Too much information?
When India's Right to Information Act came into force in 2005, the legislation's text acknowledged the conflict that could arise from revealing certain information, pointing out that there was a need to 'harmonise' the interests of the public and those who used their democratic right to seek vital information. Lawmakers were wary of possible problems, and one exemption clause in the RTI Act thus specifically states that 'information which relates to personal information the disclosure of which has no relationship to any public activity or interest' need not be disclosed. However, a significant amount of information that lies outside the purview of this section is frequently sought. One recent example of a 'successful' RTI application highlights the potential for this potent legislation to lead to inadvertent results.
In 2008, the Indian media published information about an RTI request in which Rahul Verma, the founder of an NGO called the Uday Foundation for Congenital Defects and Rare Blood Groups, was seeking information about clinical trials from the All India Institute of Medical Sciences (AIIMS) in New Delhi. This revealed that 49 sick children had died over the course of 30 months in the AIIMS paediatrics department while undergoing clinical trials. Predictably, this led to public outcry and a media firestorm. News reports suggested that children below the age of one were being specifically recruited in these then-ongoing trials, and that children of parents below the poverty line were possibly being targeted for recruitment as guinea pigs. Many newspapers gave these stories catchy headlines that suggested bad patient care and neglect in AIIMS, as well as exploitation and maltreatment of sick children from poor families.
What is known is that from January 2006 to July 2008, 49 out of 4142 children participating in these clinical trials died, a death rate of 1.18 percent. The actual outrageousness of this figure is far from clear. According to data published by the UN's children's agency in 2009, the all-India under-five mortality rate was 6.6 percent from all causes. A recent paper published in the reputed medical journal Lancet shows that pneumonia and diarrhoea together account for nearly 50 percent of deaths in the age group of 1-59 months. Thus, the under-five year mortality rate due to infection would be around 3.3 percent. The death rate for newborns less than one month old is 3.4 percent, and the Lancet report indicated that 27 percent of these deaths are due to infection. As such, the death rate for newborns would stand at around 0.89 percent. Because the mortality rate quoted in the AIIMS study includes deaths in newborns as well as those less than five years of age, a mortality rate of 1.18 percent in clinical trial-enrolled patients cannot in truth be called excessive.
Further, while hospital care in all likelihood brings down mortality rates, big public hospitals like AIIMS which admit patients in advanced stages of illness referred by other small hospitals, can have higher mortality rates. While an old report from AIIMS states 2.3 percent as the net death rate in patients admitted to AIIMS during 1999-2000, a 2008 paper looking at distribution and proportion of death in the paediatrics department of R G Kar Medical College, in Kolkata, reports a 9.87 percent death rate in all children admitted to the hospital over the course of a year. Though any death is a loss of precious life to the family involved, the death rate observed in AIIMS was, again, not unusually or worrisomely high.
A second point of contention involves the fact that children below one year of age were recruited in relatively larger proportions. It is well known that newborns are extremely vulnerable to infection and other illnesses, followed by children up to one year of age. Data from Kolkata, for example, show a gradual decrease in the proportion of children dying due to sepsis as they get older. Thus, the selection of children below one year of age in the AIIMS trials was most likely due to the fact that this is the most frequently affected population among sick children.
What about the charge that the clinical trials were targeting poor people? AIIMS is an autonomous but government-funded institution, involved in both premier medical research and teaching. Today, however, it caters to many more patients than it is technically capable of handling. The load on such hospitals has steadily increased over the years due to the apathy of central and state governments in putting money into primary health care and in health-care reforms. While patients from higher income groups are charged for their treatment, poorer patients typically get treated for almost no cost. It is no surprise, then, that the majority of those treated at AIIMS (as outpatients or in-patients) are from poorer sections of society. It would therefore not be surprising to find a large number of children recruited in the clinical trials coming from the poor sections of the society, including those below the poverty line.
Pity public health
Over the past decade, India has become a popular destination for multinational companies to conduct clinical trials. The reasons for this include an abundance of potential patients; the regulatory frameworks have been very poorly developed, making it fairly easy to conduct trials; and the expense of conducting trials in India is much lower compared to developed countries. Also, in comparison to some other developing countries, medical manpower in India is well-trained and fluent in English. Seeing the demand for running clinical trials, it is perhaps inevitable that many private organisations have come up to fill the need.
Still, there are also changes taking place. The Indian Council of Medical Research has revised guidelines for clinical trials and is attempting to fine-tune them further. Registration of every clinical trial conducted in India is now compulsory. The main regulatory body, the Drug Controller General, is also trying to tighten its work procedures. While the situation is not satisfactory, one can see a distinct improvement in the conduct of clinical trials in certain sectors, particularly in public hospitals in metropolitan areas. There is good reason to believe that clinical trials conducted in India's premier medical research institute, AIIMS, have also changed for the better.
It is in part due to the adherence to international norms of quality that this RTI case has led to a very unfortunate result. Well-performed medical trials depend on a strict regime of rules. To avoid the inherent biases of the treating physicians, such trials are conducted in a 'blind' fashion, wherein the physician does not know whether the patient is in the standard treatment group or in the experimental treatment group. Until the trial is over, identification codes are kept secret, a recommendation made by national and international norms. In the RTI case, in order to provide timely information in response to the application, the code for a trial wherein these 49 deaths had taken place had to be broken before the end of the trial period. The code had to be broken because it was necessary to ascertain how many of the 49 deaths were from the standard treatment group and how many from the trial treatment group. Analysis of the two groups of patients – one receiving normal treatment for sepsis and the other receiving an additional trial treatment – showed that the addition of the trial component was, in fact, proving to be beneficial to children with sepsis. Fewer children had died in that group as compared to those receiving normal treatment.
Since the trial code needed to be broken early, however, it is quite possible that the data, while suggestive of a trend, might not have been definitive enough for robust conclusions to be drawn. This means that an RTI application might have inadvertently caused the loss of all the funding that had gone into designing and conducting this clinical trial, aimed at better treatment of sick children.
In all of this, the media's role is perhaps one of the most important to analyse. It is also the case that many of India's elites, including the English-language news media, consider public hospitals to be overcrowded, dirty and a waste of public money. Consistent with this, year after year there is weakening of the public health system, along with encouragement for private hospitals to step in. In fact, India's health-care industry, including medical tourism, is now considered one of the highest-paying industries in the country. Given this context, it was not surprising to see detailed coverage of the AIIMS RTI findings and the resultant patronising anger it evoked from the people who do not use AIIMS.
It remains relatively uncommon for the media to show private hospitals in such a bad light, despite news of patients being mishandled in poorly regulated clinical trials in such hospitals. But then, the owners of media houses tend to belong to the social upper crust with strong links to the private sector themselves – and therefore could understandably be more in favour of, or at least personally invested in, private as opposed to public health care. Meanwhile, neither private hospitals nor media houses fall under the purview of the RTI, and hence no information about them can be brought to light through the legislation.
It seems then, reflecting on the use of RTI in this particular case, that it is a double-edged sword. While it is a boost to civil society activism in India, its usage has begun to reveal its intended or unintended consequences that the civil society and lawmakers would do well to consider seriously and respond to.
~ Vineeta Bal is a researcher in immunology, a feminist and a peace activist based in New Delhi.