U.S. health officials are moving forward with a plan to allow specialty pharmacies to produce certain peptides, a class of drugs that have been taking over the wellness industry.
Health Secretary Robert F. Kennedy Jr. has long been a proponent of peptides, describing himself as “a big fan.”
Prior to joining the administration, he publicly declared that the “FDA’s war” on peptides must end.
But as peptides are increasingly pushed by self-prescribed “wellness influencers,” experts are increasingly weighing in on their targeted uses, consequences of misuse, and how they became a social media trend.
Peptides are short chains of amino acids, the building blocks of protein, which trigger hormones inside the body needed for growth, metabolism and healing.
They have more recently made headlines in the form of GLP-1s and other weight loss drugs, but peptides are not new to the field of medicine.
“Peptides have been a very important healthcare industry for a while,” Tim Caufield, research director of the University of Alberta Health Law Institute, told Global News. “If you look at insulin, that’s a peptide.”
Peptides are naturally produced within the body, each with a different role. But scientists can also create synthetic peptides which are used to mimic the natural communications within the body’s cells.
The majority of synthetic peptide drugs are given as injections.
Peptides are pharmaceuticals and are regulated as such in Canada, but that hasn’t stopped unauthorized drugs from entering the market.
Caufield said many people are buying peptides online from wellness companies, who are claiming to have a pill or a supplement that will cure a range of ailments or conditions.
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“We’ve seen wellness people push things that we’re not even sure if they’re peptides; they’ll just use the word peptide in their product,” he said, referring to what he calls “scienceploitation.”
Some peptides are also brought in from other countries, mainly China, under the arm of research. These drugs are labelled as “not for human use,” but Caufield said that is not always a deterrent.
The concern experts have with the move to expand the sale of peptides in the U.S. is with a process known as compounding.
Compounding pharmacies mix pharmaceuticals from scratch, rather than selling a pill or medication that arrives from a manufacturer.
Many Canadians might be familiar with the term from when pharmacies during the COVID-19 pandemic manufactured supplies of children’s pain medications that were in short supply as finished products, but that pharmacies still had the core ingredients to mix for themselves.
The White House filing doesn’t give specifics of the new policy, but two people familiar with the plan told the Associated Press it is intended to allow pharmacies to temporarily compound some of the most popular peptides, including BPC-157, a chemical promoted to build muscle and heal injuries. The people spoke on condition of anonymity to discuss confidential government deliberations.
The FDA previously placed BPC-157 and more than a dozen other injectable peptides on its list of substances that are too risky to be compounded by pharmacies. Possible risks include contamination, allergic reactions and tumor growth, according to the FDA.
“Compounding is not supposed to be a way to get around regulation,” Caufield said.
There are risks and rewards to every drug but Caufield said there is greater risk when the research is slim, as it is for many peptides.
“All of these popular ones outside of GLP-1s, there’s just no good evidence to support them,” he said. “So people should be cautious, almost full stop.”
Many of the unauthorized wellness drugs are marketed based off of success in an animal study or a single clinical trial, but Caufield said this is not enough evidence to support safe human use.
“This isn’t some benign substance. A peptide has the potential to have a biological impact on the human body, it is a pharmaceutical product, so we don’t know what the long-term potential harms are,” he said.
In April, Health Canada issued a public advisory on the potential adverse consequences of unauthorized peptide drugs.
“Unauthorized drug products are illegal in Canada and have not been assessed for safety, efficacy, and quality by Health Canada,” the agency said. “They have not been demonstrated, through scientific trials, to provide the health benefits that they claim.”
Health Canada includes infections, allergic reactions and drug interactions as potential consequences of unauthorized drug use. They also said unauthorized products may contain contaminants such as solvents, heavy metals, particles of glass and plastic, or microbials.
Following the release of GLP-1s, Caufield said peptides have taken the internet by storm.
“That is a generational drug,” he said. “You don’t even see those kinds of interventions very often.”
That could be the eye catching factor that Daiva Nielsen, a professor at the school of human nutrition at McGill University, said is needed for a movement to grow on social media.
“I think it captures a lot of people’s attention, especially if people are dealing with a health issue, because people are looking for something that is equipped to help.”
Nielsen said health and wellness trends aren’t new, alluding to the groundswell of diet fad cookbooks that captivated the 90s and early 2000s. But with social media and targeted algorithms, she said digital wellness fads are reaching larger audiences.
“People tend to believe in something that they want to believe in and that can be applied to other areas of life,” she said.
Caufield said that the proven success of some peptides of GLP-1s can leverage more excitement towards unproven drugs that are promising to be effective for a range of conditions.
For that reason, Nielsen said greater media literacy is needed, not only on the role of individuals, but also on social media companies and governments to ensure that people have access to safe and proven health information.
“Digital technology has a lot of potential and there’s potential for benefit, but we’re also seeing the potential for harm and the riskiness with unsupported information being so widely accessible,” she said.
