title: Anecdotal therapies.
abstract: Traditionally, many advances in medicine have been serendipitous. Are serendipitous and anecdotal synonymous? Many of our materia medica today relate to initial probes and anecdotal reports that matured to full investigation and therapeutic indications. The recent situation regarding Skin Cap is one that highlights the downside of this scenario. Several drugs in the US continue usage largely related to anecdotal indications, and anecdotal extension of legend indications is a standard for American Dermatology. The situation with systemic drugs, such as Trental, zinc preparations, imidazoles for extended indications, lysine and melatonin, all will be discussed. Topical preparations such as skin cap, cantharone, Vioform, all also are included in this category. It is important to place this topic in perspective in regards to geographic variation and therapeutic need. Many diseases lacking specific therapy are important targets for anecdotal therapy, and this will foster continued approaches in this area. The growing standardization of medicine and pharmaceutical regulation, threatens the anecdotal approach, but it provides still an important link to the future for some forms of therapy in diseases that are difficult to treat. Traditionally, the anecdote has been the first step in the therapeutic chain. Withering discovery of the benefits of the common fox glove in dropsy, was followed by many other anecdotes arriving via folk-medicine in the New World. This approach of utilizing folk medicine has now reached new heights, with very active searches by major pharmaceutical companies throughout the third world for remedies that may have potential. Couched with this is the history of anecdotal "snake-oil" remedies, that clearly had no benefit to anyone except the huckster marketing same. The excesses in this area of unproven and false therapies, led to the gradual organization of therapeutic trials and the Food and Drug Administration in the US as we know it today. The biggest shot in the arm for enhancing FDA protocols was the thalidomide situation, an outgrowth of an ethically studied and used medication that perhaps had been released too soon, prior to sufficient trials to determine the total patient risk. As in many situations, the pendulum swings in both directions, and after thalidomide, the acceptance of new treatments required more and more rigorous studies, and studies from other countries often were not acceptable unless a small part of a larger, whole proposal. The AIDS crisis has prompted a swing back, away from such expensive and rigorous pre-marketing review, to more expedited processes for the relief of patients with this fatal disease. This has streamlined the FDA, and hopefully the swing of the pendulum will not go too far, to result in problems in the future. Anecdotal therapies and medications are the first step in many parts of the world to therapeutic trials. The most widely used aspects of anecdotal therapies, again, remains in the situation with diseases without good therapies at the present time. The so-called orphan drugs and orphan diseases, while a serious medical problem, do not present a significant volume for effective drug screening in many instances, and the FDA has developed some new approaches to circumvent this very expensive development process for patients suffering from these rare and unusual disorders. The most recent example of anecdotal therapy catching the public fancy in dermatology was the Skin-Cap Spray. This product, over the period of twelve months, got rave reviews in the lay press in the non-peer reviewed dermatologic periodicals, and amassed impressive sales figures in this period of time. It was extremely effective, and most dermatologists who used it have patients who consider it the most effective therapy in the last year. The formulation of a low concentration of zinc pyrithione seemed unusual, and this truly was an anecdotal approach, using a homeopathic dosage of a commonly used p
authors.affiliation: Department of Dermatology, Tulane University Medical Center, New Orleans, Louisiana 70112, USA. millikan@tmcpop.tmc.tulane.edu
authors.forename: L E
authors.initials: LE
authors.lastname: Millikan
mesh_terms: D000739:Anecdotes as Topic; D004282:Documentation; D017277:Drug Approval; D004341:Drug Evaluation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration