- WASHINGTON (Reuters Health) - The US Food and Drug
Administration
(FDA) may soon consider banning the sale of any product containing cow
brains or spinal tissue, whether made abroad or here in the US.
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- Expert advisors to the FDA voted 18 to 1 on Friday in
favor of urging the federal agency to begin assessing the necessity and
feasibility of passing regulations to either ban or restrict the use of
products containing these tissues, due to the theoretical risk of "mad
cow" disease.
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- These products range from soup stock and sausage casings
to cosmetics, drugs, medical devices and dietary supplements.
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- Under federal law, the FDA is authorized to make and
enforce regulations needed to prevent the introduction and spread of
communicable
diseases. It is also authorized to regulate drugs, dietary supplements,
cosmetics and most foods except meat, poultry and eggs.
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- Mad cow disease, also known as bovine spongiform
encephalopathy
(BSE), is limited to cattle. But the consumption of BSE-tainted meat has
been linked to the emergence of a new variant of Creutzfeldt-Jakob disease
(vCJD), a rare and invariably fatal degenerative brain malady. There is
also no evidence that vCJD can be contracted from anything but tainted
meat.
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- The FDA's Transmissible Spongiform Encephalopathies
Advisory
Committee's vote was based largely upon the potential risk products
containing
cow brain or spinal tissue could pose to Americans.
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- Since 1996, over 100 cases of vCJD have been documented
in France and the United Kingdom, where the mad cow epidemic began around
1980. Regulations have since been passed to limit the spread of BSE
throughout
Europe and worldwide.
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- The US instituted a BSE surveillance program in 1990.
To date, no cases of mad cow disease or vCJD have been detected in this
country.
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- The FDA already has already banned the importation of
products containing cow-derived material from countries with documented
BSE cases. It has also asked blood collection centers to defer donors who
spent 6 months or more in the UK between 1980 and 1996. However, no case
of vCJD or CJD transmission via blood or blood products has ever been
documented
or reported.
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- The FDA committee said its primary concern in making
its recommendation was the lack of a definitive, real-time test to identify
incubating infections. The committee added it was also concerned that the
US could inadvertently import contaminated products, especially dietary
supplements. The FDA had previously issued an advisory on importing dietary
supplements from countries with documented BSE cases, but not from those
that appear to be BSE-free.
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- "I don't think there is any measurable risk at this
time, but it is unknown," explained Committee Chair Dr. David C.
Bolton
in an interview with Reuters Health following the vote. "The question
is how vigilant do we want to be."
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- Bolton, head of the molecular laboratory at the New York
State Institute for Basic Research in Staten Island, added that while the
US may appear to have stopped the importation of such products, no country
could be presumed BSE-free, including the US.
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- "It is likely that a case of BSE and vCJD as well
could occur in the US," Bolton said.
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- Still, the committee stopped short of recommending the
passage of regulations.
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- Bolton said this decision was made because there
presently
is a lack of scientific data upon which to base actual policy.
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- In the UK, Bolton explained, up to one million infected
cattle may have entered the food chain before resulting in the 100
documented
infections. But the committee still felt the FDA should consider more
stringent
regulations because consequences were dire for each individual with vCJD,
he added.
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- "It a small risk statistically, but it's fatal and
tragic to the individual," Bolton observed.
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- Should the FDA follow its committee's recommendation,
which the agency generally does, it will undoubtedly face criticism.
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- Critics have charged that the FDA has already overstepped
its bounds and created the perception of a public health threat when there
was none by passing precautionary regulations and advisories. These critics
have also charged that the FDA could be creating a slippery slope by
distorting
the meaning of a real public health threat versus a minimal individual
risk.
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- Among those critics of the FDA's policies is Dr. Scott
C. Ratzan, a widely recognized authority on mad cow disease and the
editor-in-chief
of the George Washington University Center for International Health's
Journal
of Health Communication.
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- "We have to careful, but one in five billion is
still no risk," Ratzan told Reuters Health.
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- But if the FDA should follow its committee
recommendation,
there are unlikely to be any immediate consequences. The FDA's rule-making
process could take months and even years to complete, while the agency
reviews the available data and upcoming studies.
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- In the meantime, Bolton suggested that consumers might
want to exercise individual discretion.
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- "I personally love a good steak," Bolton told
Reuters Health. "But I do not take dietary supplements and would not
eat cow brains."
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