Surgeon took grant from implant maker

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Surgeon took grant from implant makerA plastic surgeon on a government advisory panel that voted last month in favor of allowing silicone gel breast implants back onto the market said Monday that he received a $25,000 grant about three years ago from the company that makes the devices.

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Posted on Tue, Nov. 18, 2003

Surgeon took grant from implant makerBy Marc KaufmanWASHINGTON POST

WASHINGTON - A plastic surgeon on a government advisory panel that voted last month in favor of allowing silicone gel breast implants back onto the market said Monday that he received a $25,000 grant about three years ago from the company that makes the devices.

, a plastic surgeon at the M.D. Cancer Center in Texas, said the grant helped pay for an informational CD-ROM he produced on reconstructive breast surgery and that the money did not influence his decision on the panel.

In a letter Monday to Food and Drug Administration Commissioner Mark McClellan, the advocacy group Public Citizen criticized the relationship as a potentially significant conflict of interest that should have been publicly disclosed.

said he had disclosed the grant to the FDA when he received it, but the chairman of the advisory panel said Monday that he was unaware of the arrangement.

The letter from Sidney Wolfe, director of Public Citizen's Health Research Group, called for an investigation into the relationship between and Inamed Corp., the implant maker, before the FDA makes a final decision on whether to approve general use of the silicone gel implants.

"The failure to do this would make a mockery out of the issue of conflict of interest and would trivialize its impact on decision-making," Wolfe wrote.

After two days of often emotional testimony about the benefits and risks of silicone implants, the FDA panel voted 9-6 to recommend approval.

was one of four plastic surgeons on the panel who supported the company's submission and played an active role in the panel's debate.

Several weeks after the vote, the panel's nonvoting chairman, Whalen of the Wood Medical School, took the unusual step of publicly recommending that the FDA disregard the panel's nonbinding (but usually followed) decision and deny Inamed's application.

Whalen said he was concerned about the long-term safety of the devices.

Monday, Whalen said he had been unaware that had received the grant from Inamed. He said he was confident that 's judgment was not colored by the relationship but added that "with this highly controversial issue, appearances matter and it behooves us to be as forthcoming as possible."

said the donation from Inamed, made through M.D. , did not affect his ability to be impartial about the company's application.

He said Inamed played no role in the making of the CD-ROM, which is given to patients at M.D. and sold to others via the Internet.

"We told them what we wanted to do, and they gave us a gift to complete it," said of his arrangement with Inamed.

"If someone wants to search for something in my professional writings or professional activities of any kind and try and construct some kind of explanation for my vote on the panel besides an objective, responsible examination of the data, they are just making a mistake," he said. "I don't benefit from the company at all."

Under FDA rules, members of advisory panels must disclose any relationship with companies whose products they might be asked to judge.

The agency's policies call for those disclosures to be made public when they would "enable a reasonable person to understand the nature of the conflict and the degree to which it could be expected to influence the recommendations the (panel member) will make."

At the beginning of the hearing on silicone implants, an FDA official said a potential conflict involving had come up but the agency had judged it to be sufficiently minor to allow him to continue on the panel.

No further details were given.

Wolfe said if other panel members had known about 's grant from Inamed, they might have viewed his arguments differently.

"Reading a transcript of the meeting, was consistently in favor of approval, while many other members were uncertain," Wolfe said. "He was an important figure, and both the panel members and the public should have known of his dealings with the company."