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Date: Tue, 22 Dec 1998 11:12:55 -0500
From: Richard Wolfson <email@example.com>
Posted by: firstname.lastname@example.org (jim mcnulty)
Date: Sun, 20 Dec 1998 18:32:06 +0000
NEW STUDY QUESTIONS RBGH SAFETY (FIRST EDITION)
GROUP WANTS RBGH PULLED OFF MARKET (SECOND EDITION)
The Capital Times
A consumer group is calling on the Food and Drug Administration to pull
bovine growth hormone off the market, charging the agency ignored potential
The Washington D.C.-based Center for Food Safety filed Tuesday with the FDA
to withdraw or suspend use of the synthetic growth hormone, which is sold
by [ Monsanto Corp. ] under the trade name Posilac to increase milk
production. The agency has 180 days to conduct the investigation and either
reject the claim or pull the drug.
Vermont Senators Patrick Leahy, Democrat, and James Jeffords, Republican,
also have asked Donna Shalala, secretary of the U.S. Health and Human
Services Department, to formally investigate the FDA's approval and whether
it overlooked key evidence about the drug's safety. The request was filed
Dec. 3, but no action has been taken so far, said Bill Hall, Shalala's
deputy press secretary.
Andy Kimbrell, director of the Center for Food Safety, said he expects the
action will end up in federal court given that "the FDA throughout has been
very recalcitrant on this drug to come clean." The charge is resurfacing
now after years of debate in states like Wisconsin and Vermont, Kimbrell
said, because a group of scientists with the Health Protection Branch of
the Canadian government have come forward during that country's nine-year
approval process with a study that contradicts the FDA's most basic
conclusions about the drug.
During the approval process, the FDA relied in part on an unpublished
animal study done by Monsanto that said rats fed high doses of the hormone
over a 3-month period showed no evidence they had absorbed the hormone.
However, the Canadians claim their review of the Monsanto study actually
provides evidence that 20 to 30 percent of the rats absorbed the hormone
into their bloodstream. They also say some male rats developed cysts in the
thyroid and had higher levels of the hormone in the prostate.
The contention that the hormone could not be absorbed was the linchpin in
Monsanto's case in Wisconsin and nationally, and convinced the government
to approve rBGH without long-term toxicity studies, said Kimbrell, who was
one of the lead attorneys in the Wisconsin court battles. Kimbrell said the
FDA should have known the hormone survives digestion and called it
unconscionable that this information has been hidden from the public, which
for the past five years has been consuming rBGH-treated milk, often without
Monsanto spokesman Gary Barton said Posilac, which is sold in all 50 states
and 15 foreign countries, is the most tested drug in U.S. history and
didn't just slip through the FDA approval process. Barton called the
Canadian scientists' statements a "non-peer review look at some of the
data" that doesn't represent a final conclusion from Health Canada. He said
the safety of rBGH will be "reaffirmed" in the coming weeks when two
Canadian peer review panels, empowered by Health Canada, are expected to
release their findings.
"They are asking all the questions and we support good science," Barton
said. "But if you look at this product's history, research around the
world, there just has been no change in the scientific support of this
Still, Barton admits there is reluctance in Europe to embrace rBGH. In June
1997, the United Nations food standards committee voted overwhelmingly to
continue a ban on the use of rBGH and delay for another two years any
review of the drug. Barton said the moratorium is based on political and
economic reasons, not health safety concerns.
Longtime rBGH opponent and Middleton scientist Dr. William von Meyer
disputes Barton's claim rBGH was well researched. He said the government
lacks such basic information on rBGH, milk containing rBGH and the parallel
hormone IGF1 as: metabolism data that would examine the effects on
reproductive systems and chronic safety tests done on large groups of
animals over 18-36 months that would examine the effect of the hormone on
all organs and the development of tumors.
"When you have no metabolism data and no chronic safety tests, what you are
saying is you don't know a hell of a lot about this stuff," von Meyer said.
In the fall of 1996, von Meyer took his concerns to Rep. Scott Klug,
R-Madison, who approached the FDA on his behalf. Klug's district director
Sam Gold said 20 months passed and the FDA refused to answer what Klug's
office felt were some very straightforward questions. Klug went to the FDA
personally and arranged a meeting this past spring, but both sides came
away frustrated that it took so long and the answers seemed to be evasive,
Gold said Klug was not aware of the Canadian study nor had he seen the [
ABC ] news story that ran this week on the subject. He reiterated Klug's
position that rBGH-treated milk remain labeled. In Wisconsin, that means
the dairy case and the innocuous expression - Wisconsin's Choice - on
cartons of rBGH-free milk. Gold said the issue has raised few concerns
among constituents in recent years after heated debates that ended at times
in milk dumpings. But he added that the Canadian reports need to be looked
at by the FDA.
Sen. Russ Feingold, D-Madison, an outspoken opponent of rBGH, could not be
reached for comment.
State Agriculture Secretary Ben Brancel was not aware of the action and
said he would be surprised if the FDA didn't do a thorough job in its
approval process, as it is usually criticized for being too slow compared
with other countries. He said the issue has "fallen off the radar screen"
in Wisconsin and that state officials do not track the use of rBGH.
No one seems to know exactly how many farmers are using Posilac, but the
most recent study by the University of Wisconsin-Madison released in July
1997 shows that 12 percent of state dairy farmers are using rBGH, compared
with 6.5 percent in 1995. The adoption rate is 50 percent for farms with
more than 200 cows, but only 4 percent for 50-cow herds. Approximately 75
percent of the state's milk volume still comes from herds of fewer than 100
UW assistant professor of agricultural economics Brad Barham said the
chances of Posilac being pulled from the market are slim, but if it were,
the overall effect would be negligible to Wisconsin farmers as it increases
milk supplies by just 1-2 percent.
"Politically, it would be another story," he said. "It would be a lot of
backtracking for a lot of levels of government and scientists."
Fellow UW ag economist Bill Dobson said the economic impact would be felt
more strongly in California and Idaho, where there are larger herds and
where it is more widely used, and would put further upward pressure on
already high milk prices.
Barton said sales of Posilac, which is now made in Austria, were up 30
percent in both 1998 and 1997, and up 45 percent in 1996. The company does
not release specific sales figures, but he said, this year Monsanto
surpassed the 100 million dose mark.
(Copyright (c) Madison Newspapers, Inc. 1998)
Richard Wolfson, PhD
Consumer Right to Know Campaign,
for Mandatory Labelling and Long-term
Testing of all Genetically Engineered Foods,
500 Wilbrod Street
Ottawa, ON Canada K1N 6N2
tel. 613-565-8517 fax. 613-565-1596
Our website, http://www.natural-law.ca/genetic/geindex.html
contains more information on genetic engineering as well as
previous genetic engineering news items
Subscription fee to genetic engineering news is $35 for 12 months
See website for details.
--Dan in Sunny Puerto Rico--
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