The 1962 Kefauver-Harris amendments required affirmative, pre-market approval. Drug makers now had to demonstrate that a new medicine was effective as well as safe. These amendments fundamentally changed pharmaceutical research by increasing the costs of regulation. Research output collapsed, as measured by the number of applications to begin clinical testing for new chemical entities (NCEs).

In the 1970s, University of Chicago professor Sam Peltzman determined that NCEs introduced annually from 1963 through 1970 were only 39 percent the number from 1951 through 1962. He attributed this to the increased regulatory burden of the 1962 amendments.

In the 1980s, professors Henry Grabowski of Duke University and John Vernon, from the University of Connecticut, found that drug makers faced a serious decline of more than one half in R&D productivity from 1962 to 1975, as measured by the ratio of the number of patents to the number of R&D employees. A more subtle effect of the regulations was the reduction in competition caused by the high cost of compliance. Columbia’s Lacy Thomas found that the 1962 amendments wielded a devastating impact on small firms, including their ability to conduct R&D, thus entrenching larger firms.

The American people do not see the loss of new medicines, medical devices, or competition that result from this vast bureaucratic power. Instead they hear a ceaseless drumbeat of horror stories, of which Vioxx™ is only the latest, that deafen them to the truth about this harmful regulatory overreach. (”The Cost of a Caring Leviathan: The FDA at 100”, John R. Graham, Medical Progress Today.)

Detta är ett av otaliga exempel som tydligt illustrerar den destruktiva relationen mellan tvång och tänkande. Uttryckt i positiva termer kan man säga att denna relation visar på varför vi av strikt själviska skäl bör respektera andras rättigheter: därför att vi gagnas enormt av andra människors rationella tänkande och handlande. Det är därför det finns ett enormt värde i att leva i ett samhälle – men bara om omständigheterna är de rätta. Det vill säga endast om det är ett fritt samhälle.