Monday, August 27, 2012

FDA SpyGate -- New Revelations Challenge The New York Times Investigation of Agency "Enemies List," Raise More Questions About the 'Government's Most Dysfunctional Agency'

Jon Entine, Contributor

According to Jon Entine, after a series of stumbles and scandals, the Food and Drug Administration’s ability to oversee the most cutting edge sectors of the medical industry, medical devices and genetic screening tests, is under increasing scrutiny.
The Food and Drug Administration and its Center for Devices and Radiological Health (CDRH) is reeling. In mid July, the New York Times accused the FDA of creating a massive e-mail surveillance program designed to net junior scientists and other critics who complained the agency was too-quick to approve medical devices that the employees maintained posed unacceptable health risks.

The Times’ story generated national headlines with its sympathetic portrayal of harassed scientists risking their careers to protect the public interest. But new revelations suggest the Time’s slanted the story by leaving out critical context. It appears that dissident employees are involved in what could be seen as an ambulance chasing shakedown scheme to profit from their allegations. In December 2009, while these “aggrieved” reviewers were publicly lobbying the FDA and Congress to crack down on scanning devices, they had secretly filed a whistleblower lawsuit against these very same manufacturers that if successful could make them multi-millionaires.

The case has exposed the underbelly of what some critics believe is one of the more dysfunctional regulatory agencies in the federal government.

The July New York Times story was a follow up to a 2010 Times report, based on leaked confidential documents supplied by the junior staffers, accusing the agency’s senior officials of ‘brushing aside’ the potential dangers of mammography and colonoscopy devices in a rush to approve a CT scanning device made by General Electric.

The dispute began less publicly in 2006, when a consultant reviewer, Robert Smith, a controversial radiologist formerly at hospitals operated by Yale and Cornell, and several center employees raised concerns that the agency was overlooking safety concerns in approving substandard medical imaging devices for mammograms and colonoscopies. The agency reviewed and rejected their concerns in 2006 and 2008.

Angered when their recommendations were overruled, and just months after quietly filing their whistleblower suit, the dissident group took the matter into their own hands. In early 2010, they began leaking confidential documents to various media outlets, most notably the Times, which came out with its first exposĂ© in March of that year under the headline “Scientists Say F.D.A. Ignored Radiation Warnings”.
FDA employees who review confidential trade secrets submitted by drug or device makers are prohibited from discussing any data before a regulatory decision has been made. But some junior scientists, convinced that current laws make it near impossible to block products they deem ineffective or dangerous, took the matter into their own hands.

Later that year, responding to appeals by Dr. Smith and by Congressmen who the former reviewer had lobbied, the FDA, then under supervision of the Obama Administration, again investigated the employees claims and found them wanting.

Concluding that the workers had violated agency confidentiality outlined in the Federal Food, Drug and Cosmetic Act, the FDA’s Office of the Inspector General (OIG) recommended that the agency take ”administrative action” against the leaders for talking to the Times. Four employees were eventually dismissed. A fifth scientist was suspended, rehired on appeal, and then left the agency last month.

FDA, culture of dysfunction?
The ‘national paper of record’ and many activist groups are now portraying the self-proclaimed whistleblowers as beleaguered heroes and victims of an agency “enemies list” designed to muzzle public minded employees. They hint at a corrosive and corrupt culture inside the FDA that is captured by big business and limits the agency from encouraging dissent.

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