughly 4-5 per 10,000 annually. Applied to a population of 4 million young women per year, that would come to a total of close to 2,000 extra deaths per year that were caused by Gardasil during the period of its launch. This is an extraordinarily high rate and may possibly be explained away by bad luck and coincidences, as the CBER review contended. But it is the only active surveillance analysis ever done on a population exposed to Gardasil. By contrast, the calculated death rate from VAERS reports gives a much lower number, over 100 times lower, a ratio that many consumer advocates (and certainly Jennifer Tetlock’s parents) believe reflects more on the poor quality of the VAERS database than the actual risk of death from Gardasil.

    But if Gardasil is successful in preventing deaths from cervical cancer, is it possible that society is still coming out ahead overall? The America Cancer Society estimates that there were 4,000 deaths in 2009 from cervical cancer. If Gardasil could prevent a significant number of these deaths in the future, then it’s possible that the benefits of the vaccine might exceed the risks. Unfortunately for the vaccine program, the deaths caused by Gardasil are immediate and the preventable deaths from cervical cancer are many years away.

    Unfortunately for the public, in assessing the reliability of any estimates of Gardasil’s future benefits there are many unknowns: we don’t know how long the immunity against HPV will last; we don’t know whether costly booster shots and a new round of adverse events will be necessary; and, most important of all, we don’t yet have any idea whether or not Gardasil will succeed in preventing a meaningful number of cervical cancer deaths. We know it provides effective immunity against two of the most common cancer-causing strains of HPV. But it’s entirely possible that, just as soon Gardasil suppresses these strains of HPV, new cancerous strains will arise to take their place leaving overall cervical cancer rates unchanged. The dirty little secret of the war on cervical cancer is that public health officials have no current way to judge how and whether widespread vaccination with Gardasil will affect the actual rate of cervical cancer and they won’t be able to make that judgment for many years.

    A similar situation holds in the case of a similarly multi-strain infection and its associated vaccine formulation: in this case the many different strains of streptococcus pneumoniae, the bacterial species responsible for invasive pneumoccoal disease (or IPD) and the so-called pneumococcal vaccine. In order to combat IPD, a leading cause of bacterial meningitis, a multi-strain vaccine called Prevnar was introduced by Wyeth in 2000. Prevnar quickly became one of the most commercially successful vaccines of all time, bringing in nearly $3 billion in revenue in 2008. But in asking whether Gardasil will actually work against cervical cancer, it’s useful to ask whether a similar vaccine product like Prevnar has been successful in actually preventing IPD?

    A recent study from Massachusetts on its effectiveness suggests that Prevnar, contrary to all expectations, did not reduce the incidence of IPD in the state. Instead, although the forms of IPD caused by strains in the vaccine went down after Prevnar’s introduction, IPD cases caused by other strains (some of which were even more dangerous than the original strains) rose almost immediately and in opposite proportions, to keep the rate of IPD in Massachusetts constant. In plain language, Prevnar, the most commercially valuable vaccine in history, created no health benefits whatsoever. It just didn’t work.

    Will this be the case with Gardasil? We will only know with any certainty what Gardasil’s benefits will be after many years, even decades of use. Right now, it’s too early to tell how many of the 4,000 annual deaths from cervical cancer might be prevented. But several things are clear in the near term: Gardasil has already injured an unknown number of young women, with these injuries likely including deaths that may number in the hundreds, possibly (based on the only data available) as many as 2,000 per year; Gardasil also has left many more young women with crippling chronic conditions like Guillain-Barré syndrome, arthritis and autoimmune thyroid conditions.

    Diane Harper has also argued that assessments of the net benefits of Gardasil have overstated its value. She told Sharyl Attkisson in her interview that, “the risks of serious adverse events including death reported after Gardasil use in the JAMA article by CDC’s Dr. Barbara Slade were 3.4/100,000 doses distributed.” This rate is substantially lower than our estimates here. Nevertheless, Harper remained concerned that Gardasil’s risks outweighed its benefits. “The rate of serious adverse events is on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year.”

    In light of the many years required to prevent cases of cervical cancer, it’s clear that the current cost of Gardasil outweighs its current benefit. Moreover, it may take many years to realize any net benefit to society from Gardasil; the crossover point where realized benefits exceed the costs incurred is far away and uncertain. At the moment, therefore, there is only one net benefit that is certain: the benefit to Merck’s bottom line. And, of course, the bottom line of Merck’s business partner at NIH.

    Revolving door culture

    DHHS has a clear conflict of interest with respect to Gardasil at the institutional level since it shares directly in Gardasil’s profits. We’ve also seen now that this conflict of interest is echoed by (and possibly sustains) a pervasive pattern of regulatory bias in favor of Gardasil during multiple stages of the decision process. But as the Gardasil body count rises, one natural question one might ask is why, at a personal level, more DHHS officials haven’t taken the principled stand of Diane Harper, who spoke up against the ACIP Gardasil recommendation because “I want to be able to sleep with myself when I go to bed at night.”

    In the case of several senior officials involved in overseeing key DHHS decisions during the Gardasil era, some portion of that answer is provided by their subsequent career moves. Indeed, these moves reveal a cultural problem that is in many ways more troubling than the direct Gardasil financial conflicts: a pervasive pattern of senior officials cashing in on their careers in public service in order to obtain lucrative corporate and consulting jobs. The career moves of these senior officials show that a virtual revolving door between regulators and the pharmaceutical, vaccine and biologics companies they are supposed to regulate erodes any meaningful sense in which these officials truly serve consumer interests, especially when it comes to product safety. This revolving door provides the cultural foundation that undergirds some of the more egregious institutional conflicts.

    A short account of the recent careers of just a few of the officials involved in regulating Gardasil shows this revolving door in action.

    • Mike Leavitt was named on December 13, 2004 as Secretary of DHHS, where he subsequently was responsible most of the critical regulatory decisions involving Gardasil. In January 2009, he left HHS and formed Leavitt Partners, a Washington DC consulting firm that helps its client “enter new markets, enhance the value of their products and navigate dynamic regulatory and reimbursement systems.” In his consulting work, Leavitt could certainly teach his clients about Gardasil and how they could follow Merck’s example in forging a model “public-private partnership.”

    • Julie Gerberding was named Director of CDC on July 3, 2002 and served in that role until she resigned on January 29, 2009. Gerberding watched over Gardasil policy at CDC during the period of FDA review in which ACIP put Gardasil on a fast track for approval in June 2006. She also was in charge of the oversight for CDC’s postlicensure safety activities during much of the period leading up to Slade et al’s JAMA submission when portions of the VAERS analysis were reviewed with ACIP. Less than a year after leaving public service, on December 21, 2009, Merck announced Gerberding’s appointment as President of the Merck Vaccine Division, effective January 25, 2010, the minimum interval allowed for a Federal official to assume a position at a company they used to regulate. Gerberding, who once regulated Gardasil, is now directly responsible for its growth and profitability.

    • Karen Goldenthal was the Director of the Division of Vaccines and Related Products Applications within CBER, the FDA division responsible for approving Gardasil’s BLA in June 2006. In 2007, shortly after Gardasil’s approval, Goldenthal left CBER to become Executive Director of PharmaNet Consulting. PharmaNet is “a global, drug development services company, provides a comprehensive range of services to the pharmaceutical, biotechnology, generic drug, and medical device industries.” Other FDA executives have taken leadership positions at PharmaNet, including William Egan, former head of Vaccine Research and Review at FDA, now a Vice President in PharmaNet’s consulting practice.

    These departures provide just a few small examples of a pervasive exodus of FDA officials, many of whom leave FDA in order to provide advice to pharmaceutical companies on how to make their way successfully through the pre- and post-licensure processes. And when it comes to vaccines, there is a specific market for former CBER officials to coach vaccine manufacturers on how to get their BLAs approved and their launches more profitable. Like PharmaNet, a consulting company called the Biologics Consulting Group (BCG) shows how active the revolving door between FDA and industry has become. Here’s how BCG describes itself.

    Biologics Consulting Group, Inc. (BCG) is a team of consultants who provide national and international regulatory and product development advice on the development and commercial production of biological, drug and device products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. Many of our consultants are former CBER, CDER, and CDRH reviewers. [emphasis added]

    In an environment so stepped in both direct and indirect conflicts of interest, is it any wonder that Gardasil regulators have leaned so steeply in favor of industry while overlooking serious safety concerns?

    The early victims of Gardasil look for justice

    The final phase of regulatory activities surrounding Gardasil have yet to play themselves out. These involve the process of adjudicating claims of injury and death due to the vaccine. The DHHS agency responsible for this work is the Health Resources Services Agency (HRSA), which houses the Division of Vaccine Injury Compensation, the group responsible for managing the Vaccine Injury Compensation Program (VICP), more commonly known as “vaccine court.” In light of the pattern of bias we’ve observed in the approach other DHHS agencies have taken to Gardasil, one might reasonably question the prospects for fair treatment of Gardasil victims in vaccine court. Can we really expect the director of HRSA to encourage a fair and generous compensation policy on Gardasil when her colleagues over at NIH are profiting from the patent license, CDC is actively promoting its use and her former colleagues at FDA are providing consulting services to companies helping them avoid regulatory pitfalls and keep their profits intact?

    As in the case of its sister agencies, the presence of conflict of interest does not necessarily mean that HRSA will demonstrate bias, negligence or failures of diligence in their approach to Gardasil. In advance of any record of decisions, however, it’s simply too early to tell how HRSA will respond. In other controversial areas such as the Autism Omnibus Proceeding, petitioners have been deeply disappointed in their treatment at the hands of the vaccine court. And it seems likely that Gardasil families are destined for their own day in vaccine court: HRSA provides “table injuries” that provide compensation for a short list of outcomes on a few vaccines, but there are no table injuries yet specified for Gardasil. (HRSA has commissioned the Institute of Medicine to develop such a list for the entire category of HPV vaccines. A candidate list of injuries can be found in the latest working list from the “Committee to Review Adverse Events of Vaccines”, see HERE ) So as Gardasil petitioners find their way into the VICP process, HRSA officials will be setting Gardasil injury compensation policy for the first time.

    And the Gardasil girls are coming to seek justice. In an early action, on March 13, 2010, the parents of Jennifer Tetlock filed the following petition with the VICP.

    The above captioned Petitioners request compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10 et seq. (Supp. 1996), for the death of minor, Jennifer Tetlock who received the third series of the Gardasil vaccination on March 1, 2007 from James Cuthbertson, M.D. in Berkeley, California and thereafter suffered from atypical amyotrophic lateral sclerosis (ALS)-like lower motor neuron disease which was caused in fact by the above stated vaccination.

    Will Jennifer Tetlock receive justice? It’s hard to imagine how any agency so inextricably linked to the Gardasil program–from invention to approval and recommendation to protection and profit—can possibly be trusted to be a fair arbiter of guilt and innocence.

    But one can always hope. After all, the guardians of vaccine safety in DHHS have children themselves. And like Diane Harper, they also need to sleep with themselves when they go to bed at night.

    SOURCE: http://www.ageofautism.com/2010/05/a-license-to-kill-part-3-after-gardasils-launch-more-victims-more-bad-safety-analysis-and-a-revolvin.html


  • Latest IOM Report Omits Vaccine Injury Data, Denies Victims, Says MMR Causes Measles

    September 14, 2011

    FOR IMMEDIATE RELEASE: Wednesday, September 14, 2011

    Contact: Vaccine Safety Council of Minnesota
    Wayne Rohde 651-705-5030 / 405-973-7049

    Latest IOM Report Omits Vaccine Injury Data,
    Denies Victims, Says MMR Causes Measles

    On August 25 the Institute of Medicine’s Panel on Adverse Effects of Vaccines issued a report that inadvertently reveals that much more rigorous science on vaccine injuries is greatly needed.

    The health advocacy group SafeMinds provided statistics from the report that have been omitted from press releases by the IOM. Out of 158 potential adverse outcomes from vaccines that were investigated, 135 or 85% had inadequate research to accept or reject a causal association. Of the 23 judged acceptable, 18 – or 78% – were found supportive of harm.

    “These statistics are hardly reassuring to parents who are now asked to give their young children over 32 vaccinations,” said Sallie Bernard, president of SafeMinds.

    The IOM report found likely causality of immune dysfunction, seizures and encephalopathy from some vaccines. These conditions are often found in individuals with autism. “The report only looked at a small set of published research studies linking just two vaccines to developmental disorders such as autism,” said SafeMinds. ”Only four epidemiological studies were considered of sufficient quality to evaluate the MMR vaccine in relation to autism, and no studies were deemed of sufficient quality for the DTaP vaccine and autism analysis.”

    Editor Mike Adams of the Natural News reported, “[T]his IOM report, even though it goes out of its way to excuse vaccines and dismiss safety concerns, still openly admits that vaccines cause measles [pg. 574], febrile seizures, anaphylactic shock, and other potentially fatal side effects.”


    According to Adams, the IOM did not interview any parents of children with vaccine-induced regressive autism, and did not review those children’s medical histories. The IOM’s mechanistic weight-of-evidence assessments gave case histories less weight, based on three elements, including a “specified and reasonable time interval (i.e., temporality or latency) between vaccination and symptoms.” But, said Adams, the IOM failed to define this temporality, stating that “[w]hat constitutes reasonable latency will vary across vaccines and across adverse events.”

    Adams also noted that the IOM’s report failed to consider long-term adverse reactions or the cumulative effects of multiple vaccines compromising the immune system or nervous system.

    “The IOM report took two years to produce, mostly behind closed doors, and was paid for by the Department of Health and Human Services, the government agency which is also a defendant against the vaccine-injured in the government’s vaccine court,” said SafeMinds.

    SafeMinds calls on Congress and our Administration to:

    • institute rigorous vaccine safety study, and establish an independent Vaccine Safety Agency,

    • launch a study comparing health outcomes between vaccinated and unvaccinated children,

    • include vaccines as an exposure variable in the National Children’s Study,

    • ensure mandatory reporting by physicians to the Vaccine Adverse Event Reporting System.

    Read SafeMinds’ review of epidemiological studies on MMR, thimerosal and autism here:



  • HDNet Report: Paper Reveals Stunning Rate of Autism Among Confirmed Vaccine Injury Cases

    August 22, 2011

    FOR IMMEDIATE RELEASE: Monday, August 22, 2011
    Contact: Vaccine Safety Council of Minnesota – Patti Carroll (651) 785-5716

    HDNet Report: Paper Reveals Stunning Rate of Autism Among Confirmed Vaccine Injury Cases

    U.S. government, CDC send mixed signals regarding vaccine/autism link

    This Tuesday HDNet TV’s World Report will broadcast an investigation of the recent analysis of
    successful claims paid out through the National Vaccine Injury Compensation Program (NVICP).

    The investigative report, “Vaccines and Autism: Mixed Signals,” will be broadcast tomorrow –
    August 23 at 8 p.m. Central time. HDNet reporters ask, “Health officials in the U.S. have consistently
    denied that there is any link between childhood vaccines and autism. So why is the government
    quietly doling out big settlements to families who say just such a link harmed their children?”

    The peer-reviewed paper that broke this story, titled “Unanswered Questions from the Vaccine
    Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain
    Injury,” was published in the Pace Environmental Law Review in May 2011.

    150 families who were successful in proving a vaccine injury through the NVICP were interviewed
    about their experience in the program and the specific vaccine damage their child sustained. In a
    stunning 41% of cases (62), the child had a confirmed diagnosis of autism, or exhibited clear autistic
    features. An additional 21 cases of autism among compensated vaccine victims were identified using
    the government’s legal database.

    There are over 1,100 additional cases of vaccine-induced brain damage that have been compensated
    through the NVICP. “These 83 cases are only the tip of the iceberg,” said Patti Carroll, a contributor
    to the paper and member of the Vaccine Safety Council of Minnesota. “Additional cases of
    compensated vaccine-induced autism have been discovered since the paper was published, and
    further investigation is ongoing.”

    The NVICP was established in 1986 to protect vaccine manufacturers from liability when their
    products injure or kill people. Compensation is paid to victims from a fund collected through an
    excise tax imposed on the sale of every vaccine. Over 2 billion dollars have been paid out since the
    program’s inception, despite the fact that receiving compensation for vaccine injuries is an extremely
    difficult and contentious process.

    The CDC and medical industrial complex have continually reassured the public that vaccines do not
    cause autism, even after information was leaked to the media in 2008 about the compensated case
    of Hannah Poling. Although Hannah’s parents wanted to go public with her medical records in order
    to educate parents and doctors about how and why vaccines caused their daughter’s autism, the
    Department of Justice sealed the records in that case.

    “Vaccine safety advocates knew then that the government was hiding something,” said Carroll. “We

    were shocked to learn that not only did they know that vaccines cause autism, but that they have
    known for over two decades. They blatantly lied to the public while quietly compensating families for
    vaccine injuries resulting in autism. It is unconscionable that it took an autism advocacy organization
    to uncover this deceit, but what is even more disturbing is that this truth had to be ‘uncovered’ at all.”

    Vaccine Safety Council of Minnesota demands a thorough investigation of those responsible, and
    supports the push for congressional hearings on the constitutionality of the NVICP.


  • 6X More Autism in Grandchildren of Mercury-Poisoning Survivors

    August 12, 2011

    FOR IMMEDIATE RELEASE: Friday, August 12, 2011
    Contact: Vaccine Safety Council of Minnesota
    Wayne Rohde 651-705-5030 / 405-973-7049

    6X more autism in grandchildren of mercury-poisoning survivors

    Research links medical Hg use & familial susceptibility to autism

    ST. PAUL, MN – A study published July 28 in the Journal of Toxicology and Environmental Health found that 1 in 25 grandchildren of mercury-poisoning survivors had an autism spectrum disorder, compared to 1 in 160 in the general population – a staggering six-fold increase in relative risk.

    Australian researchers David Austin, PhD and Kerrie Shandley investigated whether autism, a neuroimmune disorder, can be linked to the mercury exposure of people genetically predisposed toward heightened sensitivity to the neurotoxic heavy metal. The researchers looked at a large sample of grandparents who as children were diagnosed with acrodynia, or Pink Disease. Its symptoms, such as apathy, irritability and progressive loss of speech, are quite similar to those of children with autism.

    “We were simply blown away by the results,” Dr. Austin stated. “The large elevation in autism prevalence in this group of children was startling, especially given that rates of other childhood disorders were at expected levels. The thing that differentiates these children from the general population, to which they were compared, is a family history of mercury sensitivity.”
    In the early 20th century acrodynia developed in about 1 in 500 children. However nearly fifty years passed before scientists connected the disease to exposure to mercury from health care products such as teething powder, worm medications and diaper rinses – a paradox with modern parallels.

    The healthcare advocacy group SafeMinds continues to demand that the pharmaceutical industry remove mercury from all consumer products, including vaccines. According to a statement this week by SafeMinds, “43 peer-reviewed studies support a link between mercury and autism, and experts agree that autism is caused by the interaction of genetic susceptibility and environmental exposures.”

    SafeMinds board member Lyn Redwood RN, MSN, said, “The FDA has identified over 130 medical products that contain mercury and 7 vaccines that contain mercury. The continued use of these products in to the 21st century when safer and more effective alternatives exist is unacceptable and dangerous.” Redwood’s son has been diagnosed with mercury toxicity and autism.

    The Austin/Shandley study did not address differences in toxicity between temporary topical applications versus injection of mercury such as from Thimerosal, which is still in many vaccines.

    For more information on the symptoms of Pink Disease and the overlap with autism:

    Ancestry of Pink Disease (Infantile Acrodynia) Identified as a Risk Factor for Autism Spectrum Disorders
    Kerrie Shandley & David W. Austin
    Journal of Toxicology and Environmental Health, Part A
    Volume 74, Issue 18, 2011




  • Abusive “Vaccine Court” Drops 2/3 Of Non-Omnibus Cases

    May 19, 2011

    FOR IMMEDIATE RELEASE: Thursday, May 19, 2011
    Contact: Vaccine Safety Council of Minnesota
    Wayne Rohde 651-705-5030 / 405-973-7049

    Abusive “Vaccine Court” Drops 2/3 Of Non-Omnibus Cases

    Last week U.S. citizens learned that for decades their government has privately been quietly settling cases of vaccine-induced autism, while publicly stating that vaccines do not cause autism.

    A new report of those cases in the Pace Environmental Law Review found 83 cases of autism associated with vaccine injury. Those “83 Canaries” represent the tip of the vaccine/autism iceberg.

    What follows is a terrible realization: Countless more “Canaries” are struggling to live without compensation for their health damage. Thousands of cases of vaccine-induced autism have been dismissed, and countless more never filed because people believed their government’s statements.

    Out of the more than 2,500 compensated victims in the history of the National Vaccine Injury Compensation Program, approximately 1,300 were known childhood cases compensated for brain damage, either encephalopathy or residual seizure disorder. The authors of this week’s Pace study identified and contacted 150 more families from the 1,300 known settlements and in 62 cases (a rate of over 40%) the children were diagnosed with autism.

    If 40% of the full population of compensated childhood cases of brain injury, then it’s likely that over 500 autism cases have received compensation. However the true number of autism cases linked to vaccine injury in the general population must be many times larger.

    In the face of this newly revealed evidence, it’s obvious to conclude that the so-called “Vaccine Court” is nothing of the kind. It has become a mockery of justice.

    The VICP “Vaccine Court” was designed 25 years ago “to establish a federal no¬fault program under which awards can be made to vaccine-injured persons quickly, easily, and with certainty and generosity.” Instead, it has become highly adversarial and “a bitter disappointment” to families devastated financially. Only about a third of non-Omnibus cases have received compensation. Out of 6,987 vaccine injury cases filed in the NVICP, 2,540 were compensated and 4,447 were dismissed.

    The “Vaccine Court” denies petitioners basic legal rights, including discovery and the right to a trial by jury. In the recent Bruesewitz v. Wyeth decision, the U.S. Supreme Court locked victims of vaccine injury out of the legal process, denying them the recourse that Congress had clearly intended.

    Government officials have turned “Vaccine Court” into a hostile battleground. Families describe it as perversely managed by “disrespectful and combative” officials who are viewed as “absolutely horrible” and who do “whatever [they] can do to keep [families] from being compensated.” In the Omnibus Autism Proceedings, even the behavior of the “judges” in “Vaccine Court” turned abusive towards the families, issuing “scathing opinions that rejected and demeaned petitioners’ scientific theories, expert witnesses and treating physicians.”

    “It’s way past time to remove these abusive officials from their bully pulpits and start truly helping all vaccine-injured children and their families,” said Tim Kasemodel of the VSCM, parent of a child injured by vaccines. “To continue to deny and ignore this human suffering is unconscionable.”



  • New Study Of U.S. Vaccine Injury Awards Reveals “83 Canaries”: Settlements with Vaccine-Autism Link

    May 11, 2011

    FOR IMMEDIATE RELEASE: Wednesday, May 11, 2011
    Contact: Vaccine Safety Council of Minnesota
    Wayne Rohde 651-705-5030 / 405-973-7049

    New Study Of U.S. Vaccine Injury Awards Reveals “83 Canaries”: Settlements with Vaccine-Autism Link

    Until now, few people knew that for two decades the U.S. Vaccine Injury Compensation Program (VICP) quietly settled about 1,300 cases of vaccine-induced brain injury in children.

    The authors of a new study of those cases in the Pace Environmental Law Review conducted an intensive investigation and shockingly, they found 83 cases of autism associated with vaccine injury. These 83 autistic children could have been the canaries in the coal mine who warned us of the oncoming autism epidemic.

    A multi-trillion-dollar national disaster could have been prevented. Instead, government officials have been playing deceptive word games with vaccine-induced brain injury, making fine distinctions between autism and “encephalopathy” and “residual seizure disorder.”

    In the beginning of the VICP, autism cases were routinely settled under the heading of encephalopathy or residual seizure disorder. But since 2002, the VICP has used a double standard to deny vaccine-induced autism.

    When vaccine injury is not called autism but instead labeled encephalopathy or residual seizure disorder, children with autism can be compensated.

    When vaccine injury is openly called autism, compensation is denied to children with the same pattern of brain injury.

    In cases where autism is present but not cited by families, government officials and experts use the autism label as an argument for denying compensation.

    THERE IS NO JUSTIFIABLE DISTINCTION between the “83 Canaries” and the 5,000 denied vaccine injury claims in the Omnibus Autism Proceeding. The process has become completely arbitrary and unfair to families.

    Once the autism epidemic began and it became clear how many children were being injured, the government forced these cases into Vaccine Court and began shunting cases that openly included autism into the Omnibus Autism Proceeding.

    The Omnibus Autism Proceeding became a “trash can” vehicle used to deny claims and preserve the financial viability of the VICP.

    Due to the chilling effect of the Omnibus Autism decisions, thousands of new vaccine injury claims have been prevented – which is what the government wants.

    These “83 Canaries” are only the tip of the iceberg. Hundreds of cases of autism and brain injury have probably been settled while government officials who should have known better did nothing. Those officials involved in the VICP must be held accountable for this debacle.

    The ethical and financial choices are clear. The VICP requires urgent reform. The agencies responsible for this crisis must be investigated. Every child who was injured should be studied so we can prevent further vaccine injury. And we must find ways to improve the lives of all the other “canaries” – the innocent, trusting children whose health we claim to put first.



  • Published Paper Reveals Stunning Autism Rate In NVICP Compensated Vaccine Injury Cases

    May 10, 2011

    FOR IMMEDIATE RELEASE: Tuesday, May 10, 2011
    Contact: Vaccine Safety Council of Minnesota
    Patti Carroll (651) 785-5716

    Published Paper Reveals Stunning Autism Rate In NVICP Compensated Vaccine Injury Cases

    As reported today on CBS, Fox News, CNN and several other news outlets, a newly published paper reveals that a startling number of compensated vaccine injury claimants have autism. The peer-reviewed paper, titled “Unanswered Questions from the National Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury,” was published in the Pace Environmental Law Review.

    150 families who were successful in proving a vaccine injury through the National Vaccine Injury Compensation Program were interviewed about their experience in the program and the specific vaccine damage their child sustained. In a stunning 41% of cases (62), the child had a confirmed diagnosis of autism, or exhibited clear autistic features. An additional 21 cases of autism among compensated vaccine victims were identified using the government’s legal database.

    There are over 1,100 additional cases of vaccine-induced brain damage that have been compensated through the NVICP. “No doubt a similar percentage of those cases will also show children with a diagnosis of autism,” says Patti Carroll, a contributor to the paper and member of the Vaccine Safety Council of Minnesota.

    The NVICP is a program established in 1986 to protect vaccine manufacturers from liability when their products injure or kill people. Compensation is paid to injured parties out of a fund collected from an excise tax imposed on the sale of every vaccine. Over 2 billion dollars have been paid out since the program’s inception, despite the fact that receiving compensation for vaccine injuries is extremely difficult and rare.

    The CDC and medical industrial complex continually reassured the public that vaccines do not cause autism, even after information was leaked to the media in 2008 about the compensated case of Hannah Poling. Though Hannah’s parents wanted to go public with her medical records in order to educate parents and doctors about how and why vaccines caused their daughter’s autism, the Department of Justice chose to seal the records in that case.

    “Vaccine safety advocates suspected then that the government was hiding something,” said Carroll. “We were shocked to learn that not only did they know that vaccines certainly CAN cause autism, but that they have known for over two decades. They blatantly lied to the public while quietly compensating families for vaccine injuries resulting in autism. It is unconscionable that it took an autism advocacy organization to uncover this deceit, but what is even more disturbing is that this truth had to be ‘uncovered’ at all.”

    In a sickening display of greed and self-protectionism over the health and well-being of individuals, the government has allowed an entire generation of children to be exposed to products they knew were causing devastating lifelong neurological disorders. Vaccine Safety Council of Minnesota demands a thorough investigation of those responsible, and supports a Congressional investigation and potential complete overhaul of the NVICP.

    A Congressional briefing will be held Thursday, May 12 at 8:30 a.m. EST in Rayburn B-339, Washington, D.C. The paper authors, members of the Elizabeth Birt Center for Autism Law and Advocacy, will present further information to members of Congress, media and the public. Today’s press conference will be broadcast at UStream: http://www.ustream.tv/channel/ebcala .



  • CDC Failing To Investigate Vaccine Injuries

    May 5, 2011

    FOR IMMEDIATE RELEASE: Thursday, May 5, 2011
    Contact: Vaccine Safety Council of Minnesota
    Wayne Rohde 651-705-5030 / 405-973-7049

    CDC Failing To Investigate Vaccine Injuries

    Mishandling of consumers’ reports decreases immunization trust

    ST. PAUL, MN – Now that National Infant Immunization Week is over, May should be designated Vaccine Injury Prevention Month, says the Vaccine Safety Council of Minnesota.

    “Infants and children are not being monitored adequately following vaccination,” said Patti Carroll of the VSCM. “Families’ vaccine injury reports are being denied or shelved. Ethically they should be investigated to learn more about prevention of vaccine injuries, and victims should be given medical treatment.”

    For decades the U.S. Centers for Disease Control has worked with manufacturers, state agencies and media to build a network for vaccine sales and delivery. To focus on delivery and then fail to study vaccine adverse effects leaves a tragic void in the scientific process.

    State agencies like the Minnesota Department of Health assure the public that vaccines are safe and effective. However the many vaccine injury reports in medical literature and the underused Vaccine Adverse Events Reporting System prove otherwise. Some symptoms include swelling, tics, seizures, loss of mobility, difficulty breathing, and loss of consciousness.

    The National Vaccine Injury Compensation Program as of 1998 identified 8 deaths in infants attributed to the measles vaccine, and 42 cases of brain inflammation resulting in mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders. Other adverse reactions to vaccines include demyelination, neuroinflammation, autoimmunity, mitochondrial dysfunction, methylation disorder, and gastrointestinal disease.

    Doctors often fail to recognize the signs of vaccine injury, and dismiss infant developmental delays by telling parents that their child’s serious symptoms or regression were unrelated to the vaccine, or that the child will grow out of it. Often the neuroimmune damage caused by vaccines remains undiagnosed until preschool educators see behavioral deficits and aberrancies.

    Consumers are increasingly skeptical about the vaccine program after learning about its ethical and safety deficiencies. Yet vaccine policymakers deflect blame for their failures. “How did we get to the point where so many children are vulnerable?” asked MDH infectious disease director Kristen Ehresmann last month, commenting on parents choosing to skip children’s vaccines.

    “We got to this point because a significant number of parents have witnessed their child having severe adverse effects from a vaccination,” said Jerri Johnson of the advocacy group National Health Freedom Coalition. “This damage has happened often enough that lots of grandparents, aunts and uncles, friends and neighbors have first-hand knowledge of vaccine injuries.”

    Ironically families of vaccine-injured children are realizing that federal and state legislation will be necessary to enforce ethical behavior from administrators of the vaccine program. Unlike sufferers of other diseases, victims of vaccine injuries have no government clearinghouse for medical information or treatment and have had to band together for support.

    “It should not take legislation and litigation to force healthcare professionals to stop writing off so many children as collateral damage in the war on disease,” said Nancy Hokkanen of the VSCM.


    Vaccine Injury Information

    Vaccine-induced Injuries & Deaths

    Hannah Poling
    Ga. girl helps link autism to childhood vaccines
    By Alison Young, The Atlanta Journal-Constitution / Thursday, March 6, 2008

    Jade Ventura

    Ian Gromowski (see photo progression)

    Elias Tembenis

    Media Investigative Report

    CBS News Investigates: The Search for Safer Vaccines
    Sharyl Attkisson / January 19, 2011

    “[G]overnment officials have said they have no plans to study [vaccine injury] cases…”


    Government Agencies

    Vaccine Adverse Events Reporting System (VAERS)


    National Vaccine Injury Compensation Program (NVICP)


    Medical Journal Article

    Adversomics: The Emerging Field of Vaccine Adverse Event Immunogenetics

    Gregory A. Poland, MD, Inna G. Ovsyannikova, PhD, and Robert M. Jacobson, MD

    The Pediatric Infectious Disease Journal, Volume 28, Number 5, May 2009

    SUMMARY: “We believe that adversomics (the immunogenetics and immunogenomics of vaccine adverse events at the individual and population level, respectively) is critical to understanding and preventing serious adverse vaccine-related events, developing the next generation of vaccines, and to improving public con?dence in vaccine safety.”

    Consumer Advocates

    National Vaccine Information Center (NVIC)


    Autism Research Institute


    “Dr. Bernard Rimland — founder and director of the Autism Research Institute — testified before the committee that classic autism, (noticeable from birth) has largely been replaced by late-onset or ‘acquired autism’; a form of autism in which children are born normally developing but later regress into autism in the second year of life. He was one of the first to point to environmental insult through vaccine injury as a possible leading contributing factor.” [Rep. Dan Burton (R-IN) speech to Congress June 19, 2007]


  • Molecular and Cellular Scientist to Address Vaccine Safety Issues in Minnesota Thursday

    April 26, 2011

    FOR IMMEDIATE RELEASE: April 26, 2011
    Contact : Terrence Kopp (612) 327-3700
    Sound Choice Pharmaceutical Institute

    Molecular and Cellular Scientist to address Vaccine safety issues in Minnesota Thursday

    ST. PAUL, MN – Dr Theresa Deisher, Ph D, Stanford, founder of AVM Biotechnology and Sound Choice Pharmaceuticals, will visit the Twin Cities again this Thursday, April 28, in a continuation of her public efforts to shed light on key elements regarding vaccine safety, specifically as regards the likely adverse affects of human DNA residuals in many widely utilized vaccines.

    Dr Deisher’s formal testimony will anchor a special formal information committee meeting of the MN House Health and Human Services Reform Committee on Thursday, April 28, at 12:30. Minnesota Health Commissioner Dr Edward Ehlinger and key staff will meet with Dr Deisher immediately following her committee testimony. Dr Deisher had met in April 2010 with previous Health Commissioner Dr Sanne Magnan and staff on similar topics. There is a public education presentation and Q and A session, entitled “Vaccine Safety, New Considerations, Concerns and Insights”, scheduled for 7 – 9 PM on Thursday evening at the Minneapolis Central Library, in the Doty Board Room, 300 Nicollet Mall. Press representatives are welcome.

    In January, 2001, the US Department of Health and Human Services Interagency Autism Coordinating Committee (IACC) released a Strategic Plan for Autism Disorder Research. In this plan they accept the June 2009 recommendations of the National Vaccine Advisory Committee to support additional studies into the link between vaccines and autism disorders. The IACC strategic plan states that biological agents may confer environmental risk. Human DNA residuals in vaccines constitute such a biological agent. Sound Choice Pharmaceutical Institute , under Dr Deisher’s direction, is conducting cutting edge research in this realm in support of the goals of the IACC and the National Vaccine Advisory Committee.


    Theresa Diesher Biography:
    Theresa Deisher, Ph.D.
    President, Founder, Sound Choice Pharmaceutical Institute

    Dr. Deisher, an internationally renowned expert in the field of adult stem cell therapies and regenerative medicine, brings 17 years of experience in scientific and corporate leadership positions involving research, discovery, production and commercialization of human therapeutics. Dr. Deisher’s penchant for groundbreaking scientific discovery and her distinguished scientific research has resulted in 23 patents issued. She has published numerous scientific manuscripts and is a frequent invited lecturer and guest speaker in the area of stem cell technology and regenerative medicine.

    Throughout her career, Dr. Deisher has been recruited by some of the country’s top biotechnology companies, including Genentech, Repligen, ZymoGenetics, Immunex and Amgen. She has managed and mentored undergraduate honors students, post-doctoral fellows, scientific executives and over 20 research assistants/scientists at all levels of responsibility.

    Dr. Deisher graduated with honors and distinction from Stanford University, and obtained her Ph.D. in Molecular and Cellular Physiology from Stanford University.

    Subsequent to obtaining her Ph.D from Stanford, Dr. Deisher was recruited by Repligen Corporation (Cambridge, MA) and accepted a position as Research Scientist where she managed a staff of associates and scientists and directed the development of research and clinical assays in support of Phase I and Phase II clinical trials for various Repligen developmental efforts. Additionally, Dr. Deisher was selected by Sr. Management to participate in strategic alliance initiatives, including serving on the Repligen / Eily Lilly joint development committee.

    Following Repligen, Dr. Deisher accepted a position at ZymoGenetics, Inc (Seattle, WA) as Sr. Scientist, Cardiovascular Biology. While at ZymoGenetics, Dr. Deisher’s research and discovery in the area of cardiovascular biology led to the filing of dozens of patents. Dr. Deisher was the first person world-wide to identify and patent stem cells from the adult heart, including what are now called ‘very small embryonic-like stem cells’. Her discovery remains one of the most significant discoveries in the area of stem cell research. Within the field of regenerative medicine, Dr. Deisher is also a patented inventor of the most potent mesenchymal growth factor ever identified (licensed to Serono for clinical development), and of the use of cytokines to mobilize adult embryonic-like cells.

    Following ZymoGenetics, Dr. Deisher was named Sr. Staff Scientist, Vascular Biology at Immunex (Seattle, WA) where she was the project leader for both the Antithrombotic division and the Inflammation and Myocardial Repair division.

    Dr. Deisher was named Principal Scientist at Amgen, Inc. (Seattle, WA) following Amgen’s acquisition of Immunex. She led multi-disciplinary teams working on the biology and commercial development of novel co-stimulatory pathways involved in the initiation and progression of cardiac failure. Her research interests encompassed stem cell therapies for myocardial regeneration. Additionally, Dr Deisher introduced revolutionary non-invasive imaging technologies for pre-clinical research to the company, including ultrasound (echocardiography) and near-infrared imaging. As a result, the company was honored as an official ‘Site of Excellence’ by Philips Medical for her department’s pioneering work.

    Most recently, Dr. Deisher served as Vice President of Research and Development for Cellcyte Genetics Corporation, a post she held until October 2007 prior to founding AVM Biotechnology LLC, and the not for profit Sound Choice Pharmaceutical Institute.


  • CDC Vaccine Researcher Indicted for Fraud

    April 22, 2011

    He Co-created Studies Claiming Vaccines Don’t Cause Autism

    St. Paul, MN – A U.S. federal grand jury has indicted a prominent vaccine researcher for multiple counts of fraud.

    Poul Thorsen, 49, was indicted April 13 on thirteen counts of wire fraud and nine counts of money laundering of grants awarded to Denmark agencies by the U.S. Centers for Disease Control. “This defendant is alleged to have orchestrated a scheme to steal over $1 million in CDC grant money earmarked for autism research,” said United States Attorney Sally Quillian.

    Thorsen was instrumental in co-constructing the “Danish Studies” widely claimed to refute the vaccine/autism link. But according to the U.S. advocacy group Autism Action Network, critics of the studies believe “highly suspect methods were used to arrive at the conclusion that there was no association between exposure to either thimerosal or the MMR vaccine and autism, even though standard epidemiological methods showed an association.”

    “The Thorsen indictment is just the tip of the CDC’s corruption iceberg,” said Nancy Hokkanen, a Minnesota parent of a vaccine-injured child. “For more than a decade vaccine safety advocates have begged journalists to investigate systematic vaccine program corruption, which is destroying consumer health and trust.”

    The story of the theft was broken more than a year ago in the U.S. by Ginger Taylor, co-author of the bookVaccine Epidemic, on her blog Adventures In Autism. Next the story was further investigated by Age of Autism, then reported by Fox News late last year. Since the indictment was announced bloggers with links to Pharma, CDC and the Department of Defense are trying to downplay reports by saying Thorsen’s misappropriation of tax-funded millions is “isolated” and a “distraction,” and does not impact the quality of research over which Thorsen presided.

    Vaccine safety advocates are concerned that this case, which has the potential to implicate officials at the CDC/HHS, will be policed by the Department of Justice. “In the Vaccine Injury Compensation Program, the DOJ acts as the attorney to defend HHS against families’ claims that vaccines can cause autism,” Taylor said. “In the highly publicized Autism Omnibus hearings in the VICP, DOJ used Thorsen’s research to bolster their defense.”

    Taylor added, “A clear conflict of interest exists here. If DOJ earnestly investigates claims that the research was rigged to give CDC results exonerating their vaccine program, the DOJ hurts their own efforts in defending HHS in the VICP. This is especially sensitive now that HRSA, which administrates the VICP for HHS, issued a statement admitting that vaccines can cause a type of brain encephalopathy that leads to autism. We are hoping the media will step up and hold DOJ’s feet to the fire so we get to the bottom of what is going on at HHS, so this does not simply become another case of HHS investigating itself.”

    “The agency backpedaling has begun,” said Hokkanen. “Here are two reasons why the world has an autism epidemic: The CDC doesn’t investigate medical conditions of people with vaccine injuries, and journalists don’t investigate corrupt people within the CDC.”



    • Why did the U.S. government wait to act until Danish government authorities charged Poul Thorsen with forging documents and tax evasion?
    • Why did original stories report Thorsen’s alleged theft near $2 million?
    • Will the U.S. Department of Justice offer Poul Thorsen a deal in order to spare incriminating revelations about his CDC colleagues?
    • David Bowman at the Office of Communications of the Health and Resources Services Administration, the HHS department that administers the VICP, said that vaccines can cause an encephalopathy (brain damage) that “may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.” Why has this warning not been issued to physicians so that they can monitor children who present with autism-like symptoms for vaccine-induced encephalopathy or encephalitis?
    • In light of this statement, and the statement that CDC chief Julie Gerberding made on CNN that vaccines can cause “autism-like symptoms” in children with undiagnosed, asymptomatic mitochondrial disorders, why does CDC continue to allow medical professionals to labor under the presumption that there is no association between vaccines and autism?
    • If statistical epidemiology is the lowest rung on the evidentiary chain, then why is it used in an attempt to disprove adverse vaccine reactions provable by lab tests?
    • Whatever happened to Dr. Thomas Verstraeten, whose vaccine/autism epidemiological machinations were revealed in the SafeMinds Generation Zero analysis and circulation of his “It just won’t go away” memo?
    • Poul Thorsen is accused of stealing $1,000,000 and reporters are silent; so why is Dr. Andrew Wakefield vilified for making an inconvenient medical discovery replicated by other researchers?
    • On April 11, 2011, Dr. Max Wiznitzer told a Marietta College audience, “If you can’t trust the integrity of the researcher, you can’t trust the research.” Dr. Wiznitzer earns side money by testifying in the National Vaccine Injury Compensation Program against vaccine injury victims. To whom were Dr. Wiznitzer’s words in reference, and were they appropriately directed?




  • “There is No Vaccine-Autism Link. Case Closed.” – Right? Wrong.

    April 22, 2011

    By Mary Holland, Esq. and Robert Krakow, Esq.

    Click Here to Read the Article

    (SOURCE: http://www.coalitionforvaccinesafety.org/docs/Autism_File_Vaccine_Court_Holland_Krakow_7-09_F_.pdf)


  • Tobacco Science and the Thimerosal Scandal

    April 22, 2011

    By Robert F. Kennedy, Jr.

    Click Here to View the Article

    (SOURCE: http://www.robertfkennedyjr.com/docs/ThimerosalScandalFINAL.PDF)


  • On Vaccinations: Consider the Source and Follow the Money

    April 22, 2011

    Last month, Dr. Paul Offit, Chief of the Division of Infectious Diseases at the Children’s Hospital of Philadelphia and the vaccine industry’s most outspoken activist, warned Huffington Post readers not to “risk going unvaccinated.”

    When presented with conflicting information on a critically important health issue I generally follow two simple rules…educate myself on the issue and “follow the money.” When it came to Dr. Paul Offit, and the credibility of this advice, this was an easy assignment.

    I normally wouldn’t waste my time responding to Dr. Offit. After all, he is entitled to his opinion. However, this man’s relentless campaign that includes attacking concerned parents and the dissemination of false information needs to be exposed for what it is.

    Dr. Offit has been on a very aggressive crusade in defense of vaccines for years. With what appears to be unlimited resources, Offit is routinely granted ample unchallenged opportunities to mount his campaign in newspapers around the country.

    In recent years, Offit has become the “go-to guy” on all things related to vaccines. While other physicians, civic leaders and even members of congress are denied the opportunity to share their views on this issue, Offit is frequently provided with generous op-ed space to promote his views on the safety of vaccines, the need to take away vaccine exemptions, and the need to protect vaccine manufacturers from any liability. In short, if the word vaccine or autism appears in the article, so does Dr. Offit.

    In his recent Huffington editorial, Offit continues his attack on worried parents who choose not to vaccinate their children, or even just spread them out a little, which the CDC says is okay to do. He blames them for the relatively small outbreaks of childhood diseases. In this case, last year’s 135 cases of measles.

    …the reason that some parents are choosing not to vaccinate their children is based on the mistaken notion that vaccines cause autism; or that vaccines cause diabetes or multiple sclerosis or asthma or allergies; or that vaccines weaken or overwhelm the immune system; or that vaccines have not been adequately tested. Many studies have addressed these concerns and should have reassured parents. But there appears to be a rift between studies that exonerate vaccines and the public’s knowledge of those studies.

    First of all, Dr. Offit is quite frankly, “full of it.” The reason some parents are choosing alternative vaccine schedules, or to not vaccinate their children, is because they have lost confidence in the safety of vaccines and the people who recommend them, like Dr. Paul Offit. The level of distrust is evident in the nearly 500 comments posted in response to his article.

    There are also some children who have serious medical conditions, or have experienced severe life-threatening reactions to previously administered vaccines, which make them vulnerable to subsequent adverse vaccine reactions. In consultation with their physician, some children are given medical exemptions because the risk of vaccination may be greater than the disease. Does Dr. Offit think he knows better than a family’s personal physician when it comes to what is best for an individual child and that a child should be vaccinated anyway?

    Since we have Dr. Offit’s Huffington piece, let’s look at the credibility of his professional opinion and see if he is really providing parents with good advice.

    According to a 2008 study, it is Dr. Offit who might be “mistaken” when he claims vaccines don’t cause diabetes. Vaccine Induced Inflammation Linked to Type 2 Diabetes and Metabolic Syndrome, published in the Open Endocrinolgy Journal.

    [the study] shows a 50% reduction of type 2 diabetes occurred in Japanese children following the discontinuation of a single vaccine to prevent tuberculosis.The current data shows that vaccines are much more dangerous than the public is led to believe and adequate testing has never been performed even in healthy subjects to indicate that there is an overall improvement in health from immunization. The current practice of vaccinating diabetics as well as their close family members is a very risky practice,” says Dr. J. Barthelow Classen.


    Multiple studies suggest Dr. Offit might also be “mistaken” when he says vaccines don’t cause asthma or allergies. One by researchers at the UCLA School of Public Health published in 2000, examined the effectsof the diphtheria-tetanus-pertussis (DPT) and tetanus vaccines and found an asthma and allergy association in vaccinated children compared to unvaccinated children.

    The odds of having a history of asthma was twice as great among vaccinated subjects than among unvaccinated subjects (adjusted odds ratio, 2.00; 95% confidence interval, 0.59 to 6.74). The odds of having had any allergy-related respiratory symptom in the past 12 months was 63% greater among vaccinated subjects than unvaccinated subjects (adjusted odds ratio, 1.63; 95% confidence interval, 1.05 to 2.54). The associations between vaccination and subsequent allergies and symptoms were greatest among children aged 5 through 10 years. CONCLUSIONS: DTP or tetanus vaccination appears to increase the risk of allergies and related respiratory symptoms in children and adolescents.

    In another study published last year, Canadian scientists found childhood asthma could be reduced by 50% if the first dose of DPT is delayed by more than two months.

    It is Dr. Offit who is again “mistaken” when he says vaccines don’t cause multiple sclerosis (MS). Published in 2004, a prospective study from the Harvard School of Public Health examined the potential link between the hepatistis B vaccine and MS.

    Conclusions: These findings are consistent with the hypothesis that immunization with the recombinant hepatitis B vaccine is associated with an increased risk of MS.

    Just last month the US government’s Court of Federal Claims, also known as “vaccine court,” rendered ajudgment awarding compensation to a woman who received the hepatitis B vaccine, developed multiple sclerosis and then died. Several more similar cases have been awarded since 2006.

    This is just another example of the thousands of claims awarded compensation by the special court set up to review injuries caused by vaccines. It is an indisputable fact that over the past 20 years, the vaccine court has dispensed close to $2 billion in compensation to families whose children were injured or killed by a vaccine.

    Dr. Offit is also “mistaken” when he claims vaccines don’t “overwhelm the immune system.”

    Last year, government officials conceded the vaccine injury claim of a young girl with autism named Hannah Poling and agreed that the family is “entitled to compensation” from the federal vaccine injury fund. [Ga. Girl helps link autism to childhood vaccines]

    In a second decision for epilepsy, medical officials from the U.S. Department of Health and Human Services determined Hannah’s “autistic encephalopathy” was “caused” by an “underlying mitochondrial dysfunction, exacerbated by vaccine induced fever and immune stimulation that exceeded metabolic reserves.”

    The problem with Dr. Offit is he apparently sees no problem in misleading confused and concerned parents or his equally concerned colleagues. He routinely insults the intelligence of parents with a condescending attitude about their ability to make an informed decision. In an effort to bolster the safety of vaccines, he repeatedly cites a select group of studies he claims support his opinions and ignores the ones that don’t. Each one of the epidemiological studies Offit relies upon has been discredited by experts in epidemiology for their methodological flaws and the conflicts of interest of the authors involved in those studies. None of the studies he points to have ever studied what is called “regressive autism” or examined how multiple vaccines given at the same time may affect sensitive populations.

    Former NIH Director, Dr. Bernadine Healy, made this very important point abundantly clear wheninterviewed by CBS News.

    I think the government, or certain public health officials in the government, have been too quick to dismiss the concerns of these families without studying the population that got sick. I haven’t seen major studies that focus on three hundred kids who got autistic symptoms within a period of a few weeks of a vaccine. I think that the public health officials have been too quick to dismiss the hypothesis as irrational without sufficient studies of causation. I think that they often have been too quick to dismiss studies in the animal laboratory, either in mice, in primates, that do show some concerns with regard to certain vaccines and also to the mercury preservative in vaccines.

    Just to be clear, I am not against vaccines and my own child has been vaccinated. But I share the growing concerns of many parents that have studied this issue closely and question the number of vaccines given to children under today’s recommended schedule, some of the toxic ingredients in vaccines, and whether we know enough about the synergistic effects of multiple vaccines given to immune compromised children and during critical developmental windows.

    A vaccine profiteer personified — he is now a multimillionaire from his partnership with Merck — Dr. Offit doesn’t share these concerns and continually makes intellectually and factually dishonest remarks regarding vaccine safety.

    In a 2005 article in Babytalk magazine, Dr. Offit irresponsibly claimed a “healthy infant could safely get up to 100,000 vaccines at once.” By anyone’s standard this is a sensational and stupid statement that has no basis in fact, and speaks volumes about Dr. Offit’s objectivity.

    As a consultant to Merck and patent holder on the Rotavirus vaccine, Offit has built a career, and perhaps a fortune, defending vaccines. He is also affiliated with several industry-funded organizations like Parents of Kids with Infectious Diseases (PKIDs) and Every Child by Two (ECBT). In short, a highly visible, very well paid public relations machine for the vaccine industry.

    Offit is the embodiment of Upton Sinclair’s theorem; “It is difficult to get a man to understand something when his salary depends upon his not understanding it.”

    Whenever I read yet another Offit editorial I am immediately reminded of the massive propaganda campaign waged by the tobacco, asbestos and lead industries. It is called “manufacturing uncertainty,” and has been an essential industry marketing strategy for decades.

    David Michaels, a former Assistant Secretary of Energy and professor at George Washington University School of Public Health explained this strategy in The Art of ‘Manufacturing Uncertainty’.

    …By definition, uncertainties abound in our work; there’s nothing to be done about that. Our public health and environmental protection programs will not be effective if absolute proof is required before we act. The best available evidence must be sufficient. Otherwise, we’ll sit on our hands and do nothing.
    Of course, this is often exactly what industry wants. That’s why it has mastered the art of manufacturing uncertainty, of demanding often impossible proof over common-sense precaution in the realm of public health.

    The tobacco industry led the way. For 50 years, cigarette manufacturers employed a stable of scientists willing to assert (sometimes under oath) that there was no conclusive evidence that cigarettes cause lung cancer, or that nicotine is addictive. An official at Brown & Williamson, a cigarette maker now owned by R.J. Reynolds, once noted in a memo: “Doubt is our product since it is the best means of competing with the ‘body of fact’ that exists in the mind of the general public.”

    Toward that end, the tobacco manufacturers dissected every study, highlighted every question, magnified every flaw, cast every possible doubt every possible time. They also conjured their own studies with questionable data and foregone conclusions. It was all a charade, of course, because the real science was inexorable. But the uncertainty campaign was effective; it delayed public health protections, and compensation for tobacco’s victims, for decades.
    The tobacco industry, left without a stitch of credibility or public esteem, has finally abandoned that strategy — but it led the way for others…

    Decades from now, this campaign to manufacture uncertainty will surely be viewed with the same dismay and outrage with which we now look back on the deceits perpetrated by the tobacco industry. But will it be too late?


    To say Dr. Offit has a stake, professionally, financially and perhaps legally, in dispelling the risks associated with vaccines in general, and refuting any association between vaccines and autism specifically, is a colossal understatement.

    We can all learn a great deal by simply looking back on history and remembering how corporations, whose products are linked to serious diseases, employed scientists, physicians and public relation firms to disseminate misinformation and manage the business of “damage control.” By doing so, we realize that we have seen Offit’s act before.

    More than ever, as more vaccines are recommended, parents simply want safer vaccines and a more individualized vaccination schedule.

    Dr. Offit does nothing to repair the confidence chasm regarding vaccine safety. In reality, he makes matters worse with his patented brand of hubris so overbearing and uncompromising, that he undermines his own credibility and the credibility of the vaccine program he so desperately seeks to protect.

    Of course this is just my opinion.

    (SOURCE: http://www.huffingtonpost.com/deirdre-imus/on-vaccinations-consider_b_165347.html)



  • Fourteen Studies

    April 22, 2011

    Quick History

    The 1980s

    In the 1980s, most estimates of the rate of autism were that it affected 1 in 10,000 children. Today, the official estimate of the autism rate is 1 in 110, with many localities reporting rates closer to 1 in 100. That’s a 90-fold increase, or 9,000%. What’s going on?

    A recent survey showed that over 60% of parents of children with autism blame vaccines. Tens of thousands of case reports appear very similar: a normally developing child receives multiple vaccines from their pediatrician, the child appears to change soon after the appointment (or have an immediate, more serious reaction to the vaccines), and later the child is diagnosed with autism.

    An important point that is rarely discussed is the change in the total number of vaccines given to this generation of children. In the 1980s, by the age of six, a child would receive a maximum of 10 vaccines, with many receiving less. Today, the Centers for Disease Control’s recommended schedule calls for 36 vaccines, a near-tripling of total vaccines given to children. Is this increase in vaccines the primary trigger of the increase in autism? Many parents believe so.

    The “case closed” mantra

    If the mainstream media — and the paid spokespeople of the vaccine industry who are often quoted by them — were your only source of information regarding the controversy over the link between vaccines and autism, you’d get the strong impression that the case is closed and that vaccines have been exonerated by “Science.”

    Consider some of these comments from organizations and individuals within the medical establishment:

    “Groups of experts, including the American Academy of Pediatrics, agree that MMR vaccine is not responsible for recent increases in the number of children with autism. In 2004, a report by the Institute of Medicine (IOM) concluded that there is no association between autism and MMR vaccine, or vaccines that contain thimerosal as a preservative.”
    – Centers for Disease Control

    “Five large epidemiological studies have been conducted in the United States and in Europe since 2001. These studies have all consistently provided evidence that there is no association between thimerosal-containing vaccines and autism.”
    – Every Child By Two, a nonprofit entity funded by Wyeth, a vaccine maker

    “Five large epidemiological studies conducted in the United States, the United Kingdom, Denmark, and Sweden since 2001 consistently provided evidence that there is no association between thimerosal-containing vaccines and autism.”
    – Institute of Medicine

    “There are no valid studies that show a link between thimerosal in vaccines and autistic spectrum disorder. A 2004 report from the Institute of Medicine, Vaccines and Autism, concluded that the available evidence is against the existence of a causal relationship between thimerosal-containing vaccines and autism.”
    – American Academy of Pediatrics

    “The implication that vaccinations cause autism is irresponsible and counter productive. Although several carefully performed scientific studies have searched for a link between autism and the use of thimerosal in vaccines, no such link has been found.”
    – March of Dimes

    “Scientific data overwhelmingly show that there is no connection between vaccines and autism…We need more research to investigate the actual causes of autism, but it would be a disservice to the health of our children if we let vaccines take the blame for this tragic and complex disease.”
    – American Medical Association

    “It is important to note that concerns about the toxicity of thimerosal are theoretical and there is no compelling scientific evidence of a safety problem with its use in vaccines, although public perception of risk remains in some countries.”
    – World Health Organization

    “From time to time, rumors circulate that thimerosal, a mercury-based preservative once used in several vaccines (and still used in some flu vaccine), could contribute to ASDs. However, valid scientific studies have shown there is no link. The American Academy of Pediatrics (AAP), the American Medical Association (AMA), the CDC, and the Institute of Medicine (IOM) agree that science does not support a link between thimerosal in vaccines and autism.”
    – American Academy of Pediatrics

    That’s an exhaustive and compelling “who’s who” of our medical establishment and they are all saying the same thing in no uncertain terms: vaccines do not cause autism. Why in the world would any doctor, parent, or scientist try to argue otherwise?

    What is actually true?

    Like everything in life, the devil is always in the details. This website will demonstrate that:

    • Of 11 vaccines licensed for children (all given multiple times), only a single vaccine — the MMR — has been studied for its relationship to autism. This would be like trying to identify the source of a plane crash, suspecting mechanical failure, solely analyzing one of the wings, and then declaring the entire airplane free of culpability.
    • A vaccine ingredient, thimerosal, which is comprised of mercury, has also been studied, but solely in the context of vaccinated children. Often, the studies on thimerosal compare children who received various levels of thimerosal in their vaccines, rather than none.
    • No studies have ever considered unvaccinated children to compare their autism rates to those who receive vaccines.
    • No studies consider the real world and how vaccines are actually given. American children receive 6-7 vaccines simultaneously at their 2, 4, and 6 month “well baby” visits, but no science done comes close to replicating this real world condition.

    We genuinely believe that any parent, doctor, journalist, or scientist who takes the time to read this site, look objectively at the studies we analyze, and push themselves to understand if the right questions have actually been asked will reach the same conclusions we do.

    One final point: the studies we are reviewing on this site are typically filled with fairly rampant conflicts of interest. Conflict of interest tends to corrupt and bias, which is why it’s so important to understand.

    So, who are we? We are parents of children with autism. We believe vaccines have caused our children’s condition. We are not litigants against vaccine manufacturers. We will not benefit financially if vaccines are ultimately proven to be the primary trigger of autism. Our motivation is truth and we want to help other parents avoid the fate that befell us. That’s it. Thank you for reading our website.

    (SOURCE: http://www.fourteenstudies.org/)



  • The Confidence Gap

    April 22, 2011

    Why the Obama administration needs to restore public faith in the safety of childhood vaccines.

    The mainstream media applauded the U.S. federal “vaccine court”‘s decision Feb. 12 that the MMR vaccine and vaccines containing ethyl mercury as a preservative did not cause autism in three children chosen as test cases. But that’s not enough to repair the damage already done to the U.S. vaccine program.

    It’s hard for a single court decision to compete with ongoing allegations from grieving parents and celebrities that vaccines created an epidemic of autism. Those allegations have generated confusion and fear in the minds of many young parents, reduced public trust in the remarkable benefits and safety of U.S. immunization programs and put both vaccinated and unvaccinated children at increased risk from preventable diseases. Furthermore, significant unanswered questions about the safety of vaccines have been documented by the Institute of Medicine and the National Institutes of Health. For example, are some few individuals genetically more susceptible to adverse reactions from certain vaccines? A more common worry among parents is “Are too many vaccines given too soon?”

    Parents of newborn infants can’t take two years of study, as did the vaccine court, to sort out sound science from junk, innuendo and unsubstantiated allegation. As a result, rates of vaccine refusal have climbed to levels allowing clustered outbreaks of vaccine-preventable diseases such as measles, pertussis and meningitis, posing a threat to those unvaccinated because of medical contraindications, age and parental choice. For example, in Washington, statewide refusal rates now exceed 5 percent, including rates exceeding 15 percent in some counties. Other states show doubling rates. Also worrisome is the disproportionate amount of time pediatricians must now spend to assure fearful parents that vaccination is the best choice for their child. At what level will the growing refusal rates put us at risk of major epidemics?

    What has been missing in order to give parents confidence that immunization is one of the best ways to protect the health of their children? Our national failure falls into two categories. First, we’ve had inadequate ongoing, credible education of the public and health professions from trusted public-health officials concerning the known and unknown benefits and risks of vaccines. Today’s parents have little fear of diseases they mistakenly think have been eliminated by vaccines. Second, there’s been grossly insufficient investment in research on the safety of immunization. Together, these failures contributed to undermining of public confidence.

    This is not the first time parental concern has threatened to deprive our children of the benefits of immunization. In the early 1980s, a spate of lawsuits threatened to drive vaccinemakers and doctors out of the immunization business. Then three highly polarized groups—parents who believed vaccines injured their children, vaccine companies and pediatricians—collaborated to create the National Childhood Vaccine Injury Act of 1986 (NCVIA). That law, a pragmatic, compromise solution, saved a then-fragile U.S. immunization effort. It offered financial relief to vaccine-injured children, prevented the demise of a vaccine industry that had dwindled rapidly from 26 to four companies and protected pediatricians whose careers then were being jeopardized by malpractice suits, even though they were properly administering vaccines. Over the past two decades, that law has distributed $1.8 billion with financial compensation to more than 2,200 families and individuals, encouraged dramatic expansion of the vaccine industry and allowed pediatricians to remain the mainstay of our successful immunization program.

    The vaccine injury act put the secretary of the Department of Health and Human Services (HHS) in charge of planning and monitoring the effectiveness and safety of our national immunization program. There’s plenty of financial incentive for industry, venture capitalists, government agencies, clinicians and the academic community to develop and distribute vaccines. In contrast, without federal government investment, no such incentives are available to support research on vaccine safety.

    The responsibility for development, licensing, purchase, distribution and monitoring of vaccines is divided among a handful of federal agencies. Because of the wide range of scientific skills needed to study the safety of vaccines, we need a coordinated plan with funds to match. But no such plan has ever been put in effect. (In the last few months of his tenure under President George W. Bush, HHS Secretary Michael Leavitt did make some progress, but the effort was unfunded, incomplete and hampered by his short, lame-duck status.)

    What remains to be done? The incoming secretary of HHS, with the backing of the White House, must carry out aggressively the duties assigned by the 1986 law: development and implementation of a national vaccine plan that includes adequate funds for communication and vaccine-safety research. Given the current distrust of government, development and accountability for the plan deserves serious, transparent input, not just by scientists but also by more than token participation of the public. It is that public whose trust has been eroded.

    As parents, grandparents and health professionals, we know how immunization has revolutionized child health. But to maintain that progress, we must restore public trust in vaccinations. Ignoring public anxiety about childhood vaccines—and the increase in parents who skip or stretch out immunizations—risks even more serious outbreaks of vaccine-preventable diseases. We need visible leadership from the incoming secretary of HHS, supported by President Obama. The new public-health team must describe clearly the known benefits and risks of vaccines—and take into account safety issues as perceived by the public and scientific community. We know the new administration has a long list of problems to confront, but there are few issues more urgent than the health of our children. We hope they act quickly.

    (SOURCE: http://www.newsweek.com/2009/02/22/the-confidence-gap.html)





  • Fighting the Autism-Vaccine War

    April 22, 2011

    By Bernadine Healy, M.D.
    Posted: April 10, 2008

    One of the most vitriolic debates in medical history is just beginning to have its day in court—vaccine court, that is. Without laying blame, the independent Office of Special Masters of the Court of Federal Claims—with a 20-year record of handling vaccine matters—recently conceded that the brain damage and autistic behavior of Hannah Poling stemmed from her exposure as a toddler to five vaccinations on one day in July 2000. Two days later, she was overtaken by a high fever and an encephalopathy that deteriorated into autistic behavior. Even though autism has a strong genetic basis, and she has a coexisting rare mitochondrial disorder, I would not be too quick to dismiss Hannah as an anomaly.

    Click here to find out more!

    At some level, the decision was a vindication for families who have been battling with the vaccine community, arguing that some poorly understood reaction to components of vaccines or their mercury-based preservative, thimerosal, could cause brain injury. Yes, vaccines are extraordinarily safe and bring huge public health benefit. (Remember the 1950s polio epidemics?) But vaccine experts tend to look at the population as a whole, not at individual patients. And population studies are not granular enough to detect individual metabolic, genetic, or immunological variation that might make some children under certain circumstances susceptible to neurological complications after vaccination.

    A trigger? Families are not alone in searching for a trigger that might explain why autism and autism spectrum disorders have skyrocketed; now they reportedly affect about 1 in 150 kids. No doubt some of the increase is soft, due to broader diagnostic criteria, greater awareness, and—now that the notion of a detached “refrigerator” mom as a cause has blessedly fallen by the wayside—greater openness. But the rise of this disorder, which shows up before age 3, happens to coincide with the increased number and type of vaccine shots in the first few years of life. So as a trigger, vaccines carry a ring of both historical and biological plausibility.

    Go back 40 or 50 years. The medical literature is replete with reports of neurological reactions to vaccines, such as mood changes, seizures, brain inflammation, and swelling. Several hundred cases of the paralytic illness Guillain-Barré after the swine flu vaccine were blamed on the government and gave Gerald Ford heartburn—but eventually led to the vaccine court.

    Pediatricians were concerned enough about mercury, which is known to cause neurological damage in developing infant and fetal brains, that they mobilized to have thimerosal removed from childhood vaccines by 2002. Their concern was not autism but the lunacy of injecting mercury into little kids through mandated vaccines that together exceeded mercury safety guidelines designed for adults. But as in all things vaccine, this move too was contentious. Both the Centers for Disease Control and Prevention and the World Health Organization remain unconvinced that thimerosal puts young children at risk.

    There is no evidence that removal of thimerosal from vaccines has lowered autism rates. But autism numbers are not precise, so I would say that considerably more research is still needed on some provocative findings. After all, thimerosal crosses the placenta, and pregnant women are advised to get flu shots, which often contain it. Studies in mice suggest that genetic variation influences brain sensitivity to the toxic effects of mercury. And a primate study designed to mimic vaccination in infants reported in 2005 that thimerosal may clear from the blood in a matter of days but leaves inorganic mercury behind in the brain.

    The debate roils on—even about research. The Institute of Medicine in its last report on vaccines and autism in 2004 said that more research on the vaccine question is counterproductive: Finding a susceptibility to this risk in some infants would call into question the universal vaccination strategy that is a bedrock of immunization programs and could lead to widespread rejection of vaccines. The IOM concluded that efforts to find a link between vaccines and autism “must be balanced against the broader benefit of the current vaccine program for all children.”

    Wow. Medicine has moved ahead only because doctors, researchers, and yes, families, have openly challenged even the most sacred medical dogma. At the risk of incurring the wrath of some of my dearest colleagues, I say thank goodness for the vaccine court.

    (SOURCE: http://health.usnews.com/health-news/managing-your-healthcare/brain-and-behavior/articles/2008/04/10/fighting-the-autism-vaccine-war)


  • The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform?

    April 22, 2011

    Advisory Commision on Childhood Vaccines, November 18, 2008

    Statement of the National Vaccine Information Center
    Barbara Loe Fisher, Co-founder & President
    Advisory Commission on Childhood Vaccines

    “The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform? ”
    November 18, 2008

    Mr. Chairman and Members of the Advisory Commission on Childhood Vaccines:

    My name is Barbara Loe Fisher and I am co-founder and president of the non-profit organization known today as the National Vaccine Information Center (www.NVIC.org) that worked with Congress on the National Childhood Vaccine Injury Act of 1986, which included the Vaccine Injury Compensation Program (VICP) for which this Advisory Commission has provided guidance for the past 20 years. Along with our organization’s first president, environmental law attorney Jeffrey Schwartz, who was a principal co-architect of the Act, NVIC co-founder Kathi Williams and I were all parents of DPT vaccine injured children. We participated in four years of deliberations with congressional staff, representatives from the American Academy of Pediatrics (AAP), vaccine manufacturers, and the Departments of Health and Human Services (DHHS) and Justice.

    The Vaccine Injury Act included in Title 3 of Public Law 99-660
    http://history.nih.gov/01Docs/historical/documents/PL99-660.pdf was historic for several reasons.

    It was the first acknowledgement by this society that vaccine injuries and deaths are not a myth but are real with catastrophic consequences for the lives of the vaccine injured and their families, who take care of them. The law was passed by Congress at the specific request of pharmaceutical companies threatening to stop making vaccines without product liability protection, as well as organizations representing pediatricians reluctant to give childhood vaccines without liability protection. It is a matter of public record that the Departments of Health and Human Services and Justice were strongly opposed to the legislation.

    The young parents of vaccine injured children, who came to the table in the early 1980’s at the request of congressional staff to fight for the rights of vaccine consumers and the vaccine injured, agreed to work on the Act because of promises made by Congress and the AAP that the proposed legislation would provide a fair, expedited, non-adversarial, less traumatic, less expensive no-fault compensation alternative to civil litigation. We believed we were participating in the development of a law which would give – in the words of the then AAP Chairman – “simple justice to children.” In fact, Congress made it clear that congressional intent was to create a system that would be “expeditious and fair” to the vaccine injured and be unlike a trial in order to offer an attractive“non-adversarial” alternative to a lawsuit against vaccine manufacturers and physicians.

    Parents had two conditions for coming to the table: first, there would be no agreement to an exclusive remedy system that would bar a lawsuit if federal compensation was denied or too little was offered to meet the injured child’s lifetime needs; or if it could be demonstrated a vaccine manufacturer could have made a safer vaccine, or had engaged in criminal fraud or gross negligence; and second, the Act must contain provisions to make vaccines and policies safer so fewer children would be harmed and need compensation.

    We knew then, as we do now, that a law shielding vaccine manufacturers and providers from liability for vaccine harm must also contain strong provisions to ensure that the safest vaccines and policies are in place.

    The final Act did include important safety provisions requiring doctors to give parents written vaccine benefit and risk information before children are vaccinated; to record serious health problems following vaccination in the child’s medical record; to keep a permanent record of all vaccines given including the manufacturer’s name and lot number; and to report serious health problems, hospitalizations, injuries and deaths that occur within 30 days of vaccination to a new, centralized federal Vaccine Adverse Events Reporting System (VAERS). The Act also directed the Institute of Medicine (IOM) to conduct a review of the medical literature for scientific evidence that vaccines can cause injury and death, which resulted in four major reports by IOM to Congress in 1991 and 1994 providing that evidence.

    All through the Act the words “safety” and “safe” are repeated over and over again and there is language emphasizing prevention of vaccine reactions such as “to make health practitioners and the public aware of potential adverse reactions and contraindications to vaccines” and “to reduce the risk of any major adverse reactions to the vaccine that may occur.” All of the vaccine safety provisions are in the Act because parents of vaccine injured children insisted any law providing liability protection must also help prevent vaccine harm.

    In 1999, I gave congressional testimony http://www.nvic.org/Loe_Fisher/blfvicp82899.htm outlining the reasons why parents, who participated in good faith in creating the Act, felt betrayed by how it had been implemented. I stated:

    “There is bitter disappointment and pervasive unhappiness among parents and the plaintiff’s bar with the current structure and administration of the vaccine injury compensation program….public opposition to forced vaccination with multiple vaccines in the absence of adequate scientific evidence documenting vaccine safety and effectiveness is growing…and when parents are unable to obtain financial assistance to care for a severely vaccine injured child, public faith in the mass vaccination system is further eroded.”

    I noted that, in 1989 Amendments, the House of Representatives re-directed the U.S. Court of Claims “to provide for a non-adversarial, expeditious and informal process for the resolution of petitions filed under the Program,” a sentiment that was reiterated in the 1989 House and Senate Conferee Report, which made it clear Congress was unhappy that the claim’s process had become complicated, time-consuming and emotionally draining for petitioners. The Report stated “The re-invention of the adversarial process will serve neither to compensate injured children nor maintain the stability of the immunization program in the U.S.”

    In preparing to make this statement today, I reviewed the legislative history of the Act and spoke with plaintiff’s attorneys and parents, who have applied for compensation for their vaccine injured children, as well as parents being told by pediatricians that their healthy children must get 69 doses of 16 vaccines from birth to age 18 to comply with federal recommendations and, in some states like New Jersey, are mandated to give their children three dozen doses of more than a dozen vaccines to go to school.

    I sincerely regret having to come here today to reiterate much of what I told Congress in 1999, as well as provide further evidence that this program is not operating in a way that lives up to the spirit and intent of what legislators intended when parents with vaccine injured children agreed to work on this Act 25 years ago, believing the vaccine injured and their attorneys would be treated with fairness, compassion, and good will in this program.

    What has happened over the past two decades since the Act’s passage?

    Although the vaccine manufacturers and pediatricians may have been primarily concerned with liability protection while Congress was anxious to protect vaccine supply and delivery, parents in the 1980’s were assured that a  federal compensation system would even the playing field for vaccine victims and their attorneys. We were assured that, unlike a lawsuit in civil court, the federal compensation system would be based on the presumption that a vaccine or combination of vaccines caused the child’s injury or death if no other  demonstrated cause could be found. The emphasis was on presumption and there was recognition that thispresumption, in the absence of scientific data and certainty, would be in the plaintiff’s favor even if that presumption would result in some children being compensated who were not, in fact, vaccine injured.

    The emphasis on presumption was integral to the integrity of a no-fault, expedited vaccine injury compensation system. There continues to be a lack of scientific understanding of the specific biological mechanisms involved in most vaccine-associated injuries and deaths and an absence of pathological profiles to conclusively prove which health problems following vaccination are, in fact, vaccine-induced and which are not. These gaps in scientific knowledge and uncertainty means that a no-fault vaccine injury compensation system must err on the side of presumption of causation rather than proof of causation to offer a viable administrative alternative to a lawsuit.

    Even so, the architects of the Act knew that presumption could not be arbitrary but had to be predicated on evidence that, when certain signs and symptoms were present following vaccination and those signs and symptoms were followed by permanent injury or death, the vaccine could be presumed to have played a role in the absence of a demonstrated biologically plausible alternative cause.

    The mechanism to facilitate presumption agreed upon by all parties participating in the development of the Act was a Table of Compensable Events, known as the Vaccine Injury Table. This Vaccine Injury Table, devised after exhaustive review of vaccine medical literature and years of discussion with doctors, vaccine manufacturers and parents was designed to remove much of the burden of proof of cause and effect that exists in an adversarial vaccine injury lawsuit in civil court.

    For example, the Table was intended to spell out the signs and symptoms associated with DPT vaccine induced brain inflammation, including seizures within 72 hours ( a DPT vaccine-induced adverse event which had been acknowledged in more than 60 years of medical literature) in order to provide a framework to allow for a presumption of causation under the Act. Therefore, the Table was inserted into the law by congressional sponsors to ensure that the compensation process would remain, essentially, administrative rather than litigious.

    The reality of what has occurred during the past two decades is something quite different.

    In the 1990’s, DHHS chose to wield discretionary authority given under the Act to change the rules and eliminate almost all on-Table adverse events that would allow for presumption of causation. With the assistance of the Department of Justice, DHHS turned the administrative compensation process into a highly adversarial, lengthy, expensive, traumatic and unfair imitation of a court trial for vaccine victims and their attorneys. The only difference is that the trial is now conducted in the U.S. Court of Claims in front of one individual who acts as judge and jury.

    Ironically, parents who helped create the Act in the 1980’s were told that Congress needed to grant the Secretary of DHHS broad discretionary authority to alter the Vaccine Injury Table so the Secretary could expand the list of presumptions for injuries associated with existing and future vaccines to make the system more inclusive not less inclusive. We never imagined DHHS wouldtake away existing presumptions from the Table because the stated purpose of the Act was to err on the side of compensating potential vaccine victims in order to offer an effective alternative to vaccine injury lawsuits.

    But DHHS did not just remove signs and symptoms of potential vaccine reactions from the Table of Compensable Events. Federal health officials also used discretionary authority to arbitrarily redefine what constitutes a permanent vaccine injury. For example, DPT vaccine induced encephalopathy, the first signs of which can be manifested by seizures, has long been recognized by the medical community. In a move to make compensation more difficult to obtain, DHHS redefined the clinical signs that have been used for more than a century to diagnose an “encephalopathy.” One attorney representing vaccine injured children in the program commented that the re-writing of the medically recognized definition of “encephalopathy” by DHHS “is so restrictive that it is believed by petitioners’ counsels across this country that they will never again see an injury to a child that falls within the definition’s narrow confine” for the purpose of awarding uncontested compensation.

    The National Vaccine Information Center has repeatedly called for DHHS under rule making authority, as well as Department of Justice and U.S. Court of Claims officials to make the federal compensation process more fair and humane for petitioners, their families, expert witnesses and plaintiff’s attorneys. For example, DHHS has the power to add “death within 72 hours” of vaccination to the Table as a presumption event. The Department of Justice can choose to make it less traumatic for vaccine victims and their families by including in compensation awards guardianship costs; fairly calculating lost future income and expenses for housing modifications and special education; and providing mental health counseling for parents coping with their vaccine injured child’s 24-hour needs – instead of fighting most special needs costs identified by life care planners and doctors advising families.

    The U.S. Court of Claims can make it possible for more attorneys to represent vaccine victims in the program by awarding interim fees to plaintiff’s attorneys, a discretionary authority affirmed by the U.S. Court of Appeals in the Avera decisionhttp://www.ll.georgetown.edu/federal/judicial/fed/opinions/07opinions/07-5098.pdf. And both Justice and U.S. Court of Claims officials can refrain from trying to discredit and destroy the reputations of plaintiff’s expert witnesses in what is perceived by parents as an attempt to frighten and discourage doctors from testifying on behalf of vaccine injured children.

    What I heard most often when speaking with parents and plaintiff’s attorneys was that the compensation process is filled with a “mean-spiritedness” and a growing hostility on the part of DHHS, Justice and U.S. Court of Claims officials toward plaintiffs, their families, experts and attorneys. Whether that is true in every case, I don’t know, but there certainly is a sense that parents feel their children are pawns in a political tug of war that compels those in government responsible for administering the compensation program to protect the reputation of the current vaccine system at all costs – even if it means denying compensation to vaccine victims in order to limit the numbers of children acknowledged by government as having been harmed by vaccines being promoted by government.

    In retrospect, the fact Congress made DHHS and Justice – two government agencies opposed to passage of the Act – responsible for making the Act work is perhaps its greatest operational flaw.

    What are other signs that obtaining federal compensation has become a highly adversarial, time consuming process and that the Act does not do what Congress intended it to do?

    In 1986,  federal health officials recommended 23 doses of seven vaccines be given to children from two months to six years of age and most of these were mandated by states. The Act, in fact, was supposed to protect the supply of those seven vaccines for tetanus, diphtheria, pertussis, polio, measles, mumps and rubella.  Since then, 46 doses of nine new vaccines have been added to the CDC recommended schedule for girls (43 doses of eight new vaccines for boys) and many state health departments have either mandated most of them or are in the process of mandating them. Today, there are twice as many opportunities for vaccine injury or death to occur during childhood than before the Act was passed more than two decades ago.

    But with this increased vaccine adverse event risk exposure, what has been done to minimize increased vaccine risks and also to fairly compensate those injured by one or more of the new vaccines?

    DHHS has recommended every one of the nine new vaccines for universal use, which allows all nine to be added to the compensation program. This gives automatic liability protection to the drug companies marketing these nine new vaccines as well as to all doctors administering them.

    When parents look at the Table of Compensable Events, what do they see? They see that no signs, symptoms or injuries have been added to the Table for these nine new vaccines – except anaphylaxis within four hours for hepatitis B vaccine. They see that if their child is injured or dies after getting one of these vaccines, they are in for a long, hard fight to obtain federal compensation in the U.S. Court of Claims.

    And when they check out the statistics on the Health Resources & Services Administration (HRSA) website (http://www.hrsa.gov/vaccinecompensation) they find out that two out of three individuals applying for vaccine injury compensation have been turned away empty handed even though to date about  $1.8B has been awarded to more than 2,200 plaintiffs out of some 12,000 who have applied. And they learn that nearly 5,000 of the vaccine injury claims are sitting in limbo because they represent children who suffered brain and immune system dysfunction after vaccination but have been diagnosed with regressive autism, which is not listed on the Table of Compensable Events. Yet there is $2.7B sitting unawarded in the Trust Fund and people suggesting all sorts of ways to use that money for all sorts of reasons other than for compensating vaccine victims.

    The fact that the compensation program is not working the way parents were promised it would work and Congress intended it to work is also demonstrated by the fact that parents of vaccine injured children and their attorneys have been forced to seek justice in the civil courts. In a series of federal court cases beginning with the 1996 U.S. Supreme Court case Donna E. Shalala, Secretary of Health & Human Services v Margaret Whitecotton http://www.law.cornell.edu/supct/html/94-372.ZO.html the judicial system has reminded  DHHS, Justice and the U.S. Court of Claims that Congress intended the compensation program to be an “expeditious, just and non-adversarial” alternative to a lawsuit.

    In the landmark 2005 Althen casehttp://caselaw.lp.findlaw.com/data2/circs/fed/045146p.pdf the Court of Appeals for the Federal Circuit  affirmed that the burden of proof for vaccine victims filing under the Act should be lessened. The Court made it clear a person need only show a vaccine was the likely cause of the injury and that experts presenting evidence in favor of compensating the vaccine victim can base their opinions on circumstantial evidence rather than conclusive scientific evidence.

    In the 2006 Capizzano casehttp://www.ll.georgetown.edu/Federal/judicial/fed/opinions/05opinions/05-5049.pdf the Federal Court of Appeals held, once again, that the petitioner does not need to present peer-reviewed scientific literature proving causation but need only provide a medical theory linking an injury to the vaccine, a logical sequence of cause and effect, and a temporal relationship between them as evidenced by medical records or expert opinion, especially the opinion of doctors who have treated the child.

    After two decades, the federal courts are speaking and, importantly, judges are looking back at the legislative history which so clearly affirms the intent of Congress when creating the Act .In a Supreme Court of Georgia ruling on October 6, 2008 in American Home Products v. Ferrarihttp://www.gasupreme.us/pdf/s07g1708.pdf the justices unanimously held that the National Childhood Vaccine Injury Act does not give a vaccine manufacturer blanket immunity from vaccine injury lawsuits if it can be proven that the company could have made a safer vaccine.

    Georgia Supreme Court Justice George Carley wrote that the 1986 law and “the congressional intent behind it shows that the Vaccine Act does not pre-empt all design defect claims.” He added that Congress did not “use language which indicates that use of the compensation system is mandatory” but only “an appealing alternative” to the courts. He wrote that there is no evidence that“FDA approval alone renders a vaccine unavoidably safe” and said “We hesitate to hold that a manufacturer is excused from making changes it knows will improve its product merely because an older, more dangerous version received FDA approval,”adding that to do so would have “the perverse effect” of granting complete immunity from liability to an entire industry” and he concluded that “in the absence of any clear and manifest congressional purpose to achieve that result, we must reject such a far-reaching interpretation.”

    Judge Carley got it exactly right. There was no intent by Congress in 1986 to totally remove all liability from drug companies marketing vaccines for injuries and deaths cause by those vaccines. And there was no intent by Congress to put a law in place that would absolve federal agencies from their responsibility to ensure that vaccines and vaccine policies are necessary, safe and effective. That is because Congress did not just want to protect the vaccine supply. The  lawmakers also agreed with parents of vaccine injured children that everything possible must be done to make vaccines and vaccine policies safer to minimize vaccine injuries and deaths.

    In the opening Section 2101 of the Act, which established a National Vaccine Program, there is a clear statement of purpose, which is: “to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines.” Under this section, there is a subsection entitled “Evaluating the Need for and the Effectiveness and Adverse Effects of Vaccines and Immunization Activities” which acknowledges there was no a priori assumption on the part of lawmakers that every vaccine industry produces is an automatic candidate for a universal use recommendation by the CDC and inclusion under the Act for the purpose of liability protection.

    Section 2127 of the Act is entitled  “Mandate for Safer Childhood Vaccines” and it directs DHHS to  “promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market” and “to make or assure improvements…with respect to the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches of vaccines and research on vaccines in order to reduce the risks of adverse reactions to vaccines.”

    While this language, which was included at the request of parents of vaccine injured children, does not address responsibilities of this Commission in providing oversight on the implementation of the Act’s compensation mechanism, this Commission was charged under the Act with advising the Secretary in implementing responsibilities under Sections 2125 and 2127 about the “need for childhood vaccination products that result in fewer or no significant adverse reactions; gathering information on adverse reaction reporting requirements; and obtaining, compiling, publishing and using credible data related to the frequency and severity of adverse reactions associated with childhood vaccines.”

    There is enough blame to go around when looking at why the 1986 National Childhood Vaccine Injury Act has not lived up to the spirit and intent that prompted the 99th Congress to work so hard to create and pass it. Congress itself walked away from providing oversight after the 1989 Amendments were passed, even though sporadic attempts have been made in the House and Senate in bills that sought to address substantive issues such as extending the statute of limitations and increasing the $250,000 death benefit and pain and suffering limit.

    There is little that can be done to recapture a dream of justice that has turned into a nightmare for thousands of families with vaccine injured children, who have been denied federal compensation, while vaccine manufacturers and doctors have enjoyed unprecedented liability protection for the past two decades. That liability protection has made it easy for four dozen doses of nine  new vaccines to be added to the childhood vaccine schedule, some of them fast tracked, without any studies being conducted to evaluate the potential long term adverse health effects of giving children an unprecedented number of vaccines throughout childhood.

    That liability protection has made it easy for the CDC and AAP to narrow contraindications to vaccination so severely that almost no health condition qualifies as a reason not to vaccinate, placing many more vulnerable children at higher risk for suffering vaccine reactions that are often dismissed by pediatricians and government health officials alike as “a coincidence.” It is no wonder that estimates for reporting of vaccine associated health problems, hospitalizations, injuries and deaths by vaccine providers to the VAERS system is only between one and ten percent.

    The fact that unprecedented numbers of highly vaccinated children are now suffering from chronic disease and disability compared to a quarter century ago calls into question the wisdom of an Act, which has made it easier for industry to rush to market new vaccines that government officials mandate while shielding vaccine makers and providers from liability for any harm that is done. The fact that there has been no attention paid by industry and government to minimizing vaccine risks, including no scientific research – as the Act called for – into identifying individuals at high risk for suffering vaccine adverse responses so their lives can be spared – speaks volumes about the disconnect between the intent of Congress to prevent vaccine injuries and deaths and the intent of those operating the federal compensation system to deny they exist.

    For this reason, many parents I have spoken with maintain that the Vaccine Injury Compensation System is a failed experiment in tort reform that should be repealed. They believe the vaccine injured should be able to return to the courts, where discovery is allowed, to sue vaccine manufacturers for design defect and failure to warn and sue pediatricians who carelessly implement one-size-fits-all  vaccine policies rather than adhere to the precautionary principle to  “First, do no harm.”

    The decision of whether or not the Vaccine Injury Compensation Program is worth saving belongs to the smart, vaccine educated parents with young children today, who you will be hearing from as they stand up in greater numbers across this country for the legal right to make informed, voluntary vaccine decisions for their children. I promise you, they will not wait another quarter century for those of you operating this program to do what you were supposed to do a long, long time ago.

    The National Vaccine Information Center will continue to inform and educate the public and legislators about the history of the National Vaccine Injury Act of 1986 and why safety, not liability protection, must always come first in America’s public health programs.

    (SOURCE: National Vaccine Information Center)


  • CDC Vaccine Researcher Indicted For Fraud

    April 20, 2011

    FOR IMMEDIATE RELEASE: Wednesday, April 20, 2011
    Contact: Vaccine Safety Council of Minnesota
    Wayne Rohde 651-705-5030 / 405-973-7049

    CDC Vaccine Researcher Indicted For Fraud

    He Co-created Studies Claiming Vaccines Don’t Cause Autism

    ST. PAUL, MN – A U.S. federal grand jury has indicted a prominent vaccine researcher for multiple counts of fraud.

    Poul Thorsen, 49, was indicted April 13 on thirteen counts of wire fraud and nine counts of money laundering of grants awarded to Denmark agencies by the U.S. Centers for Disease Control. “This defendant is alleged to have orchestrated a scheme to steal over $1 million in CDC grant money earmarked for autism research,” said United States Attorney Sally Quillian.

    Thorsen was instrumental in co-constructing the “Danish Studies” widely claimed to refute the vaccine/autism link. But according to the U.S. advocacy group Autism Action Network, critics of the studies believe “highly suspect methods were used to arrive at the conclusion that there was no association between exposure to either thimerosal or the MMR vaccine and autism, even though standard epidemiological methods showed an association.”

    “The Thorsen indictment is just the tip of the CDC’s corruption iceberg,” said Nancy Hokkanen, a Minnesota parent of a vaccine-injured child. “For more than a decade vaccine safety advocates have begged journalists to investigate systematic vaccine program corruption, which is destroying consumer health and trust.”

    The story of the theft was broken more than a year ago in the U.S. by Ginger Taylor, contributing editor of the book Vaccine Epidemic, on her blog Adventures In Autism. Next the story was further investigated by Age of Autism, and then reported by Fox News late last year. Since the indictment was announced bloggers with links to Pharma, CDC and the Department of Defense are trying to downplay reports by saying Thorsen’s misappropriation of tax-funded millions is “isolated” and a “distraction,” and does not impact the quality of research over which Thorsen presided.

    Vaccine safety advocates are concerned that this case, which has the potential to implicate officials at the CDC/HHS, will be policed by the Department of Justice. “In the Vaccine Injury Compensation Program, the DOJ acts as the attorney to defend HHS against families’ claims that vaccines can cause autism,” Taylor said. “In the highly publicized Autism Omnibus hearings in the VICP, DOJ used Thorsen’s research to bolster their defense.”

    Taylor added, “A clear conflict of interest exists here. If DOJ earnestly investigates claims that the research was rigged to give CDC results exonerating their vaccine program, the DOJ hurts their own efforts in defending HHS in the VICP. This is especially sensitive now that HRSA, which administrates the VICP for HHS, issued a statement admitting that vaccines can cause a type of brain encephalopathy that leads to autism. We are hoping the media will step up and hold DOJ’s feet to the fire so we get to the bottom of what is going on at HHS, so this does not simply become another case of HHS investigating itself.”

    “The agency backpedaling has begun,” said Hokkanen. “Here are two reasons why the world has an autism epidemic: The CDC doesn’t investigate medical conditions of people with vaccine injuries, and journalists don’t investigate corrupt people within the CDC.”



    • Why did the U.S. government wait to act until Danish government authorities charged Poul Thorsen with forging documents and tax evasion?

    • Why did original stories report Thorsen’s alleged theft near $2 million?

    • Will the U.S. Department of Justice offer Poul Thorsen a deal in order to spare incriminating revelations about his CDC colleagues?

    • David Bowman at the Office of Communications of the Health and Resources Services Administration, the HHS department that administers the VICP, said that vaccines can cause an encephalopathy (brain damage) that “may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.” Why has this warning not been issued to physicians so that they can monitor children who present with autism-like symptoms for vaccine-induced encephalopathy or encephalitis?

    • In light of this statement, and the statement that CDC chief Julie Gerberding made on CNN that vaccines can cause “autism-like symptoms” in children with undiagnosed, asymptomatic mitochondrial disorders, why does CDC continue to allow medical professionals to labor under the presumption that there is no association between vaccines and autism?

    • If statistical epidemiology is the lowest rung on the evidentiary chain, then why is it used in an attempt to disprove adverse vaccine reactions provable by lab tests?

    • Whatever happened to Dr. Thomas Verstraeten, whose vaccine/autism epidemiological machinations were revealed in the SafeMinds Generation Zero analysis and circulation of his “It just won’t go away” memo?

    • Poul Thorsen is accused of stealing $1,000,000 and reporters are silent; so why is Dr. Andrew Wakefield vilified for making an inconvenient medical discovery replicated by other researchers?

    • On April 11, 2011, Dr. Max Wiznitzer told a Marietta College audience, “If you can’t trust the integrity of the researcher, you can’t trust the research.” Dr. Wiznitzer earns side money by testifying in the National Vaccine Injury Compensation Program against vaccine injury victims. To whom were Dr. Wiznitzer’s words in reference, and were they appropriately directed?


  • Vaccines and autism: a new scientific review

    April 5, 2011

    For all those who’ve declared the autism-vaccine debate over – a new scientific review begs to differ. It considers a host of peer-reviewed, published theories that show possible connections between vaccines and autism.

    The article in the Journal of Immunotoxicology is entitled “Theoretical aspects of autism: Causes–A review.” The author is Helen Ratajczak, surprisingly herself a former senior scientist at a pharmaceutical firm. Ratajczak did what nobody else apparently has bothered to do: she reviewed the body of published science since autism was first described in 1943. Not just one theory suggested by research such as the role of MMR shots, or the mercury preservative thimerosal; but all of them.

    Ratajczak’s article states, in part, that “Documented causes of autism include genetic mutations and/or deletions, viral infections, and encephalitis [brain damage] following vaccination [emphasis added]. Therefore, autism is the result of genetic defects and/or inflammation of the brain.”

    The article goes on to discuss many potential vaccine-related culprits, including the increasing number of vaccines given in a short period of time. “What I have published is highly concentrated on hypersensitivity, Ratajczak told us in an interview, “the body’s immune system being thrown out of balance.”

    University of Pennsylvania’s Dr. Brian Strom, who has served on Institute of Medicine panels advising the government on vaccine safety says the prevailing medical opinion is that vaccines are scientifically linked to encephalopathy (brain damage), but not scientifically linked to autism. As for Ratajczak’s review, he told us he doesn’t find it remarkable. “This is a review of theories. Science is based on facts. To draw conclusions on effects of an exposure on people, you need data on people. The data on people do not support that there is a relationship. As such, any speculation about an explanation for a (non-existing) relationship is irrelevant.”

    Ratajczak also looks at a factor that hasn’t been widely discussed: human DNA contained in vaccines. That’s right, human DNA. Ratajczak reports that about the same time vaccine makers took most thimerosal out of most vaccines (with the exception of flu shots which still widely contain thimerosal), they began making some vaccines using human tissue. Ratajczak says human tissue is currently used in 23 vaccines. She discusses the increase in autism incidences corresponding with the introduction of human DNA to MMR vaccine, and suggests the two could be linked. Ratajczak also says an additional increased spike in autism occurred in 1995 when chicken pox vaccine was grown in human fetal tissue.

    Why could human DNA potentially cause brain damage? The way Ratajczak explained it to me: “Because it’s human DNA and recipients are humans, there’s homologous recombinaltion tiniker. That DNA is incorporated into the host DNA. Now it’s changed, altered self and body kills it. Where is this most expressed? The neurons of the brain. Now you have body killing the brain cells and it’s an ongoing inflammation. It doesn’t stop, it continues through the life of that individual.”

    Dr. Strom said he was unaware that human DNA was contained in vaccines but told us, “It does not matter…Even if human DNA were then found in vaccines, it does not mean that they cause autism.” Ratajczak agrees that nobody has proven DNA causes autism; but argues nobody has shown the opposite, and scientifically, the case is still open.

    A number of independent scientists have said they’ve been subjected to orchestrated campaigns to discredit them when their research exposed vaccine safety issues, especially if it veered into the topic of autism. We asked Ratajczak how she came to research the controversial topic. She told us that for years while working in the pharmaceutical industry, she was restricted as to what she was allowed to publish. “I’m retired now,” she told CBS News. “I can write what I want.”

    We wanted to see if the CDC wished to challenge Ratajczak’s review, since many government officials and scientists have implied that theories linking vaccines to autism have been disproven, and Ratajczak states that research shows otherwise. CDC officials told us that “comprehensive review by CDC…would take quite a bit of time.” In the meantime, CDC provided these links:

    Interagency Autism Coordination Committee: http://iacc.hhs.gov

    Overview of all CDC surveillance and epi work: http://www.cdc.gov/ncbddd/autism/research.html

    CDC study on risk factors and causes: http://www.cdc.gov/ncbddd/autism/seed.html

    SOURCE: http://www.cbsnews.com/8301-31727_162-20049118-10391695.html

  • Measles, Minneapolis and Somali Kids

    April 1, 2011

    By Abdulkadir Khalif

    I am writing a response and a rebuttal to Maura Lerner’s story of 03/17/2011, (HERE) concerning Measles and unvaccinated Somali Kids in Minneapolis. This story, like so many others before it on this newspaper and others across the country, highlights the issue of autism and Somali kids. There is an increasing sense of desperation in medical circles and the media concerning the causes of autism and how to delink it to vaccinations. It is the wish of every parent in this country and around the world that causes and cures of autism are found quickly, and hopefully without forgoing the benefits of vaccines. I am a Somali parent, resident in Minneapolis and a father of a 6-year old boy who is severely affected by autism. He is still non-verbal and horribly dysfunctional.

    As a parent, I am desperately looking for answers from my son’s doctors. I am looking for a cure for my son’s conditions, or at least a treatment regime that would make him function as a human being and hopefully live an independent life once we are gone. I am not finding hope anywhere and obviously no answers for my many questions. Our doctors and scientists agree on a few things:

    • That they have no idea what causes autism.
    • That there is no known cure for autism.
    • That autism is a life-long condition for which there is no hope.
    • That behavioural therapy if administered early, consistently and over a long period of time may give some good results.
    • That vaccine and especially the suspect MMR is perfectly safe for all kids irrespective of their genes, diets, background and lifestyles.
    • That the rate of autism is increasing every year all over the world.
    • That autism has always been around and better diagnoses is giving it the attention it is getting now.
    • That some research has shown that some communities are more vulnerable than others.
    • That more research is needed to disprove earlier research.
    • That there is no money for autism causation research.
    • That they are still too ignorant about what autism is, and that instead of admitting that they would rather just deny its prevalence, rise etc.

    To me that sounds like a bunch of contradictions. It is sad that we have to trust our lives and that of our kids to a few technocrats and uncertain scientists who are voting with their pockets instead of their guts.

    I have a gut feeling (trust your gut feelings always) that my son was affected by what got into his body around the time he was 18 months. My son grew up a normal, healthy and bouncing baby. He started speaking a few words by the time he was about 15 months. He waited for me at the door everyday as I got back home from work and welcomed me inside. He knew how I opened the door and the approximate time I came home each day. He raced down the stairs and hugged me, then held my hand and led me inside. I looked forward to those moments and they were perfect moments as they relieved me of the day’s tensions and small workplace frustrations. Then one day, I came home and he did not welcome me as was his wont.

    A few days earlier, Abdimalik got his 18 months MMR vaccine as scheduled. I still remember that day. His mother was coming back from his appointment and passed my place of work to give me a ride home. Abdimalik was sitting in his car-seat, very quite, subdued and absent minded. As I took my seat I glanced back wondering if he was asleep or not. He was seated squarely in his seat but was looking straight ahead at a point in space. I called out to him and he did not respond. I shook him and he did not move. I looked at my wife and asked what happened and she explained where they came from and that everything went well. She explained how he thanked the nurse as she put a sticker on his chest before the injection in order to build rapport. After that we rode home in silence and life was never the same again.

    On all subsequent days after that, Abdimalik went from one extreme behavioural problem to another. Fortunately he did not have seizures or vomiting like many other kids we came to know. But he manifested all other behaviours like tantrums, biting, sleeplessness etc. We spent the entire next winter virtually awake at nights, relieving each other and trying everything possible to calm him down and put him to sleep. It was not until we withdrew dairy from his diet that he started sleeping. This simple advice came to us from another parent of an autistic child, and not from our medical caregivers. The doctors we visited knew exactly what the problem was but dare not tell us. One of them finally referred us to the school district, and there we heard the word “autism” for the first time.

    In the Star Tribune story I referred to above, the reporter desperately sought out a “Somali Doctor” who confirmed to him that four (4) unvaccinated Somali kids died of measles in the US and in other countries. This statement surprised me for the following reasons:

    • Why is it only this “Somali Doctor” who has statistics on the death of Somali kids all over the world?
    • How does he know about the status of Somali kids all over the world?
    • When he alludes to the fact that vaccines are perfectly safe, how does he explain the high rate of autism amongst the Somali kids of Minnesota? Does he even acknowledge the prevalence of autism amongst the Somalis of Minnesota?
    • Why is his testimony so important when he is just like any other Minnesota doctor on the pay books of the government which denies (and does not know) the causes and cures of autism? Is he not under the influence of the pharmaceutical companies just like all other doctors? I wonder what he will say if (God forbid) a relative of his is diagnosed with autism. I know a few “Somali Doctors” who have kids on the spectrum, approach us for help with diet and other therapies, and then go to their clinics to tell other families that vaccines are perfectly safe, when they themselves do not vaccinate their own kids anymore. What a shame and hypocrisy?
    • In his practice, how many unvaccinated Somali kids did he see who were also on the autism spectrum? That would be an interesting question to ask him.
    • What, according to the “Somali Doctor” is the Somali word for autism?
    • Any how, what do we expect would be the “Somali Doctor’s” response to a question from the Star Tribune? He has a job to protect, insurance money to collect, big money to make and a career to build, just like many other doctors in America and indeed the whole world.

    The vaccine scare in Minnesota or the USA did not start with a few Somali families refusing to vaccine their kids. In fact, Somali families got the word from mainstream Americans, some of who have successfully treated their kids. When I say that my son started sleeping and feeding after a Caucasian American mother advised us to remove dairy from his diet, I was not kidding. After we registered success with this step, we told our doctor and we were ignored and a direct answer was not forth-coming. How can I trust him again when he shows such a callous disregard?

    The Star Tribune, The New York Times, CNN, FOX News etc. will not stop writing or talking about autism and the Somalis of Minnesota for the foreseeable future, and we shall not give them that vacation until autism is no more amongst our children, or until the establishment acknowledges prevalence and starts looking for causation. We are even ready to forgive those who damaged our kids if they promise not to damage anymore kids. We can even sign such pledges just in case they are afraid of lawsuits and condemnations. The autism scourge is not only about Somalis or Americans or Chileans. This is an international problem and trying to localize it to Minnesota is insulting and a vain attempt to drive a wedge between us and mainstream Americans. It is a vain and naïve way of attributing color and race to an international pandemic. But whatever the motive of the powers that be, the autism community will remain steadfast and united against a superior force of big business and coward science.

    In conclusion, I wish to speak from my heart about a very emotional thing. I am a father of many kids, and all except Abdimalik were born outside this country. We have made America our home and enjoy the full benefits of any American citizenship. My first born son is now serving in Afghanistan, and his sister married an American. We are thus as American as any other American family, and I am not apologetic about speaking my mind or demanding for my rights. I feel for other American families in the same way, regardless of whether they are Caucasian, African-American, Asian or Native American. There is more that unites us than divides us, and autism should be viewed as a threat to our National Security. I say so because at the rate it is increasing, it is a fundamental threat to our very existence as a Nation and a negative influence on our role in the world. So, hiding from the truth and continuing to ignore a fast approaching disaster is a manifestation of a very unpatriotic disposition towards our country – and all this just to protect a few individuals whose aim in life is to line their pockets.

    I insist that we face the facts and turn our attention to finding the causes of autism. Prevalence in certain communities, and clusters in certain locations have already been confirmed. No more money should be thrown in the direction of confirming prevalence. We need more money to be thrown into causation research. We, the Somali parents of Minnesota have taken upon ourselves to invite caring scientists to help us unravel the mysteries of autism. The CDC woke up from the deep slumber afterwards and is now scrambling to scuttle that process by initiating yet another research to confirm prevalence. Their aim is to put a stop to this perennial Somali story by “scientifically” disproving prevalence. But I tell you sir, that whether one child or 10 children die of measles or whether dozens more contract the disease and recover, I would rather have my child suffer for a few days and then recover than to have him mentally damaged for life and be a burden on society. I would rather have one child die in infancy and join the rest in the calculation of mortality rates than to have thousands disabled and dehumanized for life. This may sound cruel, but it is not crueler than sending our young men and women to war in far away countries, knowing very well that some of them will come back in body bags. I will never accept the notion that a doctor who does not know what causes autism can still tell me what does not cause it.

    Abdulkadir Khalif is Contributing Editor to Age of Autism.

    SOURCE: http://www.ageofautism.com/2011/03/measles-minneapolis-and-somali-kids.html

  • Health Commissioner’s Statements Challenged By Vaccine Safety Council

    April 1, 2011

    Friday, April 1, 2011
    Vaccine Safety Council of Minnesota
    Contact – Jennifer Larson (952) 956-4999


    Vaccine Safety Council of Minnesota (VSCM) challenges statements by Minnesota Health Commissioner
    regarding vaccine risks.

    Trust in public health officials is rapidly deteriorating due to public policy that downplays the documented adverse effects of the MMR (measles, mumps, rubella) vaccine and dismisses parental reports of immediate seizures and developmental regression following the MMR as “coincidence.” Additionally, on two occasions this week public health officials have presented biased information about the risks of vaccination.

    March 26, 2011, the Minnesota Department of Health hosted a “Somali Educational Forum on Measles and MMR Vaccination.” Six of the Eight speakers made the false claim that vaccines do not cause autism despite governmental and judicial evidence to the contrary.

    VSCM presents the following information questioning this claim:

    • On July 20, 2007 the National Vaccine Injury Compensation Program of the U.S. Federal Courts ruled that the MMR vaccine alone had caused autism in petitioner Bailey Banks “both caused-in-fact and proximately caused by vaccination.”

    • VSCM co-founder Patti Carroll spoke with MN Department of Health Commissioner Ed Ehlinger before Saturday’s forum. She stated, “I was shocked to learn that Dr. Ehlinger, the top health official in the state, acted unaware that the head of the CDC acknowledged three years ago that vaccines can cause autism in susceptible individuals.”

    March 28, 2011, Health Commissioner Ehlinger stated in an interview with Gary Eichten of Minnesota
    Public Radio News “We have a safe & effective vaccine” when referring to the MMR vaccine.

    VSCM presents the following information to question this claim:

    • VAERS, the national vaccine safety surveillance program sponsored by the CDC and FDA, reported on the MMR vaccine “166 cases of encephalopathy [brain inflammation] occurring 6-15 days after vaccination have been identified.”

    During the MPR interview, Dr. Ehlinger responded to a caller who questioned the practice of giving multiple vaccines at once to a child. Dr. Ehlinger assured this caller that it was perfectly safe to give many vaccines at one time.

    VSCM presents the following information in questioning this claim:

    • Safety studies have never been done on the long-term side effects of multiple vaccines for the recommended 2011 schedule that are given at the same time.

    Vaccine Safety Council of Minnesota understands that parents who have witnessed adverse effects of
    the MMR with neurological damage are justifiably reluctant to give the vaccine to their other children, and we encourage medical professionals to acknowledge the truth of the parent’s experiences as well as their concerns about additional vaccines and safety. “Transparency from our health officials regarding the benefits AND risks of vaccines is the right of every individual” says co-founder Libby Rupp.

    Vaccine Safety Council of Minnesota advocates for:

    • Full disclosure by government and health officials of both the benefits and risks of vaccines

    • Promoting individual consumer safety through the use of vaccines that are free from mercury and other known neurotoxins

    • Complete transparency by government in vaccine policy-making decisions

    • Providing awareness and education for parental choice, informed consent and fair labeling

    • Ensuring that conflict of interest-free safety studies are done on every vaccine and every possible combination of vaccines that the government recommends for our children



  • Media Measles Reporting Biased and Incorrect

    March 25, 2011

    FOR IMMEDIATE RELEASE: Friday, March 25, 2011
    Contact: Vaccine Safety Council of Minnesota
    Wayne Rohde 651-705-5030

    Media Measles Reporting Biased and Incorrect

    ST. PAUL, MN – Media reporting on Minnesota’s recent handful of measles cases is biased and incorrect, says local consumer advocacy group Vaccine Safety Council of Minnesota.

    Parents of vaccine-injured children once again are asking what happened to objective investigative journalism, when reporters acted as watchdogs for all consumers rather than lapdogs repeating government and industry memos. Instead TV and newspaper articles seem calculated to create fear and coercion rather than inform consumers.

    Many Minnesota Somali parents report that their children regressed physically and mentally, often with seizures, immediately after receiving an MMR vaccine. However the Minnesota Department of Health is not visiting families to investigate and provide medical care for these sick children. Instead MDH is merely conducting statistical calculations, at a glacial pace.

    MMR vaccine efficacy problems are well documented in medical literature. A 1994 Archives of Internal Medicine article by the Mayo Clinic’s Dr. Gregory Poland noted the “Apparent Paradox of Measles Infections in Immunized Persons”: “Despite these high rates of immunization, 30% to 100% (mean, 77%) of all measles cases in these outbreaks occurred in previously immunized students.”

    MMR vaccine injuries are well documented by the U.S. government in its Vaccine Adverse Events Reporting System (VAERS). On July 20, 2007 the National Vaccine Injury Compensation Program ruled that the MMR alone had caused autism in Bailey Banks — “both caused-in-fact and proximately caused by his vaccination.”

    Because the MMR vaccine has harmed a significant number of children worldwide, many parents are justifiably wary of vaccinating – regardless of ethnicity, education or other sociological factors.

    A responsive government would continuously update vaccine policy to be consumer friendly, resulting in more babies vaccinated. The Centers for Disease Control and MDH must start accepting all vaccine consumer input, rather than denying documented adverse events.

    “Every child deserves safe vaccines,” said Vaccine Safety Council of Minnesota spokesperson Jennifer VanDerHorst-Larson. “If vaccines are causing injury, it’s unscientific, unethical and inhumane to let those injuries continue.”



    • Can the Minnesota Department of Health verify the strain of measles in the index case? Is it consistent with the other reported cases?
    • Can MDH confirm those children reported to be unvaccinated actually ARE NOT vaccinated, or is that just an assumption?
    • Can MDH confirm that any of the children who have been diagnosed with measles were actually vaccinated?
    • Since it has been a very long time since most of the doctors have seen measles, are the reported cases been lab-confirmed by the CDC as measles? Or are they rashes and/or other medical conditions?
    • Ask MDH why Merck will not supply single-dose vials of measles, mumps or rubella vaccines that consumers are demanding instead of the triple combination known as the MMR.
    • Ask MDH to produce safety studies showing that multiple vaccines given at the same time are indeed safe for infants and toddlers.
    • Ask MDH to produce safety studies showing that it is safe to repeat the MMR only one month after the first dose.
    • Ask MDH whether they encourage parents who report that their child was harmed by the vaccine to give them a second dose.
    • Ask MDH whether they encourage parents of vaccine-injured children to vaccinate their other children.
    • Ask MDH whether they take parents’ reports seriously that their child was harmed. Is MDH making efforts to listen to these stories and learn how to prevent vaccine injuries, or is MDH ignoring them or providing patronizing denials of their truth – thus putting those families and others at increased risk?
    • Ask MDH why they insist on a one-size-fits-all vaccination schedule, and resist shot schedules spaced out to accommodate individual children’s tolerances.



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