-Caveat Lector-
/** headlines: 139.0 **/
** Topic: FDA To Restrict Animal Antibiotics **
** Written 11:29 PM Feb 1, 1999 by econet in cdp:headlines **
/* Written 7:06 PM Jan 30, 1999 by [EMAIL PROTECTED] in list.ar-news */
/* ---------- "FDA To Restrict Animal Antibiotics" ---------- */
FDA To Restrict Animal Antibiotics
.c The Associated Press
By LAURAN NEERGAARD
WASHINGTON (AP) -- The government wants to impose new restrictions on
antibiotics for animals to combat concerns that on-the-farm medication
is creating drug-resistant germs that could wind up in the meat that
people eat.
Advisers to the Food and Drug Administration ruled Tuesday that the
proposed rules need fine-tuning, but that most should go into effect
despite protests from makers of animal drugs that the agency is
drastically overreacting.
Among other things, the rules would set pre-established terms for when
an animal antibiotic has shown signs of enough drug resistance that its
use should be curbed -- or banned altogether.
``It's an issue that won't go away and can no longer be ignored,'' said
Dr. Keith Sterner, an Ionia, Mich., veterinarian who chairs the advisory
panel.
But a two-day meeting to deliberate the FDA's proposals highlighted how
bitter a controversy the issue is.
On one side, public health experts say on-the-farm drugs are worsening
the already dire problem of antibiotics losing their power to fight
infections. On the other side, the animal drug industry denies any
serious risk to consumers, noting that no one has died from eating meat
tainted with untreatable germs.
Critics ``never stood at the bedside of a critically ill patient ...
hoping the antibiotics will work and having to deal with the
consequences when they don't,'' said Dr. David Bell of the Centers for
Disease Control and Prevention. He pleaded with the industry to find a
compromise that protects consumers while still giving farmers drugs
vital for animal health.
But manufacturers adamantly opposed many of FDA's plans, saying the
rules would make it too difficult -- and expensive -- to create new
antibiotics for animals. They argued that the government instead should
study whether on-the-farm antibiotics really pose an imminent threat and
educate farmers and veterinarians to more prudently use the drugs.
``We believe the agency is overreacting,'' said Dr. Brendan Fox,
president of Elanco Animal Health.
That prompted a fierce reaction from one of FDA's advisers: ``If there
is no risk, you shouldn't be afraid of'' the rules, said CDC's Dr.
Frederick Angulo.
Antibiotics are fast losing their power against numerous germs, which
get a chance to mutate into untreatable strains every time they
encounter the drugs. Most to blame are humans: Doctors who overprescribe
antibiotics, and patients who take them improperly.
But many scientists say antibiotics on the farm are forcing food-borne
germs to start mutating, too. Among the evidence: Chicken sold in
Minnesota supermarkets contaminated with food-poisoning campylobacter
that was resistant to one powerful antibiotic. In addition, a strain of
salmonella impervious to five antibiotics nearly killed a Vermont dairy
farmer.
Almost half the 50 million pounds of U.S.-produced antibiotics is used
in animals. Eighty percent is used not to treat sick animals, but
instead to promote animals' growth by adding small doses into their
feed.
Already, Europe has drawn the ire of the animal health industry by
banning six antibiotics used as animal growth promoters, including one
closely related to the vital human antibiotic vancomycin.
Among the FDA's proposals to tackle the issue:
Companies seeking to sell a new animal antibiotic would have to prove
it's not expected to cause significant resistance.
The government would test today's level of food-borne drug resistance,
and then set limits on how much that resistance could increase before an
animal antibiotic would be restricted or even banned.
FDA would rank animal drugs, giving those most closely related to vital
human antibiotics extra scrutiny. Some companies might be ordered to
conduct on-the-farm animal tests.
FDA advisers say on-the-farm testing may be too complicated to work.
But Sterner said advisers agree with most of FDA's approach, and
stressed that animal antibiotics closely related to vital human drugs
would have ``a zero threshhold'' for increasing resistance.
The agency will decide which rules to adopt after a public comment
period ends in April.
AP-NY-01-26-99 1827EST
** End of text from cdp:headlines **
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