FDA and BigPharma: Too Close for Comfort?

According to the Pharmaceutical Research and Manufacturers of America, the US drug safety system is "the best in the world." Of course, as one of the most powerful lobbies around, they're paid well to say that.

The fen-phen diet-drug fiasco was ten years ago--thousands of cases of severe heart and lung damage and several deaths after it was approved by the FDA and widely prescribed, it was withdrawn from the market. 8 million prescriptions were written for fen-phen between 1994 and 1997.

Since then Baycol (cholesterol drug) Vioxx and Bextra (pain relievers) and the Guidant heart defibrillator have been recalled, after initial FDA approval. Last month an FDA panel admitted that there's not enough proof that over-the-counter cough and cold medications work, or are even safe for young children.

In other words, the FDA and the drug companies are slow to react even when faced with evidence of drug dangers. The FDA and drug-industry critics blame the too cozy relationship between medical researchers and pharmaceutical companies, and they alledge that the industry has turned medical education seminars into drug pushing campaigns.

Dr. Bruce Psaty (University of Washington cardiologist) and Dr. David Graham of the FDA say that things are no better than 10 years ago when it comes to the FDA and their oversight of the pharmaceutical industry.

In 2005, Psaty was asked to join the Institute of Medicine's review of the FDA on drug safety. The institute, part of the National Institutes of Health, issued a scathing report in September 2006, calling the FDA dysfunctional.

In 2004, Dr. Graham sought whistleblower protection from Sen. Chuck Grassley (R-Iowa) after the FDA began an investigation to find out who had leaked information about potential links between antidepressants and teenage suicides.

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