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this out of my genuine concern regarding Gatifloxacin, which is banned in USA, definitely not licensed in the UK and withdrawn from European Marketin 2004 (Pharma Japan 2004, ISSU 1886, page 9).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the readers and the participants in the trial to be aware of Gatifloxacin's status in many countries since the drug was withdrawn only after the study had been terminated.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.
Quote:
Originally Posted by Angel  Dear Tuladhar,
Its very good that you brought up this issue. I talked to Dr. Buddha Basnyat the man behind this research. He has provided me the article published in PLOS One [ CLICK HERE to read the article]. He has following words with me
Dear Angel,
Please read the article if you have not done so. The point about the dysglycemia and possible life threatening complications is discussed in the article. There seems to be no danger in the younger population in whom our enteric fever is pretty much confined. Importantly, this aspect of the withdrawal by the USA was reviewed by our ethics board and our drug board (DDA) quite extensively only after which we received permission.
This was not a question of making guinea pigs of people, and please let us not try to spread baseless fear.
Oxford University was also involved in this study and they too have very stringent human rights record and are very politically correct. Indeed it was also passed by their ethical review board.
I urge you to read the article which I have attached and also let the good Dr Tuladhar be informed about it. There was zero conflict of interest.
Please feel free to ask any questions. Please note this drug is extensively used in India, Vietnam ( where it is the drug of choice for typhoid) and I believe is available in the UK.
Best wishes,
Buddha Basnyat, M.D.
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