The problem - or the possibility of ethics being eroded by considerations of profit - is certainly not unique to India. Thus, in 1997 there was a major controversy over a set of 15 clinical trials testing cheaper drug regimens to prevent maternal-foetal transmission of HIV in Africa and Asia. Some 16,000 pregnant, HIV-positive women were enrolled in the placebo-controlled trials. The problem was that these trials began after a drug called AZT had already been found to prevent such transmission by 50% or more, and furthermore was recommended to all HIV-positive pregnant women in western countries.
 
In other words, thousands of women in the trials were getting sugar pills to test the efficacy of the new regimens. If they had been enrolled in trials in the West, they would have received a standard course of AZT. When there was a major public outcry over this, the placebo-based tests were eventually discontinued. The response from the companies concerned (and US Center for Disease Control and the US National Institutes for Health which had sponsored the trials) was instructive, however. They acknowledged the "inherent tension between participants' risks and the public's benefits", but argued that the logistic problems of administering AZT in Africa, the drug's toxicity in malnourished women, and the cost, had made them look for "simpler, cheaper alternatives".
 
In India also there have been similar experiences. In 1997, there were trials relating to drugs for cervical cancer, conducted by the same ICMR which has specified the minimum ethical code necessary for such testing. In these trials, 1,158 women with cervical dysplasia were "monitored" to observe the rates of progression to cancer. Investigators did not obtain written consent from the participants on the grounds that most of the women were illiterate. Seventy-one women developed cancer; at least nine developed invasive cancer without treatment. Sixty-two women developed cervical carcinoma in situ before they were treated.
 
Apparently, the women were not informed that their lesions were known to progress to cancer. What is even worse is that any treatment seems to have been stopped once the study was over. In other words, the women who took part in the study on the expectation that they would receive better health care than otherwise, were denied medical help even when it was available simply for purposes of the test, and even allowed eventually to die.

The strongly economic aspect to this issue becomes even clearer when it is recognised that in both of these cases, poor women participants agreed to become party to the clinical trials because the known available medicines that could treat their diseases were so expensive as to be out of their reach. This problem of high priced drugs beyond the access of ordinary or poor people, is likely to intensify as the TRIPS agreement strengthens the monopoly patent rights of the very companies that are paying for such trials in the first place.
 
Regulation can only solve a part of the inherent problem in all this. After a major public campaign by some doctors and activists two years ago, the use of quinacrine pellets as a method of sterilisation was banned by the Indian government. In the few years before then, it is estimated that over 50,000 women in India and south-east Asia who were sterilised with the mutagenic anti-malarial drug quinacrine, administered with an IUD inserter, to cause inflammation and blockage of their fallopian tubes. There are all kinds of adverse side effects (including possibly cancerous growth) associated with this contraceptive method, which was being actively pushed by a few doctors supported by funds from western NGOs obsessed with population control in the developing world.
 
The banning of such quinacrine use was a major step forward, but it is thought that despite this ban, this contraceptive practice continues in many parts of the country, often with women who are not informed about the full implications and therefore unable too make knowledgeable choices. In some states the practice is fairly open and the justifying argument is made that this form of sterilisation is the preferred choice of the women themselves.
 
In any case, the whole issue of what is informed or voluntary choice becomes a very complex one, especially when other medical options are very limited and known drugs or medical methods are otherwise too expensive for the patient to afford. In this situation, simply to rely on the legal requirement of the "written consent" of the patient is to make a mockery of the spirit of the law. If in addition to this, the patent is illiterate or insufficiently educated, or is given the relevant information in a way which is barely comprehensible, the ethical issue becomes even starker.
 
But of course, it is precisely these conditions which make testing in Indian conditions cheaper and therefore more profitable for the companies concerned, which in turn is pushing the current relocation of such clinical trials. It works much in the same way as Lawrence Summers had once called (in an internal memo in the World Bank) for encouraging the export of "polluting" industries to the developing world, on the grounds that the costs of pollution were lower in such countries.
 
At another level, of course, this means that the Indian economy may have one more booming service sector export to rely on in the near future : one based on the poverty and vulnerability of the greater part of its population, and on the willingness of the system to place corporate gain over social good even in the basic area of human health.