The
recent decisions made in the Democratic Republic of India, leading to
the suspension of the review and approval process for any new domestic
and global clinical trial applications is a catastrophic mistake. The
decision directly and negatively impacts the lives of millions of
Indian’s across the country, under the false premise that the actions
taken will protect those individuals. Logical, fact-based and
statistically supported thinking and decision making has been sidelined
in favor of embellishment, made-for-media headlines, sound bites and raw
unchecked passion. When combined with court decisions made during the
past 18 months, the result has been a nearly two year shut down of what
was one of the fastest growing and most promising enterprises India has
seen since the dawn of the new millennium. Furthermore, data from Frost
and Sullivan, Boston Consulting Group, Price Waterhouse Coopers, Ernst
and Young and PRTM forecasted that the future could only have been
brighter. Most importantly, the vital flow of innovative new and potentially life improving treatments has come to a complete stop.
Therefore, the People for the Advancement of
Clinical Research – India (PACRI) has launched this petition to urge the
Supreme Court of India to allow the relevant government bodies to again
begin reviewing and approving clinical trials. Through this petition we
would also like to bring to the front the facts concerning clinical
research that are being smudged in this very public media trial. We
recognize that the process is not perfect and that changes must be
committed to, measured and made in order to meet Court expectations –
but a complete stop is a shortsighted and unacceptable solution. PACRI
is comprised of ordinary individuals from the following groups: ordinary
healthy citizens; patients; government officials; health enterprise
professionals; educators; patient advocacy groups and more.
Below is a list of relevant facts and findings
regarding the importance of clinical research to the physical and
economic health of the people of India. Readers of this petition will
find that many of these facts lay in stark contrast to the often vague
data points being put forward by the small- yet-loud groups, who have
stood in the way of any progress in an effort to create progress void of
risk. The groups fail to recognize that their often emotive and
misinformed statements are only turning out to be more detrimental to
the cause they espouse – protection of the research participant. The
very nature of clinical research and of any innovative enterprise, is
that progress is often fraught with risk. More than law, it is the
individuals who have to ensure that the risk is balanced with the
benefit any process will provide to people and society. If we are
realistic, we must recognize that mankind has never advanced without it.
FACT: New treatments cannot
be brought to market and become available at your local pharmacy
without first undergoing a rigorous testing process in the lab, in
animals and then in humans in the clinic, known as Clinical Research or
Clinical Trials
FACT: Clinical research
when properly conducted has a great potential to help us understand the
prevalence of various diseases and help us to more effectively prevent,
diagnose, treat and rehabilitate the affected population
FACT: Clinical research has
been occurring in India for decades and the conduct of global clinical
trials has been occurring since 2005
FACT: There is no
such thing as a clinical trial without risk for the volunteers who
participate. The very nature of a clinical trial is that it is a test to
determine whether an investigational product can be proven to be a safe
and effective treatment.
FACT: The very
individuals who want an excessive amount of safe guards imposed, have
very much benefitted from the clinical research process and the efforts
of volunteers anytime they take a medicine or receive treatment from
their physician.
FACT: There is no
statistical evidence to support that Indian citizens are being used as
the world’s guinea pigs, as is often proposed by the press and
uninformed advocacy organizations. In fact, India’s stake in the
conduct of global clinical trials is still very small: The number of
clinical trials DCGI approved in India from 2010-2012 is 1,065, while
globally, during the same period 43,325 trials were registered
officially in the US; about 2.5% of all registered studies. The opposite
case is more likely, given that most of the marketed medicines
available in India were innovated and tested elsewhere.
FACT: A statistic
widely reported in the press, often not explained fully, has led to a
massive wave of condemnation and public discourse. Specifically, the
data that 2,868 people died during clinical trials of 475 new drugs
between 2005 and 2012 is very misleading – and purposely so – it sells
newspaper and attracts website visitors. The fact is, out of the
estimated 451,000 people who participated in clinical trials between
2005 and 2012, 89 died of trial related causes. All other cases of death
reported, represent individuals who died of something else while
participating in the trial. If those people were injured or became ill
during the trial – for example, a person in a cancer trial falls in an
accident at home and dies – they are recorded as a Serious Adverse Event
(SAE) – and officially tracked and reported as part of the data package
associated with a new drug application. Therefore, 2,868 of the people
reported in the news to have died during a clinical trial – died from
something that was determined NOT to be caused by the study drug or
trial related procedures. India has 1.2B people, more than 15% of the
world’s population, while burdened with >22% of cases of disease. So,
statistics prove that during a 7 year span, 89 people out of 1.2B died
from their participation in research - research meant to advance
treatments designed to improve or save lives. While ANY loss of life is
regrettable and steps should be taken to prevent such loss, there is by
no means a greater risk of safety issues occurring in India, than there
is any other part of world where the human race is working to advance
science and save lives. The deaths in clinical trials are not unique to
India. The trials in which India participated had SAE’s and deaths
reported from other parts of the world.
FACT: In all of
2013, 9 global clinical trials were approved for conduct in India.
Essentially, there has been no advancement of treatments toward approval
in India for nearly a year due to widespread overreaction and fear.
Have people been saved or are we actually losing thousands of lives as a
result of this stoppage?
FACT: India’s
Good Clinical Practice standards – which outline the processes for the
conduct of clinical trials are more stringent than those followed by the
international community, including leading clinical research countries
in the North America, Western Europe, Japan, Australia and elsewhere
titled – called the International Conference on Harmonization – Good
Clinical Practice or ICH-GCP.
FACT: Recent
legislation requires compensation paid to clinical trial volunteers who
do not receive the intended therapeutic effect of the investigational
drug, or who receive a placebo (sugar pill) instead of the
investigational drug. These two requirements are exotic, cannot be found
in any other part of the world where clinical research exists, and
strike right at the heart of the very point of conducting clinical
trials. First, clinical trials are tests of investigational medicines so
the very point of the trial is to see if the treatment has the intended
effect. Second, to determine whether the treatment is actually working
or if it’s simple the perception of the patient, a placebo is often
used. The use of a placebo is a proven mechanism to help ensure the
validity of the treatment group results. Volunteers are explained these
things as part of the informed consent process before they even agree to
participate in the study.
FACT: The Supreme
Court is mandating the use of audio and visual recordings of the
consent process that each clinical trial volunteer must go through when
deciding to participate in the trial. This is another unprecedented step
not found in normal Good Clinical Practice anywhere in the world,
whether established or emerging market. The time, costs and logistics of
implementing such a measure will further slow the clinical research
process and create unnecessary delays in the advancement of potential
new treatments to the patient population of India. The recommended
process also does not take into account the two major ground realities
of medical care in India.
FACT: The
patient-doctor relationship in India is very strongly based on “faith”.
This A-V process will introduce an element of distrust and discomfort in
that relationship. Instead of encouraging real discussion on health and
treatment between the doctor and the patient, it will only disengage
the two parties.
FACT: A major
proportion of the Indian population culturally still protects the female
gender in a ‘purdah’ system. How will we deal with this cultural issue
in the light of the ease of electronic transmission of data in this
technological age. Who will protect their privacy?
FACT: The review
process that new clinical trial applications go through in India is as
rigorous, if not more rigorous than, most other countries across the
world, even those that have been conducting trials for many decades. The
past 5 years have seen the implementation of a number of new
regulations and strict requirements aimed at tightening the review
process after some earlier incidents. The resulting two step process
which has been in place for nearly two years now, ensures that all new
trial applications not only undergo the scrutiny of the office of the
Drugs Controller General India - but due to legislative changes in 2010 -
also now undergo an in-depth evaluation by a panel of 10 objective
physicians, who have extensive expertise in the therapeutic area/disease
being targeted by the clinical trial. Only after passing successfully
through these two layers and then being approved by independent ethics
committees located at each research center, can the trial actually
proceed.
Other Truths about Clinical Research
- Clinical trials in India are
regulated by a set of rules that are in conformity with – and in some
cases surpass - global standards
- The implementation of present set of rules must be closely monitored before moving the goal post
- Clinical research when properly
conducted has a great potential to help us understand the prevalence of
various diseases and help us to more effectively prevent, diagnose,
treat and rehabilitate the affected population
- Clinical research has provided medical access to thousands of patients since the policy change in 2005
- Since 2005, clinical research
has generated employment to thousands of professionals and has the
capacity to generate employment to a few hundred thousands of such
professionals
- Clinical research has contributed significantly to the growth of laboratories, imaging, logistical support and other services
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