updated 9/22/2004 9:53:11 AM ET 2004-09-22T13:53:11

The government is taking steps to reduce the already minimal risk of mad-cow tainted components ending up in childhood vaccines and other medications.

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Pharmaceuticals regulated by the agency, including human vaccines and animal drugs used on farms, routinely use cow products in their manufacture.

The agency this summer strengthened safety measures to reduce the chance of mad cow-tainted cow parts winding up in such consumer goods as lipstick and hairspray.

William Egan, FDA acting director in the office of vaccine research and review, told pharmaceutical representatives on Tuesday that the new rule is aimed at reducing even further mad cow risk in human and animal drugs. He did not offer specifics.

“It’s under development. That’s all I can say,” Egan said during a conference co-sponsored by PDA, an association of scientists involved in drug development and manufacture.

No reported cases from medicine
There have been no reported cases of mad cow transmitted by medications. Dozens of people, however, were infected with Creutzfeldt-Jakob disease, related to the human form of mad cow, by taking tainted human growth hormone between 1963 and 1985, according to the National Institutes of Health. The method of manufacturing the growth hormone was changed in response to that risk.

Eating beef from a diseased cow is thought to cause variant Creutzfeldt-Jakob disease. More than 150 cases of variant CJD have been reported in the world, primarily in Britain, and most of those people have died. The one case of variant CJD in the United States was in a young woman who likely contracted the disease while living in Britain.

In July 2000, the FDA told manufacturers to replace products in their vaccines derived from cows born, raised and slaughtered in countries with confirmed mad cow cases. Manufacturers hustled to find replacement materials from countries whose cows were free of the always fatal brain malady.

At the time, no North American cases of mad cow, formally known as bovine spongiform encephalopathy, had been confirmed, until May 2003, when a 6- to 8-year-old cow in Alberta, Canada tested positive for mad cow. And, in December 2003, a second Canadian cow — this one a 6½-year-old imported into Washington state — also was confirmed with mad cow.

More aggressive surveillance by the Agriculture Department since June 1, 2004, has tested 63,341 American cow samples, said Lisa Ferguson, a USDA senior staff veterinarian. Two samples initially were suspicious but, upon further testing, were found not to contain mad cow.

Alternate sources found
The FDA’s Egan said the agency has not yet decided whether manufacturers will have to replace American and Canadian cow products routinely used in vaccine manufacturing. Argentina, Australia, Iceland and Uruguay are among the dwindling list of countries provisionally free of mad cow.

Also not clear is how the FDA would handle licensed vaccines currently on the market or products progressing along lengthy development pipelines.

Even if American and Canadian sources of bovine-derived products were prohibited, it’s not clear how sweeping the impact might be.

One drug company, GlaxoSmithKline, already found alternate sources of materials it uses to produce such products as hepatitis A vaccine and recombinant hepatitis A and B vaccine. While Danielle Halstrom, a GlaxoSmithKline spokeswoman, won’t identify the source countries, she said they do not include the United States or Canada.

“The entire process was completed more than a year ago ... to ensure we only use materials from countries” with no mad cow infections, Halstrom said.

Cow remnants left over from slaughter have long been used to manufacture drugs like vaccines. Serum is drawn from cow’s blood and sugars from cow’s milk. Amino acids from cow bones are added to growth media to coax along viral vaccines grown in living cells.

Egan suggested the companies consider plant-based and synthetic compounds as substitutes, culturing methods that don’t require serum, and “closed” cattle herds known to be free of mad cow.

A Merck representative lobbied from the stage at Tuesday’s conference, urging the agency to first issue a letter with its intentions so companies would have more time to prepare for changes that could affect 80 percent of pharmaceuticals.

“We have lifesaving medicines that we produce,” said Taryn Rogalski-Salter, a director in the company’s department of global regulatory policy, warning about potential supply disruptions.

© 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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