CGS-authored
Osagie Obasogie took notice when he heard about the death of Jolee Mohr, who passed away on July 24 after participating in a gene therapy trial testing a rheumatoid arthritis treatment developed by Seattle-based Targeted Genetics. As director of the project on Bioethics, Law, and Society at the Center for Genetics and Society, a nonprofit organization based in Oakland, California, and as someone who has been studying US oversight of clinical trials, he felt the need to investigate.
So he did, and in mid-August, he published a column in the Seattle Post Intelligencer highlighting possible concerns about the trial's design, in which he noted that "the institutional review board [IRB] charged with ensuring that the trials were conducted ethically is a for-profit enterprise also on Targeted Genetics' payroll." And he wasn't the only one suggesting that might be improper.
There is no hard evidence that Western Institutional Review Board, the "for-profit enterprise" that approved the trial, was remiss in its duties, and the US Food and Drug Administration (FDA) points out that IRBs handling clinical trials expected to be used...
So he did, and in mid-August, he published a column in the Seattle Post Intelligencer highlighting possible concerns about the trial's design, in which he noted that "the institutional review board [IRB] charged with ensuring that the trials were conducted ethically is a for-profit enterprise also on Targeted Genetics' payroll." And he wasn't the only one suggesting that might be improper.
There is no hard evidence that Western Institutional Review Board, the "for-profit enterprise" that approved the trial, was remiss in its duties, and the US Food and Drug Administration (FDA) points out that IRBs handling clinical trials expected to be used...