Surgeon on FDA silicone gel panel took money from Inamed

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

 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.

Michael Miller, a plastic surgeon at the M.D. Anderson 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.

Miller 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 Miller 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.

Miller 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, Thomas
Whalen of the Robert Wood Johnson 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 Miller had received the
grant from Inamed. He said he was confident that Miller'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."

Miller said the donation from Inamed, made through M.D. Anderson, 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. Anderson and sold to others via the
Internet.

"We told them what we wanted to do, and they gave us a gift to
complete it," Miller 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 Miller 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 Miller's grant from
Inamed, they might have viewed his arguments differently.

"Reading a transcript of the meeting, Miller 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."
 

~~~~~~~~~~~

This is the same company whose president in Ireland for 4 years
harassed sick women on the newsgroup alt.support.breast-implant while
posting under an alias and refused to admit his affiliations with
Inamed.

Patrick J. O'leary was assisted in his cloak and dagger games by a
"support leader" (Susan Elaine Schaezler of Cibola, TX) who lied to
the support system of women harmed by Inamed and other breast
implants, that he was a "caring professional."