|
DISCLAIMER – The Autism Resource Foundation provides general information to the autism community. The information comes from a variety of sources, and the Autism Resource Foundation does not independently verify any of it, nor does it necessarily reflect the views and/or opinions of the Autism Resource Foundation. Nothing on this website should be construed as medical advice. Always consult your doctor regarding the needs of your family.
Excerpt from Autism Facts.com
1999
The FDA conducts its review of mercury and discovers that the childhood vaccine schedule, which added 2 new vaccines in 1988 and 3 new vaccines in 1991, all contained Thimerosal, a form of ethylmercury and that the level of mercury being given to infants totaled 187.5 mcgs. by 6 months of age. This exceeded the Environmental Protection Agency (EPA) safety guidelines by over 80%. They also found it exceeded the FDA's own more relaxed safety guidelines. It also exceeded ATSDR and WHO safety limits.
By this time, more than 50 licensed vaccines contained Thimerosal.
70 years after Thimerosal was first licensed, neither the FDA nor the industry had determined a safe exposure level to Thimerosal or ethylmercury.
Dr. Brent Taylor and colleagues examined the records of 498 children with autism and autism-like disorders in England from before and after the MMR vaccine was introduced in 1988. He examined the age of incidence and age of diagnosis in vaccinated with the MMR and unvaccinated children. He found that the percentage of MMR unvaccinated children and MMR vaccinated children with autism was the same in the North Thames Region, that there was no difference in age of onset, and that the onset of "regressive" autism symptoms did not occur within 2, 4 or 6 months of receiving the MMR.
Criticisms of this study include not studying the effect Thimerosal has in vaccines, destroying the immune system and allowing the Measles virus to grow or for the MMR to have an adverse effect due to prior Thimerosal intake in other vaccines.
Dr. Vera Stejskal, Associate Professor of Immunology in the Department of Clinical Chemistry at Danderyd Hospital and Karolinska Institute in Stockholm, Sweden, published a paper in "Neuroendocrinology Letters" titled, "The role of metals in autoimmunity and the link to neuroendocrinology." She stated:
Dr. Stejskal developed "MELISA", a scientifically proven blood test to diagnose metal allergy. The MELISA test is available in the United States. She has extensively published on the adverse effects of metals on the human body.
Eli Lilly's package insert regarding Thimerosal changes again and reads that Thimerosal is highly toxic, could cause mercury poisoning, and mental retardation in children.
The Rotavirus vaccine is added to the childhood schedule to be given 3 times at 2 months, 4 months and 6 months of age.
After just months on the market, the Rotavirus vaccine is pulled due to serious adverse events. The vaccine was causing intussusception in children. This is a life threatening condition where part of the bowel collapses and slides into the rest like a collapsible telescope resulting in the bowel becoming blocked or twisted.
By this year, 42 states were requiring 3 doses of Hepatitis B vaccine for all children in order to attend school. A child who has Hepatitis B would not be removed because the disease is not easily passed from individual to individual, yet an unvaccinated child would be denied access to or removed from school for not being vaccinated.
March, 1999
The Agency for Toxic Substances and Disease Registry's (ATSDR) Public Health Statement for Mercury states:
The agency is under the same Director as the Centers for Disease Control.
April 19, 1999
Pressure on the U.S. agencies increased as steps were being taken in Europe to remove Thimerosal from vaccines. The European Agency for Medicinal Evaluation (EMEA) met in London. The EMEA is responsible for establishing guidelines for the use of drugs and biologics in the European Union. The FDA's Dr. Norman Baylor attended this meeting.
June 1999
A consultant to the FDA, Dr. Barry Rumack, developed a pharmacokinetic model to analyze the amount of mercury to which infants were being exposed. It was dated June 28, 1999. Both charts demonstrate that most children in the 1990's received doses of ethylmercury in their vaccines that exceeded the EPA's limits for exposure to methylmercury (0.1 micrograms per kilogram) for at least the first six months of their lives. The charts also indicate that most children received doses of ethylmercury that exceeded the FDA's less-restrictive limits (o.4 micrograms per kilogram) for at least the first two months of their lives. It also exceeded the safety limits of the ATSDR and WHO.
The FDA refused to publicly admit this and continues to deny it today, stating that Thimerosal in vaccines only exceeded EPA limits.
June 9, 1999
A draft report is completed by Leslie Ball of the FDA concerning Thimerosal in vaccines. It was only shown to a few individuals which led to meetings at the Virginia Academy of Pediatrics office. The open meetings law, requiring them to hold meetings in public after announcing them in the Federal Register, was avoided, as they were not held on government property. The FDA and CDC have refused to release this initial report, even through the Freedom of Information Act.
June 20 & 21, 1999
The CDC's Advisory Committee on Immunization Practices (ACIP) met in Atlanta. Among other things, the Advisory Committee was called upon to recommend whether the CDC should issue a public statement of preference for Thimerosal-free vaccines. Three of the four DTaP manufacturers (Aventis Pasteur, North American Vaccine and Wyeth) were still producing DTaP with Thimerosal. Only SmithKline Beecham produced a Thimerosal-free DTaP. In addition, because manufacturers of the Hib and Hepatitis B vaccines had just recently converted to formulas that were Thimerosal-free or contained trace amounts of Thimerosal, older versions of these vaccines containing Thimerosal were still in inventories and being used around the country
CDC officials guided the Advisory Committee toward this conclusion. While three different options were presented to the Advisory Committee members, a detailed policy statement to be issued to the public had been prepared for only one of these options - a statement of no preference. In describing the three options, Dr. Roger Bernier of the CDC clearly indicated the CDC's desire not to state a preference for Thimerosal-free vaccines. He said:
A representative from SmithKline Beecham (now GlaxoSmithKline), Barbara Howe, stated that her company could supply sufficient amounts of Thimerosal-free DTaP vaccine to ensure that the youngest infants receiving the initial doses of the first three boosters of DTaP could receive Thimerosal-free doses:
This suggestion was passed over without any comment.
Dr. Neal Halsey made another suggestion that would limit the exposure of infants to ethylmercury. He suggested that the Advisory Committee adopt a policy that no child should receive more than one Thimerosal-containing vaccine per day:
This suggestion received no serious consideration.
In describing pros and cons of each option, Dr. Bernier returned several times to financial issues:
The advisory committee voted unanimously not to state a preference for Thimerosal-free vaccines.
June 22, 1999
Dr. Leslie Ball of the FDA presented the results of her research to the Medical Policy Coordinating Committee of the FDA's Center for Biologics Evaluation and Review (CBER). Dr. Neil Halsey attended that meeting.
June 23, 1999
Dr. Neal Halsey, Director of the Institute of Vaccine Safety at John Hopkins University, wrote a letter to the members of the American Academy of Pediatrics Committee on Infectious Diseases, which he chaired. He stated:
The European Agency for Medicinal Evaluation (EMEA) finished a document encouraging the removal of Thimerosal from childhood vaccines.
June 29, 1999
The European Agency for Medicinal Evaluation (EMEA) issued their document encouraging the removal of Thimerosal from childhood vaccines:
For vaccination in infants and toddlers, the use of vaccines without thimerosal and other mercurial preservatives should be encouraged."
An e-mail from a former FDA official Dr. Peter Patriarca to Martin Meyers, Acting Director of the National Vaccine Program Office at the CDC weighed in on the pros and cons of taking action on the removal of Thimerosal from vaccines stating the removal would:
An FDA document of an e-mail from Dr. Elain Esber to Linda Suydam, both of the FDA and referencing a conference call between the American Academy of Pediatrics, the Committee on Infectious Diseases, Committee on Environmental Sciences and Fetal Neonatal Issues, along with representatives from the FDA, CDC, NIH, NVP, Academicians, toxicologists, mercury experts and more stated that the Public Health Service was concerned that stating a preference for Thimerosal-free vaccines could:
June & July 1999
A series of meetings were held involving the FDA, the CDC, the Public Health Service, the American Academy of Pediatrics, and other agencies concerning what to do with Thimerosal in vaccines.
July 1999
CDC officials began a fight against parents in Texas, Illinois, New Jersey, Massachusetts and other states who tried to get Informed-Consent laws in their states concerning vaccines.
An article by CDC researchers appeared in the "Journal of the American Medical Association" stating:
The CDC proposed a stricter screening practice of religious exemptions for sincerity of religious belief.
Some states now require a strong statement from a religious leader that immunizations conflict with that person's religious beliefs. This requirement places parents who are religious but not directly affiliated with a specific church in a position of not being able to claim a religious right.
The CDC concluded the article with the intention of government officials taking a more aggressive approach to persuade "exemptors" into vaccination.
July 2, 1999
In an e-mail from Dr. Ruth Enzel of the Department of Agriculture also noted the Public Health Service's resistance. She sent this to Lauri Hall, Ray Koteras and Hope Hurley at the American Academy of Pediatrics:
1) Act quickly to inform pediatricians that the products have more mercury than we realized;
2) Be open with consumers about why we didn't catch this earlier;
3) Show contrition.
July 6, 1999
The charts produced by Dr. Rumack, and the FDA's analysis in general, failed to take into consideration the background levels of mercury to which children are exposed from other sources. Dr. Leslie Ball of the FDA pointed out this weakness in her e-mail to Dr. Norman Baylor, Director of Regulatory Affairs at the FDA:
One document written by Dr. Ball estimated that exposure to mercury from sources other than vaccines could total roughly 80 to 100 micrograms per year before vaccines containing Thimerosal. Background levels were included in all calculations prepared by the European Medical Evaluation Agency, which was at the time reviewing Thimerosal in vaccines in Europe. If background levels of mercury had been incorporated into the FDA's and CDC's calculations, the results would have been even more pronounced.
This simple and scientifically expected step was not taken.
Early July, 1999
* A compromise on a course of action was reached in the U.S. between the competing factions.
July 7, 1999
The American Academy of Pediatrics joined the U.S. Public Health Service in issuing a joint statement recommending the removal of all Thimerosal from vaccines, but continue to recommend that all children be immunized according to the schedule even if the vaccines contain Thimerosal. The statement included the following points:
(From the Congressional Report) They could have, but did not:
On its website, the FDA provides the following rationale for its policy on Thimerosal:
Dr. Neal Halsey, Director of the Institute of Vaccine Safety at John Hopkins University was an influential member of Federal advisory committees that oversaw the expansion of the Federally Recommended Schedule of Childhood Vaccines in the 1990s. By all accounts, Dr. Halsey was instrumental in the decision to seek the removal of Thimerosal from childhood vaccines in 1999.
After the FDA evaluation, Congress, The House Committee on Government Reform, initiated an investigation into the dangers of mercury in vaccines.
Mid-July 1999
The American Academy of Pediatrics (AAP) recommended reducing infant's exposure to mercury by delaying the first dose of Thimerosal-containing Hep B vaccine until 6 months of age for those infants born to mother's who do not have Hepatitis B. A statement issued by the CDC went against this recommendation saying that clinicians and parents should continue to vaccinate no later than 2 months of age within the existing ACIP recommendations.
July 31,1999
SmithKline Beecham, a vaccine manufacturer, sends a letter to Dr. Jefferey Koplan, Director of the Centers for Disease Control. It is stamped as received on August 6, 1999. They state in the letter:
They were prepared to supply the entire U.S. population with thimerosal free DTaP vaccines for at least the first half of 2000.
August, 1999
Congressman Dan Burton, Chairman of the House Committee on Government Reform, sent a letter to the Department of Health and Human Services Secretary Donna E. Shalala requesting detailed personnel and financial records "on every staff employee within DHHS (the Department of Health and Human Services) who is involved with vaccines at any level." Burton's committee had oversight jurisdiction over all DHHS agencies.
August 12, 1999
The Director of the FDA's National Center expressed a concern about injecting Thimerosal into infants, knowing it was not safe for topical use, at a 1999 meeting for Toxicological Research. Dr. Bernard Schwetz, who went on to serve as the Acting Director of the FDA for nearly a year stated:
Today, no study has been done by government health agencies to answer this question.
The National Vaccine Advisory Committee Sponsored a Workshop on Thimerosal Vaccines. FDA officials spoke passionately about the problem of Thimerosal and the CDC's refusal to not state a preference for Thimerosal-free vaccines. Dr. Katherine Zoon stated:
At the same meeting, Dr. Bernard Schwetz, the Director of the FDA's toxicology center, stated:
August 27, 1999
Merck Pharmaceuticals got approval from the FDA to manufacture single dose Thimerosal-free Hep B vaccine. However, Merck kept distributing their stockpiles of Thimerosal-containing vaccines until October 2001 along with the mercury-free versions. Physicans would only know by checking the labeling of the vaccines. Most did not do this as they believed all of Merck's Hep B vaccines were mercury free now.
September 14, 1999
A power point presentation, dated now, by William Egan of the FDA shows that, due to the lack of studies on Thimerosal and ethylmercury, when facing a policy decision on Thimerosal and vaccines, the FDA had to work from an assumption that the toxicity of ingested methylmercury was the same as injected ethylmercury.
October 1, 1999
Congressman Dan Burton sent another letter to the Department of Health and Human Services Secretary Donna E. Shalala, this time sharply worded with dissatisfaction with the Department's response to his earlier request for detailed personnel and financial records "on every staff employee within DHHS (the Department of Health and Human Services) who is involved with vaccines at any level."
He gave Shalala one week to produce the records or face a subpoena. A source at the committee stated that Burton, "wants to make sure that people are making decisions about vaccines based on science and not on influence from the pharmaceutical industry." His request struck heavily at the CDC where scores of staff members work on vaccine matters.
The CDC sent the records to Washington where they were screened by DHHS lawyers and then forwarded to Burton's committee in Mid-October. Included in the records were e-mails, correspondence, resumes, financial disclosure forms, records of outside activities, and travel documents for the previous three years.
The FDA, NIH, HRSA officials, and members of the CDC's Advisory Committee on Immunization Practices (ACIP) also were required to supply their information.
October, 1999
Dr. Neal Halsey made a suggestion to the CDC that would limit the exposure of infants to ethylmercury. He suggested that the Advisory Committee adopt a policy that no child should receive more than one Thimerosal-containing vaccine per day, thereby limiting their exposure levels when receiving multiple vaccines at one time. This was not done.
Fall, 1999
The CDC begins studying computerized data from the Vaccine Safety Database (VSD) to evaluate Thimerosal and its possible link to Neurodevelopmental Disorders known to be caused by mercury exposure in children.
The researchers annexed a list of disorders known to be caused by mercury and all were those that fell under Neurodevelopmental Disorders. Some conditions were Autism, ADD, ADHD, Speech Delays, Language Delays, Eating Disorders, Sleep Disorders, Emotional Disorders, Behavioral Disorders, Coordination Disorders, Tics, and others. They also added kidney disorders and, as a control, disorders not known to be associated with effects from mercury such as Mental Retardation and Cerebral Palsy.
November 1999
The CDC begins its first analysis and the study notes show that when comparing children who never received Thimerosal to those who had, the results in the category of Neurodevelopmental Disorders were extremely concerning. High risks falling well above the level of causal were found for Autism, ADD, ADHD, Coordination Disorder, Sleep Disorders, Tic Disorders, Speech and Language Disorders, Convulsive Epilepsy and Kidney Disorders. Other types of disorders such as Mental Retardation and Cerebral Palsy showed no risk to Thimerosal use.
A Merck official, in teaching a Grand Rounds session to staff, postulated that the minimum risk level of exposure to mercury would need to be multiplied by ten to reach a level at which harm would be expected through exposure. Dr. Roberta McKee of Merck wrote:
However, children received 10 times the safety level of mercury in each individual shot, let alone when they received multiple vaccines.
November 26, 1999
Jeffery Koplan, Director at the CDC, who had a unique opportunity to cut down on the use of Thimerosal-containing vaccines for infants and young children, sends a letter in response to GlaxoSmith Beecham Pharmaceuticals declining their offer to supply the entire U.S. children and infants with Thimerosal-free DTaP vaccines. They stated that they plan to:
December 17, 1999 4:40 PM
E-mail from Thomas Verstraeten to Robert Davis Cc to Frank DeStefano.
Subject: It just won't go away
Dr. Verstraeten explains different methods he used to conduct the analysis. One of them dropped the kids who got the Hepatitis B Immunoglobulin. These children received 37.5 mcgs. of mercury from Thimerosal at birth. Eliminating those children also eliminated some of the highest exposed children and about 1/4 of most disorders and 1/3 of Autism cases.
Coordination Disorders dropped dramatically.
He also comes to one conclusion based on his studies.
And another conclusion is drawn:
The "first five" that he found often in mixes with children were Autism, ADD, Speech and Language Disorders, Sleep Disorders and Coordination Disorders. If a child had one of these, they had a 20 to 100% chance of having at least another of these if not more.
December 1999
One analysis done by Dr. Verstraeten at the CDC still compared non-exposed children to those who received the highest level of Thimerosal. It focused on the 5 found in the mix of disorders. High risks were found for all 5 disorders.
Other analyses began to add new strategies that lowered the risk numbers. They began to eliminate the non-exposure to Thimerosal groups by comparing all children grouped together under 50 mcgs. of exposure to those above 50 mcgs. and other strategies that were similar.
None of these results were included in any structured study, nor were they ever released to the public, or given to Congress during their investigation.