AHRP has received an appeal for help to prevent the firing of courageous, honest FDA scientists who risked their careers to save lives by informing Congress about serious safety concerns involving dangerous, FDA-approved drugs and medical devices.

FDA employees should not be afraid to speak honestly and freely about misconduct that threatens the health and safety of all Americans.

Take Action by sending a message to Margaret Hamburg, FDA Commissioner.
See suggested text at: http://www.capwiz.com/whistleblowers/issues/alert/?alertid=22364531&type=ml

Below is my letter of protest.

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Sent: Wednesday, January 19, 2011 9:39 AM
To: Veracare@ahrp.org
Subject: Shoddy Investigations by HHS OIG to result in FDA Whistleblowers being Fired – HELP THEM

Two years ago a letter from a group of FDA reviewers to President elect Obama became public. The letter indicated that devices were approved in such a manner that the approval was "corrupted and distorted by current FDA managers, thereby placing the American people at risk."

The letter also indicated that FDA is "fundamentally broken", and that "There is an atmosphere at FDA in which the honest employee fears the dishonest employee." http://online.wsj.com/article/SB123142562104564381.html

In October 2010 it became known that the Menaflex knee implant made by ReGen Biologics was approved after the FDA was lobbied by four members of Congress acting on behalf of the company. http://www.usatoday.com/yourlife/health/healthcare/government/2010-10-14-fda -knee_N.html

The whistleblowers have also noted problems with CT scanner approvals and radiation overdoses. An investigation was begun only after Congressional requests. However after a year of investigation the FDA dismissed the claims and the HHS Inspector General again dismissed the scientists’ complaints. The scientists cried foul, saying the IG’s second investigation was a farce. One of the whistleblowers-who claims his contract at the FDA was cancelled after he filed a complaint-accused the IG office of dismissing the case without even interviewing any of the scientists.

"It’s hard for me to believe this was a bona fide investigation when they haven’t even contacted the people who reported these violations," Dr. Julian Nicholas, an Oxford-trained intestinal specialist, told The Associated Press. "Such a huge amount of money is at stake and so many people are affected that for the [Office of Inspector General] not to conduct a credible investigation is criminal in itself."

Recently, the Project on Government Oversight (POGO) has asked that the investigation be reopened. As the IG limited the investigation to criminal acts and did not include investigations of violations of FDA policies or procedures.

Now, the FDA has taken the retaliation one step farther. They have discovered the identity of some of the whistleblowers and the FDA has issued a notice of proposed removal to a 23-year veteran medical doctor and Ph.D. scientist. Her alleged crime that caused this notice was nine emails to a fellow FDA whistleblower who was acting as the employees’ attorney in reporting FDA misconduct to Congress.

The National Whistleblowers Center has information on this case and is asking that concerned individuals ask Secretary of Health and Human Services Kathleen Sebelius to prevent this retaliation. Details of the case and means to send either a form letter or an individualized letter to Secretary Sebelius can be found at:
NATIONAL WHISTLEBLOWERS CENTER: FDA Whistleblower in Serious Danger of Losing Job

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Alliance for Human Research Protection
A Catalyst for Debate
www.ahrp.org

Prescription drugs for allergies, arthritis, diabetes and other ailments kill some 200,000 Americans every year, and put another 8.8 million in the hospital. This means that only cancer and heart disease kill more patients than drugs.

The safety hazards posed by FDA-approved defective drugs and medical devices are documented in an ever growing number of criminal and civil lawsuits against manufacturers. The latest case (aired on CBS 60 Minutes) involved a drug company whistleblower whose documented investigation of a GSK manufacturing plant–following a slip shod FDA investigation– resulted in GlaxoSmithKline pleading guilty to criminal marketing of drugs it knew to adulterated: the antidepressant, Paxil CR, the diabetes drug, Avandia, a cancer drug,  Kytril, and Bactroban." The company was convicted and ordered to pay $750 million in settlement.  http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247_page4.shtml

GSK has spent $3.4 billion in legal costs related to Avandia lawsuits in the fourth quarter of 2011. This drug was pulled from the European market by the EU Medicines Agency which determined the risks outweigh any benefit. Yet, the FDA allows its continued marketing in the U.S. 

The FDA has a well-known track record of retaliating against employees who step up and raise concerns. Instead of intimidating its conscientious scientists, the FDA must protect and encourage its employees to report any misconduct they witness that threatens the public health.  I strongly request that you do not fire dedicated FDA scientists who report managerial misconduct to Congress and the American people.

 FDA managers, concerned with pleasing industry through fast approvals, have pushed to approval medical devices that lead to unnecessary risks, cancers, and even death. Many FDA scientists, appalled by the fast-tracking of these approvals, have tried to report the misconduct to Congress and the President. Their reward? . . . a hostile work environment and termination.

 The most recent FDA notice of proposed removal is of a 23-year veteran medical doctor and PHD scientist for alleged misconduct. Reason? . . . nine emails sent to her Congressional liaison in an effort to report FDA misconduct to Congress. Positively chilling!

 Are we living in a totalitarian state? We need more not less WikiLeaks to disclose the underhanded behavior of government officials in their handling of the nation’s business–especially medical practice which is literally a matter of life and death.

 The first and most immediate step to take is to immediately rescind the letter of proposed removal of the 23-year veteran scientist (EEO Case # FDACDRH02410).

 Do not fire this American hero. Reward her.

 

Vera Hassner Sharav
President
Alliance for Human Research Protection

veracare@ahrp.org