[anilpandit]

We didn't stop the trail. It was independent DATA Safety Monitoring board which advised us to stop the trial. They figured out following two points

achievment of clinical significance before target sample size
adverse effents (Mortality) in cefixime arm.


I am really saddened that not a single reader has brought up the issue that there was a MORTALITY in cefixime group. One of the reason why trial was stopped.

To the question of not measuring blood glucose level. The evidence before NEJM article in 2006 regarding dysglycemia was meagre (few case reports). By the time the NEJM article got published, the trial was already over and there was no point doing blood sugar level because most of the patients in the study had already compeleted six month follow up too. However , none of the followed up patients in gatifloxacin arm got admitted as they say gatifloxacin has serious dysglycemia requiring hospitalization.

We have 1000 patients' prospective data in which gatifloxacin is used (Nepal and Veit Nam combined) and none of them have dysglycemia which will be hopefully published soon.

Every one is focussing on gatifloxacin. I agree there are many questions to be answered regarding gatifloxacin. Another important hit of this study is showing the failure of cefixime which many of trust to work and have knee jerk reflex of prescribing it to the typhoid patients and the WHO still continues to recommend it. We got about 37.2% failure rate!!!!


It is very sensible to be concerned about clinical trail being done in countries like Nepal. However, Britol Mayer Squib or any other companies had no role whatsoever in conduct, design, interpretation and the conclusions of the study. It was funded by the Welcome Trust.

To the question of trial being done in the UK, whereelse would you expect to do trail of typhoid ? UK doesn't have very many typhoid patients to do a trail neither does the US. In the US there are 400 typhoid patients in a year seen in travellers only. It is our disease, we have the disease , we need the research , we need newer treatment as other flouroquinolones are failing. We didn't do this study to advocate on behalf of gatifloxacin. We were not compensated by the drug company for doing research either. There are few people who try to do greater good, sacrificing their own time and energy expecting that their work will fruit the help to many people around them need.

After this issue of dyglycemia came up, we have been following up patients treated with gatifloxacin with blood sugar level (another trail on the way), we didn't find any dysglycemia in any of the patients. We are equally concerned as you all are about the safety of the patients. If we were not, we would have continued the trail because stopping of trail is not considered favourable for the researchers.

I would love to answer any of the questions put forth if the questions are genuine.

About the drug being registered in the NEpal, we registered the drug in Department of Drug Administration for the trial purpose. It is upto DDA to approve it or not for commercial use. It is approved and widely used in INDIA and other countries for other purposes.

Anil Pandit, MD
Maryland General Hospital
University of Maryland Medical System
Baltimore, Maryland
USA