Re: Surgeon took grant from implant maker

[Guest guest]

Thank goodness! It looks to me like the " vote " is falling apart.

It sounds like we all have a fighting chance afterall! Thanks to

conflict of interest and Dr. Whalen! Personally, I wondered why the

plastic surgeons were allowed to vote....I thought THAT would

be " conflict of interest " . Those surgeons could potentially make

money if silicone became " FDA approved " .

Kacey

> 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.

> The full article will be available on the Web for a limited time:

> http://www.bayarea.com/mld/cctimes/news/7289681.htm

> © 2003 Contra Costa Times and wire service sources. All Rights

Reserved.

> Posted on Tue, Nov. 18, 2003

>

> Surgeon took grant from implant maker

> By Marc Kaufman

> WASHINGTON 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. "