The lowdown: The timing of the announcement could not have been more embarrassing for Pfizer. In an analysts' meeting, Pfizer executives had been bullish about the potential of its high-density lipoprotein (HDL)-cholesterol-raising drug for cardiovascular disease, torcetrapib. Two days later came the news that the company was immediately halting all trials of the treatment for safety reasons. In a 15,000-patient trial, 82 people died or suffered cardiovascular problems after taking the drug plus Lipitor (atorvastatin), compared with 51 in the group who took the statin alone. The shock waves were felt almost immediately, with US$20 billion in Pfizer's market cap wiped off within days. In the wake of the biggest trial failure in Pfizer's history, all observers were asking two big questions. The first is whether the deaths are due to the compound or the mechanism of raising HDL cholesterol. One possibility is that this could involve a blood pressure effect. In November last year, preliminary data from the trial showed that the torcetrapib/Lipitor combination increased systolic blood pressure by an average of 3–4 mmHg. All eyes will be not only on Pfizer as it tries to identify the reason for the deaths, but also on other companies developing drugs in the same cholesteryl ester transfer protein inhibitor class — including Japan Tobacco/Roche's JTT-705 and Merck's candidate drug. Another of Merck's drugs in development, MK-0524A, will also be under close scrutiny as this extended-release-niacin-based treatment also works by raising HDL cholesterol. The second major question is how will Pfizer react to this bombshell? The company faces its biggest sellers going off-patent and no obvious drugs in the late-stage pipeline that could plug the gap. The likelihood is Pfizer will enter into another burst of M&A activity as the company tries to buy in late-stage compounds. There could also be further cuts in staff. The week before the torcetrapib announcement, Pfizer said it would cut 20% of its US sales force, a move that could save more than an estimated $400 million a year. Those cuts could continue, and there are growing rumours that this could soon spread to the R&D departments.
The lowdown: Andrew von Eschenbach, the former director of the National Cancer Institute, has been the acting FDA chief since September 2005, when Lester Crawford resigned over questions about his financial dealings with companies regulated by the FDA. The nomination of von Eschenbach has faced a series of delays from Senators, who have raised concerns about issues ranging from the agency's approval decision for the Plan B emergency contraceptive pill to the Bush administration's policies on drug reimportation from Canada. Senator Charles Grassley has also been fighting for access to officials and internal documents concerning the agency's approval and post-market surveillance of the antibiotic Ketek (telithromycin; Sanofi-Aventis), which has been linked to acute liver failure and deaths. In the face of a threatened filibuster by Grassley to block the vote, the Senate took the unusual move of voting to invoke closure and end debate on the nomination. So what's in store for the FDA under von Eschenbach's leadership? In speeches leading up to the Senate confirmation, von Eschenbach has focused on the importance of emerging new technologies, in particular stressing the importance of the agency's Critical Path Initiative, and has spoken about the need to examine the drug-review process to see whether it can be streamlined and accelerated. But in what will be a pivotal 101st year for the agency, the Democratic party will have control of Congress, and will be pushing their own agenda, namely how the safety of newly approved drugs are monitored. More importantly, the Prescription Drug User Fee Act must be renewed in 2007, and the Democrats are expected to use the reauthorization of the legislation as a vehicle to push for changes at the agency.
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