Alternative therapy si, gene therapy no?

Comment From the Editors Alternative Therapy Si, Gene Therapy No? everal times in this forum, we have written about alternative therapy, usually with concern. Blind acceptance and popularity of alternative therapy, however, is all more paradoxical in the context of real advances in molecular biology and genetics. Investigators are homing in on molecular mechanisms of disease, providing novel clues to therapeutic intervention; the human genome is yielding its secrets, and the promise of gene therapy lurks on the horizon. A striking chasm exists, however, between much of society and the scientific community as highlighted by disparate views of gene therapy/ molecular medicine and alternative therapy. Public enthusiasm for the prospects of gene therapy have been dampened in the wake of the recent, unfortunate death of a research subject, and federal officials have reacted appropriately to this tragedy, prompting a review of human studies rules and regulations. Inevitably, valuable improvements in the oversight of research in human subjects will emerge, but the cost has been high. The inquiry into human studies has turned the entire national clinical-research effort on its head, culminating in the closure of highprofile clinical research centers and the halting of many important, carefully conceived human gene-therapy research projects. The review has already resulted in an unprecedented new level of administrative oversight, and the pendulum seems to have swung to extremes for a clinical research enterprise that is in need of tweaking but is fundamentally sound. Despite their potential for enormous societal benefit, clinicalresearch programs are being scuttled or reigned in. Contrast this response with that generated by the recent deaths of persons taking herbal medications and re-

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ports of renal failure and malignancies in those taking others. A few calls for more oversight were heard, but the deaths and adverse outcomes caused by alternative therapies resulted in barely a ripple. The $15–$30 billion-per-year so-called “health-food” industry did not miss a step, and no attempt was made to challenge the patently ridiculous notion that anything labeled a food supplement is shielded from the prospective purview of the Food and Drug Administration. The irony is disconcerting. Based on comparably worrisome adverse events, the public and public figures are quick to deflate the prospects for a scientifically based new discipline but barely question commitment to unproven nostrums. Apparently, new therapies developed in scientific laboratories are assumed ineffective and unsafe until proven effective and safe, while alternative medications are assumed to be effective and safe unless proven ineffective or unsafe. The irony is amplified by the dramatic, tangible impact “scientific” medicine has had on our lives vs. the absence of any proven benefit of herbal and alternative medications. Furthermore, the American people complain about the high cost of health care but think nothing at all about spending as much as, or substantially more than, the entire annual National Institutes of Health (NIH) budget on nutritional supplements and alternative therapies of unproven value. Especially ironic is the fact that concerns by the public and the business community over the rising costs of medical care launched the current managed-care imbroglio; in turn, managed care limits the time a physician can spend with a patient, motivating patients to explore alternative “practitioners” and their false promises. What is the source of this state of affairs? Many sophisticated people will not hesitate to take an alternative rem-

edy based on a friend’s recommendation. Yet, they are often loathe to accept a scientifically validated therapy, concentrating more on known or imagined risks. How one and the same person can be so overly skeptical of a validated therapy while at the same time so uncritically accepting of an unproven one defies logic. These almost kafkaesque experiences suggest to me that we have failed as a society to teach science in our schools, to convey the simple, elegant principles on which scientific undertaking is based. As has been pointed out repeatedly, no dichotomy exists between “scientific” medicine and other approaches; any therapy should be amenable to standard rules of empiric, scientifically sound, rigorously controlled investigation. Therefore, as dubious as I am about the value of “alternative” therapies, I applaud, with some reservations, the NIH and medical schools that have established centers for the scientific study of alternative therapies. Although these study initiatives have the potential to divert funds from other, higher-priority scientific pursuits and to lend unearned credibility to the proponents of alternative therapies, on balance, the time is long overdue to apply scientific methods to the validation or debunking of currently unproven therapies. Once the validation of alternative therapies becomes the subject of scientific scrutiny, the next rational step should be to eliminate the distinction in government oversight between scientific and alternative medicine; nothing we use to improve our health should be sheltered from scientific inquiry. Claims for efficacy and safety of alternative medicines, molecular and genetic therapies, and conventional pharmaceutical therapies should be based on the same scientific criteria. JULES L. DIENSTAG, M.D. Associate Editor doi:10.1053/gast.2000.19650

GASTROENTEROLOGY 2000;119:1189