Today’s edit page of The Indian Express has my column on the Indian drugs regulator’s decision to ban pioglitazone, an anti-diabetes drug reportedly taken by 30 lakh patients. I have argued that India is paying for its historically casual attitude to pharmacovigilance or tracking drug safety. I have reproduced parts of the IE column below (in italics). You can read the full column here.
Call the thought idealistic if you will, but if Indian regulators, companies and the medical community take safety seriously then by leveraging its huge patient base they can add to statistically significant information on a drug’s safety and efficacy once it’s on market. Indeed, this is a lot more doable than even clinical trials where the risks go up significantly thanks to the experimental nature of the drug, calling for tons more caution. This effort will help in taking crucial decisions, such as this one, for Indian patients. It can even contribute to a better undertanding of drugs, globally.
For those interested in the status of India’s nascent pharmacovigilance effort, an earlier post on this blog gives some information. See below excerpts from the IE column.
“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.
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.”
Pic sourced from the photostream elycefeliz on Flickr.