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Pharmaceutical R& D
Washington Times, 12-8-06

The Washington Times suggests that Democratic efforts to inflict price controls on the Medicare prescription drug benefit bodes ill for the development of safer and more effective medicines.

Winston Churchill noted, "Success is going from failure to failure without loss of enthusiasm." That's an attitude pharmaceutical and biotech firms must have to stay in business. Pfizer's experience with torcetrapib, a novel medicine that raises good cholesterol, underscores the risks of drug development. The idea of elevating cholesterol—and combining it with drugs that reduce bad cholesterol—was based on research that it could reverse atherosclerosis, the cause of nearly 500,000 deaths a year in America. The study was halted when it became clear that while the drug worked, in a small percentage of patients, more people died on the combination torcetrapib and Lipitor than on Lipitor alone. Researchers did not know which people the drug harmed. Indeed, like torcetrapib, only 8 percent of all medicines that enter clinical testing get FDA approval, and that typically occurs nearly a billion dollars and a decade later.

Most of these failures are a result of not identifying the small percentage of patients who are harmed more than helped by medicines early in the drug development process. Hence, targeting medicines is critical to advancing drug development and public health. Drug and biotech companies—many of whom are losing money—are moving in this direction at an additional cost and some risk as they attack such illnesses as Alzheimer's, cancer and Parkinson's. Pfizer has other drugs in the pipeline using this novel approach. Democrats are proposing to cut Medicare drug prices by 60 percent. The last time a Democrat (Sen. Hillary Clinton) suggested that, biotech venture capital dried up and the market value for biotech and pharma stocks dropped by half. No one can or should guarantee scientific success. But reintroducing Hillarycare as Medicare "reform" will kill the enthusiasm for failure required to sustain medical progress.

Project FDA.
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