Bioethics on trial

At the first national bioethics conference held in Mumbai, the discussions centred on India as a hot destination for clinical trials and medical research.

HAS India become a massive human laboratory? What does the country offer that makes it one of the most attractive destinations for medical research in the world? And the more fundamental question: Is the research being conducted ethically?

The first National Bioethics Conference held recently in Mumbai addressed these and other important issues concerning the medical profession and its related industry. Organised by Indian Journal of Medical Ethics (IJME), the conference brought under one roof government and non-governmental organisations, including some international bodies, think tanks, research groups, activists, and government and private educational institutions to debate and discuss the ethics of the profession and industry.

While the central theme of the discussions was unethical practices in the medical arena, almost every debate brought out the point that India has to pay more attention than it does to issues surrounding medical and pharmaceutical research. With some of the papers outlining the use of unethical research methods in ongoing trials, the concerns of the medical fraternity in this regard may not be misplaced.

Ethical issues in Human Immuno-deficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) and issues regarding day-to-day health care, organ transplant and sex determination were also debated at length and the papers and discussions invariably veered towards research ethics. The organisers believe that the conference was a platform for those who wanted to voice their views on this pressing concern and they hope that it will spur an aggressive movement to promote better ethics.

"India has become a big player in medical research. There has been a sharp increase in the number of clinical trials in India mainly because of the growing capacity for new drug development by the pharmaceutical industry in India as well as the opening up of the Indian market for the marketing of new drugs from multinational pharma companies," said Abha Saxena of the World Health Organisation (WHO) Research Ethics Review Committee. "Yet the regulatory mechanism has not been able to keep up with the growth of this sector," she added.

Abha Saxena conducted a workshop on Ethical Issues in International Research. She said: "The Government of India says `come to India', but it has to provide adequate safeguards. People must know why a test is conducted. They must be provided health care during trials. Apparently this is not happening. Also, the government should see how Indians would benefit from it. Therefore, there is a growing need to increase the awareness among policymakers and researchers, particularly when they deal with vulnerable populations."

India is an ideal destination for trials on account of its highly skilled medical professionals, sophisticated medical infrastructure and huge and diverse population. Earlier this year the government amended Schedule Y of the Drugs and Cosmetics Act to allow multinationals to conduct clinical trials on their own or in collaboration with domestic organisations. It has also lifted customs duty on research supplies. Also, procedures for regulatory approvals are not so stringent in India, although such approvals take three months as opposed to 30 days in the United States. Besides, the bottom line is that trials are "much cheaper" in India.

Given these incentives, clinical trials constitute a sector that is waiting to explode. In fact, Contract Research Organisations have mushroomed across the country, providing services ranging from the translation of consent forms to the identification of people willing to be part of a trial. Various industry reports estimate the clinical trials market in India to grow to $250-300 million by 2010 from the present $30-35 m.

Almost every big pharmaceutical company is present in India. Industry reports estimate that Pfizer has invested $13 million in research in India and it is at present conducting 20 clinical trials in the country. Eli Lilly India has about 17 projects going on in about 40 hospitals across the country and GlaxoSmithKline PLC has started seven trials recently.

Undoubtedly, India has among the best doctors available and the finest medical training establishments, but it is the population that makes it attractive for research, said Bebe Loff, head of human rights and bioethics at Monash University, Melbourne. India could be defined as a country in "Epidemiological transition". This means India has moved from being a country that is linked with diseases related to poverty to one that has diseases and ailments associated with industrialised countries, such as diabetes, cardiovascular diseases and oncology. "If a country is in that transition then it is useful for an international drug company or research groups to experiment, as it serves the high-income countries' interests," Bebe Loff told Frontline.

If the research benefits the population, it would seem justified. Yet most of the time the drugs experimented are patented abroad and are much too expensive for the population it was tested on. "This is what India has to check. India's population must not be exploited," she said.

Furthermore, if something should go wrong there is little recourse in India. "The legal system does not protect the way it does in some other countries. Who are the researchers accountable to? It can be safe to say that some people who are in trials may have never been to a lawyer, let alone seek the protection of one, she said. "It is imperative to have a more stringent system," said Bebe Loff. She added that Research Ethics Committees should play a proactive role in ensuring safe trials rather than just be a formality in the trial procedure.

"In 2005 there has been a 300 per cent increase in clinical trials in India," said Brady Beecham of the Achutha Menon Centre for Health Science Studies at the Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram. Presenting a study on the rapid increase in clinical trials in India, Beecham said a U.S. government web site, where it was mandatory for all drug companies to list their studies, showed eight or nine being done in India in early 2005, but by November the number had increased to 50.

Beecham said it was extremely difficult to get specific or detailed information on many of the trials. "This just goes to show how little knowledge the public has of these things. There needs to be much more transparency in the system - internationally and domestically," she told Frontline. Moreover, said Beecham, publication of negative findings must be made compulsory. This would save repeat trials with the same or similar drugs.

A paper on informed consent in the Indian context brought out an interesting aspect of the Western demand for informed consent clashing with cultural issues in India. The data brought out that gender dynamics, the family unit, financial constraints, and religion influenced the researcher-participant relationship as well as the decision-making process. The aim of the paper was to develop a culturally relevant model applicable to Indian community research.

In the U.S., to get Food and Drug Administration (FDA) clearance involves adhering to rigorous procedures and meeting strict regulations. The penalty for any manipulation is severe. A researcher in India being funded by a huge U.S. organisation must understand the importance of this procedure, said Richard Cash from the Harvard School of Public Health. Often the funding is attractive and the researcher compromises the community. A policy on international collaborations is extremely essential in order to protect people who are subjected to tests and those who use the medicine.

India, however, is not completely unobservant of unethical trials. Five years ago the expose of tests of anti-cancer compounds discovered by Johns Hopkins University researchers on 27 cancer patients at the Regional Cancer Centre in Thiruvananthapuram without obtaining their informed consent led to an exhaustive investigation, which included scrutinising the involvement of medical professionals (Frontline, August 17 and August 31, 2001 and December 16, 2005). In 2004, biotech firms Biocon India, and Shanta Biotech were hauled up by the Supreme Court for conducting trials of a new drug, Streptokinnese, on unsuspecting patients. There are checks, but they are not enough, say some doctors.

THE conference was divided into four sub-focus themes: ethical challenges in HIV/AIDS; ethics of life and death in the era of high-tech health care; ethical responsibility in violence, conflict and religious strife; and ethics and equity in clinical trials. HIV/AIDs-related issues attracted a fair amount of attention. Papers presented ranged from the informed consent for the AIDS vaccine trial participation in India, gender sensitivities while conducting trials for HIV/AIDS, ethical issues related to care of people suffering from this debilitating disease, policies and priorities and community involvement during trials. "In essence, HIV/AIDS seems to be an arena where massive bioethics, human rights and public health battles will be fought," said a statement from the organisers.

The epidemic has disproportionately affected the poor and the marginalised. HIV/AIDS elicits considerable stigma and discrimination, devastating the lives of the infected individuals. This has led to direct interventions by people living with HIV/AIDS in defence of their human rights, including their right to treatment, according to one of the papers presented at the conference. Health professionals and services are criticised for harbouring the same prejudices as a less-knowledgeable society. Researchers have been accused of reinforcing the stigmas and policy-makers have been criticised for either neglecting the issue all together or misusing the funds that pour in for tackling this epidemic. "This is an area which cannot be neglected. It is not a disease of `others'. Work in HIV/AIDS has to be streamlined and managed efficiently and effectively in India or the future will be very bleak for this country," said the paper.

An interesting area that the conference covered, which seemed topical given the number of natural calamities that have struck South Asia recently, was ethics in disaster management. Prof. Aasim Ahmed, a nephrologist at the Aga Khan University in Karachi, in his presentation, said humanitarian workers came across novel situations, resistant diseases and unique combinations of medical and social problems. He suggested that researchers must document these for reference in similar situations in the future, but care must be taken in the collection of data. It is difficult for the victims to say no to aid-givers and researchers as they are in a vulnerable position. They must not be exploited. The information obtained would be very useful in disaster management, hence an ethical framework should be in place for these situations, he remarked.

The conference achieved many things, said Amar Jesani, a writer with IJME. To begin with, 20 organisations, some of them traditional rivals, came together to host the event. "The fact that we were able to work in tandem towards a common cause has given the medical ethics movement a huge boost. It just shows people are interested in the moral aspects of medical care. We are confident it has triggered an interest among the non-converted, and lastly the journal's position has strengthened," he said. Funding for the conference came from the organisers in keeping with the spirit that the ethics movement must be autonomous and completely free from corporate funding.