http://www.latimes.com/business/la-fi-vaccine8feb08,0,624328.story?coll=la-home-headlines
'91 Memo Warned of Mercury in Shots
By Myron Levin
Times Staff Writer
February 8, 2005
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 used 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 were 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 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 clinics 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 "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 multi-dose vials.
If you want other stories on this topic, search the Archives at
latimes.com/archives.
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