Wednesday, June 22, 2011

The Human Guinea Pigs

25 Indian women became volunteers for a clinical trial for breast cancer. Food every day and payment in thousands of rupees were the appeasements. After their three-month sojourn at a posh hotel in Hyderabad, enjoying old Telugu movies and no burden of hard labour, these women are now repenting that they had to pay a huge price for the luxuries offered by the multi-national pharma companies.

The women in the age group of 25 to 45 years were not aware of what drugs were given to them and opted to give blood in exchange of cash and became volunteers for a clinical trial. They were paid amounts ranging from Rs 5,000 to Rs 1 0,000 depending on the number of doses of drug they were ready to consume. After taking the drug, six women had to be hospitalised for complications.

"...the injections made me weak, and I am suffering from chest pain, body ache and nausea,” - Dhanalakshmi

"...I am not in a position to attend even to the routine household work,” - Ademma

Poor illiterate women being lured by money to come for drug trials. Brokers are used to lure people with money for clinical trials. In the case of what has happened in Andhra Pradesh, it's a woman from Guntur who hired the guinea pigs. There are rules against it, but companies blatantly flout it. Evaluating clinical trials of drugs for breast cancer, acute mania and schizophrenia, journalist Sandhya Srinivasan and researcher Sachin Nikarge found that the pharmaceutical companies took advantage of patients who were desperate for any kind of medical care and, in the case of psychiatric patients, probably incapable of providing genuine informed consent. A Center for Studies in Ethics and Rights report claims that psychiatric patients suffering from mania and schizophrenia were denied the normal treatment for their diseases and given placebos during clinical trials — likely because placebo-controlled studies are faster and more conclusive than studies that compare the experimental drug to an existing treatment. And, though the company concluded it was “not considered treatment related," one schizophrenic patient in the placebo group committed suicide during the trial of an anti-psychotic manufactured by AstraZeneca

Human clinical trials are conducted in four phases.In the first phase, an experimental drug is tested on a small group 0f 20-80 people. This stage is to evaluate how safe the medicine is and identify its side effects. Permission to carry out tests in phase 1 is given based on data of animal studies.In phase 2, the drug is given to a larger group of 100-300 people. This is to see if it is effective and to further evaluate its safety. The drug is administered to 1000-3000 people in the third phase. This is to confirm its effectiveness, side effects and compare the drug to other commonly used treatments. Post marketing studies are carried out in the fourth phase to gather additional information. Permission for each phase is given on the basis of data of the previous stage.

India is an easy target for clinical trials. It is a $400 million business in India -- and growing fast. Clinical trials are up to 60 percent cheaper to conduct in India than in developed countries, and companies are cashing in.

Poor unsuspecting people are easy meat for those trying out tests of drugs, which are in the very preliminary stage of development. More than 1,500 people have died in clinical experiments in the last 28 months. Last year, after seven young girls died during testing of a new vaccine for the Human Papillomavirus (HPV), a sexually transmitted disease that can cause cervical cancer, Sama and Jan Swasthya Abhiyan, another non-governmental organization (NGO), conducted a fact finding study. The NGO probe allegedly found evidence of serious ethical violations in the design and execution of the project — which was funded by the Bill and Melinda Gates Foundation and carried out by PATH, an internationally respected nonprofit.



Wirral Socialists said...

How would clinical trials be conducted under socialism?

ajohnstone said...

There are no simple answer but think how the non-existence of profits and budgets would change the present situation. Less duplication of effort from the lack of competing companies vying for exclusive patent rights. And those pharmaceutical companies no longer publishing bias scientific papers to capture markets.
It is proving cheaper and more "efficient" to conduct clinical trials of drugs in the developing world that ethically they are not permitted to carry out in the researchers home countries so the same standards will be worldwide in socialism.
The same question can be asked about animal testing and their necessity.
We can tentatively say though there will be a big drop in the numbers and requirement of clinical trials