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Poverty and ignorance facilitate unethical clinical trials by many multinational pharmaceutical companies in India, find researchers, and caution that stricter vigil is needed in the field. Ranjita Biswas reports
The economic downturn and the subsequent global meltdown has not affected India (with a projected 7 per cent growth) and China that badly compared to the West, say experts. But whether one likes it or not, it has already affected the workforce in the two countries and is bound to affect more in the coming months. The World Bank now says new research shows that weaker economic growth will push 46 million more people below the poverty line in the new year.
In India, it is already being reflected in seemingly unrelated areas, often unnoticed. In the health sector, for example. Reports from Gujarat in a leading daily reveal that more and more unemployed or sacked employees in the diamond industry are lining up at labs, spread across Ahmedabad, Vadodora and Surat for clinical trial of drugs conducted by pharmaceutical companies. Surat, the hub of diamond cutting industry, which supplies the bling to be encrusted in jewellery for the country’s as well as the world’s rich and famous, has reportedly seen a rush of volunteers offering their bodies as guinea pigs as it can fetch quite a considerable amount of money depending on the duration of the trial. With less available money in the market and a tightening of purse-strings, the demand has gone down, diamond merchants admit.
These trials by the pharmaceutical companies may well be above board, but findings by health-sector researchers often throw up unsavoury truths about clinical trial by multi-national companies in developing countries. Poverty and desperation for drugs both drive people to become volunteers. Sometimes they are not even informed about the implications. Touts who procure these volunteers from vulnerable sections take advantage of their ignorance too.
A recent report by Sandhya Srinivasan, journalist and researcher, alongwith team-mate Sachin Nikarge document ethical concerns in four clinical trials in India - one for a drug for breast cancer and three for psychiatric drugs, for the Centre for Studies in Ethics and Rights, Mumbai. It was found that “These trials exploited the fact that most Indians do not have access to good quality and affordable care and therefore may accept offers that might provide better quality and free treatment. They were conducted on people who were vulnerable because they could not afford good quality treatment or the most effective drugs.”
Citing the case of ‘Lapatinib’ a drug for seriously ill breast cancer patients, and manufactured by GlaxoSmithKline (GSK), the report says, “By carrying out this clinical trial in India, GSK took advantage of the vulnerable position of breast cancer patients.”
It further adds that “The statement by a representative of GSK suggests that patients, who stopped responding to Lapatinib, were not assured treatment once the trial was completed.”
The investigative report was conducted at the initiation of the health advocacy organisation WEMOS and the research organisation Centre for Research on Multinational Corporations (SOMO), both based in Amsterdam. In 2006, WEMOS and SOMO prepared an overview of 22 known examples of unethical clinical trials in different places of the world; out of them eight were in operation in India.
The recent report has created quite a stir, particularly as Lapatinib ‘has been conditionally approved for the European market by the European Medicines Agency,' informs WEMOS. Lapatinib is now available in India but is too expensive for most breast cancer patients.
According to the Indian Council of Medical Research (ICMR), the incidence of breast cancer in India is rising and is rapidly becoming the number one cancer in females pushing cervical cancer to the second spot. There are currently around 400,000 Indian women with breast cancer; most of whom cannot afford to pay for the treatment they need.
The report by Srinivasan and team is available at www.FairDrugs.org. FairDrugs.org. is a campaign by a worldwide coalition of health organisations and scientists led by WEMOS.
Srinivasan, however, is not surprised by the findings. “All of us are aware of the vulnerability of patients in India - and especially poor patients. These trials only confirmed this.”
The documentations covered a wide spectrum of metros: the cancer trials were conducted in Pune, Delhi and Hyderabad. The psychiatric drug trials covered a much greater number of cities.
Adds Srinivasan: “All the companies have refused to give information on the economic background of the patients in the four trials. However, the comments of researchers clearly indicated that the poor are most likely to join clinical trials.” She reveals that one of the institutions clearly stated that the patients in their trial were "middle and lower middle class mostly".
More disturbingly, she adds, “Some doctors actually believe that patients should join clinical trials to get medical care that they could not otherwise afford - an experimental drug is better than nothing.” In the case of the psychiatric drugs, the comments of researchers indicated, Srinivasan reveals, that the poor may join clinical trials to get free care (in private hospitals), or better care (in government hospitals). “The majority of patients in one of the psychiatric drug trials were in government hospitals which are used by the poorest of patients.”
In 2004, a report titled “Quinacrine, non-surgical sterilisations in West Bengal: What we learnt from the women on the ground’’ found that the drug banned in the West and by the country’s Supreme Court since 1998 was blatantly used by gynaecologists in the eastern state. The report brought into focus unauthorised and hence unethical use of drugs. It could just the tip of an iceberg.
The investigation was funded by the MacArthur Foundation and was led by Shree Mulay, director of the Centre for Research and Teaching on Women at the McGill University, Canada, and included Indian journalist Rajashri Dasgupta and economist Navsharan Singh.
Starting from 2001, for two years the team interviewed women in Uluberia in Howrah district of West Bengal where it was found 32 had been sterilised with Quinacrine (QS) and 30 underwent surgical sterilisation (SS). The National Family Health Survey-2 data showed that there was poor access to healthcare and a high percentage of infant mortality in that area. “None of the women interviewed knew that QS was an unauthorised method, with potential health hazards. Most of the women who underwent QS said that the provider never asked them to sign or give their thumb-print on any consent form or other document,” says Dasgupta.
Originally, Quinacrine was used during the Second World War as an anti-malaria drug. But in the 1960s, Dr Jamie Zipper of Chile discovered its anti-fertility qualities. Later, two US doctors, Stephen Mumford and Elton Kessel, collaborated with Zipper to make the semi-liquid mixture into solid pellets.
Quinacrine helps to block pregnancy by acting as a corroding agent that burns the uterine tissue and forms scabs. The inflammation results in the formation of scar tissues blocking the fallopian tube. The drug was promoted in several poor countries, but in the mid-1990s several research studies declared it unsafe for women.
Says Dasgupta, “Clinical trial is a major industry in the country because we have millions of poor and illiterate patients who are not aware of health hazards involved in trials, their health rights etc.” Besides, she points out, over here it involves minimal cost compared to drug trials in the western countries. “Therefore, India is a haven for clinical drug trial.”
Srinivasan echoes her thoughts: “We should be very worried that the increase in drug companies' clinical trials in India will lead to such exploitation in a very big way.”
Dasgupta also says that “The implementation of the drug laws [in our country] are lax, and there is hardly any strict monitoring.” She feels that the ethics committee of various drug trials need to be revitalised to oversee that patients’ rights are being maintained and their health and security are not jeopardised.
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