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The dilemmas thrown up by high-technology and market-driven medicine were amongst the subjects discussed at India's first National Conference of Bioethics in Mumbai
“Drugs that are banned for adults in the West are officially permitted for use on children in India,” said Dr Chandra Mohan Gulhati, editor of Monthly Index of Medical Specialities, New Delhi. “And only 30 countries in the whole world actually have well-established drug regulatory bodies -- and all of these are in developed countries!”
Dr Gulhati was speaking on a rational approach to allowing new drugs in India at the first National Conference of Bioethics (NBC) organised by the Indian Journal of Medical Ethics, in Mumbai, from November 25 to 27, 2005. He noted that almost 80% of Indians use herbal medicines and some of these interact with allopathic medicine. “Few data are available on this, and the problem is compounded by the fact that 75% of drugs sold in India do not have package inserts and none of them have patient information sheets.”
Three hundred and fifty participants registered for the first day of the NBC, from all over India as well as Pakistan, Sri Lanka, Bangladesh, Iran, Norway, the United States and Canada. The unexpectedly large turnout was one indication that healthcare ethics is coming of age in India. Twenty government, private and NGO institutions collaborated for the conference and were represented in the plenary speakers. Over 60 papers were presented on subjects ranging from clinical trial ethics to end-of-life care, from disaster response and research to the relevance of community involvement in AIDS research.
Access to care
P Koushalya, president of the Positive Women’s Network, Chennai, spoke on services for people with HIV/AIDS. “We desperately need trained counsellors, we need anti-retroviral drugs in the smaller towns and primary health centres, we need the government to do something about the Patent Act to ensure access to second-line drugs,” she said, emphasising that HIV-positive people faced extensive stigma when seeking care, and HIV-positive women were further restricted by gender inequities. “Even when treatment is available, women may opt out in favour of the husband.” Suniti Solomon of YRG Care, Chennai, noted that barely 8% of those who need anti-retroviral drugs are on this therapy.
“The biggest priority is providing care to the poor in the villages, towns and cities of India,” said Dr Sunil Pandya, neurosurgeon and founding editor of IJME. “But when the Mumbai Municipal Corporation permits full-time staff to do private practice, senior doctors will be treating private patients instead of working in the public hospitals. Who will do the teaching? Who will treat the patients who are flooding public hospitals?”
There is a wide gap between what is researched and what we need, said Dr Vasantha Muthuswamy, senior deputy director general of the Indian Council of Medical Research. “Perhaps it’s a utopian dream, but we need to work on reducing the 10/90 gap,” she said, referring to the WHO’s finding that 90% of the world’s resources are used to research the diseases of just 10% of the world’s population. Dr Muthuswamy also lamented that many hospitals do not have ethics committees, nor is ethics a routine part of medical education.
Dilemmas of medical practice
“We have always been deeply conscious of problems faced in our day-to-day practice,” said Professor P N Tandon, president of the National Brain Centre in Manesar. “When babies are born with severe disabilities, when a brain-dead person is on the ventilator…we must make difficult choices and we often have no mechanisms, no guidelines to answer such questions.” Among the fundamental concerns that Tandon identified were issues of life and death ranging from when life begins to when it should end; the impact of patents on access to drugs and the need for professional conduct.
Tandon also spoke about the Indian Council of Medical Research’s efforts to enact legislation on the basis of its guidelines for biomedical research. “Right now, there is no monitoring of research, ensuring that the decisions of the ethical review committee are followed. There is no mechanism for punishment. Draft legislation based on the ICMR guidelines has been drawn up, and we’re waiting to see when it gets enacted into a law.”
The market and high-tech medical care
“Healthcare has moved from a vocation to an industry,” noted Dr V I Mathan, senior gastroenterologist, referring to high-technology care, one of the four sub-themes of the conference (the others were HIV/AIDS, clinical trials and violence). Dr Mathan, who holds the ICMR chair for epidemiology at the Christian Medical College and Hospital, Vellore, placed the new trends in healthcare firmly within the context of a market-driven world. So, we see shifting paradigms of medical practice, from duty and responsibility to patients to duty for wealth creation, from a focus on treating the poor to the promotion of medical tourism.
Indeed, some particularly vibrant discussions revolved around issues of high-technology care. Participants at one workshop discussed the Indian Society of Critical Care Medicine’s consensus position statement on end-of-life care. Another on new reproductive technologies looked at the role of the private sector in this field, especially in the area of stem cell research. A meeting on transplant and other high-technology interventions noted that even as laws such as the Human Organ Transplantation Act were abused, transplants were really the privilege of the rich, not the right of everyone who needed such treatment.
Controversies in day-to-day practice
Is it unethical for specialists to give a referral fee, or kickback, or ‘cut’ to the referring doctor? Do such practices drive costs up and affect the quality of patient care? Should drug companies be involved in sponsoring continuing medical education? Should patients give their informed consent to undergo treatment? These were just a few of the hotly debated subjects at a workshop on ethical controversies in day-to-day practice.
Research on the displaced and other vulnerable populations
Dr S Parasuraman, director of the Tata Institute of Social Sciences, Mumbai, spoke on research on displaced populations where researchers must both hold the state accountable and bring justice to those who are researched. Such research is more often commissioned by the promoters of such displacement than by the government or the communities themselves, he noted.
“Indeed, we were shocked to see that disaster relief was tinged by communalism,” said Aravind Menon a public health student from Thiruvananthapuram. Dr Menon and his colleague Dr Ashis Das reported on discrimination in disaster relief following the 2004 tsunami.
In a related discussion, Dr Aasim Ahmad, senior lecturer in bioethics at the Aga Khan University, Karachi, noted that survivors of disasters should be treated as vulnerable populations when it comes to research. “Such research is essential for future disaster management efforts, but only essential studies should be done, and they should benefit the people participating.”
“Research on sex workers can actually increase their vulnerability,” noted Maryam Shahmanesh who described the complexities of participatory research with sex workers in Goa, where their homes were demolished by the government. “Is it ethical to ignore the plight of the disenfranchised community with whom organisations work? Are ‘target groups’ merely laboratories where interventions are tested? Do the organisations have an ethical duty to address the structural forms of violence that increase the vulnerability of these groups?”
Clinical trials, regulation and informed consent
Another rich collection of papers referred to various aspects of clinical trials in India. A number of participants pointed out the growing trend of trials in this part of the world, sponsored by commercial organisations in the West.
“There has been a 300% increase in the number of such trials in India after the introduction of the amended Schedule Y,” noted public health researcher Brady Beecham, referring to a clause in the Drugs and Cosmetics Act which now permits ‘same phase’ clinical trials in India of drugs from abroad. Beecham and other researchers pointed to the various regulatory changes that have taken place in recent months to encourage India as a site for drug trials. Is such research exploitative?
Researchers in a separate study on informed consent in sterilisation services commented on the poor quality of information given to women. Also discussed were studies of informed consent in vaccine and microbicide trials. Many participants noted that one of the most interesting sessions was on community involvement in clinical trials, specifically referring to HIV-related research.
Violence and medical ethics
“Violence is emerging as one of the leading causes of death for women in the reproductive age-group -- and this is also true in India,” said Manisha Gupte, co-convenor of the women’s health organisation MASUM, in the third day’s plenary. But health professionals are reluctant to take their responsibilities seriously in this area. So they don’t ask questions when they see wounds on a person in police custody, or when a woman explains away bruises or broken limbs as an “accident”. They may not even know what they should do -- how to collect and preserve evidence, for example. There were a number of related paper presentations from Mumbai and Vellore on collecting proper evidence, on the ethics of doing research in such situations, on ensuring that services for violence survivors respect their rights, and so on.
Ethics and public health
Finally, in the concluding session, virologist T Jacob John from the Christian Medical College, Vellore, spoke on the difference between medical care and public health, between medical ethics and human rights. Medical care is guided by the ethics of the doctor-patient relationship, in which the patient’s needs are paramount, whereas public health functions in the interests of the larger group. Public health can also clash with individual people’s rights -- for example, the rights of infected people. This traditional view of the conflict between public health and human rights has shifted with the HIV/AIDS epidemic. For the first time, the HIV-positive person is seen as a part of public health efforts.
The second National Bioethics Conference is planned for November 2007. If the various collaborating organisers can keep up the momentum from this first conference, one can look forward to the development of a community of healthcare providers, researchers, activists and policy makers concerned with this subject, in India.
InfoChange News & Features, December 2005
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