more on Big Pharma - "How a Drug's Risks Emerge"

[Duppers]

AP Analysis: How a Drug's Risks Emerge

from the Seattle Post-Intelligencer

How does a drug go from blockbuster to bust? How can big safety issues go undetected in medicines taken by millions of people for many years, as happened this week with the diabetes pill Avandia and a few years ago with the painkiller Vioxx?

Or with devices like drug-coated stents, which came under a cloud last year after 6 million heart patients had already received them? All roads - and fingers this week - point to the U.S. Food and Drug Administration. From a company's labs to a consumer's lips, the chronically understaffed federal agency has the power and duty to keep dangerous products from harming the public.

But not the sole power. Increasingly, consumer groups, government whistleblowers and private scientists doing independent research are calling attention to safety problems the FDA has been slow to detect and resolve.

The Cleveland Clinic's cardiology chief, Dr. Steven Nissen, on Monday published an analysis suggesting Avandia raises the risk of heart attacks by 43 percent. He used information that Avandia's maker, GlaxoSmithKline PLC, published on a Web site to settle a lawsuit over another drug. The suit was brought by Eliot Spitzer, then New York attorney general and now governor - not the FDA.

...
Congress plans hearings on the safety issue and the FDA's conduct. The Senate recently passed a bill aimed at strengthening the agency, but many think it does not go far enough.

...
Q. What can be done to uncover risks of other drugs already on the market?

A. The FDA could require more companies to do further studies or keep a registry to track patients' experiences. However, enforcement is poor. From 1998-2003, only one-fourth of such required studies were actually completed by drug makers, Psaty and Furberg write. Nearly 900 remain pending - "a desultory approach," they say.

more:
http://seattlepi.nwsource.com/health/1500AP_Risky_Drugs_Analysis.html


And that awful rag, The Nation, had an article on big pharma in 02:
http://www.thenation.com/doc/20020805/newman20020725

The Bushies have finally proposed an increase in the FDA's '08 budget after years of cutbacks, probably due to youknowwhat.

[live love laugh]

1. kick