Institute of Medicine report concludes that the FDA is not doing adequate job of assessing drug benefits and risks

Two weeks ago, I headlined my blog with this question: Is the FDA violating its own mandate to approve safe drugs? Four days later, the national Institute of Medicine (IOM) released a 233-page report concluding that FDA’s current approach to drug oversight “is...

Is the FDA violating its own mandate to approve safe drugs?

Is the Food and Drug Administration violating its own mandate to approve safe drugs? That was the question that Donald Light, co-author of The Risk for Prescription Drugs and a long-time medical sociologist, posed at a talk yesterday at Brandeis University. The...

How drug companies continue to hide the true story of Tamiflu and other drugs from the American public

I’ve been reading Dr. David Healy’s new book, Pharmageddon, and while some of it may seem like old news, I was struck by his fresh analysis of how the pharmaceutical industry has turned the original purpose of clinical trials inside out. As Healy, a noted...

When it comes to scientific misconduct, should there be a statute of limitations?

I was hesitant to weigh in at first when I learned that Brown University’s School of Medicine had decided not to pressure a psychiatric journal to retract the seriously flawed Paxil study that I wrote about in Side Effects. After all, Brown has been covering up...

Enforcing anti-kickback laws: a powerful deterrent against ghost-writing in medicine

The Obama administration recently made it clear that it will require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment under the new health care law — see the New York Times. Large numbers...

From the Pentagon Papers to Allen Jones: Why it’s so hard to be a whistleblower

Allen Jones, the whistleblower in an ongoing landmark trial against the pharmaceutical giant Johnson & Johnson, was very much on my mind this past weekend. I was participating in a workshop to develop curriculum to teach college students about the importance of...