Letter to Editor, MIMS

Sir,
With reference to the editorial “Chronic clinical investigators : New breed of body hunters “(May 2011), we , the six principal investigators at M.Y.Hospital / M.G.M.Medical College Indore, want to put up with following facts and answers. We demand that our version be given equal space and emphasis but are not sure whether you will follow journalistic ethics, morality and courtesy.
The study on Tadalafil in pulmonary hypertension was not a randomized trial. It was an observational study without any sponsorship. The drug is already approved for and is available in market for this indication. Primary pulmonary hypertension is common in young female, hence there is nothing alarming or unusual about the demographics of study participants.
Similarly there is nothing alarming or unusual about the number of 1521 patients (1170 being children) enrolled between 2005-2010 at Indore. WHO sponsored trial on polio vaccine required large number of children to be recruited. The monitoring and auditing teams from WHO did not find any irregularities. The data uploaded from Indore center were approved and accepted and finally included in a land mark publication in Lancet [Volume 376, issue 9753, pages 1682-1688, 13 Nov 2010]. An accompanying editorial highlighted the importance of this trial in eradicating the remaining stubborn pockets of polio in India.
The various amounts quoted against each principal investigators are gross receipts, 60-80% of which is spent in conduct of trial. That the remainder is a legitimate, taxable, professional (consultancy) income of doctors was even accepted by the minister of Medical Education in M.P. Vidhansabha in reply to a question by one of the members. The medical teachers and other doctors in Madhya Pradesh are permitted private practice and their monthly incomes are much higher than the salaries. The income from clinical trials is relatively minor, considering the time, energy and expertise of senior consultants.
The use of Government infrastructure was minimal. The expenses for staff and office equipments were met from the trial budget. The accreditation of trial budget into personal accounts of principal investigators was done with the knowledge, permission and participation of college authorities including head of departments, hospital superintendent, Dean (s), institutional ethics committee, Executive Council of college ( headed by commissioner) and General Council of college (headed by minister). The Executive Committee and General Council were seized with the matter. Based on the decisions taken in these meetings two subsequent Deans instructed the principal investigators in two different orders to deposit 10% of gross receipts in to a departmental (not institutional ) account, which they have been doing. Over and above the 10% percent contribution, trial budgets have also been used in procuring permanent and temporary assets for the department like civil works, laboratory equipments, computer, printers, fax, internet connections, furniture, air conditioners, refrigerators , stationeries etc.,
All participants in trial were paid for travelling expenses and loss of day’s wages as per ICMR guidelines.
How could a trial on Dopnepezil 23 mg in Alzheimer’s disease be unethical which was approved by institutional ethics committees at 219 centers and Drug Controller Generals in many countries in North America, South America, Europe, Asia, Australia and south Africa. A total of 1467 patients were enrolled all over the world, out of which only six were from Indore. Thirteen deaths were reported during the study or within 30 days of study discontinuation from all over the world. Sheela Geete was not one of them because she died 8 months after the conclusion of the trial. Based on the results of this trial, a new formulation of this “dangerous” high dose of 23 mg donepezil has been approved for marketing not only in India but also in United States of America. There was no case of compensation to be paid because the death or any adverse event was not related to study drug. There were no instances of trial related injury and resultant lost wages in Rotigotine trial in parkinson’s disease.
All clinical trials are not successful or positive. It is a matter of chance. All trials which are successful or positive may not be land mark or pivotal or be “relevant to the country”. Yet the trials at Indore have had a larger share of important contribution. In addition to polio vaccine, others have been swine flu vaccine and polypill for prevention of cardiovascular and cerebrovascular occlusive disease.
Your editorial is extremely biased, one sided, prejudiced , ill informed and malicious. It should be retracted.