Tuesday, April 10, 2012

Friday Sem Replacement Activity - Week of April 13th

NIH Ethics Grand Rounds

“Should Patients have Access to Experimental Treatments?”

Speaker: Ezekiel J. Emanuel, MD, PhD

April 4th 2012


The ethics grand rounds began with presenting the case: an anonymous phone call that was received by NIH from a woman with a progressive neurological disorder who was a subject in an NIH double blind placebo control trial. At the end of the study all participants would be eligible to receive the experimental treatment being studied. The study had been going on for several years and the subject’s condition was deteriorating. Because of this, she believed that had been randomized to the placebo arm of the trial. Specifically she was concerned that her condition was deteriorating so rapidly that by the time the study ended (at least one year in the future) and she was eligible for the experimental treatment it would be too late to help her. She was frightened and believed that the experimental treatment would be her last chance to the stop the progression of her disease – a belief that she said had been confirmed by her MD (not related to the study). The anonymous caller had contacted NIH prior to contacting the PI of the study. The questions raised by this case study were:

  1. Under what conditions, if any, should patients have access to experimental treatments?
  2. Who should pay for such treatments?
  3. Does someone who participates in research have a greater claim to access to experimental treatments?

One of the conclusions reached by Dr. Emanuel was that participating in a research study does not cause said subject to become entitled to experimental therapies of unproven effectiveness.

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