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Health ministry's arbitrary ban on anti-diabetes drug

The manner in which pioglitazone, a drug used in the treatment of diabetes, was banned shows the health ministry in a poor light. What set it in motion, it has been reported, was a letter written by a Chennai-based doctor, V Mohan, who runs a diabetes treatment centre, to Prime Minister Manmohan Singh in January this year. The letter had pointed out that prolonged use of the drug increased the risk of bladder cancer. The Prime Minister's Office (PMO) passed on the letter to the health ministry, which banned the drug on June 18. It has now come to light that the ministry did no independent analysis of the side effects of pioglitazone before announcing the ban. Pioglitazone was big business for drug makers, including Sun Pharma, Lupin and Abbott - its annual sales were worth almost Rs 700 crore. The ban will wipe out this business. After these drug makers said the decision was unsound and not based on any scientific study, the health ministry held a meeting of doctors and pharmacologists to elicit their views on July 11, almost a month after the ban was announced! The Drug Technical Advisory Board, which decides such matters, will now meet on July 19 to take a view.

A more dangerous example of arbitrariness would be hard to find. These consultations should have preceded the decision, not followed it. It is not about the commercial interest of drug makers. The health ministry should realise that thousands of people take the medicine every day; so to ban it without proper homework, and without taking all stakeholders in confidence, is irresponsible. Such opacity in the field of public health should be removed and dealt with firmly.

Meanwhile, another aspect of the controversy has unravelled in the last few days. The doctor whose letter to the PMO triggered the ban runs Dr Mohan's Diabetes Education Academy - of which MSD Pharmaceuticals, the Indian arm of Merck, supports a course. MSD, it so happens, sells sitagliptin (under the brand Januvia) for the treatment of diabetes in India. Companies that have been affected by the ban on pioglitazone allege that Januvia stands to gain the most from it. Dr Mohan has said that he wrote the letter "in good faith" and "in the interest of science" and had no commercial interest in the whole affair. This may be true. But the upshot is very clear: doctors need to make full disclosures while taking up the cause of a medicine or while lobbying against one. Till that happens, scientific debates will always be undermined by such controversies.