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FDA is Deeply "Corrupted and Distorted," Claim Its Own Scientists in Protest Letter


Monday, January 12, 2009


by Mike Adams, the Health Ranger, January 12, 2009
Key concepts: FDA scientists, Obama and Corruption

(NaturalNews) FDA scientists have become so fed up with the criminal behavior of their own administration that they've filed a strongly-worded complaint with President-elect Obama, alleging the FDA has been deeply "corrupted and distorted."

FDA managers, the letter explains, are "placing the American people at risk" by using tactics of intimidation to censor scientific debate within the FDA. This scientific censorship agenda, of course, mirrors the exact same tactics used by the FDA outside the agency against makers of nutritional supplements or herbal products. Intimidation and censorship, it seems, are part of the very fabric of the FDA.

The letter explains that FDA managers "have ignored serious safety and effectiveness concerns of FDA experts." It then goes on to explain:

"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."

In other words, the FDA is being run like a criminal mob operation with a complete disregard for actual science.

Fascinatingly, this letter shows that the FDA's own scientists agree with the NaturalNews view that the FDA is running a criminal racket, using the very same tactics relied on by organized crime!

The scientists also complain that 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."

This is the latest escalation in a war of words between FDA scientists and FDA managers. A previous incident occurred in November, 2008, when many of the same scientists sent a letter to members of Congress and the House Energy and Commerce Committee (http://www.naturalnews.com/024910.html). NaturalNews characterized the action as a "revolt" of FDA scientists.

That revolt has apparently escalated into something that might turn into outright mutiny.

This article continues as a feature article on NaturalNews. Continue reading here: http://www.naturalnews.com/025298.html

(Please post all comments about this topic on the feature article page, not this page, thank you.)


Click to read:
FDA is Deeply "Corrupted and Distorted," Claim Its Own Scientists in Protest Letter
http://online.wsj.com/article/SB123142562104564381.html

From Online.wsj.com: A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law.




http://www.naturalnews.com/News_000655_ ... ption.html

Related article.




JANUARY 8, 2009, 10:50 A.M. ET

FDA Scientists Ask Obama to Restructure Drug Agency

WASHINGTON -- A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law.

The nine scientists, whose names have been provided to the transition team and to some members of Congress, say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal.

"There is an atmosphere at FDA in which the honest employee fears the dishonest employee," according to the letter, addressed to John Podesta, head of Mr. Obama's transition team.

The letter will likely increase pressure on Tom Daschle, Mr. Obama's choice to head the Department of Health and Human Services, to make sweeping changes at the agency.

The scientists' main concerns are with the agency's scientific review process for medical devices, which they characterize as having been "corrupted and distorted by current FDA managers, thereby placing the American people at risk."

They sent a similar letter in October to the powerful House Energy and Commerce Committee, but the latest one provides more detailed allegations about problems at the agency, such as the threat of disciplinary action against scientists who dissent from management.

The FDA has been working "very closely" with Mr. Obama's transition team and will address any issues or concerns the team presents, said agency spokeswoman Judy Leon. She said the agency is "actively engaged in a process to explore the staff members' concerns and take appropriate action."

The group says they have taken their concerns to the head of the FDA, Commissioner Andrew von Eschenbach, and his assistant commissioner for accountability and integrity, attorney Bill McConagha. The scientists say no one has been held accountable, and say some of the problematic managers have been promoted and rewarded.

The Energy and Commerce Committee's Democratic and Republican leaders sent a letter to von Eschenbach in November, saying it had "received compelling evidence of serious wrongdoing" at the agency. The members wrote that they were told McConagha had found the FDA doctors' evidence compelling, and that their findings supported removal of certain managers in the device division.

The agency has been under fire from both parties in both Houses of Congress as being too close to industry. Several leading politicians, including Sen. Chuck Grassley have complained that FDA leaders often ignore or suppress their own scientists' opinions on safety issues involving drugs and devices.

Those concerns were also aired in a report by the National Academy of Sciences' Institute of Medicine in 2006. FDA leaders, including drug division chief Janet Woodcock, have said they are working to improve the culture at the FDA, and are listening to dissent from their experts and doctors.

In addition to Mr. Daschle, the letter was sent to the doctor leading the transition team's assessment of problems at the FDA, Joshua Sharfstein, and to nine members of Congress including Sen. Edward Kennedy who chairs the Health Committee.

Members of the transition team weren't available to discuss the letter or whether they intend to address it publicly.

The scientists appear to hope that their concerns will pressure Mr. Daschle to quickly change leadership at the FDA. Von Eschenbach has said he is planning to step down on Jan. 20, the date of Mr. Obama's inauguration.

Indeed, the group said Mr. Daschle has recognized in his book, Critical: What We Can Do About the Health-Care Crisis, that the 1998 approval of some mammography computer-aided detection devices is an example of the breakdown of the independent scientific review process at the FDA.

The group says the FDA approved such devices without clinical evidence showing they were effective in detecting breast cancer. Since 2006, FDA physicians and scientists have recommended five times that these devices not be approved without valid scientific and clinical evidence.

The group said there needs to be a complete restructuring of the evaluation and approval process, and that Mr. Obama needs to sign new legislation giving protection to government employees who speak out against corruption.

Write to Alicia Mundy at alicia.mundy@wsj.com and Jared A. Favole at jared.favole@dowjones.com



http://online.wsj.com/article/SB123142562104564381.html

Kudos to these scientists for speaking out publically!

U.S. Food & Drug Administration Homepage
http://www.fda.gov/

RELATED ARTICLE and Video


FDA scientists allege mismanagement at agency


Scientists work with regulating mammogram machines, contact lenses, heart stents

Scientists say review process for devices is "corrupted and distorted"

They claim scientists, doctors were told to ignore FDA regulations

They say managers without appropriate experience are in charge of regulation



VIDEO

http://www.cnn.com/2009/POLITICS/01/09/ ... nnSTCVideo


From Louise Schiavone
CNN

WASHINGTON (CNN) -- Nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk."


FDA scientists wrote a letter to President-elect Barack Obama, saying the agency is "fundamentally broken."

The agency is "fundamentally broken" and "failing to fulfill its mission," according to a copy of the six-page letter obtained by CNN.

The scientists work in the FDA's Center for Devices and Radiological Health, which regulates items ranging from rubber gloves and contact lenses to heart stents and mammogram machines.

The scientists claim that "the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk." Watch the FDA come under fire »

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the letter said. "Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal."

Among the charges:

• Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.

• Devices have not been properly labeled.

• Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.

• FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."

• Manufacturers have been allowed to market their products without FDA approval.

An internal investigation of the charges, the scientists said, has resulted "in absolutely nothing: No one was held accountable, no appropriate or effective actions have been taken, and the same managers who engaged in the wrongdoing remain in place and have been rewarded and promoted."

In a statement, the Food and Drug Administration told CNN, "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."

Congress is also looking into the allegations.

http://www.cnn.com/2009/POLITICS/01/09/ ... index.html