Is greater scrutiny of drug trials in India bad for the industry’s health? Last week this question, which typically triggers a polarising debate, was back in the news when the Supreme Court pulled up the Union government for not ensuring that multinational pharma majors compensate those who suffer adverse effects during clinical trials.
India is attractive to foreign companies looking to conduct clinical trials because of many reasons, a huge pool of patients, a wide range of diseases, a technically competent workforce and relatively low costs of conducting clinical research.
Increasing public scrutiny, however, is throwing up uncomfortable questions about the way many global clinical trials are being conducted in this country. An article by Dr Eric Suba, director, Clinical Laboratories, Kaiser Permanente Medical Center, San Francisco, in the latest issue of the Indian Journal of Medical Ethics (IJME) has added to the ongoing turbulent debate about the care and protection needs of vulnerable populations participating in research. “Since 1998, randomised trials in India funded by the US National Cancer Institute (NCI) and the Bill and Melinda Gates Foundation have compared cervical cancer death rates among 224,929 women offered cervical screening to those among 138,624 women offered no screening whatsoever. To date, at least 254 women in unscreened control groups have died of cervical cancer. The United States Office for Human Research Protections (OHRP) determined that the subjects in the studies were not given adequate information for the purpose of providing informed consent. The determinations of the OHRP contradict assurances given by other American medical and bioethical leaders,” writes Dr Suba.
“It has been claimed that having unscreened control groups is ethically justified in India because no-screening is considered ‘standard care’,” he writes, and adds, “If, at any time during the past 15 years, the 138,624 women in the unscreened control groups had been told the simple truth that cervical screening would lower their risk of death from cancer, they would have left the control groups and sought screening on their own, thereby nullifying a scientifically defective experimental design.”
Dr Suba says that “high-quality screening must be provided to all surviving unscreened women without further delay,” and that “US-based global health organisations should institutionalise a commitment to improving health outcomes as rapidly as possible among as many people as possible. Those who suffered avoidable harm and death, as well as their families, should be promptly and fairly compensated.”
The concerns flagged in the IJME article and during the hearings at the Supreme Court are very real. Health activists say multinational companies cannot argue that the work on the ground is being done by the Contract Research Organisations (CRO), and that as funders of a drug trial, it is as much as their responsibility as that of the CROs to ensure transparency and patient safety.
There were 500 Global clinical trials (GCR) in India in 2010. That dropped to 262 approvals in 2012 after tougher regulations were imposed.
Those who sponsor clinical trials were asked to cough up more compensation and institute independent ethics committees to monitor the trials. Since 2009, it is mandatory to register all clinical trials with the government. Further changes introduced in February 2013 made it compulsory for clinical investigators to have detailed information about those who take part in clinical trials and their families so that compensation can be given easily in case of any adverse situation.
All this has happened because of pressure by health activists, public outcry and judicial intervention. Following an order of the Supreme Court last year, all clinical trials studies now require video recordings of the “informed consent” of volunteers apart from written “informed consent”.
Industry and contract research organisations are not happy. They say that the stringent regulatory environment is damaging India’s image as a choice location for clinical trials, that it will reduce Indian patients’ access to new therapies and that global pharma innovators are now likely to bypass India and shift drug trials to other Southeast Asian countries.
Last week, in response to a public interest litigation by Swasthya Adhikar Manch, an NGO, the apex court directed the government to ensure that drug companies specify whether the risk involved in testing new formulations is justified by the benefits expected from the exercise, whether there are unmet needs for the drug in this country necessitating the innovation, and whether safer methods are available. The Swasthya Adhikar Manch has alleged that many of the pharma companies conducting clinical trials of new pharmaceutical compounds did not have adequate safeguards for patients. The government has given the drug companies about two months to respond.
Monitoring of drug trials is inadequate due to acute shortage of supervisory staff, vast pools of poverty co-existing with widespread illiteracy, lack of awareness and lack of rights consciousness. What does “informed consent” really mean in such a scenario? By the health ministry’s own admission, between 2005 and 2012, there were 89 deaths due to clinical trials. A much larger number of people suffered “serious, adverse, effects” not leading to death. Activists say that many deaths were never properly investigated and that most of those who developed other health issues as a result of the drug trials were not compensated, or received little money.
In the coming days many questions will be asked about profits and patient safety. Are they implacably opposed? Instead of dismissing all clinical trials as rotten, we need to plug potential loopholes and implement existing laws stringently It is naïve to pretend that conducting clinical trials in India is the same as it is in a developed country. Many among those volunteering are not able or equipped to assert their rights and to figure out if the trial is following ethical guidelines.
Greater transparency and better protection for those volunteering for trials are in the long-term interest of both patients and the business. Members of the European Parliament have voted overwhelmingly to tighten regulations on clinical trials in Europe. Turning a blind eye to global concern about unethical trials is bad business strategy. Regular monitoring to ensure the safety of participants in a clinical trial will dispel mistrust and boost public confidence. It is also the best way ahead for patients and profits....