In a recent article in Science magazine, Constance Holden reports that European researchers are contemplating a revival of fetal tissue transplantation for the treatment of Parkinson’s disease. As the article recounts, fetal transplants were subjected to sham controlled studies in the late 1990s; none performed better than sham, and several caused disabling dyskinesias. So should… Continue reading Remembrance of Things Past: Fetal Tissue Transplantation and Parkinson’s Disease
Author: Jonathan Kimmelman
Disclosure in Phase 1 Cancer Trials
Followers of this blog may recall my continuing concern with the way informed consent is obtained in phase 1 trials involving patient-volunteers (typically, these patients have exhausted standard care options and enter phase 1 trials as a final shot at managing their disease). Language used by investigators in these studies is often suggestive of therapeutic… Continue reading Disclosure in Phase 1 Cancer Trials
Quack You! Medical Tourism and Stem Cells
In the September 2009 issue of Nature Biotechnology, Jane Qiu reports on a thriving trade in nonvalidated stem cell interventions for incurable illnesses (“Trading on Hope”). The article provides numerous examples of overseas clinics that cater primarily to North American and European clientele in offering pricey, unproven stem cell transplants for incurable conditions like spinal… Continue reading Quack You! Medical Tourism and Stem Cells
Accelerated Approval: Safe at Any Speed?
Drug regulatory authorities like the FDA have a mandate to protect public health by requiring and evaluating evidence of safety and efficacy before licensing new drugs for commercial sale. But for decades now, patient advocates have argued that FDA bureaucracy kills by keeping promising drugs from the IV’s of terminal patients. In response to these… Continue reading Accelerated Approval: Safe at Any Speed?
Ted Kennedy: 1932 – 2009
Ted Kennedy, who died two days ago, championed many of the issues covered in this blog, among them access to health care, funding for research, and a strong drug regulatory system. To those who care deeply about these issues, his indefatigable advocacy will be missed. Among the many landmark laws and regulations that owe their… Continue reading Ted Kennedy: 1932 – 2009
Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask
After scandals involving tainted toothpaste, poisonous pet food, adulterated milk, contaminated heparin, and counterfeit medicines, and a thriving trade in organs, one shudders to imagine how well human subjects are protected in drug studies performed in China. Apart from an occasional report in the medical literature, there is little easily accessible information about Chinese human… Continue reading Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask
Help Wanted, Part 2
So, what are some of the intriguing ethical questions of Kolata’s August 2d article? Here is one: when researchers conduct studies and ethics committees review protocols, resource allocation is an important consideration. If, as Kolata alleges, mediocre trials siphon eligible patients away from good trials, then there is a case to be made that IRBs… Continue reading Help Wanted, Part 2
Red Tape: More IRB-bashing
Slow news day, I guess, at the New York Times. In today’s paper, American Enterprise Institute scholar Sally Satel laments that “federal ethics regulations” have become “so stringent and unwieldy that the ethics oversight system often impedes the kind of careful research we should be promoting.” And the paperwork, according to Satel, is driving up… Continue reading Red Tape: More IRB-bashing
Help Wanted- For the War on Cancer
Earlier this week (Aug 2), Gina Kolata of the NYTimes ran a fascinating story about challenges recruiting patients to cancer clinical trials. The story contains interesting facts, credible claims, analysis, and unfortunately, some misleading conjectures. The problem of patient recruitment also invites some hard headed ethical analysis. First the facts. According to the article, one… Continue reading Help Wanted- For the War on Cancer
Confessions of James Wilson
It’s coming up on ten years since Jesse Gelsinger died in a gene transfer study investigating a rare hereditary liver disorder, OTC deficiency. Gelsinger’s death In two recent articles, James Wilson, who led that study, has gone public with regrets, lessons learned, and warnings. The first consists of a confessional 1- The clinical protocol is… Continue reading Confessions of James Wilson