According to an article appearing today in the New England Journal of Medicine, the end of 2011 marked the fiftieth anniversary of the withdrawal of the controversial drug, thalidomide, from most worldwide markets. For anyone interested in the role of federal regulation of consumer/professional products, the thalidomide story is one well worth remembering.
In 1961 the same debates about intrusive federal regulations were raging that we hear today. One debate at the time was whether a federal agency, the Federal Drug Administration, should have the authority to set standards for whether a drug should be registered based on health and safety standards set by the government. Physicians, the argument ran, should be the final arbiters about whether a drug should be available. About this time, a rookie medical review officer in the FDA made the decision to deny registration to a drug with the trade name Kevadon, based on the scanty human safety data available at the time. As a result, Americans were largely spared the large number of thalidomide babies that were being born to women in Europe and other developed countries. By the time doctors raised the alarm, over 10,000 were born withsevere limb-reduction defects, in some cases with hands or feet emerging directly from their torsos.
The story got me thinking about the value of regulatory standards and the role of government as a, supposedly, unbiased gatekeeper for drugs or pesticides or allowable pollutants. Although we don't always agree with the governing authorities, I, for one, am grateful that someone is looking out for my welfare through science-based standards. And let's hope we never have to relearn the lesson of thalidomide.