<-- Drug Trial Victim " Yatharth".
As penalties for subjecting patients to guinea pig treatment go, this one would not even register on the blip screen.
A dozen government doctors in Indore got a mere slap on the wrist on Saturday evening when they were fined Rs.5,000
for allegedly conducting controversial drug trials on 1,883 poor and
unsuspecting hospital inmates, many of whom suffered from side effects
and some even lost their lives.
The trials, that took place over a period of four years in three
hospitals, shockingly did not either have the government's permission or
the patients' informed consent. What was worse, the accused appeared to
have covered their tracks by not furnishing the details of the drugs or
vaccines used in the experiments as also the names and particulars of
the victims. In these circumstances, assessing the precise extent of
damage in terms of side effects and fatalities was an onerous task.
Instead of looking at the criminal conduct of errant doctors
belonging to government hospitals of Indore, the probe conducted by the
city's chief medical and health officer (CMHO), Dr Sharad Pandit, merely
invoked the Madhya Pradesh Nursing Homes and Clinical Establishment
(registration and licence) Amendment Act, 2003, to impose the paltry
penalty. The Madhya Pradesh government's disdain for the victims was
further laid bare by the untouched provision of the same law that
provides for a maximum fine of Rs.50,000.
Even that amount, however, would not have been a serious deterrent
for the doctors who, according to Paras Sacklecha (an Independent
legislator from Ratlam), had pocketed Rs.1.44
crore from private pharmaceutical companies to conduct the trials.
"They lured poor and illiterate patients without telling them about the
implications involved," Sacklecha alleged. It was he who obtained the
figure of 1,883 victims, including children and mentally challenged
persons, from the government under the RTI Act.
"In fact, without taking permission for the drug trial from the
government, the doctors have not only taken the huge sum from pharma
majors but also embarked on foreign tours," Sacklecha added. The
penalty, interestingly, was imposed on the doctors for not furnishing
the details of the victims who had been subjected to the trials.
"A fine of Rs.5,000 each has
been imposed on 12 doctors of autonomous medical colleges and hospitals
attached with them for conducting drug trials on children and mentally
challenged persons. The doctors had expressed their inability to provide
details of drug or vaccine trial, citing a provision of the Drug and
Cosmetics Rules, 1945," medical education department deputy secretary
Shyam Singh Kumre said.
In effect, therefore, action had been taken only for their failing to
provide data to the CMHO under the nursing homes Act. Even the press
note was silent on the illegality of the doctors' action. It merely
talked about new norms: "The state government is serious about the
complaints received in this connection and fresh guidelines will be
issued after chalking out new parameters."
But Dr Anand Rai, the whistleblower and a government doctor of Dhar district, said: "A maximum fine of Rs.50,000
could be imposed if the nursing homes were not registered or were
unable to furnish monthly data. Yet the fine slapped on the doctors was
the bare minimum."
Rai felt the government had simply let off the doctors despite their
performing drug trials on patients who had gone to the government
hospitals for routine treatment. "Putting such patients under clinical
drug trials without taking their consent is a criminal offence," he
added.
Between 2006 and 2010, the paediatrics department of MGM Medical
College, Chacha Nehru Bal Chikitsalay Avum Anusandhan Kendra, and the
department of medicines and neurology of M. Y. Hospital - all Indore-
based - allegedly conducted thousands of clinical trials on children,
men and women.
The MP government looked the other way till the issue rocked the
state assembly in the last monsoon session, forcing chief minister
Shivraj Singh Chouhan to order an enquiry by the Economic Offences Wing.
The latter curiously did not come out with the names of the culprit
doctors, the beneficiary corporations or even the victims. However, last
month, Chouhan claimed that no patient had died during the drug trials
in Indore.
"The state bureau of investigation of economic offences has submitted
a chart, along with its report on unethical drug trials, on important
facts and statistical data. This chart shows that 81 people had died or
fell unwell after the trials. But it has not come to our notice that
anyone died directly as a result of the drug trials," the CM told the
House, leaving enough room for doubt about whether the home ministry was
proficient enough to probe the cause of deaths after the trials.
Recently, the National Human Rights Commission (NHRC) served a notice
to the MP government over reports alleging illegal drug trials on
mentally ill patients in Indore. The NHRC asked the state chief
secretary to submit a report within four weeks, referring to a media
report alleging that 233 mentally ill patients were subjected to drug
trials in Indore.
The NHRC wanted to know whether guidelines of the Indian Council of
Medical Research (ICMR) were adhered to by doctors while taking approval
for the trials from independent ethics committees attached to private
hospitals. It also sought information on whether the nature of the drugs
being tested had been revealed. Furthermore, the panel asked whether
any survey had been conducted about the status of health of the mentally
ill patients who underwent drug trials.
"Every medicine has some side effects or risks associated with its
use. It is very difficult to say what kind of side effects the patients
on whom the drugs were tested may have suffered. The most shocking part
of the entire Indore drug trial fiasco is that the doctors conducted
investigational vaccination trials on illiterate persons without telling
them about the implications involved," Dr Anand Rai said.
