Want To Sell An Anti-Aging Pill With No Human Testing? Make It A Supplement


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.

— Bijan Salehizadeh (@bijans)

ID: 8735675

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.

View this image ›

Eric Marcotulli, CEO, Dan
Alminana, COO, and Leonard Guarente. Elysium
Health

ID: 8735569

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.

ID: 8745181

UPDATE

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

ID: 8738473



Source link