Arteries Unplugged
Pfizer's is pulling the plug on a drug that it had hoped would unplug people's arteries:
Pfizer Inc. said Saturday it has cut off all clinical trials and development for a cholesterol drug that was supposed to be the star of its pipeline because of an unexpected number of deaths and cardiovascular problems in patients who used it. The world's largest drugmaker said it was told Saturday that an independent board monitoring a study for torcetrapib, a drug that raises levels of HDL, or what's commonly known as good cholesterol, recommended that the work end because of "an imbalance of mortality and cardiovascular events."
That last line is an important one. It means that people who took the drug died and/or had heart problems because of it. The pain and suffering for Pfizer can be measured in dollars and cents, cost-cutting and lost jobs:
The news is devastating to Pfizer, which had been counting on the drug to revitalize stagnant sales that have been hurt by numerous patent expirations on key products. It has said it was spending around $800 million to develop Torcetrapib. There were already concerns about the drug because a recent study showed it triggered a slight increase in blood pressure, but it was unclear if that was behind the patient deaths and cardiovascular problems. Pfizer said it is asking all clinical investigators conducting trials to warn patients to stop taking the drug immediately. However, Pfizer said the loss of the product would mean an acceleration of cost cutting measures it promised in October, which were already supposed to extend beyond the promise it made last year to slash $4 billion in expenses by 2008. Earlier this week, Pfizer said it would cut 20 percent, or 2,200 positions, from its U.S. sales force, in a move analysts said could save the company between $400 million and $500 million annually. Pfizer said at the time more details on how it would transform the company would be announced in January.
Most distressing in all of this is how the company was apparently blindsided by results of the independent monitoring board:
Pfizer's decision to end the drug's development highlights the perils of drug development and safety, which have been under a harsh spotlight since Merck & Co. withdrew pain killer Vioxx from the market two years ago. Dr. Philip Barter, chairman of the steering committee overseeing the study, said in Pfizer's release that the findings of the data safety monitoring board Torcetrapib were a surprise "in light of prior study results. We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug," said Barter, Director of the Heart Research Institute in Australia.
This suggests one of two things, neither of which is good. Perhaps Pfizer knew the drug was harmful and brought in an independent study group to give them plausible deniability and cover for the unpopular decisions which are sure to come. Or perhaps they didn't know there was such a big difference between their own results and those that outsiders would find. If so, it calls into question Pfizer's capacity for self-monitoring. With no blockbuster soon to emerge from its pipeline, let alone anything to replace best-seller Lipitor, Pfizer seems headed for a rough patch. At least they still have Viagra.
Note: in a previous version of this post I used the words "compete directly with Lipitor" when I meant to write "replace best-seller Lipitor." I regret the error.
See also: Arteries Unplugged II: Great Expectations
Disclaimer: I own no shares of Pfizer, of its competitors, or any other pharmaceutical or biotech company.