NOW: Uninformed 'Choice' is No Choice at All

[Guest guest]

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