At a recent meeting of the American Association for Cancer Research, a Duke University oncologist warned that emphasis on comparative effectiveness research for new drugs may impede cancer research.
By implementing a policy requiring a comparative effectiveness standard -- in which the most effective or cost-effective drug would gain market exclusivity -- the first drug into the market for any condition would basically be granted monopoly status, says Dr. Ross. In addition to the onerous requirements of safety and effectiveness testing, trying to prove that a new drug is better than an extant drug is such a financially risky proposition that pharmaceutical companies will be less likely to invest the billions of dollars required to research and develop new drugs, further stifling innovation.
Stier adds, We know from empirical data that newer drugs tend to be more effective and safer than older drugs. But having to prove that they'll be more effective introduces a new financial risk to the already risky proposition of drug development. The current regulatory scheme is skewed towards trying to almost completely eliminate risk, but regulators don t realize what they're doing will have negative health consequences. By forcing the makers of new drugs to show they are better than the ones already on the market, they're creating yet another disincentive to invest in developing newer and better drugs. It s a typical example of the unintended consequences of strict government regulation.