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Sunday, December 01, 2002The Quinns' advocate, David Casarett, a bioethicist and geriatrics specialist at the University of Pennsylvania, is being sued by Irene Quinn. But notably absent from the lawsuit is Samuels, with whom the Quinns had grown close and who, ultimately, was the person responsible for ensuring they were fully informed and getting them to sign the consent document. The advocate, according to the article, has no financial ties to the company. His very existence was to try to avoid just the sort of misunderstanding about experimental procedures that seems to have happened here: In setting up the trial, Abiomed, the Danvers, Mass., firm that makes the AbioCor heart, took steps beyond those required to help families make informed choices about participating. The company set up a trust establishing an independent patient advocacy council to provide advocates not affiliated with any of the trial sponsors to help patients understand the informed-consent process. The advocates typically have medical training and are experienced in end-of-life issues and medical ethics. "What's new here is that a commercial organization has hired a person experienced in patient care and ethics to serve as an advocate for each patient," said Robert A. Levine, Yale University professor of medicine and bioethics. "We believe it's the most progressive practical model yet devised to protect patients in high-stakes clinical trials," said Abiomed Vice President Edward E. Berger. "We're very proud of the effort that was made by the clinical staff at Hahnemann Hospital and by the original patient advocate to assure well-informed decision making. We do intend to defend against this lawsuit very vigorously." This could be the first time that an “ethicist” was sued. What makes someone an “ethicist” anyway? Are they given some special key to the wisdom of the ages? Are they trained to know right from wrong any differently than the rest of us? Of course not. They’ve just been given a title to mark them as such, much like the Scarecrow in the Wizard of Oz gets his brains by being given a degree. Not that the advocate is necessarily guilty here. We don't know what sort of role he actually played in the consent process. Traditionally, it's the surgeon who is responsible for explaining the procedure and its risks. You have to wonder, though, if setting someone up as a secular authority on the manners of morality isn't setting him up for a fall. posted by Sydney on 12/01/2002 07:01:00 AM 0 comments 0 Comments: |
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