Chemistry slaves
Sep. 20th, 2012 04:35 pm![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
nairiporterBayer Loses Drug Ruling in India
http://online.wsj.com/article/SB10001424052702304537904577277001285472654.html
Patent Agency Forces Drug Maker to Grant License to Local Generics Firm for Cancer Drug
This is a step in the right direction, which would hopefully transform the drugs market in the second most populous country in the world, and improve access of patients to life-saving medicines. It is a first step on a very long road to rectifying the rampant problem of pharmaceutical monopolies suffocating the local industry.
But then, there is this other problem, one that we could call the problem of "chemistry slavery". Western pharmaceutical companies regularly test new drugs on poor Indian citizens, many of whom do not even suspect they are being used as lab mice in medical experiments.
Of course the counter argument would be that they are doing this voluntarily. It is a fact that almost every big Western pharmaceutical company does its product trials outside of Europe or the US, and a large part of those tests are now done in countries like India. Last year the German company Bayer AG had to pay compensations for five fatal cases of test subjects. The amount was... 4000 euros per person. The ridiculous, even humiliating compensation had prompted the Indian government to work on introducing new rules that would force the companies to pay higher compensation in case of injury or death of trial patients.
At present, in order to license a given drug in Europe or the US, it has to pass several trial phases that would prove its efficacy and safety. And this of course costs a lot of money. And time, too. Because every day is of essence. The sooner a drug is released on the market, the cheaper its realisation would be for the producer.
In India the testing of new medicines is considerably cheaper than in the West. Besides, in a country like India one could find it much easier to recruit volunteers for the medical experiments. However the tests are supposed to match the international standards, as stipulated in the Helsinki Declaration of the World Medical Association. It requires that every patient, no matter how poor and illiterate, should be duly informed that they are taking part in an experiment, and they should know all the risks.
But the problem is that many of the recruits have never heard of the Helsinki Declaration. Some don't even know that they are participating in an experiment. The lab representative would often invite the patient to their private cabinet where they would offer them a "Western drug for free" for their illness. Then ask them to sign a few documents, explaining that these are "mere formalities". Once they have signed, the patients would involuntarily become part of the trials, and the company would eventually make enormous profits at their expense, as was the case with the company Boehringer Ingelheim. When the WDR television inquired about this case while making a documentary on the subject, the company replied that they had all the papers duly signed by the patients, the patients had clearly given their consent, and moreover the local independent ethics committee had issued a note of approval.
What they are omitting to mention is that anyone in India could create an ethics committee and issue such permits. That is what Indian medic and journalist Chandra Gulhati reports, himself having been a long-time member of such an "independent" ethics committee. The scheme is really simple: the committee gets paid, it issues the signature and puts the stamp. In fact, the ethics committees hardly defend the patients' rights. Everyone makes profit from this scheme - the pharmaceutical company, the doctor and the hospital, even the committee members. Except for the patient, who gets crumbs in return for risking their health and their life. The big Western companies know this too well, and that is why they flock into India. With the introduction of new rules that would give opportunities for the development of generic drugs, hopefully these monopolies will be broken, and less people would be compelled to become chemistry slaves.
http://online.wsj.com/article/SB10001424052702304537904577277001285472654.html
Patent Agency Forces Drug Maker to Grant License to Local Generics Firm for Cancer Drug
This is a step in the right direction, which would hopefully transform the drugs market in the second most populous country in the world, and improve access of patients to life-saving medicines. It is a first step on a very long road to rectifying the rampant problem of pharmaceutical monopolies suffocating the local industry.
But then, there is this other problem, one that we could call the problem of "chemistry slavery". Western pharmaceutical companies regularly test new drugs on poor Indian citizens, many of whom do not even suspect they are being used as lab mice in medical experiments.
Of course the counter argument would be that they are doing this voluntarily. It is a fact that almost every big Western pharmaceutical company does its product trials outside of Europe or the US, and a large part of those tests are now done in countries like India. Last year the German company Bayer AG had to pay compensations for five fatal cases of test subjects. The amount was... 4000 euros per person. The ridiculous, even humiliating compensation had prompted the Indian government to work on introducing new rules that would force the companies to pay higher compensation in case of injury or death of trial patients.
At present, in order to license a given drug in Europe or the US, it has to pass several trial phases that would prove its efficacy and safety. And this of course costs a lot of money. And time, too. Because every day is of essence. The sooner a drug is released on the market, the cheaper its realisation would be for the producer.
In India the testing of new medicines is considerably cheaper than in the West. Besides, in a country like India one could find it much easier to recruit volunteers for the medical experiments. However the tests are supposed to match the international standards, as stipulated in the Helsinki Declaration of the World Medical Association. It requires that every patient, no matter how poor and illiterate, should be duly informed that they are taking part in an experiment, and they should know all the risks.
But the problem is that many of the recruits have never heard of the Helsinki Declaration. Some don't even know that they are participating in an experiment. The lab representative would often invite the patient to their private cabinet where they would offer them a "Western drug for free" for their illness. Then ask them to sign a few documents, explaining that these are "mere formalities". Once they have signed, the patients would involuntarily become part of the trials, and the company would eventually make enormous profits at their expense, as was the case with the company Boehringer Ingelheim. When the WDR television inquired about this case while making a documentary on the subject, the company replied that they had all the papers duly signed by the patients, the patients had clearly given their consent, and moreover the local independent ethics committee had issued a note of approval.
What they are omitting to mention is that anyone in India could create an ethics committee and issue such permits. That is what Indian medic and journalist Chandra Gulhati reports, himself having been a long-time member of such an "independent" ethics committee. The scheme is really simple: the committee gets paid, it issues the signature and puts the stamp. In fact, the ethics committees hardly defend the patients' rights. Everyone makes profit from this scheme - the pharmaceutical company, the doctor and the hospital, even the committee members. Except for the patient, who gets crumbs in return for risking their health and their life. The big Western companies know this too well, and that is why they flock into India. With the introduction of new rules that would give opportunities for the development of generic drugs, hopefully these monopolies will be broken, and less people would be compelled to become chemistry slaves.
