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Corruption among FDA Managers Revealed in Letter to Obama Team

Kathleen Blanchard's picture

Nine FDA scientists have revealed a serious level of corruption among FDA managers in a terse letter written to President Obama's transition team.

The letter, written on the FDA Center for Devices and Radiological Health letterhead reads, "The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."

Allegations from FDA employees include intimidation practices from managers that disallow debate regarding the safety of medical devices. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

The FDA scientists also say managers…"have ignored serious safety and effectiveness concerns of FDA experts". A congressional official has provided a copy of the letter to the Associated Press.

Judy Leon, spokesperson for the FDA says, "We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action."

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Lawmakers are supportive of an FDA shake-up, but fears about delays in approval of new drugs and devices prevail.

The scientists singled out computer aided mammography devices, citing studies that show computer-enhanced mammograms lead to unnecessary breast biopsies from unclear studies. In the letter, the FDA experts point out that they asked for further studies a total of five times before the FDA managers overruled and approved the mammography devices.

According to the letter, FDA managers "committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."

The Center for Devices and Radiological Health is responsible for testing and approving imaging devices, breast implants stents, MRI's, and other medical devices for safety before they are used in patient populations.

The Obama transition team has not issued a statement about the scientists complaint of corruption among FDA managers.

Source: Associated Press