FDA Scientists Say that FDA is "Fundamentally Broken"

“The FDA is "fundamentally broken" and requires reforms, according to a letter sent to the transition team of President-elect Barack Obama by nine agency scientists, Dow Jones reports." (Kaiser.org 1/8/08).

With what A.P refers to as an “unusually blunt letter,” the group of federal scientists contacted "John Podesta, head of the transition team, as well as former Senate Majority Leader and HHS Secretary-designate Tom Daschle (D-S.D.); Baltimore Health Commissioner Joshua Sharfstein, who has led a team assembled by Obama to assess FDA; Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.); and eight other lawmakers," according to Kaiser.

A.P reports that the letter was written on FDA 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 letter reads in part as follows:

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. Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts. 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. (emphasis added)

To say that these managers had “incompatible” and “discordant” scientific and clinical expertise in devices is one thing. One expects a certain degree of disagreement within the scientific community—and to some extent, one reasonably relies upon the crucible of such “discordant” viewpoints in scientific debate to provide tested answers to real problems. But the scientists who wrote this letter added one more word: “irrelevant.” And in this context, that leaves us uncomfortably with the knowledge that in the estimation of these nine scientists, the determining force in these particular scientific inquiries—the managers—lack relevant scientific expertise in the pertinent subject matter—medical devices.

The Wall Street Journal Health Blog reports that earlier today, HHS Secretary-designate Tom Daschle appeared at “a friendly hearing before the Senate’s Health, Education, Labor and Pensions Committee.” Daschle, who was one of the recipients of the FDA scientists’ letter, did not mention it in his prepared speech. Daschle did, however, state the following:

Unfortunately, there is growing concern that the FDA may have lost the confidence of the public and Congress — much to our detriment. When Americans are nervous about eating spinach or tomatoes or cantaloupes, that’s not good for our health and it is terrible for our farmers. When nearly two-thirds of Americans do not trust the FDA’s ability to ensure the safety and effectiveness of pharmaceuticals, the result is Americans may hesitate to take important medications that protect their health. This is unacceptable.