Experts say pioglitazone difficult to substitute and health ministry has imposed ban without a back up plan
A ban on diabetes drug pioglitazone has created a problem for millions of patients and doctors, who do not have an alternative drug they can prescribe that costs about the same. The Endocrine Society of India (ESI) has shot off a letter to the government on Thursday, asking it to roll back the decision.
The Union Ministry of Health and Family Welfare (MoHFW) had issued a notification on June 18 and suspended the manufacture, sale and distribution of pioglitazone along with two other drugs, analgin (painkiller) and deanxit (an anti-depressant). The ban on pioglitazone created a furore; diabetes experts claim proper procedure was not followed and that the ban was imposed without preparing a back up plan.
In its notification, MoHFW says: “The government is satisfied that the use of the drug pioglitazone and all drug formulations containing pioglitazone are likely to involve risk to human beings and whereas safer alternatives to the said are available.”
Secretary general of the Indian Pharmaceutical Alliance, D G Shah said that there are many problems with the ban. There is complete secrecy/confusion about what led to suspension of the drug. According to him, the impact of sudden ban will be faced by at least 3 million patients who are stabilised on the drug. “Will these patients not be forced to switch to new and more expensive drugs (gliptins), marketed by the MNCs?” they ask.
Cheaper and deals with insulin resistance
Experts say that the medicine is going to impact patients in many ways. Pioglitazone was hardly costing patients Rs 1 to Rs 4 per day's course. But now they will have to shell out at least Rs 40 per day. And nothing suits patients better than pioglitazone in India, they claimed.
It is suited to Indian patients because the problem of insulin resistance is very common here and pioglitazone is the only medicine which deals with the resistance, said Vijay Panikar, secretary of the Association for Diabetes Care and Prevention. He termed the decision of banning the medicine strange.
The decision was based on few studies that showed that the medicine causes bladder cancer, he said, adding that a research on more strong sample is about to be published which will show complete negative finding compared to the previous one.
Weak association with cancer?
Bladder cancer in men has been reported with the use of pioglitazone with a cumulative dose of 28,000 mg in the initial two years of exposure in Diabetes Care journal. However this association was weak and no cause and effect relationship could be established in several other clinical studies, say the doctors opposing the government ban on the drug.
Experts say that the usual dose of pioglitazone, which has been shown to have glycemic benefits, is 7.5-30 mg/day. But in India, majority of the patients receive 15 mg /day, therefore, it is unlikely they would be exposed to the high dose required to have the carcinogenic effect in the initial years. Moreover, the prevalence of bladder cancer is much lower in our country as compared to a few European countries (France and Germany) where its use has been prohibited, says experts. Germany has banned the medicine while France has restricted its use.
Reconsider decision: experts
With all these details, ESI sent a letter to MoHFW to reconsider its decision of ban and reintroduce pioglitazone for the management of Type 2 Diabetes in India.
Chairperson and head of endocrinology and diabetes department at Medanta Medicity, Ambrish Mithal who is also associated with ESI, said there are two aspects related to decision. First, there is definitely a side effect but all medicines carry some side effect. In absence of any India-specific data, it is completely unscientific to ban a medicine which will impact several million patients.
The policy makers did not consult experts, it seems, he said, adding, “I am yet to know the name of the experts they have consulted before banning the medicine. I know all experts in the field and in my view; they have not talked to anybody.”
“If you find any problem, there is way to resolve the matter. You can’t get up and give order to ban the medicine one morning. Now, doctors and patients, both are feeling trapped,” he said.
Pioglitazone was developed in Japan and subsequently approved by USFDA on July 15, 1999, and is currently used in most countries. Pioglitazone is recommended for use by all major international associations and guidelines, including International Diabetes Federation, American Diabetes Association (ADA)/ European Association for Study of Diabetes (EASD) and American Association of Clinical Endocrinologists. The most recent ADA/EASD guidelines (2012) suggests pioglitazone as a first add on to metformin, and puts it at par with sulfonyureas, incretin-based therapies and insulin, leaving the choice to the physician. The USFDA continues to approve pioglitazone with a black box warning and pioglitazone continues to be widely used in the US. It is noteworthy that many other drugs for diabetes and other conditions carry black box warnings, all of which are marketed and prescribed in India as well.
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