NOW: Uninformed 'Choice' is No Choice at All

[Guest guest]

NOW: Uninformed 'Choice' is No Choice at All

http://www.phxnews.com/fullstory.php?article=24008

Today we call on the United States Congress to step in

and fully investigate the entire circumstances

surrounding the U.S. Food and Drug Administration

(FDA) decision to send an approvable letter regarding

dangerous silicone gel breast implants - from the

allegations of fraud and deception made under oath by

managers of the company that makes these implants, to

the role of a senior manager at the FDA who acted more

like a representative of the manufacturer than a

person carrying out a public trust.

In their extensive public relations campaign to

pressure the FDA to approve risky silicone gel-filled

breast implants, while denigrating the women's health

advocates who are demanding long-term safety data,

manufacturers are attempting to position implants as a

" choice " that women must be free to make.

No reasonable person would suggest that untested drugs

be sold to anyone who'll pay the price, on the basis

that it's their " choice " to use a drug that hasn't

been proven safe. If that were permitted, there would

be charlatans on every corner peddling their cures for

cancer, and making a lot of people sick. Come to think

of it, that's exactly what these breast implant

companies are doing - making a lot of women sick.

And the FDA seems to be on its way to helping them,

with its reckless decision to issue Mentor Corporation

an approvable letter to market their implants. The

FDA's own scientific staff told the Advisory Panel

considering the Mentor application in April that the

company's data were not sufficient to demonstrate

long-term safety of their product. And nothing has

changed - except that the public has heard allegations

from former Mentor staff, via the New York Times, that

implant data was falsified or manipulated to eliminate

bad results.

Women will risk a lifetime of grave complications from

faulty breast implants because the Bush administration

and their appointees value short-term profits over

women's long-term health. Bush-appointed FDA

Commissioner Lester Crawford is rewarding a company

that has been accused by former employees of

falsifying and withholding data about these implants,

and was the subject of a long criminal investigation

by the very agency he heads.

The FDA is not being coy about its political agenda.

The testimony of women who suffered from silicone-gel

leakage and migration to other organs, painful

capsular contraction and disfigurement, and increased

risk of death from suicide, brain cancer and lung

cancer - all which have been documented by clinical

research and recognized by FDA staff - apparently

don't offset the lobbying campaign directed at

political appointees like Commissioner Crawford by

their corporate supporters.

What happened to the FDA that once protected women

from the cruelty

of thalidomide and other dangerous drugs - putting

public health

above the greed of corporate interests? The FDA must

not place corporate profits over women's lives and

safety.

It's an insult to suggest that women need to have the

" choice " to put a dangerous product into their bodies

- without even enough data to demonstrate safety over

the reasonable life of the product. It's no " choice "

when the long-term safety data has been withheld from

the public - or worse, when there is every indication

that the safety data has been manipulated. Reality:

There is no silicone gel- filled breast implant that

has been shown to be " safe. "

Mentor conveniently " lost " thousands of women in a

prior clinical trial on this implant product - is it

reasonable to assume that many of these " lost " women

may have experienced problems with rupture, leakage,

capsular contracture or other serious injuries and

illnesses due to their implants? Apparently Mentor did

not want FDA reviewers or the general public to know

about what might have happened to these women. In

fact, there are indications that they intentionally

omitted from their studies any woman who was made so

miserable by her implants that she did not replace

them after removal. Only women who replaced their

removed implants with new implants were included in

the data.

According to the New York Times, Mentor Corporation -

once the subject of a criminal investigation - is

alleged to have falsified information about their

implants, hidden defective implants from government

investigators and changed their data to minimize the

rupture problem. According to that report, a former

Mentor product manager testified under oath that " top

executives instructed him to destroy reports detailing

the high rupture rates and poor quality of some types

of implants " and another manager accused Mentor of

dramatically underreporting failure rates of their

implants.

Extending the deception even further, the FDA stated

that the approvable letter would be issued with

specific conditions that Mentor must satisfy:

presumably expensive MRI procedures that might or

might not detect rupture or leakage and other

procedures that may be difficult to assure. The agency

has no authority to enforce these conditions; so in

actuality there are no future assurances of implant

safety or even of the gathering of helpful safety

data.

Approval of a device that is potentially harmful for

hundreds of thousands of women is both duplicitous and

dangerous - taken by the federal agency whose main

mission is to safeguard the public's health.

Former FDA Commissioner Mark McClellan set a standard

of safety in 2004. The FDA's own review of the data in

the companies' applications presented at the Advisory

Panel meeting clearly concluded both Mentor and a

second company, Inamed Corp., failed to meet the

standard established by Commissioner McClellan. The

FDA's clear shift in precedent marks a change in the

agency's mission to protect the public's health: it is

now buyer beware.

It is time for Congress to step in and conduct a

thorough investigation of how the FDA came to make

this compromised and deceptive decision. NOW has also

sent the agency a Freedom of Information Act (FOIA)

request for copies of documents pertaining to the

criminal investigation of Mentor Corporation and is

asking for details about the specified conditions

under which the FDA approvable letter to Mentor has

been offered. We are asking the Food and Drug

Administration to withdraw the Mentor approvable

letter, to open its files to Congress, and to comply

with our requests.

Women deserve the facts - without them, there is NO

real choice.

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For links to the breast implant controversy:

www.BreastImplantAwareness.org