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Thomas E. Radecki, M.D., J.D. 566 S. Third Ave. Clarion , PA 16214 (814) 226-9545 ; (814) 298-1130 (pager); (217) 417-4557 (cell)
December 24, 2005 Chief Executive Sharp Mary Birch Hospital 3003 Health Center Drive Dear Sir: I noted in a recent article (Anesth Analg 2005 Apr;100(4):1065-74) that your hospital is listed as the affiliation of the lead author, Dr. Gambling. I presume this means that part of the DepoDur study of lower abdominal surgery was conducted at your institution and that you have an independent (hopefully) ethics board which is charged with reviewing research before it is conducted in your institution. This particular study appears to be unethical in that it did not include any non-narcotic comparator. The study appears to have been a great favor to the narcotic manufacturer Endo Pharmaceuticals since it was primarily a dosage study involving 541 patients having lower abdominal surgery. Patients were divided into six groups and five of the groups were given differing doses of DepoDur while the sixth group received morphine. There are dozens of studies comparing the use of a narcotic with a non-narcotic pain reliever in various types of surgery, of which I have found four covering abdominal surgery. In all four of those studies, the non-narcotic did as well at relieving pain as the narcotic and in two the side-effects were greater with the narcotic. Indeed, in the studies I have found comparing narcotics to non-narcotics in surgery, it is more common for the non-narcotic be significantly more effective at relieving pain than the non-narcotic (14 out of 41 studies I have tabulated so far favored the non-narcotic and 2 of 41 favored the narcotic and no difference in effectiveness in the rest although in many the narcotic caused more side-effects). Did your ethics board even consider the issue of including a non-narcotic control? Obviously, it is in the financial interests of Endo Pharmaceuticals to avoid a non-narcotic control, since the chance of the non-narcotic doing at least as well as DepoDur is very high. Did you ethics board require that patients be told in writing before agreeing to be involved in the study that non-narcotic alternatives were available, even if they weren’t available in the study or are patients in your hospital forced to agree to be subjected to narcotics without given any informed choice? If the latter is the case, is that ethical? In fact, none of the studies funded by Endo for either DepoDur or the 15 funded for oxymorphone include non-narcotic comparators. There is a very strong ethical argument that patients should not be forced to take narcotics if equally effective narcotics are available. By colluding with Endo Pharmaceuticals in its obvious desire to avoid comparison with non-narcotic controls, it appears to me that your hospital has committed an ethic violation. I would like to have your ethics board review this matter. The fact that the FDA is colluding with Endo Pharmaceuticals is not a waiver for your ethics board to fail to investigate an important ethical issue. The fact that the FDA at present will happily license any narcotic, no matter how addictive, for any pain, no matter how minor, so long as the narcotic manufacturer shows that the narcotic relieves pain better than a placebo, is no excuse for your ethics board to fail to consider the matter. In fact, Endo has recently published a study using oxymorphone, a drug 8.7 times more potent than morphine, for brief, mild pain in a study of orthoscopic knee surgery in which 25% of the patients had only mild pain. And yes, this was an FDA sanctioned study. Any narcotic, no matter how addictive, for any pain, no matter how minor. There are numerous cases of patients first getting started on narcotics in surgical operations with this exposure triggering the development of serious narcotic dependency. In fact, current published evidence suggests that roughly 25% of all modern heroin addicts had their first exposure to narcotics by being given an unsolicited narcotic prescription when seeking help from a physician for a legitimate pain problem. I look forward to your reply. Do feel free to have your ethics board call or communicate with me in regards to any issue. Sincerely,
Thomas E. Radecki, M.D. J.D. |