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Ethics Shakeups At FDA

Posted by Jane Akre
Thursday, August 13, 2009 12:17 AM EST
Category: Protecting Your Family
Tags: FDA, Drug Approvals, Medical Devices, Medical Device Safety Act, Riegel V. Medtronic

HHS is investigating a conflict of interest allegation concerning the official in charge of drug approval.


IMAGE SOURCE: Janet Woodcock, Wall Street Journal Web site

Shakeups are underway at the Food and Drug Administration, specifically in the areas of medical devices and drug research.


Daniel Schultz, is leaving the FDA’s medical device division “by mutual agreement” with FDA Commissioner Margaret Hamburg.

The medical device division of the FDA has been the subject of questionable approvals, including malfunctioning defibrillators, and the synthetic surgical mesh IB News reported on in “Suffering in Silence.”

Synthetic mesh has not been reviewed for safety, but is approved for marketing if it's “substantially equivalent” to some other product on the market under the agency’s 510(k) approval process.

Even when that “predicate device” is removed from the market over safety concerns, as happened in the case of Ethicon's TVT synthetic surgical mesh, there is no procedure within the agency to re-review the subsequent devices.

Earlier this year, nine scientists spoke up to incoming President Obama that they had concerns about how medical devices were approved without adequate checks for effectiveness and safety.

Then in April, the agency asked manufacturers for more proof their devices already on the market were safe.

Companies such as Medtronic, Royal Philips Electronics, Zoll Medical Corp, Covidien, Zimmer Holdings, Johnson & Johnson, and Abiomed, were all asked to provide additional proof of safety. The companies may have to pay for additional clinical trials or have them reclassified as less risky.

Sen. Chuck Grassley has also been looking into why devices were approved over the objections of scientists and doctors, reports the Wall Street Journal.


And the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, is under investigation for alleged conflict of interest, according to the Wall Street Journal.

The alleged conflict came to light when a drug company, Amphastar Pharmaceuticals, filed a complaint that a competing firm had access to Woodcock at critical times during the approval of a generic blood-thinning drug.

Amphastar complains that Dr. Woodcock even co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. which gave them a market advantage. The company has asked her to recuse herself from the issue within the FDA.

Dr. Woodcock has been with the agency for 20 years. The inspector general of the Department of Health and Human Services is conducting an ethics investigation. #

1 Comment

Posted by Lana Keeton
Thursday, August 13, 2009 2:07 AM EST

The Synthetic Surgical Mesh investigation team at the FDA needs to be investigated now that Schultz is gone.

In a conference call with Dr. Schultz and 12 other senior personnel at the FDA on June 16, 2008, (listed below) Dr. Schultz commented "Maybe doctors want the mesh to contract after it is implanted." Dr. Schultz is a surgeon, obviously an uneducated one.

Contraction of the mesh is not the goal. Native tissue is supposed to grow into the interstices of the mesh and create a connection simulating human connective tissue. That does not happen because the mesh is inherently defective.

In July 2008, I supplied Dr. Murray Malin at the FDA's Office of Compliance with significant documentation of the fraud of Johnson & Johnson, Gynecare and Ethicon on the FDA. The reply from Dr. Malin: Don't call me anymore."

These shakeups at the FDA have to continue... Americans are put at risk EVERY SINGLE DAY to be harmed by "minimally invasive, outpatient procedures" implanting synthetic surgical mesh for hernia repair, bladder suspension and pelvic organ prolapse.

The complications include death by bleedout, death from strangulation of the bowels, perforation of the bladder, male infertility, necrotizing fasciitis, inability to urinate, hernias, colostomies, to mention only a few.

Synthetic Surgical Mesh is a very dangerous product being surgically implanted in millions of Americans every year. The manufacturers of these products know they cause serious permanent injury to patients, but continue to sell them as safe and effective.

The complications put patients permanently in the health care system, cost insurance companies millions and millions of dollars and create thousands of medical malpractice lawsuits.

Contact Lana Keeton at truthinmedicine@bellsouth.net.

Dr. Daniel Schultz, Former Director
Center for Devices and Radiological Health

Dr. Murray Malin
Division of Enforcement A
Office of Compliance

Ann Ferriter
Network Leader, General Surgery,
Physical Medicine, OB/GYN Network

Tim Ulatowski
Director Office of Compliance, CDRH

Betty Collins

Thomas Knott
General Surgery Devices Branch

Wayne Miller

Harriet Albershiem
Div of Device User Programs
and Systems Analysis

Laurie Bernato
Emergency Room Nursing

Scott McName

Les Weinstein
CDRH Ombudsman, Liasion to Industry

Dr. Roxolana Horbowyj
Senior medical officer in CDRH

Vicky Wolfhard

Comments for this article are closed.

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