Early DMSO Research Shows Promise
Early studies in animals and humans showed that DMSO rapidly penetrates the skin and quickly relieves the pain and inflammation associated with injuries such as ankle sprains. Drs. Jacob and Herschler thought DMSO could effectively treat arthritis and possibly act as a drug-delivery system. Their first paper on DMSO’s pharmacology, published in the journal Current Therapeutic Research in 1964, drew the attention of a number of pharmaceutical interests and made headlines in Oregon newspapers. It was quickly picked up by the New York Times.
“A front-page Times article that called DMSO the most exciting thing in medicine created a great deal of interest,” Dr. Jacob recalls. “Six pharmaceutical firms were licensed by Crown Zellerbach to begin wide and well-funded evaluations of DMSO’s safety and effectiveness. The studies primarily used DMSO applied topically to the skin.”
According to Dr. Jacob, three companies—Merck, Centex, and Squibb—found DMSO to be safe and effective for a wide array of musculoskeletal problems like tendonitis and osteoarthritis. Minor side effects included a garlicky breath odor, temporary itching, flaking, and burning at the application site, and occasional nausea or drowsiness. While the companies submitted New Drug Applications to the FDA in 1965 stating that DMSO was safe and effective and ready to be a prescriptive agent, ongoing animal toxicity research revealed that DMSO caused changes in laboratory animals’ eyes (myopia, or nearsightedness). Although no such problems were seen in humans, the FDA grew concerned. Then, on September 9, 1965, the Wall Street Journal reported the death of an Irish woman after undergoing DMSO treatment for a sprained wrist. Although no autopsy was conducted, drug company officials speculated the death was the result of an allergic reaction to DMSO.4
FDA Overreacts, Halts DMSO Research
Dr. Jacob recalls that the FDA “halted all studies of DMSO on November 10, 1965, even though they had data in their files on more than 70,000 patients submitted by approximately 1,500 physicians in the US showing its safety and effectiveness.”
FDA critics contend that the agency overreacted in halting the studies, considering how unconcerned the agency appears today with the number of deaths that occur from both trial and approved pharmaceuticals.
According to Jack de la Torre, MD, PhD, who has researched DMSO’s role in treating central nervous system injuries, “Years ago the FDA had a sort of chip on its shoulder because it thought DMSO was some kind of snake-oil medicine. There were people there who were openly biased against the compound, even though they knew very little about it.”5
Adding to the FDA’s skepticism was that, in many ways, DMSO simply sounded too good to be true. Says Dr. Jacob, “In the 1890s, if someone had said, ‘I have this little white pill and if you take it, it will relieve pain, reduce inflammation, protect you if you have a heart attack, and so on,’ you’d say, ‘Well, I don’t believe it.’ Yet aspirin does all those things. DMSO is similar in that it doesn’t fit the ‘one-pharmacologic-agent-for-one-indication’ philosophy of the FDA”.
Since DMSO was knocked off track, it has been a grueling uphill battle for Dr. Jacob and other researchers trying to get FDA approval of DMSO for any use.
FDA Later Reconsiders DMSO
Dr. Jacob resolutely continued his work on DMSO. In 1971, he and his colleagues brought so much pressure on the FDA that it commissioned the National Academy of Sciences (NAS) to evaluate the DMSO controversy. The NAS published its findings in 1972, concluding that DMSO was a promising and probably safe and effective agent. The FDA was unmoved. Dr. Jacob, however, finally achieved success and some vindication when the agency approved DMSO for treating interstitial cystitis in 1978.
In 1980, DMSO re-emerged in the media, causing the public and even Congress to take note. Continued pressure from Dr. Jacob and other researchers led to congressional hearings, and demands for federal studies of DMSO were introduced in several bills. Unfortunately, none of these bills ever left committee, and a provision in another bill was deleted just before passage.
As the leading expert on DMSO, Dr. Jacob was called to testify at a hearing before the US Senate Subcommittee on Health. “DMSO is one of the few agents in which effectiveness can be demonstrated before the eyes of the observers,” he told the committee. “If we have patients appear before the committee with . . . sprained ankles, the application of DMSO would be followed by objective diminution of swelling within an hour. No other therapeutic modality will do this.” At the time, ongoing studies of DMSO’s treatment potential covered a range of conditions, including stroke, breast and prostate cancer, head injuries, bursitis, herpes, retinitis pigmentosa, spinal cord injury, and arthritis. The results showed much promise.3
Public demand for DMSO grew strong and the FDA went on the defensive after millions watched Dr. Jacob appear on the CBS investigative series 60 Minutes. An “underground” market in DMSO sprung up, with sales rumored to be over a billion dollars a year. This, Dr. Jacob notes, was from selling not pharmaceutical-quality DMSO, but rather so-called “underground” DMSO. It was not illegal to sell DMSO, and the public could purchase the industrial product virtually anywhere, from the local health food store to the dry cleaners, ice cream shops, hobby stores, and from the trunks of cars. It was also inexpensive: distributors paid about $1 a pint in bulk, and consumers were happy to pay about $20 a pint for a product that brought relief for conditions such as arthritis and sports injuries.3 The FDA, however, began seizing DMSO from distributors and retailers. It became harder to obtain, and eventually the furor died down. For Dr. Jacob and other DMSO researchers, however, the battle with the FDA continues to this day.
Focus on Profits Prevents DMSO Research
An additional (though related) obstacle to DMSO’s widespread use is its lack of potential profitability for drug companies. The few early patents granted on DMSO expired in 1987, and without patent protection for the DMSO molecule itself, drug companies cannot make money on it. Sales of so-called underground DMSO have moved to the Internet, where buyers usually cannot be certain of the strength or purity of the chemical-grade and industrial-quality product offered.
A search of the medical literature turns up more scientific articles about or referring to DMSO than for penicillin, cortisone, or aspirin. The future of DMSO, according to Dr. Jacob, lies not so much in its use alone in topical administration, but more likely mixed with other substances and given by injection or intravenously—an area he would like to explore.
“We’re not dealing with just another chemical, we’re dealing with what I always call a therapeutic principle,” Dr. Jacob explains. “A given drug or medicine will treat a given disease or more, but a therapeutic principle is an entirely new concept in therapy.” Dr. Jacob believes that DMSO, like aspirin, will have a profound effect on many areas of medicine.
Despite DMSO’s long and frustrating history, its true value as a medicinal agent may still be undiscovered. Dr. Jacob and other researchers believe DMSO will be looked on quite favorably in the years to come, as more evidence of its safety and efficacy accumulates—and particularly as new investigations explore its use in treating closed head trauma.
“It’s fallacious when people talk about DMSO in the same breath as other substances that don’t have a good scientific basis,” says Dr. Jacob. “While they might say that the story of some other agent is like the story of DMSO, there’s really nothing quite like DMSO in its history and potential usefulness.”
To learn more about Abela Pharmaceuticals, contact Abela’s CEO, Dr.Colette Cozean, at 949-855-2885.