WASHINGTON -- The Federal Bureau of Investigation is interviewing federal regulators about how American Home Products Corp. won the government's approval for a once-popular diet drug, people familiar with the matter said.
Since last month, FBI investigators have been questioning Food and Drug Administration employees who were involved in the U.S. agency's controversial 1996 decision to approve Redux, said a federal agent and another person involved. Redux was pulled from the market in 1997 along with Pondimin, a similar diet pill sold by AHP, after they were linked to heart-valve problems. Both pills dull the impulse to eat.
The FBI is trying to find out whether AHP and other companies involved told the FDA all they knew about adverse reactions to the diet pills, the federal agent said. Investigators also are looking into the deliberations of an FDA advisory committee that recommended approval of Redux, the agent said.
During the FDA deliberations, AHP was an adviser to Interneuron Pharmaceuticals Inc. of Lexington, Mass., which has the U.S. rights to Redux and had joined with AHP's Wyeth-Ayerst Laboratories to produce and market the drug.
Investigators are trying to determine whether there is evidence warranting a formal criminal inquiry, the agent said, adding that officials were trying to decide whether the investigation, if warranted, would be handled by the Washington or Baltimore FBI offices.
Greg Horner, a spokesman for the FBI's Washington office, said, "I can't confirm or deny the existence of an investigation." Barry Maddox, an FBI spokesman in Baltimore, said, "We right now don't have a case open." The FDA, based in the Washington suburb of Rockville, Md., had no comment, a spokeswoman said.
'Lawful and Appropriate'
In a prepared statement, Louis Hoynes, AHP's general counsel, said the company was "absolutely unaware of any investigation" by the FBI. "We have made a considerable effort to determine whether such an investigation exists and have been unable to do so," he said. He said that the company's actions "with respect to Pondimin and Redux were at all times lawful and appropriate." An Interneuron spokesman said the company hasn't been contacted by the FBI.
FDA approval of Redux didn't come easily. The advisory committee initially rejected the drug in September 1995 by a vote of 5-3 because of safety concerns. Later that year, the panel reversed itself, deciding 6-5 that the benefits for the clinically obese, the drug's target market, outweighed the risks. A number of prominent neuroscientists said at the time they remained concerned about evidence of brain-cell damage in animal experiments. It still took the FDA until April 1996 to formally approve Redux. The FDA generally follows the recommendations of its advisory panels, but isn't required to do so.
The chemical name for Redux is dexfenfluramine, or d-fen. During the 1990s, more than six million Americans took Redux or its chemical cousin, Pondimin, which had been on the market since the early 1970s. The pill was usually prescribed with another drug, phentermine, in a combination known as fen-phen.
The FDA began its own internal inquiry into the approval of Redux within weeks after the drug was pulled off the market in 1997, people involved say.
Questioned by FDA Agents
Last week, in a sworn deposition in one of several civil suits filed against AHP by diet-pill patients, Robert Levine, a former Wyeth-Ayerst employee, said he was questioned by two FDA agents at home about the company's handling of alleged valve-damage reports. He was questioned soon after the drugs were recalled.
Mr. Levine, formerly safety surveillance director for Redux, said that the FDA agents inquired, among other things, about a report that another employee had removed a number of valve-damage reports from the company's diet-pill data base. Mr. Levine indicated he didn't have any direct knowledge of the incident, but testified that it would have been "contrary to Wyeth policy." Mr. Levine, who left AHP in June 1997, couldn't be reached for comment. An FDA spokeswoman declined to comment.
Marc Farley, a Newark, N.J., lawyer working on AHP's diet-pill trial team, said the company believes the FDA concluded an investigation last year, following a detailed inspection of the company and the way it reported "adverse event" data, primarily from diet pills. He said the company agreed to improve its record-keeping and other procedures. Mr. Farley said any information about valve damage that may have been removed from company files was done so only temporarily and was later restored, to the FDA's satisfaction.
The FBI has been following the civil cases brought against AHP in Texas, New Jersey and elsewhere, the agent said.
Lawyers in the Texas and New Jersey cases say the company played down safety issues with Pondimin because they were concerned about jeopardizing FDA approval of Redux.
The lawyers have introduced evidence indicating that AHP officials knew about 31 potential cases of heart-valve damage, starting as early as 1992. Court documents indicate AHP knew of a much larger number of deaths associated with the lung condition known as pulmonary hypertension than was indicated on Pondimin's warning label. The label was later updated.
The company said the risks of hypertension were known, and that any variation between its labels and the incidence of problems wasn't material.
If a criminal investigation is launched, it would be the latest in a string of setbacks for AHP. In early 1998, the company withdrew its application for approval of Verdia, a blood-pressure medication, because of regulators' concerns about liver problems. Soon after that, the company had to recall Duract, a painkiller that caused fatal liver problems in some long-term users.
Just last month, it suspended shipments of its rotavirus vaccine after it was linked to serious bowel obstructions in 32 infants. Finally, the company last week said it is recalling nearly 600,000 allergy kits because the medicine inside might lose potency before the expiration date.
--Robert Langreth in New York and Chris Adams in Pittsburgh contributed to this article.
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