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)