Letter from Elizabeth Birt to Congressman Burton

[This letter was sent to Congressman Burton from Liz Birt. Liz is Counsel for Safe Minds, the founder of Medical Interventions for Autism, and a parent of a child with autism. Liz was responsible for obtaining the "secret" CDC VSD Study and the Simpsonwood meeting minutes for Safe Minds though the Freedom of Information Act.]

March 7, 2002

Congressman Dan Burton

Chairman

Government Reform Committee

United States House of Representatives

2157 Rayburn House Office Building

Washington, D.C.

Re: British Medical Journal Article, May 27, 1972 “Danger of Skin Burns

>From Thiomersal”; Adverse Drug Reactions Acute Poisoning Revenue

Article, 1986 “Organic mercury compounds and their toxicity”(“1986 Adverse Drug Reaction Article”) Testimony by Dr. William Egan, FDA and Dr. Roger Bernier, CDC on July 18, 2000

Dear Congressman Burton:

As you requested I am sending to you copies of the above referenced articles. As you can see, much was known about thimerosal prior to 1999. I am sure that through the process of subpoenas we will discover much more.

Of particular note is the 1986 Adverse Drug Reaction Article written by K.A. Winship, Senior Medical Officer, Medicines Division, Department of Health and Social Security for the United Kingdom. It is my understanding that this person would be in a similar position as a top administrative officer of our FDA. Page 171 of this article states: “Multidose vaccines and allergy-testing extracts contain a mercurial preservative, usually 0.01% thiomersal, and may present problems occasionally in practice. It is therefore, now accepted that multidose injection preparations are undesirable and that preservatives should not be present in unit-dose preparations (emphasis added).”

On July 18, 2000 you asked Dr. William Egan of the FDA the following question: When did the FDA and CDC first start being concerned about mercury in vaccines?” Dr. Egan responded, “I guess the major concern started somewhere around May of 1999?” I can not believe based upon articles such as this that the FDA did not know that thimerosal was a problem in vaccines before May of 1999. If a senior official in the United Kingdom stated as a matter of fact in 1986 that multidose preparations were undesirable because of thimerosal what were our FDA officials doing? My “hunch” is that there was extreme pressure from the drug companies not to make a change because of cost. Here we are 15 years later and the FDA has not mandated that thimerosal be removed from all vaccines nor has it acted to recall pediatric vaccines containing thimerosal. I find the conduct of our FDA officials reprehensible.

In addition, Dr. Egan at the same July 18, 2000 hearing was asked the following question by Congresswoman Chenowith-Hage “With regards to the introduction of the HIB vaccine and hepatitis B vaccine, could you advise the committee on what studies were done with regards to these new vaccines that would prove thimerosal was safe?” Dr. Egan’s response was “There was a long history of the use, the safe use of thiomerosal, you know, in vaccines since they were- since it was first introduced. And at that time (1990) there was no data to suggest that the added mercury from the introduction of those new vaccines would be harmful.” Congressman Burton, I find this statement by Dr. Egan to be patently false. By 1990 there was a mountain of evidence that thimerosal was unsafe and ineffective. In point of fact, in 1987 the Commission of the European Communities initiated a research project of 10 known or suspected spindle poisons including thimerosal. In 1993, as described in Mutuation Research, 287 (1993) 17-22 thimerosal was identified as a strong inhibitor of microtubular assembly, a process which is essential for proper neuronal development. Again, I find it incomprehensible that officials at our FDA could have overlooked this research, if they did so they are grossly incompetent. In addition, since 1992 the FDA has employed a researcher by the name of Joan May to test thimerosal in various biologic products including vaccines. If the use of thimerosal was proven to be safe why was the person employed by FDA?

In addition, I would also like to point out testimony given by Dr. Roger Bernier of the CDC at the July 18, 2000 hearing that was false. Dr. Bernier was questioned by Congressman Waxman as follows: Congressman Waxman: “ The question that I would like to ask, and I am sure parents want to know, is this being done because there are known adverse related events or as a precautionary measure? CDC convened an expert panel to examine data that showed a possible weak link between thimerosal and certain developmental delays. The panel presented its findings to CDC’s Advisory Committee on Immunization Practices and concluded that the data were insufficient to show a causal connection between thimerosal and certain developmental delays. Is that true? Is that the position that the CDC has taken?” Dr. Bernier responded: “That’s correct, Mr. Waxman. At the present time CDC has no evidence of harm to any children from thimerosal in vaccines. We have constantly acted to look at safety. Following the episode last summer, CDC did begin to look at the data in the Vaccine Safety Datalink, and one of the outcomes was autism, and there was no suggestion of any association between thimerosal exposure and autism in the Vaccine Safety Datalink study.(emphasis added)”

Congressman Burton, based upon the documents that CDC turned over to SAFEMINDs last year I believe that Dr. Bernier perjured himself at the July 18, 2000 hearing. My belief is based upon the following facts: 1) Dr. Verstraeten’s 2/29/00 VSD study found a relative risk for autism of 2.48 at a thimerosal exposure of 62.5 mcgs of thimerosal and above; 2) Dr. Verstraeten’s 2/29/00 and 6/1/00 VSD studies found a statistically significant positive correlation between: 1) the cumulative exposure at 2 months of age and unspecified developmental delay; 2) the cumulative exposure at 3 months of age and tics; 3) the cumulative exposure at 6 months of age and attention deficit disorder; 4) the cumulative exposure at 1, 3 and 6 months of age and language and speech delays; and 5) the cumulative exposure at 1, 3 and 6 months of age and neurodevelopmental delays in general. Dr. Bernier was copied on both of these studies. I do not believe he was truthful in his testimony when he made these categorical remarks to your committee.

As you can probably tell from my comments I am extremely distrustful of individuals at CDC and FDA. They have a history of outright lying. In addition, when possible they engage in the distortion of facts to suit their purposes. Please know that I am committed to finding out the truth about the relationship of vaccines to neurodevelopmental disorders including autism. I am willing to work on any project that would be useful to your committee at any time without compensation. I feel that this work must be done for the children and their families.

Thank you for your support on this matter.

Best Regards,

Liz Birt

Cc: Congressman Dave Weldon

Beth Clay