YOUTH NOW

Drowning in the Fountain of Youth

The fight over a promising longevity supplement keeps getting worse

Illustration: Benedikt Luft

TTwo companies are convinced they’ve hit the anti-aging jackpot—and you can already buy their products online. ChromaDex and Elysium Health both sell supplements, called Tru Niagen and Basis, respectively, which are readily available for around $40 a bottle. Though the product labels make vague claims about cellular optimization and better aging, what they really purport to do is restore levels of a compound called nicotinamide adenine dinucleotide, or NAD.

As people and animals grow older, NAD levels naturally decline. Some researchers reason that restoring those levels could help stave off some of the effects of aging and potentially prolong our lives. ChromaDex and Elysium Health both sell the pill form of a molecule called nicotinamide riboside—or NR for short—which has been shown to boost NAD levels. The companies are founded by distinguished scientists and backed by billionaire investors and Nobel Laureates who say they take the pills daily. They’re testing their products through clinical trials to prove the supplements provide real health benefits for a variety of conditions, from improving cognition to preventing kidney injury and more.

“The whole industry is just a promise.”

They’re also embroiled in a messy legal battle, after a once-cordial collaboration soured.

As the NAD field heats up, everyone involved has a lot to prove, not just to lawyers and courts—but to consumers. The fact that NAD-related supplements are being sold before research can determine that they’re beneficial has spurred plenty of criticism. After all, scientists don’t actually know whether boosting NAD levels has any benefits for people.

“The whole industry is just a promise,” says Eric Verdin, an aging researcher and CEO of the Buck Institute for Aging in California, who argues that when companies sell their products as supplements rather than waiting for the drug approval process (which he plans to do), it “jeopardizes serious research into determining whether they are effective or not.”

“Why fund research when you can just buy the supplement at the health food store?”

InIn 2013, David Sinclair, a geneticist at Harvard, published a high-profile paper showing that aging mice became more youthful when they were dosed with a NAD-enhancing compound. More specifically, the mice exhibited improved metabolism and better muscle tone.

Sinclair likes to quip that, without NAD, “you’d be dead in 30 seconds.” After all, NAD is involved in a number of key bodily functions, including protecting cells from stress and DNA damage.

“We believe the reason we become more susceptible to diseases as we age is in large part because our NAD levels stay low,” Sinclair says.

NAD itself is ineffective in pill form, so researchers needed to find other ingredients, or so-called precursors, like NR or another compound called NMN, to raise NAD levels in mice. At the time of Sinclair’s study, only one company was selling NR to scientists: ChromaDex.

The promise of Sinclair’s NAD study and others fueled enthusiasm for ChromaDex’s NR product, Niagen, which the company began selling in 2013 as a research ingredient to universities and other companies, eventually including Elysium. In 2012, ChromaDex had licensed patents for NR from Dartmouth College based on the work of scientist Charles Brenner, who says he was “minding my own business working on another enzyme,” when he made the important discovery that NR is naturally present in milk and acts as a NAD precursor. Worms and yeast that were given NR lived longer than those that weren’t fed the supplement. Brenner is now chief scientific adviser for ChromaDex.

“We think NR will promote healthy aging in people,” Brenner says. He adds that while “NR has a really strong safety dossier,” there remain many “big unknowns” about NAD and NR that are being investigated.

In February 2015, Elysium was founded by MIT biologist and aging expert Leonard Guarente—who was also studying NAD—and former tech investors Eric Marcotulli and Dan Alminana. “Aging research isn’t about skin creams or wrinkles or late-night infomercials,” says Marcotulli, the CEO of Elysium. “It’s about looking at something that we once thought was an inevitability and now saying, we can quantify these things and potentially intervene.”

The company soon recruited Nobel Prize winners to its board of directors and, in 2016, raised $20 million in funding. Elysium’s strategy to take its product to market was an unusual one: start selling NR to consumers now and do the science later. Today Elysium sells Basis for $40 a bottle or $50 a month.

In March 2017, ChromaDex got into the direct-to-consumer market too. Rob Fried, a former film producer and business executive with no background in science, took over as president of ChromaDex and saw huge potential in Niagen. “There were too many companies endeavoring to take advantage of ChromaDex,” Fried says. “So I suggested that we refocus as a business and channel our efforts and develop our own consumer product.”

That’s when the company launched its supplement, Tru Niagen, which it sells online and in retail stores for $39.95 a month.

Fried, now CEO, says online sales—the company’s primary distribution method—are increasing more than 25 percent per month. In August, the company reported $7.8 million in revenue for the second financial quarter, up 85 percent compared to the same period last year. Tru Niagen accounted for two-thirds of all NR-related product sales. (Elysium is a private company and hasn’t released sales or subscription numbers.)

Unlike drugs, supplements are considered safe until proven otherwise and are lightly regulated by the U.S. Food and Drug Administration (FDA). That’s how Elysium and ChromaDex started selling pills directly to consumers without conducting clinical trials (though both companies say they’re doing so anyway). Technically, supplement sellers can tout the health benefits of their pills without claiming they can cure, prevent, or treat disease. Both companies avoid explicitly saying their pills have anti-aging properties though. Instead, ChromaDex says its product, Tru Niagen, can “energize your cells” and “increase cellular metabolism.” Elysium boasts that its formulation, Basis, which combines NR with pterostilbene, a compound found in blueberries, “works to support the health of each and every one of your cells.”

A trial in 120 adults conducted by Elysium showed that its product Basis could increase NAD levels. Those results were published last year. Another study, published earlier this year by researchers at the University of Colorado and funded by ChromaDex, found that NR was safe to take in high doses for six weeks.

Both ChromaDex and Elysium are planning more human trials. Elysium is launching a study in 2019 that will investigate the effects of its Basis product on what’s known as photoaging: the premature aging of skin caused by repeated exposure to UV rays. Another trial, scheduled for early next year, will be what the company is calling a “wellness” study, looking at the impact of Basis on sleep and energy levels, says Elysium CEO Marcotulli.

Much of the supplement industry runs on preliminary results in rodents that have no relevance for that ingredient in human health.”

ChromaDex is also launching a handful of clinical trials to assess the effects of Tru Niagen, including on cognition in older people and nerve damage from chemotherapy in breast cancer patients.

A trial that would definitively show that NR can extend human lives would require that researchers follow people for decades. Instead of studying whether supplements can extend our lifespans, researchers have shifted to talking about the buzzword “health span,” or quality of life as we age. At least 18 clinical trials of NR—by ChromaDex, Elysium, and a handful of universities—are either starting soon or ongoing for conditions ranging from heart failure to mild cognitive impairment, according to Clinicaltrials.gov, a government-run registry for human medical studies.

ChromaDex and Elysium aren’t the only companies interested in NAD. Several biotech firms are investigating drug-based approaches. In August, Verdin launched Napa Therapeutics, which he says will use artificial intelligence to identify potential drug candidates to target NAD. One of Sinclair’s companies, MetroBiotech, is developing a drug to boost NAD and mimic the effects of exercise. And Jeff Milbrant, a geneticist at Washington University in St. Louis, has started a company called Disarm Therapeutics that plans to find drugs that would preserve a person’s NAD levels after nerve damage.

Verdin thinks his approach is better than putting out a supplement. “Typically when the supplement industry sells something, they’re not really interested in testing whether it works or not, ” he says.

The Breakup

After Elysium launched, the company became ChromaDex’s biggest customer, buying the ingredients to make its Basis product until 2016. Then the relationship imploded.

In December 2016, ChromaDex filed a lawsuit alleging, among other things, that Elysium failed to pay them for nearly $3 million worth of ingredients. Elysium filed counterclaims alleging that ChromaDex violated an agreement to give Elysium the best pricing on NR and that only Elysium could sell a combination of NR and pterostilbene or similar ingredients.

Elysium stopped ordering from ChromaDex in mid-2016 and started buying NR from a different supplier.

The bad blood between the two companies got even worse in July 2017, when Elysium filed a petition to the U.S. Patent and Trademark Office (USPTO), asking the agency to determine whether two of ChromaDex’s NR patents were valid. Elysium argued that NR was an obvious invention and shouldn’t be patentable.

In August 2017, ChromaDex filed what’s known as a citizen petition to the FDA, alleging that it tested Elysium’s Basis pills and discovered that they were contaminated with a chemical found in paint and fingernail polish. Elysium shot back in September 2017 with a lawsuit accusing ChromaDex of “false advertising,” “trade libel,” “deceptive business practices,” and “tortious interference.” ChromaDex’s motion to dismiss those allegations is currently pending before the court.

ChromaDex followed up two months later with a $200 million lawsuit against Elysium for “false advertising,” “unfair competition,” “deceptive trade practices,” and “tortious interference with prospective economic advantage.” In the lawsuit, the company alleges that “Elysium’s marketing falsely ‘borrows’ ChromaDex’s research and regulatory achievements to endorse Elysium’s new product.” Elysium’s move to dismiss that case is also pending.

In a win for ChromaDex, the USPTO’s Patent Trial and Appeal Board in January denied Elysium’s request to invalidate one of Chromadex’s patents. The board has set a trial date in October to examine the other one.

In March, Elysium filed new claims against ChromaDex, alleging ChromaDex had lied about the quality of the Niagen it sold and concealed that the Niagen was contaminated.

Chromadex upped the ante this September (yes, again) when the company announced another lawsuit against Elysium, this time with Dartmouth College, alleging patent infringement. The various lawsuits could take years to resolve.

In a statement provided to Medium, Elysium says, “Our dispute with ChromaDex has at its core ChromaDex’s pattern, beginning at the very outset of our relationship, of concealing from us that it was not selling us what it promised on the terms it promised.”

ChromaDex says, through a statement, that the company has “confidence in the validity of the licensed patents and in the strength of our intellectual property.”

The Way Forward

Though the companies have a lot at stake, scientists say their infighting is unlikely to harm the greater field of NAD-related aging research, though it could create confusion among consumers.

“Much of the supplement industry runs on preliminary results in rodents that have no relevance for that ingredient in human health,” says Lenny Teytelman, a geneticist and early critic of Elysium, who penned an open letter to the company’s scientific advisory board in 2016. “But it has not killed trust in basic or clinical research.”

Even if restoring NAD levels ends up being important in age-related diseases, it’s not known how big an increase would be needed and if supplements would be enough to do it. It could be years before ChromaDex and Elysium publish data about whether NR affects any of the conditions they’re studying it for.

For customers, these ambitious trials might not matter. Studies have shown that many vitamins and supplements don’t provide any health benefits, but people still buy them, and the market for such products keeps growing. The compound resveratrol, which is found in red wine, had not long ago been hailed as an anti-aging elixir. Whether it provides any health benefits in people still isn’t known, but resveratrol supplements continue to be sold online and in drug stores.

There’s no denying that NAD is a promising area of research for a spectrum of medical conditions associated with aging. But it doesn’t mean a pill to solve aging is coming to a pharmacy shelf near you anytime soon.

Former staff writer at Medium, where I covered biotech, genetics, and Covid-19 for OneZero, Future Human, Elemental, and the Coronavirus Blog.

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