AIDS TREATMENT NEWS No. 004 - May 23, 1986
John S. James

Later we heard anecdotal reports that several patients in later trials in two cities (not including San Francisco) developed pancytopenia, a serious bone-marrow disease. We called Burroughs-Wellcome Corporation, which is developing AZT; they told us that there have been some changes in hematological measurements in both phase 1 and phase 2 tests, but that sometimes these changes occur in persons with AIDS without any therapy, so more study is necessary before we can draw conclusions.

We will have to wait for more information. Meanwhile, here are some points to consider about all clinical tests on experimental drugs, not only AZT.

First, this writer and many others have been urging faster action on the development of new treatments. Often there is a trade-off between speed and risk; for example, researchers could reduce the risks of side effects by scheduling months or years of animal tests before any human trials begin. But persons with AIDS should have the right to make their own decisions about accepting the risks of trying new treatments, instead of being given a flat "No". And everyone benefits when treatment research moves quickly ahead. For these reasons, we should not criticize but commend researchers and physicians who make decisions which are right at the time, even if wrong in hindsight -- which balance the risks of doing something against the risks of doing nothing. They are taking a personal risk when they could so easily cover themselves by refusing to do clinical trials until exhaustive preliminaries have been completed.

Also, we should make sure that no treatment gets lost unnecessarily, even if side effects occur. For example, AZT worked very well in at least one clinical trial (published in Lancet, March 15, 1986). Problems discovered in other trials may be manageable. For example, side effects could be dose-related; the published results of AZT suggest this possibility, as the higher doses tested sometimes produced a B-cell deficiency, though never a serious one. Perhaps it will prove possible to predict who will react adversely to a drug, or to monitor blood tests in order to catch problems in time. Side effects can even result from impurities in experimental drugs, which are not regularly manufactured but often made up in a new batch for each study, by scientists who have probably never prepared that substance in pharmaceutical purity before. And even if it's not possible to avoid a danger, the benefit of the treatment may outweigh it.

Unfortunately, research institutions which conduct a test which fails due to side effects may never find it in their interest to publish or announce the results, due to fear of legal liability or other reasons. If they don't publish, other clinicians who have heard of the problems but don't have the details won't dare to try the drug again, and a useful treatment which might be safe if used differently will be lost. Sometimes we may have to insist that when persons have risked their lives in drug trials, the public has at least a moral right to have the results published so that they can help other scientists and doctors to save lives in the future.

FDA MAY TRY TO RESTRICT VITAMINS -- AGAIN

Ten years ago the U.S. Food and Drug Administration tried to regulate vitamins as drugs if they contained more than one and a half times the recommended daily allowance. All but the smallest doses of vitamin C, for example, could have been banned from over-the-counter sale.

That proposal touched off one of the most massive public outcries in history. Not only did the FDA have to kill its plan, but an act of Congress prohibited the agency from regulating food substances like drugs in the future, unless it could prove that they were dangerous.

Earlier this month the FDA, working with the American Dietetic Association and with support from the American Dairy Board, set into motion a sophisticated plan which could lead to new restrictions on food supplements. While not directed against treatments for AIDS, resulting new rules might affect or even ban a number of "alternative" therapies.

So far, all that's happened is that the FDA has warned that Americans might be poisoning themselves, and asked physicians to voluntarily report any suspected adverse effects of vitamin overdose, on the same form already used to report side effects of drugs. No one has objected to collecting such information, which could be used legitimately to warn vitamin users and doctors about any dangers. The health-food industry has been complacent, apparently expecting the data to vindicate its claim that vitamins and other food supplements are safe.

The problem is that asking all the4 doctors in the country to report suspected bad effects of food supplments, and only the bad effects, will produce such masses of data that there will be enough horror stories to fill any number of Congressional hearings. Erroneous reports alone could do so, even if the vitamins were innocent. The FDA can select these horror stories and use them at the times and places of its own choosing. The requirements of patient confidentiality will probably prevent independent analysis by outsiders.

Then Congress will have the choice to let babies be poisoned, etc., or to do something. And if Congress does act, it will most likely grant broad regulatory authority, instead of narrow powers which would have to be re-legislated every year as situations changed. In this way the FDA will satisfy that driving hunger which is the ultimate motivation of any active bureaucracy -- the relentless quest for more power.

What can we do? It's hard to protest, because so far there's nothing to protest against. If horror stories do get used, it will be hard to protest without appearing heartless. The plan is a masterpiece of strategy for taking away people's power over their own lives, and putting that power into the hands of a medical establishment which is not only expensive, but usually unwilling to run the legal risks of trying alternative treatments at any price.

One thing we can do is make sure that people know what's going on. And we can raise the question of whether we are a nation of people who make their own decisions, using warnings and advice from the experts, or whether a committee of experts should decide what's best for you, and use police powers to enforce your compliance.

Copyright 1986 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. Distributed by AEGIS, your online gateway to a world of people, knowledge, and resources. 714.248.2836 * 8N1/Full Duplex * v.34+ / 714.248.0433 * ISDN

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