Over the last month, I have been diligently working to alert the public to the decades of evidence demonstrating the remarkable therapeutic potential of DMSO. In turn, quite a few of my colleagues have shared patients are now asking them about DMSO, and a few are shifting their practice to focus on it (e.g., Pierre Kory has done so and is already having numerous amazing results).
Likewise, I’ve now received hundreds (often unbelievable) reports of it it being life changing for people (which can be read here), and it now seems there is a temporary supply shortage of DMSO because so many people (and their friends) have been buying the brands I recommended.
For those who have not read the series, thus far I have made the case that:
•DMSO treats many circulatory and neurological disorders (e.g., Reynaud’s and varicose veins) and profoundly transforms the outcomes of some of the most challenging conditions in medicine (e.g., strokes and spinal cord injuries)—to the point millions would have been spared from a life of disability or paralysis had it been adopted (discussed here).
•DMSO is a miraculous therapy for chronic pain, wounds (e.g., burns or surgical incisions), injuries (e.g., sports injuries) and all types of chronic pain (discussed here).
•DMSO is highly effective for treating a variety of challenging autoimmune disorders (discussed here).
•DMSO is highly effective for treating a variety of connective tissue issues such as scars and adhesions, collagen contractures, scleroderma, FOP (discussed here).
•DMSO is able to treat a variety of protein misfolding diseases (e.g., amyloidosis) including genetic disorders (e.g., Down Syndrome) which are classically considered to untreatable (discussed here).
•DMSO is incredibly safe, having only a limited number of known and manageable side effects alongside no risk of toxicity or death (provided it is used appropriately).
•There are thousands of studies that demonstrate both the safety and efficacy of DMSO (making it one of the most researched medical substances in history).
In contrast, most of the previously mentioned diseases have lackluster conventional options available for treating them, many of which are highly toxic, kill tens of thousands of Americans each year and simultaneously cause far more non-fatal injuries. Worse still, many of them simply are “untreatable” and have no option for what can be done with them.
In short, if what I’ve said so far is true, the fact that DMSO has been kept from us is so egregious, it’s understandably hard to believe. It’s specifically for this reason, that despite the fact I knew it could help a lot of people I really wanted to help by broaching this subject sooner, I had to wait until I had built a decent degree of credibility here before I spent hundreds of hours to begin trying to put the case for DMSO together, then once I did so, do so in a very specific order. Nonetheless, I still do not think anyone would have believed me or had the courage to try DMSO had they not just witnessed almost every medical authority in the world collude to suppress safe and widely used drugs (e.g., ivermectin and hydroxycholoroquine) so that dangerous and ineffective (but incredibly lucrative) pharmaceutical products could monopolize the COVID-19 market.
In turn, while I still desperately want to cover DMSO’s utility for a variety of other challenging conditions (e.g., vision loss, tinnitus, cancer, chronic infections, shingles, and a wide range of skin disorders), I feel I first must touch upon another question—why did the FDA keep it from us, and how were they able to do it to something so much of the public and the scientific community demanded they legalize?
In my eyes, this story is critically important to understand because it:
•Helps us to understand the origins of the mentality within the FDA that to this day continues to ruin people’s lives by burying promising therapeutics that compete with the medical industrial complex. Despite my best efforts over the last two years (e.g., with ultraviolet blood irradiation, AIDS treatments, or GHB for insomnia), I’ve still only scratched the surface of this (e.g., what’s been done with cancer is really depressing).
•Provides a window into the remarkable dedication of a group of Americans which illustrates what our scientific apparatus could be capable of doing for us if it was not shackled by politics.
•Provides some context to why this recent statement from RFK Jr. is so, so, important:
Note: a significant portion of the first half of this article is an abridged version of the history detailed within DMSO the Persecuted Drug (internet archive link here)
The Discovery of DMSO
The simple compound dimethyl sulfoxide can be found throughout nature, and is present in many fruits and vegetables. It was first synthesized by Russian chemist Alexander Zaytsev in 1866. It was essentially forgotten until the 1940s, when industrial chemists, looking for more solvents were curious if this waste product from producing paper could be used instead of being thrown away.
Note: this chronology has been compared to how fluoride (an industrial waste product from aluminum and phosphate production) entered the water supply. The critical difference was that disposing of fluoride (due to its toxic and corrosive nature) was a major expense and liability for these industries (e.g., it regularly severely injured workers). As such, the desire to get it into the water supply was done to absolve the industries from their liability (e.g., “How could it have injured a worker if it’s safe enough to put in the drinking water”). Initially, due to its evident toxicity, the government opposed this. Still, due to fluoride being necessary to produce original atomic bombs and destructive leaks of it creating immense damage to the surrounding areas, for national security purposes, the government relented (all of which is detailed here). In contrast, DMSO was simply looked at as a potential source of revenue that was being erroneously thrown away.
In the 1950s, Crown Zellerbach, a large American paper manufacturing company, began producing DMSO and soon became the world’s largest producer. Curious if uses existed for DMSO besides being a highly effective solvent, Zellerbach assigned Chemist Robert J. Herschler to research it and other tree derived chemicals. Through a lab accident, he discovered that DMSO mixed with a dye would bring the dye into the skin, and before long verified it could be used to bring antibiotics and antifungals into plants.
Eager to share this discovery in 1961, he connected Stanley Jacob MD, a renowned surgeon with dozens of publications (in hours, he could produce first-rate papers that took others months to write) and professional memberships who taught at Oregon Health Sciences University (located across the river for Herschler). Jacob (whose brief biography can be read here), was searching for ways to preserve organs and had recently learned of DMSO’s ability to function as an anti-freeze agent. After Herschler shared DMSO’s unusual property, Jacob decided to test it by mixing it with iodine, noticed he could taste it, and realized that not only did DMSO bring things into the skin but also spread them throughout the body.
As this delivery method revolutionized pharmacology, Jacob immediately shifted his focus to it, and the next day topically applied it to his lab staff (the 1960s were a different time), many of whom then developed its characteristic odor. As DMSO dried the skin and wet skin often causes burns to become infected, he decided to test it on rats that were burned and saw a potential therapeutic effect, which then inspired Herschler to try it after a subsequent significant chemical burn. Since it gave immediate relief, Herschler then tried it on a sprained ankle in a lab assistant (where it also gave immediate relief) and then for an arthritic thumb (where it also gave immediate relief).
This early data convinced Jacob to put all his focus into DMSO (which was possible since his intellectual capacity allowed him to rapidly produce the high quality lectures required for his actual job). In turn, after many sleepless nights, and many tests on himself, Jacob became certain DMSO would revolutionize medicine. In turn, he began carrying DMSO on him to give to anyone in need (the 1960s were a different time), and quickly had numerous miraculous cures (e.g., headaches, sports injuries, cold sores, sinusitis, crippling rheumatoid arthritis), Simultaneously he also realized making a standardized dose was almost impossible because people’s response to it was so variable and the timing often was critical (e.g., it only prevented adhesions in rats if given before surgery but not after).
Once Jacob had exhausted his personal funds on DMSO (e.g., he often treated people for free) another remarkable serendipity happened—rather than shoot his research down (as physicians at the medical school had predictably already begun complaining about Jacob doing something unorthodox), his dean decided to approve funding for Jacob’s research (which almost any other dean then and particularly now would have rejected).
Note: it’s hard to describe how extraordinary this confluence of events was. Had a single piece come together like it did, we likely would have never heard of DMSO.
The Thalidomide Era
As Herschler now puts it, “If there is such a thing as a Murphy’s law of new drug development, DMSO proves it. Everything that could go wrong did go wrong.”
Discovered in 1952, thalidomide began being marketed in 1957 (initially over the counter) by a German company (Chemie Grünenthal) as a miracle cure for morning sickness, insomnia, colds, and headaches, and before long 14 pharmaceutical companies were selling it in 46 countries under at least 37 trade names. Reports soon emerged of infants born with defects, in 1959 it was observed to cause peripheral neuritis, and at the end of 1961, it was taken off the German market in November and then globally in December after an Australian Obstetrician was able to get a letter published in the Lancet about it causing birth defects (after having unsuccessfully tried to sound the alarm since June of 1961).
Note: during its brief availability in Germany, thalidomide was estimated to have caused over 10,000 birth defects and the deaths of approximately 2,000 children.
Thalidomide’s adoption in America was slower since the initial company Grünenthal approached (GSK’s predecessor) found it lacked any efficacy in their preliminary trials and hence didn’t want to market it. By the time a second company began testing it across America at the end of 1960, concerns existed about thalidomide. This led the FDA reviewer assigned to thalidomide, Frances Oldham Kelsey, to repeatedly stall its approval (despite it already being approved in Canada). As a result, roughly American 20,000 women received it during the extended clinical trials (with many injuries being observed throughout that period by the FDA). Still, it was kept away from the general population (excluding doctors who gave it to their personal circle because the manufacturer had not told them it was still experimental).
Kelsey’s actions resulted in only 17 American birth defects occurring (from the preliminary testing done across America) and earned her a presidential medal from Kennedy on August 7, 1962. More importantly, it got Congress to unanimously pass the 1962 Kefauver–Harris Amendment to address the concerns about the FDA’s inability to block dangerous drugs (Kelsey had instead stalled thalidomide’s approval) by requiring drug manufacturers to prove their drugs were “safe and effective” and accurately disclose each drug’s side effects.
While well intentioned and necessary (e.g., it gave the Secretary of Health and Human Services clear authority to deny the approval of any drug which had not adequately proven its safety), the act also allowed approval to be denied (or for it to be pulled from the market) if:
There is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.
The term ‘substantial evidence’ means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”
All of this led to a few major problems.
First, Kelsey’s actions dramatically increased the prestige of the FDA, both emboldening the agency and simultaneously leading to many other jealous officials wishing to get the recognition she did for stopping the next thalidomide (which DMSO conveniently fit the profile of). Because of this, the pace of new drugs entering the market dramatically slowed, and ever since then, a consistent complaint of Congress has been the FDA blocking medical therapies the public needs.
Secondly, it galvanized the FDA into rapidly establishing its authority and creating numerous divisions to “police” questionable drugs without the organization being structured to effectively or appropriately administer that authority (which led to perpetual mismanagement, chaos, and frequent abuse of that power).
Third, the FDA chose to define “well-controlled” as a double-blind trial (to the point they clung to this specific argument in 1980 when Congress and the Senate grilled them over their decision to stonewall DMSO).
This was a huge issue because:
•I believe it was what enshrined the scientific supremacy of randomized controlled trials (RCTs).
•RCTs are extremely expensive. As such, most can only be done by the pharmaceutical industry, which due to their cost, consistently frames them (presented in favorable ways, ignoring or adjusting harmful data) to protect the company’s investment (which leads to RCTs frequently being highly inaccurate). This in turn, rapidly increased the cost of drug approval, effectively turning drug approval into a pay-to-play type situation (e.g., currently, the cost to bring a new drug to market is estimated to be between 0.98–4.54 billion dollars, which makes it impossible for any unpatentable product ever to get FDA approval).
•RCT fundamentalism is highly misguided as smaller observational unblinded trials will typically yield the same results as large (non-corrupt) RCTs (proven by this 2014 Cochrane Review), especially if the effect of a drug is significant (rather than a tiny one that can only be detected in a large controlled study and hence is likely inconsequential).
•It was impossible to test DMSO in a blinded fashion because it immediately produced a significant benefit everyone (including the patient) could see; it irritated the skin (to some extent this could be worked around), and it had a characteristic odor. Furthermore, since it was absorbed systemically, it could not be tested on only one side of the body (which would then be compared to the other side, that got a placebo). Additionally, the dose of DMSO patients required greatly varied (and hence made it difficult to standardize trials).
Note: somewhat analogously, I’ve had numerous frustrated patients ask me to find them a seed-oil free infant formula. I eventually discovered that the Infant Formula Act of 1980 (which was virtually unanimously passed by Congress in response to more than 100 infants becoming seriously ill from nutritionally inadequate soybean oil-based formulas), due to outdated science from the 1970s (specifically these 1976 AAP recommendations which did not exist in the AAP’s 1967 recommendations), required infant formulas to have at least 2.7% of its calories (300mg per 100 Kcal) comes from linoleic acid (the problematic ingredient in seed oils). Beyond this making it illegal to sell infant formula without them, I and many others believe this is a root cause of the childhood obesity epidemic in America as seed oils impair mitochondrial metabolism and cause you to gain weight (e.g., this systematic review shows infant formulas cause excessive and rapid weight gain).
In short, while it was necessary to give the FDA the power to block dangerous drugs, giving in the ability to block “ineffective” drugs was a huge issue as “ineffective” is immensely subjective and often becomes a completely unreachable standard.
The ABC-TV program “Good Morning America”, on February 5, 1981, where David Hartman interviewed Robert Herschler, helps put all of this into context:.
Herschler: … the toxicity of DMSO is very low. It’s not true that it is dangerous. Compared to aspirin, DMSO is a much safer drug. People are killed taking aspirin; no one has ever been killed taking DMSO.
Hartman: If this is the case and you are so sold on it, why has the FDA not approved its use?”
Hershler: In 1964, the FDA complained bitterly about DMSO because it was both a commercial solvent and a drug. They could not control it. Beyond that, we had a meeting with Francis Kelsey of the FDA where she raised her hands and said, ‘We simply cannot cope with a product like DMSO. We envision hundreds of applications [NDA’s] coming in, and we simply don’t have a budget or staff.’
From then on they took a hard line against DMSO . . . There are many controlled studies that prove it is both effective and safe. And the FDA knows it! The FDA has at least 100,000 clinical [patient reports], and if they statistically evaluate them, and they have, and if they try to prove it is not safe and effective, they simply cannot do it. They have been using this gambit of ‘double-blind’—being able to use the ‘double-blind’ as the reason for rejecting it.
Note: I believe one of the strongest proofs that the thalidomide disaster was nothing more than a tool for the FDA was how quickly they abandoned the fundamental foundational principle it had enshrined and which the FDA’s authority originated from (do not give pregnant women experimental medications) during COVID-19—which has sadly created entirely predictable fertility impairments that precisely mirrored what had been done with the HPV vaccines.
The post The FDA’s War Against DMSO and America appeared first on LewRockwell.
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