Jewels1986 Posted March 15, 2007 Report Share Posted March 15, 2007 You are involved in a drug trial of a new antibiotic. Of your 4 patients in the trial, 3 developed moderately severe diarrhea. When you report this finding to the pharmaceutical company, they are polite but don’t seem interested in your concerns. How would you deal with this problem? Link to comment Share on other sites More sharing options...
clkt Posted March 16, 2007 Report Share Posted March 16, 2007 How are you involved? They usually have an MD presiding over the trial, is that what you mean? If the diarrhea is life threatening to any group of patients or if it does not outweigh the benefits that antibiotic has over the antibiotics already on the market, then I'd just refuse to sign on it and leave the study. If the drug is not doing something drastic like killing the patients, I don't think there's much you can do about it considering the information belongs to the company... Link to comment Share on other sites More sharing options...
bustylegs Posted March 16, 2007 Report Share Posted March 16, 2007 Interesting scenario. Brings to mind the Viox story when Merk failed to report the side effects of Viox to the regulatory authorities... If I were you, I'd take the patient finding very seriously and follow the SOP on reporting all side effects, especially since a phase-I trial, like the one described, is meant to flush out dosing/side effect issues. Link to comment Share on other sites More sharing options...
Superking25 Posted March 16, 2007 Report Share Posted March 16, 2007 I would tap my nose, give 'em a wink, tuck that tidy little cheque in my pocket and drive home in my Ferrari. *wink* Link to comment Share on other sites More sharing options...
Jewels1986 Posted March 16, 2007 Author Report Share Posted March 16, 2007 In case anyone's curious, this came from the Family Medicine Bioethics Curriculum, and they didn't give any other information, so I'm not sure about the how are you involved question, but I think they just meant having some of your patients participating in the study. Link to comment Share on other sites More sharing options...
Kuantum Posted March 16, 2007 Report Share Posted March 16, 2007 This reminds me of a situation where a UofT professor was working with Apotex and disclosed that the drug may have adverse affects. Apotex said she had no right to do that because she had signed a confidentiality agreement. Thus, they sued her. UofT didn't back her...she was fired from the faculty. In this situation, I believe you have a moral responsibility to report it, however, it would seem in some cases that ethical responsibility conflicts with legal responsibilities. Nonetheless, if you believe people's lives are in danger, you have a moral responsibility to alert them. Link to comment Share on other sites More sharing options...
bustylegs Posted March 16, 2007 Report Share Posted March 16, 2007 Great point on the confidentality, Kuantum. I guess what I meant to say was not disclose it to the public, but disclose it according to the standard operating procedure as set out prior to the start of the trial; instead of making the adverse effect data "disappear". Link to comment Share on other sites More sharing options...
kaymcee Posted March 16, 2007 Report Share Posted March 16, 2007 This reminds me of a situation where a UofT professor was working with Apotex and disclosed that the drug may have adverse affects. Apotex said she had no right to do that because she had signed a confidentiality agreement. Thus, they sued her. UofT didn't back her...she was fired from the faculty. A perfect example of ethics not coinciding with the law. Sometimes you have to go with the decision that won't get your ass sued/fired. Link to comment Share on other sites More sharing options...
Recommended Posts
Archived
This topic is now archived and is closed to further replies.