Weighing True Cost Of Delays In The Drug-Approval Process

Investors.com ^ | November 4, 2009 | THOMAS SOWELL

[Kaslin]

This is the seventh installment of a nine-part series excerpting the chapter on medical care from the new edition of economist Thomas Sowell's "Applied Economics." All parts of the series can be seen at IBDeditorials.com.

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It is illegal for a pharmaceutical company to begin selling a drug without prior approval by the Food and Drug Administration. The drug-approval process tries to reduce the risks of new and untried medicines before they are made available to the general public.

In addition to being reasonably safe for most people, pharmaceutical drugs must also be shown to be effective for whatever medical conditions they are intended to treat.

A medicine that is safe but ineffective is not only a fraud but a danger, as it may be used for diseases and conditions for which there are alternative treatments that are in fact effective, thereby depriving sick people of benefits that are already available, and perhaps costing them their lives.

Yet the question of how safe and how effective, and at what cost, must be considered as regards the years of tests and trials prescribed by the FDA's drug-approval process.

The more years that the trials go on and the larger the number of people in the sample taking the drug, the more reliable the end results as to both safety and effectiveness — and the more sick people will be left to suffer and perhaps die while these processes go on.

[Kaslin]