The Difficulty of Tracking Drugs on the Market

Commentator Philip Hilts, the author of Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation, explains how hard it is for researchers to find out how well a drug is doing after it goes to market.

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Mr. PHILIP HILTS (Health Historian; Author, "Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation"): When patients are hurt by prescription drugs, why does it take years to find that out?

ROBERT SIEGEL, host:

Commentator and health historian Philip Hilts.

Mr. HILTS: It's because researchers are having trouble getting hold of enough data about how patients are doing on the drug. To find the information they are reporting this week, they couldn't just look it up on the FDA Web site. They couldn't just pick up the phone to call the company and say: Give us all your data.

Researchers had to pull it together from 42 studies, some of which were only available because the New York attorney general required the company to disgorge the data.

In a society awashed in information, where billions of dollars are spent tracking purchases and credit scores, where I feel like my every move is tracked - almost mouse click by mouse click. And within weeks of buying a dress shirt, I have emails, catalogues, and letters from clothing companies. It seems odd to have this one area of life, the safety of drugs, where there is something of a data dead zone.

It takes years after a drug goes to market to find out how well it is doing, and it is medical researchers largely on their own who often have to go data diving to find the crucial information. Consumer watchdogs like Public Citizen have complained about this for years, and the most prestigious medical group in America, the Institute of Medicine at the National Academy of Sciences, has even written out a detailed plan about how to fix this problem and catch the data quickly and effectively, but it hasn't happened.

And now, a new law is being debated in Congress that has even passed the Senate. It would require drug companies to make more data available so researchers don't have to be data detectives as well as medical researchers to find the information. It also would give more money for the FDA to look at and analyze data, as well. The new bill doesn't go far enough, but it might be a start. Considering what data could actually be collected and analyzed in 2007, this bill might bring us more up-to-date, say, all the way to 1987.

Maybe lawmakers should remember Vioxx and the 16 other drugs that have been pulled off the market in the last few decades. They should go ahead and fix the problem for real, 2007-style, with a full system of keeping track of all the problems and the successes of medical drugs in America.

SIEGEL: Commentator Philip Hilts is the author of "Protecting America's Health: The FDA, Business and 100 Years of Regulation."

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