By Lisa Seachrist

Washington Editor

WASHINGTON — European measures to prevent the transmission of "mad cow" disease to humans could in turn deny patients life-saving medicines and hurt — rather than promote — the public health, the Pharmaceutical Research and Manufacturers of America (PhRMA) has warned U.S. health and trade officials.

On Jan. 1, 1998, a ban of "specified risk materials" in all foods, cosmetics and pharmaceuticals could remove all drugs containing bovine-derived gelatin or tallow from the shelves of European drugstores because of the presumed risk of transmitting the prion-based disease Bovine spongiform encephalopathy (BSE) to humans. The ban could include up to 85 percent of all medications imported from the United States.

"The real irony here is that this ban will significantly harm the public health by denying people their much needed medicines," said Gillian Woollett, assistant vice president for biologics and biotechnology at PhRMA. "The problem is that we are on the interface of science and policy and the European Commission is setting the public health policy on a perceived fear of BSE rather than sound science."

In the late 1980's and early 1990's, approximately 150,000 cattle in the United Kingdom and a few on the European Continent were stricken with BSE — a fatal brain disease that produces characteristic pitting of the animal's brain. The disease is caused by an infective protein known as a prion. The epidemic appeared to be caused by cattle feed derived from sheep that died of another prion-based disease, scrapie.

In 1988, the European Union (EU) banned the use of ruminant offal in ruminant feed to try to stem the tide of new infections. While at the time there was concern that BSE could be transferred to humans and cause the prion-based disease Creutzfeldt-Jakob disease (CJD), there was no evidence of an increased incidence of the disease.

In March 1996, researchers in the U.K. announced that a new variant CJD (nvCJD) had killed 10 young people. This variant has been linked to BSE because CJD ordinarily strikes after the age of 40. This link, however, hasn't been scientifically proven.

In order to prevent the spread of nvCJD, the European Union has agreed to a wide ban on the use of specified-risk bovine material, particularly brains and spinal cords, in foods, cosmetics and pharmaceuticals. That ban goes into effect the beginning of next year.

"Pharmaceuticals can contain bovine-derived gelatin and tallow as part of the formulation of the tablets and capsules," Woollett noted. Biologic products and vaccines can contain bovine-derived hydrolyzed proteins and other bovine products. "The idea that biotech from the United States would be less safe than biotech from Europe is ridiculous."

Because the European Commission has banned the use of these materials throughout the European Union and has set forth feeding and slaughtering guidelines, the assumption is that these products won't be used in products manufactured in Europe. Products manufactured in other countries, including the United States, would have to certify that these specified-risk materials are not part of the products.

CJD Risk From Drugs Called Minimal

"This is a ridiculous requirement," Woollett said. "BSE isn't in the United States, and we have the surveillance in place to find the problem. And we don't have a method of certification. That would require an agreed-upon standard of good rendering practices that would be required of everyone."

The fact that there is a requirement for certification for countries outside of the EU violates World Trade Organization (WTO) agreements. Woollett said that should the EU fail to alter the ban, the U.S. could take it up with WTO; however the organization does not have the means to force changes in the ban.

Representatives from the FDA met with their European counterparts on Oct. 8 and 9 to discuss the issue. While nothing has been settled, the agency has highlighted the effect that the ban could have for patients.

"My understanding is that they are beginning to see the problem, but they haven't quite figured out how extreme it is," Woollett said.

In contrast, Woollett noted that risk of contracting CJD from pharmaceutical products is minuscule. Gelatin doesn't contain the highest-risk materials and is highly processed, which eliminates more than 99.9 percent of infectious agents.

In addition, a peer-reviewed risk analysis funded by PhRMA indicates that the risk of contracting CJD from taking three gelatin capsules a day for a year is one in 100 billion. By comparison, the risk of getting cancer from eating a peanut butter sandwich every day for a year is a million times higher.

"Of course, we need to reduce any risk of transmitting CJD; but we need to do it scientifically, and removing life-saving medications from patients hardly provides a benefit commensurate to the risk," Woollett said. "I personally have a real concern that [the EU] is pandering to a fear with a fix that is ineffective." *

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