Thursday, May 21, 2009

F.D.A. Scientists Accuse Agency Officials of Misconduct

Recently, in The New York Times there was an article entitled, F.D.A. Scientists Accuse Agency Officials of Misconduct. Eight F.D.A. scientists wrote a “private” letter to Congress accusing top F.D.A. officials of “engaging in serious misconduct by ignoring concerns of scientists at the FDA and approving for sale unsafe or ineffective medical devices.”

According to the article these medical devices include products like cardiac stents, nerve stimulators to relieve depression, imaging equipment and breast implants.

The New York Times article states, “The letter says that the scientist have documentary evidence that senior agency managers corrupted the scientific review of medical devices by ordering experts to change their opinions and conclusions in violation of the law.”

In working on my film, Absolutely Safe, I filmed from beginning to end the last two F.D.A. regulatory hearings on silicone breast implants. In the 2005 hearing, I witnessed F.D.A. scientists heavily criticize the amount and quality of the scientific data that one of the breast implants manufacturers presented to the panel. Despite the scientists concerns, the scientific panel recommended approval of silicone breast implants.

I watched a breast implant manufacturer acknowledge an important point about the data accumulated in their studies. If a woman had her implants removed she was dropped from their study because she no longer had their product in her chest. If a woman is having problems from her implants and has them removed, it is essential to follow that woman’s health. What are her symptoms? Does her health improve after explantation? Does her health get worse? Valuable data lost because of essentially a loophole where the manufacturer can claim they do not have to include that vital information. No F.D.A. official publicly protested this methodology in the hearing.

I questioned an F.D.A. official on the issue of conflict of interest. In the last hearing there were four plastic surgeons that earned as least part of their livelihood putting in implants. Could they be unbiased in their opinion? Was it a conflict of interest? I posed these questions to an F.D.A. official and she said the F.D.A. needed their expertise on the these panels. There was no acknowledgement of a possible conflict of interest.

There have been serious questions raised on the quality and amount of research done by breast implant manufacturers for years. Silicone implants were FDA approved on two to three years of safety data. It is widely accepted that problems with implants increase over the amount of time a woman has them in her body. So where is the research on women who have had implants for 10 years or 20 years? Implants have been on the market for over 40 years.

The content of this letter should be not be private. Hundreds of thousands of women are getting breast implants every year. If there are serious questions about the approval process of these devices the public needs to be warned immediately. The House Committee on Energy and Commerce will investigate the accusations of this letter. Their investigation should be speedy, thorough and transparent. The health of thousands of women is at stake.

1 comment:

  1. Lindsay Rosenwald Rosenwald, 33, specializes in finding and underwriting promising medical and biotechnology companies