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An Educational Article on the Business of Selling Nicotinamide Riboside

Readers here probably recall the hype surrounding sirtuins in cellular metabolism, followed by the breathless marketing of compounds supposed to affect their expression such as resveratrol, all of which went to the usual destination for such things, which is to say nowhere. Some knowledge was added to the grand map of mammalian biochemistry, some people were fleeced, some people made a bunch of money on the backs of promises that never materialized, and that was that. This happens over and again. Every time a new link is uncovered in the complex chain of protein machinery relating to cellular repair mechanisms, upregulated in many of the ways to extend life in lower animals, or calorie restriction, a practice that extends life in short-lived mammals such as mice, and along the way alters near every aspect of the operation of metabolism, then the marketing begins for any supplement that can be linked, tenuously or otherwise, to that research.

If you recognize the general pattern, then you should be well placed to see how things will play out for nicotinamide riboside. This is yet another molecule that can be used as a supplement, and which influences some of the mitochondrial biochemistry associated with cellular maintenance processes. In mice it has been shown to modestly reduce some forms of age-related decline, either by spurring greater maintenance or greater stem cell activity. It is an open question as how much of this will be recapitulated in humans; short-lived species are much more readily influenced by this sort of thing. Their life spans are plastic, and so are their metabolic operations. Regardless, it is of course the case that a bunch of people got together to form a company in order to sell nicotinamide riboside as a supplement. That company is called Elysium Health.

The differences between this and past efforts of this nature are that (a) more reputable scientists from the aging research field are involved, more is the pity for their reputations, and (b) the whole affair is just a little closer to a sensible take on how to make progress in the field, rather than being an absolute money grab. In fact I agree with a fair bit of what cofounder Leonard Guarente has said in public on his motivations for doing this: that progress must be made more rapidly, that there is a space between the worthless supplement market and the highly regulated world of medicine in which good work can be done, and that it is important to put new approaches out there in the world to gather data. I just don't think that this particular approach has any merit in and of itself. Regular readers will know my position on tinkering with metabolism via drugs and found compounds in order to gain tiny and dubious benefits. It is a a waste of time and effort, and definitely not the road to meaningful outcomes in the treatment of aging. Further, even putting that to one side, the founders of Elysium haven't gone about this in the right way at all. They should have sold their product as an open trial of nicotinamide riboside wherein people pay for participation, doubled the price of the supplement, and used that extra money to collect data from participants. Instead they, as everyone is, are corrupted by the fiduciary duty that comes with running a company where the primary focus is selling a branded supplement - so now they are in the supplement business, not the science business. It should be an object lesson for the next group who are thinking of doing something like this.

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

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. It's no wonder the dietary supplement company Elysium has attracted attention in an industry not exactly known for scientific rigor. One of the main ingredients in Elysium's supplement, Basis, is a chemical called nicotinamide riboside. It has, in fact, shown promise making mice healthier. No research has shown it to be effective in humans - a fact that Elysium's cofounders will readily admit. But they're also out to prove that NR isn't just snake oil. 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. It's already touting NR's benefits for DNA repair and energy, which is perfectly legal under the Food and Drug Administration's (loose, sketchy) rules about dietary supplements. You can say almost anything you want as long as the claims aren't about specific diseases.

As others have pointed out, Elysium's supplements business is a savvy way of sidestepping the FDA's more onerous regulations around drugs. The agency doesn't 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 getting FDA approval for NR right now. It wouldn't be an anti-aging drug - again, aging isn't a disease - but would instead get approved to treat a rare, genetic disease in kids called Cockayne syndrome. 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.

Dozens of studies have sketched out a promising story: Levels of NAD decline with age. Boosting it seems to rejuvenate cells in mice. But does taking NR boost NAD levels enough to slow aging in humans? Nobody knows. Nevertheless, the mouse studies created 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 consumer 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 supplying scientists with the compound. Martens, the UC Boulder researcher, had been working with a different NAD precursor in mice when he found out about ChromaDex's NR. He reached out to the company, and they are now collaborating on a human trial that looks at NR's effect in healthy, older adults. That's independent of Elysium's trial.

Elysium is differentiating itself with Nobel prize winners and with savvy branding. Despite Elysium's pledged allegiance to scientific rigor, it is still selling a supplement unproven in humans - an expensive one, at that. Guarente told me he thought the nonhuman evidence was convincing, and he wanted to put the information out to let the customer decide. "You don't have to start now. If you want to wait, wait. We're taking it." I caught my self feeling that Elysium's 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? It's all the exact same NR made by ChromaDex. Branding is a powerful thing.

I'm very much in favor of freedom. For my money, all of medicine should be as open as this: that anyone can invest the time and money to package and sell a product, that consumers can easily find all of the research online to read up on what the scientific community has to say, and that reviewers can take that information to provide digests for those who don't want to read the research. Freedom means the existence of marginal products as well as great products, and people doing things you personally think are a waste of time as well as people doing things you agree with, but you can always identify these as such. You just have to take a little time to read around the topic before you reach for your wallet. Freedom also means a far greater set of activity and greater experimentation and availability of new approaches than would take place if all of this was hammered flat beneath the cost of regulation, and that, I think, would be worth the price of admission. Successes will prove themselves by virtue of the fact that sellers will find it worth the cost of setting up formal trials to demonstrate effectiveness, for example.

Comments

Dietary supplements are not a way of side-stepping FDA drug approval regulations. Drugs are to prevent, cure, treat disease, supplements restricted for health (yet they prevent, treat and cure disease). Would you say vitamin C is side-stepping the FDA because a maker of vitamin C tablets says it prevents or cures scurvy? That is the absurdity of the FDA. You can't even say that on a label. The drug approval process is largely confined to single synthetic patentable and often over-priced molecules. Most of the biological actions of drugs can be replicated with dietary supplements, which reveals another farce the FDA is. And how come FDA-approved drugs have so many side effects while the dietary supplements harm so few? Dietary supplements are safer than table salt, table sugar and aspirin.

Posted by: Bill Sardi at July 10th, 2016 11:57 AM

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