Despite general agreement on the pivotal role and
necessity of “clinical trials” to usher in better treatments and to keep
pushing the boundaries of what medical science can achieve, the term continues
to evoke suspicion and cynicism in the minds of the public.
The history of clinical trials has been both epoch
making as well as shameful.
During my recent discussions with an international
pharmaceutical organization that has developed some promising new molecules for
Hepatitis B and C and was trying to identify reliable hospitals and clinical
investigators in India, I was told that clinical trials are banned in some
states in the country.
Some investigator-doctors here had obviously
flouted safety and research norms and jeopardised the lives of innocent
patients. But why did they do it? The
possible reasons:there is often unusual eagerness to recruit patients in a
trial as successes in the eyes of industry sponsors as well as financial
remuneration are linked with the number of patients that a doctor recruits. Once
recruited, many busy doctors often do not find time to closely monitor them for
side effects. And if a patient does complain of unusual symptoms while on the
trial therapy, the investigator-doctor is often reluctant to withdraw the
patient from the drug as he fears his numbers might crumble.
All these failings of doctors are compounded in
great measure by illiteracy and poverty of our patients. Speculations begin
with how truly informed the ‘’informed consent” usually is for a patient who
cannot read the 4 page document that he is expected to put his thumb impression
on. Further, in a paternalistic medical climate ‘’where doctor always know
best’’, does a poor patient who has surrendered himself completely and suffered
a complication of a trial-treatment really has a voice to be heard?
Despite all these ugly tales, successful stories that
have benefitted mankind can be found around each medicine that we prescribe or every
procedure that we perform today. The discovery of the first antibiotic,
penicillin, serves as a milestone. When two doctors, Chain and Florey embarked
upon a clinical trial to test Dr Alexander Fleming’s new antimicrobial,
patients and the public must have been just as sceptical. Severely infected
patients were treated either with the potions of the day or with the
experimental drug obtained from the penicilliummould. A few weeks later the
researchers noted that while most who received the “standard of care treatment”
of the day died, most receiving the ‘’experimental one” pulled through!
Perhaps the greatest challenge of our present times
is to bask in the belief thatwe have reached the pinnacle and need not try out
newer treatments any more. We should learn from the other systems of medicine
that have all had their days in the sun but have stagnated due to lack of
on-going researchand now live on as withered wisdom in moth-eaten books.
As published in HT City ( Hindustan Times) dated 11 August, 2013.
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