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l~~ r r1DN l ll~ ) S "+hinf;Lon, DC Y~_ 11 14 ~ 1-1 Probe of 3 FDA Officials Sought Industry Ties Before Approval of Bovine Growth Hormone Are at Issue By John Schwartz w,.eiorcon e~.c stdl erka Three members of Congress have called for a federal investigation into possible conflicts of interest involving three officials of the Food and Drug Administration, which approved a controversial genetically engineered Monsanto Corp. drug last year. All three agency officials had some ties to Monsanto before coming to the FDA, but an agency spokesman denied there was any miscon- duct. In a letter Friday to the General Accounting Office, Reps. George E. Brown Jr. (D Calif.), David R. Obey (D- Wis.) and Bernard Sanders (I-Vt.) asked the watchdog agency to conduct a 30-day review of the FDA's approv- al of recombinant bovine somatotropin (bST), a sub- stance that increases milk yields in cows. "A troubling pattern of unanswered questions is emerging that suggests an altogether too cozy relation- !~hip between some FDA officials central to this food safety decision and their close dealings with the Monsan- to Company," Sanders said in a statement. The letter-which cites an anonymous March 16 complaint ostensibly written by members of the FDA's Center for Veterinary Medicine (CVM)-asks the GAO to probe the roles of three "key" FDA officials in the ap- proval of the Monsanto drug. The highest ranking is Michael R. Taylor, deputy commissioner for policy, a past FDA employee who re- joined the agency in 1991 from the Washington law firm of King and Spalding, which represents Monsanto. Also named was Margaret A. Miller, deputy director of the agency's office of new animal drugs. The letter charac- terized her as "a former Monsanto company employee" who wrote the FDA's opinion on why milk from bST- treated cows should not require speciallabeGng. A third staff member, Susan Sechen, was described as a data reviewer at FDA who had worked as a graduate student for a Cornell University professor who conduct- ed Monsanto-sponsored research on bST.) Anti-biotechnology activist Jeremy Rifkin first made the charges about Taylor in February, when he peti- tioned the FDA to rescind the approval of bST and inves- tigate the three staff members' role in the agency's poli- cy- On March 15, FDA Commissioner David A. Kessler sent Rifldn a four-page letter stating that "none of the ac- tivities of Mr. Taylor cited in your petition were in viola- tion of any applicable law or regulation, or were other- wise inappropriate.... I believe that Mr. Taylor's behavior adhered to all applicable ethical standards." Kessler said that Taylor had not been "intimately" in- volved in Monsanto's efforts to obtain approval, as Rifkin charged, and that he was involved in the FDA's bST poli- cy only in the final stages of review. Kessler attached a nine-page memo by FDA ethics of- ficial Jack M. Kress supporting that position. Upon arriv- ing at the FDA in the summer of 1991, Taylor recused himself for ope year from taking part in any agency ac- tion dealing directly with Monsanto or any other King and Spalding clients. Some longtime agency critics found the charges against Taylor misplaced. Sidney Wolfe, a physician who heads the Public Citizen Health Research Group here, has filed complaints with the FDA about revolving-door ethics issues concerning other officials. But he said yes- terday that "It's barking up a silly kind of tree to be going up against Mike Taylor." Wolfe said that "as far as we're concerned, he's done a perfectly good job." Wolfe compared Rifkin's charges to saying that anyone who worked for a drug company and began working for the FDA should not be allowed to say anything about drugs in general-a stance that Wolfe characterized as "preposterous." As for the two other FDA employees named in the House members' letter, agency spokesman Jim O'Hara said there was no impropriety. "As we have learned of these allegations, we have looked at them. The appropri- ate safeguards against conflict of interest have been tak- en," O'Hara said. Mitler was not involved in the decision to approve bST, and Sechen's involvement with the bST review was ~889EGMZ i Dairy-state Reps. Bernard Sanders, left, David R. Obey, center, and George E. Brown Jr. signed letter to the General Accounting Office regarding FDA approval of recombinant bovine somatotropin (bST), which raises cows' milk yields. approved at the outset by the FDA's ethics and program integrity division, which "determined that there was not a conflict of interest based on the information they were provided," O'Hara said. Although reluctant to comment in the face of a possi- ble investigation, Taylor said yesterday that "I would welcome any scrutiny of my actions." Much of the material used in the lawmakers' letter, in- cluding the anonymous CVM letter alleging Miller's con- flict of interest, came from Rifkin, a long-standing oppo- nent of bST. Bill Goold, a spokesman for Sanders, said the search of scientific literature relied upon by Sand- ers's staff in drafting the letter came from Rifkin's orga- nization. Rifkin has fought against the approval of bST for more than seven years as part of an all-fronts assault against biotechnology. He called his ethical charges "a significant scandal" that he said showed moral weakness at the top of the organization. "We want Kessler s resignation," Rif- kin said yesterday. He said that the nine-page' ethics memo by FDA's Kress was "people in government trying to protect their own." Sanders and Obey have previously taken stands against the approval of bST and its use without consum- er labels that identify the milk as coming from cows treated with the drug. But many Capitol Hill staff members were surprised to see Brown-who chairs the Science, Space and Technol- ogy Committee-as a signer of the letter. Sources familiar with the process said key committee staff members felt they had been end-run by activists. One congressional aide said staff members who normally would be informed of such an action were unaware that Brown had signed the letter. "George's issue is with the process of approval. He wants to make sure people are squeaky-clean," the aide said. Brown did not see the FDA response to the Rifkin petition before signing the Sanders letter, an aide said. Obey said yesterday that he had seen the FDA response, and "I'm frankly not impressed." Some acquaintances of Taylor were incredulous lhat the official would be the object of ethical scrutiny. `There's no more ethical person in this town than Mike Taylor," said Wayne Pines, a former FDA official who now consults with companies on FDA matters. "Mike ~ would never get involved in a situation in which there's a conflict-that's a no-brainer." r