That the Union Health Ministry takes critical decisions affecting a large number of people without any scientific basis does not portend well for public health in India. Neither the ban imposed on the oral anti-diabetes drug pioglitazone on June 18 nor its revocation a month later with a requirement that the medicine be sold with a boxed warning highlighting the adverse side-effect of bladder cancer was based on any scientific evidence from India. The excessive haste and utter secrecy in which the drug was banned raises serious concerns about the decision-making process. It is shocking that eight ‘cases’ of bladder cancer in patients who are on pioglitazone was the only ‘data’ the ministry relied on to ban a drug that has been used by a sizeable number of diabetics for about a decade. As if the statistically insignificant number of ‘cases’ it relied on to take a decision was not shocking enough, it relied on ‘data’ that never came under scientific scrutiny. This best portrays how cavalier policymakers can be. If the basis on which the drug was banned is baffling, the grounds on which the ban was revoked with a box warning is puzzling. After all, an Indian study of 958 patients who are on pioglitazone but with no cancer after two years of treatment is the only scientifically valid data currently available. It is also well known that Indians have a different genetic profile from Caucasians and very contrasting characteristics, which make them more susceptible to diabetes.
While a few large studies conducted elsewhere have shown increased risk, a few others have not. The fact that three countries have placed varying restrictions on the drug’s use should have prompted Indian officials to conduct large-scale studies. Even now, there are overwhelming compulsions to immediately undertake such studies to know the actual risk. Any decision to continue with, remove or rephrase the contents of the boxed warning should be based on those results. Last month’s decision by an advisory panel to the U.S. Food and Drug Administration to “ease restrictions” on the sale of Avandia (rosiglitazone), a much maligned diabetes drug, is a case in point. Avandia was found to increase the risk of heart failure and death. But a re-evaluation has led to a softening of stand. Tobacco being a leading cause of bladder cancer is well known. With millions of tobacco users in the country, only well-designed studies can help in pinpointing the pioglitazone-cancer causative association. The cheap and effective drug has been in the market for about a decade and many thousands have been using it for a long duration and at lower dosages than in the West. The government may have the power to act but Indian diabetics have the right to an informed decision.