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Introduction
Chapter I: pre-1999
There's Mercury In Vaccines?
Chapter II: 1999-2000
Simpsonwood
Chapter III: 2001
IOM: Biologically Plausible
Chapter IV: 2001-2002
CDC World Travel
Chapter V: 2003
It's Rotten In Denmark
Chapter VI: 2004
IOM slams the door (quickly)
Epilogue: present day
Better science, better kids, and a DJ
The Entities
The primary entities discussed on this website include:
Public entities
The Department of Health and Human Services. The Secretary of the Department of HHS is Michael Leavitt, a member of the President's Cabinet. HHS is one of fifteen Departments of the U.S. Government which also includes Agriculture, Commerce, Defense, Education, Energy, Homeland Security, Housing and Urban Development, Interior, Labor, State, Transportation, Treasury, and Veterans Affairs.
Two divisions of the Department of Health and Human Services are the focus of this Website:
Centers for Disease Control and Prevention
Responsible for implementation of the National Immunization Program. Dr. Julie Gerberding is the Director of the CDC. She was recently asked in a press conference, "Has the government ever looked at the autism rate in an unvaccinated U.S. population, and if not, why not?"
Her response:
"In this country, we have very high levels of vaccination as you probably know, and I think this year we have record immunization levels among all of our children, so to (select an unvaccinated group) that on a population basis would be representative to look at incidence in that population compared to the other population would be something that could be done.
But as we're learning, just trying to look at autism in a community the size of Atlanta, it's very, very difficult to get an effective numerator and denominator to get a reliable diagnosis.
I think those kind of studies could be done and should be done. You'd have to adjust for the strong genetic component that also distinguishes, for example, people in Amish communities who may elect not to be immunized (and) also have genetic connectivity that would make them different from populations that are in other sectors of the United States. So drawing some conclusions from them would be very difficult.
I think with reference to the timing of all of this, good science does take time, and it's part of one of the messages I feel like I've learned from the feedback that we've gotten from parents groups this summer (in) struggling with developing a more robust and a faster research agenda, is let's speed this up. Let's look for the early studies that could give us at least some hypotheses to test and evaluate and get information flowing through the research pipeline as quickly as we can.
So we are committed to doing that, and as I mentioned, in terms of just measuring the frequency of autism in the population some pretty big steps have been taken. We're careful not to jump ahead of our data, but we think we will be able to provide more accurate information in the next year or so than we've been able to do up to this point. And I know that is our responsibility.
We've also benefited from some increased investments in these areas that have allowed us to do this, and so we thank Congress and we thank the administration for supporting those investments, not just at CDC but also at NIH and FDA."
Food and Drug Administration
Responsible for monitoring the safety of all drugs, including vaccines. Soon after the joint statement of 1999, letting the world know about the high levels of mercury in children's vaccines, an FDA employee noted in an email:
"You should also be aware that if the U.S. (and perhaps the EU) adopts a position that the theoretical risk of ethyl mercury exposure outweigh its potential benefits to the point where no vaccines used in the US or Europe will contain thimerosal {which is where things appear to be headed}, this could also have a severe impact on global ('third world') vaccination programs, particularly for hepatitis B and whole-cell DTP vaccines which for various reasons, will almost certainly have to have thimerosal as an ingredient for potentially many years to come. WHO has already made a plea to the American Academy of Pediatrics to "tread lightly" and "consider the global ramifications" of their evolving policy. Finally, in my own personal opinion - and as a heads-up because I believe it could come up -- the greatest point of vulnerability on this issue is that the systematic review of thimerosal in vaccines by the FDA could have been done years ago and on an ongoing basis as the childhood immunization schedule became more complex. The calculations done by FDA are not complex. I'm not sure if there will be an easy way out of the potential perception that the FDA, CDC and immunization policy bodies may have been 'asleep at the switch' re: thimerosal until now."
Private entities
The American Academy of Pediatrics. The AAP is a private membership organization that represents approximately 60,000 pediatricians. The AAP also provides lobbying activities for issues germane to their membership. The AAP is against the Combating Autism Act, according to this article written by Evidence of Harm author David Kirby, because the bill will devote millions of dollars to
"research on a broad array of environmental factors that have a possible role in autism, including but not limited to vaccines, other biological and pharmaceutical products, and their components (including preservatives)." In other words, Congress wants to study thimerosal -- the mercury containing vaccine preservative and possible contributor to some autism cases -- and that makes the powerful AAP very, very unhappy. "Any bill that contains any questions about vaccines, we are not going to endorse," one lobbyist informed the group.
Also, the AAP has lobbied to try and prevent states from banning Thimerosal in children's vaccines. In October 2005, parents staged a rally outside the AAP's annual convention in Washington, D.C., as this article from Mothering Magazine recounts. An excerpt:
"In what might be the most puzzling about-face in its history, the AAP has apparently reversed course, abandoned the 'precautionary principle' and appears to no longer be concerned about mercury-containing vaccines. In Action Alerts to their membership and newspaper editorials, the AAP has engaged in an aggressive campaign to rehabilitate thimerosal, going so far as to endorse its continued use in vaccines. Earlier this year, the AAP encouraged its membership to write letters of opposition to the Governor of New York and officials in other states considering legislation to limit thimerosal use in vaccines given to infants, children, and pregnant women."
The Institute of Medicine. The IOM is a private division of the National Academies. According to their website, "The Institute provides a vital service by working outside the framework of government to ensure scientifically informed analysis and independent guidance. The IOM's mission is to serve as adviser to the nation to improve health. The Institute provides unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large."
The 2006 Board of the IOM includes members who would appear to be in a position to suffer negative consequences if Thimerosal and autism were found to be related:
Gail H. Cassell, Ph.D. - 2007
Vice President, Scientific Affairs and Distinguished Lilly Research Scholar
for Infectious Diseases
Eli Lilly and Company
Note: Eli Lilly created Thimerosal and is the subject of thousands of lawsuits by parents of autistic children.
Helene D. Gayle, M.D., M.P.H. - 2007
Director, HIV, TB and Reproductive Health
Bill & Melinda Gates Foundation
Note: The Gates Foundation funds the worldwide distribution of Thimerosal-containing vaccines.
Peter S. Kim, Ph.D. -- 2008
President
Merck Research Laboratories
Note: Merck has sold millions of doses of Thimerosal-containing vaccines for children and is the subject of thousands of lawsuits by parents of autistic children.
The Institute of Medicine has been commissioned to review the safety of vaccines on eight occasions:
Immunization Safety Review: Vaccines and Autism
May 17, 2004
Conclusion:
The committee concluded that the body of epidemiological evidence favors rejection of a causal relationship between the MMR vaccine and autism. The committee also concludes that the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism. The committee further finds that potential biological mechanisms for vaccine-induced autism that have been generated to date are theoretical only.
Immunization Safety Review: Influenza Vaccines and Neurological Complications
Oct. 6, 2003
Conclusion:
The committee concluded that the evidence favored rejection of a causal relationship between influenza vaccines and exacerbation of multiple sclerosis. For the other neurological conditions studied, the committee concluded the evidence about the effects of influenza vaccine is inadequate to accept or reject a causal relationship. The committee also reviewed theories on how the influenza vaccine could damage the nervous system. The evidence was at most weak that the vaccine could act in humans in ways that could lead to these neurological problems.
Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy
Mar 12, 2003
Conclusion:
The committee concluded that the evidence favors rejection of a causal relationship between some vaccines and SIDS; and that the evidence is inadequate to accept or reject a causal relationship between other vaccines and SIDS, SUDI, or neonatal death.
Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer
Oct 22, 2002
Conclusion:
However, because these epidemiologic studies are sufficiently flawed, the committee concluded in this report that the evidence was inadequate to conclude whether or not the contaminated polio vaccine caused cancer.
Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders
May 30, 2002
Conclusion:
Evidence of possible biological mechanisms that could produce this effect was weak. Additionally, the committee found that the epidemiological evidence favors rejection of a causal relationship between the hepatitis B vaccine in adults and multiple sclerosis.
Immunization Safety Review: Multiple Immunizations and Immune Dysfunction
Feb 20, 2002
Conclusion:
The committee found that evidence favors rejection of a causal relationship between multiple immunizations and increased risk for infections and for type I diabetes. They also found that epidemiological evidence regarding risk for allergic disease, particularly asthma, was inadequate to accept or reject a causal relationship.
Immunization Safety Review: Thimerosal - Containing Vaccines and Neurodevelopmental Disorders
Oct 1, 2001
Conclusion:
The Committee concludes that although the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders is not established and rests on indirect and incomplete information, primarily from analogies with methylmercury and levels of maximum mercury exposure from vaccines given in children, the hypothesis is biologically plausible.
Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism
Apr 23, 2001
Conclusion:
Rejection of hypothesis.
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