PROTEST AGAINST UNETHICAL MEDICAL RESEARCH

PROTEST AGAINST ICMR - SUPPORTED

UNETHICAL MEDICAL RESEARCH

Newsletter March 1998

In our campaigns against hazardous contraceptives, including the anti-fertility vaccine and the use of Quinacrine as an agent for chemical sterilisation by various non-governmental organisations in India, we have been critiquing the nature and conduct of research that targets poor, illiterate women as targets for trials. The question of ethical guidelines for clinical trials has also been focused upon.

On 2nd December 1997 a report in the Times of India brought to light another sordid story of poor women from the neighborhoods of Delhi becoming victims of research undertaken by the Institute of Cytology and preventive Oncology [ICPO] in 1976.

ICPO, an institute funded by the Indian Council of Medical Research [ICMR], undertook a survey on women attending public hospitals in Delhi. Some 65,000 women were examined over a period of 8 years ending in 1984 and those suffering from cervical dysplasia, a potentially precancerous condition, were included in the follow-up study. The objective of the study as published in the Acta Cytologica (Vol.31, pg.226-33), was to study the ‘Natural History of Precancerous and Early Cancerous Lesions of the Uterine Cervix.’ In normal circumstances, women having cervical dysplasia (a potentially precancerous condition) continue to harbour the condition for years. In some of them, it could develop into frank cancer. The objective of the study was the identification of risk factors and the detection and management of the precancerous and early cancerous lesions in order to prevent invasive cancer of the uterine cervix.

Out of about 1,100 women followed up for about four and a half years, 22 developed cancerous conditions inspite of early detection due to their participation in the study, they were not offered immediate treatment for cancer but were further followed up. Some women developing cancer died before the end of the study and the exact cause of death was not known!

In addition to the callous attitude of the doctors in not offering treatment as a first choice, the issue of informed consent from women participating in the study is a vexing one. The results of the study published in 1987 by the ICPO investigators state that ‘a formal consent in writing from subjects included in a study is not standard practice in India’. However, In February 1980, while the said ICPO study was going on, ICMR came out with a policy statement on ethical considerations involved in research on human subjects, stating that written informed consent cannot be dispensed with.

ICMR is the apex medical body of the country instrumental in formulating guidelines about clinical trials for new drugs, new vaccines, other studies involving long term follow-up and so on. As an ICMR funded Organisation it is deemed essential that the study conducted by ICPO would implement ethical guidelines about informed consent during the study. However, investigators at the ICPO turned Nelson's eye towards the guidelines. Some of the guidelines state: ‘experimentation on human subjects in the country are required to make certain that the risks to an individual are outweighed by potential benefits to him or to society or by the importance of the knowledge to be gained' and further that ‘informed consent is obtained from the individuals by methods that are appropriate and adequate'. The study quoted, violated both the norms - women who developed cervical cancer were followed up without offering immediate treatment thereby incurring a personal loss. Secondly, all that the ICPO did in lieu of informed consent was to send these women a card saying that their Pap test [a test done to detect the presence of cervical cancer] is abnormal and that they should come to the hospital on a given date!

Following the newspaper reports, Saheli took the initiative, and was joined by AIDWA, Action India, Nirantar, Magic Lantern Foundation, PUCL, ABVA, DGMA, Jagori, MARG and others to stage a protest at ICMR on Human Rights Day, 10th December 1997. A memorandum was submitted to Dr Badri Saxena, Addl. D.G of ICMR and a member secretary of the 1980 ICMR Ethical Guidelines Committee. Dr Saxena was also pressurised to publicise the ICPO study, and during this meeting with women's groups on 18th December 1997, admitted that there was no procedure under which the ICMR could initiate action against those who had sanctioned the project or been part of it.

In the meantime a draft for ethical guidelines on biomedical research involving human subjects has been prepared under the Chairmanship of Justice MN Venkatachaliah, who is also chairman of the National Human Rights Commission. These new guidelines are expected to include newer areas of research and make the clinical trials more humane and ethical! However, a key question of implementing the existing guidelines and punishing those not abiding them is still unanswered. During the meeting with ICMR, we also asserted our right to analyse and evaluate the proposed ethical guidelines. Vigilance by women's groups is essential to ensure accountability of public institutions like the ICMR and ICPO.

We demand:

ICMR SHOULD ACCEPT ITS RESPONSIBILITY, SPEED UP THE PROBE INTO THE VIOLATION OF MEDICAL ETHICS.

STRINGENT ACTION SHOULD BE TAKEN AGAINST ALL THOSE RESPONSIBLE FOR SUCH UNETHICAL AND INHUMAN RESEARCH.

WOMEN SUBJECTED TO THE STUDY SHOULD BE FOLLOWED-UP, GIVEN PROMPT AND ADEQUATE TREATMENT AND AWARDED SUITABLE COMPENSATION FOR WHAT THEY HAVE SUFFERED.