Pfizer Stirs Concern With Plans to Sell Heart Drugs Only as Pair

By ALEX BERENSON

Published: March 7, 2005

 A drug that could be one of the most promising new heart treatments in a decade is generating controversy even before it is approved, because its maker, Pfizer, plans to sell it only in combination with the company's best-selling cholesterol treatment, Lipitor.

At a cardiology conference in Orlando, Fla., today, researchers sponsored by Pfizer are expected to present positive new results about the drug, which has been shown in preliminary studies to substantially raise levels of what is known as good cholesterol, a novel approach to preventing heart disease.

The new drug, called torcetrapib, still must clear many hurdles before it is approved, including concerns that it may raise blood pressure, a serious side effect for a heart medicine. It would not reach the market before 2007, at the earliest. Still, scientists say the medicine could be an important new treatment, while Wall Street views its success as crucial for the future of Pfizer, the world's largest drug company.

Pfizer's critics, who include prominent cardiologists, say the company should offer torcetrapib as a stand-alone pill, so that patients can take it either with Lipitor or with similar drugs not from Pfizer that may work better for them. For some patients, torcetrapib might even work best by itself, they say.

The company says that selling torcetrapib and Lipitor in one pill makes sense because the two drugs work in complementary ways, and that it has the right to market its medicines as it sees fit, especially given the huge cost of developing torcetrapib.

The existing cholesterol drugs, called statins, work by cutting so-called bad cholesterol, which can cause fatty plaques to build up in the arteries and lead to heart attacks. In contrast, the good cholesterol that torcetrapib increases may actually stop the buildup of plaque.

"That's an unfortunate decision on Pfizer's part," said Dr. Michael Crawford, the chief of clinical cardiology at the University of California, San Francisco, referring to the company's decision to only sell the drug in combination with Lipitor. "It's not going to sit well with people. But, you know, they're going to be just crying all the way to the bank."

Dr. Crawford said that he thought Pfizer was combining the drugs mainly to protect Lipitor from competition. Lipitor, which loses its patent protection in 2010, is the world's top-selling medicine, with sales of almost $11 billion last year.

Pfizer also says it has worked closely with the Food and Drug Administration to design its clinical trials, on which the company is spending $800 million in tests involving 25,000 patients. In the tests, Pfizer is examining whether the torcetrapib-Lipitor combination reduces heart disease more effectively than Lipitor alone. A spokeswoman for the F.D.A. said the agency had a policy of never discussing drugs that have not been approved.

But authorities on drug development say that the F.D.A. may have no choice but to approve a combination treatment if it proves more effective at preventing heart disease than Lipitor by itself.

When the F.D.A. reviews a new medicine, its main concerns are safety and efficacy. The agency has little authority over the cost of new drugs or ability to encourage competition among drug companies.

If further trial results are promising, Pfizer could apply for federal approval to sell the drug by late 2006, although analysts say an application in 2007 is more likely. Other companies are working on similar drugs, but Pfizer is many years ahead, the analysts said.

"We're talking about a combination of molecules that could have a great effect," said Dr. John L. LaMattina, the president of Pfizer's worldwide research and development division. Dr. LaMattina said he believed patients and doctors should be happy to use torcetrapib with Lipitor, which some studies have shown to be the most effective statin.

Pfizer has tested torcetrapib on its own in small trials, including the ones to be presented today in Orlando. According to an abstract of that presentation, which was posted on a Web site about the conference, the studies showed similar results for both torcetrapib alone and for the torcetrapib-Lipitor combination.