From snake oil to biotech breakthroughs: The business of immortality and its impact on consumers

When do discoveries stop being headlines and start being a product on the shelf available for purchase? The short answer, according to John Marchica, faculty associate in the W. P. Carey School of Business and the College of Health Solutions, is approximately 10 years. If, that is, the discovery truly has merit and can be readily applied as some kind of healthful solution.

At one time, if you heard news about a treatment that could impact aging, one could easily assume it was hype or a hoax, or both. But these days, news reporting on breakthroughs relating to anti-aging and age reversal science are a fairly regular occurrence. One such breakthrough occurred not too long ago at ASU when Professor Julian Chen in the School of Molecular Sciences uncovered a crucial step in the telomerase enzyme catalytic cycle, which can make cells immortal. This is scientifically significant and exciting to read about. But what does it really mean for those of us who would like to possibly benefit from such breakthroughs? When does this stuff stop being headlines, and start being a product on the shelf available for purchase?

The short answer, according to John Marchica, faculty associate in the W. P. Carey School of Business and the College of Health Solutions, is approximately 10 years. If, that is, the discovery truly has merit and can be readily applied as some kind of healthful solution.

“The good news is there is a well-oiled machine for getting a drug from the lab to the marketplace,” Marchica says. “If there is a there there, then we have a way to prove it out through the clinical trial process. It’s not foolproof, but it’s the best system we have.”

The route to market

The journey from lab discovery to saleable drug has three major phases, according to Marchica. It starts with testing the initial insight in limited use, which often involves animal trials such as mice models. In this phase, the drug is tested for an early assessment on efficacy and side effects.

Phase two in commercial drug development is limited trials, which involve a small number of human subjects, possibly 30 to 40 people. Limited trials allow developers to observe the efficacy of a drug in humans, as well as to dial in the proper dosage, and to identify obvious side effects.

Only after a drug has passed these first two phases of testing, does it enter double blind placebo controlled clinical trials. “Double blind” means that neither the clinician who is conducting the trial, or the subject participating in it, knows if the actual drug is being administered or if it’s a placebo. This helps ensure the reliability and objectivity of the results.

“Double blind is the gold standard of drug testing,” Marchica says. “Many new drugs fail at this point or before. In fact, drug companies would rather fail earlier instead of later, because it costs them less.”

It’s important to note that biotech innovations are patented upon discovery. That’s when the clock starts running on the 20-year span that a patent owner can control production and sale of a drug. This is often the justification drug manufacturers use for the high prices they charge. If they spend perhaps 10 years moving a drug through the development process, that leaves them only 10 more years to recoup their investment and make a profit before the patent runs out and their competitors can sell the same drug under a generic label.

A monopoly on immortality

Should there be significant breakthroughs in age-reversal drug development, some concern has been expressed that such wonder drugs would only be available on a limited basis to the very rich. But Marchica suggests that such absolute exclusives are rare in pharmaceutical development.

“When something gets discovered,” he says, “it ends up being presented at conferences and other people try to replicate it. They want to see if it’s legit and look for similar ways to skin the cat. Even if it’s a novel discovery, usually there are others to reach comparable results.”

Marchica points to the example of the hepatitis C drug, Harvoni, which was followed up by competitors’ versions about a year later, driving prices down.

Some answers are already here – but are we listening?

Another point worth making is that there are obvious steps we can all take to fight aging that cost nothing, such as not overeating, which we as a society are failing to do.

“Anti-aging drug therapies are certainly one of the holy grails of medical research,” says Marchica. “As long as we’ve been on this planet, we’ve been trying to live longer than those who came before us. But it’s ironic that we’re in this constant quest, when many answers are right there for us, and we don’t do them.”

Marchica points out that we’re not just a nation of aging people, we’re a sick nation of aging people. It’s common sense that the healthier we are, the longer we are likely to live. Unfortunately, our obesity rates and diabetes rates are significantly higher than other developed countries. “These are things we can control,” he says, “and we’re not doing a very good job of it.”     

The larger trends

The previous trend in drug development was to focus on treating major health conditions that impacted massive patient populations at relatively lower costs. This saw the creation and marketing of antibiotics, blood pressure drugs, cholesterol drugs, and diabetes drugs, which have been broadly prescribed. The current trend in pharmaceutical and biotech is developing specialty drugs, designed for a fewer number of patients, but costing much more, such as hepatitis C drugs.

Since aging is the ultimate broad-based condition – we all have it – this trend would seem to point away from anti-aging innovation. But there is another trend in effect as well, and that is one toward precision medicine based on our individual genome. It’s about creating the custom formula for each individual. And when it comes to cracking the code for curing aging, the answer might not be one miracle pill, but something more tailored to your unique makeup.

There are other reasons for optimism as well. “As a nation, we provide sick care rather than health care, and certainly that model is changing,” Marchica says. “There’s a lot more focus on prevention.”

One area of anti-aging research that has received a good amount of investment is the fight to treat Alzheimer’s and dementia. Unfortunately, according to Marchica, the results so far “have been pretty poor. There’s been a lot of investment but nothing available currently or in Phase 3 has people jumping up and down.”

Still, even in this there is room for optimism. “Right now, there’s nothing out there for true age-reversal,” says Marchica, “so there’s nothing but upside.”