The perfect storm and why pharma and medical device makers may need someone like Peter Rost as FDA Commissioner

Nov/19/2008 05:50

The Department of Justice is investigating the off-label use of a Medtronic Inc. implant for promoting bone growth, bringing government scrutiny of such unapproved uses to the heart of the $189 billion medical-device industry. "While the law establishes that doctors can prescribe any approved treatment, but off-label promotion by manufacturers is not allowed, there's growing concern that the line is being crossed, and a Justice Department review is the right kind of response to those questions," said Sen. Charles Grassley (R., Iowa) who has been looking into whether inducements by Medtronic have led doctors to use its products off-label.

Last year, after news broke that the diabetes drug Avandia was linked to a high risk of heart attacks, reports that the drug's maker had tried to stifle safety questions from a prominent Duke University researcher years earlier provoked a furor. Now it turns out that the Duke researcher wasn't alone in suggesting a tie to heart problems. A doctor from a small Maryland hospital linked Avandia to congestive heart failure in 2000, but the drug's maker, GlaxoSmithKline PLC, rejected her warning and tried to make her stop talking about it with other doctors and hospitals, according to documents and interviews. Glaxo defends its effort, which it says was an attempt to correct "inaccuracies." The head of the doctor's hospital says he ignored Glaxo's overture.

The Senate and House in 2007 began looking at whether Glaxo suppressed information and threatened the Duke researcher, charges that Glaxo has denied. Now the Senate probe, led by Chuck Grassley of Iowa, is investigating whether Glaxo's efforts to defend Avandia's safety led to intimidation against other doctors who were suggesting possible links to cardiac dangers. Mr. Grassley, the ranking Republican on the Finance Committee, has demanded documents from Glaxo and is expected to release a detailed report on Avandia soon, according to staffers.

The perfect reasons for Congress to step in and "over regulate" the pharma/medical device industry. Peter Rost is right ! This industry consistently shoots itself in the foot and then backs off and shoots itself in the other foot ultimately leaving it crippled. The logic of trying locked doors in hopes of finding an open one to market products is beyond me and obviously something needs to be done to ensure that they get the message LOUD and CLEAR.