Nonprofit Clinical Trials

In his excellent article "Understanding Clinical Trials," Justin A. Zivin focuses on drugs and medical procedures. But diet therapy and lifestyle changes can also treat certain conditions, with fewer side effects. To date, only a handful of dietary regimens have been tested rigorously, and most of these relate to heart disease. I am treating two ADHD children with diet therapy because, for them, this is more effective than drugs. Is this an anomaly, or does it represent a trend? If diet therapy helps even 3 percent of the millions of children on Ritalin, we need to establish

^ this fact and make it known to parents ^ r and physicians. Yet nobody is anxious to fund the relevant clinical trials because Q such treatments do not yield profits for investors. In fact, drug companies usually play devil's advocate because they don't • ^ want to lose any of their current customers. How can we, as a nation, deter-^ mine the safety and efficacy of dietary and lifestyle changes when the corresponding studies are not profitable and cannot possibly be double blind?

KARL DAHLKE

Zivin replies:

II harmaceutical companies are businesses and have legal obligations to their share-^ holders to try to be profitable. They therefore ^ have disincentives to evaluate therapies they I cannot patent or that have very limited market potential. Patient advocacy groups and individual philanthropists have relatively limit-^ ed resources, which they generally devote to basic investigation of disease processes. Only ^ the government can be expected to fund the testing of treatments that are unlikely to be profitable. The National Institutes of Health, the primary source of medical research grants, devotes a sizable fraction of its allocations to such clinical trials. But among NIH adminis-^ trators and their external scientific advisers, there are substantial differences of opinion concerning how best to distribute those resources. Additionally, political pressures and unrelated federal budgetary constraints can shape funding priorities. Diet and other lifestyle choices can be studied using clinical trial methodology in many instances, but such research is very expensive, and only government can be expected to support it.

Letters to the editors should be sent by email to [email protected] or by post to Scientific American, 415 Madison Ave., New York, NY 10017.

ERRATUM

In The Amateur Scientist [April], readers were advised to plug the heating rope into a ground fault switch (GFS) to help protect against electric shock. Good advice. But a GFS doesn't trip when the leads are shorted. Rather these devices disconnect a circuit if excess current flows to ground. Reader Leonard Herzmark, an engineer in Tucson, cited the National Electrical Code when he wrote to recommend that a three-prong plug be used to connect the thermos case to ground.

SCIENTIFIC

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