Notes on a Scandal: Blowing the Whistle on the FDA

A short while ago, we blogged about a 2006 report in which the Food and Drug Administration (FDA) Science Board concluded that, among other things, “The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.”  The report further stated that the FDA’s “scientific workforce does not have sufficient capacity and capability” and that “its information technology (IT) infrastructure is inadequate.”

That report showed that there were serious problems at the FDA six years ago at the very least. It is unsurprising, then, to hear that the FDA is having issues today as well. According to the Washington Post, a group of FDA scientists and doctors are suing the agency for secretly monitoring their personal communications informing Congress that “the agency was approving medical devices that they believed posed unacceptable risks to patients.”

Stop and think about that a minute. The FDA is approving medical devices that its own scientists and doctors think are too risky for patients’ use. To put that in context, all the whistleblowers reviewed devices for cancer screening and other purposes – in other words, they reviewed items used by people who are fighting for their lives and need every last bit of help they can get. These were the people the FDA was perfectly fine with selling out:

Three of the devices risked missing signs of breast cancer, the scientists and doctors warned, according to documents and interviews. Another risked falsely diagnosing osteoporosis, leading to unnecessary treatments; one ultrasound device could malfunction while monitoring pregnant women in labor, risking harm to the fetus; and several devices for colon cancer screening used such heavy doses of radiation that they risked causing cancer in otherwise healthy people, the FDA scientists and doctors said.

Warning Congress about the FDA’s behavior only brought the whistleblowers harassment or dismissal, since the FDA had been secretly monitoring their personal e-mail. The FDA, like any other powerful body, has its own way of dealing with critics, and they tried time and time again to discredit the scientists, claiming the whistleblowers were breaking the law by saying anything against the FDA at all.

Yet this wasn’t the first time the FDA had been accused of such problems. In 2009 and again in 2011, the Government Accountability Office warned that the FDA had an unduly lenient review process that lead to the approval of risky medical devices, and the Institute of Medicine concurred with this view in a study last year that concluded that “the FDA process for approving medical devices needed to be revised and based on “sound science.””

With Congress taking an interest in the case, and major newspapers reporting on the subject, it is heartening to see that for once, the FDA will not get away with such brazen neglect of public welfare. However, at the same time, the case reminds us that those who are entrusted with our safety and health are not always to be trusted. We need to do our own research, because clearly the agencies that are meant to safeguard us have other priorities, and they are not our own.

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  1. […] their undoubtedly expected responsibilities to the public welfare. Last week’s news about the harassment of FDA scientists and doctors who informed Congress that the FDA was approving risky medical devices showed the lengths to which […]



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