Harvard Heavyweights To Head FDA

I enjoyed reading more about Dr. Hamburg and Dr. Sharfstein's background. They indeed have a large job in front of them and having two public health professionals, from outside the beltway, should be a positive step for the agency.

As a former FDAer I have only one small technical quibble with this post. FDA regulates 25% of the entire U.S. economy, or what's left of it, not 25% of the food, drugs, and chemicals in the U.S. So their job is even tougher than stated.

My comment is that the FDA needs to Amend the FDCA ACT to include the Devise and Prescription drugs to product liability list. To bring the Law into effect so that All Drug Manufacturing Companies are responsible for their creations. To make sure the person who is taking the drug has information and signs an agreement that they are willing to take an experimental drug for test purposes and to inform them of any problems that can arise from the study. This also makes the drug company responsible for their actions. This will help cut down on the public being at risk if the Company knows they are no longer immune to prosecution if they put a drug or devise on the market with false information presented to the FDA. The Congress has to step up to the plate and use the FDCA ACT added Product Liability.

If Dr. Joshua Sharfstein was actually the front runner, he should then have been appointed the FDA Commissioner. I find it disturbing that the reason behind his not being appointed is that the drug lobby opposed his appointment.

The drug lobbyist evidently knew that he was on the side of public safety, and protecting the consumers from their harmful medications and medical devices, which is why they opposed his appointment. It is exactly for this reason that he should have been appointed. I believe he would have facilitated change within this government entity, and that the American People would have been safer for these changes. I imagine under his direction that the “kickbacks” the doctors receive from the pharmaceutical companies would have been substantially squelched, and this would affect a change in a doctor’s attitude as to how they go about recommending drugs and medical devices to their patients.

I was glad to see that there will now be two leading doctors heading the FDA, and my hope is that between these two, the FDA will receive a total overhaul, in which it does away with the 510K process. This is the flawed process by which a medical device manufacturer can get FDA approval for their medical devices only having to show “substantial equivalence” to a similar product on the market. These device makers do not have to conduct clinical trials to test the safety and efficacy of these products, and the result is that people are being irrevocably harmed.

I am one of those such people, harmed by a medical device, the TVT model number 810041B. Ethicon, a subsidiary of Johnson & Johnson unleashed on the world market the Gynecare Tension Free Transvaginal Taping (TVT) System in 1997. At the time, the product was owned by Medscand Medical AB. Why Ethicon chose to launch the product remains to be seen, but I strongly suspect they had a monetary interest in this product even before they formally purchased it in 2000.

Americans because of the 510K process are being used as the clinical trials for medical devices approved with no prior clinical trials being required. I feel as though I was used as their guinea pig to test their product, despite the fact that I never consented to be a part of any clinical trial. I was simply told by my doctor what a “wonderful device” this was, and how much it would help me. It did help, until the time when it eroded my tissues away, and became exposed. I was never told of this risk or the many other risks I now know are associated with this product.

It is the duty of the Government to protect its people, and the FDA, a government entity, too, needs to be accountable for their actions. It is irresponsible to approve medical devices that are implanted in people in the willy-nilly way of the 510K process.

I too would like to see the FDA changed in a way that all doctors who are involved in the approval process for both drugs and medical devices can have no stock options what-so-ever in any of these pharmaceutical companies. I am of the understanding that under the current system they cannot be on the approval committee if they own stock in a company applying for approval, but who’s to say that they are not scratching the backs of fellows doctors who do have an interest in the product. We all know how the “good ole boys” network works, or should I say, doesn’t work. These doctors took the Hippocratic Oath, vowing to do no harm to anyone. To that I say, do your job with integrity, protect patients from harmful devices, and do not agree to scratch each others backs in the interest of monetary gain.

Well Said Suzanne! why is the medical device from Ethicon still on the market? especially when they compared it to another manufacturer and later this manufacturer's device was recalled by the FDA!!

The medical device which was approved by the FDA is the Ethicon Gynecare TVT Device, which shows on Ethicon registraton letter dated Jan 28 1998, however, Ethicon on their letter states the predicate device compares to this other manufacturers name and is the SAME device by this other manufacturer, this device was recalled back in 1999 by the FDA.

Just goes to show how incompetent they all are!

WAKE UP!!!!!!!!! and get this medical device off the market!