Trial and error: why we should drive the drug industry out of the clinical test business

Washington Monthly, Oct, 2004 by Merrill Goozner

To counter this effect, Angell would establish a new institute at NIH to conduct prescription-drug trials of all new pharmaceuticals, funded by a new tax on pharmaceutical-company revenues--money which the companies currently spend running their own trials. Industry would then bring its new drug applications to the agency, which would contract with independent researchers to conduct the trials. This would eliminate industry's control over clinical trials, which can often lead to the suppression of negative results. In a nod to Reinhardt's idea, Angell would also have the new agency compare the new drug's effectiveness to existing therapies to determine if it makes a useful contribution to medicine. She would also bar any researcher who takes industry money from participating in the trials.

If we're ever going to get objective evidence from the clinical trial system, the argument for separating these trials from the process in which companies research, design, and manufacture pharmaceuticals makes perfect sense. It would provide researchers with an alternative funding source derived from the tax on industry revenue for their investigation into the potential uses of new and older drugs, and in doing so would restore the economic base for academic medicine which in recent years has increasingly turned to the drug industry for support. (In 1980, drug companies paid 30 percent of the costs of the nation's clinical trials; now they pay 60 percent.)

But in her most ambitious reform--one she calls the most important on her agenda--Angell goes too far. She wants to deny FDA approval to any drug that "offers trivial or no advantages over drugs already available, and may be even worse. Overnight, that reform alone would force the industry to concentrate on innovative drugs instead of me-too drugs."

Such a step would do deep damage to the drug industry: In order to devote the millions of dollars necessary to bring a drug to market, you'd have to be nearly positive that the new pharmaceutical would be better than any existing therapy, a risk executives would almost never take. Even if drug companies were entirely noble, every drug submitted for testing would not surpass existing remedies. That is something only scientific investigation can discover, and a company shouldn't be penalized for seeking the answer.

Reforms on this scale are always difficult. The pharmaceutical companies enjoy a great deal of power, and this Congress and administration have been inclined to loosen regulation of the industry, rather than tighten it. But there is a growing sense in Washington and the country that drug prices have gotten out of control. If that spirit translates into genuine political will in the White House and on Capitol Hill, then Angell's reforms may get a hearing in the places that matter most.

Merrill Goozner is the author of The $800 Million Pill: The Truth Behind The Cost of New Drugs and director of the Integrity in Science Project at the Center for Science in the Public Interest.