Live Longer at What Cost?

A scientist is so sure his new development will make people live longer that he’s decided to skip the required FDA testing. Really?

Exciting news: We might all be able to slow aging and live longer! Even though it sounds too good to be true — and that’s a personal red flag for me — multiple credible organizations and studies are showing this to be (possibly) what is happening in their lab rats.

As reported widely, a new chemical, NR (nicotinamide riboside), has shown great promise in slowing the signs of aging and, even more importantly, staving off the diseases that are hallmarks of aging, like dementia and organ failure.

The catch? Testing it in humans will take lifetimes to prove. The FDA requires that drugs be tested in human trials to prove that they are safe and effective. Giving it to a test group of humans starting now means having to wait until past their normal lifespans to see if it works and if it’s safe. This is a drug that would be taken daily for life. Understanding the long-term impacts of NR on organs like the kidney and liver, or if it can be toxic if taken for an extended period, is not yet known.

The length of time that would be required to conduct human testing makes some scientists impatient. One MIT professor is so convinced that this is a fountain of youth — and a fountain of profit — that he has figured out a way to get around FDA approval.

What’s in a Name? How to live longer?

Rather than have the chemical be recognized as a drug and conduct clinical trials, he will call NR a “nutriceutical.” That’s a neat trick because nutraceuticals and supplements are not drugs and, therefore, no FDA approval (or safety and effectiveness testing) is needed. A chemical becomes a “drug” when a company claims it can prevent or treat a disease

Leonard Guarente is an MIT biologist who founded a company called Elysium that will sell a combination of NR and pterostilbene, named “Basis,” and call it a nutriceutical. NR is a precursor of NAD (nicotinamide adenine dinucleotide), and is a source of Vitamin B3. Pterostilbene is the primary antioxidant component of blueberries.

Ingenious? Yes, some might even say diabolical. Because there is a reason for FDA testing. NR has been tested on mice and dogs in limited quantities (the dog tests have just started). The tests are not conclusive and even if they were, drug trials often have different outcomes in human trials than seen in animal trials. That’s why human trials are required. We don’t know the short-term side effects and we definitely don’t know the long-term risks.

Elysium’s website claims pterostilbene “stimulates enzymes” and “relates to critical cellular processes.” For NR, it uses phrases like, “direct precursor to NAD+,” “NAD+ plays a crucial role in regulating core metabolic functions including cell function, DNA repair and energy production,” but never claims Basis will extend life, slow the aging of organs or stave off dementia.

There’s a Reason We Test

Marketing Basis in this way seems a blatant avoidance of the most basic and reasonable precautions. Even animal trials have not been extensive or conclusive. What is a beneficial amount of NR to take? How much would be an overdose and what happens then? The difference between helping and hurting is often how much you take of an ingredient. Even aspirin will kill you if you take too much. If you take too little, you could spend your life paying for and taking a drug with no benefit. Without testing, the company — and the MIT professor — are just guessing.

More than 2 million serious adverse drug events — meaning ER or doctor office trips — happen every year. More than 100,000 Americans die from drug reactions each year. It’s not easy to predict safety or harm, uselessness or effectiveness. That’s why new drugs cost millions of dollars before they are allowed to be used. And even then, we sometimes get it wrong. This seems like too much risk for the hope of a benefit.