Blackout on DMSO

Until 1963, dimethyl sulfoxide was just another liquid solvent used in industry. Then University of Oregon researchers reported that DMSO had varied medicinal properties--that, in fact, it was a wonder drug. Daubed on the skin, they said, it soothed not only the superficial pain of burns, but also the deep pain of crippling rheumatoid arthritis. It helped burns and wounds to heal faster; it eased itching--and cured athlete's foot.

Soon 1,000 U.S. physicians were testing DMSO on their patients. Some boldly dropped the colorless substance into patients' eyes, or instilled it into their bladders through tubes. Then the Food and Drug Administration suddenly halted all testing. That was 18 months ago. Now the question is: How can anyone hope to find out how good DMSO really is--and for what?

The FDA was clearly right in curbing the free-for-all use of DMSO. Because of premature and wildly optimistic claims, many doctors were trying it without FDA approval. As FDA Commissioner James L. Goddard said later, these were not scientific studies. And because the commercial-grade chemical is so widely available, many victims of severe rheumatic and related disorders were recklessly using DMSO to treat themselves.

Through the Motions. Even so, the FDA ban was criticized on two grounds: it was based on flimsy evidence of damage to the eyes and bladders of laboratory animals when DMSO was used in massive, nonmedical doses; and it was so sweeping that it halted fact finding by even the most cautious medical researchers. Dr. Goddard relented only to the extent of allowing continued use on 50 patients who had benefited from nothing else.

Last December the agency went through the motions of releasing the drug for further study. But tight restrictions were also formulated and had the effect of reaffirming the ban. DMSO can be used only externally, is limited to the few longstanding conditions, such as rheumatoid arthritis, for which there is no other satisfactory treatment. All patients must have eye examinations every three months, plus liver-function and blood tests every four weeks. Even after a doctor wins FDA approval for his research plan, he must still persuade a drug company that he is legally entitled to use DMSO.

Many of the most reputable physicians have given up. Before the ban, the Cleveland Clinic's Dr. Arthur L. Scherbel was getting significant and hopeful responses in scleroderma, or "hidebound disease," a disorder of collagen throughout the body that makes it difficult for the victim to clench his hands, and in many cases causes hideously painful fingertip ulcers. Dr. Scherbel has not used DMSO since the ban, except for patients who still have a supply. "We have tentative permission to use DMSO," he says, "but how do you get a drug company to release it?" Fearful of FDA reprisals, drug companies will not even discuss the doctors' predicament, much less resolve it.

Into the Bladder. As for the eye changes reported in animals, Cornell University's Ophthalmologist Dan M. Gordon reports that he used DMSO to treat swollen, waterlogged corneas, conjunctivitis and inflammation of other eye-related tissues. In many cases, results were excellent; in none could DMSO be blamed for any lens changes. One of the most distressing conditions that DMSO seemed to help was Hunner's ulcer, an inflammation of the bladder causing painful urination as often as every ten minutes. No other generally effective medical treatment is known. But any urologist now giving DMSO directly into the bladder is liable to FDA punitive action.

Says the University of California's Dr. Chauncey D. Leake, one of the deans of U.S. pharmacology: "Rarely has a new drug come so quickly to the judgment of the members of the health professions with so much verifiable data from so many parts of the world, from both animals and man, as to its safety and efficacy." Only in the last few weeks, since some members of Congress began to complain about DMSO as "the persecuted drug," has the FDA hinted that it may soon permit a genuine resumption of the investigation.

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