1. No, it could be unethical to the placebo/control group. If the trial statistically and without a doubt demonstrates that the new drug improves therapy (considering also toxicities,etc) then it would be unfair to continue the trial and stop the control group (with placebo or another less-effective drug treatment) to obtain the improved therapy.

Posted at 10:58AM on Aug 29th 2007 by J. Melendez-Zajgla

2. In a book by Sinclair Lewis called Arrowsmith, it addresses the issue of the morality of interrupting a clinical trial before it has produced definitive, unchallengeable results. Do you give the drug to everyone because you have an inkling, but no proof that it works? Or do you leave the control group hanging? We tend to say, sure, it's unethical to have the control group, where patients are left untreated. It's not a trivial question.

The FDA has reported that in one of the tweleve research areas that need to be addressed to try an improve clinical trials, are efforts to search for new ways to measure cancer progression. There is growing evidence that X-rays, long the standard, may not accurately assess a patient's disease. For decades, X-rays have been the principal means for researchers to judge whether a cancer drug works. If tumors appear to shrink or stop growing after therapy, the drug is thought to be working.

Posted at 5:46PM on Aug 29th 2007 by Gregory D. Pawelski

3. An article published by the National Institute of Health concluded that "about one fourth of abstracts at American Society of Clinical Oncology (ASCO) Annual Meetings have an author with a personal financial interest." Since many of these abstracts are about the results of clinical studies, this means that the study results are being penned by authors that may have a "personal financial interest" in the outcome. (JCO, 2007 Aug 20;25(24):3609-14)

Attitudes toward research participation and investigator conflicts of interest among advanced cancer patients participating in early phase clinical trials. (JCO, 2007 Aug 10;25(23):3488-94.)

These two articles touch on a critical subject - when an oncologist recommends a treatment the reason behind the recommendation may be complex. It can be a result of the doctor's training and experience in combination with the investments made by the hospital or the doctors own research interests or their financial relationships with various outside entities. In short, a patient and their family must be their own best advocate and get at the heart as to why a specific treatment regimen is being suggested. Don't be afraid to ask questions to make informed treatment decisions! (Cancer Wire)

Posted at 11:24AM on Sep 1st 2007 by Gregory D. Pawelski

4. Cephalon took issue with the apparent claim that it markets Fentora for uses other than cancer pain.

http://www.cancer2blog.com
http://www.cancerdelete.com
http://avemar.world-cancer.net

Posted at 8:28AM on Apr 22nd 2008 by Joddy