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More Labs Than Patients : Desire to Be First Colors Gene Studies

Gene Studies

December 14, 1987|BARRY SIEGEL | Times Staff Writer

The first human trials will in the end also need approval from an institutional biosafety committee, the full RAC, the director of NIH, and the FDA, but the front-line deliberations will come from this RAC subcommittee. The next meeting is scheduled for late March. It is not clear when they will face the decision Anderson intends to force upon them.

We want to approach this rationally, the panel's members said in interviews. We want a reasoned process, a legitimate procedure.

But most on the panel also say they are generally inclined to rely on the critiques sent in by the 10 reviewers. We must look, they explain, to what the scientists tell us.

Judgments Colored

That the experts' judgments are colored by matters of training, philosophy and politics as well as by the hard facts is a condition that the panel must accept.

It is partly an epistemological question, said the bioethicist LeRoy Walters, the RAC subcommittee chairman: "How do you know the truth? There is no alternative but to listen to the experts. Who are the experts? The experts are those who are acknowledged by experts to be experts. At a certain point, it gets to be a circle."

"There may be gray areas," Gartland said, "but at least we can agree that there are these gray areas and go ahead anyway. We can at least agree about what we are basing our decision on."

The type of question less likely to be agreed upon has more to do with the scientists than the science.

Is the clinician French Anderson's fiercely willed drive toward a finish line a danger to science, or what's required in order to make transcendent leaps?

How do you reach the landmark discoveries?

Intuitive Advances

It is true that the history of science abounds with sudden, intuitive advances. Yet it is also true that many of those came not from acts of directed will, but rather, from unplanned, unexpected random twists of fate in a lab.

One morning recently, a member of the RAC leafed through the critical reviews of Anderson's preclinical data document. He could not hide his puzzlement. The RAC had received not a single piece of paper, not a phone call, from any other scientist interested in filing a protocol.

So he had a question. What was it with French Anderson? Was he a visionary, that far ahead of the others? Or was he something else? Was he off the wall?

That question was put to Anderson the same day.

"I don't know who is right," he said. "I don't know if I'm right or not. Was Lindbergh right? If he crashed into the Atlantic he would have been wrong. The simple issue is that if you're a pioneer, most pioneers by definition flame out. They fall off cliffs, their ship sinks, their plane crashes, something else happens. Were they right or were they wrong? If they were lucky and they got there, they were right."

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