Does the Medical Industry Have a Fundamental Lack of Integrity?

Two recent articles—one in the New York Times, the other in the Wall Street Journal—speak to a crisis of integrity in the medical industry that has led insiders like Dr. Jerome Kassirer of Yale and Tufts to muse that some of their colleagues appear to act as “paid prostitutes for the drug industry.”

The Times article discussed a Colorado company that drug and medical device makers paid to oversee patient safety during clinical trials, prompting a Congressional hearing on whether such companies adequately supervise medical trials. The hearing follows incidents in recent years in which patients have died during clinical trials or companies have submitted fraudulent data to the FDA to get new medical products approved. During this period, the oversight of clinical trial safety has shifted from academic medical institutions to commercial firms like company in question.

The company was snared when undercover federal investigators created a sham medical study to see how closely firms evaluate the studies they are paid to review. This company approved a trial, involving a make-believe surgical product and researchers who did not exist. There was testimony at the Congressional hearing that some companies “shop for an accommodating oversight board” when their research is questioned by more stringent reviewers.
The Wall Street Journal article reported that the Alliance for Human Research Protection has protested the “unprofessional and intimidating” tactics from the editor-in-chief and executive deputy editor of the Journal of the American Medical Association. An academic questioned the lack of acknowledgement by JAMA of the financial relationship between a drug company and a study’s author.

We would expect the FDA to be outraged over these claims, since they are sworn to protect Americans’ health. Yet the FDA appears to only mind the interests of the companies whose fees add to their coffers. Medical device makers and pharmaceutical companies have their eye on the bottom line, but the FDA is supposed to balance these vested interests. The time to reform the FDA from the ground up is NOW.