додому Últimas notícias e artigos The Billion-Dollar Gamble: Selling Unapproved Gene Therapy in Tax Havens

The Billion-Dollar Gamble: Selling Unapproved Gene Therapy in Tax Havens

Longevity just went off the grid.

An injectable treatment promising to halt aging is hitting the market soon. The catch? It hasn’t been rigorously tested. It has no FDA approval. No major regulatory body says it’s safe. It’s just… out there.

Minicircle, an Austin-based firm, calls it a breakthrough. Ethicists call it reckless. They might have a point.

The Klotho Promise

The product targets klotho. Named after a Greek goddess who spins life’s thread. Scientists noticed back in the 1990s that mice lacking klotho aged like jerky—fast and ugly.

Mice engineered to produce extra klotho? They lived thirty percent longer. Old monkeys injected with it showed better memory. It sounded too good to ignore.

Humans, unfortunately, are not mice.

Klotho levels drop as we get older. Minicircle wants to fix that. They’re using minicircle DNA. Tiny rings of genetic instructions. Injected into abdominal fat. The fat cells read the code and start pumping klotho into the bloodstream. The DNA stays outside the main chromosomes. It doesn’t rewrite your genome. It just sits there, working, until it breaks down.

Up to a year of effect, they claim.

“This is the ‘move fast and block things’ mentality… but the risk is that moving fast may break people.”
— Christopher Rudge, University of Sydney

The Regulatory Loophole

Here’s the rub.

Testing drugs properly is expensive. The FDA wants proof. Minicircle estimates the price tag at $300,00+ just to apply for a trial. Then wait three years for approval.

Who wants to wait? Not Minicircle. Not their clients.

So they’re bypassing the system entirely. They’ve set up waitlists. The treatment launches in the next six months. But not in the US. Instead, fly to Honduras. Or Panama. Or the Bahamas.

These locations have what the company calls “innovation-friendly” regulations. In Próspera, Honduras, developers can pick the rules that suit their business model. It’s medicine without the guardrails.

A “proof of concept” trial already ran there. About twenty-four people. No control group. Duration: less than a year. Results? Unpublished.

Minicircle says they’re “preparing data for publication.” That’s vague. The CEO, Mac Davis, tried it himself. He reported dizziness. Time felt weird. He claims his immune system boosted up and food sensitivities vanished. Symptoms resolved. Or maybe he’s just biased? He built the machine.

New Scientist asked for the actual study data. Minicircle didn’t respond.

Too Much of a Good Thing?

We know klotho isn’t a magic bullet.

An infant once suffered a rare condition that gave her excess klotho. Result? Weak bones. Growth problems. Too much protein seems to hurt you.

Miguel Chillón in Barcelona tested a similar gene therapy in mice. The rodents lived twenty percent longer. But they also suffered anal bleeding and skin ulcers. Side effects are real.

“There have been so many things found to extend lifespan in mice that just don’t work in humans.”
— Christopher Gyngell, University of Melbourne

Gene therapy is volatile. Even controlled trials kill people. Putting this in twenty-four folks for a few months? Christopher Gyngell thinks it’s inadequate. “In five years’ time, you’ll see serious adverse effects.”

Maybe.

The Fallout Risk

This isn’t just about Minicircle’s shareholders. It’s about everyone else trying to cure aging properly.

If this goes wrong, the backlash will be nuclear.

Alex John London from Carnegie Mellon sees the danger. “If somebody goes off… and there’s a bad adverse affect, it could derail the whole field.”

The people playing by the rules spend years ensuring safety. Why? Because human biology is stubborn. Hard. Complex.

The regulations people hate aren’t just bureaucracy. They’re scar tissue.

“They’re the direct inheritance from past tragedies. And that’s easy to forget.”
— Christopher Rudge

Muscle, Money, and Bryn Johnson

This isn’t the first time Minicircle skipped the line.

Since 2022 they’ve sold another therapy. This one boosts follistatin, a protein linked to muscle growth. Again, offshore clinics. No control group.

They claim lean muscle went up by 770 grams in three months for 43 test subjects. Ages ranged from 23 to 89. No reported side effects. But was it real? Or placebo? Who knows.

Bryan Johnson. You know him. The tech billionaire obsessed with not dying. He featured in a documentary taking the follistatin shot. Cost: $25,00. He claimed a seven percent muscle increase.

If people want to be guinea pigs? Christopher Gyngell has sympathy. Sort of.

But only if they understand the risk. In this case, he doubts anyone truly does.

We’re watching a line get drawn in the sand. Silicon Valley logic applied to human cells. Fast. Unregulated. Expensive.

And the sand keeps shifting.


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