Intended for healthcare professionals


Commentary: Will 20th century patient safeguards be reversed in the 21st century?

BMJ 2015; 350 doi: (Published 25 March 2015) Cite this as: BMJ 2015;350:h1500
  1. Gregg Gonsalves, lecturer in law, Yale University, New Haven, CT, USA,
  2. Diana Zuckerman, president, National Center for Health Research, Washington, DC, USA
  1. Correspondence to: D Zuckerman info{at}

Most physicians and patients assume that medications are proved safe and effective. This hasn’t always been the case. The US Food and Drug Administration was born out of a series of 20th century tragedies: contamination of vaccines at the turn of that century; dangerous substances found in commonly sold medicines in the 1900s; deaths of over 100 children and adults in 1937 from a sulfa drug dissolved in diethylene glycol (antifreeze); extensive birth defects caused by thalidomide in the early 1960s; and infertility and deaths caused by the Dalkon Shield intrauterine device in the 1970s.1 Those tragedies all inspired laws that strengthened the criteria used to allow medical products on the market.

Subsequently, the first effective challenge to the FDA’s growing authority came from an unlikely source: people with HIV/AIDS. In the 1980s, as people with AIDS faced certain death, they criticized the FDA’s drug approval process as too slow and unresponsive to their needs. AIDS activists pressed for expedited drug approval and making experimental therapies widely available, demonstrating at FDA headquarters, and speaking out to FDA officials, the media, and Congress. They were remarkably successful, helping shape FDA reforms, including pathways for accelerated drug approval and expanded access programs for experimental medicines.

AIDS activists quickly learnt, however, that speedier approval …

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