FDA Scientist to Obama: Fix Corrupt Agency

It’s confirmed.  The Food & Drug Administration (FDA) is rife with corruption.  A number of media outlets just broke the news that some scientists at the FDA wrote to President-Elect Barack Obama’s transition team basically begging for help and outlining a number of problems with an agency they describe as “fundamentally broken,” reports The Wall Street Journal (WSJ).

The FDA is responsible to ensure that <"http://www.yourlawyer.com/practice_areas/defective_drugs">drugs, <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices and products, some human and animal <"http://www.yourlawyer.com/practice_areas/food_poisoning">food products, cosmetics, and other consumer goods are safe to the American public.  The scientists’ letter backs up critics who charge it has failed and has put untold citizens at risk in a variety of areas.

On Wednesday, the group of FDA insiders sent a letter to  Obama’s team—addressed to John Podesta, team head—asking that it restructure the FDA and pointing out that, in addition to other ethical fiascos, FDA managers have “ordered, intimidated, and coerced scientists to manipulate data in violation of the law,” the WSJ said.  The letter said that, “There is an atmosphere at FDA in which the honest employee fears the dishonest employee,” the WSJ quoted, adding that the transition team and some members of Congress have been provided with the nine names, which have not yet been publicized.

It seems this is not the first letter of its kind that the group has sent out.  An earlier letter was sent this fall to the House Energy and Commerce Committee, said the WSJ, which noted that this week’s letter gave specifics on details such as how scientists who differed in opinion from management were threatened with disciplinary action.  MedHeadLineNews pointed out that the October letter prompted the Committee to notify Andrew von Eschenbach, FDA Commissioner and Bill McConagha, an attorney who is also the FDA’s assistant commissioner of accountability and integrity, that it had “received compelling evidence of serious wrongdoing,” quoted the WSJ.  MedHeadlineNews said that McConagha since recommended the removal of some managers within the medical devices division.  von Eschenbach has announced that he will step down when the Obama team is sworn in later this month.

The medical device area is of particular concern to the nine scientists who stated that that particular department has been “corrupted and distorted by current FDA managers, thereby placing the American people at risk,” reported the WSJ.  And while the FDA defends its activities and how it is handling the allegations, the scientists say no one has ever been held to task for the corruption and that the agency gone so far as to reward and even promote some of the managers with whom they accuse of inappropriate practices, the WSJ said.

The group is hoping that Tom Daschle, the upcoming head of the Department of Health and Human Services, will overhaul the ailing agency.  As a matter-of-fact, the group noted Daschle’s book, Critical: What We Can Do About the Health-Care Crisis, in which Daschle discussed the 1998 approval of some mammography computer-aided detection devices that confirmed how independent scientific reviews were being handled inappropriately at the FDA.  The group noted the devices received FDA approval without the required scientific evidence to confirm that they actually detect breast cancer, said the WSJ.  Worse, notes the WSJ, in the past two years, FDA physicians and scientists have issued five recommendations that these devices not receive approval without correlative and valid scientific and clinical evidence.

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