A patented double dilemma

Alternative Medicine Review, March, 2004 by Al Czap

It was midnight, and I was still searching a site for the "black box." I never thought finding something that could save numerous lives would turn into such a difficult task. The black box I was searching websites for was not of the airplane variety, but the one that should be on the package insert for prescription statin drugs. It was rumored to be on Canadian statin drug inserts, but apparently that was just a rumor.

So here is the double dilemma: Two well-written petitions for a black box warning on statins have been awaiting FDA action, one from Public Citizen (with an inadequate warning proposal), and the second from the shy and retiring Julian Whitaker, M.D. (with a warning addressing a solution for the problem). Statins (HMG CoA reductase inhibitors) can cause rhabdomyolysis, preceded by muscle pain or weakness, by blocking biosynthesis of coenzyme Q-10.

If the FDA acts on Dr. Whitaker's proposal, the agency would require a black box warning stating that all patients taking statins should also take supplemental CoQ-10. However, U.S. Patent No. 4,929,437 and No. 4,933,165 protect the patent holder's fight to supplement statin patients with CoQ-10. Dilemma number one is that the patent holder is Merck, the maker of the statins Mevacor and Zocor. Although the FDA has approved other statins, it would be faced with directing other statin manufacturers to infringe on Merck's patents. I am certain that Merck would love nothing better than to have never seen these patents, since they are not flattering to statins. Although it is not a black box warning, the Canadian Pharmacists Association, in its Compendium, states that statin administration can cause decreased CoQ-10 levels. They leave it to the physician to make the leap to supplementation of CoQ-10.

Dilemma number two is that if the FDA were to recommend supplemental CoQ-10, there would not be enough in the worldwide supply chain. All CoQ-10 is manufactured in Japan, by only five companies, and currently there is a substantial supply shortage. This is because CoQ-10 came off prescription in Japan last year and their domestic demand increased five-fold literally overnight. Based on recent evidence, researchers and practitioners in the United States have increased the recommended daily dosage of CoQ10 dramatically, which has increased its demand. Even worse, ten percent of the world production of CoQ-10 was recently purchased by a U.S. discount vitamin company and is slowly being released into their product line at a discount, to attract customers into purchasing their other products.

Consequently, the price of CoQ-10 has tripled in the last year and the effect will soon be felt in the marketplace. The largest producer (almost half the market) is attempting to add production capacity, but it is not expected to be functional until later this year. With expected manufacturing capacity to be online in Korea by next year, there may be some relief, but not if demand will even outstrip future capacity.

For the FDA it is a familiar road of "damned if you do and damned if you don't," with a patented twist thrown in. Hopefully, the FDA will make the decision that benefits the patient.