Mad Cow In Medicine
And Supplement Gel Caps?
Source: American Journal of Epidemiology 1997; 145:959-969
Note: How did U.K. cattle get Mad Cow disease? "Scrapie" is a long-standing neurological disease of sheep. And ground-up sheep (i.e., meat and bone meal or "MBM") is part of the diet of cattle. Until the 1980s, Meat and bone meal preparation involved the use of chemical solvents. Solvent use (unwittingly) prevented transmission of scrapie via MBM to cattle. But in the 1980s, use of chemical solvents stopped because of expense and more stringent health and safety measures in industrial processes.
[Source: American Journal of Epidemiology 1997; 145:959-969.]

Mad Cow In Gel Cap
Controversy Rages
US Questions Europe on Mad Cow Move
By Lauran Neergaard 12-5-97
WASHINGTON (AP) -- A pending European ban on animal byproducts in medicines because of fears of mad-cow disease endangers the supply of drugs overseas and in the United States, U.S. health officials say.
Eighty percent of oral medicines contain animal byproducts that the European Union has ordered banned by Jan. 1. The EU fears the byproducts could spread the fatal cattle disease, so named because of cows' symptoms, to people.
If the EU does not amend the ban, the time needed to change drug ingredients ``is such that there would be shortages everywhere,'' said Sharon Smith Holston, deputy commissioner of the Food and Drug Administration.
``The infinitesimal risk of transmission ... compared to the risks from not having your needed medications -- there's just no comparison,'' she said.
An unusual coalition of FDA regulators and drug manufacturers is pressuring Europe to back off. The European Commission, the policy-making body of the 15-nation EU, issued a statement this week suggesting a compromise that could give many drug makers another year to comply.
U.S. companies immediately said even another year is too little time to find new recipes for vital medicines. At a private meeting in Washington Friday, U.S. officials reiterated their concerns to European Commission members.
The Clinton administration has warned Europe the ban could cause a trade dispute, with $4 billion in U.S. pharmaceutical exports at stake.
But the FDA and the industry's Pharmaceutical Research and Manufacturers Association contend public health is a bigger worry. The association estimates the European ban could cause shortages in 85 percent of medicines sold on the continent.
Because companies use the same ingredients in U.S. and European versions of drugs, FDA officials fear domestic shortages also as companies struggle to change how they make drugs. Agency officials are making repeated flights across the Atlantic to argue for exemptions.
Mad cow disease caused a panic last year after the British government announced that eating infected beef may cause a new version of a fatal human brain illness. It has been blamed for killing about 20 people, mostly in Britain.
Mad cow disease has not appeared in the United States. But the EU contends that nowhere is completely safe, particularly because mad cow disease is from a family of ``transmissible spongiform encephalopathies,'' or TSEs, that attack different animals. Indeed, U.S. sheep can get one such illness, called scrapie.
So the EU in July decided to ban from medicines ingredients made with ``risk materials'' such as brains, spinal cords and other bones and tissues.
Yet almost every pill or capsule contains tallow, made from boiled cattle carcasses, and gelatin, made from animal bones. To use such ingredients, companies would have to find suppliers who made them from animals specially slaughtered to avoid the banned parts.
TSEs have never been found in tallow or gelatin, drug makers say. Still, the Pharmaceutical Research and Manufacturers Association did a worst-case estimate and predicted a one in 100 billion chance of sickness.
Finding new supplies of risk-free gelatin could take eight to 12 months, not counting the time needed to manufacture new pills and win FDA approval of the manufacturing change, Holston said.

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