I am very glad to see so much of discussion around this topic and interest so generated by this on everyone concerned and this is how it should be. This does help in dissemination and sharing of our knowledge.
But I am deeply saddened by some of the quotes and comments from the authors. Those comments are unwarranted, unasked for and not expected from a responsible medical professional. Here, we are trying to have a healthy debate. In any research, there is always bound to be questions asked on different aspects of the study and it is the duty of the researchers to convince readers or answer the questions correctly and appropriately. This may or may not convince the individuals and it is up to the individuals to rate the study on that ground. This is what happens worldwide. The response from one of the authors is like that of someone immature who has never been criticised, never could take criticism and reflect on it nor has humility to respond and clarify the queries politely.
I was drawing attention at the side effect of Gatifloxacin, the very reason this drug came to disrepute and was given “Black Label” by USA Food and Drug Administration Agency. The investigators have ignored to look for this side effect. Have they proven that dysglycaemia is not a problem in this study; I believe the results would have been more robust. The authors tried in their defence of omitting blood sugar level by quoting another study involving children. If this study is a full description of all the safety data available, then this appears to have occurred without new data demonstrating real rather than imagined concerns about the safety of Gatifloxacin. The safety data in this study is hardly enough to conclude that Gatifloxacin is safe.
References:
Pichichero ME, Arguedas A, Dagan R, Sher L, Saez-Lorens X, et al. (2005) Safety and efficacy of gatifloxacin therapy for children with recurrent acute otitis media (AOM) and/or AOM treatment failure. Clin Infect Dis 41: 470–478. Merchant CD. (2005) Gatifloxacin Therapy for Children: An Antibiotic Still in the "Back Room" Clin Infect Dis 41: 479-480.
The analogy of side effects of Gatifloxacin and other fluoroquinolones seemed inconceivable. We still wait to see a drug which doesn’t have any side effect. But one cannot put price on the cost of life, which we are debating in case of Gatifloxacin and compare it with any side effects leading to morbidity (like cartilage toxicity of other fluoroquinolones).
If my conviction, based on available evidence but not on experience only,tells me to encourage or discourage my patients to use or stop taking the drug, I would do so irrespective of who they are (my near or dear ones or anyone of any race, religion, caste or nationality) as expected of any medical professional.
It is quite interesting to see that there are five authors based in the UK, where Gatifloxacin is not licensed, with ethical approval for this study granted by Oxford Tropical Research Ethics Committee. I just wonder whether they would have received ethical approval to conduct any study involving Gatifloxacin in the UK. They might but not in million years on the current available evidence.
However, this paper is a very good example in demonstrating why we need to screen through all 10 points in the appraisal tool while reading an article (Refer
“How to critically appraise an article?” on sticky section of Journal Club forum in the xenoMED forum).