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.