Conflict of Interest Alleged in BGH Approval

Three congressmen, including Rep. George E. Brown Jr. (D-Riverside), have asked the General Accounting Office to look into a possible conflict of interest involving the federal government’s 1993 approval of the controversial animal drug recombinant Bovine Growth Hormone (rBGH).

Brown, who chairs the influential House Science and Technology Committee, and Reps. Bernard Sanders (I-Vt.) and David Obey (D-Wis.) have formally asked the Government Accounting Office to investigate the Food and Drug Administration’s approval of the Monsanto Co. drug, designed to increase milk production in cows by as much as 20%.

GAO, the investigative arm of Congress, would review allegations that two top FDA officials with former ties to Monsanto continued to play a role in the agency’s rBGH approval process and a subsequent labeling regulation after joining FDA. The drug is the first major food product developed through biotechnology or genetic engineering.

“There is a lot at stake here,” said Rep. Sanders in a telephone interview with The Times from his Burlington, Vt., office. “Monsanto is a multibillion-dollar company that invested hundreds of millions in rBGH development, and that is a huge investment for any size company. . . . The whole process has been extremely controversial from the beginning. . . . And if, in fact, it can be shown that the process was tainted--that you had key people in FDA who made approval and labeling decisions who are closely affiliated with Monsanto--then you call into question the entire process and the legitimacy of the process.”

The focus of the allegations are Michael R. Taylor, FDA deputy commissioner for policy, and Margaret A. Miller, deputy director of FDA’s office of new animal drug evaluation.

Taylor, while an attorney for the Washington-based firm of King & Spaulding from 1980 until 1991, did work for Monsanto. Miller, an endocrinologist, was employed as a senior research biologist for Monsanto and was a key participant in the company’s rBGH safety tests between 1985 and 1989. Both went directly from their previous positions to the FDA.

Jim O’Hara, FDA deputy commissioner for public affairs, said the agency’s legal counsel had thoroughly reviewed Taylor’s case and found no ethical conflicts.

He added that at no time was Miller involved in FDA’s review of the Monsanto application for rBGH, nor did she participate in writing any of the subsequent regulations.

“We have looked at these allegations in the past and feel comfortable that we have taken appropriate safeguards against conflict of interest,” O’Hara said. “If a third party wants to also look at them, then we welcome that.”

Taylor did sign the FDA’s interim regulation, which appeared in the Federal Register in February and stated that milk from rBGH-treated cows did not need to be labeled as a product of biotechnology. The guidelines also placed strict limits on claims that could be made for dairy products that originated from cows that did not receive the rBGH drug.

The regulation angered consumer groups and some in the dairy industry because it prevents firms from using any “rBGH-free” terminology on milk and milk products. Instead, companies that want to differentiate their products from those produced with the assistance of Monsanto’s rBGH drug must include extensive language stating, in part, “No significant difference has been shown between milk derived from (rBGH) treated and (non-rBGH) treated cows.”

(Just last week, Vermont and Maine signed into law regulations mandating that milk and milk products derived from cows treated with the rBGH drug be identified on the label.)

FDA’s O’Hara said that while Taylor’s signature appeared on the interim regulation, he did not write it. The authors, he said, were scientists in the agency’s Center for Food Safety and Applied Nutrition.

What’s more, Taylor was operating within federal ethics guidelines when he signed the regulation. Taylor came to FDA in 1991 and recused himself from any matters involving former clients--such as Monsanto--for a year, as required by law.

The 12-month recusancy expired well before FDA formally approved Monsanto’s rBGH drug in November, 1993, and issued the labeling guidelines in February, 1994.

Taylor’s former law firm, King & Spaulding, which still represents Monsanto, has sent numerous letters on behalf of the drug company to dairy processors who have attempted to adopt rBGH-free labeling, warning them they are out of compliance with FDA regulations. As part of the correspondence, King & Spaulding include a copy of the FDA’s interim guidelines, the same guidelines signed by former King & Spaulding attorney Taylor.

“Yes, King & Spaulding have sent letters on our behalf to companies that we believe were not following the law in terms of what they were saying about their products and the use or non-use of rBGH,” said Tom McDermott, Monsanto’s director of communications in St. Louis.

In addition, Monsanto has filed lawsuits against two dairy processors who have persisted with rBGH-free labeling, McDermott said.

The congressmen said their request for the GAO investigation was prompted, in part, by an unsigned letter, dated March 16, from employees in FDA’s Center for Veterinary Medicine who contend that former Monsanto employee Miller has been active in the agency’s rBGH policy deliberations which they contend was an apparent conflict of interest.