WASHINGTON _ Federal investigators have cleared three FDAofficials of allegations that they had improper ties with the maker ofa recombinant hormone that boosts cows' milk production.Investigators for the General Accounting Office (GAO) reportedthey have found "no conflicting financial interests" in the federalprocess that led to the approval or labeling of recombinant bovinesomatotropin (BST), produced by the Monsanto Company, of St.Louis.In their review of more than 40,000 pages of documents, however,the GAO investigators found that two FDA officials had published11 research articles "whose publication may have been contrary tothe FDA's requirements for prior approval of outside activities,"reported Robert Murphy, GAO's acting general counsel.But the GAO also concluded that the guidelines covering suchoutside activities are not well understood within the agency.FDA spokesman Jim O'Hara told BioWorld Today that the "GAOobviously did a very thorough and comprehensive examination ofthe facts surrounding the activity of these employees."The report exonerates them, and they have the full support of theagency," O'Hara said.Monsanto spokesman Tom McDermott said in a statement that theGAO report was the fifth by Congressional agencies in the past threeand one-half years. "Every one has concluded that the FDA'sscientific review and subsequent approval of our product wasproperly handled," McDermott's statement said.Three congressmen _ George Brown Jr. (D-Calif.), David Obey (D-Wisc.) and Bernard Sanders (D-Vt.) _ had requested theinvestigation in April. The GAO, a Congressional watchdog agency,examined the activities of FDA employees named Margaret Miller,Suzanne Sechen and Michael Taylor.Miller was a former Monsanto lab director who became the head ofthe FDA division in charge of reviewing BST.Taylor, the FDA's deputy commissioner for policy from 1991 to1994, had previously represented Monsanto as a partner in theAtlanta law firm of King & Spaulding. He did not, however,represent the company on issues related to BST. Taylor has since leftthe law firm to become a food safety official for the AgricultureDepartment.Sechen, who was the primary reviewer of BST, never workeddirectly for Monsanto, but she had worked for a Cornell Universityscientist who had acted as a consultant to Monsanto. BST is a nearly exact copy of a cow's natural growth hormone. It isinjected twice every month at the base of a cow's tail, and it isintended to increase a cow's milk production by as much as 20percent. In the six months after the product went on sale in February,approximately 10,000 farmers injected 6.8 million doses of thegenetically engineered hormone into more than 800,000 cows,according to the company. The U.S. Department of Agricultureestimates that the drug helped boost milk production in September to10.5 billion pounds, 3 percent higher than last year.Critics of BST, which went on sale in February, said the reportdemonstrated that the FDA had permitted corporate influence todrive the drug approval process. Activist Jeremy Rifkin of the PureFood Campaign in Washington has characterized the episode as "asignificant scandal," and has described the report as "devastating."O'Hara dismissed Rifkin's characterization of the episode, sayingthat any violations of FDA rules were minor and resulted fromignorance rather than malfeasance. He said the agency would takesteps to make sure employees understood the guidelines under whichthey are required to operate. The Pure Food Campaign has led a national boycott of dairyproducts produced with BST. As a result of the boycott, some of thenation's largest supermarket companies and dairy firms havedeclined to buy products that come from cows treated with the drug.(For more on another federal investigation related to Monsanto'sBST, see BioWorld Today, Oct. 18, 1994, p. 3.) n

-- Steve Sternberg Special To BioWorld Today

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