BOSTON GLOBE: Senate looks at FDA moves on implants

[Guest guest]

> Note: forwarded message attached.

> > Date: Wed, 03 Aug 2005 10:42:04 -0600

> From: Ilena Rose <ilena03@...>

> Subject: BOSTON GLOBE: Senate looks at FDA moves on

> implants

> <Undisclosed-Recipient:;>

>

> Blank

>

>

> EXCERPT: Zuckerman, president of the National

> Research Center for Women and Families and a former

> US House investigator, was among those who filed

> complaints about Mentor and was interviewed by a

> Senate investigator.

>

> ''The impression I got -- and I say this as a former

> congressional investigator -- is that they are doing

> a comprehensive investigation, " Zuckerman said.

> ~~~~~~~~~~~~~~~

>

http://www.boston.com/business/globe/articles/2005/08/03/senate_looks_at_fda_mov\

es_on_implants?mode=PF

>

> Senate looks at FDA moves on implants

> Groups allege conflicts of interest in decision on

> easing silicone ban

> By Diedtra , Globe Staff | August 3, 2005

>

> WASHINGTON -- Congress is investigating whether

> conflicts of interest led a panel to suggest

> relaxing a 13-year ban on silicone gel breast

> implants.

>

> The investigation was launched by the Senate Health,

> Education, Labor and Pensions committee after

> complaints from 10 organizations, including the

> National Organization for Women. Among their

> concerns: A plastic surgeon who accepted money from

> a company seeking Food and Drug Administration

> approval to sell the implants was allowed to vote on

> the application and an FDA scientist critical of the

> implants was not called to testify.

>

> ''The committee is in the process of reviewing those

> allegations, " said J. Craig Orfield, the Senate

> committee's spokesman.

>

> Last week, the FDA signaled through an ''approvable

> letter " that Mentor Corp., based in Santa Barbara,

> Calif., will be allowed to market its implants

> subject to conditions. Silicone implants are thought

> to look and feel more natural than the

> saltwater-filled versions now available. The FDA

> banned silicone implants from general use in 1992

> due to safety concerns.

>

> The investigation into alleged conflicts of interest

> is the second recent confirmed inquiry into how the

> FDA handles disputed devices.

>

> The Senate Finance committee wants to know why the

> FDA reversed itself and approved a controversial

> device made by Cyberonics to treat depression,

> despite objections of agency scientists.

>

> ''Congress has an important oversight role. The

> agency looks forward to cooperating fully with

> them, " said Dr. Gottlieb, FDA's deputy

> commissioner for medical and scientific affairs.

>

> Letters exchanged between Senate Finance chairman

> Grassley and the FDA also suggest an inquiry

> may be looming into how the FDA addressed risks

> posed by devices made by Guidant Corp.

>

> Grassley, an Iowa Republican, said his interest in

> device safety is a natural extension of his push for

> safer prescription drugs.

>

> ''What we want this agency to do is have respect for

> the scientific process, " he said. ''In other words,

> I shouldn't have to worry about whether something is

> safe. They've got scientists that are looking into

> that -- as long as they let the scientific process

> work. "

>

> Mentor's press release explaining the FDA's actions

> last week did not mention the Senate investigation.

>

> , a spokeswoman for Mentor, declined to

> comment.

>

> An analyst who tracks medical device manufacturers

> said that news of an investigation might have only a

> temporary drag on stock prices if the FDA eventually

> rules favorably on a new product, as it did for

> Cyberonics.

>

> ''They got final approval, and the risk has all but

> evaporated for Wall Street investors, " said

> Gunderson, a senior research analyst at Piper

> Jaffray.

>

> Until now, high-profile congressional FDA hearings

> have focused on the drug safety.

>

> ''This is new territory for us in devices, "

> Gunderson said. ''There are very few precedents for

> us to go back and say, 'Oh, this is what happened

> when Senator Grassley investigated a company

> previously.' "

>

> US Senator Enzi, Republican of Wyoming,

> hired two investigators when he became Health,

> Education, Labor and Pensions committee chairman in

> January.

>

> Zuckerman, president of the National Research

> Center for Women and Families and a former US House

> investigator, was among those who filed complaints

> about Mentor and was interviewed by a Senate

> investigator.

>

> ''The impression I got -- and I say this as a former

> congressional investigator -- is that they are doing

> a comprehensive investigation, " Zuckerman said.

>

> But a former member of the FDA advisory panel on

> silicone gel implants said he does not expect the

> investigation will uncover significant industry

> conflicts.

>

> ''It's fueled by people who do not want to see

> silicone gel implants on the market, " said Dr.

> Olding, chief of the division of plastic

> surgery at the Washington University Medical

> Faculty Associates. ''I think science will trump

> politics. "

>

> Olding, one of two plastic surgeons on the panel,

> stepped down as the advisory panel began hearings on

> applications that could boost annual sales of

> silicone gel implants by $75 million.

>

> Olding amended a previous disclosure statement to

> reflect ownership of Medicis Pharmaceutical Corp.

> stock after Medicis said it sought to purchase

> Inamed, an applicant before the panel.

>

> Diedtra can be reached at

> dhenderson@....

>