Monday, Apr. 28, 1980

DMSO Dustup

Wonder or quack drug?

It relieves the pain and swelling of arthritis, heals burns, soothes toothaches, eases headaches and muscle strains, and clears up viral, fungal and bacterial infections. It helps retarded children, prevents paralysis from spinal-cord injuries, and even grows hair on bald pates. And it is safe to use. At least so claim the dedicated defenders of dimethyl sulfoxide (DMSO), which was enthusiastically promoted as a "wonder drug" in the early 1960s but then fell from grace after the Food and Drug Administration halted its testing in 1965 because of possible harmful side effects.

Now a combination of a congressional hearing, an erroneous press report that the Arthritis Foundation had urged FDA approval of the drug and a segment on the TV show 60 Minutes have put DMSO back in the spotlight and renewed the controversy over its effectiveness. Is DMSO, as its supporters stubbornly claim, "the aspirin of the 21st century"? Or is it, as its detractors insist, merely a quack drug, "another Laetrile"?

Though DMSO was discovered by a Russian scientist in 1866, it attracted little interest until the 1950s when increasing industrial uses were found for it. DMSO, derived as a byproduct in converting trees to paper, is an antifreeze and a versatile solvent for a broad spectrum of chemicals. But scientists were startled to find it also had a remarkable capacity to penetrate skin and tissues and enter the bloodstream; its only apparent side effects were an oysterlike taste in the mouth and a garlicky breath odor.

A pioneer in exploring DMSO's medicinal uses, and an ardent champion ever since, was Surgeon Stanley Jacob of the University of Oregon Health Sciences Center, who in the early 1960s began by trying it in isolated cases of burns, sprained ankles and arthritis. From those beginnings, he says, "the uses grew like Topsy."

By 1965 some 100,000 people were using DMSO, primarily to treat sprains, bruises, minor burns and arthritis. The FDA'S concern about such widespread use of an experimental drug grew into alarm when animal studies indicated that DMSO might cause eye damage. That led to a virtual ban on clinical tests of the drug. But only a year later the restrictions were eased to permit experiments in such hard-to-treat illnesses as interstitial cystitis (a painful bladder inflammation), scleroderma (a condition characterized by thickening and hardening of the skin and sometimes internal organs as well) and rheumatoid arthritis.

Though no one is sure of the long-term side effects of human use, DMSO is now generally held, even by the FDA, to be a comparatively safe drug, though it can cause skin rashes and hives, and has been associated with headaches and nausea. Eye damage, reported in laboratory animals, has not been confirmed. The big sticking point in the DMSO debate is efficacy. So far, the drug has won FDA approval for general use only in cystitis. The agency contends that it has received few applications for controlled tests of the drug and that most data supporting its use for other ailments come from poorly designed studies, something Jacob and other enthusiasts dispute.

Evaluating DMSO has proved exceptionally difficult in part because of its peculiar properties. Drugs are usually evaluated in what are known as double-blind, controlled experiments in which patients receive either the test substance or a placebo. To ensure objectivity, neither the patients nor the doctors know who got what until after the study is over. But the distinctive taste and odor of DMSO leave no doubt about which patients have received the real drug.

Jacob, who admits he is obsessed with DMSO (he attributes his three divorces to his fascination), claims that bureaucratic obstinacy has hampered approval of the substance. Says he: "DMSO's too good. If I had said it was only of value for sprained ankles, it would have been approved. But when I talked about a huge gamut of usage, it was anathema. It had not been seen before." The FDA disagrees, claiming that it is open-minded about the drug Dr. J. Richard Crout, director of the FDA bureau of drugs, testifying last month at a hearing on DMSO before the House Committee on Aging, insisted that the agency was "willing, indeed anxious" to approve further uses for the drug if claims were substantiated.

Despite the restrictions on the use of DMSO, thousands of Americans still manage to obtain it. Some use a form of the drug that has been approved for veterinary use or even resort to the industrial solvent. Others travel to shady DMSO arthritis clinics in Mexico. This has alarmed the Arthritis Foundation, which, despite erroneous press reports, has advocated only the testing of DMSO. Says Foundation Official Charles Bennett: "There is a good deal of evidence that DMSO may be effective as a short-term painkiller, but there is no scientific proof that it reduces swelling and inflammation. We advise arthritis victims not to listen to the DMSO siren song and not to try to get the drug by some devious means."

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