[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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