Peptides, on the record

This action begins to restore regulated access and will immediately begin shifting demand away from the black market.

You're going to get a lot of charlatans, and you're going to get people who have bad results. ... Leaving the whole thing in the hands of pharma is not working for us.

If a therapy has good data, we'd like to see it.

The black market and the gray market are running amok. American consumers would be a lot better off if the FDA would allow compounding of peptides that have a demonstrated track record of safety.

Given the scale of demand - demand that is going to be met, if not by a state licensed compounding pharmacy, then by the black and gray markets - we believe the lens that the FDA is using related to these peptides is the wrong lens.

The greatest public health danger today lies not in medically supervised use, but in these unchecked black and gray markets.

This wasn't supposed to be a route for unapproved drugs to get into the market. Not even Congress was thinking that.

It would be a disruption of the societal pact we have had since 1962 that drugs will be studied to see if they work before they are marketed in the U.S.

You don't even know what you're buying inside that bottle. It could be a peptide. It could be a steroid. It could be something just like water.

Honestly, I feel bad for the FDA, because they're playing a game of Whac-a-Mole.

The reality is people are getting them, and they're getting them from very disreputable sources where they don't know what's in them. They're injecting themselves with things that are potentially dangerous.

Even if it may have anti-inflammatory properties injected into your knee ... if it causes liver failure, it's a concern, right? These types of things just have to be evaluated.

The question will be whether the FDA can follow up enough so that consumers aren't misled and more black market and shady producers don't pop up on the scene.

It is illegal for people to sell experimental therapies on the Internet for human consumption. There is nothing grey about it.

What's going on here is the advisory committee may be stacked with people who are known to have certain viewpoints on a topic rather than who are coming at this in an unconflicted and unbiased way.

Anyone who undergoes any sort of medical treatment, no matter how benign, needs to be very wary that even the most benign intervention can have fatal side effects.

The FDA's actions during the Biden administration opened up the Wild Wild West.

This is not a dozen or so things you can buy at the gym. This is a revolution in science. It's going to start a new era of drug discovery.

People should not be taking them until they're fully tested. The history of shortcuts is not a happy one.

The GLP-1 category is approaching another important inflection point, driven mainly by the launch of oral therapies and the expansion of Medicare access. These new dynamics are likely to significantly expand adoption.

This is not about me getting prizes. It's about me actually not being erased from the scientific literature.

Seeing something go from discovery to patents to approval, it's like winning a lottery.

I'm part of two experiments, not just one. I was part of the experiment that made us so much more obese. And now I'm part of the experiment that's reversing that using drugs.

There is no hiding place for those who cynically put the public's health at risk for profit. Medicines regulation isn't discretionary - it exists to protect people.

There has been a sharp rise in illegal medicines ... often sold via fraudulent websites and promoted on social media. These products are not authorised and do not meet necessary standards of quality, safety and efficacy.

As the availability of unapproved peptide products has increased, so too has evidence of potential risk to consumers.

The stable gastric pentadecapeptide BPC 157 is an anti-ulcer peptidergic agent, safe in inflammatory bowel disease trials, native and stable in human gastric juice.

BPC-157 has been unjustly accused of potentially harmful effects.