The FDA does not protect us, but at least a few of the scientists there are bringing it to Obama’s attention.

In today’s New York Times was an article that is not new or surprising but simply confirms what many of us already know:

The Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting.

Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort.

In 42 percent of clinical trials, the agency did not receive forms disclosing doctors’ financial conflicts and did nothing about the problem, according to the investigation, which was conducted by the inspector general of the Department of Health and Human Services and whose results were scheduled to be made public Monday.

In 31 percent of the trials in which the agency did receive the required forms, agency reviewers did not document that they looked at the information. And in 20 percent of the cases in which doctors revealed significant financial conflicts, neither the F.D.A. nor the sponsoring companies took any action to deal with the conflicts, the investigators found.

Karen Riley, a spokeswoman for the F.D.A, said the agency opposed reviewing doctors’ financial conflicts before trials because they represented just one possible source of bias.

A similar investigation by the inspector general last year found that the National Institutes of Health did almost nothing to police the financial conflicts of university professors who received federal money. And like their colleagues at the F.D.A., officials at the health institutes said they did not want to start doing so, that investigation found.

The inquiries feed a growing debate about how money that doctors routinely collect from drug and device makers may hurt patients and skew studies.  (read the rest here)

Gratefully there are a few good seeds in there too. From three days ago  the Associated Press reports scientists inside the FDA wrote a letter to Obama complaining of widespread corruption:

In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe. (read the rest here)

2 thoughts on “The FDA does not protect us, but at least a few of the scientists there are bringing it to Obama’s attention.

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  1. A big pill for healthcare to swallow By Laura MacCleery and Zachary Proulx
    December 22, 2008 (Boston Globe)

    The drug companies have mastered the art of purchasing favorable results. In the same election cycle that brought record presidential fund-raising from grassroots donors, the pharmaceutical industry contributed over $22 million to members of Congress. It hedged contributions evenly between the Republican and Democratic parties for the first time in nearly 20 years. Pfizer, a longtime donor to the GOP, is now doling out 51 percent of its campaign contributions to Democratic candidates.

    I hope President-Elect Obama receives the message and changes things accordingly.

  2. Given this current war between FDA brass and its own scientists I believe America will have to howl to their respective State Attorneys General to get the job done.

    Obama has picked Tom Daschle to become HHS Sec. Daschle has already taken $2 Million in campaign money from the health care industry, and retains numerous connections to that money through the lobbying firm of Alston and Bird.

    Dick Durbin (D-Illinois) recently stated that FDA overhaul is “an issue that will have to wait its turn”.

    FDA’s current budget of $2.2 Billion contains $500 Million direct from Drug and Med Device manufacturers. That money Must be taken out of FDA management’s hands. Instead; this year’s proposed $2.4 Billion FDA budget (as of Feb ’08) includes an Increase in manufacturer “User Fees” from $500 Mill to $628 Mill.

    State AGs will remain the only help America can expect: as in the current Texas $1 Billion filing against J&J/Risperdal/TMAP. Key that to Texas interest in the upcoming Pennsylvania sentencing of twice convicted felon/Pharmacist Steven Fiorello on Jan 21, and we May get real action.

    If Fiorello goes to prison (10 years for a $12K bribe) and Texas refiles on J&J officers for Prison on top of that $1 Billion, FDA brass will come under much wider public scrutiny to quit covering for their “User Fee” paying friends Pharma.

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