- 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
- Mad Cow In Gel Cap
- Controversy Rages
- US Questions Europe on Mad
- 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
- 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.