Efficacy Trials Before 1962

Efficacy Trials Before 1962

There are hundreds of conditions that a given drug may be effective at treating. However, it’s impossible to know which conditions a drug may improve until it is tried by real-world patients.

Prior to the 1962 regulations, it cost a drug manufacturer an average of $74 million dollars (2020 inflation-adjusted) to develop and test a new drug for safety before bringing it to market. Once the FDA had approved it as safe, efficacy testing was performed by the third-party American Medical Association.

When all other treatments had failed, the 144,000 Physicians in the American Medical Association were allowed to offer suffering or dying patients the option of trying proven-safe treatments for which the effectiveness was not yet known.

The AMA would collect data from its 144,000 physicians members on the efficacy of different drugs for various conditions. Once it was determined which conditions a drug was or was not effective for, the results would be published in the Journal of the American Medical Association (JAMA). The AMA would only give its seal to drugs which it had determined were safe and effective for specific conditions.

The 1962 regulations made these large real-world efficacy trials illegal. Ironically, despite the fact that the new regulations were primarily focused on ensuring that drugs were effective through controlled FDA efficacy trials, they massively reduced the quantity and quality of the efficacy data that was collected for several reasons:

  1. New Trials Were Much Smaller
  2. Were Far More Expensive
  3. Participants Were Less Representative of Actual Patients
  4. They Were Run by Drug Companies with Conflicts of Interest Instead of the 3rd Party AMA

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