A nation (1.1 billion strong) of guinea pigs

I just finished watching a BBC documentary on unethical drug trials in India (can't stop thinking about this topic). Anybody else who's interested (and has an hour to spare) should watch it too.
http://news.bbc.co.uk/nolavconsole/ifs_news/hi/newsid_4700000/newsid_4702800/nb_wm_4702883.stm

Better still, just read my take on the issue. Well, it looks like heads are turning and hearts warming, to this menace of unethical drug trials conducted in India without the informed consent, or at times, without the KNOWLEDGE of patients. It was appalling to hear a central officer in the drugs control commission trying to sell India as a great 'site' for testing experimental drugs. Not only are there a lot of patients here covering a broad spectrum of diseases but most of them are 'treatment naive'. For a trial to be statistically sound, confounding variables (like previous treatment) need to be removed from the subjects, so that one can say with confidence that the effect seen after administering the drug can be attributed to the drug alone. So, a statistical ideal would be a naive patient who has been diagnosed but not treated at all. I am sure you realise that in real life, one cannot expect a recently diagnosed patient to throw caution to the wind and try out a completely new drug that has previously only been used on lower mammals when other well-established alternative treatments exist. So, while the rest of the world ensures that experimental drugs are resorted to only as a last alternative, Indian authorities jump up and down with glee, probably thinking of how much money they are going to make.

And it does seem to boil down to money. The BBC documentary disclosed that while patients are not compensated for their participation, doctors are paid for every patient they can recruit to the trial. Think of the kind of patients who belong to the 'treatment naive' class. After many attempts at evading this uncomfortable topic, the Drug Control Commission officer admitted (or rather, was trapped into admitting) the reason why these patients have not sought out any treatment for their illness. The main reasons are that they are (a) poor, (b) illiterate and ignorant or (c) both. As a graduate student on a meager stipend, I understand how eye-catching the word FREE can be. But in the documentary one Indian doctor admitted that often, the only word the patient understood in the consent forms (written in English) was just that... FREE. When given a choice between no treatment and a suspicious one, what would you choose? Will your answer change if I tell you that only one of five drugs tested in humans is approved. Also, the reasons for unsuccessful trials include fatal toxicity or paralysis.

There are alternatives to using 'treatment naive' patients for a study. One can for example, 'wash-out' the effects of prior treatments by keeping the patients off them for a while. But which self-respecting drug company will deviate from the absolute ideal which is available with a little manipulation?

Another complicating factor is the involvement of researchers in the dealings of drug companies which was clearly at play in the M4N trial conducted in India without informing patients. M4N was suggested to be a potential anti-cancer drug by Dr. Huang of Johns Hopkins University, USA. Since regulations in USA require that the drug be tested on two lower (less complex, to be politically correct) mammals before being tested on humans, trials for M4N could not be conducted on US grounds. So to speed things up, India which allowed the trial was chosen as the trial site. Researchers are always eager to see their discoveries out in the market, but I believe it is unethical for them to have any role in the actual clinical trials themselves in order to completely exclude the bias introduced by 'personal ambitions'. In the M4N case, the institution home to Dr Huang was an indirect stakeholder in the drug company (Biocure) and Dr Huang's lab shared a close relationship with the director of technologies at Biocure. Inspite of these allegations, Dr. Huang's career is still more-or-less unharmed and she still claims M4N as one of her major research interests.

I find it odd that the documentary ignored the comments of almost all patients interviewed that they likened their doctors to Gods. It comes as no suprise since the practitioners of medicine in India have for long encouraged a no-questions-asked stance from their patients. I myself have had a firm belief in the commonly held view that Indian doctors are among the better doctors in the world. However, my current experiences with doctors in USA has modified my opinion. It is the doctor's responsibility to keep abreast of new research and take an interest in the process by which new discoveries get fixed in the community as established fact. Indian doctors (well, most of them anyway) are seriously lacking in this respect. If any doctor should be empowered to conduct clinical trials (s)he must be tested on his understanding of the ethics and statistics involved. Otherwise, the trial has no meaning.

On a funnier note, GSK allowed the documentary team to capture on video a patient being signed up for a drug trial. It was nice to see that the doctor started to explain everything on the consent form to the patient in English, but switched to Marathi on the insistence of the patient. The patient asked if he will benefit from the treatment. The doctor replied in marathi that he will (!!) and went on to explain to the BBC reporter that he had said it could go either way. I guess he had not that anticipated a Marathi mulgi will ever watch the documentary (Oh, the advantages of being multi-lingual).