THE LIFE/DEATH RATIO: Benefits and Risks in Modern Medicine

This book is an indictment of the present system of drug research, development, and regulation. It is not news that it takes millions of dollars and years of time to bring forth a new compound. It is news that some of this time-and-money investment is due to the 1962 Kefauver-Harris amendments to the Food, Drug and Cosmetics Act following the thalidomide disaster. Ross, a free lance writer for Reader's Digest and the American Cancer Society, comments that Kefauver originally was out to legislate drug pricing and patent-licensing of drug formulas. But the amendments established new requirements for safety and efficacy, which, Ross contends (and many agree) have led to a serious drug lag in the US, discouraged clinical research, raised prices, and, ironically, may not have achieved either safety or efficacy. (The rule of efficacy has kept Laetrile off the market, however.) On the whole Ross' stance is conservative, pro-pharmaceutical industry, pro-FDA, and anti-Kennedy, Congress, and other politically minded bodies who are ready to call for investigations at the drop of a saccharine tablet. One is not convinced by his arguments that the big companies are in economic straits or are as pure, honest, and safety-minded as he states. The issues of drug regulation are extremely complex and reflect social attitudes, a present climate of suspicion and malpractice suits, and a demand for instant cures and health ""delivery."" That something must be done to improve drug development is clear. Here Ross' painting of the political background, his analysis of drug-associated deaths (often it is older drugs such as digitalis which are involved), and his chapters on how other countries deal with drug testing and regulation are valuable summaries which may point the way to how we could do it better.