Allegations and truths about Clinical Drug Trials at Indore

Allegations and truths about Clinical Drug Trials at Indore – 1. Allegation-1 : The doctors did illegal trials Truth – All trials at Indore have been legal, as they were approved by Drug Controller General of India and other countries and Ethics Committees, not only at MGM Medical College, Indore but also all other participating centers. 2. Allegation-2 :- The doctors did the trials secretly, clandestinely, without informing government. Truth – All trials at M.Y. Hospital were done with full knowledge, permission and participation of the Dean or Superintendent of the hospital. In addition, various administrative councils of the autonomous medical college (academic, executive, general) were also privy of the fact of ongoing trials as supported by many documents including signatures on tripartite trial agreements by Deans and Superintendent. There was no rule about need to inform government. 3. Allegation-3 : The doctors did the trials without proper informed consents from patients or caregivers. Truth – All subjects were properly explained and informed about their participation in trials. Informed consent forms have been dully filled and signed, the process of obtaining Informed consent has been duly documented. The subjects kept coming for all followup visits without any complaints. Drop outs or discontinuation rates were within internationally observed range. The monitoring and auditing teams from sponsors kept a close watch on all proceedings in a uniform standard manner at all centers all over India and other country including ours. 4. Allegation-4 - The Ethics committee at M.G.M. was not properly constituted and violated ICMR guidelines and code of good clinical practice. Truth –The Ethics committee was properly constituted and functioning as per the guidelines. It had eminent nonmedical members like (retired) High Court Justice Mr. P.D. Muley, Gandhian social worker Padmshri Govindan Kutti Menon, Journalist Jayantilal Bhandari, Advocate Yogesh Mittal, The objection to EC members themselves, sometimes being Principal Investigators is not tenable as per the guidelines and practices as all over the country. 5. Allegation-5 - The doctors have earned crores of rupees. Truth – It is true that as principal investigator we received trial budget into our personal accounts. The medical teachers in M.P. are permitted private practice. The Dean/Superintendent and various administrative councils who were aware of this fact, did not forbid us from doing so. Various figures ranging from 10 Lac to 1.5 Crores are doing rounds in the media. These are gross receipts, the majority of which is spent in the conduct of trial. The residual income was duly accounted in the audited returns for Income Tax. The minister of Medical Education Mr. Mahendra Hardia declared on the floor of Vidhansabha that this is a legitimate, taxable, professional income for the doctors7. The Economic Offence Wing of police, after a very detailed and thorough enquiry exonerated us by saying that there is no evidence for any economic crime.8 6. Allegation-6 - So many deaths (and serious adverse events) have occurred but subjects were not paid any compensation. Truth – A figure of 81 death is repeated ad infinitum in the media, glossing or fudging over the truth that there were ………. Deaths and ……. Serious adverse events. (………….+……………. = 81). None of the deaths and SAEs were due to or related to the participation of the subjects in the trial as supported by a report of the adjudication committee constituted by Ethics Committee 9 and also stated by Mr. Shivraj Singh Chouhan, Chief Minister in M.P. Vidhansabha 10. Hence there was no valid claim for compensation by any patient or survivors of deceased subjects 7. Allegation-7 - The doctors pocketed all the money and did not pay anything to the patients. Truth – As per ICMR guidelines, no inducement money can be given. Only the travel expenses and per diem honorarium can be paid. 8. Allegation-8 - The doctors travelled to foreign Junkets on the expense of drug companies Truth –The Principal Investigators all over the world, including India, travel to attend Investigators Meeting at locations which are logistically suitable for the sponsors. These meetings are serious business and mandatory, without which principal investigators and his team members cannot be trained for proper conduct of that given trial. 9. Allegation-9 - The doctors violated MCI code of conducts. Truth – None of us violated any code of conduct by MCI, before or after the date, they were supposed to come in force in April 2009. The code does not prohibit doctors from collaborating with pharmaceutical companies in the capacities of Principal Investigators, consultant etc. 11 10. Allegation-10 - The doctors are hiding lot of information when sought for through RTI, Vidhansabha questions, police and other investigating agencies Truth – We have fully cooperated with all investigating agencies and RTI querreis baring a few legal exemptions – which are supposed to be confidential12 because of (a) confidentiality agreement between sponsoring company and principal investigator as per patent protection and business practices. (b) Fiduciary relationship between patient and doctors, according to which every subject has a fundamental right to privacy and particulars of his/her medical condition and demographics can not be disclosed. The sole ulterior motive of our detractors has been to reach out to as many of the subjects, misguide and misinform them, lure them and persuade them to lodge complaints. As a result of a high decibel sustained propaganda and numerous home visits, the mischief mongers have been able to persuade 3-4 families (out of 2000) to lodge complaints against principal investigators 11. Allegation-11 – One Mr. Sharad Gite has complained against Dr. Apoorva Pauranik that his wife Mrs. Sheela Gite died due to participation in a trial about which they did not know Truth – Mrs. Sheela Gite, 70 yrs-Female was suffering from Alzheimer’s disease, since two years prior to inclusion in a study using Donepezil which is already available in market for 10 years. The couple came for 11 follow up visits over 1 ½ yrs and did not complaint while signing on all papers on more than one occasion after having been explained all aspect of study. The last scheduled visit was in January 2010. There after she did not report. I learnt about her death, 10 months later in October 2010 through newspaper when her gullible, innocent husband was misguided to lodge a complaint seeking compensation for the death of his wife. 13 Mr. Sharad Gite was made to believe by Dr. Anand Rai (who wrote the letter in his own handwriting on behalf of Mr. Gite) that he will get hundreds of thousands of dollars in bargain. 12. Allegation-12 – The EOW has indicated us of many wrong doings. Truth –The EOW did exonerate us from any Economic Crime which is their sole domain. But the investigating agency, out of over enthusiasm, possible prejuicide and naiveté went beyond the mandate and area of expertise and made a few critical remarks about minor administrative and procedural issues which have been blow out of proportion by media. We have responded to all the comments in a thread-bare manner14 and Government of Madhya Pradesh has apparently accepted our explanation. 13. Allegation-13 –12 doctors have been fined Rs. 5000/- for conducting illegal, unethical drug trials. Truth –The fine has nothing to do with legality or ethics of drug trials. A notice was served to us by Civil Surgeon Dr. Sharad Pandit in July 2011 under M.P. Nursing Home and Clinical Establishment Act 1973, under which all doctors are required to register their hospital or clinic and to send a list of the patients seen by them every quarter. The act is on statue books only and never implemented or forced in reality. If every doctor starts sending the details regularly, there will no space in civil surgeon’s office to store it. We were selectively targeted by Dr. Sharad Pandit (though being medical teachers, we do not fall in his administrative jurisdiction) for not providing patient’s names and other trial related information (which we had already given to other government agencies including EOW and Vidhansabha). We made our written representation against the notice in June 2011 and did not listen anything about it, till this news broke out in media in Jan 2012. We have not paid any fine so far15. The penalty on paper is not for conducting illegal or unethical drug trials (as the headlines cry) but for not giving some information under an old archaic impractical law. 14. Allegation-14 - Doctors at Indore did the unthinkable by conducting trials on mentally ill (read insane) patients. Truth – This is a recent and most hilarious story so far, had it not been tragic and ironic for five psychiatrist at MGM Medical College (again the same poor institution – the same punching bag for the media), who conducted legal (approved by DCGI) and ethical (approved by a well established independent ethics committee) clinical trial of a drug dupoxitine (already available in market) for men suffering for erectile dysfunction (a common disorder treated by psychiatrist in subject who are otherwise sane or mentally sound and capable of giving informed consent). An investigating team from DCGI has cleared the investigators from the charges of illegality and incapacity of subjects giving consent. 15. Allegation-15 – Two doctors have been banned by DCGI from doing clinical trials for 6 months. Truth – This was a technical error by DCGI officials which has been contested by concerned doctors. 16 16. Allegation-16 – Because of illegal trials, M.P. Government has banned trials in the state. Truth – Following the uproar in media and Vidhansabha, M.P. Government temporarily banned initiation of new trials but permitted continuation of the ones which were already ongoing (and are still going on). The ban had nothing to do with legality or ethics worthiness of trials. 17. Allegation-17 – The doctors travelled to foreign countries on expense of drug companies18. Truth – The travels were for attending Investigator’s meeting, which is a scientific and procedural requirement before initiation of the site.   References – 1. A summary of some salient trials done at MGM Medical College, & M.Y. Hospital 2. Vikas Bajpai, Anoop Saraya, Industry sponsored clinical research, National Medical Journal of India. Vol.24, No.5, 2011, 300-302 3. Copy of Letter to Medical Council of India by Clinical Researchers at Indore complaining about Anand Rai. 4. Letter to Editor, Times of India by Clinical Researchers at Indore 5. Letter to Editor, Monthly Index of Medical Specialties by clinical researches at Indore. 6. Yuji K et al. Sharing information on adverse events. The Lancet, Volume 377, page 1654, 14 May 2011. 7. Statement by Mr. Mahendra Hardia, Minister for Medical Education 8. The report submitted by Economic Offence Wing of Police 9. Report by Adjudication Panel of Ethics Committee of MGM Medical College, Indore 10. Statement by Shri Shivraj Singh Chouhan (Chief Minister of Madhya Pradesh) in state assembly 11. Code of conduct for doctors by Medical Council of India 12. Confidentiality of Information – judgment by Chief Information Commissioner, Dated…… 13. My answer in response to complaint by Mr. Sharad Gite, husband of deceased subject Mrs. Sheela Gite. 14. Our response to some of the critical observations by Economic Offence Wing. 15. Our protest against Rs. 5000/- penalty 16. Response to DCGI by Dr. Anil Bharani. 17. A partial list of various centers where same clinical trials were done as by Dr. Apoorva Pauranik. 18. Our response about foreign travels to attend investigators meetings.