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DMSO Is Not a Cure-All. But the FDA’s Panic Over It Birthed a Myth.

Imagine a drug so powerful, your government didn’t want you to have it. Now, add the claim that this drug is all natural (it’s not) and that people report it cured them of any ailment you can think of, and you have the recipe for a good old-fashioned conspiracy theory. An online survey of a nationally representative set of 1,351 American adults in 2013 revealed a shocking statistic: over a third agreed that their regulatory agency, the Food and Drug Administration (FDA), was deliberately preventing the public from getting natural cures for diseases like cancer because of pressure from drug companies. Another third said they neither agreed nor disagreed with that statement. The story of DMSO is a good illustration of why this belief is so widespread. This foul-smelling by-product of the wood-pulp industry has acquired over the decades a very broad health halo, which includes treating sprains, pains, strokes, and scars. But the main reason for this halo is what happened when the FDA, in the shadow of a worldwide tragedy, had to decide what to do with DMSO in the 1960s. Paper profits DMSO or dimethyl sulfoxide is a small molecule centred around a sulphur atom. Its isolation was first reported in 1867 by Russian chemist Alexander Zaytsev. Importantly, it is generated as a waste when wood fibres are broken down during the manufacture of paper. At the beginning of the 1960s, an Oregon-based paper goods manufacturer, the Crown Zellerbach Company, asked its staff chemist Robert Herschler if all of this DMSO that they had to get rid of could be used commercially in some fashion. Why throw something away when it could make you money? Herschler was approached by a professor of surgery at the local university named Stanley Jacob, who was interested in preserving biological material at very low temperatures for transplantation. A British team had noted that DMSO was a good antifreeze when storing blood cells, and Jacob wanted to get his hands on DMSO, so he went to the Crown Zellerbach Company. Following his meeting with Herschler, Jacob started to experiment with DMSO in the lab and this is where we find the origin story of DMSO as a medicine. As with most origin stories, it morphs in the telling. Apparently, one of Jacob’s assistants had burnt themselves in the lab… or had sprained their ankle. Jacob applied a bit of DMSO and voilà! It worked like magic. The thing about DMSO is that it has a tell-tale sign. It penetrates the skin very quickly and very efficiently, gets into your bloodstream, and reaches the lungs, where a bit of chemistry transforms it into dimethyl sulfide, which you exhale. It makes your breath smell of garlic, which like DMSO contains a lot of sulphur. This prompted Jacob and Herschler to think that DMSO—so deft at going through the skin and circulating throughout the body—might be a potent medicine. The story of the wood-pulp by-product wonder drug circulated as quickly as the drug itself does in the body, starting in the local media before quickly landing on the front page of The New York Times in 1963. The scientific press had been bypassed; instead, DMSO’s miraculous properties were cited in Newsweek and Life. Stock of the Crown Zellerbach Company temporarily shot up the day the NYT covered Oregon’s DMSO marvel: from $4.50 a share to an incredible $60.25. Pharmaceutical companies descended upon Crown, which had received an approval from the FDA to research the promising molecule. These companies wanted to put DMSO through its paces and eventually market it as a drug. Crown issued six research licenses in 1964 to some of the largest pharmaceutical companies at the time. After some testing, Schering was able to market DMSO in Germany in 1965; meanwhile, Merck, Squibb and Syntex filed new drug applications with the FDA in the US and crossed their fingers. This is where the seed for conspiracy ideation was planted. Safety is in the eye of the beholder The FDA did not always exist, and there was a time when medicines were not tested for their effectiveness or safety. Regulation often followed in the bloody footsteps of public health disasters. In 1961, in West Germany, pediatricians discovered that an outbreak of underdeveloped limbs in newborns—a congenital abnormality known as phocomelia—had been caused by thalidomide, a sedative often recommended to pregnant women for morning sickness and sleeping difficulties. Thalidomide famously had not been allowed entry into the U.S. market at the time, because Frances Kelsey, a reviewer for the FDA, had wanted to see more safety data. The rule was that a new drug was approved in the U.S. if an application was filed by its maker and the government took no action within two months. The government had to act to prevent a drug from being marketed, and drugs did not have to show that they were effective to be approved. Meanwhile, a senator from Tennessee, Estes Kefauver, wanted to tighten the screws around the drug industry to better protect consumers, and the worldwide thalidomide disaster lent credence to his proposal. In 1962, and for the very first time, a new drug in the United States now needed substantial evidence for its safety and effectiveness before being approved. And it is in this new regulatory landscape that DMSO enters the story. When Merck submitted its DMSO data to the FDA, it included a report from a veterinary at the University of Pennsylvania who had found that DMSO caused abnormal changes in the eyes of laboratory animals. Meanwhile, a woman in Ireland had used DMSO to heal a sprained wrist and had died three days later, possibly because she was allergic to the substance. This association was reported in The Wall Street Journal. The FDA—which was now much more cautious and was wielding a new decisional power over drugs—decided to deny the new drug application for DMSO. It also cancelled the paper manufacturing Crown Company’s power to hand out research contracts for the drug. In November 1965, it even sent telegrams to American doctors testing DMSO, to U.S. embassies, and to the World Health Organization: DMSO was possibly toxic to the eye and the FDA was recalling all unused doses of it. DMSO’s use in humans was effectively banned in America. (I recommend Phillip W. Davis’ paper on this whole story if you want the play-by-play.) This sudden fall of the hammer turned DMSO from a miracle drug into a persecuted drug, and it catalyzed the growth of an advocacy movement centred around Dr. Jacob, now the “father” of DMSO. The evidence for DMSO’s toxicity has since been mixed, with the drug receiving no robust, long-term studies of its safety. Testimonials for the drug’s effectiveness in treating an ever-longer list of illnesses replaced scientific evidence, and the FDA only ever approved its use for one disease: interstitial cystitis, a poorly understood bladder pain syndrome. DMSO’s popularity comes in bursts, with the last big one occurring at the beginning of the 1980s following a segment on the TV show 60 Minutes. Athletes swore by it, with a 1981 Sports Illustrated article declaring that “DMSO stinks up NFL locker rooms.” But does it even work? From that same article, the golden quote belongs to 22-year-old Alberto Salazar, one of America’s premier distance runners, who would go on to win a number of marathons before becoming embroiled in controversy. When asked about DMSO at the time, he said, “It is fickle stuff. Sometimes I get immediate relief and other times it doesn’t seem to work at all on a similar problem. It’s mysterious.” Smells fishy The scientific evidence for DMSO’s role in treating any disease is far from convincing. Research done in humans tends to come in the form of cohort studies, where people choose to use DMSO and are followed to see what happens to their ailment. There is no control group to see what would have happened without resorting to DMSO. In the few clinical trials done, placebo arms are rarely used. These lax methodologies invite a positive result that may not survive more rigorous testing. A systematic review of the evidence for DMSO in the treatment of osteoarthritis unearthed a measly four clinical trials. The trials using higher concentrations of the substance were negative, while the ones using lower concentrations were, mysteriously enough, positive, although the studies had a number of issues which makes them less than reliable. Even the evidence for DMSO being effective for interstitial cystitis is not great: a 2017 review of the evidence only lists three randomized clinical trials, and only one of them used a placebo arm. One of the strengths of a proper clinical trial is blinding: the person receiving the treatment and the person administering it should be blind to whether they are dealing with the real treatment or a placebo. This helps remove psychological factors that might influence the outcome, such as patients reporting feeling better simply because they knew they were receiving a drug. But with DMSO’s “death breath,” blinding is challenging. I have worked with DMSO in the laboratory. Its smell was often described as fish-like and you could tell when someone had opened up a small bottle of the stuff at the other end of the lab. I found one trial where the placebo was a very low dose of DMSO, in order to produce a similar smell. Thus, the blinding of almost every trial of DMSO should be questioned. DMSO is a great solvent, and it can be used as an effective “vehicle” to transport active drugs through the skin. When a team of researchers were looking for better treatments for knee osteoarthritis, they set their sights on diclofenac, which you can now buy at the drugstore under the name Voltaren. But they were clever. They tested diclofenac in a DMSO vehicle to facilitate its penetration through the skin… but they also tested DMSO on its own, as well as a placebo. The whole study lasted 12 weeks. And wouldn’t you know it, there was no difference in self-reported pain, physical function or overall health between the patients who had received DMSO by itself and those who had received a placebo. Just as DMSO’s effectiveness as a treatment is highly questionable, so is its safety. Some researchers have reported eye toxicity—even at low doses like 0.1%—while others write that no such toxicity was observed in their studies. To this layer of uncertainty, we must add another one when people buy industrial-grade DMSO for use as medicine. This grade of DMSO, useful as a solvent and a paint thinner, can contain dangerous impurities. Applying industrial-grade DMSO to the skin means facilitating entry of these impurities through the skin and into the bloodstream, where they can cause health problems. Neither the lackadaisical scientific evidence nor the niggling safety concerns will sway the true believers, however, who believe this molecule is being hidden from the public. There are books, like Healing with DMSO, that crown the solvent as a cure-all, and even a website dedicated to preserving the memory of Dr. Stanley Jacob, who died in 2015, and his activism for the substance. Of course, you will also find on his site a link to buy the miraculous substance from an online store. How the FDA treated DMSO in the 1960s, in an attempt to avoid an American repeat of thalidomide, created a martyr. We have seen a similar phenomenon more recently with ivermectin and hydroxychloroquine for COVID-19. But just because a regulatory agency comes down on a promising drug does not mean it is a secret panacea reserved for people in the know. The stink of what happened half a century ago unfortunately lives on, having birthed a conspiracy we still live with today. Take-home message: - DMSO is a foul-smelling solvent that is claimed by some to be a cure-all - The Food and Drug Administration in the 1960s did not authorize its use as a drug because of a report that it might be causing eye toxicity in laboratory animals, and this outcome led to the birth of an advocacy movement - The evidence for DMSO’s effectiveness in treating any medical condition is not convincing due to the lack of a control group in most human studies, and its safety is still unclear, although industrial-grade DMSO contains impurities that could cause health problems @CrackedScience

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