whistleblowers accuse fda of systemic corruption

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http://industry.bnet.com/pharma/10007170/fda-corruption-letter-authenticated-lawyers-start-your-engines/

FDA "Corruption" Letter Authenticated: Lawyers, Start Your Engines!

Jim Edwards
Mar 12, 2010

Lawyers who want to sue drug companies will be drooling over the news that the FDA has “certified” a 2009 letter sent anonymously by FDA staff to President Obama describing “systemic corruption and wrongdoing that permeates all levels of FDA.”

The FDA’s official recognition of the letter means that lawyers who want to use it to demonstrate that the FDA isn’t perfect won’t have to go through weeks of tedious discovery demands to find someone at the FDA who can officially say, “Yup, we sent that.” That’s going to be a headache for drug companies who often defend their drugs in court by saying, “Hey, the FDA said this product was fine and we did everything they asked — so it’s not fair to hold us responsible.”

Plaintiffs’ lawyers can now hold up the letter in court and argue that drug companies have been on notice that the FDA is riddled with politics, conflicts of interest and outright corruption, and is, as the letter says, “fundamentally broken.”

The letter made headlines when it was sent last year to John Podesta of Obama’s transition team. Written by a group of scientists on FDA letter head — but with their names blacked out for fear of retaliation — the letter describes a nightmare of bungling and self-dealing among higher-ups at the drug safety agency. It begs Obama to step in and reform the shop:

… many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.

The letter cites three dark chapters in FDA history:

• Former chief Andrew von Eschenbach’s interference with the approval of a knee device.
• The approval of a breast cancer detection device by director of the Office of Device Evaluation Donna-Bea Tillman even though all FDA experts voted against it, following a phone call from Connecticut congressman Christopher Shays.
• And the approval by Daniel Schultz of a medical device that prevents tissue scarring against the unanimous opinion of his scientific staff.

According to Doug Kreis, who sues drug companies, “Consumers have been given a slight fighting chance now against [the] ‘FDA Defense,’ based on this certification.”

Still unanswered: Who wrote the thing.

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

JANUARY 8, 2009

FDA Scientists Ask Obama to Restructure Drug Agency

ALICIA MUNDY and JARED A. FAVOLE

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