In January 2013 the Indian Supreme Court issued the following statement: ”It pains us that illiterate people and the children of India are being used as guinea pigs by the multinational drug companies … uncontrolled clinical trials are creating havoc in the country.” Over the past seven years, an increasing amount of stories about negligently conducted clinical trials in India appeared in the international media. Is the country’s highest judicial authority needed to protect its people from the pharmaceutical industry?
Moving clinical trials to threshold countries has been a trend in the pharmaceutical industry for the past decade, but the situation in India spiraled out of control following a significant constitutional amendment in 2005. Before 2005, Indian law allowed clinical trials only after a trial phase was completed abroad. The amendment of 2005 allowed companies to conduct clinical trials that had not been run anywhere else before, turning India into a paradise for clinical trials. It is estimated that companies save up to 40% of the costs during the different testing phases of a new drug in India. However, the financial aspect is not the only factor making India attractive for the pharmaceutical industry.
Many Indians are considered ideal trial participants for two medical reasons. First, a large portion of the population is “treatment-naive”, meaning that since they have not accessed medical care previously, they have never been treated with other drugs. This allows pharmaceutical companies to observe the unadulterated effect of the trial drug – something that is impossible when conducting trials in industrialized countries, where people take many drugs throughout their lives. And second, Indians are genetically prone to type II diabetes and cardiovascular diseases – conditions that Western pharmaceutical companies will gladly invest in.
When conducting clinical trials with patients who are uneducated and lack experience with medical care, one would assume that a great deal of ethical and cultural sensitivity is required. The pharmaceutical industry works with two main guidelines regarding ethics: the Declaration of Helsinki and the Good Clinical Practice. Both repeatedly stress the importance of obtaining informed written consent from every trial participant. In a country with an illiteracy-rate of nearly 50 percent, this poses a great problem. Between 2007 and 2012, an increasing number of claims have been made that poor, uneducated people have been enrolled in clinical studies without their consent. The stories of these “trial victims“ sound shockingly similar: They sought medical attention and, despite of their lack of money, they were being treated in private rooms with expensive foreign drugs. What they were told was that the drugs were paid for by a special government program for families living below the poverty line. They were not informed that they were taking part in adrug trial.
For most of the involuntary trial participants, this was the first medical care they received in their lives and they felt privileged to receive drugs from a government program. Another problem that makes it all too easy for Indian doctors to “enroll” patients is the God-like social standing of doctors in India. While pharmaceutical companies pay large commissions to doctors for every patient they enroll, the patients trust their doctors unconditionally. “People could never believe that the doctor they trust does not care about their health, only about making money from these trials,“ says Dr. Anand Rai, who blew the whistle on a clinical trial scandal in central India.
Is there no regulation in place to control these trials? There is, in theory. The law states that every clinical trial must be overseen by an independent ethics committee, headed by a medical official and consisting of 7-15 members who have no relation to the trial. In reality, however, experts issue these committees little credibility. Basically, everyone in India can form an ethics committee and issue registration papers. In many cases the physician conducting the trial appoints the leader of the ethics committee, who then chooses the members of his/her committee. Another common practice is that the physician-in-charge purchases the required registration papers for a certain price. Some ethics committees even openly post the price for their signature on their homepage.
The “havoc” that the Indian Supreme Court referred to in its statement can be briefly summarized in numbers: Between 2005 and 2012, 57,303 patients were officially enrolled in trials, 39,022 finished them, 11,972 suffered serious adverse effects (SAE) and 2644 died. Five hundred SAEs and 80 deaths were linked directly to the trial drug while the other deaths and SAEs were linked to the pre-existing critical condition of the patient. No matter the cause of these events, experts claim that many SAEs and deaths could have been avoided by stricter regulations.
The Indian Supreme Court has taken a first stance towards better regulations by revoking the power of the Central Drug Standard Control Organization and ordering the health secretary to supervise clinical trials in the country. But in order to make a real change, pharmaceutical companies need to take a clear stance against corruption and collusion and finally accept the responsibility they have for their trial participants. Negligently conducted drug trials do not only threaten the health and safety of Indian trial participants, but they also pose a real threat for patients around the world who are treated with drugs that did not undergo a safe and strictly monitored trial phase.