January 14, 2013
In a guest column, Jay Taylor, vice-president (international affairs) at US-headquartered Pharmaceutical Research and Manufacturers of America (PhRMA), a vocal representative of Big Pharma interests, argues that “much of the characterization of the clinical trial environment has been sensationalized.. (is) overstated or simply wrong.” Among other things, he states that the death rate for patients enrolled in clinical trials in India is approximately half of the death rate for the country’s general population. Read on for his views.
Recently much has been written about clinical trials in India.
Clinical trials are perhaps one of the most essential elements in the research and development of new medicines and technologies that prevent, treat, diagnose or cure diseases.
Globally, over the past several decades, medical innovation has cut the death rate from cardiovascular disease in half. Medical research and innovation has turned diseases like AIDS and many cancers into manageable conditions. Medical innovation has also reduced the social and economic burden of disease. Innovation has played a major role in increasing life expectancy and has enabled healthy aging for much of the world’s population.
The importance of clinical trials in assessing the benefits and risks of new medicines and technologies cannot be overstated.
In India, concern over the oversight and transparency of clinical trials has rightfully been expressed. As a global leader in pharmaceutical development and production, India needs to take its place at the forefront of medical research. To do that requires a world-class regulatory environment so that patients around the world can trust in medicines and medical technologies that are researched and developed in India.
Research protocols for clinical trials around the globe are consistent in demanding that all entities that conduct clinical trials stringently adhere to certain norms and safeguards. These include but are not limited to ensuring that all trials are registered with the appropriate authority and are subject to rigid oversight and that patients who are recruited for trials have given informed consent. There can be no excuse for any deviation from these norms.
In fact PhRMA companies have adopted Principles on the Conduct of Clinical Trials that govern clinical trials wherever they are conducted.
As India’s capacity for world-class pharmaceutical development and production has grown so too has its importance as a hub for clinical research, including clinical trials. Despite this significant growth it should be recognized that currently India accounts for less than 2 percent of global clinical trials despite the fact that India accounts for approximately 20 percent of the global disease burden.
Recently much of the characterization of the clinical trial environment has been sensationalized. Many of these characterizations are overstated or simply wrong.
It is wrong to characterize patients who participate in clinical trials as “guinea pigs.” People who participate in clinical trials in India and elsewhere, more often than not, are patients with serious underlying conditions such as cardiovascular diseases or cancers. Patients who through informed consent are involved in a trial often are given higher levels of care than patients who are part of the medical mainstream. Clinical trial patients are subject to greater monitoring and assessment than regular mainstream patients.
In 2011, according to a recent paper published in The Lancet, it is estimated that there were approximately 150,000 patients enrolled in approximately 2,000 clinical trials in India.
Because most clinical trial patients have serious underlying disease or conditions some of them will die during the course of the trial, but the safeguards within a trial should be such that very few will die from an adverse event associated with the trial.
Media reports have highlighted that in 2011, 438 patients in clinical trials in India died. But missing from many of the media accounts is that the death rate for patients enrolled in clinical trials is approximately half of the death rate for the general population in India, and very few of these 438 deaths were as a consequence of a serious adverse event associated with the trial.
According to India’s Minister of Health, in 2011, 16 deaths among the 150,000 clinical trials participants are suspected of being associated with a serious adverse event caused by the patient’s participation in a trial.
Even one death of a patient from an adverse event caused by a clinical trial is one death too many. Much more needs to be done in India to ensure that clinical trials are held to the most rigid international standards of oversight and transparency. However it is equally important that these serious issues be publicly examined with a proper regard to the facts and circumstances. This will ensure that the extent and magnitude of the issues that have been raised are fairly and accurately assessed.
The needs of patients around the world depend on the shared dedication of researchers and government, and perhaps more importantly, to the willingness and commitment of those patients and volunteers who, through informed consent, participate in clinical trial research that is essential in determining the risks and benefits of new medicines and technologies that have the potential to save millions of lives.
Prior to Joining PhRMA, Jay was a partner at the international law firm, McDermott, Will & Emery, where he specialized in international trade policy, export controls and Foreign Corrupt Practices Act (FCPA) matters. Previously, he served as Associate General Counsel at the Office of the United States Trade Representative (USTR). He received his undergraduate degree from Princeton University, and a law degree from Tulane University.