Are foreign pharmaceutical giants making Indians guinea pigs in clinical trials?
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.
(Photo credits: First photo is from echinachem.com and the second is copywrited to me)