Profits over patients health?

Jul/31/2007 10:25 Filed in: Pharma Business
31drug.190
The FDA called an advisory board to review the safety of Avandia and when it was all over patients lost and big business won. By saying there isn't enough data they essentially are telling patients "you decide if you want to take the risk". Even a leading physician, interviewed on NBC Nightly News, didn't know what to recommend to his diabetic patients. So new warnings will be included on the label of Avandia and the drug industry has lost another chance to gain consumer trust.



Dr. David Graham, a drug safety officer at the federal agency, called for withdrawing the drug and estimated that its toxic effects on the heart had caused up to 205,000 heart attacks and strokes, some fatal, from 1999 to 2006. For every month that Avandia is sold, Dr. Graham said, 1,600 to 2,200 patients will suffer more of those problems. Dr. Robert Meyer, director of the F.D.A. office that approved the initial Avandia application, immediately disagreed. “I think it’s important that the committee understand there’s a fundamental disagreement” within the agency, Dr. Meyer said.


So while the FDA argues internally patients health is put at risk. GlaxoSmithKline argued strongly to the panel that its drug was safe. A vice president, Dr. Murray Stewart, said the company had in recent months examined data on 1.35 million diabetes patients from large managed care companies. The analyses, Dr. Stewart said, showed that patients on Avandia suffered no greater risk of heart problems than patients on other drugs. Forgive me for not believing the drug industry given the current track record. Forgive me for believing that GSK is more worried about profit than patients health. You see what we have here is a basic level of credibility bought on by a mistrust of big pharma's motivation for the almighty dollar.


In all likelihood sales of Avandia will never reach the level they were before the story broke in the NEJM. I am sure that the media will be ready to pounce on this story again in and when someone has a heart attack and is also on Avandia. Physicians are just as confused and may not want to take the risk or prescribing a product that may increase the rate of a heart attack.


The disagreement within the FDA is indicative of deep problems within an underfunded and over tasked agency. Someone should have reminded these people that their first job is to protect patients not profits.

Tags:

|