"While voluntary informed consent to participate in research has long been an "axiom of bioethics," in reality there has been a "process of erosion and retreat" from this principle, said Alexander Capron in the Beecher Award Lecture on December 2, 2010 in New York. Capron noted the relevance of this trend in light of President Obama's request last month that his bioethics commission examine the ethics of human subjects research."
DEPT. OF MEDICAL ETHICS
GUINEA-PIGGING by Carl Elliott
JANUARY 7, 2008
a couple excerpts:
"As it turned out, the disciplinary action was a response to the injuries or deaths of forty-six patients under Abuzzahab’s supervision. Seventeen of them had been research subjects in studies that he was conducting. These were not healthy-volunteer studies. According to the board, Abuzzahab had “enrolled psychiatrically disturbed and vulnerable patients into investigational drug studies without ensuring that they met eligibility criteria to be in the study and then kept them in the study after their conditions deteriorated.” The board had judged Abuzzahab a danger to the public and suspended his license, citing “a reckless, if not willful, disregard of the patients’ welfare.”
One case, which was reported in the Boston Globe, concerned a forty-one-year-old woman named Susan Endersbe, who had struggled for years with schizophrenia and suicidal thoughts. She had been doing well on her medication, however, until Abuzzahab enrolled her in a trial of an experimental anti-psychotic drug. In the trial, she was taken off her regular medication and became suicidal. When Abuzzahab gave her a day pass to leave the hospital unsupervised, she threw herself into the Mississippi River and drowned. In another case cited by the board, Abuzzahab had prescribed a “large supply of potentially lethal medications” to a woman with a history of substance abuse, “shortly after a serious suicide attempt.” She committed suicide by taking an overdose.
The public portion of Abuzzahab’s disciplinary file is freely available from the Minnesota licensing board, and has been posted on the Web site of Circare, a watchdog group that documents research abuse. When I ran a Google search on “Faruk Abuzzahab,” the first hit I got was a 1998 article in the Globe on his trial disasters. Yet none of this seems to have derailed Abuzzahab’s research career. Even after his suspension, the Times has reported, he continued to supervise drug trials, and to receive payments from at least a dozen drug companies. In 2003, the American Psychiatric Association awarded him a Distinguished Life Fellowship." (emphasis mine) Read more here
via Mother Jones:
The Deadly Corruption of Clinical Trials
When you risk life and limb to help test a drug, are you helping science—or Big Pharma? One patient's tragic, and telling, story.
an excerpt:
"IT'S NOT EASY TO WORK UP a good feeling about the institution that destroyed your life, which may be why Mary Weiss initially seemed a little reluctant to meet me. "You can understand my hesitation to look other than with suspicion at anyone associated with the University of Minnesota," Mary wrote to me in an email. In 2003, Mary's 26-year-old son, Dan, was enrolled against her wishes in a psychiatric drug study at the University of Minnesota, where I teach medical ethics. Less than six months later, Dan was dead. I'd learned about his death from a deeply unsettling newspaper series by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto that suggested he was coerced into a pharmaceutical-industry study from which the university stood to profit, but which provided him with inadequate care. Over the next few months, I talked to several university colleagues and administrators, trying to learn what had happened. Many of them dismissed the story as slanted and incomplete. Yet the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan's death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them." (emphasis mine) read the rest here
Guinea Pig Picture source: CavyMadness © 1999-2003 Nhan and Tammy Rao
No comments:
Post a Comment