[Congressional Record Volume 151, Number 13 (Wednesday, February 9, 2005)]
[House]
[Pages H481-H483]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                        MERCK SAW VACCINE RISKS

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Indiana (Mr. Burton) is recognized for 5 minutes.
  Mr. BURTON of Indiana. Mr. Speaker, over the past 4 or 5 years, I 
have, as chairman of the Committee on Government Reform and chairman of 
the Subcommittee on Health and Human Rights, held a number of hearings 
regarding mercury in vaccines and what kind of an impact it had on 
children.
  When we first started having the hearings, we were concerned that 
there was an epidemic of autism and other

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neurological disorders in children, and we found from scientists who 
testified before the committee over the years that there was no doubt 
that one of the major contributing factors to neurological problems, 
including autism among children, was the mercury in vaccines under the 
title of Thimerosal, which is a preservative.
  Thimerosal is a preservative which contains 50 percent ethyl mercury, 
and as children got more and more vaccinations, as many as 30 now 
before they start in the first grade, the incidence of neurological 
disorders, autism and other childhood mental problems, grew 
dramatically. It used to be 1 in 10,000 children were autistic, 
according to the Centers for Disease Control. Now it is 1 in 150. We 
have an absolute epidemic of autism.
  The pharmaceutical companies for years have said that there is no 
correlation between the mercury in vaccines and the autism and other 
neurological childhood disorders, and things like Alzheimer's in 
adults. But this past week on the front page of the Los Angeles Times 
there was a very, very long article, and I want to read to you, Mr. 
Speaker, some of the things that were in that article.
  The title of the article was ``'91 Memo Warned of Mercury in Vaccines 
and Shots.'' '91 was the year. The March 1991 memo, obtained by the 
Times, shows that nearly a decade before our Federal health agency 
first publicly disclosed the potential dangers of mercury in vaccines, 
senior executives from Merck & Company, a major pharmaceutical company, 
were already aware that infants were getting an elevated dose of 
mercury in vaccinations containing the widely used preservative 
Thimerosal, a preservative containing nearly 50 percent mercury by 
weight.
  In fact, the memo clearly states, ``If eight doses of Thimerosal-
containing vaccine were given in the first 6 months of life, the 
mercury given, say to an average-size infant of 12 pounds, would be 87 
times the daily allowance of mercury for a baby of that size.'' Eighty-
seven times.
  The memo further states, ``It is reasonable to conclude that 
Thimerosal should be removed from single-dose vials when it can be 
removed, especially where use in infants and young children is 
anticipated.''
  At the time this memo was written, U.S. health authorities were 
recommending an aggressive expansion of the immunization schedule for 
children in their first 6 months of life, adding five new shots to the 
schedule. And many of these shots, as well as shots already included in 
the vaccine immunization schedule, contained mercury and Thimerosal.
  What did the pharmaceutical company do after learning this? They did 
nothing. Absolutely nothing. It took 8 years before they started 
removing Thimerosal from any of the children's vaccines.
  It is criminal, it is criminal in my opinion, that this sort of thing 
takes place. Mercury in any vaccination, whether it is a child's 
vaccination or an adult vaccination, should be removed. Mercury is one 
of the most toxic substances on Earth. It is toxic to the neurological 
system of adults and, especially, infants, and yet children have been 
getting as many as 30 vaccinations before they start in the first grade 
of school; and we have an absolute epidemic of neurological problems, 
including autism.
  Mr. Speaker, I will submit this article for the Record. I am going to 
send a ``Dear Colleague'' around to all of my colleagues, and I hope 
everybody, and my good friend the gentlewoman from California has been 
working with me on this for a long time, I hope that everybody will pay 
attention and talk to their pharmaceutical representatives and get 
mercury out of all vaccinations, but especially every childhood 
vaccination. The future of America depends on that, because these 
children are going to grow up, they are going to become dependent upon 
the taxpayer and it is going to cost all of us trillions of dollars if 
we do not deal with the problem now.

               [From the Los Angeles Times, Feb. 8, 2005]

                  '91 Memo Warned of Mercury in Shots

                            (By Myron Levin)

       A memo from Merck & Co. shows that, nearly a decade before 
     the first public disclosure, senior executives were concerned 
     that infants were getting an elevated dose of mercury in 
     vaccinations containing a widely use sterilizing agent.
       The March 1991 memo, obtained by The Times, said that 6-
     month-old children who received their shots on schedule would 
     get a mercury dose up to 87 times higher than guidelines for 
     the maximum daily consumption of mercury from fish.
       ``When viewed in this way, the mercury load appears rather 
     large,'' said the memo from Dr. Maurice R. Hilleman, an 
     internationally renowned vaccinologist. It was written to the 
     president of Merck's vaccine division.
       The memo was prepared at a time when U.S. health 
     authorities was aggressively expanding their immunization 
     schedule by adding five new shots for children in their first 
     six months. Many of these shots, as well as some 
     previously included on the vaccine schedule, contained 
     thimerosal, an antibacterial compound that is nearly 50% 
     ethyl mercury, a neurotoxin.
       Federal health officials disclosed for the first time in 
     1999 that many infants were being exposed to mercury above 
     health guidelines through routine vaccinations. The 
     announcement followed a review by the U.S. Food and Drug 
     Administration that was described at the time as a first 
     effort to assess the cumulative mercury dose.
       But the Merck memo shows that at least one major 
     manufacturer was aware of the concern much earlier.
       ``The key issue is whether thimerosal, in the amount given 
     with the vaccine, does or does not constitute a safety 
     hazard,'' the memo said. ``However, perception of hazard may 
     be equally important.''
       Merck officials would not discuss the contents of the memo, 
     citing pending litigation.
       Separately, the drug giant is trying to fend off a legal 
     onslaught over Vioxx, the popular painkiller it introduced in 
     1999. The company, based in Whitehouse Station, N.J., faces 
     hundreds of lawsuits claiming that the drug caused heart 
     problems and that Merck concealed the risks. Merck, which in 
     September pulled Vioxx off the market, has denied the 
     allegations.
       The legacy of thimerosal, meanwhile, also is causing 
     problems for Merck and other drug companies.
       More than 4,200 claims have been filed in a special federal 
     tribunal, the Vaccine Injury Compensation Program, by parents 
     asserting that their children suffered autism or other 
     neurodevelopmental disorders from mercury in vaccines. A 
     handful of similar claims are awaiting trial in civil courts. 
     The plaintiffs cite various scientific studies that they say 
     prove the dangers of thimerosal, including at the levels 
     found in vaccines.
       Thimerosal has been largely removed from pediatric vaccines 
     in recent years in what health officials have described as a 
     precautionary measure. (This has been accomplished as drug 
     makers have voluntarily switched from multi-dose vials of 
     vaccine, which require a chemical preservative like 
     thimerosal, to single-dose containers.)
       In September, Gov. Arnold Schwarzenegger signed legislation 
     prohibiting vaccines with more than trace amounts of 
     thimerosal from being given to babies and pregnant women. 
     Iowa has a similar ban.
       For their part, Merck and other vaccine makers, along with 
     many government health officials and scientists, say there is 
     no credible evidence of harm from the amounts of mercury once 
     widely present in kids' shots. They cite a report in May by a 
     committee of the national Institute of Medicine concluding 
     that the evidence ``favors rejection of a causal 
     relationship'' between vaccines and autism.
       The seven-page Merck memo was provided to The Times by 
     James A. Moody, a Washington lawyer who works with parent 
     groups on vaccine safety issues. He said he obtained it from 
     a whistle-blower whom he would not name.
       The memo provides the ``first hard evidence that the 
     companies knew--or at least Merck knew--that the children 
     were getting significantly more mercury'' than the generally 
     accepted dose, the lawyer said.
       He also provided a copy to attorneys for Vera Easter, a 
     Texas woman who blames thimerosal for the condition of her 7-
     year-old son, Jordan, who is autistic and mentally retarded. 
     The Easter lawsuit is pending in U.S. District Court for the 
     Eastern District of Texas. The defendants include Merck; 
     rival vaccine makers GlaxoSmithKline, Aventis Pasteur Inc. 
     and Wyeth; and thimerosal developer Eli Lilly & Co.
       Easter's lawyer, Andy Waters, described the memo as 
     ``incredibly damning and incredibly significant.'' After 
     receiving it in the fall, he confronted Merck lawyers about 
     why he hadn't seen it earlier.
       In a letter to Waters in October, Merck attorneys said they 
     had in fact made available 32 boxes of records, but that the 
     copying service hired by the plaintiffs for some reason had 
     failed to copy several of the boxes--including the one with 
     the Hilleman memo.
       ``The memo,'' said company spokeswoman Mary Elizabeth 
     Blake, ``was produced voluntarily by Merck in the ordinary 
     course of discovery proceedings.''
       Hilleman is a former senior vice president of Merck who 
     developed numerous vaccines for the company. A 1999 profile 
     in the Philadelphia Inquirer said that ``it is no 
     exaggeration to assert, as many scientists do, that Maurice 
     Hilleman has saved more lives than any other living 
     scientist.''
       Hilleman, 85, currently director of the Merck Institute for 
     Vaccinology, had officially retired and was a consultant to 
     Merck

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     when he wrote the '91 memo. He declined to be interviewed.
       The memo was sent to Dr. Gordon Douglas, then head of 
     Merck's vaccine division and now a consultant for the Vaccine 
     Research Center at the National Institutes of Health. Douglas 
     also declined to comment.
       The memo stated that regulators in several countries had 
     raised concerns about thimerosal, including in Sweden, where 
     the chemical was being removed from vaccines.
       ``The public awareness has been raised by the sequential 
     wave of experiences in Sweden including mercury exposure from 
     additives, fish, contaminated air, bird deaths from eating 
     mercury-treated seed grains, dental amalgam leakage, mercury 
     allergy, etc.,'' the memo said.
       It noted that Sweden had set a daily maximum allowance of 
     mercury from fish of 30 micrograms for a 160-pound adult, 
     roughly the same guideline used by the FDA. Adjusting for the 
     body weight of infants, Hilleman calculated that babies who 
     received their shots on schedule could get 87 times the 
     mercury allowance.
       The Swedish and FDA guidelines work out to about four-
     tenths of a microgram of mercury per kilogram of body weight. 
     A stricter standard of one-tenth of a microgram per kilogram 
     has been adopted by the Environmental Protection Agency and 
     endorsed by the National Research Council.
       These standards are based on methyl mercury, the type found 
     in fish and airborne emissions from power plants. Though 
     toxic, the ethyl mercury in thimerosal may be less hazardous 
     than methyl mercury, some scientists say, because it is more 
     quickly purged from the body.
       ``It appears essentially impossible, based on current 
     information, to ascertain whether thimerosal in vaccines 
     constitutes or does not constitute a significant addition to 
     the normal daily input of mercury from diverse sources,'' the 
     memo said.
       ``It is reasonable to conclude'' that it should be 
     eliminated where possible, he said, ``especially where use in 
     infants and young children is anticipated.''
       In the U.S., however, thimerosal continued to be added 
     throughout the '90s to a number of widely used pediatric 
     vaccines for hepatitis B, bacterial meningitis, diphtheria, 
     whooping cough and tetanus.
       It was added to multi-dose vials of vaccine to prevent 
     contamination from repeated insertion of needles to extract 
     the medicine. It was not needed in single-dose vials, but 
     most doctors and clinic preferred to order vaccine in multi-
     dose containers because of the lower cost and easier storage.
       The Hilleman memo said that unlike regulators in Sweden and 
     some other countries, ``the U.S. Food and Drug Administration 
     . . . does not have this concern for thimerosal.''
       A turning point came in 1997 when Congress passed a bill 
     ordering an FDA review of mercury ingredients in food and 
     drugs.
       Completed in 1999, the review revealed the high level of 
     mercury exposure from pediatric vaccines and raised a furor. 
     In e-mails later released at a congressional hearing, an FDA 
     official said health authorities could be criticized for 
     ``being `asleep at the switch' for decades by allowing a 
     potentially hazardous compound to remain in many childhood 
     vaccines, and not forcing manufacturers to exclude it from 
     new products.''
       It would not have taken a rocket science'' to add up the 
     amount of exposure as the prescribed number of shots was 
     increasing, one of the e-mails said.
       While asserting that there was no proof of harm, the U.S. 
     Public Health Service in July 1999 called on manufacturers to 
     go mercury-free by switching to single-dose vials. Soon 
     after, Merck introduced a mercury-free version of its 
     hepatitis B vaccine, replacing the only thimerosal-containing 
     vaccine it was still marketing at the time, a company 
     spokesman said.
       By 2002, thimerosal had been eliminated or reduced to trace 
     levels in nearly all childhood vaccines. One exception is the 
     pediatric flu vaccine made by Aventis and still sold mainly 
     in multidose vials.

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