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Should terminally ill patients have the right to take drugs that pass phase I testing? No

BMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39245.429525.AD (Published 06 September 2007) Cite this as: BMJ 2007;335:479
  1. Dean Gesme, community medical oncologist
  1. Minnesota Oncology Hematology Professional Association, 800 East 28th Street, Minneapolis, MN 55407-3799, USA
  1. dean.gesme{at}usoncology.com

    The United States is considering allowing experimental drugs to be given to people at the end of life. Emil J Freireich believes patients should be able to judge the risks for themselves, and Dean Gesme counters that use o such drugs outside trials will damage both individuals and science

    Partially tested therapies cannot be allowed to substitute for good medical care. Hippocrates stated that our role as doctors is always to help or, at least, to do no harm. Those precepts apply equally to patients with minor ailments and those with terminal conditions.

    In the United States, the Food and Drug Administration has proposed expanded access to investigational drugs for patients with terminal illnesses after initial safety (phase I) trials but before final approval for marketing.1 This would apply to selected drugs already in phase II and III testing. The much publicised legal action filed against the FDA by the Abigail Alliance also seeks to make available drugs for which phase I safety data are known.2 The US Supreme Court is yet …

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