vaccines: link to mad cows? (warning: VERY LONG)

[Guest guest]

Hi List,

Sorry about posting something so lengthy but I don't

have a " link " to send instead. In fact, I don't know

where this article is from, it was forwarded to me.

I doubt that anyone on the list needs ANY more reasons

to dislike vaccines, but thought some of you might want

the information anyway.

--Moria

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5 Drug Makers Use Material With Possible Mad Cow Link

February 8, 2001

By MELODY PETERSEN and GREG WINTER

For the last eight years, the Food and Drug Administration has

repeatedly asked pharmaceutical companies not to use materials from

cattle raised in countries where there is a risk of mad cow

disease.

But regulators discovered last year that five companies, including

some of the world's largest drug concerns, were still using

ingredients from those countries to make nine widely used vaccines.

Some of the companies say that they found the F.D.A.'s request

unclear and do not believe they did anything wrong. Others say they

could not keep up with the government's expanding list of countries

where cattle could be infected. One, however, acknowledged that it

could have moved more quickly.

The nine vaccines include some regularly given to millions of

American children, including common vaccines to prevent polio,

diphtheria and tetanus. They also include the anthrax vaccine,

which the government requires for soldiers serving in the Persian

Gulf.

Federal health officials stress that the vaccines are still

considered safe. They calculate that the odds of these vaccines

passing on the disease, in the worst eventualities, are between one

in 40 million and one in 40 billion doses.

The officials say that the very slight chance that someone could

be infected is far outweighed by the benefits that these vaccines

bring in fighting disease and preventing death. Indeed, it is now

only a scientific theory that a vaccine could infect someone with

the human form of mad cow disease — called new variant Creutzfeldt-

Jakob disease. No one is known to have contracted the disease this

way.

" Any risk is very remote, " said Dr. Midthune, director of

the F.D.A.'s Office of Vaccine Research and Review. " But if we have

the ability to bring this remote risk to zero, that is something we

want to do. "

Nonetheless, the fact that these suspect materials slipped into

the nation's vaccine supply — and that the F.D.A. did not discover

it for seven years — raises questions about the agency's ability to

ensure that all medicines are free of the infectious proteins that

can cause mad cow disease.

The F.D.A. so far has only investigated the vaccine makers and has

not looked to see whether other medicine is free of possible mad

cow contaminants. Some experts say they worry more about dietary

supplements. Unlike drugs, supplements are largely unregulated. The

F.D.A. is not even sure how many supplement makers there are.

" It's just insane not to have greater safeguards " for supplements,

said Dr. W. Brown, chairman of the F.D.A.'s advisory committee

on mad cow disease. " The potential exists for abuse. "

All five vaccine makers, which include GlaxoKline, Aventis

and American Home Products, have now agreed to stop using the

suspect materials, which include blood, fetal calf serum and meat

broth.

But it will take a year or more to replace existing supplies with

reformulated products, because it can take many months to grow

cultures used in making vaccines. Both the companies and the F.D.A.

say that the current products are safe and should remain on

pharmacy shelves.

They point out that the suspect ingredients, for the most part,

are used only in the early stages of manufacturing, when cultures

are grown. Blood, for instance, may be used to feed the bacteria

and viruses in these cultures. The cultures are then significantly

diluted in the final vaccine.

The F.D.A. first asked the vaccine makers in a 1993 letter to stop

using materials from cattle raised in Britain and other countries

where there was a threat of mad cow disease. Regulators followed up

with another letter in 1996 in which the agency " strongly "

recommended that drug companies take " immediate and concrete steps "

to make sure they were not using the materials.

In interviews, regulators said it was not until last year that

they learned that some vaccine makers were not complying. During a

routine review of a company's application for a license, the F.D.A.

discovered that the company, which it will not identify, was using

cattle parts from a high-risk country.

Regulators immediately demanded that all vaccine makers identify

where their biologic ingredients were coming from. That review

found the nine vaccines.

Dr. Murray M. Lumpkin, a senior medical adviser at the F.D.A.,

said his agency's investigative resources were limited.

" You have to prioritize where the greater risk is, " Dr. Lumpkin

said. For example, the F.D.A. now has inspectors visiting animal

feed companies, he said, after it found that many of them were not

following regulations adopted in 1997. Those rules, in part,

prohibit using beef parts to make cattle feed. Scientists contend

that cattle in Britain were infected after eating feed that

contained parts of other infected cows.

" That is where we think the greatest risk for Americans is at this

time, " Dr. Lumpkin said.

But critics including doctors, scientists and consumer advocates

say that the F.D.A. should have acted more aggressively by

ordering, rather than asking, companies to follow the agency's

recommendations.

" The companies acted recklessly because, in part, the F.D.A.

failed to regulate them, " said Dr. G. Lurie, another member

of the F.D.A's advisory committee on the disease.

Dr. Lurie, a researcher at Public Citizen, the consumer group,

said he agreed that the vaccines should stay on pharmacy shelves.

But he faulted both the companies and the F.D.A. for possibly

undermining public confidence in the safety of vaccines.

In their defense, F.D.A. officials said they expected companies to

heed their requests.

" The expectation, " Dr. Lumpkin said, " is that people will behave

responsibly. "

Mad cow disease, which is always fatal, is believed to be caused

by an infectious protein called a prion. In sick animals or humans,

the prion twists into an abnormal shape, often in the brain. These

misfolded prions accumulate in toxic clumps, eventually destroying

normal brain tissue and creating spongelike holes.

Cattle ingredients are used in a myriad of drugs other than

vaccines. But the F.D.A. says it cannot release a list of these

drugs because many details of how a product is manufactured are

proprietary corporate information.

But regulators say, for instance, that many drugs contain gelatin,

made from the bones or hooves of cattle. And calf lungs are used to

make surfactants, which help premature infants breathe.

As for dietary supplements, the industry's trade groups say that

hundreds of products use an array of cow tissues, from ground

prostate glands and testicles in pills that supposedly bolster

sexual vitality to thymus extract for healthy skin.

Many organs that scientists consider particularly risky for the

transmission of mad cow disease are also used, including

freeze-dried brain and pituitary glands in supplements that

manufacturers say stimulate memory, adrenal extract for energy,

even powdered spleen to help clear the sinuses.

As with vaccines, the F.D.A. has urged supplement makers not to

use cow tissue from certain countries. But the F.D.A., which has no

specific manufacturing rules for supplements, cannot say whether

products sold in the United States are free of such ingredients.

" The F.D.A. is toothless, " Dr. Brown said. " Their purview over

dietary supplements is infinitesimally small. "

Without comprehensive federal guidelines, the Natural Nutritional

Foods Association, the largest trade group, started a voluntary

program in 1999 to test whether its members' products are free of

contaminants, including mad cow disease. But of about 500 companies

eligible, only 20 have gone through the review.

For its part, the F.D.A. inspects only about 60 of the more than

1,000 supplement manufacturers each year. " We rely on the industry

to do the right thing, " said Dr. , director of the

F.D.A.'s dietary supplement division.

In 1995, the F.D.A. told its border agents to detain any imports

of suspect cattle parts or products made from them. Regulators say

they have not found any supplements sold in the United States that

contain the materials.

And one industry executive said there was little incentive to even

try to import such materials. " These glands are not very

expensive, " said Matt Schueller, vice president at Enzymatic

Therapy, a supplement maker in Green Bay, Wis.

Even so, Dr. Brown and others say that the border controls are not

enough.

Every year, more than $1 billion of supplements are imported from

high-risk countries, according to a 1999 F.D.A. study. Only about 7

percent of these products say on their labels that they contain

animal parts, but there could be more, Dr. Brown said. Foreign

labeling laws vary widely, he said, making it hard to know what

some imports contain.

The companies that make the nine vaccines say they have tried to

comply with the F.D.A.'s requests and, over the years, have

provided regulators with any information they asked for.

They say that in most of the vaccines, the ingredients that

regulators have questioned are in the cultures used to start each

batch. They say that some of these cultures, which are used year

after year, were created in the 1980's, before the F.D.A. told them

to stop using material from certain countries.

American Home Products has been working for five years to change

the material used in bacterial seed cultures for its vaccine, Pnu-

Imune 23, which prevents pneumonia, said Dr. R. Paradiso, a

top researcher in the company's Lederle Vaccine subsidiary. The 23

cultures making up the vaccine must be modified one at a time, he

said, with regulators approving each one.

" The risk is very, very minuscule, " Dr. Paradiso said. He

calculates the risk of Pnu-Imune passing on the disease, in a worst

case situation, at one in 2.4 trillion doses.

At Aventis, Len Lavenda, a spokesman, said that the company had

believed that IPOL, its polio vaccine, complied with the F.D.A.'s

request. But last year, regulators disagreed, he said, because the

company cannot trace the origin of some ingredients purchased in

the 1980's.

In ActHIB, Aventis's vaccine to protect against haemophilus

influenzae Type B bacterium, the company used small amounts of

hemin, a blood derivative, from cattle in the Netherlands. Material

from the Netherlands was banned in 1997, but Aventis decided not to

change its supplier, he said, because its scientists believed that

infectious material could not survive the production process.

" That was probably a mistake, " Mr. Lavenda said. The vaccines are

safe, he said, but the company fears its decision could weaken the

public's confidence in the vaccines.

BioPort, which makes vaccines against rabies and anthrax, said that

it did not understand until last year that the F.D.A. wanted the

companies to change seed cultures created before 1993.

GlaxoKline, the British pharmaceutical giant that sells three

of the vaccines cited by the F.D.A., declined to answer specific

questions. Carmel M. Hogan, a company spokeswoman, said the company

had been trying since 1990 " to move away from using bovine

materials from infected countries. "

The F.D.A. said the problem with Infanrix, one of

GlaxoKline's vaccines, which prevents diphtheria, tetanus and

pertussis, stems from an ingredient made for it by Chiron Behring

in Germany. Chiron stopped using material from German cows in

September, said Schick, a Chiron spokesman, after American

regulators visited its factory.

The final vaccine, Certiva, also for children, was made by North

American Vaccines until 1999 when there were production problems.

Baxter International, which purchased North American last year,

said the company did not intend to sell Certiva again.