A group of the nation’s top scientists sent a letter on Wednesday, January 7, to the transition team for President-elect Barack Obama in which they urge a restructure of the US Food and Drug Administration (FDA) because it has become “fundamentally broken.”  Of particular concern is the way the agency intimidates and coerces its scientists to manipulate data for financial gain and in ways that violate federal law.

The group, comprised of nine scientists whose names have not been made public, describe the FDA workplace as one where honest employees are faced with fears of reprisal when trying to conduct agency business with integrity.  The letter, addressed to John Podesta,  says the atmosphere at the agency is one where “the honest employee fears the dishonest employee.”

Podesta is head of the Obama transition team but others receiving copies include Tom Daschle, Obama’s pick to lead the Department of Health and Human Services; Joshua Sharfstein, the physician leading the transition team’s assessment of FDA activities; and Senator Edward Kennedy, chairman of the health committee.

The current scientific review process which approves or denies medical devices for public use is a major concern to the scientists, who describe it as “corrupted and distorted by current FDA managers” who place the American public at risk by adhering to faulty scientific evidence of safety and efficacy.  The letter indicates scientists face disciplinary action when their opinions differ from those of management.

This is not the first attempt by this same panel of scientific experts to improve working conditions and the review process at the FDA.  However, their previous communications have produced no apparent improvements.  In some cases, instead of being held accountable, many of the managers identified as problematic were promoted or otherwise rewarded.

The same panel of scientists sent a similar but less detailed letter to the House Energy and Commerce Committee in October 2008, which then notified FDA Commissioner Andrew von Eschenbach that allegations of “serious wrongdoings” had surfaced against the agency.  Also receiving that letter was Bill McConagha, an attorney serving as assistant commissioner for accountability and integrity for the FDA.  McConagha is believed to support the allegations, including the recommendation that certain managers in the medical devices division be removed.

For his part, von Eschenbach has announced his plan to vacate the commissioner’s position on January 20, when Obama is inaugurated, thereby leaving the position open for Daschle to quickly find a new leader for the troubled agency.

The January 7 letter to the Obama transition team asks for federal regulations that protect government employees’ jobs when they report corruption in the workplace.  Also requested is a complete restructuring of the process by which the agency evaluates and approves medical devices.

Thus far, there has been no public comment on the matter from the Obama transition team.