By Lisa Seachrist
WASHINGTON — With the imminent implementation of a proposal designed to prevent the transmission of "mad cow" disease to humans, but which would inadvertently eliminate up to 85 percent of all medicines from the shelves of European pharmacies, the European Union (EU) agricultural ministers are meeting today to decide whether to repeal the ban or let the flawed law go into effect Wednesday.
The implementation of the ban, which was adopted July 30, 1997, was delayed for three months in late December to allow the ministers time to find a way to ban certain sheep, cow and goat byproducts without in effect banning lifesaving medicines. However, late last week, the standing veterinary committee of the European Commission (EC) failed to modify the ban, effectively leaving the original law in place.
An EU spokesperson in Washington said the agricultural ministers now must make the choice of dropping a proposal designed to safeguard against transmission of spongiform encephalopathies or allowing a ban to go into effect that would eliminate many medicines made from animal byproducts.
"The idea that the July 30 decision is off the table is ideal given that it was never based in science," said Gillian Woollett, assistant vice president for biologics and biotechnology at the Pharmaceutical Research and Manufacturers of America (PhRMA). "But I am not sure how easy it is for the ban to be removed from the books. It's awfully close to the deadline."
The dilemma began with the announcement that mad cow disease could be contagious to humans. It is thought that bovine spongiform encephalopathy (BSE), or mad cow disease, was caused by cattle feed that had been derived from sheep infected with scrapie, another prion-based disease. In March 1996, researchers in the U.K. announced that a new variant of the human prion-based Creutzfeldt-Jakob disease (nvCJD) had killed 10 young people and appeared to be linked to BSE.
At the time, the EC came under scrutiny for failing to act to protect the citizens of member countries from a potential health hazard.
Last July, the EC took action and adopted a proposal to remove specified risk materials (SRMs) from the human and animal food supply in an effort to prevent the transmission of prion-based spongiform encephalopathies. The proposal bans SRMs — the brains, spinal cords and eyes from cows, sheep and goats over one year of age, as well as the spleen from sheep and goats of any age — in all foods, cosmetics and pharmaceuticals.
However well-intentioned the action, Woollett noted the ban was put into effect without anyone conducting a risk-benefit analysis to determine what costs the ban could inflict. PhRMA has conducted its own analysis, finding that the risk of contracting nvCJD from three gelatin capsules a day for a year is one in 100 billion.
At issue for the biotechnology and pharmaceutical manufacturers is the fact that the regulation could effectively ban all bovine-derived gelatin and tallow from medicines. Tallow serves as a source of magnesium stearate, which is a component of many pill formations. Biotechnology products relay on hydrolyzed proteins for cell cultures. And vaccines are produced in a variety of bovine-based nutrient broths, including brain-heart infusion broth. PhRMA estimates 85 percent of medicines contain these products.
Because several issues, including the effect on medicines, had not been resolved in December, the veterinary standing committee opted to postpone implementing the proposal Jan. 1, 1998, for three months in order to find a suitable compromise.
Last week, the EC took the unusual step of announcing in a press release that it wouldn't postpone implementation a second time, in an attempt to get member countries to approve a modified proposal.
In that release, the EC stated the only options were to accept the modified version or repeal the proposal entirely. The veterinary standing committee failed to get a "qualified majority" of its members to accept the modified proposal, leaving it likely that the agricultural ministers will vote to repeal the law today.
"From the point of view of the science, repealing the ban is definitely the way to go," Woollett said. "But this has never been a scientific debate." *