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Times of India
03 June 2011
By Rema Nagarajan

Over 1,100 Kids Used As Guinea Pigs, Reveals RTI Query
Indore Doctors Flout Clinical Trial Norms, Earn Lakhs
Nearly 40 doctors and 18 hospitals in Indore, from both the government and the private sector, are being investigated for malpractices in clinical trials conducted by them.

This follows shocking revelations of the details of some of these medical trials.For instance, over 1,100 children have been used in clinical trials from which doctors in a leading government medical college earned lakhs of rupees.

In one shocking case, out of the nine subjects of a trial on the possible use of the drug tadalafil in pulmonary hypertension (otherwise used for male erectile dysfunction), seven were women and one was a 17–year–old boy, all from poor families.

Replying to an RTI application filed by health activists, the Madhya Pradesh legislative assembly gave details of clinical trials conducted by various doctors in MGM Medical College and associated M Y Hospital amounting to lakhs of rupees in the period 2005–10. Dr Hemant Jain of paediatrics made Rs 56 lakh, Dr Anil Bharani of cardiology made Rs 44 lakh, Dr Apoorva Pauranik of neurology made Rs 42 lakh, Dr Ashok Bajpai of medicine made Rs 41.37 lakh and Dr Salil Bhargava of chest and TB made Rs 40.19 lakh.

In comparison, the take–home salary of the senior most professor at MGM Medical College is Rs 75,000. Clearly, the clinical trials are the dominant source of income for these doctors.According to an editorial in the latest issue of the Monthly Index of Medical Specialties (MIMS), during 2005–10, of the 2,365 patients enrolled for clinical trials in five medical colleges in Madhya Pradesh, just six doctors in MGM Medical College and associated M Y Hospital recruited 1,521 patients, the bulk of them – 1,170 – were children.

Even though all the patients were recruited through the medical college, which was the trial site, and the facilities of the hospital were used to conduct investigations on the trial participants, the college got nothing from the lakhs earned through these trials as the doctors received all the money in their personal accounts.

In an RTI reply this month, the college authorities admitted that the college had not earned any money from clinical trials in the last five years.A clinical trial agreement between Dr Pushpa Varma, professor of ophthalmology, and a clinical research organization, Quintiles Research (India) Private Ltd, for a pharma company called Alcon gives an idea of how the money is diverted.

In the agreement, the payment was to be made to "Dr Pushpa Varma, MGM Medical College and M Y Hospital, 61 Juni Kasera Bakhal, Indore–452001", which is her private address and not that of the college and she gave her own PAN number, so that all the money was credited to her account. Dr Varma was paid Rs 26,000 per patient enrolled in the trial to test the eyedrop moxifloxacin of Alcon. With 35 patients, she pocketed a cool Rs 9 lakh.

"In the case of 15 clinical trials, instead of obtaining permission from the on–site ethics committee of the medical college, permission has been obtained from strange non–verifiable entities claiming to be ethics committees located thousands of kilometers away in Pune or Ahmedabad," pointed out MIMS editor Dr C M Gulati.

After the issue of clinical trials was raised in the assembly last year, two committees were constituted, one by the secretary of medical education and another by the health department headed by chief medical and health officer Dr Sharad Pandit.

While the medical education committee is yet to submit its report, Dr Pandit has submitted a preliminary report which has raised concerns about ethics committees being constituted against norms. Dr Pandit’s committee noted how a trial located in the medical college got approval from the ethics committee of a private hospital and other such irregularities.

The final report of the CMHO’s five–member committee is expected within a week.Members of Swasthya Adhikar Manch, a network of NGOs who had filed several RTI applications to expose the manner in which clinical trials were being conducted, have expressed concern over the lack of any government action.

"The issue was raised last year. The accused doctors continue to hold their positions. They can easily influence the poor patients who they enrolled for the trials and manipulate documents. They should have been transferred to ensure free and fair probe," said Amulya Nidhi, one of the members of the Manch.The medical superintendent of M Y Hospital Dr Salil Bhargava and former dean of MGM medical college Dr M K Saraswat when contacted refused to comment saying that the matter was before the state assembly.

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