The fallout of the pioglitazone debate

"Today it is pioglitazone, tomorrow it could be a BP drug and then a cholesterol drug,” says diabetologist V.Mohan, calling for surveillance on medicines consumed in the country, in the aftermath of the shrill debate around pioglitazone.

Chennai-based Mohan runs a chain of diabetes clinics and is in the eye of the storm around diabetes drug pioglitazone.

His letter to the drug regulator, urging caution on the use of this medicine, given its possible link to urinary bladder cancer, is perceived as being a trigger for the hurried “suspension” that the Health Ministry imposed on pioglitazone.

Review call

The suspension of the drug, though, unleased a high-pitched call for its review. And the debate among doctors brought back into focus the dark and dangerous relationship between doctors and drug companies.

But a silver-lining is emerging from this dark cloud, as doctors agree on the need for a dynamic surveillance on medicines sold in the country, even though they hold opposing views on the benefits of pioglitazone.

Reporting side-effects

Authorities should have an independently run system, where a doctor from any part of the country is able to report an adverse event linked to a medicine, says Mohan.

Just a mobile phone should be enough for a doctor to report a drug-linked side-effects into the system, agrees another Mumbai-based doctor.

Rajiv Kovil, who runs diabetes centres in suburban Mumbai, agrees that pharmaco-vigilance, adverse event reporting and epidemiological surveys need to be done in the country.

It should not be part of a private or industry initiative, but the federal or State governments need to run these simple systems where doctors can report a side-effect, he says. Kovil, incidentally, does not support the suspension of pioglitazone, which he says, is well suited for Indian patients.

But, even if there was a system — would doctors report side-effects linked to medicines, or would they fear persecution by authorities, says a doctor to whom Business Line spoke to.

“It is a double-edged sword,” agrees Kovil, but if the system is clear and fair, doctors will not hesitate to report incidents.

At present, doctors report side-effects to companies, who in turn submit the reports to the drug regulator. But this does not show the entire picture, as there could be under-reporting, or there may not be details of where the incident occurred.

For instance, patients often go back with an old prescription or just an empty pack and get a fresh stock of the required medicine from the chemist.

The authorities should encourage doctors to record and preserve data, and ensure that medicines are sold only on prescriptions and for a particular period of time, he suggests.

Though 35 lakh patients are estimated to be on pioglitazone, there is little locally generated data to swing the debate for or against its use. A good fall-out though, is that doctors across the country are awakened to the reality of drugs, their side-effects and the need for surveillance, says a local doctor.

>jyothi.datta@thehindu.co.in

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