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News for the week of 12-04-0206

Scrutiny of Other Heart Drugs Could Grow After Failed Trial
The New York Times, 12-4-06

Editor's Notes:

This week's biggest headlines were garnered by Pfizer's announcement that it was pulling the plug on torcetrapib, the most promising drug in its development pipeline. The news came in the midst of a 15,000 patient late–stage clinical trial for the drug in combination with Lipitor, another Pfizer product. Safety monitors suspended the trial after data showed that torcetrapib plus Lipitor caused increased deaths and heart problems compared to patients on Lipitor alone (82 deaths attributed to torcetrapib vs. 51 with Lipitor).

It is too early to determine the cause of the deaths—torcetrapib in particular, the mechanism the drug targeted, or perhaps some interaction with Lipitor—but what is clear is that it is an enormous setback for Pfizer and patients with heart disease. Pfizer had spent $800 million developing the drug and lost $20 billion in market capitalization after it announced that it was suspending clinical trials. Pfizer's setback also has important implications for other similar drugs in development by its competitors—these medicines will now face even greater regulatory scrutiny.

For the estimated tens of millions of Americans at risk for heart disease, Pfizer's announcement that it has ended its trials of torcetrapib is doubly disappointing. Not only has a highly publicized treatment been proven too dangerous, but similar drugs being from other companies will face greater scrutiny—and delays—in getting to market.

Statins like Lipitor and Zocor, which have been on the market for 20 years, have been shown to reduce low–density lipoproteins—the so–called bad cholesterol—that form plaque on the walls of arteries, inhibiting blood flow and increasing the risk of a heart attack. While useful for millions of Americans, statins only reduce cardiovascular event rates by about one–third.

"The most important thing to understand is that we have got to get beyond the limits of what we can do with statin drugs," said Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and lead investigator of an earlier torcetrapib clinical trial. "They work great, but if we put statins in the water supply, cardiovascular disease would still be the leading cause of death in most Western countries."

The next great leap in treatment was to be drugs like torcetrapib that would also increase high–density lipoproteins—the so–called good cholesterol—by more than 30 percent. Good cholesterol makes it more difficult for bad cholesterol to form plaque, which is why doctors typically express a patient's cholesterol risk as a ratio of total cholesterol to good. (Statins also increase good cholesterol, but only by about 5 percent.)

Because it still hasn't been determined what caused the health problems in the torcetrapib study, similar drugs will come under intense scrutiny. Roche, the Swiss pharmaceutical company, is developing a good cholesterol drug that is scheduled to enter the final phase of study before approval, called phase three trials. Industry analysts said last night that the Food and Drug Administration would likely now require lengthy outcome trials, spanning between three and five years.

Pfizer's catastrophe offers a window into the complex and largely opaque world of drug development, where companies take enormous financial gambles on drug candidates that—the vast majority of the time—never pan out. In short, the next time you wonder why new drugs are so expensive, take a few minutes to consider the $800 million and years of research that Pfizer lost in one afternoon.

For a more technical analysis of the issues dogging torcetrapib, see Derek Lowe's commentary on his blog In the Pipeline.

[permanent link]



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