Hi, folks -
More background on FDA and DMSO. I'll just excerpt part of the text, and the link will give the complete story.
However, it's becoming clearer by the minute that retrograde, sloppy thinking by bureaucracies has probably been the primary impediment to DMX's success.
I would add that this kind of lazy, sloppy, logically indefensible muddleheaded "thinking" (to use a kind word) has likely also impeded the successful use of WF10 by millions of people who need it badly.
The text is from the May 20, 1986 issue of Policy Analysis: I recommend it highly.
Jim
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COMPASSION VS. CONTROL:
FDA INVESTIGATIONAL-DRUG REGULATION
On occasion, sponsors have been forced to abandon a drug investigation altogether following the refusal of an IND application, as in the case of the aspirin study mentioned earlier.
Another notable instance involved the drug DMSO, an industrial solvent of possible benefit to victims of arthritis, bursitis, sclerodama, muscle sprains and strains, and brain traumas. Permission for human testing of DMSO was effectively revoked by the FDA in 1967 following a series of disputes between agency officials and Stanley Jacob, a principal investigator. The arguments invoked by the FDA to support its position appear to have been medically questionable.[35] DMSO had been administered to over 50,000 patients, with hardly any adverse reactions, and many patients reported unique pain-relief benefits. Before its testing was halted, DMSO was approved by the FDA for the treatment of a relatively rare condition known as interstitial cystitis and for veterinary treatment of arthritis.
Despite FDA disapproval, many patients continued to use DMSO, which remained legally available on the gray market as an industrial solvent. DMSO was widely sold in hardware stores, health-food shops, and elsewhere, though often in impure, medically sub-standard formulations. Ironically, despite the fact that DMSO is a potent solvent with the unique ability to transmit poisons through the skin, it is legally sold only in bottles not labeled with instructions regarding human use because such instructions would have made the product subject to FDA regulation as a "mis-branded" unapproved drug. The FDA's sanctions against Jacob have done nothing to settle the dispute over DMSO, and testing of the drug has resumed after 20 years of fruitless controversy.
cato.org |
