Author: Jonathan Kimmelman

  • You are being (ethically) watched!

    In the current issue of Bulletin of the World Health Organization, authors Margaret Carrel and Stuart Rennie describe ethical challenges presented by demographic and health surveillance activities performed in low-income countries (“Demographic and Health Surveillance: Longitudinal Ethical Considerations”).  What’s the link to translational research and gene transfer? A number of issues identified in this article…

  • Stemming Medical Tourism (part 1)

    The July 17 issue of Nature reports that a patient participating in a Vienna-based cell transfer study for urinary incontinence won a lawsuit against the University Hospital in Innsbruck for not being “told… the procedure was experimental.” The case was described in an earlier post in my blog (May 27, 2008: Bladder Trouble at the…

  • Ethics, Phase 1 Trials, and the Developing World

    Under what conditions is it ethical to perform phase 1, translational clinical trials in low and middle-income countries? Together with lead author Alex John London (Carnegie Mellon, Philosophy), I attempt to answer that question in the July 5 issue of Lancet (“Justice in Translation: From Bench to Bedside in the Developing World”). The article makes…

  • Are Phase 1 Volunteers Vulnerable?

    In the January 2008 issue of Archives of Internal Medicine, an NIH team led by Christine Grady reports the results of a study (Participants in Phase 1 Oncology Research Trials: Are They Vulnerable?) surveying the demographics of patients who participate in phase 1 cancer studies. They report that these volunteers are overwhelmingly white, have pretty…

  • On Not Getting It…

    Here is the scenario: you have cancer, and your doctor has told you there is no way to treat it. But there is an experimental drug that is being offered in a phase 1 study. Your doctor asks if you’re interested. You join the study because its your best shot. You know there are likely…

  • Collins Resigns (part 2)

    Nature ran an elegiac editorial in the June 5 edition on Collins’ resignation. It provides a desiderata for future directors: “the new director will have to ensure that the implications and applications of those projects are fully explained to all concerned… genomics is now at the point where the science and technology are moving much…

  • Also at ASGT: Collins Steps Down

    Francis Collins spoke for the first time after announcing his resignation after fifteen years as director of the National Human Genome Research Institute. Collins presided over the completion of the human genome project, as well as a series of other genome sequence and other “big-science” programs like the HapMap. Attendance at Collins’ talk seemed surprisingly…

  • Also Noted: Almost Licensed

    Also noticeable at this year’s ASGT meeting was what seemed to be a larger volume of phase 2 and 3 studies. One session was devoted to “late stage” clinical trials. I did not attend this– it conflicted with sessions on immunology and cancer gene transfer. Still, one observer told me, informally, that the first gene…

  • Also Hot: Diplomatic Immunity for Vectors

    Also hot at the ASGT annual meeting: immunomodulation and gene transfer. The immune system has proven the bane of successful gene transfer (truth be told, there are other banes-like delivery). It confounds results. It causes toxicity. It stymies efficacy. It’s unpredictable. It behaves one way in some tissues-the blood- and another way in other tissues-…

  • What’s HOT: ASGT Annual Meeting

    I’ve just returned from the annual American Society of Gene Therapy Meeting.  In the next several posts, I share my impressions on the state of the field in 2008. What’s Hot? Retinal gene transfer. The buzzzzzz of the meeting was the recent promising results for the Leber’s Congenital Amaurosis study (discussed in previous posts). In…