The wonders of research and advancements in science and technology, never ceases to amaze but the news of an impending series of animal studies to test what could end up being the world’s first “vaccine” against alcoholism to get ‘problem drinkers’ to quit on their own raises various layers to a health and social issue. The announcement from the Centre for Biochemical Engineering and Biotechnology at the University of Chile has said pre-clinical studies of the candidate vaccine developed there, would be conducted in India beginning next month. The studies are to be taken up by a clinical research agency in Navi Mumbai specializing in toxicological studies on rodents. Typically, all pre-clinical studies involve administering mice or rats, the new drug or vaccine to determine whether it has any harmful side effects and always precede human trials of any product. If the tests on the rodents turns out well, the next logical step would be to look at human trails. While there is no solid news regarding where the human trails will be conducted, it is to be noted that the Supreme Court has directed that no new clinical trials will be approved in India for at least two months, till the time the health ministry defines a regulatory regime for such tests in the country. The Supreme Court directives had come in response to a public interest litigation filed by activist group in February 2012. In October last year, the apex court had asked the health ministry to make public information regarding deaths during trials, the compensation being paid and other general practices related to the conducting of such trials.
India’s track record with clinical human trails is dismal. In fact, the Drugs Controller General of India (DCGI) said in a 3 January filing to the Supreme Court that between January 2005 and June 2012, it approved 475 clinical trials for “new chemical entities” not used as drugs elsewhere in the world. The figures it quoted were alarming. It said that 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials and put deaths from trials at 2,242 over the last five years. What is implied in the figures is that a lot of these numbers and statistics had happened because people participating in the human trails were ill informed about the risks involved, were paid poorly and were not being regulated properly. There are alarm bells over the ethical norms of clinical trails being flouted with news emerging that children and the disabled were encouraged to take part in such trails without their full and informed knowledge or permission.
But while the courts and regulating bodies debate and discuss on the area, what is interesting is that a vaccine against alcoholism may well be within sight in a matter of a few years time. When such a vaccine against alcoholic tendencies does become a reality, it may root out the impact of chronic alcohol use on the human body. But it is yet unclear if such a vaccine will also address issues of people who resort to verbal abuse, uncouth behavior and even physical violence while under the influence of alcohol. Alcohol abuse as we know not only encompasses health but touches upon human and social behavior, not to mention gender stereotypes. The other good news that such a vaccine would herald would be for those in the liquor business for they can well continue selling the poison drink with the confidence that people vaccinated against it would be spared of its ill effects. There may be a futuristic scene sometime in the years ahead where, along with vaccines for DPT, Hep B etc children are also vaccinated with the anti alcoholic shot!
Many in the State would be happy if a medical miracle brings about a one shot treatment of people who have become alcoholics as well, considering that there are not too many options available for treating someone who is already a chronic alcoholic. If indeed such a thing becomes a reality, many social organizations who have taken upon the role of moral guardians may have to begin looking for other issues to tackle.