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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?


To: John F Beule who wrote (779)12/16/1998 8:20:00 AM
From: jopawa  Respond to of 2539
 
Tuesday December 15, 11:26 pm Eastern Time
Senators want review of growth hormone's FDA approval
WASHINGTON, Dec 15 (Reuters) - Senators from the U.S. dairy state of Vermont last month asked Health Secretary Donna Shalala to review a federal approval of a bovine growth hormone, a spokesman for one of the senators said on Tuesday.

Republican Senator Jim Jeffords and Democrat Patrick Leahy, had urged Shalala to investigate whether the U.S. Food and Drug Administration (FDA) had correctly appraised studies on the safety of the genetically engineered bovine growth hormone recombinant bovine somatotropin (rBST).

The hormone is used to boost average milk yields in dairy cows by 10-15 percent.

Canadian authorities reviewing an application for use of the growth hormone in Canada have raised questions about one of the studies the FDA cited when it gave Monsanto Inc.(NYSE:MTC - news) permission to market rBST in the United States.

Canadian scientists said the study, prepared by the company itself, included evidence that 20-30 percent of test rats given high doses of the hormone showed signs of the chemical entering their blood streams.

Some of the rats developed cysts and prostate problems, the researchers found, concluding that more studies were needed on the long-term effect of rBST use. They also raised questions about the effect of the drug on cows.

Jeffords and Leahy had also cited concerns raised by Canada's review of the Monsanto study, and asked Shalala to evaluate the FDA's handling of the hormone's approval, said Leahy's spokesman David Carle.

Shalala's office had received the letter and promised the senators a speedy reply, Carle added.

ABC News reported earlier on Tuesday that a consumer group, the Center for Food Safety, had initiated legal action against the FDA, alleging the agency had not paid enough attention to the possible dangers of using the hormone.

Mark Ritchie of the Institute for Agriculture and Trade Policy said the hormone should be withdrawn from the market immediately until possible health risks could be assessed.

''We now see there's potential of cysts in thyroids, of prostate, perhaps breast cancer,'' he told ABC. ''It should come up until we know what are the long-term impacts.''