What’s behind the trendy peptide injections being sold by influencers and allies of RFK Jr.

WASHINGTON (AP) – More Americans are injecting themselves with unapproved chemicals touted as a way to build muscle, rejuvenate skin and extend lifespans, the latest example of the nation’s fascination with health. alternative therapy and wellness hacks.

Behind the trend is rapidly increasing in popularity GLP-1 weight loss druga class of so-called peptides approved to help users quickly reduce pounds.

However, the peptides being promoted are influencercelebrities, and health guru Many are not approved for use in humans, and much of their claimed evidence is based on studies in rats and other animals. Some peptides, such as BPC-157 and TB-500, have been banned by international sports authorities. doping substance.

“None of this is proven,” says Dr. Eric Topol, a research methods expert and director of the Scripps Research Institute’s Translational Institute. “None of us have done proper clinical trials, and yet a lot of people are undergoing clinical trials. This is actually very unusual.”

Here are some who highlight the benefits of peptides: Secretary of Health Robert F. Kennedy Jr.The person who built the nationwide following among health experts, pharmaceutical companies, and Americans who are deeply skeptical of traditional medicine.

For many years food and drug administration We’re trying to police the space. Warning statement We have added more than 20 peptides to the list of ingredients that should not be manufactured by specialty pharmacies, which often custom mix formulations for clinics promoting their products.

That approach may be coming to an end.

President Kennedy vows to end ‘FDA war’ on peptides, etc. alternative treatments it is accepted by many make america healthy again movement.

Some of Kennedy’s friends fellow Among its biggest supporters is Gary Brecka, a self-proclaimed “biohacker” and “longevity expert” who sells peptide injections, patches and nasal sprays for $350 to $600 each through his website.

During an appearance on Brecka’s podcast in May, Kennedy again promised to “end the war at the FDA” on peptides. stem cells, psychedelic and other peripheral therapies.

“It’s music to my ears,” Brekka replied.

Brecka declined to be interviewed for this article.

Peptides are now part of a ‘circus’ of unproven wellness products

Peptides are essentially building blocks of more complex proteins. In the human body, peptides trigger hormones necessary for growth, metabolism, and healing.

The FDA has approved many peptides as drugs, including: insulin for diabetics It is given to children who do not naturally produce human growth hormone and who have developmental disorders caused by low hormone levels.

However, many other peptides promoted online have never been approved, making them technically illegal to sell as medicines. Under current FDA guidance, these peptides are also not eligible for the following products: mix — The process by which a pharmacy prepares a customized medication for a patient.

Nevertheless, that hasn’t stopped celebrities and influencers from promoting them.

Joe RoganFor example, we repeatedly praise BPC-157, a peptide derived from acids present in the intestines.

“I had tendinitis in my elbow, so I started using BPC-157 and it healed within two weeks,” Logan told podcast listeners last year.

He is one of the celebrity customers listed on the website of Ways 2 Well, a Texas-based company that provides peptides. stem cells, vitamin drip and other alternative treatments.

It’s all Health and longevity clinicsaid Topol, who has written about the industry.

Ways 2 Well offers a “peptide consultation” with a doctor for $99, after which the company will ship the peptide vials along with “a full kit including dosage, instructions, and syringe,” its website states.

The company’s founder, Brigham Buehler, is a former pharmaceutical sales representative. He did not respond to requests for comment.

Peptides are often promoted as a “natural” alternative to modern medicine.

Consulting executive Andrea Steinbrenner said she became interested in peptides after hearing about their benefits for “longevity, repair, anti-aging and energy” from a friend who runs a clinic outside San Diego.

In addition to daily supplements, Steinbrenner and her husband now receive monthly IV infusions at the clinic.

“I think peptides are popular right now because we are an older generation and we are looking for alternatives to modern medicine,” she said. “I absolutely believe in modern Western medicine. It’s necessary. But there are many other things in the universe that Earth provides.”

Proponents of peptides often claim that their products are safe because they are based on substances found in the body.

“Unlike synthetic drugs, peptides are recognized naturally by the body,” Brecka told his more than 2 million Instagram followers in February.

Critics say the peptides on the market are often incompletely synthesized and taken in doses far higher than any other peptide in the body, increasing the risk of allergic reactions and other harm.

Brecka sells more than six peptides, including Ipamorelin and CJC-1295. Both FDA flagged If there is a significant safety risk.

Like other peptides sold on Brecka’s website, vials of Ipamorelin are labeled “for research use only.”

Research claims are often a ploy to evade regulators

The term “research use” is pervasive throughout the peptide industry, as well as in forums where users exchange tips for purchasing, dosing, and “stacking” different drug combinations.

One Facebook group teaches its members which words to avoid. “Rather than ‘ingesting’ peptides, you’re ‘researching’ them.”

Lawyers working in the field argue that this language is an attempt to circumvent FDA regulations. The agency does not oversee chemicals that are not intended for human use.

It is often unclear whether these peptides are manufactured in U.S. pharmacies and falsely labeled for research use, or purchased from chemical manufacturers, many of which are located in China and are not subject to FDA drug quality standards.

“Research-grade peptides are going to contain junk,” says Paul Knopfler, a cell biologist at the University of California, Davis. “It will contain chemicals used in the purification process and unwanted peptide fragments.”

On platforms like TikTok, companies from China and other countries are offering to ship dozens of peptides to the United States for as little as $5 per vial.

“What’s actually in there?” Knopfler said. “If someone injects it under the skin, what do they get?”

FDA has been working on restricting peptides for years

meanwhile, COVID-19 pandemicFDA has issued more than 6 documents Warning statement A company that promotes peptides that have the power to boost immunity.

And in 2023, the agency added nearly 20 peptides to the list of substances that should not be combined due to safety risks. Dispensaries that violate this measure could face fines, legal action, or loss of their state license.

This sparked a backlash from wellness entrepreneurs and pharmacies, and a lawsuit was filed.

One of the coalition, Save Peptides, warned its supporters that “our fundamental human right to access alternative medicines using regenerated peptides is being taken away by the FDA.”

A lawsuit filed by a major compounding pharmacy alleges that regulators omitted legally required steps in adding peptides to the FDA’s list of high-risk substances. The lawsuit forced the FDA to back down, and late last year the agency agreed to convene two public meetings with outside advisers to review several peptides that had been flagged for safety risks.

In each case, experts agreed with the FDA and voted that the substances were too dangerous to synthesize.

Some in the industry disagree.

“Physicians should have every arrow in their quiver to treat disease, and FDA’s inaction is preventing them from doing so,” said Lee Rosebush, who is representing a large compounding pharmacy group and is helping bring the case against the FDA.

change may come

Under President Kennedy’s authority, the FDA recently removed many experts from its compounding advisory committees.

This could pave the way for the FDA to appoint more peptide-friendly experts who could vote to allow some drugs it had previously banned. Alternatively, the FDA could publish a list of peptides and tell pharmacies and clinics that the agency will not enforce bans on them.

For now, doctors say they are fielding more questions from patients excited about the peptide and seeking prescriptions.

“Patients should seriously ask their health care professionals: Are these drugs safe long-term?” says Dr. Anita Gupta of the Johns Hopkins University School of Medicine, who served on the FDA’s compounding committee until earlier this year. “That’s the question I would ask if I were a patient.”

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AP video journalist Javier Arciga contributed to this article from San Diego.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.