Letter to Editor, Times of India

Sir,
This refers to news item published in TOI, New Delhi, Lucknow, and Bangalore editions on 3rd June 2011 (Friday) entitled “ Indore DOCS flout clinical trial norms, earn lakhs“ by Rema Nagarajan.
It is very unfortunate and shocking to learn that the most trusted news paper TOI is publishing a totally unconfirmed biased , derogatory unscientific and misleading report on an extremely sensitive issue of clinical drug trials in India.
The published report is based on an entirely baseless, mischievous , biased and motivated propaganda on clinical drug trial research conducted at M.G.M.Medical College, Indore by a section of local press with ulterior motives, fueled by some people with vested interests during last 10 months.
The fact remains that all the clinical drug trials undertaken by us have been multicentre/ multinational endeavors and have been conducted following all the existing rules , regulations and available guidelines in the country. Such studies, as ours , have also been conducted simultaneously all over the country including centers like AIIMS, New Delhi, PGI, Chandigarh, SGPGI Lucknow, St. Johns Medical College, Bangalore , Fortis group of hospitals, Apollo Group of hospitals, KEM hospital , Mumbai , Narayan Hridayalaya, Bangalore etc., using same protocols , guidelines and budget planning. All these protocols have been approved by Drug Controller General of India(DCGI) , New Delhi and the institutional Ethics Committees of all the participating centers and were monitored and audited by experts in the field.
The published report comments “ in one shocking case , out of the 9 subjects of a trial on the possible use of the drug tadalafil in pulmonary hypertension (otherwise used for male erectile dysfunction) 7 were women and one was 17 year old boy all from poor families “ Please note that the referred study used tadalafil in patients with Group-I pulmonary hypertension which occurs most commonly in young women and tadalafil is the approved therapy of choice for this life threatening disease ( class – I indication) . This is an ongoing legitimate faculty pilot research project with no funding from any outside source and having due approval from institutional ethics and scientific review committee. We do not select participants based on their social status,caste or economic background.
The report also quotes various amounts received by principal investigators as their income but does not indicate that actually the referred amounts are trial budgets provided to the principal investigators by the sponsors to run the research protocol at respective centers and is similar for all the participating centers all over India. This amount is utilized for staff salaries , patient investigators and patient reimbursements and towards honoraria to sub investigators and investigators. The information about the trial budget and other aspects of a planned research protocol is well known to the head of the institution as he is a signatory in the tripartriate clinical trial agreements (CTAs).
Government has constituted a committee to form rules and regulations for conducting clinical trials in a state of Madhya Pradesh and has permitted all the ongoing clinical trials to continue till finish. Autonomous society of M.G. M. Medical College, Indore had permitted clinical trial research in the institution and issued orders to deposit 10% of the research grant in the respective departments (not necessarily college account) to be utilized for improving the existing facilities. We have been following these orders and depositing the above amount in the respective departments, the accounts of which are duly audited.
All the Clinical trials conducted by us are as per ICH-GCP – ICMR guidelines and as per schedule “ Y” of the Drugs and cosmetic act revised 2005. All trial participants have provided well informed written consent in language understood by them i. e. Hindi in majority.
Sir, no Government agency has ever found any misconduct or flouting of clinical trial norms by us nor has any CRO/ Sponsor / institutional Ethics and Scientific Review committee has found any irregularity done by us till now.
Your report alleges about having used children like guine pigs in vaccine trials. In fact vaccine trials carried out by one of us have contributed significantly for helping in developing a vaccine to irradicate existing polio pockets in India and for developing the most wanted affordable swine flu vaccine (H1N1 vaccine) in the country. These achievements were published in TOI with praise at that time . All vaccine trials were conducted following exisiting rules and regulations with high ethical principles .
Sir, we would highly appreciate if the sensitive issues like clinical drug trials that are otherwise imperative for human health are reported without bias and after confirming the facts from all concerned parties and not simply based on false, motivated, unilateral, unconfirmed, unscientific reports from a section of press with vested interests.
Sir,you will realize that it takes decades to build physician’s reputation that may be spoiled with such reports in no time which is unfair, highly injurious and unjustified.
We hope that you will kindly give space to this letter in TOI editions.
Thanking you