|FOR IMMEDIATE RELEASE
AUGUST 9, 2005
CONTACT: National Organization for Women
FDA Deception: Uninformed 'Choice' is No Choice at All
WASHINGTON - August 9 - Statement of Kim Gandy, President, National Organization for Women.
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.