“ A Parliamentary Standing Committee (PSC) used dignified language to explain the criminality of an American company and support to it by corrupt Indian officials. “They are murders. But we call ‘deaths’ before enquiry and ‘killings’ in conclusion. Most surprising is we do not even give exact number of children killed, we simply say some deaths. This is trivialisation of corporate murder of Khammam children with support of corrupt bureaucrats.” –says Prof Madabhushi Sridhar.
We are notoriously corrupt! People are poor and ignorant also. They do not even try to know. Multinational companies (MNCs) are clever. Doctors are either compelled to be silent or actively involved. As the main motive of the young doctors is to recover the cost of their education and make quick money they are simply toeing the ambitious and unethical profit maximization plans of corporate businessmen.
The silence or criminality of doctors is an important facilitating factor behind converting Indian poor into gullible victims of injurious clinical trials. Human life has no value for them. They do not mind causing slow deaths. They do not intend killing a specific person, but do not care if some poor is either severely injured with diseases or even succumbs. Deliberately the pharma companies do not disclose what and why they are trying and consequences of clinical tests.
The consent of the people is extracted without full disclosure of all relevant facts about clinical trials. Even if the people die of those trials, none cares, neither the government, nor the companies. The clever corporate companies secure permits from corrupt officials of the state and execute dubious trials with silent doctors.
They made India rendezvous for clinical trials and Indians, the gullible guinea pigs! There are no strong regulatory laws. No disclosure is insisted. In the absence of factual disclosure informed consent is impossible.
Colin Gonsalves, the founder of the Human Rights Law Network, says in a report that on account of all clinical trials conducted by various pharmaceutical companies, nearly 2,800 patients were said to have died between 2005 and 2012 in India. A parliamentary panel report found all parties involved of gross ethical violations — the ministry, Drugs Controller General of India (DCGI), Indian Council of Medical Research (ICMR) and those who conducted the clinical trials.
The Drugs and the Cosmetics Act was amended in 2005 only to permit multinational pharmaceutical companies to conduct tests called Phase II clinical trials on Indians in India. This is for the first time that such permission was given. Those companies breach their duty to provide needed reports from their countries.
Colin Gonslaves says: “…clinical trials in India have been accompanied by large-scale criminality as doctors, officials and pharmaceutical companies understand well enough that India is a cesspool of corruption where clearances can be had for a pittance.
While there have been many cases since, the underbelly of India’s clinical trial industry came to the spotlight in 2005 when 3,300 patients were subjected to 90 clinical trials that followed no protocols at a hospital in Indore, Madhya Pradesh. In American law, such violations automatically attract the criminal charge of battery. In India, the poor don’t count at all”.
Non-disclosure angle is the worrying factor as the subjects/victims of these tests are not fully informed. Once they concede to the tests, no individual has a right to withdraw. There is no comprehensive medical insurance or meticulous monitoring after the drug was administered on them.
These are the serious crimes being perpetuated against them. They die. But nothing happens. None notices. Media does not bother, nor highlight. Mostly corporate media is paid to be friendly with corporate pharmaceuticals. For political parties, it is no issue.
Gonsalves pointed out that 16,000 tribal girls in Andhra Pradesh and Gujarat were used for these trials without consent from the girls’ parents. $3.6 million worth human papilomavirus (HPV) vaccines were tested on these poor girls. There were allegations of adverse effects.
The 72nd Parliamentary Standing Committee Report, in a scathing indictment of India’s then booming clinical trial industry, implicated the DCGI for licensing the vaccines without adequate research on safety and efficacy; the Health Ministry for not questioning violations in the licensing process; the ICMR for promoting a drug even before it was approved and the NGO for setting up a trial without following basic protocol.
The parliamentary committee found commercial interests were influencing government policy, and that authorities were “overenthusiastic to act as willing facilitators to the machinations” of foreign institutions.
The committee recommended that henceforth, trials ought to be conducted only in the 330 medical colleges that have emergency facilities. It also sought — among other things — an investigation into the illegal approval of drugs and of doctors who submitted “ghost” letters recommending drugs for approval.
