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The most contentious panel at the Translational Longevity Summit?

It wasn't mine, which was about longevity practices.

It was the debate on Right to Try.

The movement aims to let people try treatments that aren't yet FDA-approved. The question that got everyone going:

Should that include healthy adults?

If you've been following peptides, this isn't abstract. People already buy unapproved products. The argument is over what legal access should look like.

As you might imagine, there were strong opinions and emotions on both sides. Read on for a look into this debate at the heart of the longevity movement.

The Right to Try panel, Translational Longevity Summit, Boston, October 9.

Take retatrutide and BPC-157. Retatrutide completed a Phase 1b trial at four US sites, in people with type 2 diabetes. For BPC-157, FDA reports no or only limited safety information for the proposed routes. These aren't the same starting point.

And a studied drug isn't the same as a vial with its name on it. FDA has warned an online seller offering retatrutide as an unapproved product, despite its "research use only" label.

Can we offer a more honest, supervised route without treating access as proof that a peptide works?

Right to Try grew out of a hard question: if you're dying and have no good options left, should you have to wait for full drug approval?

FDA already had expanded access, often called compassionate use, for serious or immediately life-threatening illness. It lets doctors seek an unapproved treatment outside a trial, with FDA and ethics review and the company's agreement.

That system is notoriously less than easy to access, however.

The federal Right to Try law arrived in 2018. It created a separate route for certain patients with life-threatening illness, without FDA review of each request. The drug must have completed Phase 1 and meet other limits; the company offering the intervention can still say no.

Now the longevity debate asks: why should you have to wait until you're that sick?

On the panel, G. Alexander "Zan" Fleming drew on his years at FDA and spoke about handling compassionate-use requests. Among the lawyers were Ian Huyett, who advocates for state-level experimental access, and Andrew Ittleman, whose practice includes FDA law and regenerative medicine.

My take from the room: everyone agreed the federal approval system needs reform. They disagreed, sometimes sharply, over how much freedom to allow while the evidence is still incomplete.

Montana removed its terminal-illness restriction in 2023. Its 2025 SB 535 added licenses for experimental treatment centers; operating rules took effect this July.

Under the state's patient requirements, you need to evaluate approved options, get a clinician's recommendation, and give informed consent, with documentation. You don't need a life-threatening illness. Its consent language includes desired health outcomes, not just disease.

A qualifying treatment must still have completed Phase 1 and meet further evidence requirements. Phase 1 is important to ensure that a product has some basic safety review.

This isn't blanket permission to sell any peptide. The treatment still has to qualify, and state rules don't erase federal ones.

Federal Right to Try still requires a life-threatening condition, exhausted approved options, and inability to join the relevant trial.

This compares illness requirements, not every condition for access.

You can refuse care your doctor recommends, provided you can make the decision. That includes choices with terrible consequences.

Steve Jobs is a painful example. My earliest oncology work focused on neuroendocrine tumors, or NETs, the family his cancer belonged to. Many pancreatic NETs grow slowly, and surgery can cure localized disease, though their course varies with grade and spread.

Walter Isaacson described Jobs's nine-month delay while he tried alternatives, followed by surgery and regret. He delayed potentially life-saving treatment. We can't know what earlier surgery would have changed for him.

But respecting a patient's choice means accepting a decision I fear could cost them their life.

Refusing care and letting a business sell an unapproved product aren't the same thing. Still, for a field built around prevention, requiring severe illness before you can try a treatment feels backwards.

A big difficulty is knowing whether the intervention actually helps. Even in someone who's gravely ill, improvement doesn't prove the treatment caused it. A healthy person who feels great after taking a peptide wouldn't know for sure if they would've felt great after doing nothing too.

Healthy adults can already join suitable trials. We're talking about access outside trials, often for a fee, which brings up some ethical questions.

The cancer comparison makes sense to me up to a point. A person may accept risks their doctor wouldn't choose for them.

But someone with progressing cancer and no good options may face a grave threat within months. A healthy person may take on years of treatment without knowing whether it helps...or perhaps hurts.

Treatment isn't free to make or deliver. I don't think a developer or clinic should have to provide it at a loss. But covering costs isn't the same as profiting from an unproven promise.

For peptides, the vial isn't the whole bill. Quality checks, clinical care, and follow-up cost money too.

Montana allows payment arrangements; insurers don't have to cover them.

Federal rules still limit charging: expanded access generally needs FDA authorization to recover limited drug costs, while federal Right to Try keeps direct-cost limits and restrictions on promotion.

Still, there are ways the manufacturers can inflate costs. Oftentimes, even an at-cost price is very expensive given the low volume.

That leaves a real fairness problem: people who can pay get options others don't.

The strongest argument against broader paid access is that it could turn Phase 1 and 2 into a commercial market. Those early trials study safety and possible benefit; completing them doesn't automatically make a treatment ready for routine use.

If a company can profit from selling a peptide after early trials, why fund larger, controlled trials that might show it doesn't work?

Trial recruitment could suffer, too. If people can buy the treatment, they may prefer that to a trial where they could get a placebo.

That's the concern about dismantling the approval system: companies could keep selling after early testing without producing the evidence needed for approval. Patients would get access, but we might never get a reliable answer about whether the treatment actually works.

On the other side, the biggest argument supporting broader Right to Try-like access is that people already buy unproven therapies (like peptides!) in gray and black markets, through clinics, online sellers, and trips abroad. Some of these products may do nothing; others cause harm, as FDA's warnings about unapproved regenerative treatments document.

So part of this debate is whether to give legal permission and a little bit of oversight to something people already do.

And a clinic's license could persuade someone who'd never buy peptides online. A license can look like proof that a treatment works, even when it isn't. Legal sales might grow the market, not just replace underground ones.

That's where the "Wild West" concern gets real. Montana has facility and review rules. If other states follow, will they copy those safeguards or try to attract clinics by asking less of them?

Right to Try is about access to an unapproved treatment. The proposed THRIVE Act, from Kitalys and the Healthspan Action Coalition, asks a different question: how could FDA approve a claim that a product helps us stay healthy across age-related diseases?

For a peptide, permission to try it and permission to claim it slows aging aren't the same.

It's still draft legislation. Its three evidence tiers range from early support for a healthspan claim to strong evidence from well-controlled studies, with duties and financial incentives to gather better evidence along the way.

That could give companies a clearer reason to study healthy aging.

How long until federal law changes? I don't have a reliable date to give you. A draft still needs a sponsor, votes, passage, and rules to put it into practice. Montana's law doesn't tell us when that will happen.

Whether we expand Right to Try or build a new approval system, I'd start with three things:

1. A real safety standard. Completed Phase 1 testing is a common starting point. It studies early safety and dosing; it isn't a certificate that a treatment is safe, works, or extends life. I'd want the evidence to fit the actual product, dose, and route, with quality checks, independent review, medical oversight, and clear rules for stopping.

2. A way to cover costs. Developers and providers shouldn't have to lose money on each treatment. Here I mean payment for real costs, not a promise that insurance will reimburse them. Prices and financial interests should be open, and the system should address unequal access by ability to pay. Cost recovery mustn't become permission to make unsupported claims.

3. A duty to advance the research. Set outcomes, follow-up, stopping rules, and the analysis plan before treatment starts. Collect data from everyone, protect their privacy, and publish harms and lack of benefit as well as good results. No selecting only the success stories.

For peptides, that means more than "I felt better." What changed, what went wrong, and what can the next study learn?

Those records can help spot risks and guide trials. They can't, on their own, tell us whether someone did better because of the treatment. Broader access should support controlled trials, not replace them.

Set the outcomes and follow-up plan before the first dose. These records support controlled trials; they don't replace them.

Where would you draw the line? I'd be curious what you think.

Hillary Lin, MD

More years. More choices.

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