Autism/Thimerosal Timeline 2001

Excerpt from Autism Facts.com

January 2001
In addition to the public advisories, the FDA established an aggressive "Education Plan on Methyl Mercury." Associate FDA Commissioner Melinda Plaiser, responded to Congressman William J. Coyne (D-PA) regarding the National Academy of Sciences' report on Methylmercury and wrote:

• "[L]et me reiterate, the FDA's commitment to protecting the public's health and the environment regarding mercury."

The FDA training materials for employees on mercury's toxicity: (date unknown)

• "People are exposed every day to a tremendous number of substances in our environment. These substances include major and trace elements that may or may not be essential for sustaining life...Other elements are not known to be essential but are constantly found in living tissues...Of these elements that have no known nutritional value, some have been found to be toxic at concentrations well below those of other nonessential elements. Lead, cadmium, and mercury levels are examples of elements that are toxic when present at relatively low levels."

January 10, 2001
The Congressional Autism Caucus (C.A.R.E.) was created by Democrat Mike Doyle of Pennsylvania and Republican Chris Smith of New Jersey. It was created to call attention to autism and to focus its efforts on the disorder. They are committed to improving research, education and support services.

March 2001
An FDA advisory states:

• "Some fish contain high levels of a form of mercury called methylmercury that can harm an unborn child's developing nervous system if eaten regularly. By being informed about methylmercury and knowing the kinds of fish that are safe to eat, you can prevent any harm to your unborn child and still enjoy the health benefits of eating seafood...While it is true that the primary danger fro methylmercury in fish is to the developing nervous system of the unborn child, it is prudent for nursing mothers and young children not to eat these fish as well."

Aventis Pasteur's DTaP did not become Thimerosal-free until now and Thimerosal-containing vaccines on the shelves of doctor's offices around the country continue to be used in spite of the fact that Thimerosal-free versions were available.

April 2001
The Institute of Medicine issued its report on the MMR vaccine, entitled, "Immunization Safety Review-Measles-Mumps-Rubella Vaccine and Autism." The IOM determined that:

• "The evidence favors rejection of a causal relationship at the population level between MMR vaccine and autism spectrum disorders."

   
The IOM noted that it:

• "...does not exclude the possibility that MMR vaccines could contribute to ASD" and recommended "this issue receive continued attention."

   
They stated that the epidemiological (statistical studies) evidence available showed no evidence of an association, however, the authors cautioned that if the vaccine triggered autistic disorders among a small number of children who were predisposed to an adverse reaction, the population studies that had been done to-date would be too imprecise to detect them. They recommended further research to determine if a small number of children were at risk of developing autism with the MMR vaccine and studies to follow up on Dr. Andrew Wakefield's case studies of 12 autistic children with autism and chronic bowel inflammation also had vaccine-strain measles virus in their tissues.
   
The IOM made the following research recommendations:

• Use accepted and consistent definitions and assessment protocols for ASD (autism spectrum disorders) in order to enhance the precision and comparability of results with surveillance, epidemiological, biological investigations.
• Explore whether exposure to MMR vaccine is a risk factor for ASD in a small number of children.
• Develop targeted investigations of whether or not measles vaccine-strain virus is present in the intestines of some children with ASD.
• Encourage all who submit reports to VAERS of any diagnosis of ASD thought to be related to MMR vaccine to provide as much detail and as much documentation as possible.
• Case reports in VAERS or elsewhere of "rechallenge" should be identified, documented, and followed up. (In the context of MMR vaccine and ASD, rechallenge refers to children who appeared to have experienced some form of neurological regression after the first dose of MMR or other measles-containing vaccine and who appeared to have experienced another regression following a second dose of MMR or other measles-containing vaccine.)
• Study the possible effects of different MMR immunization exposures.
• Conduct further clinical and epidemiological studies of sufficient rigor to identify risk factors and biological markers of ASD in order to better understand genetic or environmental causes.

These recommendations were essentially ignored by our federal agencies.

Dr. George Lucier, Ph.D., a toxicologist and former Director of the Environmental Toxicology Program at the National Institute for Environmental Health Sciences presented a slide of the "Comparative Toxicity of Ethyl and Methyl Mercury" at the National Toxicity Program on Thimerosal's nomination as a potentially toxic substance. It listed the "Clinical Manifestations of Ethylmercury Poisoning Episodes" as:

• Speech disorders
• Vision disorders
• Tremor
• Ataxia
• Spasticity
• Delirium
• Death
  

Subtle measures of developmental neurotoxicity...have not been evaluated.
   
He had also reviewed this information for the Institute of Medicine's Immunization Safety Review Committee.

To comply with the Children's Health Act of 2000, Secretary of Health and Human Services, Tommy Thompson, delegated the authority to establish the Interagency Autism Coordinating Committee (IACC) to the National Institutes of Health. The National Institute of Mental Health (NIMH) at the NIH was designated the lead for this activity.

April 25, 2001
Dr. Boyd Haley, Chairman of the Chemistry Department at the University of Kentucky, testified to Congress. Dr. Haley has spent many years studying the effects of mercury on the human body.

• "I cannot say, nor would I say, that vaccinations cause autism. However, if the data holds up that I have been seeing with the relationship, I think it is an awfully good suspect, at least one of the co-factors that might aid the onset of this disease..."
• "I was requested to do an evaluation of the potential toxicity of vaccines containing thimerosal as a "preservative" versus those vaccines not containing thimerosal. The results were very dramatic..."
• "Our results are very consistent with the reported toxicity of thimerosal-containing vaccines versus non-thimerosal containing vaccines as observed in cell culture studies reported in 1986..."
• "Ethyl-mercury is a well known neurotoxin. Further, combined thimerosal with millimolar levels of aluminum cation plus significant levels of formaldehyde, also found in vaccines, would make the vaccine mixture of even greater risk as a neurotoxic mixture..."
• "Infants, with their immature physiology and metabolism, would not be expected to handle mercury as efficiently as mature adults. Using this vaccine mixture on infants, who do not have fully developed bilary (liver) and renal (kidney) systems, could dramatically increase the toxic effects, especially if they are spuriously ill. The toxic effects of exposure to thimerosal in infants cannot be reasonably compared to those observed in adults made toxic by exposure to similar ethyl-mercury containing compounds. Mercury is primarily removed through the bilary system and aluminum is removed by the renal system. Inability to rid the body of these toxicants would greatly increase the damage they are capable of doing in infants."

   
Dr. Haley described one possible genetic risk factor. He stated that there is a protein in the brain called APO-E that removes dangerous waste material out of the brain. He added that some individuals are born with a variety of this protein that is very efficient at removing mercury, and some individuals are born with a variety of this protein that is very inefficient at removing mercury:

• "If you look at the chemistry of the APO-E proteins, this can be reflected in the fact that it is a housekeeping protein that clears the brain of waste materials. If you have APO-E2, you can carry out two atoms of mercury for every atom of APO-E that goes out. If you have APO-E4, you can carry out none.
• He [Dr. Mike Godfrey of New Zealand] took this and looked at autistic children. When he did the screen of autistic children, there was a huge preponderance of them that had APO-E4, indicating that there is a genetic risk factor, which deserves further study. And it does imply that the inability to detoxify the cerebral spinal fluid may be at least part of the neurological aspect of this disease."

April 26, 2001
Dr. Jeffery Bradstreet testified at a Congressional Hearing:

• "At a recent autism conference in Chicago, and prior to either my own presentation or that of Dr. Wakefield, I asked the audience of 500 parents if they felt their child regressed following a vaccine. In that obviously non-scientific survey, approximately 90 percent of the parents raised their hands...When I asked for how many had reported the event under the VAERS system, fewer than 15 said they had. Then I asked if their pediatrician had offered to report this, they just laughed. I have now conducted this simple survey with over 5000 parents at conferences around the world with similar findings...and despite efforts by policymakers at CDC, FDA, AAP, IOM and elsewhere to reassure parents of the safety of vaccines, they remain unconvinced."

May 2001
The first lawsuit is filed against vaccine manufacturers and manufacturers of Thimerosal on behalf of a five year old boy who was diagnosed with autism and then was found to have high levels of mercury exposure.

Summer 2001
Safeminds Organization obtains hundreds of documents by the CDC using the Freedom of Information Act (FOIA).

Mid-2001
Vaccine manufacturers completed their transition to Thimerosal-free vaccines but had not completed the transition to physicians until late 2001/early 2002. Stockpiled vaccines continued to remain on the shelves of doctor's offices in the United States that contained mercury and were being given to infants and children.

June 2001
The CDC Advisory Committee again rejected the idea of expressing a preference for Thimerosal-free vaccines, despite the fact that all manufacturers of Hib, Hepatitis B and DTaP had shifted to Thimerosal-free products at that point. As a result of their inaction, children continued to receive vaccinations containing ethylmercury that were never recalled and still lingered on the shelves of doctor's offices.

July 2001
The Institute of Medicine (IOM) held a meeting about the safety of Thimerosal in vaccines and its link to autism. They called in Dr. Verstraeten, the lead researcher in the CDC studies, to testify. He began his testimony by announcing that, just hours before the meeting, he was hired by GlaxoSmithKline. GlaxoSmithKline is one of the vaccine manufacturers who produced thimerosal-containing vaccines and was one of the pharmaceutical companies named in the lawsuits being filed by parents of autistic children. Dr. Verstraeten continued to work on the study for the CDC, designed to determine if Thimerosal-containing vaccines were the cause of autism and other neurodevelopmental disorders on the rise, for another 3 years until 2004 even though he was employed by GlaxoSmithKline.

October 1, 2001
The IOM reviewed the unpublished Phase 1 of the CDC Verstraeten Study and issued its second report, entitled, "Immunization Safety Review - Thimerosal-Containing Vaccines and Neurodevelopmental Disorders. They stated that the link between thimerosal containing vaccines and neurodevelopmental disorders is "biologically plausible" and that there was not enough evidence to reach any conclusions about a possible relationship between Thimerosal and autism spectrum disorders.

• "The committee concludes that the evidence is inadequate to accept or reject a causal relationship between exposure to thimerosal fro vaccines and the neurodevelopmental disorders of autism, ADHD, and speech and language disorders."

   
The IOM also noted that Thimerosal had not been removed in all vaccines and medicines given to children and pregnant women. The report specifically cited the influenza vaccine, the diphtheria-tetanus toxoid vaccine, and some nasal sprays.

They stated:

• "The committee recommends the use of the thimerosal-free DTaP, Hib, hepatitis B vaccines in the United States, despite the fact that there might be remaining supplies of thimerosal-containing vaccine available."

   
They urged that:

• "...full consideration be given by appropriate professional societies and government agencies to removing thimerosal [in] vaccines administered to infants, children or pregnant women in the United States."

   
They also recommended much more research on the issue. These were their recommendations:

• Case-control studies examining the potential link between neurodevelopmental disorders and Thimerosal-containing vaccines
• Further analysis of cohorts of children who did not receive Thimerosal-containing doses of vaccines during clinical trials.
• Epidemiological studies comparing the prevalence of neurological disorders in children, who received vaccines before Thimerosal was removed, to children who received vaccines after it was removed.
• An increased effort to identify the primary sources and levels of prenatal and postnatal exposure to Thimerosal.
• Clinical research on how children metabolize and excrete metals.
• Theoretical modeling of ethylmercury exposures, including the incremental burden of Thimerosal on background mercury exposures with other sources.
• Research in appropriate animal models on neurodevelopmental effects of ethylmercury
• Rigorous scientific investigations of chelation as a treatment for neurodevelopmental disorders.
• Research to identify a safe, effective and inexpensive alternative to Thimerosal for countries that decide they want to follow up the example of Europe and the United States and terminate its use in vaccines.

   
Not one of these recommendations by the IOM were followed.

October 2001
Merck Pharmaceuticals sends out the last batch of Thimerosal-containing Hep B vaccine to pediatricians and physicians. Most doctors and parents are unaware that Merck continued to send out the mercury containing vaccines, despite the fact that they were also sending out mercury free versions. They had misled doctors and the public with a statement that all of the Hep B vaccines were now being produced in Thimerosal Free versions in 1999. No one knew they continued to send out their stockpiles as well. The vaccines will expire during the year 2002.

 

 

 

 

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