Word: lasagnas
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Dates: during 1970-1979
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...quack cures and unsafe medicines that it is in some danger of stamping out or at least slowing the development of new drugs. The latest report is by two pharmacologists from the University of Rochester School of Medicine and Dentistry. The current laws, argue Drs. William Wardell and Louis Lasagna in a new study titled Regulation and Drug Development, are so strict that they actually inhibit the development of new drugs. As a result, American patients are not only being deprived of drugs already in use in other countries, they are also paying more for those they can obtain...
...more important result of these regulations has been to put the U.S., whose medical technology is the world's best, behind other countries, particularly Britain, in the development of new drugs. The Wardell-Lasagna study shows that of 180 new drugs introduced in the two countries in the decade beginning in 1962, a mere 21 were first made available only in the U.S. In fact, at the beginning of the decade, 77 drugs, including many that U.S. physicians now consider not only safe but effective (see box), were not authorized...
...combat this drug lag, Wardell and Lasagna urge several changes. Among them...
REALISTIC STANDARDS. The drug that is 100% safe at all dose levels has yet to be developed and probably never will be, say Wardell and Lasagna. Therefore, it is unreasonable to expect drug developers to prove that their product is totally without risk. Every drug represents a compromise between risks and potential benefits. Only when the risks clearly outweigh the benefits should a drug be forbidden...
POST-MARKET MONITORING. U.S. drug policy currently emphasizes premarket testing of drugs. It would do better to pay more attention to what happens after a drug is cleared, say Wardell and Lasagna. "When widespread drug toxicity has occurred, it has only been after a drug has been marketed, and never in the early phases of development...