Prescription Drug Industry Needs New Drug Development Model, Experts Say

The AP/Newark Star-Ledger on Monday examined how some pharmaceutical companies are beginning to pursue less expensive methods to develop new products. According to AP/Star-Ledger, drug companies "have long justified the high prices they charge for new medicines by citing the staggering sums they must spend in the search for breakthrough discoveries." However, experts say that Pfizer's recent decision to abandon the development of cholesterol drug torcetrapib "after spending $800 million on its development suggests that this economic model may no longer be viable," the AP/Star-Ledger reports. In an effort to improve their performance, drug companies are increasingly focusing on treatments for niche diseases with small patient populations that require small drug trials. Companies are also creating tools that streamline drug development and are beginning to use biomarkers -- cellular signals that can indicate whether a drug will be effective in treating certain patients -- to select appropriate study enrollees in an effort to make clinical trials more efficient. Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, said, "It is a tough time in the industry right now. Almost every company is having pipeline problems. There has been no systematic change in the way companies bring products to market." Steven Nissen, a cardiologist at the Cleveland Clinic, said, "There is no low-hanging fruit anymore. Companies are reaching farther than ever" (Agovino, AP/Newark Star-Ledger, 12/11).