People's Democracy

INDORE CLINICAL TRIALS

CPI(M) Leader Demands Urgent Action

IN a letter written to Dr V G Somani, the Drug Controller General of India (DCGI), on January 4, 2012, CPI(M) Polit Bureau member and former Rajya Sabha member, Ms Brinda Karat, drew the former’s attention to the shocking fact of the notorious Indore drug trials. One recalls that senior doctors in government hospitals and also private doctors involved in these trials have flagrantly violated the minimum ethical standards in conducting clinical trials on their patients without informed consent. The letter also pointed out how the chairperson of the Ethics Committee in the MGM Hospital, one of the main hospitals, which had conducted the illegal trials, was himself found guilty of unethical practices.

There are several issues involved, the letter said. These include (a) lack of informed consent from the subjects of the trials, and (b) the vulnerability of the subjects, as almost everyone of them is from poor sections of the population and was, moreover, dependent on the doctor whose treatment he/she was under. Yet, shockingly, even a year after the flagrant violations of the trial were exposed and the facts made public, the DCGI has failed to act against those involved.

The Madhya Pradesh government had earlier set up an enquiry under the NHCE Act of Madhya Pradesh, and the enquiry found some of the doctors guilty of not reporting the trials, not keeping records etc. For these violations, however, they were fined a small amount only. In yet another enquiry conducted by the Economic Offences Wing of the state government, it was found that doctors conducting the trials in government hospitals were paid per subject recruited and that these payments ran into lakhs of rupees and even crores in some cases. While these are clear violations for which the licenses of the doctors should have been cancelled, the state government took no action. However, the enquiry report had also specifically recommended that as far as the violations of the Drugs and Cosmetics Act as well as violations of the guidelines issued by the Indian Council of Medical Research (ICMR) or Medical Council of India (MCI) are concerned, there should be further investigations by the DCGI and the ICMR.

The letter pointedly asked the following questions: Has the DCGI received the report? Is the DCGI aware of the multiple violations that have taken place in the conduct of the trials regarding the absence of informed consent, vulnerability of the subjects, conflict of interests of the doctors conducting the trials, number of serious adverse events that have occurred on subjects of the trials etc, and the role of the Ethics Committees? Since the Indore trial scandals have been widely reported in the press, is it not a case for the DCGI to have taken suo moto notice for appropriate action?

While noting that these serious violations of the clinical trials have gone unpunished, Brinda Karat’s letter also pointed out that apart from the doctors involved, the pharma companies who sponsored these trials must also be held responsible under the law for these violations. Unfortunately, the latter said, it is the power of these powerful lobbies which prevail and the guilty in these shocking and shameful cases escape unpunished.

The CPI(M) leader said in plain terms that the Indore trials are symbolic of much that is wrong in the system of clinical trials in our country, which considers human subjects as guinea pigs and caters to the dominant interests of powerful pharma companies. It therefore demanded that the DCGI office must act urgently. The letter raised the following specific demands:

(1) Institution of a time-bound enquiry into the Indore trials and the violations for which there is ample prima facie evidence.

(2) Coverage in the scope of the enquiry the members of the Ethics Committee who acquiesced in these violations.

(3) Blacklisting of the companies that sponsor the trials in which these violations have occurred.

(4) Recommendation of cancellation of the licenses of doctors involved.

The CPI(M) leader stressed that it is only stringent action which would help eliminate the gross violations of the law in the conduct of clinical trials, of which the Indore trials are a classic example.