Thursday, March 10, 2005

US senator says FDA needs independent safety office

I think Senator Grassley has his priorities correct. As I wrote in a piece "Reflections on the future of drug safety surveillance from the Medical Informatics perspective" , pharmaceutical companies and regulatory agencies that ignore non-RCT data and studies such as retrosepective reviews on a dogmatic basis (due to a belief in the absolute ascendancy of controlled clinical trials) do so at their own peril. Such studies need to be factored into an overall risk portfolio of drugs to be consumed by millions, where even a small risk of major side effects could lead to catastrophe due to volume.

Unfortunately, this change in thinking will apparently not occur from within the industry.

DISCLAIMER: my views on this topic may be shaded due to the fact that various pharmas and CRO's would not hire me into positions involving drug safety and surveillance, or adverse events data analysis because, essentially, they felt I did not have enough experience. Oddly (and there's a lot of oddness in this domain), one major decisionmaker on this issue was himself a former high-level FDA adverse events official now working in pharma. He barely even gave me the time of day even though his staff wanted to hire me badly, if only for improving the primitive system they had for getting to adverse events data that was basically warehoused and rationed by the pharma's IT personnel.

Dr. David Graham of the FDA said the FDA's Office of New Drugs "unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not" [via clinical trials]. That rule does not protect consumers, Graham told the Senate committee. "What it does is it protects the drug," he said.

For those less scientifically-inclined, a somewhat crude and provocative translation of his statement might read: "a drug will be considered safe for consumption by tens of millions of people unless some small clinical trial on a few thousand (or sometimes just hundreds) of random people shows greater than 1-in-20 odds (say, 1 in 10) that the drug's suspected harmful side effects are real, and might actually harm or kill you. And, by the way, if the trial shows the chances at only 1 in 21, hallelujah! Sales! And, the stock price and the value of executive stock options go up!"

These observations have led me to a somewhat master-of-the-obvious hypothesis: that insights into process flaws, inadequate leadership skillsets, and perhaps even corruption in high-stakes industries can be gleaned by who they won't hire.

-- SS

US senator says FDA needs independent safety office
Thu Mar 10, 2005 08:15 AM ET

WASHINGTON, March 10 (Reuters) - The Food and Drug Administration needs an independent drug safety office with the power to order pharmaceutical companies to add warning labels to dangerous medicines, a top U.S. Senate Republican said on Thursday.

Senate Finance Committee Chairman Charles Grassley said he was preparing legislation to establish such an office in response to controversies surrounding Merck & Co. Inc's (MRK.N: Quote, Profile, Research) withdrawn arthritis pill Vioxx and other drugs.

"We need reforms, both administrative and legislative, to bring greater responsiveness and transparency to the FDA," Grassley said in remarks prepared for delivery at a Consumer Federation of America conference.

The new drug safety office "would have an independent director and the regulatory authority to require label changes," the Iowa Republican said.

Grassley and other lawmakers are investigating the FDA's monitoring of drug side effects, which came into question during the past year when two agency scientists said their warnings about drug dangers were ignored or suppressed.

Many critics have called for a drug safety office independent from the FDA's Office of New Drugs, which approves medicines for sale. They argue scientists in the Office of New Drugs may be reluctant to later acknowledge safety problems from medicines they have approved. The FDA responded to criticism by announcing the creation of a drug safety board, but Grassley and others said that board did not appear to have enough independence.

Last week, a top FDA official told Congress that stronger authority over drug warning labels could help ensure important safety information gets to the public quickly.

Grassley said the FDA had done "decades of good work" but became "too complacent" and "too cozy" with drug makers, who in some cases had engaged in fraud.
He said the Justice Department was aware of about 100 whistle-blowers who had made fraud allegations against 200 drug companies.

"In this fraudulent environment, the FDA's mission is more important than ever before. The FDA absolutely has to do a top-notch job on ensuring drug safety," he said.

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