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Safety last

The ban on a popular diabetes drug only shows poor side-effects monitoring

The ban on a popular diabetes drug only shows poor side-effects monitoring

The Indian drugs regulator recently banned popular anti-diabetes drug pioglitazone for its link to bladder cancer in globally reported studies. This link had led France and Germany to ban the drug in 2011. The move is a wake-up call to India’s drug industry and its doctors — either significantly scale-up adverse event reporting and post-market studies of drugs or face repeats of this scenario in future.

The Indian Pharmaceutical Alliance says over 30 lakh Indian patients are on the drug. There is an uproar among doctors and drug companies. They are outraged by the ban’s suddenness. They argue the drug still retails in the US,albeit with a black box warning regarding cautionary use. Importantly,they argue the drug has shown no evidence of a heightened risk of bladder cancer among Indian patients.

Let’s take each of these arguments by turn. First,the suddenness. Prima facie,the move seems out of the blue. But pio’s link with bladder cancer had already become a matter of concern for some years. In early 2012,the Journal of the Association of Physicians of India (JAPI) devoted a special issue to the drug,taking up various facets of its risks and benefits. Irrespective of what they concluded,the fact is that pio was in the dock. Doctors knew it,and companies knew it.

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Second,the “US does it” argument. Let’s rewind a bit. Not too long ago,another popular painkiller in India,nimesulide,turned controversial for its link to liver toxicity. That drug was never approved in the US. When the Indian government sought to restrict its use,some doctors and companies (not the same ones) objected that it wasn’t right for India to base its actions on those of the US and harked to approvals in some European countries! In this context,what is the sanctity of either argument?

Third,doctors say there is no evidence linking pioglitazone use in Indians to bladder cancer. Which begs the question — how representative has been the attempt to look for it? True,there have been some studies conducted in India. But these don’t account for more than a drop in that ocean of 30 lakh Indian patients supposedly on the drug,let alone the patient data tracked in the global studies. And this is the crux of the problem.

Globally,there is a system to keep track of unforeseen side effects of on-market drugs through a network of doctors,companies and the drugs regulator. It’s called pharmacovigilance. Then there is post-marketing surveillance supposed to be undertaken by companies,which is meant to throw up any danger signals. Underlying these efforts is the premise that even a drug approved after rigorous clinical trials might throw up unacceptable risks when given to a larger population. Or it might not. The system works imperfectly,but it does work. It has kept many drugs on market,even if it has taken some off it.

Neither has been taken very seriously in India,until very recently. In general,doctors are unaware of or too busy to observe and report adverse events or don’t know how. In general,companies have not prioritised it either. The government’s drug safety tracking programme,into which doctors and companies should ideally feed information,is just taking off after several false starts (and tracked pioglitazone to some extent).

As a result,the country still relies very heavily on the moves of foreign regulators — such as the FDA — to decide its own course of action. Those regulators are subject to local realities,and pulls and pressures that have little to do with India. Also,when they do leave controversial drugs on market,their feedback systems are superior to India’s.

This is no longer tenable,given the rising safety bar globally and India’s status as a leading pharma market. Assume for a minute that India’s pharmacovigilance effort had been working optimally,or that Indian companies had collaborated on largescale post-marketing studies that the regulator was kept aware of. Perhaps funded partly by the government,given our diabetes epidemic. Studies that leveraged the existence of a 30 lakh pio-consuming patient base to get a meaningfully large sample.

If pio was indeed proved safe,there would be sufficient material to counter any concerns. Such data can add to the global clinical evidence on the drug,thus potentially boosting pio’s chances to stay on market and raising India’s stature in the scientific community. Lakhs of pio users would benefit as a result. Even the Indian drugs regulator said something similar. Give us the evidence it’s safe,he said,and we’ll put it back.

India takes great pride in having influenced the global debate on drug patentability and affordable medicine. It is about time the country took the lead on safety as well.

The writer is a Mumbai-based independent pharma and healthcare commentator and founder,Apothecurry

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