The Weird Business Behind a Trendy ” Anti-Aging ” Pill

October 25, 2016

A renowned MIT aging scientist as cofounder. Not one , not two, but six Nobel prize laureates as scientific advisors. Oh, and a product that could just maybe help you stay feeling young. Its no wonder the dietary supplement company Elysium has attracted attention in an industry not exactly known for scientific rigour. And while Elysium is careful to tout cellular health rather than explicit asserts about anti-aging–the companys image is all about scientific rigor–headlines have been quicker to make the leap.

One of the main ingredients in Elysiums supplement, Basis, is a chemical called nicotinamide riboside. It has, in fact, indicated promise making mice healthier. No research has shown it to be effective in humans–a fact that Elysiums cofounders will readily acknowledge. But theyre also out to prove that NR isnt merely snake oil. Weve stressed with this company that it is going to be science-based, says Leonard Guarente, the MIT researcher who cofounded Elysium with former tech investors Eric Marcotulli and Dan Alminana.

And so Elysium is currently running a human trial to suss out the effect of NR in older adults. Not that the company is waiting for those results. Its already touting NRs benefits for DNA repair and energy, which is perfectly legal under the Food and Drug Administrations( loose, sketchy) regulations about dietary supplements. You can say almost anything you want as long as the claims arent about specific diseases.

As others have pointed out, Elysiums supplements business is a savvy route of sidestepping the FDAs more onerous regulations around drugs. The bureau doesnt even consider aging a disease. Why make a costly, time-consuming bet on FDA approval when you can start selling supplements for $50 a month right away?

But another company, ChromaDex, actually is interested in get FDA approval for NR right now. It wouldnt be an anti-aging drug–again, aging isnt a disease–but would instead get approved to treat a rare, genetic disease in kids called Cockayne syndrome which, yes, has symptoms that appear a lot like premature aging. The disease is rare enough that ChromaDex is hoping for an orphan narcotic designation, a fast track to approval for medicines is targeted at diseases that affect very few people.

The point? While ChromaDex is waiting for that approval, it makes and sells raw NR to several companies, who repackage the supplement and sell it under their own brands–including, yes, Elysium. Were food ingredients technology company, says ChromaDex CEO Frank Jaksch. ChromaDex holds patents for making NR, and it wants the ingredient to be as widely used as possible–be it in prescription drugs or dietary supplements. Elysium has attracted press because of its scientific stars, but ChromaDex is quietly blurring the boundary between narcotic and supplement.

The NAD Story

Scientists didnt think much of nicotinamide riboside–a tracing molecule in milk–until they realise the human body converted it to another molecule: nicotinamide adenine dinucleotide. NAD is vital to how cells use energy, a leading player in metabolism. Im always reluctant to say theres about to become a miracle molecule that is the next great thing, says Christopher Martens, an aging researcher at the University of Colorado Boulder, but NAD seems to be very important.

Dozens of studies have sketched out a promising tale: Levels of NAD decline with age. Boosting it seems to rejuvenate cells in mouse. But does taking NR boost NAD levels enough to slow aging in humen? Nobody knows.

Nevertheless, the mouse analyzes generated demand for stable molecules that turned into NAD in the body. In 2011, ChromaDex licensed a patent for synthesizing NR in a lab–far cheaper than trying to purify it from milk. They named the product Niagen. You can buy it from several different customer brands online, including Elysium.

To boost future demand, ChromaDex has set up 70 research agreements with universities or research institutes to study nicotinamide riboside, putting up money and furnishing scientists with the compound. Martens, the UC Boulder researcher, had been working with a different NAD precursor in mice when he found out about ChromaDexs NR. He reached out to the company, and they are now collaborating on a human trial that looks at NRs effect in healthy, older adults. Thats independent of Elysiums trial.

Meanwhile, hopes of turning NR into a drug for Cockayne syndrome rest on another research collaboration, this time with the National Institute of Health. Vilhelm Bohrs lab at the NIH analyzes aging by looking at genetic diseases like Cockayne. He too realise the importance of NAD and get in touch with ChromaDex. In mouse genetically altered to have Cockayne syndrome, NR has looked promising, he says. The group is now collecting data to submit an Investigational New Drug application to the FDA, which would allow the researchers to conduct a clinical trial for the disorder.

If the trial is approved, if the narcotic works, and if the drug is approved–which would take years–NR could be sold as a prescription drug for Cockayne syndrome and an off-the-shelf dietary supplement.

Drugs v. Supplements

Weird as that might seem, it wouldnt be the first time. In the mid 2000 s, the pharmaceutical giant GlaxoSmithKline began selling Lovaza, an excerpt from readily available fish petroleum, as an FD-Aapproved drug for high blood triglyceride levels. Marketings of the narcotic made $1.1 billion a year before generic versions of the compound came along. And of course physicians have long given out prescriptions of high dosages of vitamins and minerals.

But what stimulates NR different is that lots of factories can pump out vitamins, minerals, and fish petroleum. Only ChromaDex has the patents for making NR in the US.

Whats to stop clients from merely buying the cheaper supplement version? You can thank health insurance. If your copay is cheaper that the store price of the supplement, your selection is easy–even if the cost to the insurance company and the overall health care system is higher. So splitting the market for NR into supplements for healthy people and drugs for the sick means more ways to make money. Thats two separate marketplaces for a single product.

But thats screwed up, right? Misaligned incentives here? Im not going to disagree, says Steve Mister, chairperson and CEO of the Council for Responsible Nutrition, a dietary supplement trade association. But it is perfectly legal. Companies can continue to sell NR or fish petroleum as dietary supplements–again, as long as the supplement bottle doesnt attain asserts about specific diseases.

Getting the FDA to approve a drug for a disease is hard–but once youve done it, that same roadblock maintains out competitor. The opposite is true with dietary supplements: fewer regulations, lower barriers to entry, and a lot more competition. So you find away to differentiate yourself.

Elysiums Way

Elysium is distinguishing itself with Nobel prize wins and with savvy branding. The company buys NR and pterostilbene–a natural compound similar to resveratrol may be in red wine–from ChromaDex and repackages both as Basis, a daily dosage of pills. Lots of other companies also buy from ChromaDex and package NR in their own bottles.

But Basis by Elysium merely seems different. The other companies use cheap-looking plastic bottle. Elysiums pills come in a minimalist white jar, more reminiscent of expensive Japanese face cream than multivitamins. And you cant buy it in a drug store. Theres a quite a bit of fragmentation in this marketplace and absence of leadership, says Elysium CEO and co-founder Eric Marcotulli. There needs to be a brand and company where people say, I believe what this brand is saying. I can trust that.

To make Elysium that brand, the cofounders ran around recruiting a scientific advisory stacked with heavyweights. The list is headlined by six Nobel Prize Winners, but includes more than a dozen other scientists from Harvard, Yale, Stanford, and the Mayo Clinic. When I asked Meir Stampfer–a prof at Harvard Medical School and head of the famous long-running Nurses Health Study–how he got involved, he told me he had originally gotten a call from Marcotulli but was busy and not interested. Then he got a call from Eric Kandel, a Nobel-prize winning neuroscientist who had signed on as scientific advisor to Elysium. Hes one of my heroes. When I was in college I was supposing if I should go to graduate school and study with him, says Stampfer. He basically reassured me indeed they truly wanted to do solid work and it wasnt, you know, a fly-by-night operation. So I said, OK, Im in.

Another member of the board, David Moore , now a metabolism researcher at Baylor, told me he was recruited by Jack Szostak, another one of Elysiums Nobel prize wins. Moores and Szostaks labs were next to each other at Harvard, and Szostak knew his former colleague was interested in natural products. I dont have much to say because I havent been in much direct contact with them, Moore said when I called. Ive emailed backward and forward but nothing substantive.( Stampfer says he has been more closelyinvolved; he’s given feedbackinto the design of Elysium’s humantrial .)

Despite Elysiums pledged allegiance to scientific rigour, it is still selling a supplement unproven in humans–an expensive one, at that. Guarente told me he thought the nonhuman proof was persuading, and he wanted to put the information out to let the customer choose. You dont have to start now. If you want to wait, wait, he says. Were taking it.

Elysium does have serious scientists who have put their names to the product. And I caught my self feeling thatElysiums pills, packaged in a sleek jar and backed by so many experts, seemed more legitimate than the bottles of NR online. But then why should I? Its all the exact same NR made by ChromaDex. Branding is a powerful thing.

Bohr, the NIH scientist analyse NR for Cockayne Syndrome, told me he was uneasy with the supplements pushing. I think its a very promising thing, but dietary supplements are not controlled, he says. They dont have to go through FDA. They dont “re going to have to” do through through real interrogation.

If NR truly does end up reversing the signs of aging in humen, the FDA will decide how to regulate it–as a supplement or as a drug. Or as both, which companies looking to maximize payments from clients and insurance companies might prefer.

Read more:

About the Author

Leave a Comment: