FDA Scientists Are Revolting!
Perhaps the title should have read, "FDA Scientists Are In Revolt!" Scientists from the FDA's Center for Devices and Radiological Health are rebelling against their managers, whom they claim are corrupt and have criminally "corrupted and interfered with the scientific review of medical devices." The mainstream media has largely ignored this story.
With the exception of the New York Times, this story has not yet been reported on widely in the mainstream media.
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.
The latter quote, with respect to Dr. von Eschenbach, appears controversial insofar as Dr. von Eschenbach ordered an inquiry into the reports and turned it over to William McConagha, who did in fact investigate and make recommendations.
* 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.
However, the scientists allege that Dr. von Eschenbach more-or-less ignored the recommendations made by McConagha and allowed the alleged violations to continue without corrective action.
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.
While von Eschenbach's initial reaction (investigation) appears appropriate, alleged later actions (ignoring recommendations, allowing continuing alleged violations and/or reprisals) may belie his innocence.
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.
It seems that the scientists have been intimidated or coerced by their managers / bosses into signing off on various products or devices they would have otherwise taken issue with. Likewise, it has been alleged that letters from the scientists to the FDA, even to the FDA director, have gone unheeded or uninvestigated. Their option of last resort appears to have been a drafted letter to Congress, informing them of the alleged malfeasance and requesting an inquiry.
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."
It seems that Congress does not take such reports lightly nor lying down. Representatives John Dingell and Bart Stupak seem to have heard the message loud and clear, and are apparently opening an investigation into the issue.
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.
However, it seems that this issue had already been investigated by the FDA and recommendations made back in May of 2008, but no corrective actions have yet been made as of November (quickly approaching December) 2008.
In fact, rather than address the issues, it is alleged that retaliatory actions have been taken against the whistleblower scientists (whose names have been withheld by Dingell, Stupak et al for confidentiality purposes).
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.
So, it seems that "whistleblowers" are not necessarily safe at the FDA, in terms of performance reviews, promotions and careers. Obviously, that is not good anywhere but most especially at the institution tasked with protecting American citizens from harmful foods, drugs, products and/or devices under its regulatory purview.
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.
On the one hand, it's good to see Congress taking action to uphold the laws that protect the American public and to protect whistleblowers who report malfeasance requiring correction. However, on the other hand, it's unfortunate to see that the FDA may be dragging its feet on responding to its own scientists claims that it is cutting corners, doing bad science, approving products which shouldn't be approved (without coercion) or allowing products onto the market that may in fact harm some small or large portion of the population.
With some trepidation, we'll have to wait and see how the FDA responds to Dingell and Stupak's inquiry.
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