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Originally Posted by Anil Tuladhar  Thanks Angel for forwarding our concern to the senior investigator and posting his reply and also forwarding me the original article. I am no way trying to belittle their hardwork and effort on this study and provide cheaper drug for one of the commonest infectious disease in Nepal. It is a superb paper as far as looking into the outcome measures.
I am writing this out of my genuine concern regarding Gatifloxacin, which is banned in USA, definitely not licensed in the UK and withdrawn from European Marketin 2004 (Pharma Japan 2004, ISSU 1886, page 9).
I would be most grateful if any of the authors be kind enough to comment on our following concerns:
1. What was the safety reason for which this study was prematurely terminated (though not mentioned in the original paper)? Please read following link: ISRCTN75784880 - An open randomised comparison of Gatifloxacin versus Cefixime for the treatment of uncomplicated enteric fever
2. I would be reassured if you could clarify whether this study was approved by Oxford Tropical Research Ethics Committee. Please refer to the above link once again.
3. Were the subjects given sufficient information (including the major side effects) before being enrolled for the study? One of the posting in this thread mentions it otherwise. There wasn't enough clarity in the "Participants" section in this regard.
4. Though senior investigator mentions in his reply in this thread, it would have been more informative to the readers and the participants in the trial to be aware of Gatifloxacin's status in many countries since the drug was withdrawn only after the study had been terminated.
5. I would be most interested to know if Oxford University Ethics Committee would find it ethical in approving similar study involving Gatifloxacin in the UK. |
Here is the reply from Prof. Basnyat I just got a mail from him...
Yes dr Tuladhar please read the article as many of the answers are in the article. I would also invite you to write in PLoS one website because this is an open access journal and they invite your comments there and everyone related to the article could read your comments.
1. What was the safety reason for which this study was prematurely terminated (though not mentioned in the original paper)? Please read following link: ISRCTN75784880 - An open randomised comparison of Gatifloxacin versus Cefixime for the treatment of uncomplicated enteric fever
As the article clearly states the trial was stopped because gati was found to be so effective in comparison to cefxime that the data safety monitoring board thought it was unethical to continue the trial based on priori defined numbers. This was not for safety reasons.
2. I would be reassured if you could clarify whether this study was approved by Oxford Tropical Research Ethics Committee. Please refer to the above link once again.
Yes again may I suggest you please read the article carefully. It is the first sentence in the Methods section.
3. Were the subjects given sufficient information (including the major side effects) before being enrolled for the study? One of the posting in this thread mentions it otherwise. There wasn't enough clarity in the "Participants" section in this regard.
Yes.
4. Though senior investigator mentions in his reply in this thread, it would have been more informative to the readers and the participants in the trial to be aware of Gatifloxacin's status in many countries since the drug was withdrawn only after the study had been terminated.
The drug company pulled the drug out in the USA whilst the trial was going on and in the discussion we do indeed talk abou the NEJM article that caused the company to pull the drug out in the USA. Where typhoid is rampant ( eg in India and Vietnam) this drug is indeed used quite a lot as I mentioned earlier. Again as I clearly mentioned earlier and also as is mentioned in the article the side effects in the NEJM study were confined to an elderly population with usually renal failure.
5. I would be most interested to know if Oxford University Ethics Committee would find it ethical in approving similar study involving Gatifloxacin in the UK.
I have no idea.