The Food, Drug and Cosmetic Act of 1938 began the system of drug regulation that required prescriptions for certain drugs. The Durham-Humphrey amendment (1951) further solidified requirements that drugs be available only by prescription unless they have been specifically approved for sale over the counter (OTC). The argument follows that patients should be under the care of a doctor and rely on physicians’ expertise before ingesting chemicals that can affect a change in their bodies.
People mostly do not question the requirement that their doctors must authorize prescription drug therapies. This is slowly changing, however. Patients increasingly turn to telemedicine websites, whose presence seems to consist of little more than web-based questionnaires. These are often services with limited treatment areas, such as men’s health, women’s health, hormone replacement, erectile dysfunction, weight-loss, etc. Instead of visiting their regular primary care physician, patients sometimes pay nominal fees to telemedicine websites for access to drugs they want.
Doctors were once the primary source of medical information. Nowadays people can spend an hour on the Internet and learn more about diseases and conditions than their physicians would ever have time to discuss. People turn to artificial intelligence chatbots for questions when their doctors are too busy. Google receives 1 billion heath queries per day, or about 70,000 a minute. Physicians on YouTube provide expertise about treatment options and disease conditions to anyone willing to watch. Many YouTube physicians have a thriving side gig as social media content creators, providing health education to millions of people who are not their patients.
There is a large segment of the population who routinely turn to self-care. They self-treat using dietary supplements, OTC drugs, and research peptides. The market for dietary supplements is estimated at $40 billion in 2025. The market for OTC drugs is more than four times as large ($180.1 billion). Nearly 1,000 OTC drug products were once available only by prescription. This number needs to increase.
Another self-care avenue that is increasingly popular is using research peptides for so-called biohacking. These are people who want to go beyond normal medicine in pursuit of longevity and regenerative medicine. There are plenty of experts, including medical doctors and university researchers willing to teach and often sell products to those who are eager to buy. Research peptides are not hard to find. Most peptides are too delicate for stomach acids and generally injected just under the skin. The sellers always display warnings that these are not for human use and are only for research. Some research peptides are copies of FDA approved drugs, most commonly for weight loss. Others are essentially experimental drugs or drugs not approved for use in the U.S. The following is an explanation from STAT News:
Peptides are chains of amino acids produced naturally in the human body, and they influence a whole host of bodily functions, from metabolism to inflammation to muscle growth. Synthetic peptides have been used in medicine for quite some time — insulin, for example, is a synthetic peptide.
The New York Times even reported on peptide therapy, saying “The Internet Loves Peptide Therapy. Is It Really a Miracle Cure?” Peptides control many aspects of human biochemistry. One YouTube doctor called peptides text messages between cells. The following is a list of some peptides and what they do. All the popular GLP-1 weight loss drugs are peptides. Insulin is a peptide. The feel-good hormone, oxytocin is a peptide. BPC-157 and TB-500 promote healing. NAD+ (nicotinamide adenine dinucleotide, technically not a peptide but popular with the peptide crowd) improves cell communication and is thought to reduce aging. PT-141 is similar to an FDA approved drug to increase libido in pre-menopausal women. It apparently also works on men and post-menopausal women. Sermorelin was once an approved drug to boost growth hormones in undersized children. It was withdrawn from the market as unprofitable. It is now popular with body builders and biohackers. SLU-PP-332, MOTS-c and AICAR mimic the results of exercise, except without the hassle. They are sometimes referred to as exercise in a bottle. There are numerous others: too many to list. There are plenty of influential proponents. Celebrities and influencers have touted the treatments, including Joe Rogan and even the HHS secretary, Robert F. Kennedy.
Now that the genie is out of the bottle, will the FDA be able to get it back in? I hope not. Nor should the agency try. The FDA should actively work to reduce the proportion of drugs that require prescriptions and boost those available over the counter and behind the counter.
New York Times: The Internet Loves Peptide Therapy. Is It Really a Miracle Cure?
STAT News: Inside the peptide craze: Hype, science, and risk | STATus Report