Masters Swimming and Illegal Supplements

Originally posted by Bob McAdams Industry experts have estimated that the cost of gaining approval for a new drug would be substantially reduced if the manufacturer only had to demonstrate safety, leaving it to doctors to determine whether its efficacy had been adequately demonstrated for a particular disease before prescribing it. As it is, the additional costs of proving efficacy are passed along to consumers in the form of high drug prices. If supplements were to be regulated in the same way, there would be one important difference: Supplements, by definition, cannot be patented. Consequently, a manufacturer who spent millions of dollars demonstrating a supplement's safety and efficacy to the FDA's satisfaction would never be able to recoup their expenses, since they would have no period of exclusive right to production during which they could charge an inflated price. Efficacy is established through clinical trials, allowing physicians to practice evidence-based medicine (rather than relying strictly on their own experience or anecdotal reports). The term "efficacy," as applied to supplements, is an oxymoron. Most randomized clinical trials of supplements have failed to show a clinically significant benefit, and in many cases have demonstrated risk.

Originally posted by Bob McAdams Industry experts have estimated that the cost of gaining approval for a new drug would be substantially reduced if the manufacturer only had to demonstrate safety, leaving it to doctors to determine whether its efficacy had been adequately demonstrated for a particular disease before prescribing it. As it is, the additional costs of proving efficacy are passed along to consumers in the form of high drug prices. If supplements were to be regulated in the same way, there would be one important difference: Supplements, by definition, cannot be patented. Consequently, a manufacturer who spent millions of dollars demonstrating a supplement's safety and efficacy to the FDA's satisfaction would never be able to recoup their expenses, since they would have no period of exclusive right to production during which they could charge an inflated price. Efficacy is established through clinical trials, allowing physicians to practice evidence-based medicine (rather than relying strictly on their own experience or anecdotal reports). The term "efficacy," as applied to supplements, is an oxymoron. Most randomized clinical trials of supplements have failed to show a clinically significant benefit, and in many cases have demonstrated risk.