The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients.
The proposed Bill S.1956 is a bad law. Wide early access to minimally tested treatments cannot be expected to lead to better or more compassionate care of the seriously ill patient. The long history of medicine is replete with treatments that initially seemed promising to patients, doctors, and especially to their own inventors, but which careful study revealed to be worthless or harmful. We understand the desperate plight of these patients and the importance of hope for them and their families. However, although the proposed law is portrayed as an effort to help patients in desperate need of treatment, in fact its effect would be to undermine the system of scientifically valid testing of new drugs that has been a bulwark of health care for several decades. The effect of the law would be to provide many more possible choices of treatment but much less information upon which to make the choice. Patients would be very unlikely to end up receiving an effective treatment. They would be much more likely to receive useless or possibly harmful treatments in the last days of their lives. The Society for Clinical Trials strongly opposes this legislation.
D002986:Clinical Trials as Topic; D016638:Critical Illness / Q000628:therapy*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence*; D012955:Societies, Medical; D035703:Therapies, Investigational / Q000706:statistics & numerical data*; D014481:United States