We are not a nation of human guinea pigs

In a country of 120 crore people, where lakhs are born and almost the same number die every day, life comes pretty cheap — as shown by the unabashed continual of human drug trials sans conformation to ethical norms.
The recent expose by Lancet on unethical human trials that took place in a Madhya Pradesh government hospital shows the extent to which pharma companies have been able to sabotage the very system that should ensure good practices.
For pharma companies who want to conduct human trials, India offers several advantages such as low operational costs, large number of high-end private hospitals, English-speaking doctors and technicians and most importantly — a massive supply of diverse, impoverished people who can be used as human guinea pigs.
Getting information on medical records itself is difficult and involves a maze of rules, procedures and not the least, miles of red tape.
Well… there is more bad news. Only a small segment of the human trials take place in government hospitals, the rest take place in private clinics — which are not obliged to provide any information under the Right to Information Act.
Figures provided by the Lancet speak for themselves — up from about 50 human trials cleared in 2003, there have been 1,852 projects registered with the Clinical Trial Registry India (CTRI) in mid-2011. Ironically, this registry was set up only in 2007.
An even more shocking aspect is that the Madhya Pradesh government had banned all human drug trials in the State as recently as 2010 and the ban is still in force. The aberration that has been exposed in Madhya Pradesh is just the tip of the iceberg.
Drug companies of repute, both national and international, use clinical research organisations (CROs) to do the dirty work for them. The CROs, in turn, use services of dubious characters as agents to recruit the subjects (read victims).
Informed consent, which is mandatory, remains a farce as the subjects are usually illiterate or barely-literate and cannot read the elaborate forms (usually in English) that they sign. They are also equally unaware of the nature of the drug that is going to be tested on them and the possible side effects.
And even when the side effects surface at a later point of time, these people rarely have the means to get treatment or a collective mechanism to seek compensation. The most preferred human guinea pigs are tribals, most of whom are neither organised nor literate.
“The CRO industry generated $485 million in revenue in 2010—11 and has been growing about 12 per each year. The number of CROs grew from a handful before 2005 to more than 150 today. However, there is no government registry for CROs in India,” points out another reference in the Lancet report.
The worst part about the whole human drug trial episode is that the doctors, who have sworn to protect life and uphold medical ethics, are the facilitators for these unethical practices.
It has been only been seven decades since the notorious human experiments of Nazi doctors on inmates of concentration camps. We might be a democracy, but with laxity on regulations, we swing dangerously close.

(This article was published as the editorial column in Postnoon on February 8, 2012)

This high-steak game could land you in jail

The president has given her approval for Madhya Pradesh’s anti-cow slaughter legislation after a delay of almost two years. Not just slaughter, even consumption of beef can land you in jail for seven years.
It also has provisions allowing a whole range of officials beginning at head constable to barge in anywhere and conduct checks on mere grounds of suspicion.
Cow slaughter is one topic that has been the centre of heated debates and disputes over it have led to innumerable communal clashes across the country but not a single government, Central or State, has been able to come up with an amicable solution.
Such legislations’ implications don’t stop at socio-religious spheres but spill over into guidelines on state policy that defines the right of an individual.
Ours is a country where there are thousands of castes, sub-castes and communities — each with its own culture, tradition and way of life. One sweeping law like that is a blunt statement to those in the minority to let go of all that and be in ‘conformity’ with what’s ‘acceptable’.
For many communities, beef is very much a part of their regular diet and a cheap supply of essential proteins. Beef dishes are part of ceremonies ranging from birth to death. It would be gross injustice to force them to abandon their culture using legal coersion.
What about the Northeastern states or a State such as Kerala, where beef is a delicacy popular among all communities? Who will protect the rights of millions of Hindus spread across the country who eat beef?
Now imagine a scenario where two of the biggest minorities were to declare onion as sacred to their faith. Will the governments introduce laws to prohibit farming, sale, transportation and consumption of onions because it would hurt the religious sensitivities of the minorities?
The essence of a functional democracy is presence of an environment of tolerance where every segment can enjoy their unique way of life without being arm-twisted to fit into a larger picture.
If a plural country like ours can’t ensure their rights, how different are we from countries where rape victims are stoned to death because they did not follow the lifestyle demanded by the majority religion?
For a country to progress the people have to feel motivated and for that they need to feel that they are valued for what they are. If not, the feeling of alienation would creep in and the social, economic and political cost would be too much to bear.
The harassment and humiliation people from Northeast face all over India, with hardly any help coming from the police or the otherwise vigilant civil society, because of their ‘different’ lifestyle has left scars that reservations and economic packages can’t heal.
When Indians are targeted abroad in racially motivated attacks there is an outrage across the country. Media, civil society and politicians compete to outdo each other in pointing out the stark contrast between our ‘tolerant’ heritage and the narrow-minded West. Next time your blood boils at the news of racial abuse of Indians, think of what we are doing to our people in our country.
A possible solution doesn’t require rocket science to arrive at. It’s called the policy of ‘live and let live’.