Now that the Ministry of Health and Family Welfare (MOHFW) has rolled back the ban on pioglitazone, it is time to mull over the key takeaway messages from this episode. Two stories in the August 16-31 issue attempt to do this from two different perspectives.
The story, ‘Pioglitazone: The saga continues’ mirrors the dilemma of the prescribing community: how do they heal without harming? Every doctor wants only the best for his patient. But, do we have a system in place to find out if today’s wonder drug is truly as good as it seems? Unfortunately, the answer is no. Pioglitazone has been available in India since March 2001 but more than a decade later, we still do not have the data to show us conclusively that it has no long term side effects on patients in India. So, do we conclude that the absence of proof is proof enough of its safety?
The second story, ‘Pharmacovigilance: Is India losing the way?’ is an analysis of India’s attempts to put in place a drug safety monitoring system and the many challenges along the way. Experts argue that while the Pharmacovigilance Programme of India (PvPI) looks good on paper, the reality is very different. The biopharma companies who do have a PV structure in place unfortunately look at PV as a cost, required by law, rather than implementing it in the true spirit. PV spends need to be positioned as an extension of a company’s commitment to patient care.
In fact, pioglitazone’s re-entry into the market could well be the acid test of the PvPI as well as other regulatory mechanisms of India’s health ministry. For instance, who will monitor that not only do all packs of pioglitazone and its formulations have a ‘red box’ warning but also have product inserts and promotional literature with the same warning in bold red letters? Who will check that doctors follow all four conditions laid out in the ‘Advice to healthcare professionals’ checklist? Who will ensure that doctors are in fact reviewing the response of the patients on the drug at three-six month intervals?
The fact that diabetes has reached epidemic proportions in our country make it all the more urgent to have a robust system in place to search for the proverbial needle in the haystack. Many factors, like genetic variations, cultural and dietary habits, concurrent use of traditional medicine, complicate the equation between medication use and clinical outcomes in India and thus a glitch-free PV system is a safety net we must have.
The silver lining to the whole controversy is that hopefully, patients and their relatives are today more aware that all medicines can potentially have side effects. This awareness needs to be increased and sustained, because at the end of the day, a patient is a consumer and sooner or later, the patient community will have to take care of its interests.
This is already happening in other countries. Industry observers point out that patients in the US who developed bladder cancer after being on pioglitazone for four years, sued the pharma company alleging that it did not provide adequate warnings to doctors and patients on the drug’s link to an increased risk of such cancers. India has a relatively poor history of such product liability claims, and it is likely that again the lack of data will be cited as a reason to discredit such claims. Just as patient groups have had to agitate for more affordable cancer medication or stop improperly conducted clinical trials, unless pressure builds up on the PV front, progress will be sluggish.
Everyone – from patients, doctors, biopharma companies and finally the health authorities – will have to work together to develop a fool proof system to test even the most trusted of medicines. After all, it is better to be safe than sorry.
Viveka Roychowdhury
Editor
