PHARMACEUTICAL R& D
December 8, 2006
Pfizer's recent experience with torcetrapib, a novel medicine that raises good cholesterol, underscores the risks of drug development, says the Washington Times. 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 torcetrapid study was halted when it became clear that while the drug worked in a small percentage of patients, more people died on a combination torcetrapib and Lipitor than on Lipitor alone, even though researchers did not know which people the drug harmed.
This underscores a greater problem with overall clinical testing, says the Times:
- Most 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.
- 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, compounding the problem.
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.
But that may be soon thwarted. 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.
Source: Editorial, "Pharmaceutical R&D," Washington Times, December 8, 2006.
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