U.S. Request on Vaccines
Ignored by Drug Firms
For 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
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
Some of the companies say
they found the agency'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
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. Karen Midthune, director of the agency'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 country's vaccine supply - and that
the agency 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 Food and Drug
Administration 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
"It's just insane not
to have greater safeguards" for supplements, said Dr. Paul Brown, chairman
of the agency's advisory committee on mad cow disease. "The potential
exists for abuse."
The five vaccine makers are
GlaxoSmithKline, Aventis, American Home Products, Bioport and North American
Vaccines (which was acquired by Baxter International last year).
The five vaccine makers
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 months to grow cultures used in making vaccines. Both the companies and
the agency say the current products are safe.
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 Food and Drug
Administration first asked the vaccine makers in 1993 to stop using materials
from cattle raised in Britain and other countries where there was a threat of
mad cow disease.~folo~Florence Has Protest Barbecue~/folo~Italian agricultural
and tourist associations organized free beef barbecues Thursday in restaurants
and piazzas in Florence to protest new mad cow restrictions imposed by the
European Union, The Associated Press reported from Florence.
About 250 kilograms (550
pounds) of fiorentina, a T-bone steak that is Tuscany's culinary pride, were
prepared to be cooked up in a central piazza in Florence, said Gilberto Bacci,
a spokesman for Confesercenti, an association of restaurants, hotels and other
At least 40 restaurants
around Florence said they would also offer a free taste of the steak.
Elsewhere in Europe on
Thursday, German officials said the country would create a government agency
for food safety.
In Dublin, Irish officials
said banned nerve tissues had been found in a shipment of beef from Germany.
The officials said they
were raising the discovery "as a matter of urgency" with German
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