Protecting the Vulnerable in India

With a population of over one billion people with an increasing prevalence of cancer, diabetes, and cardiovascular diseases, India has become an attractive location for foreign and local companies to conduct low cost clinical trials.

Clinical trial regulations and guidelines, a clinical trial registry, and ethics committee approval processes have been implemented to make clinical trials in India transparent, credible, and ethical. India has a pool of excellent trained investigators, clinical trial coordinators, and CROs working to maintain good clinical practice standards.

Why all the media hype from the Indian and foreign press regarding deaths in clinical trials and exploitation of vulnerable populations, leading to the assumption that clinical trials in India are unethical?

India has a fast-growing economy and middle-class population. However, approximately 645 million people or 55% of the population are poor, with a high illiteracy rate. The country has a poor public health and educational system, and corruption in the public and private sectors is not an isolated exception. According to the United Nations, India has six doctors and nine hospital beds for every 10,000 of its people, compared with 14 and 30, respectively, in China. Many have no access to proper healthcare. This vulnerable population may take refuge in a clinical trial—this is the population that sustains the clinical trials in India. The middle- and upper-class people who can afford medical treatment rarely choose to take part in clinical trials.

There was widespread media coverage when the Union Health Ministry released figures last year suggesting that as many as 462 people taking part in trials died in January through June 2010. Were all these deaths the result of a clinical trial? We have all heard the story about the 49 babies under one year of age who died at the All India Institute of Medical Sciences (AIIMS) in 2008 in Delhi while being subjected to trials for new drugs and therapies. What much of the press initially failed to report was that many of these children had serious illnesses where death may have been an inevitable outcome. Writing in the Indian Journal of Medical Ethics, Jul-Sep 2009, the leader of the All India Peoples Science Network says that while a committee set up by the ministry of health "subsequently cleared AIIMS" the high number of deaths among clinical trial subjects are nevertheless a "cause for concern." The media should be more cautious in ascribing the real reasons for the deaths that can be truly attributed to the investigational product, not just report a sensationalized number, creating unfounded fear.

Subjects enrolled in trials in India are vulnerable; most of them are illiterate or semi-illiterate with often no awareness of the trial's implications for their illness, and more importantly may not fully understand their rights when participating in a trial, even if explained to them by the investigator. Undue influence cannot be ruled out—the final decision is often taken with another family member serving as an impartial witness. Is a family member impartial? How can we ensure that the subject's rights have not been jeopardized? Should we not redefine the ICH definition of an independent witness?

Constructive public awareness about clinical trials in India is needed so that any potential patient entering any trial is an informed citizen able to understand and assert their rights. We need to think beyond the current regulatory framework and look to other solutions to ensure that trials in India are not just safe, ethical, transparent, and free of potential coercion and corruption, but are also seen to be so.

Susan Trainor

CEO

Trainor & Partners

E-mail: [email protected]