The Hindu, Sunday Magazine, June 12, 2011
THE OTHER HALF
Falling ill is precarious business anywhere in the world. But in India, if you are poor, or live in a village, overcoming even routine illness can sometimes become an insurmountable hurdle. First, there are few health facilities within reach. Those that exist are ill equipped. Doctors don't come. Medicines are not available. Even if you somehow make it to the nearest district hospital, there is no guarantee that you will be treated. And if you seek private care, something 80 per cent of Indians are forced to do, you will end up permanently in debt. Most Indians have no health insurance.
Better than nothing
In such a situation, if someone approaches you and says they will actually pay you if you agree to take a new treatment for an illness that you have, most poor people would agree. What harm can it do? Often doctors, in whom the majority of patients put their complete trust, endorse the trial.
But harm there can be, and is possible from participating in what are ‘clinical trials' where new drugs are tested for their efficacy on humans. And despite regulations, codes of ethics and monitoring, every now and then we hear of people who die during these trials.
Last year, an intervention by a women's health rights group, SAMA, exposed the manner in which a study, where tribal girls between the ages of 10-14 years in Andhra Pradesh and Gujarat were given the Human Papilloma Virus (HPV) vaccine that prevents cervical cancer, went horribly wrong. Seven girls who received the vaccine died. Their parents believed the reason was adverse effects of the vaccine (see The Hindu, Sunday Magazine, April 18, 2010). The SAMA report prompted the Central government to set up an inquiry committee to look into the study and in the meantime asked that it be suspended.
The report of the government committee appointed on the HPV vaccine study was released in February this year but became public only a few weeks ago. Although it concludes that the seven deaths were “most probably unrelated to the vaccine”, it also adds that “the cause of death in all the cases cannot be established with certainty.” And as for violation of ethical norms, it observes “several minor deficiencies in the planning and conduct of the study”.
However, it is these so-called “minor deficiencies” that can sometimes make the difference between life and death for people who are already vulnerable. In the case of these tribal girls in Khammam district in Andhra Pradesh and Vadodra district in Gujarat, the deficiencies included the absence of “informed consent” (the consent forms were signed by hostel wardens instead of the parents of the girls being informed and their consent sought). Furthermore, a proper procedure to monitor the health of these girls for adverse effects was not in place. This is particularly important as most of these girls were already undernourished. The committee's report notes that there was no uniform reporting system for Adverse Events Following Immunisation (AEFI), which included nausea, vomiting, diarrhoea and abdominal pain as well as giddiness, jerky movement and neurogenic shock. Worse still, the girls had no health insurance cover for treatment in case they fell ill on being vaccinated.
Consent by proxy
Although the committee does not indict either the drug company or the organisation that conducted the study, and also concludes that the inclusion of girls between the ages of 10 and 14 was justified given the nature of the drug, it has questioned the “legality and morality” of the circular from the Andhra Pradesh government permitting hostel wardens and head masters to sign the consent forms on behalf of these girls without informing their parents. It has gone further by stating: “The committee stresses that everyone shall desist from research on tribal population, unless of specific benefit to them.”
The HPV vaccine controversy draws attention to one aspect of clinical studies and trials, how vulnerable groups are roped in without proper consent and without health support in the event of problems. In this case, the connection between the vaccine and the deaths could not be conclusively established. But even where it is, the companies try and get away without paying compensation.
On June 6, newspapers reported that the Drug Controller General of India (DGCI) had summoned nine drug companies who conducted clinical trials that led to the death of 25 people. According to the DGCI records, last year, a total of 670 people who were part of clinical trials died. But the death of only 25 could be linked to the drugs. Of these, only five families were compensated within a range of Rs. 1.5 to 3 lakhs.
This news item gives us a small window into the ‘industry' of clinical trials in India that is worth millions of dollars. It has been clear for some time that these trials need to monitored much more closely. Some of this kind of scrutiny is taking place. Apart from official bodies like the DGCI, there have also been some independent studies. One of these, by Sandhya Srinivasan titled, “Ethical concerns in clinical trials in India: An investigation” for the Centre for Studies in Ethics and Rights, is particularly instructive. Ms. Srinivasan has looked at the trials of three drugs, a drug to treat breast cancer and two drugs for psychiatric conditions. Many of these drugs are expensive and it is tempting for those with terminal conditions, like cancer, to agree to be part of such trials. The report reveals the many loopholes in the rules and regulations that allow drug companies to appear to be sticking to the letter of the law while violating the spirit.
Going unnoticed
The ethics of human clinical trials is a complex subject that requires more space to discuss than is available in this column. But the two developments – the report of the government committee on the HPV vaccine and the DGCI's intervention on the question of compensation for trial related deaths – illustrates how so many things remain hidden until there is a crisis, or some independent group investigates. The problems remain hidden particularly when the people involved are the voiceless, like the young girls of Khammam district. Had it not been for groups like SAMA, perhaps no one would have ever known about what was going on.
This is not to say that new drugs should not be developed to combat disease. No one questions the need to test these on humans before they are licensed for use. But the process of certification of their safety should not lead to death or disability of those who are part of the trials. Nor should the precondition of consent be abused the way it was in Andhra Pradesh. And nor should the financial vulnerability of the majority of people in India when faced with a health crisis be cynically exploited for such trials. The onus is on the manufacturers of these drugs, who claim they are producing them to save human lives, to actually do so.
(To read the original click on the link above)
THE OTHER HALF
Falling ill is precarious business anywhere in the world. But in India, if you are poor, or live in a village, overcoming even routine illness can sometimes become an insurmountable hurdle. First, there are few health facilities within reach. Those that exist are ill equipped. Doctors don't come. Medicines are not available. Even if you somehow make it to the nearest district hospital, there is no guarantee that you will be treated. And if you seek private care, something 80 per cent of Indians are forced to do, you will end up permanently in debt. Most Indians have no health insurance.
Better than nothing
In such a situation, if someone approaches you and says they will actually pay you if you agree to take a new treatment for an illness that you have, most poor people would agree. What harm can it do? Often doctors, in whom the majority of patients put their complete trust, endorse the trial.
But harm there can be, and is possible from participating in what are ‘clinical trials' where new drugs are tested for their efficacy on humans. And despite regulations, codes of ethics and monitoring, every now and then we hear of people who die during these trials.
Last year, an intervention by a women's health rights group, SAMA, exposed the manner in which a study, where tribal girls between the ages of 10-14 years in Andhra Pradesh and Gujarat were given the Human Papilloma Virus (HPV) vaccine that prevents cervical cancer, went horribly wrong. Seven girls who received the vaccine died. Their parents believed the reason was adverse effects of the vaccine (see The Hindu, Sunday Magazine, April 18, 2010). The SAMA report prompted the Central government to set up an inquiry committee to look into the study and in the meantime asked that it be suspended.
The report of the government committee appointed on the HPV vaccine study was released in February this year but became public only a few weeks ago. Although it concludes that the seven deaths were “most probably unrelated to the vaccine”, it also adds that “the cause of death in all the cases cannot be established with certainty.” And as for violation of ethical norms, it observes “several minor deficiencies in the planning and conduct of the study”.
However, it is these so-called “minor deficiencies” that can sometimes make the difference between life and death for people who are already vulnerable. In the case of these tribal girls in Khammam district in Andhra Pradesh and Vadodra district in Gujarat, the deficiencies included the absence of “informed consent” (the consent forms were signed by hostel wardens instead of the parents of the girls being informed and their consent sought). Furthermore, a proper procedure to monitor the health of these girls for adverse effects was not in place. This is particularly important as most of these girls were already undernourished. The committee's report notes that there was no uniform reporting system for Adverse Events Following Immunisation (AEFI), which included nausea, vomiting, diarrhoea and abdominal pain as well as giddiness, jerky movement and neurogenic shock. Worse still, the girls had no health insurance cover for treatment in case they fell ill on being vaccinated.
Consent by proxy
Although the committee does not indict either the drug company or the organisation that conducted the study, and also concludes that the inclusion of girls between the ages of 10 and 14 was justified given the nature of the drug, it has questioned the “legality and morality” of the circular from the Andhra Pradesh government permitting hostel wardens and head masters to sign the consent forms on behalf of these girls without informing their parents. It has gone further by stating: “The committee stresses that everyone shall desist from research on tribal population, unless of specific benefit to them.”
The HPV vaccine controversy draws attention to one aspect of clinical studies and trials, how vulnerable groups are roped in without proper consent and without health support in the event of problems. In this case, the connection between the vaccine and the deaths could not be conclusively established. But even where it is, the companies try and get away without paying compensation.
On June 6, newspapers reported that the Drug Controller General of India (DGCI) had summoned nine drug companies who conducted clinical trials that led to the death of 25 people. According to the DGCI records, last year, a total of 670 people who were part of clinical trials died. But the death of only 25 could be linked to the drugs. Of these, only five families were compensated within a range of Rs. 1.5 to 3 lakhs.
This news item gives us a small window into the ‘industry' of clinical trials in India that is worth millions of dollars. It has been clear for some time that these trials need to monitored much more closely. Some of this kind of scrutiny is taking place. Apart from official bodies like the DGCI, there have also been some independent studies. One of these, by Sandhya Srinivasan titled, “Ethical concerns in clinical trials in India: An investigation” for the Centre for Studies in Ethics and Rights, is particularly instructive. Ms. Srinivasan has looked at the trials of three drugs, a drug to treat breast cancer and two drugs for psychiatric conditions. Many of these drugs are expensive and it is tempting for those with terminal conditions, like cancer, to agree to be part of such trials. The report reveals the many loopholes in the rules and regulations that allow drug companies to appear to be sticking to the letter of the law while violating the spirit.
Going unnoticed
The ethics of human clinical trials is a complex subject that requires more space to discuss than is available in this column. But the two developments – the report of the government committee on the HPV vaccine and the DGCI's intervention on the question of compensation for trial related deaths – illustrates how so many things remain hidden until there is a crisis, or some independent group investigates. The problems remain hidden particularly when the people involved are the voiceless, like the young girls of Khammam district. Had it not been for groups like SAMA, perhaps no one would have ever known about what was going on.
This is not to say that new drugs should not be developed to combat disease. No one questions the need to test these on humans before they are licensed for use. But the process of certification of their safety should not lead to death or disability of those who are part of the trials. Nor should the precondition of consent be abused the way it was in Andhra Pradesh. And nor should the financial vulnerability of the majority of people in India when faced with a health crisis be cynically exploited for such trials. The onus is on the manufacturers of these drugs, who claim they are producing them to save human lives, to actually do so.
(To read the original click on the link above)
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