Heart care hurdles

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Pfizer's recent decision to terminate its 15,000-patient study of torcetrapib and abandon further development of this HDL-raising drug, while completely justified by the 60 percent increase in deaths among those taking it, casts a cloud over a whole class of cardiovascular therapeutics -- which is very bad news for millions of Americans at risk for heart disease.

The drug, which researchers hoped would spearhead a new era in therapy to further reduce the toll of the Western world's leading killer, has instead been killed itself. The loss to Pfizer shareholders -- both in immediate market losses and the absence of anticipated blockbuster profits over the next decade -- is serious, to be sure, especially coming on the heels of other recent bad news (Pfizer also faces the 2010 expiration of its patent on the world's best-selling drug, Lipitor, which earned more than $12 billion last year). But from a public health perspective, torcetrapib's failure dwarfs even these economic concerns.

Much recent research has been aimed at finding an effective drug to raise HDL ("good" cholesterol) levels and, it is hoped, thereby reduce cardiovascular risk. If the entire concept of reducing heart disease via raising levels of HDL is shown to be fruitless, physicians will be left with only the statins, which reduce LDL ("bad" cholesterol).

Although statins were wonder drugs when first introduced almost 20 years ago, safely reducing atherogenic (artery-clogging) LDL cholesterol and reducing heart risk by one-third, the numbers show heart disease still kills well more than 600,000 Americans yearly -- by far the leading cause of death.

The real question now is: Did torcetrapib's failure result from a unique toxicity or other property inherent to the drug? Or did the increase in death and adverse cardiac events come from the nature of the HDL-raising process, inhibition of the specific enzyme CETP? If the latter, several other similarly-acting drugs in the pipelines of Pfizer, Roche and Merck are doomed as well.

This sad outcome would be -- or should be -- a wake-up call to those who have demonized the pharmaceutical industry over the last few years, especially since the Vioxx recall of 2004. Even those whose raison d'etre is denouncing "greedy" companies for making "risky drugs" can't ignore the stark facts in this case: Pfizer invested almost $1 billion and 15 years of research into torcetrapib, and now neither their shareholders, nor consumers hoping to avoid (or delay) heart disease, have anything to show for it.

Some so-called "consumer watchdogs," devoted to painting Pfizer as evil, will gloat. To them I say, without this drug or others like it, many hundreds of thousands will die prematurely or require hospitalization and invasive procedures.

Those who attack drug companies either don't know or willfully ignore the fact that in addition to saving lives and relieving suffering, effective drugs reduce health-care costs for everyone. If America's drug industry is regulated and negotiated into becoming an arm of government, as some wish, and if importation allows foreign price controls into our country like a Trojan horse, our pharmaceutical innovation will come to resemble that of Europe's during the last 20 years: overly cautious, sluggish, and marked by decelerating progress. When the EU bureaucrats heeded alarmists' cries about "expensive, risky drugs" and socialized their pharmaceutical industry, the result was a reversal of the European dominance of drug discovery that had held sway since the Industrial Revolution. Europe's regulatory overreach allowed America's pharmaceutical industry to rise to dominance.

Speculation (from the expected sources) that torcetrapib's inadequacy should provoke more stringent scrutiny and regulation of future, similar drugs makes no sense whatsoever. In this case, the system worked just as it should. The decision to pull the plug was a good one, from scientific, ethical and (in the long run) business perspectives.

Pfizer's disappointment should highlight the real risks of drug R&D. Who will take such risks to develop the next generation of innovative, lifesaving drugs, other than an industry with abundant capital, intellectual resources, and the freedom to use them? Where will the next generation of innovative drugs come from? Not from Washington, and not from antibusiness activists. Only a vibrant, market-based, unfettered pharmaceutical industry can continue to provide us with a steady stream of lifesaving, cost-effective drugs.

Gilbert Ross, M.D., is the executive and medical director of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).