FDA Scientists Are Revolting!

In a breaking story that the mainstream media has completely ignored, top FDA scientists have accused their bosses of engaging in criminal acts of corruption, using intimidation tactics to force scientists to sign off on dangerous medical devices that will likely harm or kill countless Americans.

The CDRH allegedly “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.” The CDRH staffers also claim they were forced to use “unsound evaluation methods, and accept clinical and technical data that is not scientifically valid or obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects.”

Even the FDA director ... Dr. von Eschenbach ... has routinely ignored the multiple letters sent to him by these scientists complaining of the same criminal behavior taking place at the agency.

* On May 31, 2008, ... FDA physicians and scientists ... wrote to the FDA Commissioner, Dr. Andrew von Eschenbach (See attached letter).

The Commissioner immediately asked Mr. Wiliam McConagha, the Assistant Commissioner for Integrity and Accountabilty, to begin a full investigation.

The Director of CDRH then conducted his own investigation and concluded that we, FDA physicians and scientists, need to "move forward," thus allowing managers to avoid and evade any accountability and without taking any curative or disciplinary actions whatsoever. The Director of CDRH has further aggravated the situation by knowingly allowing a continuation of management reprisals.

Keep in mind this is from the FDA's own scientists! This isn't some outsider ... ranting about the FDA being a criminal organization; these are the words of the very people who work there!

FDA scientists ... have rallied against their bosses in an attempt to save the lives of American health consumers who have been targeted for financial exploitation by greedy, unethical FDA bureaucrats.

... the mainstream media has virtually ignored this story[.] You might think that a revolt of FDA scientists against their criminal bosses would be a huge story worthy of front-page treatment at USA Today or the Washington Post, right? Only the NY Times bothered to report this story, as far as I can tell.

The House Energy and Commerce Committee received a letter dated October 14 from a ‘large group’ of scientists and physicians at the FDA’s Center for Devices and Radiological Health division, who complained that CDRH managers have “corrupted and interfered with the scientific review of medical devices.”

The letter from the FDA's ... scientists goes on to say, "It is evident that managers at CDRH have deviated from FDA's mission to identify and address underlying problems with medical devices before they cause irreparable harm, and this deviation has placed the American people at risk."

Washington, D.C. – Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations ... launched an investigation into whether managers within the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) knowingly corrupted the scientific review process and approved or cleared medical device applications in gross violation of laws and regulations designed to assure the safety and effectiveness of medical devices. Such activity could allow potentially unsafe and ineffective medical devices into the U.S. market.

“These allegations are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of America consumers,” said Dingell. “I commend the FDA scientists for courageously sounding the alarm on what appears to be a serious problem. I look forward to pursuing the steps necessary to ensure that the medical devices Americans depend on are safe and effective.”

“Our investigations have found that the FDA has allowed contaminated food and unsafe drugs to enter the market, and now serious allegations have been raised about the scientific integrity of the FDA medical device approval process,” Stupak said.

And in a letter to FDA commish Andy von Eschenbach, the lawmakers note that the same CDRH employees wrote last May to FDA officials to complain, and that William McConagha, assistant commissioner for integrity and accountability, investigated the allegations and recommended removing some CDRH managers.

Although McConagha called the “evidence is ‘compelling,’ ‘convincing,’ and ‘sufficient’ to justify disciplinary and curative actions,” Dingell and Stupak say no action has been taken, and that retaliatory behavior against the employees occurred.

Additionally, documentary evidence reviewed by [the congressional] Committee indicates that CDRH scientists who raised concerns up their chain of command have experienced reprisals for their insistence on adherence to a scientific and regulatory basis for medical device review. To protect these CDRH scientists who have risked their careers to bring their concerns to the attention of this Committee, we will not disclose their identities at this time.

In a letter sent ... to FDA Commissioner Andrew C. von Eschenbach, Dingell and Stupak requested a briefing on what actions the Commissioner has taken to date and how the Commissioner intends to resolve all issues raised by the CDRH scientists and physicians.