Approving new drugs is a risky business. Despite best efforts (and frankly, some less than best efforts), newly approved drugs frequently turn out to have unexpected toxicities. One example is unexpected heart toxicity associated with the use of the common pain-killers like rofecoxib (i.e. Vioxx). Another is the surprising heart toxicity associated with the wonder… Continue reading Age of Risk: Biologicals
Author: Jonathan Kimmelman
What Will the New Year Bring?
My hope is that, with a new Presidential administration, certain research and ethics policies of the U.S. government might be revisited. One such policy is the FDA’s replacement of the Declaration of Helsinki with the International Conference on Harmonization’s Guideline for Good Clinical Practice (GCP) for foreign studies. Recall that, in May, I lamented what at… Continue reading What Will the New Year Bring?
Stems and Blossoms (part 2): Really Informed Consent
There is a strain within the clinical and bioethics community that takes a minimal view of informed consent: investigators are supposed to provide requisite information to volunteers; if research subjects fail to comprehend this information, pity for them. This view brings to mind a memorable exchange between Inspector Clouseau and a hotel clerk (Clouseau: “does… Continue reading Stems and Blossoms (part 2): Really Informed Consent
Stems and Blossoms (part 1): Justice
Shortly before I left for holiday, the International Society for Stem Cell Research (ISSCR) issued a policy paper, “Guidelines for the Clinical Translation of Stem Cells,” outlining ethical and scientific considerations for researchers designing translational trials involving stem cells (whether stem cell derived, adult, or embryonic). In my opinion, the document wins the award for… Continue reading Stems and Blossoms (part 1): Justice
GenetEx Cathedra
On December 12, the Catholic Church issued what the New York Times called “the most sweeping document on bioethical issues,” its Dignitas Personae. The document– the summary of which is available on the web– is dominated by discussion of in vitro fertilization, embyro research, and stem cells. But there is a section on gene transfer–… Continue reading GenetEx Cathedra
Soft Cells and C-Sections
The American Society of Gene Therapy is renaming itself: “American Society of Gene and Cell Therapy” (membership has yet to finalize the name change.” The European Society of Gene Therapy has already done so: “European Society of Gene and Cell Therapy.” Why is gene transfer going cellular? The publicly stated reasons are two fold. First… Continue reading Soft Cells and C-Sections
Northern Lights? Canada and the New Tricouncil Draft
Since it’s issuance in 1998, Canada’s Tricouncil Policy Statement (Canada’s policy on the ethics of human research) has had an influence on the practice of research ethics that has outsized Canada’s population. The three research councils– CIHR, NSERC, and SSHRC– are presently revising the Tricouncil, and a few days ago, a revised draft was presented… Continue reading Northern Lights? Canada and the New Tricouncil Draft
Sourgene
Heaven help those perseverant souls who pursue translational research on neurodegnerative disorders. New interventions in this area have just about the highest failure rate of any area of medical research. And last week, yet another promising strategy was shown ineffective in a phase II study. The trial in question was testing Ceregene’s gene transfer strategy… Continue reading Sourgene
In Brugge / No Compassion (Part II)
Further to the therapeutic outlook on first-in-human studies at the Brugge meeting was Adrian Thrasher’s thoughtful presentation on his own X-SCID study at Great Ormand Street Hospital. Thrasher’s study was able to restore immune function in nearly all volunteers. Recently, however, his team reported a lymphoproliferative disorder like those seen in a very similar Paris… Continue reading In Brugge / No Compassion (Part II)
No Compassion
“They say compassion is a virtue….” so sang David Byrne of the Talking Heads. But what about “Compassionate Use?” This refers to the practice of giving terminally ill patients who are otherwise ineligible for early phase clinical trials access to investigational agents. At the Brugge ESGCT meeting, Finnish researcher Akseli Hemminki described providing 125 patients compassionate… Continue reading No Compassion