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FDA Has No Beef With Hormone

March 17, 1995| Times Wire Services

The Food and Drug Administration has found no unusual problems with cows injected with the bovine growth hormone BST, despite a new round of criticism by opponents of the drug designed to enhance milk production.

The FDA reviewed reports from farmers during the first 12 months of U.S. sales and was unable to detect any unusual problems with bovine somatotropin, said Dr. Stephen Sundlof, director of the FDA's center of veterinary medicine. He said its evaluation of udder infections, cow deaths, reproductive disorders and other problems "raises no new animal health concerns based on data from clinical trials."

Monsanto Co. has sold BST since February, 1994, and is the sole marketer of it. The drug is sold under the brand name Posilac. Critics say there has been an increase in reports of problems at farms where BST had been used. But Sundlof said the critics used raw data and took information from reports not directly linked to the drug.

Posilac increases a cow's level of BST, a naturally occurring protein in animals. When the FDA approved the drug, it initiated a two-year monitoring program, telling farmers to disclose problems to Monsanto, their veterinarians or the FDA, which then evaluates these claims.

Sundlof said the FDA ordered a change in the reporting system of these claims, causing an increase in the number of reports. After BST's first six months on the market, the FDA had received 96 "adverse reaction" reports from 10,000 farmers. But after 12 months, it had received 806 reports from 13,000 farmers. This prompted BST foes to renew calls for the agency to suspend sales of the drug until it conducts a thorough investigation.

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