FDA Finds Five Drug Makers Using Materials Possibly Linked to Mad Cow Disease
FDA regulators have discovered that five drug makers -- GlaxoSmithKline, Aventis, American Home Products, Bioport and Baxter International -- had been using ingredients from cows raised in countries where there is risk of mad cow disease, even though the agency had asked companies not to use such products, the New York Times reports. The companies use materials from cattle to make nine "widely used" vaccines, including those to prevent polio, diptheria and tetanus and to thwart the effects of an anthrax attack. The "suspect" ingredients -- blood, for instance -- generally are used during the early stages of manufacturing, when cultures are grown. When the final vaccine is made, the cultures are "significantly diluted." FDA officials said that the vaccines are still considered safe and should remain on pharmacy shelves, calculating the odds of the vaccines passing on the disease as between one in 40 million and one in 40 billion doses, the Times reports. Dr. Karen Midthune, director of the FDA's Office of Vaccine Research and Review, said, "Any risk is very remote. But if we have the ability to bring this remote risk to zero, that is something we want to do."
In 1993, the FDA asked the vaccine makers to cease using cattle raised in Britain and other "high-risk" countries, following up with another letter in 1996 that "strongly" recommended that the drug companies take "immediate and concrete steps" to ensure they were not using such materials. FDA regulators said that it was not until they performed a routine review of a company's application for a license last year that they discovered some vaccine makers were not complying with the request. Since then, the five vaccine makers have agreed to stop using the potentially harmful materials. But some companies said that they found the request to stop using the materials "unclear," while other companies said that they "could not keep up with the government's expanding list of countries where cattle could be infected." Dr. Peter Lurie, a member of the FDA's advisory committee on mad cow disease, said, "The companies acted recklessly, because, in part, the FDA failed to regulate them."
The Times reports that the fact that the suspected materials "slipped into the nation's vaccine supply ... raises questions" about the FDA's ability to ensure all medicines are free of the infectious proteins that cause mad cow disease. Many drugs contain gelatin made from cows' hooves or bones, and dietary supplements are made from an "array of cow tissues," including prostate glands, testicles, thymus extract, freeze-dried brain, pituitary glands, powdered spleen and adrenal extract. The FDA so far has only investigated vaccine makers and has "urged" supplement manufacturers not to use cow tissue from certain countries. However, the agency does not have specific manufacturing guidelines for supplements and "cannot say whether products sold in the United States are free of such ingredients," as many supplements sold here are imported (Petersen/Winter, New York Times, 2/8).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.