Clinical Drug Trials and Contract Research: Need for Monitoring System
Finally the country has got
its attention towards the unethical clinical trials following the Supreme Court
judgment that central government and its various departments failed in
controlling deaths and serious health hazards due to drug trials in human
beings. The Supreme Court bench consisting of Justice R.M Lodha, Justice Kurian
Joseph also reprimanded government for not giving compensation to the victims.
The Supreme Court’s indictment was made in response to the petition submitted
against illegal clinical trials by the Swasthya Adhikar Manch, the National
activist group based in Indore.
A health centre in Trivandrum
was also recently accused of conducting such unethical drug trials. In
response, the suggestions made by the Committee with Dr. V. N Rajasekharan
Pillai as Chairman have not been implemented even now. . It is not even
confirmed that which agency has the authority to monitor clinical trials
whether the Drug Controller or the Medical Education Department.
The health department claims
that there were strict rules on conducting trials. Only those who register in
the clinical trials registry under Indian council of Medical research (ICMR)
with sufficient information can have the right to do clinical trials. It is also stipulated that the research
papers prepared on the basis of studies
that are conducted without following the rules should not be published in any
Medical Scientific Journals. In 2006, ICMR stipulated the Ethical Guidelines
for Biomedical Research that should be strictly followed while conducting
clinical trials. Besides this, the institutions conducting trials have to form
an Institutional Ethics Committee consisting of medical and legal experts and
its stipulated that only after getting clearance from this committee a trial
can be initiated. But the arguments presented before the before the Supreme
Court show that all the rules are getting violated.
During 2012-13 period due to
drug trials around 4000 people suffered from serious health consequences and
1000 died as submitted by Swasthya
Adhikar Manch. But according to the Drug Controller, only 506 faced health
problems from which 89 were died which still is alarming. The multinational companies were choosing the
developing countries like India for their experimentations due to various
reasons. Its quiet expensive to discover and market a brand new drug in
developed countries. About 40% of total budget need to be spent on phase three
clinical trials. In developed countries conducting clinical trials on human
subjects requires an approximate of 150 million dollars for each drug molecule.
Only half of this amount need be spent in countries like India. The growing
opposition of people from developed nations to be a part of such trials is also
one of the reasons for MNCs to move to developing countries like India. . In
US, the drug trials conducted on prisoners had to be discontinued due to
opposition from human rights activists. In 1995, US conducted ran clinical
trials on 4000 persons in different countries.
Through the clinical trial outsourcing 4 lakhs of subjects were
recruited for such experiments in 1999. By 2005, about 40% of trials were
transferred to the developing countries. The poor patients from countries like
India for whom the treatment itself is not affordable are willing to receive
the free medicines as the part of research. Only after obtaining the informed
consent from the respective patient, the trials can be started in developed
countries.
In India by utilizing the
loopholes in law, absence of monitoring system and illiteracy of people, any
studies can be done. Higher incidence of life style diseases in India is
another reason why such trials are done in India. For example it has reported that, there were
2 crore diabetic patients in India. Many anti diabetic drugs are in
experimental phase. The genetic diversity due to presence of various diseases
is also favorable for conducting such studies.
At the same time the pharmaceutical industries were not all interested
in discovering drugs for diseases which are relevant to the developing
countries or for those which affect only small population. Such diseases were
referred to as Neglected Diseases and the drugs necessary for treating such
diseases as Orphan Drugs. The Peoples Health Movement and health activists are
demanding the establishment of global research fund for conducting relevant
research without depending upon the MNCs.
In 2005 amendments were made in Indian patent
act as per World Trade Organization stipulations. Therefore the Indian
Pharmaceutical Companies can no longer manufacture those drugs that patented in
other countries by another process. With
the result that many of the Indian Pharmaceutical companies are now acting as
agencies that carry out contract research for the multinational companies. In
this way Indian companies received 200 million dollars in 2007. A business of
ten billion crore dollars was carried out in 2010. The number of clinical
trials registered in 2006 was 64 which increased to 425 and 1506 in 2009 and
2011 respectively. The Indian states like Maharashtra, Karnataka, Andhra
Pradesh, Gujarat, Delhi and Tamil Nadu are were the states where clinical
trials are done in large scale chosen. In 2007 and 2010, 132 and 670 human
subjects respectively lost their lives due to the participation in trials. In
2011 the drug controller stated to Supreme Court that 2000 people subjected
drug trials died and a very few of their families received compensation.
.
The 59th report of
the Parliamentary Standing Committee on Health and Family Welfare, presented on
may 2012 had revealed that a number of
drugs not subjected to clinical trials either in India or outside are being sold in Indian market. The report pointed that approval was given to
market 33 such medicines during the period between January 2008 and October
2010. The report also noticed the failure of Central Drugs Standard Control of
Organization, the nation’s main regulatory body for pharmaceuticals, in
implementing its various activities. But the government did not take any
appropriate action on rectify the problems pointed out by the report till
today.
Many of the institutions that
carry out clinical trials don’t have the basic facilities necessary to conduct
such trials. Among the 7 lakh practicing
physicians, only less than thousand had received training in clinical research.
The drug companies are offering INR 30,000/ patient to the hospital where drug
trials are conducted. At the same time only 150 hospitals among 20,000 general
hospitals are equipped with basic facilities to conduct trials. The amendments
made in Indian drugs and cosmetics act 2005 also aided in conducting trails
without much difficulty. Phase 1, 2, 3 of clinical trials involves drug testing
on human beings. According to the existing regulatory provisions, the clinical
trials should be conducted in other countries before being carried out in
India. But as per the amended rules it
is not mandatory to conduct Phase 1, 2, 3 trials in other countries. . By
utilizing these favorable conditions 20 lakhs patients are enrolled in 2010 for
the trial of new chemical entities. The women from tribal community and lower
socio economic status are being exploited for many unethical drug trials. The Programme for Appropriate Technology in
Heath (PATH) a US agency funded by Bill
and Melinda Gates Foundation in
partnership with state governments of Andhra Pradesh and Gujarat and ICMR implemented
a vaccination trial programme to prevent cervical cancer in 2009. For the study
13791 and 10259 young adolescent girls from Khammam district of Andhra Pradesh
and Vadodhara district of Gujarat respectively who belongs to indigenous
community were recruited and vaccinated.
The health activists intervened and found that the study violated
ethical norms and Indian laws and regulations following which the agencies
concerned had to halt the trials in April 2010. But the state governments had
not initiated any legal action against the organizers that violated the ethical
norms.
Dr.B.Ekbal .
Former
Vice Chancellor of the University of Kerala.
Health Activist,
Joint Convenor, Jan Swathya
Abhiyan (Peoples Health Movement India)
and Consultant Neurosurgeon, Former Professor of Neurosurgery.
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