How to End Drug Marketing Trials

The Sunday edition of the New York Times carries a well-executed investigation of the drug industry's use of suspect physicians for marketing and testing new drugs. By cross-referencing Minnesota's database of drug company payments to doctors -- it's required under a new law -- with medical discipline records, the Times identified over 100 physicians who had received substantial payments from drug companies after receiving disciplinary actions.

The lead anecdote involved the former head of the Minnesota Psychiatric Society who, after having his license temporarily revoked for wilfully disregarding the welfare of his patients, including several who committed suicide, resumed his career earning tens of thousands of dollars from at least a dozen drug companies for either testing or promoting their new drugs.

Responding to the reporters' query, the Food and Drug Administration's Janet Woodcock vowed to examine the agency's oversight of clinical trials. As usual, an agency that doesn't have the resources to do its job responsibly is promising to do better. Next up: Hope the furor goes away.

I can't help but point out that nothing in any of the FDA reform bills now moving through Congress touches on the question of clinical trial oversight. And, as the article suggests, the drug industry appears uninterested in policing itself.

The Times didn't make it clear in its story, but these trials usually involve getting doctors to sign up patients to test aready approved drugs in situations that are slight wrinkles from the approved indication. Does the serotonin reuptake inhibitor (SSRI) that has already been tested in people with obsessive compulsive disorder also work in people with depression? The real goal of this type of trial is to get physicians prescribing the drug, not to prove it works in a different set of patients.

When the doctors involved get thousands of dollars for each patient they enroll in the trials, they are much more likely to prescribe it off label for that and other indications. That's why they are called seeding trials -- a phrase that unfortunately didn't make it into the story. I've always wondered about the ethicical bearings of the institutional review boards that approve such trials. But that's another story.

So what is to be done? The better FDA reform bills in the House (not the Senate version, which passed 93-1 last month and is backed by PhRMA, the industry trade group) would make the results of all clinical trials public. If it passes, enterprising reporters and researchers will have a field day pointing out the scientific nonsense behind many of these trials. But as we've seen over and over again, this is an industry that takes its anti-shame pills.

Perhaps the time has come to start talking about judging the science behind all clinical trials, whether pre- or post-approval. One way to do that is to put the process of conducting all clinical trials in the public domain.

Companies would still be allowed, indeed, encouraged to sponsor trials. But they would submit their proposed protocols to a public agency, which would then put it out for peer review to determine its scientific validity. Once a protocol was approved, the agency would then advertise for investigators to conduct the trials, just as the National Institutes of Health now does through its clinical trial networks for testing HIV/AIDS and cancer drugs. The system would be paid for by industry user fees -- just like industry user fees now pay for the FDA reviewers who evaluate the results of trials submitted to get experimental drugs approved.

The Times story quotes an outraged David Rothman, head of the Institute on Medicine as a Profession at Columbia University. “Clinical trial investigators must be culled from only the finest physicians in the country,” he said, “since they work on the frontiers of new knowledge. That drug makers are scraping the bottom of the medical barrel is an outrage.”

These seeding trials are not the frontiers of medicine. They're marketing schemes, greased by lucrative payments to the doctors who enroll their patients. Moral outrage won't get industry to stop. Nor does the FDA have the resources to police them.

User fee-financed public funding won't get rid of all the specious trials. But applying outside scientific oversight in the form of peer review and competitive bidding ought to cut down on the worst abuses.

Posted by gooznews at June 2, 2007 07:42 PM