Monday, May 18, 2015

Experimental Drugs May Come to Patients with Few Other Options

Should patients with few other treatment options for serious conditions or diseases get a chance to use unproven experimental drugs if they are not part of a research study ("J & J Creates Ethics Panel to Allow Access to Experimental Drugs," CBC/Radio-Canada, May 7, 2015)? The Food and Drug Administration (FDA) takes requests for "compassionate use" unproven medicine for patients with incurable or chronic conditions, though federal law in the United States does not allow corporations to distribute unsanctioned pharmaceuticals. The newly formed approval group at Johnson & Johnson (J & J), including medical personnel, bioethicists, and "patient representatives" will decide who gets the untested drugs now instead of individual medical researchers. Personal physicians can request access to experimental drugs for their seriously ill patients through a J &  J phone number or web site.

Discussion Questions:
  1. The article goes on to state that there will be legal issues if patients experience negative or no effects from the unproven drugs. If you had to serve on the ethics board to decide whether a patient should be able to take an untested drug, what factors would you consider when making a decision? Would you give an unproven drug to someone who is terminally ill, believing that they have a very small chance to improve with any medication?
  2. Is it fair to give seriously ill people false hope with these experimental drugs? There is no mention of the cost of these untested drugs. Do you think the drug companies should make these drugs free or at low cost if users are required to report their results which would benefit the pharmaceutical industry and potentially speed up the process for getting the drugs approved?