We, the Guinea Pig Nation

A diabetes drug suspected of causing heart failure is being tested on Indians.

Among consumers ‘new and improved’ is a well-proven success mantra, one that ramps up sales of soap, butter, televisions or any other such product. Among patients, ‘new and improved’ is much more—it’s a prayer. Right now, this is a prayer going unheard in India, home to the world’s largest diabetes population. 

Ever since 2007, studies have shown that rosiglitazone, the drug most widely prescribed and used for type II diabetes, causes cardiac risks and deaths. In India, rosiglitazone, manufactured by GlaxoSmithKline (GSK), sells as Windia and Windamet. Both drugs have provided the company a good perch in this fast-growing therapeutic area. In America, where it sells as Avandia, GSK’s blockbuster drug has run into serious controversy.   

Here’s what studies reveal. When compared to pioglitazone, a safer and improved molecule, rosiglitazone is more likely to cause heart failure by about 50 per cent.  Rosiglitazone-induced heart failure actually leads to more deaths than pioglitazone. Studies of this drug’s cardiac risks were ordered by the United Stated Food and Drug Administration (USFDA). Even after the American and European Diabetes Associations advised against it, the drug hasn’t been withdrawn. In fact, on 14 July, the FDA decided to allow Avandia to sell with ‘more severe labels’ and ‘patient education’. 

But would either of these spell out the truth? That this pill could kill you? “This is the first time that a clinical trial is being conducted to prove that a drug is not inferior to another drug. Usually, this is done to prove a drug is superior,” says CM Gulhati, editor of the most authoritative reference guide for prescription drugs in India, MIMS (Monthly Index of Medical Specialities). 

In what is a continuing fraud upon patients, the Drugs Controller General, India, (DCGI) has allowed GSK to conducts trials at ten sites to study if this drug causes cardiovascular effects. Gulhati declares: “There is no justification for the DCGI approving this trial; it will expose Indians to morbidity.” In fact, the trial consent form does not even present the risks in proper perspective. “It is most unethical and inhuman to administer a drug that is known to be inferior to the comparative molecule,” says Gulhati. Next time you’re at the diabetologist, ask—no, demand the safer, improved anti-diabetes pill.