Wednesday, January 23, 2008

Cholesterol in the News

Cholesterol is making news. Big news.

It all precipitated from Merck and Schering-Plough's belatedly reported and somewhat disappointing outcome of an ENHANCE trial. While Zetia and Zocor in the Vytorin combo drug lowered bad cholesterol (LDL) more than Zocor alone (consistent with prior studies), no statistically significant difference was observed in modifying the plaque thickness of the carotid (neck) arteries among 720 patients with Heterozygous Familial Hypercholesterolemia, a rare genetic predisposition for about 0.2% of the population. In short, no enhancement in reducing plaque formation is seen with the ENHANCE trial.

The Wall Street took this no good news as bad news and punished both MRK and SGP stocks harshly, which lost over 20% market values in less than two weeks.

This news could not have come at a worse time when leading presidential contenders (Democrats and McCain) and major news media are training their smoking guns on the drug industry. Opposite to Merck and Schering-Plough's full page ad in today's Wall Street Journal is a critical article entitled "Pharmaceutical Industry Faces Increased Scrutiny". Quoted therein was an inflammatory remark from JAMA's editor in chief, who will publish articles "to show how they (pharma companies) manipulate the data and why we have to be cynical about them". BusinessWeek's cover story this week on Lipitor and other statins cautions, "For many people, cholesterol drugs may not do any good". Apparently, we who are in the drug industry are in a protracted uphill battle to win back our reputation of science-driven medical research.

Granted the drug industry is both science and profit-driven and has lots of soul searching and self-critique to do, the anti-pharma irrational exuberance may have under-appreciated the complexity of biomedical research which entails substantial capital investment, long cycle of drug development, and high failure rate.

Drug industry is keenly interested in finding the most valuable and profitable medicine for every major disease. To the extent of constantly evolving scientific understanding about, say, cardiovascular diseases, the drug industry tries its best, not always successfully, to correlate a particular (or a set of) biomarker effect to a clinical outcome. True, cholesterol is only one player in cardiovascular diseases. True, managing cholesterol level (bad vs. good type in LDL vs. HDL, respectively) may not have all the immediate benefits to most people. True, cholesterol drugs, like any other drug, have undesirable side effects. Still, we must live out lives according to the immediate light shone on our path. The prevailing wisdom according to the American College of Cardiology, the American Heart Association, and the National Lipid Association suggests in unison that lowering one's elevated bad cholesterol level is sound practice for one's health.

It looks like that the bad guy (cholesterol) is having a heck of a good time in this global economic downturn. Until it is tamed, the drug industry may not hitchhike with a recovering economy in the future.

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Ph.D Biochemist, Itinerant Evangelist