Ever wondered what makes one natural health solution a dietary supplement while another is classified as a pharmaceutical drug? And what about these new terms: nutraceutical, functional food, medical food? The answers are murky and, I’m afraid, they’re about to get even murkier.
Take, for example, Lovaza, Glaxo Smith-Kline’s new blockbuster Omega-3 prescription for high triglycerides. It’s just fish oil, right? Not according to GSK. They go to great lengths to point out that “you can’t get it at a health food store” and that it’s “the only Omega-3 medication that’s FDA-approved”. Notice the use of the term medication. Of course it’s the only Omega-3 medication that’s FDA-approved. All others Omega3 supplements are... supplements.
Confused? You’re not alone. Is Lovaza any better than high-quality over-the-counter (OTC) Omega3 supplements in regards to providing quality fish oil nutrition? GSK claims proprietary purification and concentration methods make it so, but I’ve seen no research to prove it. It’s certainly more expensive; but, since it’s classified as a pharmaceutical it’s likely to be covered by insurance. So ok, depending on your co-pay it may cost you less, but your insurance company is picking up the rest of the tab and GSK is making millions.
Each one-gram capsule of Lovaza contains 465 mg of EPA and 375 mg of DHA. That’s more than you’ll find in any one softgel of an OTC product, but it’s not beyond what can be achieved by taking more than one OTC softgel per serving.
So if Lovaza is a medicine, where does that put the supplement you’ve been taking? Is that medicine too? Or does a natural product become medicine only when subjected to intense scientific manipulation that qualifies it for patent protection, thereby making it worthwhile for a drug company to spend millions on clinical research and political maneuvering to obtain FDA approval?
Don’t get me wrong—I am not comparing fish-oil Omega-3 supplements to pharmaceutical drugs and I’m not arguing that they should be classified as such just because GSK managed to do so. Such statements would certainly violate FDA policy on marketing and representation of dietary supplements. I’m simply examining an issue that is sure to be on the minds of consumers and is bound to become more of a concern in the years ahead.
Another interesting item that demonstrates this issue is the recent censure of two GSK executives for their involvement in an organization selling resveratrol supplements. The two executives came to GSK through the company’s purchase of Sirtris Pharmaceuticals, a firm founded to develop resveratrol-based pharmaceuticals.
While development of the drugs has been encouraging at times and generated lots of excitement early on, activity has slowed due to recent setbacks that included the halting of one large-scale study due to potentially harmful side-effects. Meanwhile, the market for natural resveratrol supplements has skyrocketed.
Although the organization was apparently nonprofit, it seems as though the former Sirtris execs were afraid others were making money off their basic discovery while their proprietary drugs remained off the market and mired in the big-pharma development process. So they founded an organization called the Healthy Lifespan Institute and began selling natural resveratrol online at a price of $540 for a year’s supply.
When GSK discovered their commercial activity, the two execs were forced to resign their posts at the Healthy Lifespan Institute and the organization immediately altered its website to remove the commercial sale of resveratrol. In a statement, a GSK spokesperson was careful to point out that “The two products – resveratrol and SRT501 [GSK’s drug] – are different formulations. The resveratrol is a 250 mg powder capsule. SRT 501 is a 5g liquid suspension. SRT501 is a formulation of resveratrol with higher bioavailability than the chemical alone”.
It appears that with the growth of natural health options, the positive results of clinical research on health and nutrition supplements and the increasing amount of investment in such studies, big pharma may be slowly reversing their course of attack and adopting an “if you can’t beat ‘em, join ‘em” approach.
To those of us in the supplement field, this new climate provides some sense of validation for our work. But what does it mean for the future of both dietary supplements and pharmaceuticals? More important, how will it affect our health care, our access to affordable options and our freedom as consumers?
Only time will tell, but if only I had a crystal ball . . . then again, I’ve yet to see a double-blind placebo-controlled study on clairvoyant glass orbs.