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The Anti-Aging Supplement Gold Mine

Elysium Health claims to have hit the jackpot with a pill that rejuvenates aging cells. But researchers are divided over the safest way to deliver such products to consumers.

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For more than a year, New York startup Elysium Health has been selling a pill, formulated after decades of research at a famous anti-aging lab at MIT, that claims to make our aging cells healthier, leading to better energy, sleep, and memory.

According to the company, “tens of thousands” of people have bought subscriptions of about $50 a month for a daily supply of the pill, called Basis, with the expectation that they will feel healthier even as the years fly by.

But some researchers who study aging are deeply skeptical that the compounds in the pill will have any effect at all, because there is no evidence that it works in people. The company has avoided the stringent clinical testing required of pharmaceutical drugs by selling Basis as a dietary supplement.

“If it was me personally, I would like to see some data in people before I start recommending to people that they take this compound,” Matt Kaeberlein, professor of pathology at the University of Washington, told BuzzFeed News. “It’s their reputations that are on the line if this turns out not to work.”

And yet, it may be a shrewd business strategy for any product whose ingredients happen to already be a part of our diet (one of Elysium’s is found naturally in blueberries, and another is a form of vitamin B3). By marketing its pill in the loosely regulated supplement category, the investor-backed startup has bypassed the expensive, complicated, and lengthy challenge of demonstrating age-reversal to the FDA. Elysium has also dodged the question haunting the field at large: How do you prove that a person has lived longer than they otherwise would?

In an ideal world, clinical trials of Basis would have preceded sales, Thomas Südhof, a Nobel Prize winner and one of the company’s 22 high-profile scientific advisors, told BuzzFeed News.

“But I am not sure if that is realistically financeable,” Südhof said. “People who fund companies, startups, would not want to fund having a first-trial kind of approach.”

Elysium’s leaders declined to disclose their financial backers, or how much money they have raised.

@ethanjweiss chicken and egg indeed. VCs wouldn't fund until they had revenue. Ps. I'm advisor not VC in this company.

Countless pills, creams, and tonics are already on the supplement market claiming to extend the human lifespan. But in the last few years, several prominent startups — like Calico, owned by Google's parent company, Alphabet, Craig Venter’s Human Longevity, and Elysium — have cropped up, aiming to take a more science-based approach to that goal.

“The anti-aging supplement space is nascent,” Michael Ringel, global topic lead of research and product development at Boston Consulting Group, told BuzzFeed News. “At the end of the day a success is something that actually helps patients and ties back to profits for the company.”

Those profits could be big. McKinsey & Company has estimated that the U.S. supplement market would be worth $30.8 billion by 2017. And 36% of those supplement customers will be 65 or older.

Elysium’s biggest group of customers are between the age of 40 and 60. “The Baby Boomer generation are perhaps the ones that hear the message most clearly because they are so young at heart — or maybe they notice they don’t manifest themselves physically in a way that mentally they feel they should,” Elysium CEO Eric Marcotulli told BuzzFeed News.

To answer its doubters — and to set a high bar for future competitors — in February Elysium began the first of a series of clinical trials of Basis, and expects to have results before the end of the year.

Anecdotal reports of the pill’s effects are intriguing: Elysium’s first customers report sleeping better, feeling more energized, and seeing their hair and nails grow faster, Marcotulli said.

But as the latest of a string of attempts by scientists to isolate an anti-aging molecule, all of which turned out to disappoint, Elysium will struggle to convince some visitors — at least until its clinical trials are complete.

“When I look over their site as a consumer I’m unconvinced about buying this stuff,” Richard Faragher, a professor of biogerontology at the University of Brighton in the U.K. told BuzzFeed News by email.

Pterostilbene, one of the two main ingredients in Basis, is also found in blueberries, Faragher noted. So why not just eat more of those, or buy cheaper supplements that also use it as an ingredient?

“I’m a pretty health conscious man, but before I bought Basis at $50 per month I would want hard evidence that taking [it] would be better for my health than other options for the same price,” he wrote.

The ingredients may be natural, but Elysium’s website reminds visitors of its product’s high-tech origins in the MIT lab of co-founder Leonard Guarente, who has been studying aging for more than three decades.

In the late 1990s, Guarente helped discover that a class of proteins called “sirtuins” adjust metabolism in ways that let worms and mice live longer. Sirtuins and the genes that made them, it seemed, were a handful of dominoes in a cascade of changes that took place in cells as they aged.

A few years later, David Sinclair, who worked as a post-doctoral researcher in Guarente’s lab, showed that resveratrol, a molecule found in foods such as red wine, was able to enhance the work of sirtuins in obese mice and keep them healthier for longer. Sinclair created a company, Sirtris Pharmaceuticals, to develop drugs targeted at age-related diseases like diabetes, and Guarente became one of its scientific advisors.

GlaxoSmithKline bought the company for a staggering $720 million, only to shutter the effort after trials in people failed to yield results. Although resveratrol’s role in reversing aging is still in question, a $30 million market for the compound as a supplement continues to thrive.

Guarente got another chance at commercial success when approached by Marcotulli — a Harvard Business School graduate with no scientific training — with an open-ended pitch about starting a company based on health-boosting compounds derived from food, supplements sometimes called “nutraceuticals.”

“I said, there’s a lot happening recently,” Guarente recollected. “So if there was a way to structure a company around that wisely, I think it could do very well, and it could also do good.”

One of the two ingredients in Basis, pterostilbene, is a form of resveratrol – a more effective avatar, Guarente said. The other ingredient is nicotinamide riboside, which enters the body and turns into NAD, a molecule that participates in cell metabolism. Other labs have shown that boosting NAD in aging mice helps sirtuins perform better.

“The take-home message is that NAD levels decrease with aging, and if they can be restored with precursor the old animals enjoy better health,” Guarente said.

But sirtuin studies across the board have been inconsistent. “There’s a fairly public and well-known controversy around sirtuins,” João Pedro de Magalhães, an aging researcher at the University of Liverpool in the U.K., told BuzzFeed News.

(In 2014 and in 2016, Guarente retracted two of his papers that investigated the role of sirtuins. "The two retracted papers were written by the same post-doc who assembled the images in an incorrect way, prompting me to retract the papers when I became aware of the issue," Guarente said. "Many studies over the past five years clearly validate the earlier findings that sirtuins regulate aging and dispel any controversy caused by a single contrary publication published in 2011.")

In the last decade, other labs have uncovered dozens of other anti-aging candidates — genes, cells, drugs — that have kept mice, yeast, and worms alive for much longer than usual. Kaeberlein is more convinced about evidence from other such avenues: the diabetes drug, metformin, for example, or from the immunosuppressant drug rapamycin. But those drugs, unlike resveratrol, pterostilbene, and nicotinamide riboside, are heavily regulated by the FDA.

Elysium’s first trial hopes to enroll 120 adults between the ages of 60 and 80, receiving either a regular dose, a double dose, and no dose at all. A variety of health indicators will be measured over eight weeks — such as blood pressure, heart-rate, balance — most of which Guarente expects to be tempered by Basis-activated sirtuins. The trial will also look for increased NAD levels in the blood, an indication that Basis is acting as expected.

“It’s asking a lot to see something in two months, but we’re hopeful,” Guarente said.

Despite his misgivings about the approach, Magalhães also sees the upside to launching an investor-backed startup as a fast-track to payoff. “If I discovered a drug that I was convinced could work in people, and I could sell it as a supplement, maybe I would do the same thing,” he said.

The one thing that researchers seem to agree on is this: The FDA has a blind spot when it comes to regulating drugs that affect the aging process.

Based on the biology of the molecules, said Kaeberlein of the University of Washington, “there’s no scientific reason for not regulating [Basis] and regulating other classes of molecules that the FDA regulates — there’s no justification for that.”

But how to properly design trials for anti-aging drugs is still something of a puzzle. A fundamental hurdle is that such trials could span, at the very least, the length of a person’s life.

Researchers who are testing promising life-extenders will also confront unique ethical quandaries. For example, a drug that helps some people live longer could shorten the lives of otherwise healthy others, Andrew Dillin and Celine Riera of the University of California, Berkeley, noted in a paper published in Nature Medicine last year.

But because age is the primary risk factor for major killers, including cancer, heart disease, and diabetes, the reward could be well worth the wander through the fog.

“If you retard it a little bit, like you can do in animal models already, it will have an unprecedented health and medical impact,” Magalhães said.

UPDATE

This story has been updated with comments from Guarente about his two retractions.

UPDATE

This story has been updated to clarify that Calico is now owned by Google's parent company, Alphabet.


Nidhi Subbaraman is a Science Reporter for BuzzFeed News and is based in Washington, DC.

Contact Nidhi Subbaraman at nidhi.subbaraman@buzzfeed.com.

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