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Trial Lawyers and Clinical Trials

Medical research falls deeper into bureaucracy.

Friday, October 11, 2002 12:01 a.m. EDT

Readers of today's column should count themselves as lucky if they never have to give this subject another thought. Members of their family or their closest friends, however, may not be so lucky.

The subject is medicine's search for new ways to treat terrible illnesses using surgery, chemistry or biology, for example Parkinson's disease or spinal paralysis. Unlike the architectural plans now being drawn for the empty World Trade Center site, medical solutions can't be done just with pencil and paper or by tapping at a computer. Solutions to the problems of the human body have to be found, as they have for centuries, by seeing if they work in real people who are very sick and have little hope of recovery.

In modern jargon these tests are known as "clinical trials." The Institute of Medicine, an arm of the National Academy of Sciences, has just issued a little noticed but important report on the search for medical solutions titled "Responsible Research: A Systems Approach to Protecting Research Participants."

A "systems approach"? This alone signals that something is awry.

The issue taken up by the institute, at the urging of Congress and the government, is whether the people who enter such clinical trials are adequately protected from harm. The institute itself needs more than 300 pages of text to answer this question, and from that one may infer that somebody believes people are not sufficiently safe from their doctors.

That "somebody" today includes ethicists, plaintiffs lawyers and their clients, Ted Kennedy, the press and some government officials. As for patients who are--or may some day become--very ill with cancer, AIDS, Alzheimer's and the like, their participation in shaping the rules for research will be zero, nil. Indeed, it's not clear to me that the people directly involved in this exercise know quite what the problem is. Mainly what they appear to have is a PR problem.

The modern issue of whether patients are safe in medical experiments dates back to the postwar Nuremberg Code, a reaction to the horrors of Nazi doctors. Subsequent incidents--such as thalidomide, the Tuskegee syphilis experiments and most recently the death of Jesse Gelsinger in a gene therapy experiment at Penn--always produced calls for ever-greater regulatory oversight. That call has been answered.

The people behind the movement for a larger regulatory framework assume and blandly assert that their "systems approach" will not kill good medical solutions in the cradle, that more rules will cost society nothing in terms of lost cures or palliation. Really?

How can they know that? For starters, they have no reliable data on how much harm occurs now in the nation's clinical trials, or even if harm is due to the underlying disease or the experiment. What they have are highly publicized incidents, which have rained down bad publicity on the affected institutions, such as Duke University. The panel chairman, Daniel Federman of Harvard, wants to keep "public trust from being irrevocably eroded." I think he means media trust.

With this has come the threat of medical research falling into the maw of patient-plaintiff litigation (at Penn, the Fred Hutchinson Center in Seattle, and the University of Oklahoma). One plaintiffs lawyer, asked the basis for suing the members of a university review board, replied that the federal government had opened the door by officially dumping on the performance of review boards.

In America, the moat built around any such threat is more bureaucracy. Run-of-the-mill research will muddle through the sludge. And the new rules will ensure political support for the continued flow of tens of millions of federal and corporate research dollars through the nation's universities (there are by now perhaps 4,000 Institutional Review Boards monitoring thousands of experiments). But I don't believe that the eminent members of the Institute of Medicine's "Responsible Research" panel can guarantee that their regime won't deter or frustrate the genius who somewhere is dreaming of the next L-dopa, lithium or open-heart surgery.

The cost alone of bringing a new drug to market, mainly due to the need for massive clinical trials, is now more than $800 million. Knowing that figure today and the bureaucracy behind it, the next Alexander Fleming, whose lab was a famously disordered mess, might conclude that the next penicillin-level revelation looks fascinating--but who needs the headaches? How much easier it is to run a trial for the next generation of, say, Claritin.

If there is one overarching issue here it is the steady, disintegrating status of the physician in U.S. society. Whatever the substance of the managed-care debate, a problem doctors helped create, the fact is that it has eroded traditional physician autonomy. Amid that, we have a concurrent movement, led largely by professional ethicists with access to politicians and the media, who argue that physician-researchers cannot be trusted. In their minds, regulatory rationalism in response to perceived dangers exists not as a political idea, but as a religion. And the community of physician-researchers had better genuflect to their new betters.
The arguments inside the folds of this debate can be interesting because medicine and science are complex now. But what's missing from the process, and may be dead, is any voice willing to speak for the most intuitive scientific and medical minds, the ones that don't fit comfortably inside the new norms of oversight, protection, legal insulation and abstract claims for the "rights" of patients.

Congress, led by Ted Kennedy, will take this up next year, and likely without much opposition from Bush officials will put more rules in place. They have the weight of past incidents on their side, wile arguments for future innovations and patients not yet ill seem irrelevant.

The U.S. is still the envy of the world's medical research community. But keep in mind that all those glorious Nobels we keep winning were for work done years ago. Load up our doctors with enough concerns, though, and some day your health may be the least thing on their minds.

Mr. Henninger is deputy editor of The Wall Street Journal's editorial page. His column appears Fridays in the Journal and on

© 2002, Wall Street Journal