Pfizer ends development of key cholesterol drug

Torcetrapib had been shown to raise blood pressure in some patients but the other two compounds haven’t displayed such a side effect, according to Pfizer.

Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, said it is too soon to say whether the entire class of drugs known as CETP inhibitors is dangerous or if there was something specific to torcetrapib that caused the deaths. He said that Roche Holding AG is developing drugs of the same type, and there’s speculation that Merck & Co. is too. Merck declined to say if it had such a drug in its pipeline.

The safety concerns that doomed the cholesterol drug will lead to more U.S. scrutiny of similar medicines in development, a top Food and Drug Administration official said Monday.

“The products in development from Pfizer and other companies in the same class are going to receive more scrutiny,” Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, told reporters.

Roche spokesman Darien Wilson said its compound, slated for introduction in 2009, has not shown a risk of elevated blood pressure in clinical trials.

Pfizer was hoping to seek approval for torcetrapib in the second half of next year.

Nissen said he will examine the results of the study, and if the trial showed the drug actually increased plaque, it would indicate that there is something wrong with the way the class of drugs works.

Nissen, an outspoken critic of the pharmaceutical industry, said he doesn’t believe Pfizer will face any liability issues over the trial because it acted swiftly to tell the public and researchers about the problem. The results were unexpected because the review board examined the trial data in October and didn’t see an increase risk of death, Pfizer said.

“I have to give Pfizer credit. They did everything the right way,” Nissen said.

Analysts said that patients sign waivers, acknowledging that they are willingly participating in an experiment, which protect companies from most lawsuits. However, Fordham University School of Law professor Benjamin Zipursky said warning patients of risks doesn’t necessarily mean they can’t sue later, especially if information about the trial wasn’t adequately detailed or the company downplayed or hid any potential negative data about the drug.

Pfizer was planning to sell torcetrapib in combination with Lipitor. According to Pfizer spokesman Paul Fitzhenry, 82 patients taking the combination of torcetrapib died, compared with 51 deaths among patients taking Lipitor alone. Each arm of the study had 7,500 patients. Pfizer said the study didn’t raise any questions about Lipitor’s safety.

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