Expert: Post-marketing Studies Must be Strengthened to Find Meaning of "Signals" Early On

On June 29, 2005 Dr. David Wofsy, a rheumatologist associated with the University of California at San Francisco, told an audience that the Vioxx recall demonstrates the need for better post-marketing drug studies and quicker FDA regulatory action when "signals" of potential drug side-effects first emerge.  Dr. Wofsy was addressing a meeting sponsored by the Congressional Biomedical Research Caucus on Capitol Hill when he made his comments.  Dr.Wofsy is the immediate past president of the American College of Rheumatology.

Consistent with many other experts, Dr. Wofsy said the signal, or initial sign, that Vioxx might raise the risk of heart attacks and strokes first emerged in a drug study whose results became available at least three years before Merck pulled Vioxx from the market in September 2004.

In relevant part, Dr. Wofsy commented:

…in 2001 when this signal came up, there should have been a way for us to say, we have to answer this question….  My own view is what makes sense is to have a post-marketing surveillance system that at least says, if we identify important danger signals for public health, we will insist on answering those questions with the same rigor as the original studies were done.

As is well-known by now, the FDA’s current system for monitoring side-effects after a drug has been approved — generally referred to as post-marketing surveillance — has been roundly criticized since the September 2004 Vioxx withdrawal.  In an attempt to address this criticism, the FDA is in the process of establishing a Drug Safety Oversight Board.  While the Oversight Board, says the FDA, will be "independent" from the agency’s drug-approval process, some critics want such an entity to be taken out of the FDA bureaucracy altogether in order to ensure that there is true independence from any FDA control or influence.

(Posted by: Tom Lamb)