Drug trials open a can of medical worms17 August 2011 shiv karan singhBHOPAL, 17 AUG: An investigation by the Madhya Pradesh Economic Offences Wing (EOW) has revealed that doctors in the state have been treating thousands of unsuspecting, mainly poor patients like lab rats. Government doctors have grossly violated ethical guidelines in clinical trials and pocketed millions of rupees in corrupt profits, the final EOW report accessed by The Statesman has said. Critics said the report only underlines the inaction of the BJP-led state government on the issue and exposes the spread of this unconscionable medical malpractice across India ever since the UPA let big pharmaceutical companies' profit motive take precedence over protecting vulnerable citizens. The EOW investigated a complaint made last year by NGO Swasthya Samarpan Sewa Samiti against six prominent doctors of the Indore-based Maharaja Yashwant Rao Hospital ~ Dr Anil Bharani (Cardiologist), Dr Hemant Jain (Paediatrician), Dr Salil Bharghav (Chest Physician), Dr Apoorva Puranik (Neurologist), Dr Ashok Bajpai (Chest Physician), and Dr Pushpa Verma (Ophthalmologist). The findings show allegiance to hypocrisy, not the Hippocratic Oath. The doctors subjected 3,307 individuals, a majority of them children, to experimental drug and vaccine trials between 2006 and 2010. This netted them approximately Rs 5 crore (deposited in spouse/relative bank accounts), the EOW report states. The doctors also availed of foreign trips sponsored by multinational pharmaceutical companies. According to the findings of the EOW, the doctors used the infrastructure and students at the government hospital without the official permission of the dean of the institution and worse, the precondition of "voluntary informed consent" for drug trials was got around by picking on the most vulnerable. Most of these "volunteers", essentially patients who thought they were being treated in the regular course of things, had their thumb impressions taken without the presence of witnesses, the EOW found. Doctors did not share experiment risks with the patients, 81 of whom died or fell ill during the process. Doctors hid facts about deaths and compensation has not been paid. Those who fell ill were not treated post-trial and, in the absence of post-mortems, doctors have explained away the deaths as unrelated to the trials, states the report. The Drug Controller General of India (DCGI) can suspend a drug trial or blacklist entities, but it has shown no will to use this power as a deterrent. Schedule Y of the Drugs & Cosmetics Act includes no clause to impose penalties or bring criminal charges against doctors, ethics committees (ECs), fly-by-night contract research organisations (CROs) or companies that violate Indian Council for Medical Research (ICMR) and Good Clinical Practice guidelines. In the USA, fines for illegally conducting even animal trials are as high as $2,500; in India, forget fines and the fact that human beings are being subjected to highly suspect drug trials, the country does not even have a system of mandatory independent medical audits to investigate trial deaths. It has been left to individual ECs to ensure rights, safety and determine compensation. But with no system to regulate ECs, conflict of interest and unconscionable violations in drug trials is the norm. In the Indore trials, for example, not only did the doctors sit on their own ECs, they became members of each other's ECs and approved each other's deeds. It is not mandatory for trials to be overseen by institute ECs. This has spawned a racket of so-called "independent ECs" often located thousands of kilometres from trial sites. Some openly advertise rate-cards and charge a "fee" as high as Rs 50,000 per trial. Others avail stock options and royalties from drug companies on the sly. "There is a deep nexus between independent ethics committees and the drug industry," affirmed Dr CM Gulati, Editor, Monthly Index of Medical Specialties, who has closely followed the clinical trial boom in India. How can such ECs, dependent in the main or even solely on the drug company for income, be expected to safeguard the subjects of the trial and make the company compensate for death and injury, he asked. The Centre has disclosed that 1,593 trial deaths have taken place in the past three years. The Indore cases documented extensively in the EOW report show this is most likely to be gross underestimation because doctors and ethics committees hide deaths. Drug companies, incidentally, have only paid for 22 trial deaths. The compensation has been a little over Rs 2.5 lakh per patient. In US dollars, that's roughly 2,500. Evidently, American animals and Indian people are roughly worth the same, in monetary terms at least. "Based on my knowledge and that of students made to work on trials by their HoDs, at least 150 patients died," said Dr Anand Rai, the principal whistleblower who was fired from his job by the government after he spilled the beans on the Indore trials, told The Statesman. The state high court ordered his reinstatement but the Shivraj Singh Chauhan regime has obtained a stay on appeal. Non-existent or difficult to implement regulations, harmful chemicals, rapacious companies and no value for human life... all these factors are in the mix and provide a reminder of the Bhopal gas tragedy. In fact, between 2004 and 2010, trials have also been secretly conducted on gas disaster survivors at the Bhopal Memorial Hospital, the sole source of treatment for the overwhelming majority of the victims. The allegation backed by a lot of evidence collected by those in the field is that at least 10 of the 215 survivors experimented upon by pharma companies with drugs not approved for human use anywhere have died during these trials. The EOW has not investigated such private or other public hospitals in the state, where trials, not salaries or consultation fees, have become the primary source of wealth for many doctors. For instance, documents available with The Statesman show harmful adjuvants, banned in the USA, have been used in vaccine trials on children in Indore. The EOW has, however, recommended action against the six Indore doctors in accordance with the Indian Medical Council Act, medical education department rules, and the Medical Council of India code of ethics. But there's been no action yet and the chief minister, who holds the Cabinet portfolio of medical education, has been accused of siding with well-connected doctors. Whilst the whistleblower has been victimised, doctors named in the state's own report have been promoted. The EOW report was submitted two months ago. A spokesperson for the Madhya Pradesh government said when contacted for a reaction on the lack of action on its recommendations: "We are awaiting the expert opinion of the principal secretary, health education." The unethical trials in Indore have exposed the dark side of what is growing into a multi-billion dollar industry. Six years since the necessary amendments were made by the UPA to allow clinical trials, around 2,000 trials across the country involving hundreds of thousands of citizens have been conducted. It is evident that government monitoring is non-existent. The lack of any law to protect drug trial "subjects" has meant that profiteers are laughing their way to bank whilst vulnerable citizens with serious medical conditions who more often than not have no choice but to blindly trust doctors at government hospitals bear the brunt of one of the world's weakest public health systems. www.currenthealthscenario.blogspot.com |
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