title: Clinical experimentation. Lessons from lung volume reduction surgery.
abstract: Although the advancement of medical science can occur only with the systematic evaluation of new interventions, novel therapies continue to be introduced and accepted prior to thorough study. The recent development of lung volume reduction surgery for emphysema provides an illustration of the unwillingness or the inability of the medical community, unconstrained by legal or reimbursement limitations, to assure the safety and efficacy of a new procedure prior to widespread utilization. Medical practitioners must learn to recognize the experimental nature of new procedures independent of the courts and third-party payers. The nature of the informed consent that must be obtained for an experimental therapy is different from that which is required for standard medical practice and this difference can provide a test of whether a new treatment is experimental. A comparison between the introduction of lung volume reduction surgery and the rigorous scrutiny required of any pharmacologic interventions for emphysema underscores the double standard that exists for evaluating new surgical (and some medical) innovations. Such a double standard cannot be defended on ethical or scientific grounds. Specific changes in the way experimental therapies are introduced and disseminated are suggested. Until all new medical and surgical interventions are required to undergo a thorough evaluation prior to becoming standard of case, the promise of evidence-based medicine can never be fulfilled.
authors.affiliation: Department of Medicine, University of Washington, Seattle, USA.
authors.forename: M R
authors.initials: MR
authors.lastname: Tonelli
authors.forename: J O
authors.initials: JO
authors.lastname: Benditt
authors.forename: R K
authors.initials: RK
authors.lastname: Albert
mesh_terms: D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D007349:Insurance, Health, Reimbursement; D008168:Lung / Q000601:surgery*; D006278:Medicare; D011656:Pulmonary Emphysema / Q000601:surgery*; D011785:Quality Assurance, Health Care; D014481:United States