US drug industry faces business model threat

The decision by global drug giant Pfizer to discontinue development of torcetrapib (Marketletter December 11), a drug that was intended to treat high cholesterol levels using a novel approach, would probably have attracted a lot of comment from drug industry critics and supporters alike.

Pfizer admitted that it had spent over $800.0 million on developing torcetrapib, an intended blockbuster replacement for the soon to expire patent on the statin Lipitor (atorvastatin). As the issue of price controls for branded drugs is raised by the imminent change of party in control of the US Congress, the Food and Drug Administration ponders ways of improving the safety and speed of drug approvals. The consequences of torcetrapib's failure have become the focus of a debate about the future of pharmaceutical R&D.

Supporters of the drug industry, such as Peter Pitts, director of the New York, USA-based think-tank, the Center for Medicine in the Public Interest, note that the decision by Pfizer to walk away from an investment that is variously reported as between $800.0 million and $1.0 billion, because of safety concerns about its drug which only emerged in Phase III trials, justifies the view of the drug industry as fundamentally ethical. Mr Pitts described the decision to scrap torcetrapib as "Pfizer's Pfinest Hour," stating that, "when torcetrapib clinical trial results were presented to Pfizer chairman Jeff Kindler, he did not equivocate. Despite the financial implications, the trials were stopped immediately. Tough choice? Yes. But, more importantly, principled choice." Mr Pitts added: "it's not a principle unless it hurts to stand by it."