'91 Memo Warned of Mercury in Shots

[Guest guest]

An internal memo of Merck & Co. dating from 1991

says 6-month old children who received their

shots on schedule woud receive mercury at a dose

of up to 87 times greater than the limit

indicated by guidelines for the maximum daily

consumption of mercury from fish...

 

Kind regards

Sepp

 

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

 

 

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 Š 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.

 

 

 

 

 

--

 

 

The individual is supreme and finds its way through intuition.

 

Sepp Hasslberger