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News: Weekly Archives
News for the week of 12-04-0206
Scrutiny of Other Heart Drugs Could Grow After Failed Trial
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 latestage 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 deathstorcetrapib in particular, the mechanism the drug targeted, or perhaps some interaction with Lipitorbut 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 competitorsthese 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 scrutinyand delaysin getting to market.
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 thatthe vast majority of the timenever 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.
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