WUNRN
World Medical Association - Declaration of Helsinki -
Ethical Principles for Medical Research Involving Human Subjects
Original
Text Amended over Years including 2013
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INDIA - DISPUTE ON ETHICS OF
CERVICAL CANCER CLINICAL TRIAL - 254 UNSCREENED POOR WOMEN DIE
It is a well established fact that any kind of cervical screening reduces the
incidence of the cancer. Yet, almost 140,000 women in the control arm of the
trial were not screened. After a complaint made to it, the United States Office
for Human Research Protections (OHRP) determined that the women were not given
adequate information to give informed consent.
Those arguing that the trial was unethical also say it violated the
international ethical guidelines on medical research, the Helsinki
Declaration's guidelines, which clearly state that "the benefits, risks,
burdens and effectiveness of a new intervention must be tested against those of
the best current proven intervention".
Even Indian Council of Medical Research (ICMR) guidelines stipulate that a
placebo can be used only if the disease is self-limiting or when no proven
preventive, diagnostic or therapeutic method exists.
"Clearly these trials violated both international and national
guidelines," said Sandhya Srinivasan of the Indian Journal of Medical
Ethics (IJME), who in her editorial on the subject in April last year pointed
out that "these studies would not have been permitted in the country of
the funding organizations (US National Cancer Institute and the Bill and
Melinda Gates Foundation (BMGF)."
An article in the latest issue of the IJME by Dr Eric Suba, a San
Francisco-based pathologist, who had filed a complaint in the US in May 2011
against the trial, has demanded compensation for the families of the women who
died and immediate screening and treatment, where necessary, of the women in
the unscreened group.
The three-cluster randomized controlled trials looked for a cheap screening
treatment for cervical cancer for introduction into the public health
programme. The screening treatments being examined were Visual Inspection with
Acetic Acid (VIA) screening, Pap smear — which is the standard of care in the
west — and HPV screening.
The trials were conducted among Indian women of the lowest socioeconomic status
in Mumbai slums, villages in Osmanabad in
In the IJME article, Dr Suba asked what purpose was to be served by keeping
140,000 women without screening when the effectiveness of cervical screening is
well accepted. "...people should not be used to demonstrate exactly how
much death results from lack of medical care," stated Dr Suba.
Trial researchers claimed that having unscreened control groups is ethically
justified in
Since at the time of the trial there were no doubts about the benefits of
cervical screening, the creation and maintenance of unscreened control groups
in the US-funded studies in
If, at any time during the past 15 years, the women in the unscreened control
groups had been told the simple truth that cervical screening would lower their
risk of death from cancer, they would have left the control groups and sought
screening on their own, thereby nullifying a scientifically defective
experimental design, Dr Suba argued. The OHRP determined that it was thus
difficult to presume that the BMGF-funded studies are not compromised by the
inadequate informed consent, wrote Dr Suba.
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Asian Human Rights Commission
http://www.humanrights.asia/news/ahrc-news/AHRC-STM-070-2014
Insia - Cervical Cancer Clinical Trials - 254
Women Die under Supreme Court’s Watch
Unethical clinical trials conducted without obtaining informed consent of the
participants have struck India again, killing 254 women from the most
marginalised sections of society. The deaths, or rather murders, have taken
place in the course of a 15-year long United States funded clinical trial for a
cervical cancer screening method. The women who perished were part of a control
group kept without screening. This, according to information available through
various media reports, was done to study death rates in unscreened populations.
The trials flouted the basic ethical norms of medical
research. Approximately 140,000 women were kept uninformed that cervical cancer
screening reduces the incidence of cancer, thereby duping them into being part
of the control group. That the unethical trials were conducted intentionally is
further betrayed from the fact that the participants for the control group were
chosen from the slums of Mumbai and villages in Osmanabad and Dindigul, as
against the 224,929 women better-off backgrounds who received different types
of cervical screening. The the women were not provided adequate information for
informed consent was later confirmed by the United States Office for Human
Research Protections (OHRP).
Unfortunately, this is not the first time big
pharmaceutical companies have turned the lowest strata of Indian citizenry into
guinea pigs and gotten away with it. This time it has happened under the
watchful eyes of the Supreme Court of India as it is hearing a writ petition
(WRIT PETITION (CIVIL) NO(s). 33 OF 2012) filed by the Swasthya Adhikar Manch,
Indore and others against the Union of India over the issue.
On 22 October 2013, the Supreme Court had stopped 157 clinical trials over
serious problems in adherence to both the Helsinki guidelines on medical
research, which state that “the benefits, risks, burdens and effectiveness of a
new intervention must be tested against those of the best current proven
intervention” and the guidelines of the Indian Council of Medical Research,
which specify that a placebo can be used only if the disease is self-limiting
or when no proven preventive, diagnostic, or therapeutic method exists. (More details
in an earlier AHRC statement here).
Cervical cancer screening methods exist and often prove to be life saving for
many potential victims.
How did this trial continue with impunity? How did the
trials escape the new three tier regulatory system put in place by the Supreme
Court that consists of New Drug Advisory Committees (NDACs), technical
committees, and the apex committee? Finally, what was the Supreme Court doing
to ensure that its orders were honoured and enforced by an executive that was
primarily responsible for enforcing them on its own, without the intervention
of the judiciary? The answers to these questions expose a rotten system, a
so-called democracy that does not bother with the death of its lesser citizens.
Clinical trials have ended in serious adverse effects,
including the death for more than 4,000 people in 2012 and 2013, of which the
government admits to only 506 in the ongoing writ petition. In an earlier
response, the government has stated that compensation was paid to only in 22
cases of deaths out of the 89 deaths it conceded. The absurdity of both the
response and the data was lost on neither the Court nor the petitioners.
The Court recently asked the government why
compensation was paid only in cases of death, and not for the participants that
had been seriously affected? The absurdity of the government figures is
betrayed by the figures submitted by Ministry of Health and Family Welfare,
which has accepted 2,868 deaths of participants of clinical trials in India
during the 2005-2012 period, qualifying a mere 89 of them as trial-related.
On 10 March 2014, the Supreme Court directed the Union
government to provide details on the number of deaths and severe adverse
effects caused to people subjected to clinical trials. It has also asked the
government about the continuing discrimination in compensating only deaths and
not the people suffering lifelong adverse effects due to the experimental
medicines.
It is in this context that the stakeholders cannot
absolve themselves from criminal culpability in these murders. The Indian
government is the biggest culprit for firstly failing to institute a foolproof
regulatory system, and, subsequently, for protecting those responsible for such
murders, from the doctors conducting trials without obtaining informed consent,
to the contract research middlemen, to the pharmaceutical companies themselves.
Perhaps such behaviour can be seen as consistent for a government that persists
in denying starvation deaths in the country by blaming them on diseases ranging
from diarrhoea to tuberculosis even while accepting widespread prevalence of
malnutrition.
Almost all of the participants for the trials in
question, be it in the HPV vaccine trials in Andhra Pradesh, where 14000 tribal
girls in the 10-14 age group were made to participate on the basis of consent
form signed by their wardens, or the current one, are marginalised and come
from poor backgrounds. Many participants are known to be enticed into these
trials for ‘wages’ often as low as Rs. 100 ($ USD 1.6). What can one say for a
government that pushes its citizens into becoming guinea pigs, a government
whose citizens choose possible death by experimental medicines over death by
starvation?
The Supreme Court of India appears culpable in this
case – being aware of the facts and yet taking no actions against the guilty.
Between the Court and the government, why has no one responsible for the
illegal trials halted by the Court ever been prosecuted, so as to serve as a
deterred to others indulging in similar crimes?