The U.S. is deciding whether to reclassify certain peptides. Doing so will broaden the availability of the unproven treatments. In a striking rejection of scientific integrity, federal advisers recently voted to allow a slate of unproven, injectable peptides to be prepared by compounding pharmacies and then marketed directly to consumers.
The decision directly overrode evidence presented by the Food and Drug Administration’s staff scientists, who had researched the issue extensively and issued a strong warning against reclassifying these peptides. What happened at that meeting and what does it mean to the American consumer? In an unprecedented intervention, the Secretary of Health and Human Services handpicked an advisory panel loaded with individuals with a direct financial stake in peptides.
Many on the committee sell the very peptides they were charged with reviewing — a stark violation of the agency’s usually high conflict-of-interest standards. The actual, unbiased scientists on the committee fought for a “no” vote, pointing out that the data presented was observational at best, often consisting of little more than testimonials from a few “patients.” None of the information established safety beyond doubt. If the FDA agrees with the panel’s recommendation, six of the seven injectable peptides they evaluated will no longer be barred from pharmacy compounding.
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Drug mills will be permitted to churn out compounds without names, such as BPC-157 and TB-500. The latter has zero data from medical studies conducted in humans, yet it’s held up as a salve for everything from muscle building to treating ulcerative colitis and opioid addiction. The peptides are routinely used in “stacks”; chosen at random, with arbitrarily chosen doses; and two drugs from the same class may be included for reasons that defy explanation.
They will be promoted on social media and television by washed-up athletes and unscrupulous influencers paid well for their perfidy. The committee’s decision was unusual and ignored the opposition of agency scientists, according to Time magazine. NPR described the outcome as a striking rejection of the FDA’s stance, pointing out that every one of these compounds lacks the large, well-controlled clinical trials required to prove safety and effectiveness in humans.
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