An article published in the New York Times on November 6th discussed some ethical issues pertaining to the leadership and conduction of clinical studies of one of the top military trauma surgeons. Col. John Holcomb is the head of the Army’s Institute of Surgical Research based on the campus of the Brook Army medical Center in San Antonio. He is a strong advocate of clinical trials to improve trauma care; however, research in trauma medicine can be an ethical challenge because it involves novel treatments on severely injured patients who cannot give informed consent. Holcombe’s argument in support of conducting these clinical trials is that any ethical concerns “pale in comparison to the toll that traumatic injuries take on civilians and soldiers every day.”
One of the ethical issues is regarding the use of Factor VII, which promotes clotting in severe cases of bleeding. Some physicians feel that there is a lack of data on the benefits of Factor VII use (including some evidence that it can increase risk of blood clots), however Army surgeons have aggressively treated trauma patients with it under Holcombe’s direction. A clinical trial showed that Factor VII reduced the need for transfusions in patients and showed a nonsignificant trend toward reducing mortality (N=300). A larger trial to confirm outcomes is currently underway. Defending the use of Factor VII, Holcombe was quoted as stating, “You have a drug that you know is safe from the prospective randomized controlled clinical trials, and you have to make a decision. It’s not something you can decide to talk about. It’s really yes or no. You have a lot of people bleeding to death in Iraq.”
Holcome has also been criticized for advocating and participating in an ongoing clinical study of Polyheme, an experimental blood substitute that failed in a previous clinical study. The completed study, which ran from 2003 through last year, included patients with severe traumatic injuries who could not give informed consent. 54% of patients receiving Polyheme in the study experienced severe adverse events. It is interesting to note, however, that the FDA approved the currently ongoing trial even after review of the unpublished negative data of the first trial. This seems to indicate that the current evidence supports that the potential benefits of Polyheme outweigh the risks. Per Holcombe, “We’re not irresponsible people going out and doing evil experiments on small groups of patients.”
Source: http://www.nytimes.com/2007/11/06/health/06prof.html?emc=eta1
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