Update on the Parexel incident

A couple of days ago, I wrote about the Phase I trial in the UK in which 6 healthy volunteers were seriously harmed by an experimental drug. At the time, I told you I didn't have enough information to know whether there had been serious ethical violations in this case.

Thanks to Blake for sending me this story by Arthur Caplan which clarifies that indeed, two of the possible concerns I spoke about were warranted. Similar substances had previously caused problems in animals and humans, and the recruitment materials made insufficient disclosure of risk.

Dr. Caplan (who, like me, is not a real doctor but a doctor of philosophy) thinks that having so much human testing done by for-profit companies is a bad idea. That's probably true although people working for non-profits may also have personal incentives -- the desire to get credit for a great discovery, for example -- to cut corners. Recent major scandals in the U.S. concerning human subjects happened at universities -- Johns Hopkins and the University of Pennsylvania. These processes need to be very open, and closely scrutinized by regulatory authorities. Just because an institution claims to have a humanitarian or public service mission doesn't mean the people who work there are all going to behave themselves.