Pharmaceutical multinationals, seeking to ramp up profits through cheap drug trials, are increasingly turning to India with its combination of a vast pool of poor, ignorant patients on the one hand and skilled medical personnel and fine research infrastructure on the other.
The trend was noted in the United Nations Conference on Trade and development (UNCTAD) in its Trade and Development report for 2005. The U.N. body estimated that pharma firms could reduce costs on research and development by 20-30 percent through outsourcing to India.
But there are flies in the ointment. A rash of cases of unethical trials conducted by contract research organisations (CROs), that are rapidly mushrooming up, have been reported recently by both international and local media.
In April, a BBC investigative report cited several examples of unethical trials and authorities are now waking up to what may be large-scale exploitation of unsuspecting patients, desperately in need of medication for various ailments.
Already under investigation is the 'wrong use' case of a pharmaceutical company inducing doctors to prescribe to more than 400 women 'Letrozole', a breast cancer drug. The results of the covert trials were then used to promote the drug for unapproved use.
At the Indian Council of Medical Research (ICMR), Dr. Vasanthi Muthuswamy is one very worried person. As deputy director general of the institution, which is supposed to approve all medical trials in India, she oversaw the writing in 2000 of new guidelines for medical research in this country.
Muthuswamy told IPS in an interview that it is common for patients in India to take part in an experiment with no idea of what they are getting into. "The doctors say they won't understand anyway. They produce forms and ask patients to sign on the dotted line. The patient thinks it has to do with the treatment and agrees."
And what if the patients do know? In Bangalore city, Lakshmikanth, 62, has twice taken part in an experiment with new asthma medication and, because it worked and is free, he is waiting to be called again.
''The new medicine worked really well but, since the end of the experiment in January, I have had to revert to the old one. My condition has deteriorated, so I'm waiting for a new experiment. No, I'm not scared of side effects -- I didn't have any the last time. During the study the medicine was free and I was given a full health check every two weeks. That gives me a safe feeling. I cannot afford such checks myself."
Lakshmikanth's family is worried because they have to rush him to hospital every time he loses consciousness from breathing difficulty. Generally, Lakshmikanth avoids going to hospital. "On a monthly pension of Rs 6,000 (135 US dollars) asthma medication is expensive."
At the hospital, doctors said they would be calling Lakshmikanth and the other patients for a new study of the drug developed by GlaxoSmithKline (GSK), but cannot treat him regularly since the medicine is yet to be proved safe and effective.
Muthuswamy finds that improper and feels that Lakshmikanth had the right to keep taking the test medicine if it worked for him.
"The drug is safe for this patient, and he has already been exposed to the possible risks,'' added Dr. Chandra Gulhati, editor of the Indian Monthly Index of Medical Specialities. But then, like most Indians, Lakshmikanth does not have health insurance, and he cannot make any claims on GSK because he received no document to prove he had taken part in a test.
Such disinclination by pharmaceutical companies to accept responsibility for the patients they carry out tests on is now increasingly being resisted by some hospitals and by conscientious doctors.
"Our hospital rejected a test last year because the company only pays treatment if it's proven their medication caused the side effects. But what should a patient without money do until this is sorted out ?" asks Dr. Sanjeev Jain of the prestigious National Institute for Mental Health and Neurosciences located in this city.
''Many doctors that I talk to, seem very concerned about their patients and sometimes reject trials. But does that solve the general issue? We get about 4,000 dollars per patient. That's a lot of money in India -- therefore people cut corners,'' said Jain.
According to Gulhati, very often the medicines are too expensive for the people they are tested on. ''Take herceptin, a cancer drug of Roche. This was tested in India and came on the market in 2003.You have to take it for a long time and the yearly cost in India is 45,000 dollars. Nobody here can afford that."
GSK officials told IPS that they cannot be responsible for what they say has to do with people's access to health care.
India demands clinical tests to be authorised by the ethical committee of the hospital that will conduct the trial, and by the Drugs Controller General (DCG), which is a part of the health ministry. But it is only a check of paperwork and there are incidents where proper authorisation was lacking. Also, DCG approval is not needed for testing medicines already on the market.
Curiously, the DCG does not pass information to Muthuswamy at the ICMR. ''We have no clue what is happening, especially in private hospitals", she says.
'We authorise yearly about 150 clinical trials for international companies, on average at 3- 4 locations,'' says DCG chief Ashwini Kumar. But most tests are meant for authorisation of a medicine in Europe or U.S. and do not benefit patients in this country..
Kumar's vice-controller B. Ramteke says that with a staff of only four pharmacists, three biochemists and a handful of administrative staff, it is impossible for the DCG to handle all the requests that are coming in. ''We are responsible for both authorisation of trials Ã¡nd authorisation of medicines on the Indian market -- that is too much work for too few people."
Gulhati says he has strong evidence that the DCG is corrupt. ''The DCG is a huge reason for concern'', says a clinical trials associate with an Indian CRO - one of the many that coordinate clinical trials for international companies. "The DCG is approached by consultants who are paid well by the company. That ensures that everything gets approved."
Muthuswamy would like to see a streamlining of the ethical committees in the hospitals. "Often the dean of a medical college is the chair of the committee -- this is illegal. Some committees approve 80 -100 research projects per meeting. It is impossible to do that seriously."
''A lot of doctors have told me that their only training to conduct trials comes from the company or CRO,'' says Muthuswamy, who is training committees and doctors with support from abroad. "But it is very hard to reach the whole country. We need more money."
"Big pharmaceuticals offer doctors foreign trips, and then those doctors start conducting clinical tests for that company", says Dr. Kalantri of the Mahatma Gandhi Institute at Sevagram, a rural area in central India. He has himself conducted several trials.
Prof. S. Thanikanchalam, cardiologist at the Sri Ramachandra hospital in Chennai, said he refused a surgical trial from an international company because he found it unethical that a placebo group also had to undergo surgery. He does not know whether some other hospital did conduct the test.
"If one hospital refuses, we contact another -- we never change the protocol,'' said the clinical trials associate at the CRO, who asked not to be identified.
Larger companies say that since damaged reputations cost more than clinical trials, players keep within ethical limits. Chris Hunter-Ward of GSK-Biologicals sees nothing amiss. "We rigorously check ourselves and use auditors. In India, we do not work through CROs,'' said Chris Hunter-Ward at GSK Biologicals.
"We translate the informed consent papers in, sometimes, ten languages. We give patients two weeks to think. We give the doctors a week's training before every test. We can't do much more. We have never stopped a trial for ethical reasons. India has such a sophisticated economy and people -- it is obvious it has the right systems to do clinical trials,'' Hunter-Ward said.
Not everyone is convinced. Muthuswamy said that with the number of clinical trials steadily increasing there is a clear need for greater monitoring.
For now, what she says cannot be heard above the ring of the cash registers. The global consultant McKinsey estimates that by 2010, global pharma majors would have invested up to 1.5 billion dollars in India's clinical trials outsourcing industry.
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