Big Pharma’s India shadow
The nexus between pharma companies and
hospitals in India is pushing up treatment costs while exposing patients to
huge, unknown risks.
The medical world is in the grip of a fierce
debate triggered by the findings of two academic studies both related to the
impact on us of statins, the group of drugs which act to reduce levels of
cholesterol in the blood and are routinely given to those who have cardiac
issues. An article in The Lancet , ‘Interpretation of the evidence for the efficacy and safety
of statin therapy’, concluded that “statin therapy has been shown to reduce
vascular disease risk during each year it continues to be taken, so larger
absolute benefits would accrue with more prolonged therapy, and these benefits
persist long term.” It de-emphasised the side-effects from prolonged
use of the drugs.
On the other hand, an older piece and its
more recent follow up in the venerable British Medical Journal (BMJ) stated that “statins have no
overall health benefit in this population”, while suggesting that
side-effects of statins are very common, perhaps suffered by as many as 20% of
people taking them.
While it is difficult to pick sides
particularly since both sets of academics appear to have been compromised in
some ways by being associated with companies that are either selling these
statins or are pushing non-statin cholesterol-reducing drugs, the overwhelming
research over the last 20 years supports the BMJ findings. A 2015
investigation, ‘Statin Therapy and Risk of Acute Memory Impairment’, by doctors
Brian L. Strom,
Rita Schinnar and Jason Karlawish concluded that “when compared with matched nonusers of any
lipid-lowering drugs (LLDs)… a strong association was present between first
exposure to statins and incident acute memory loss diagnosed within 30 days
immediately following exposure.”
This latest attack on Big Pharma confirms how
in the conflicting
demands of drugs for profit and drugs for curing diseases, there can
be only one winner and it is certainly not the patient. The harmful impact of
silicone breast implants or certain hormone drugs were revealed long after they
had been in use for decades. Expecting a pharma company to willingly give up
billions of dollars in potential sales is unrealistic. After all, Pfizer’s
Lipitor, the original cholesterol-lowering statin, is one of the best selling
drugs of all time having grossed over $125 billion in sales for the company. Hence,
studies of the kind quoted above are virtually the only lifeline for patients.
That’s sadly not even an option in India
where the nexus between pharma companies and hospitals is pushing up treatment
costs while exposing patients to huge, unknown risks. Atorvastatin, the generic
formulation of Lipitor, is extensively recommended for use in India. Ranbaxy,
the original generic pharmaceutical manufacturer of atorvastatin since 2011
(three years after it was acquired by Japanese company Daichi Sankyo where Akira
Endo the original creator of statins did his initial work in the 1970s before
the Japanese company shelved the project), ran into enough problems with the US
Food and Drug Administration (FDA), to suggest that the future well-being of
consumers of its products was the last thing on its mind. Indeed, in India,
where branded generics dominate the pharma market, constituting nearly 80% of
the market share (in terms of revenues), there is little oversight,
particularly since generics are not required to replicate the extensive
clinical trials that have already been used in the development of the original,
brand-name drug. Over the last decade, drug withdrawals from the Indian market
have been mainly due to safety issues involving cardiovascular events.
Nor is it any comfort that there are
competent agencies in the developed markets that from time to time do blacklist
potentially harmful drugs. The typical lag between the banning of a drug in
developed markets and in India is 3-5 years.
There is a process in place for this very
purpose. Pharmacovigilance, as defined by the World Health Organization,
relates to the detection, assessment, understanding and prevention of adverse
events or any other possible drug-related problems. In India, the pharmacovigilance
programme is run by the The Central Drugs Standard Control Organisation
(CDSCO), under the ministry of health & family welfare and coordinated by
The Indian Pharmacopoeia Commission (IPC). The trouble is any such programme
relies upon spontaneous reporting by healthcare professionals in an effort to
prevent or reduce adverse drug reactions (ADRs). Predictably, that’s not
happening in India, where the ADR reporting rate is below 1% compared to the
worldwide rate of 5%.
With India emerging as the diabetes and
coronary heart disease capital of the world, it is also among the fastest
growing markets for pharma products. But as much the benefits of these accrue
to Indians, the absence of adequate oversight and monitoring for long-term
effects shouldn’t leave the country in the shadow.
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