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, 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.
Sundeep Khanna is a consulting editor at Mint and oversees the newsroom’s corporate coverage. The Corporate Outsider will look at current issues and trends in the corporate sector every week. To read more from The Corporate Outsider, click here