Sam Uretsky

We Used to Care

It happens every Tuesday. The local paper, with its Tuesday science section, has a report of a new drug study that may offer promise of a new treatment for some rare but invariably fatal disease that is only seen on daytime television talk shows.

Every now and then there's a report that a new drug turned out to be no better than an old clunker that has been selling for 2 cents a tablet, and of course the reports on the adverse effects of the COX-2 inhibitors, the pain relievers that caused fewer ulcers but more heart attacks and stokes, even made the front pages; but overall there's a steady drumbeat of promises and progress.

Faith and hope matter a lot -- and maybe that's why responsible people, presumably with the best possible intentions, were willing to enroll foster children in AIDS research programs without proper protections.

On May 4, the Associated Press reported that researchers in Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas had enrolled children in research protocols without following the review procedures required by federal and local regulations. The research institutions included some of the most prestigious hospitals in the country, including the Johns Hopkins Medical Center and New York's Columbia-Presbyterian Hospital.

In 1983, the federal government set special protections for foster children, requiring that before they are enrolled in drug research, an advocate be appointed to review the risks and benefits of the child's participation. The advocate must have a reasonable degree of medical knowledge in order to make the decision on behalf of the child. According to the AP report, none of the Illinois children and only about one-third of the New York children actually had advocates appointed. In some cases, the research center promised to appoint advocates in order to get the children enrolled, and promptly forgot their promise.

The responses have varied. Representatives of one institution said that what was most vital was to get the children on medication. Another crisis manager said that no advocate was required, because no adverse effects had been expected. If true, this would be a valid reason, since studies where no adverse effects are anticipated are exempt under law. The trouble is, AIDS drugs do have adverse effects. Some cause anemia; some cause damage to the pancreas, digestive disorders, nerve pain and hepatitis. The exemption might be valid for a study of multivitamins; it doesn't apply here.

And the notion that it's important to get the children on medication holds water only if the medication is known to be effective, or if there is no proven treatment. Investigational studies are not -- repeat, not -- cutting-edge care. They're studies. Research. Or, to use a term that's not considered politically correct, experiments.

The number of bright and cheerful Tuesday science-section reports has been the result of publication bias -- the fact that studies with a favorable result are more likely to be submitted for publication than studies with an unfavorable result. Study sponsors have a vested interest in good results. They've been known to block publication of studies that aren't favorable to their products.

Occasionally a study does lead to a major advance in treatment -- but the new drug may be no better, and it may be worse. The role of the advocate is to review both the risks and benefits to participation in a trial -- is the child beyond the reach of established therapies? If not, what special benefits does this study promise? Medical research may help us all eventually, but the immediate question is, "What's best for the child?"

The history of drug studies, whether in the US or worldwide, is not always admirable. The current system of informed consent and peer review dates only from the 1940s, as a response to the Nazi system of human experimentation. Patient protections were improved after Jessica Mitford's 1973 Kind and Usual Punishment pointed out the serious deficiencies of drug research conducted in prisons. The children in these AIDS drug studies are disadvantaged, those most in need of protection. We're assured that the various review committees and regulations protect us from being human guinea pigs.

Time was, nobody involved in a drug study would cut corners, because the FDA would reject imperfect data. There were rare occasions of frauds, but at least every form had to be forged, every space filled in. In this case, hundreds of vital pieces of documentation were missing, and the agency charged with our protection didn't seem to care.

We would like to think of ourselves as a nation of good people. But we've sorted out our children, particularly poor children, into guinea pigs, and then talk about "values." Cancer research and AIDS research are important, but there's a research subject even more important than those: How do we get back to what we were?

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.

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