BBC shows the World, The dark side of clinical trials
Much has been talked about the recent documentary on BBC World. Yeah, I’m referring to ‘Drug Trials, Dark side’, which investigated into the ethical lapses in clinical trials being conducted in India. It didn’t surprise me a bit, provided the fact that I’m aware of such practices being working in the same area.
I wont discuss those lapses here at the moment. Let us keep that topic for another day. With the factual data of unethical trials done in India and post BBC documentary, we have no choice but to accept the grave error. In most cases if not all, these lapses are because of the greedy investigator. One can argue of a malicious chain tracing back to the Pharma industry. But finally, the onus of informing the patient & guiding him comfortably through the consent procedure lies with the study doctor.
Having said that, it is not true that only Indian investigators are greedy and end up doing this. This can as well happen in the developed countries. USA has the most infamous clinical trials to its list. The matter of concern here is that an average Indian patient is not well informed of clinical research. He is not aware of the very fact of someone doing an experiment on him. He trusts his doctor and evading that ‘trust’ for some quick bucks is the worst possible crime.
Jane Barret writes in her article ‘How informed are the country's clinical trial participants?’ in response to the BBC documentary, “……The loss of this fundamental principle of research derives from a combination of poverty, ignorance, and total trust in doctors. Trial medication is free, patients are often in awe of their doctors, and it does not occur to them to ask questions.”.
Though it is relatively not practical (I may sound cynical) to eradicate such practices, we have every chance of minimizing it. Video recording of the complete consent process is one viable idea, which has been introduced by some sites. Properly structured IRB/Institutional Ethical committee is another requirement. I know of few IRBs that are there for namesake. There is a need to generate awareness about clinical research in general public.
Seeji.
PS: For trivia
Some infamous clinical trials in India
M4N trial in a Thiruvanathapuram hospital on Oral Cancer patients
Letrozole trial by Sun Pharma
Quinacrine in West Bengal
PPS:
An interesting part from the documentary which I overlooked has been captured by a fellow blogger, Kaumudi. ROTFL stuff...
“……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).”
The post on the BBC documentary was quite an eye opener.I heard about the M4n n Letrozole tragedy,but never gave a serious thought..
After going through the post I looked up the details of a few of these trials..
Implementing stricter rules,setting up 'properly structured' IRBs n video recording the IC procedure r few things(as u've mentioned) that can be done with good intent to mitigate the sufferings of the subjects
But how foolproof will that be is the question.More important is to generate public awareness.
The point Im trying to make is lets not depend on the investigator or the IEC to make the participants 'informed' of the downsides of a trial.
The problem is since the concept(of a cl experiment) is new to our people,they fail to understand its implications.
Its the onus of the society to organise meetings,use the media n the NGOs to generate awareness which is generalised n not confined to isolated patients entering trials without even knowing what a cl trial is all about.
Regulatory measures will only work when the people whose interest they r supposed to protect will make a conscious effort to stop being vulnerable...
Tinni
Anonymous says
in clinical trails most the diagnostic samples do not belong to subject under trials. All reporting is done at false bases.
Sample is some one else, sample is of some one else. No one comsume medicine.
System is so greedy it just make money and making good trips to other countries nothing more.