Clinical Trials in India

[Anoushka]

Last night I was watching this program on Tele about clinical trials being conducted in India. I have nothing against clinical trials. I would sign up as a volunteer for one if I know that it would be useful for at least a group of people in the future and if I am clearly explained what the whole thing is about and what I could expect to get out of it - both negative and positive.

They showed a few different cases.

1. A drug that wasn't ready for testing on humans in US got tested in India. The Doctor from John Hopkins in US got banned from taking part in any clinical trials in her life when they found out. But she is considered a humanitarian in US. How can someone like her do something like this? Is the value of life in India any different? This is neither legally correct nor morally correct - at least according to me!

2. Most patients were not informed that they were a part of clinical trials.

3. Some people were taken off their current medication for a period of time before starting the clinical trial. Reason being they wanted to flush the body of the effects of current medication before doing their tests with their new medicine. In some cases they were given placebos as a part of their test. People were misinformed about their current medication - as in, some of them were told that their medicine has been taken off the shelf so they have to use a new medicine which comes for free.

4. After the trial period, the patients were taken off their new medication and started back again on their original medication.

5. None of them got paid anything extra to undergo clinical trials.

They actually interviewed doctors, patients from different parts of the country (Kerala, Ahemdabad, Bombay) and also a doctor who actually let this info out and got thrown out of his job.

One of the doctors that was interviewed echoed my opinion and he also said, whatever we say, there will be at least 2.5 million people on clinical trials in India in the next few years easily!

I found it worrying that patients and their near and dear were not informed clearly (they were made to sign on consent forms without being explained what it was for). Most of them were either too poor (so free medicines would help) or too ignorant, or thought that their doctor was God and whatever they said would be right!

Do you think this is right? What can be done to change this so that people can make an informed decision on what treatment they could get?

[scorpio]

Anu- Which channel? :shock: Any idea if it is shown in India?

[Anoushka]

Scorpio: It was on BBC2. I am not sure if it was shown in India

This World: Drug Trials - the Dark Side

Documentary looking at how thousands of poor and illiterate patients are being recruited on to clinical trials in India to test new drugs for the West

http://news.bbc.co.uk/1/hi/programmes/this_world/default.stm

http://news.bbc.co.uk/1/hi/world/south_asia/4932188.stm

[NM]

Anou :
I've also read about the recently failed clinical trial in the Uk where several volunteers had severe heart problem (?) during the trial.
Clinical trials must undergo various steps from Lab testing to 3 phases in human testing - Phase one with healthy volunteers, phase 2 with small number of patients and phase 3 -larger number of population after which the drug gets approval and licenced to sell.....I guess these doctors are just cutting shorth the whole trial business and India is oen of the countries they get sue as scapegoat. I was watching a documentary last night where they talked about newly developed drugs for malaria which are 'tested' on actual patients with this disease without proper clinical trials phases ..and this time, the country is Thailand. A few months ago, similar trials were conducted in Africa...
I really think the hospital authority / govt should put a stop to this and impose a regulation..just FDA or TGA! :evil:

[ssanjinika]

padikumbothe ratham kodhikuthu.My GOD!! Why are Indians made scapegoats??That too by other Indians!!What a pathetic state of affairs.If there are clinical trials then it should be after informing the patients of all the effects of the new medicine.Let them make the decision whether they want to be a part of the trial or not.

[Lambretta]

padikumbothe ratham kodhikuthu.My GOD!! Why are Indians made scapegoats??That too by other Indians!!
Simple.....bcos the 'scapegoats' r obv. tempted by the 'other Indians' w/ $$$! :evil: :(


Let them make the decision whether they want to be a part of the trial or not.
'not sure if offering them $$$ wud help them in making decisions.....! :roll:

[ssanjinika]

Hey Lamby they were not paid any money.Did u read Anou's post completely? If they were told of the risks and then offered money for the clinical trials,then its totally their fault..but otherwise :roll:

[Lambretta]

Hey Lamby they were not paid any money.Did u read Anou's post completely? If they were told of the risks and then offered money for the clinical trials,then its totally their fault..but otherwise :roll:
Ok sorry.....misread it..!
But I'd heard of cases wher ppl. here agreed to go thru a similar risk bcos they wer offered money for it! :x :(

[ssanjinika]

yeah..that happens..but then you cannot blame anyone else but yourself rite?Those I guess are ok since the people know abt it and they agree to it inspite of the risks.

[Lambretta]

yeah..that happens..but then you cannot blame anyone else but yourself rite?Those I guess are ok since the people know abt it and they agree to it inspite of the risks.
No, like in the cases I mentioned ther r many ppl. who r in desperate need of money so they r easily taken advantage of in this way..! :(
Besides, my parents told me tat they'd heard of one such case happening in the US too! (wen we wer in Baltimore).....

[r_o_j_a]

it is not fair in order to have medical treatment , they must consent to clinical trials.

i think this is the current situation in Africa where it is a tit for tat deal for better medical access. This was highlighted in the recent film The constant gardener.

recently nearly more than 5 ppl were critically ill after a clinical trial went wrong in the UK. the uk govt. proposed to look deeper into clinical trials in the uk . apparenly they were paid 2 do the trials. The bad part is that the pharmaceutical company cant be sued for compensation and the "human guniea pigs" dont get a penny for the clinical trial.

[Anoushka]

I am not against clinical trials, only against doing it without letting the concerned people know.

NM: I do remember the trials that became a problem in UK where people got really really sick. But in those cases, they were informed that it was clinical trial.

Roja: In most cases in India, it is the poor people in India that can't afford medical treatment that is lured into this by telling them that they get free treatment!

SS: I had the same feeling too when I saw the program, I was quite upset that is the reason for starting a thread here!

Lamby: Clincal trials and experiments happen all over the world but in some countries like ours, the patients are exploited :(

[RP]

Regarding Clinical trials..........personally have seen tremendous changes in the way they r being handled.........and there has been a lot of professionalism now as comapred to 10 yrs back......
yet India has miles to cross...

[Anoushka]

RP: Are you a doctor? Or do are you in the medical field? Can you please throw some light on what is happening, please? I still can't get over what I saw and I hope things are seriously better now!

[nms]

In India we don't have enough laws or standards that has to be applied in the health sector.

The previous issue that got highlighted was pesticide residues in our Globally branded softdrinks.

Lack of laws helps them to continue their trials or businesses with just one thing in their mind "We are not doing anything illegal in India".

[RP]

RP: Are you a doctor? Or do are you in the medical field? Can you please throw some light on what is happening, please? I still can't get over what I saw and I hope things are seriously better now!

Well yup am a doc(though I consider myself in the wrong field!!)
Sorry have'nt seen what u saw but yes .......clinical trials in India need to go a long way.........things r better than say 10 yrs back :) but I think we r 5 yrs behind ...... :cry:

[Anoushka]

Thanks for responding RP. If you do hear or see anything on this topic, can you please post it here.