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Are foreign pharmaceutical giants making Indians guinea pigs in clinical trials?

August 28, 2008
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49 babies out of 4,142 dead in clinical trials conducted by a foreign pharmaceutical company in India…this implies two things. One that the babies died due to the drugs tested and two, that foreign pharmaceutical companies are exploiting us. So how much truth is there in these implications?

Financial advantages (India):
India is the world leader when it comes to bagging outsourcing jobs in clinical research. It has double the market share of its nearest competitor, Italy, and nearly four times as much as the next in line, Spain. In 2005 contract research in India was valued at $100-120m and growing at a rate of 20-25 per cent each year. (Chemical Pharmaceutical Generic Association). Other projections (McKinsey report) say that clinical research in India will be a $1bn (€800,000m) industry by 2010.

Other advantages (India):

  • Foreign sponsors must adhere to international rules and this could force India to better its regulation and monitoring process. India has certainly streamlined regulatory approval procedure and more regulation is on the cards.
  • Infrastructure improves…in fact new clinical research centres are being built and people are being trained.
  • Outsourced trials bring new technology, treatments, diagnostics and drugs to India.

Financial advantages (International pharma companies.)
The average cost of running a US-based clinical trial per patient is $19577. In India it can cost up to 60 per cent less than in the US. Getting trials done in India also saves time as not only are more people available, they are easier to convince. In the US patients with decent healthcare and health insurance will be reluctant to participate as they see few benefits. Time is money for the companies, particularly as patents are given to drug companies for limited periods.

The murky side
So these foreign companies come here to profit…but before we blame them we need to know that our own companies can be lackadaisical in carrying out clinical research. There was this incident where 200 adolescent students from an elite school in Delhi were stripped and examined (without permission from their parents). All this was done by a private research group called Health Care and Research Association for Adolescents (Noida-based). Other Indian companies like Bangalore-based Biocon and Hyderabad-based Shantha Biotechnic as well as Mumbai-based Sun Pharmaceutical Industries have come under a cloud for conducting medical testing of drugs without following proper procedures.

Patients often don’t know they are being tested
I think this is an important point which is often glossed over. The TIME article (all references are given at the end of this post) mentions that “despite regulations” most patients are not told by doctors that they are taking part in a trial. Doctors, hospitals are in cahoots as they gain financially.

My personal experience: My mother-in-law was given an injection just before her cataract operation and when I asked the nurse what the injection was for I got a vague answer. After my mother-in-law was wheeled into the OT, I confronted the nurse. He was aggressive and rude, but admitted that the hospital was conducting a ‘study’ on older patients with cataract and as they were doing this for the “benefit” of patients why the hell was I complaining! He had the temerity to tell me that they cannot inform patients in advance as patients will refuse!

This can happen to anybody…and makes me wonder how many unsuspecting patients are unknowingly participating in medical studies?

Clinical trials carry risks
All clinical trials carry a certain degree of risk, and some can be outright dangerous. For example Mumbai based Sun Pharmaceutical Industries Limited conducted trials where patients were given an anti-cancer drug to see if it would induce ovulation, despite the known toxicity of the drug to embryos. Another example: The world’s biggest pharmaceutical company Pfizer announced that clinical trials of its new cholesterol-reduction drug Torcetrapib were being halted due to the high death rate among the 15,000 trial subjects spread over three continents. More examples here.

In clinical trials victims cannot claim damages as they often agree to waive such rights before participating in trial.

Risks for Indians
It has been alleged that poor and illiterate patients and sometimes even mentally ill patients in India are being used for clinical trials. Patients being illiterate often do not understand the risks nor do they understand their rights. And at times they don’t care because at least they have access to medical facilities if they take part in a trial. In any case, as mentioned above, patients are often not told at all (even educated ones) that they are taking part in a study or trial.

Negligence during trials can happen due to untrained staff doing the work. India has a shortfall of skilled personnel in this field…hospitals turn a blind eye as they want to hurry through the trials.

Add to this lax enforcement of laws in India. So although we have good regulation regarding this issue, the monitoring body doesn’t really keep a strict check.

Considering that this clinical trial procedure is new in India, the likelihood of things going wrong is very high. Why, in the United States, even after 40 years of building this clinical trial infrastructure, there are problems!

Problems in clinical trials in the United States
A recent survey of clinical trial participants in the US has shown that “the informed consent process is not up to scratch”. Here are the findings:

  • 3 percent of respondents said that they “did not receive an informed consent form prior to starting the study.”
  • 9 per cent of those who got the form admitted that they read it only partially
  • 3 per cent admitted they did not read it at all!
  • 27 per cent of survey respondents said that no one reviewed the informed consent with them
  • 24 per cent said they did not understand that neither they, or their doctor, would know what medication they were receiving during the study
  • 21 per cent said they did not realise that their study would carry ‘additional risks and discomforts.’
  • 4 per cent of those surveyed did not realise they could quit the study at any time
  • 10 per cent said the information they received prior to the trial ‘did not match their actual experience’ or that they had in fact received ‘no prior information.’

If this is the case in America, what can we expect in India where this industry is in its nascent stage?

So were those babies harmed?
When it comes to the current scandal, that of 49 babies dead, one cannot help but be suspicious. The AIIMS (All India Institute of Medical Sciences) has denied that the deaths are due to the drugs administered during the trial. The deaths, says AIIMS represent the “normal mortality rate of 1.8 per cent.” An internal five-member commission of inquiry has been set up, but in any case considering that the inquiry will be internal, one cannot be 100 percent sure that the truth will be revealed.

(References: [1], [2], [3][4] and [5] )

(Photo credits: First photo is from echinachem.com and the second is copywrited to me)

Related Reading: Indian students made guinea pigs in sex study
Do we value life in India?

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41 Comments leave one →
  1. compulsivewriter permalink
    August 28, 2008 10:00 am

    my goodness! its very scary… How can the hospitals conduct these experiments on patients without their consent? It enrages me…
    Hope your ma-in-law is doing well. Wish her a speedy recovery🙂

    enrages me too…I was so angry that say! But it happened last year, but when we went in for the second operation, we chose another hospital, not the “famous” one this time. Wockhart btw, is the hospital we went to the first time. – Nita.

  2. August 28, 2008 10:13 am

    Worry not, the market forces will take care of these problems in due time – there has to be at least one pharmaceutical company that is ethical, and the market will reward it while punishing the unethical ones. Besides, the pharmaceutical companies are responsible only to their share-holders and increasing their profits, rest all is irrelevant. And to make an omelet, some eggs need to be broken – think of the cure that will save the lives of thousands of people.
    /tongue-in-cheek

    Amit, thank god for your last line or rdoc might have actually thought he had converted you!🙂

  3. August 28, 2008 10:13 am

    cheap labor, cheap standard of living, cheap life… it seems like too much human resources have been more of a curse than a boon to us and the U.S…. I cant imagine how easily people can actually agree to be a part of “such” studies…

    Pharma firms have always been on the line of endangering human life and moral cause.. such a what-can-be-such-a-noble work is just transformed into money-swindling-motion…

    The Great Pharmaceutical Hoax : http://hypocrisytoday.com/drugs.html

    Rashmi, I guess poor people can think they can benefit, but often they don’t know. – Nita.

  4. August 28, 2008 10:22 am

    well nice we let them do whatever they want…it is wrong to hurt any creature,can’t they come up with some other way to test? Shouldn’t they first come up with a way where no one is harmed?And if these companies who are world leaders,do such things,then what example are they setting?

    the only example they set is the balance sheet example. – nita.

  5. August 28, 2008 10:57 am

    There are lot many more issues and more complicated than meet the eyes. Though we are always ready to blame the international companies, our own are not so great. Also the yu have not idea how patients can behave and what goes on on the other side of the table!

    Though that doesn’t exclude anybody of their resposibilities starting from DCGI to pharma companies to doctors to patients themselves!

    everybody has a responsibility, true. every patient if he is educated, should read the forms, if that is what you meant. however I think that just to be on the safe side, it should be explained to them too, to avoid complications later. – nita.

  6. August 28, 2008 12:14 pm

    seems people have known this for a long time….

    There was even a tamizh movie based on this couple of years back.

    http://en.wikipedia.org/wiki/E_ (film)

    you think anybody cares….if its done on poor people?

    no one does…not really. If these babies who died had been rich babies, the tv channels would be airing this news day in and day out. – nita.

  7. August 28, 2008 1:47 pm

    This is shocking! How’s your mom in law doing?
    I think we need stringent application of laws that requires forms being read out to the illiterate in front of witnesses, and every patient MUST be informed of what is being done to them. Allow the patients to sue and win a few cases against AIMS (49 babies can’t die just like that), and other research institutes- so the Institutes know they are not unaccountable and patients know they are not helpless. Just think of these babies’ parents!

    well, this happened some time back and as i have no idea what the doctors were up to, I have no idea whether the injection had any effect. no one told us anything. my mom-in-law being naturally healthy is doing fine. – nita.

  8. August 28, 2008 2:24 pm

    @ Amit: I don’t think R-Doc has read it yet😉

    @ Nita: Interesting post, right up my street!

    Drug trials also go hand in hand with diseases in a region. One couldn’t possibly run a trial for Tay Sachs in India for instance. There is an alter native view that is gaining ground – that poor countries are the best teachers of doctors. Doctors see diseases that do not occur in their home countries but are now being brought there by the great masses of travelling humanity.

    Many western countries do not have adequate legal provisions for prosecuting their home-grown firms for egregious behaviour abroad. The US does and there are several pending cases against big pharma firms in US courts against their doing immoral stuff abroad (in Africa mostly). Even when legal provisions exist, an interested – and reasonably deep-pocketed – party must lodge a lawsuit and there must be some belief that the cases will proceed and come to trial or be settled out of court for damages. In case of India, we are quite weak on several fronts altogether and combined with poverty, illiteracy and resultant desperation, that makes for a potent combination with not always desirable consequences.

    There is also the clinical aspect highlighted in the US study you cite. Explaining risk is a very tricky job. Informed consent is complicated by things such as the age of the subject (a child for whom consent must be given by the parent, whose judgement may be clouded by emotion and desperation) and the difficulty of explaining probabilities of success. We haven’t yet added illiteracy into the mix! In the UK, there are clear guidelines for clinicians to communicate with patients in trials and the ethics committees oversee the wording of such communication.

    That said, in an alert democracy, on a path of evolution, there is still hope. I would not wish a repeat of the Tuskegee Trials on India but may be the hand of the regulators will be forced by a tragedy, nothing less. But yes, India does need a speedy clean-up of regulation and more importantly, enforcement in this area.

    Good post, if I haven’t said that already🙂

    Thanks Shefaly. Your additional points are valuable inputs to the post. I agree that informed consent is a very tricky area. The chances of mis-communication are very high indeed, even with educated patients, as you pointed out. And also one so often assumes that the other has understood. – nita.

  9. August 28, 2008 2:25 pm

    @ Nita:

    Sorry to add:

    “..a child for whom consent must be given by the parent..” – this is strictly true where the child is not deemed competent to say ‘yes’ or ‘no’ himself. In British law, we have precedence for establishing this competence; not sure re the US.

  10. August 28, 2008 2:50 pm

    Few years back, I did a research on clinical trials as a part of my project about pharmaceutical companies. I was surprised to find many case studies where victims (patients) sued the company because they were not informed of risks. Life stories of some of the victims said they did it for money, as they hailed from under-priveleged backgrounds. But they had no idea that they were putting their life at risk.

    When I read new about AIIMS, I was shocked. IT ahppened at AIIMS, one institute I respect. Why did they choose to use kids as guinea pigs? And fact that kids were involved here made the news story more heart-rending for me.

    Good post at right time.

    thats interesting poonam. sad to hear that patients were not informed of the risks, but can’t say I am surprised. and about AIIMS, it its happened there you can imagine what goes on in smaller hospitals. – nita.

  11. August 28, 2008 4:04 pm

    It’s kinda sad because when I was doing my cancer research at Roswell Park, there were four simultaneous clinical trials entering Phase III (human trials) and the only countries they were considering were India, Pakistan and China…

    Well, I guess the more dangerous it is, the more liklihood of it happening here! – nita.

  12. Vivek Khadpekar permalink
    August 28, 2008 4:07 pm

    @ Amit/Nita,

    You missed one a important point — the positive fallout in terms of population reduction. The gains of culling before people reach reproductive age are doubly beneficial — because the elderly population will continue to die or natural causes anyway.

    And if, as you say, the poor are most at risk, that is a further blessing — eliminating poverty by eliminating the poor.

    [Tongue-in-cheek].

    pretty chilling, tongue in cheek though it may be! – nita.

  13. August 28, 2008 4:35 pm

    And with more Pharmaceutical/Drug companies directly foraying in to hospitality/health care business like Wockhardt or Ranbaxy’s Fortis(Although Ranbaxy is selling its drug business), clinical trials like this will increase… coz. they will own the Hospitals and its employees where they plan to conduct clinical trials. Making their own internal systems(rules/regulation) for their own benefit.

    Well, if enough awareness is created, then patients can demand their rights. – nita.

  14. August 28, 2008 4:37 pm

    As far as Ethics go, in all businesses globally, ethics are followed after the work gets done, till its not done, lets just screw the ethics.

  15. krenim permalink
    August 28, 2008 5:02 pm

    Well lets look at this practically.Drugs need to be tested before being massproduced.What India needs is a competent regulatory body to a>oversee the trials b>Follow up with the patients to see that the practices are adhered to.

    Also, patients need to be made aware. – nita.

  16. August 28, 2008 5:36 pm

    @ Anshul:

    “As far as Ethics go, in all businesses globally, ethics are followed after the work gets done, till its not done, lets just screw the ethics.”

    That is a remarkably cynical view from a young person🙂 I have closely seen the processes at work in the UK and I have reasonable confidence that ethics are not ‘screwed’ in the process of approving and then overseeing clinical trials.

  17. August 28, 2008 5:52 pm

    @Shefaly: Should I change ‘globally’ to ‘in India’ to make it look like less cynical ?🙂

    & How do you know that I am ‘so’ young ?🙂

  18. August 28, 2008 6:16 pm

    @ Anshul

    It is not a question of changing ‘globally’ to ‘in India’. It is I think a matter of expectations.🙂 I expect firms to behave legally and ethically, which means when they do not, I do not dismiss those behaviours and instead challenge them. But may be I am too optimistic.

    As for what makes me think you are so young: it is a safer bet than the alternatives.😉 Few complain if they are assumed to be younger; but almost all are offended if you guess them to be older than they are.

  19. August 28, 2008 6:33 pm

    @Shefaly:

    Even I do expect firms to behave legally, ethically and in a socially responsible way, but not all firms run that way. And when I say “lets just screw the ethics”, its not what I advocate or support, I said it on behalf of those organizations who are unethical.

    //”As for what makes me think you are so young: it is a safer bet than the alternatives.😉 Few complain if they are assumed to be younger; but almost all are offended if you guess them to be older than they are.”

    This is something strange, I thought it was vice-versa. But may be I am too young😉 to think unlike that.

  20. Ulag permalink
    August 28, 2008 7:10 pm

    A very informative post Nita! But i don’t think its that surprising that such things are happening in India. There are so many scandals of illegal organ transplants. When those patients aren’t even informed that they are being operated for their kidneys etc. its hardly surprising that they are not informed about the kind of medication given to them. The difference being that this illegal organ trade happens in the more rural regions but clinical trials are conducted in prestigious medical institutions where people actually trust the doctor and the staff. My point is that if these major hospitals stop these tests the pharma corporates will simply move into the rural hinterland to carry out these trials and the situation will be far less transparent and out of control then. Therefore instead of a complete ban the hospitals must be directed to provide all information, regarding the test to be conducted, and its side-effects to the patient but that will result in lesser people accepting these trials. Hence its pretty much a vicious cycle.

    thanks ulag. agree, it’s not at all suprising that people are hoodwinked. I mean, I might have not even asked the nurse what the injection was for…we can have such blind faith in doctors. – nita.

  21. August 28, 2008 7:35 pm

    Nita, unfortunately in our country life has little value, especially if you are poor.In Tamil nadu 35 people lost vision after treatment for their eye ailments at a free eye camp a few days ago. The camp had earlier left 20 other people blind. They were being administered medicines to reduce pain. Preliminary investigations indicated the hospital used outdated medicines for post-surgery treatment, causing blinding of the patients. This is not the first incident, sometimes people die due to fake medicines, sometimes due to adulterated food or even liquor. The optimistic part is that things are going to only improve from here. With an active and independent media these incidents can’t be brushed under the carpet and gradually people will be held accountable for that. In the AIIMS case also people are asking questions and I am sure, sooner or later situation is going to improve.

    Prerna, these eye-camps are ostensibly to help the poor, but land up harming them! very sad indeed. I too think that because these things have come to light, things will keep improving. – nita.

  22. August 28, 2008 7:37 pm

    My wife has participated in several clinical trials and the consent forms always state there is a risk of complications and possible death from the drugs being tested.

    All clinical trials have a risk of injury or death. It’s a problem when the patients being tested are not informed of the risks. Since drug companies pay to have volunteers be tested, they face limited liability if a consent form is signed by the patient.

    thats interesting Brian. have you or she written a post on this? it would be very interesting to read about her experience. – nita.

  23. August 28, 2008 7:59 pm

    Wow, this is really bad. The other day I was reading in the Times of India that India is the home to the largest amount of poor people in the world or something. I guess when you have such issues, this is just another issue. The best possible remedy can be to make sure that these companies are not able to conduct human testing through Government hospitals which is where most poor patients end up anyway.

    well, the private hospitals are difficult to monitor, so one is not sure what will work. – nita.

  24. August 28, 2008 9:22 pm

    I had no idea about this. Thanks for the informative post.

    thanks Reema. – nita.

  25. August 28, 2008 10:20 pm

    Super post, very wide angled indeed!
    Well, Nita, what did you expect Amit to say?
    Thanks to all, especially Shefaly, for very good comments.
    There are several related issues:
    1. When it comes to research, do not forget that the greatest breakthroughs are largely done by multinational corporations. Whether it is anti-tubercular drugs or the latest anti-cancer wonder drug, it is a so-called ‘evil’ corporation that is making profit and extending benefit to society.
    2. As far as informed consent is concerned, it is a slippery ground: how can you handle patients who CANNOT handle information? I face it all the time. People in the US are not that different: how many of us read all the terms and conditions to websites (including travel purchase, membership, etc.) before clicking ‘I agree’?
    3. As far as I know, the larger companies follow ethical and legal norms very, very strictly: they stand to lose a hell of a lot by getting caught in some shortcomings. They get flak irrespective of doing trials conscientiously in case side effects are discovered post-facto. There are clinical monitors, ethics committees, and other formal check mechanisms to prevent illegal human exploitation (yes, Amit, you are right in thinking now: ‘so legal human exploitation is okay, is it?’).
    4. In India, often the ethics committee in a hospital doing an alleged trial consists of the owner of the hospital, his subordinate (superintendent or Medical Director) and the doctor (or his friend/wife): they then claim they have followed norms and got ethics committee clearance for doing some experimental procedure they want to learn and then encash upon.

    thanks rdoc. important points raised, particularly about the “I agree.” About the bigger companies being more careful, yes I agree, they have more to lose and therefore try to follow the norms. your point no, 4 is a typical examples of what can happen in a hospital. thanks for the insider view – nita.

  26. August 28, 2008 10:31 pm

    well , i was oblivious of this actually that patients can be used for testing without them knowing it ..
    its quite shocking..

    yep! – nita.

  27. August 28, 2008 10:36 pm

    I am speechless, this is an eye opener article for me. I always knew about the clinical trials that the drug companies do in US as I see a lot of ads that pay for these trials. They also mention side effects on the ads. I had a vague idea it might be happening in India too but not in this way. I am disturbed to hear these atrocities. I guess I have to be careful when I go to a hospital in India, or perhaps have a reliable well known family doctor.

    best is to ask questions, even to known doctors. – nita.

  28. August 29, 2008 1:03 am

    Nita🙂

    I don’t always disagree with doc and his analysis – the disagreement is more over what approach to take.

    ==

    Well, Nita, what did you expect Amit to say?

    doc, the same applies to you too, doesn’t it?🙂

    (yes, Amit, you are right in thinking now: ’so legal human exploitation is okay, is it?’).

    Assuming too much regarding what I’m thinking? A true objectivist would go by empirical proof instead of making assumptions, no?😉
    😀

  29. Ravi permalink
    August 29, 2008 1:28 am

    Nita

    I was doing this project on Micro devices and I need to take blood samples from human subjects. Before I did anything I was properly trained for lyke two weeks then I took a 4 hour online test on human ethics.

    When I first took the test I got only 72% and I was really shocked to the msg saying that I need to retake the test. The thing that sucked was I need to register on this website and while doing so I was asked to give out my adviser’s business ID to which it would automatically send my certificate saying that I successfully completed the test. It was such a pain in ass to take that for the second time and read those never ending boring moral fiber.

    My point is I barely did any of this regular clinical testing of human subjects. I inquire for students with specific blood groups and all this training was to make me aware of the importance of confidentiality of patient’s information. If a student in US has to go all through this tedious process how come in India they don’t even care to test drugs on people.

    This is really shocking to see that babies in India are used for clinical trials by drug companies. If our leaders don’t make this political then it shouldn’t start with hating American companies instead they can change the way in which these trials are carried out. Implement more regulations in choosing people for trials like age limit, persons and parents/guardians consent and good allowance.

    Please don’t start with hating America. If there is any place on this planet where cops (at least most of em) aren’t corrupt, women have freedom, people love each other as they are and irrespective of language/region/race/religion…it is only in US. Oops! I’ve started to deviate from the topic..sorry!

    Ravi, thanks for sharing that! you are absolutely right, we have a lot to learn from these countries where law is taken seriously. – nita.

  30. August 29, 2008 1:57 am

    @ R-Doc:

    “..often the ethics committee in a hospital doing an alleged trial consists of the owner of the hospital, his subordinate (superintendent or Medical Director) and the doctor (or his friend/wife)”

    Are you saying that there is no central ethics oversight of these trials at all? That would be extremely dangerous!

  31. August 29, 2008 6:07 am

    Nita,

    Thanks for the very informative post. Unfortunately in the world that we are living right now, it is inevitable to not face this issues. Pharmaceutical giants are busy making big bucks conducting illegal and uninformed clinical trials, whilst scientists are busy cloning humans. We are at the stage of our life where humans are defying god’s will and nature. It’s a disgrace.

    I am glad your mom in law is healthy. Thank god. I never knew that such barbaric act does take place in hospitals.

    Kiran

    thanks Kiran. you brought up the topic of cloning humans. I agree it’s a disgrace even though it is not for religious reasons. I feel we are fiddling with the laws of nature. These things should remain the stuff of SF. – nita.

  32. August 29, 2008 6:42 am

    While it is true that pharmaceutical companies run the trials, may I remind everyone that they only do so if an ethics committee has approved a trial, and they do not have any direct patient contact.

    If the public believes inappropriate trials are being done, then perhaps the ethics committees need more training.

    It is the doctors that see the patient that are responsible for informing the patients, not the pharmaceutical companies. If patients are not being consented properly, one should look at why the doctors aren’t doing that. There is only so much training clinical research monitors can give to doctors, but at the end of the day it is up to doctors individually to follow internationally accepted guidelines for running trials and informing patients.

    It is not in the best interests of pharmaceutical companies to run trials inappropriately as it puts at risk the chance the products will receive approval, should trial prove them to be useful products.

    And if pharma companies didn’t take on the commercial risk of developing new products, who would? Our governments can’t afford it. Do you want your taxes to triple?

    thanks Janelle for visiting and for the comment. there are pros and cons to what you say…I am tempted to agree woth you on many points, but I think the pharma cos need to take final responsibility and by law they have to – nita.

  33. Vivek Khadpekar permalink
    August 29, 2008 8:40 am

    @ Janelle:

    //It is the doctors that see the patient that are responsible for informing the patients, not the pharmaceutical companies.//

    So, you are saying, the pharmaceutical corporates are not accountable. This assumes, among other things, that the doctors themselves are well-informed. This often does not seem to be the case.

    And the kinds of “incentives” that pharmaceutical companies offer to doctors, to encourage patient participation in clinical trials as well as to endorse/promote particular drugs or procedures that have not been adequately tested, is legendary.

    I have this as unsolicited information from a number of intimate friends working on both sides. And let me assure you that the parties in question have reputations to protect.

    PS: It no longer surprises me that the term “hospitality industry” as I now see it used, sometimes apparently includes health care establishments.

  34. Vivek Khadpekar permalink
    August 29, 2008 8:46 am

    @ Janelle:

    //…if pharma companies didn’t take on the commercial risk of developing new products, who would? Our governments can’t afford it. Do you want your taxes to triple?//

    If, in return for triple the level of taxation, we get good preventive health care, environmental sanitation and hygiene, clean drinking water, clean air, uncontaminated foodstuffs and healthy, nutritious food — and also the minimum essential conventional health care at one-tenth of what we now pay for it, that would not be such a bad idea.

  35. August 29, 2008 1:48 pm

    This is a very complicated issue, with many sides to it. I agree with many of the comments too.
    This subject is very close to my heart, and I feel angry that the less aware and less informed public of developing countries are chosen as easy experimental subjects by International Drug Companies.

    But before complaining about foreign companies, we need to look in our own backyard, and assess how aware doctors and hospital management are about what is ethical practice.

    There have been incidences where Indian pharma companies restamped expired drugs and sold them again to retailers. So a certain Pharma company may be a very ambitious and aggressive corporate entity, just like a phone company or a software company. And equally prone to follow unethical and fraudulent policies to make money and establish dominance.

    The strongest opinions about any issue are held by people who really know little about it and have not faced the issue in any personal way. People who feel angry about trials (on humans and animals) – many of them would see it differently if a loved person is dying and a trial drug is offered.

    As for informed consent, many patients don’t want to understand, sometimes they cannot understand and sometimes they misunderstand.

    But that is no reason for us not to tell them the risks and the options. In my department (during my specialization), informed consent was greatly stressed upon, and we learnt how to be honest, considerate while trying to explain the nature of procedure/ treatment, risks and possibilities of failure. That needs a LOT of patience, perseverance and you also have the risk of getting a permanent hoarse voice. And it has its own dangers, like the patient running away before surgery, as you are promising him less than what the other doc in town (or worse, his village) is promising him.

    But when I worked in Chattisgarh for few months, my superior would once in a while advise me, “Don’t talk to patients, if you tell them so much, they will know things, aur sar pe chad baithenge. Why do they need to know such details? Just treat them!” But I did not change my ethics, because I know, if anything, I am on the right side (legally at least, if not ‘practically’ from money-making point of view).

    I am sorry to hear about the incident with your mother-in-law, exactly what I hate about the attitude in most of the hospitals in India.

    I didn’t know that a pharma company had knowingly sold expired drugs…that’s indeed shocking, but not so if one looks at them simply as profit making entities. unfortunately we expect more from a drug company as compared to a shoe company. And you said it, it is when the shoe is on one’s own foot that suddenly all theories go out of the window. and I am really shocked that a teacher was advising you such a thing! no wonder doctors are so reluctant to talk. But I never return to a doctor if he is irritated with my questions. And actually good doctors are not that hard to find, but if one just tolerates the one that one has, then one suffers. Many people have this attitude, of not changing doctors, taking any kind of treatment (I don’t mean medical) from them, rudeness etc. ofcourse finally the competence counts…funnily I have found that the most competent doctors are the most polite as well. just my experience. – nita.

  36. August 29, 2008 3:39 pm

    “If, in return for triple the level of taxation, we get good preventive health care, environmental sanitation and hygiene,…….”
    Vivek:
    There is such a place where all the criteria you list are fulfilled: La La Land!

  37. August 29, 2008 3:44 pm

    I guess people get paid for clinical trials in the United States.
    If the companies here want to test it on humans, then they should let the patient know and if he is ready, pay him aswell !!

    The news about the children death is shocking !

    //when I asked the nurse what the injection was for I got a vague answer. //
    This has happened to me as well, some doctors are rude if we ask them about the kind of medication they are giving us or what each medicine is for. I think we have the right to know.

    sure we have a right to know, but they don’t want to tell you and the more swanky the place is, the ruder they can be. we also get intimidated easily. – nita.

  38. August 29, 2008 6:10 pm

    Nita and others,
    Here is another example of how the clinical trial round may be so slippery: a Nature report released today. Warning: only for science buffs.

  39. jagmeet singh sapra permalink
    September 18, 2008 7:09 pm

    this is just one incident that has come to the limelight.No one knows how cleverly these companies are exploiting the Indians.Patient consent is must for performing a clinical trial and any firm which violates this should be imposed a ban for that particular molecule in addition to a heavy fine and should not be allowed to perform the clinical trials in the future in india.

  40. Nisha permalink
    December 26, 2008 3:52 am

    Some things that I remember from the time I worked for a Pharmaceutical company:

    For any clinical study data that is submitted to the drug authority of any country, signed informed consent from all participating patients is a must. That means you will be asked to sign something. As others have mentioned before, it is also necessary for someone to explain it to you, but that often does not happen or is kept to a minimum. Make sure you read what you are signing. There are limits to the minimum font size of this document and also they should be given in the participant’s language if they don’t understand English. The company also wants to know things like what other drugs the patients are taking at the same time in case it interfere’s with their drug. It is in the interest of the company to get all these things done properly as they stand to lose all the money and time that they have invested if anything is found to be done wrongly later. But the thing to be noted is that the study is not directly done by the company, but through other companies specialising in clinical trials, hospitals and doctors with god complex.

    Participants also are to be payed money, but only for the time that they put in to it and the money offered should not be so much that they will be tempted to overlook the possible dangers of the trial. Problem with this is that such an amount for an American will be absolutely irresistable for a poor unemployed Indian.

    I think when your MIL was medicated without her consent it most probably was for a student’s project where also they are supposed to get consent, but since it does not go through anything like a drug authority, but only through the hospital ethics committee, things were lax.

    Camps, if what I have heard from medical students is correct, are for learning/ practising. Doctors in India are strangely averse to being questioned or asked for details. They seem to get intimidated by informed patients and think that we are somehow challenging them if we ask for the scientific details of any treatment. My own aunt who was my doctor during my pregnancy got irritated with me when I asked her for details of the drugs being given and told me that I am the patient, she is the doctor and not to ask so many questions!! [In her defence, I did ask a lot of questions :)]

  41. piksss permalink
    March 17, 2010 12:36 am

    this our india .in one side it market is growing up…..and in other hand we are using illiteracy……..
    great work …………..nita

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