New Delhi: GlaxoSmithKline Plc.’s diabetes treatment drug Avandia, sold in India as Windia, has rung alarm bells across the world, with a study linking its use to increased risk of heart attack.
Currently, India, with the world’s largest diabetic population, has 10 drug makers selling versions of the same drug, rosiglitazone. Some 10 million people across the country use rosiglitazone, or nearly a quarter of the 40 million diabetics.
The furore has been created by a study (see detailed story on Page 18) conducted by Cleveland Clinic’s cardiologist, Steven E. Nissen, and published by the New England Journal of Medicine, that has found a 43% higher risk of heart attack in diabetics that took Avandia, compared with other drugs or plain sugar tablets. Nissen looked at a series of past studies as part of his research.
The US Food and Drug Administration (FDA) has already issued a safety alert on the world’s largest-selling oral diabetes drug, even as it investigates “contradictory evidence (from various studies) about the risks in patients treated with Avandia”. Meanwhile, the UK-based drug maker has pitted in a strong rebuttal of the findings, calling them “absolutely false”.
GSK India MD Hasit Joshipura was out of the country, but the company said it “stands firmly behind the safety of Windia when used appropriately, and... believe(s) its significant benefits continue to outweigh any treatment risks. No direct causal relationship has been established with rosiglitazone (Windia) for the adverse events identified in the data”.
The risks in India, experts say, are potentially larger as there are many versions of the drug. Besides GSK, drug majors Sun Pharmaceuticals Ltd, Torrent Pharmaceuticals Ltd, Cipla Ltd, Aristo Pharmaceuticals, Glenmark Pharmaceuticals Ltd, Micro Laboratories, Emcure Pharmaceuticals Ltd, Wallace and Orchid Chemicals & Pharmaceuticals Ltd all sell versions of the drug.
Most of these drug makers are now taking a wait-and-watch approach as researchers, overseas regulators and the drug company battle it out.
The Avandia drug situation also illustrates the pressing need for a drug safety regulatory framework for foreign drugs and their generic variants sold in India. Currently, drugs tests approved by FDA and the UK’s Medicines and Healthcare Products Regulatory Authority are accepted as proof of a drug’s efficacy by the Drug Controller General of India. To be able to sell generic versions, local drug makers then just have to prove that the specific therapeutic effect of these drugs is the same as the US or UK-approved drug. Further, the Drugs and Cosmetics Act, 1940, the main law that governs pharmaceuticals in India, does not have a provision for recall of drugs already sold or compensation for those affected by consumption of drugs. Citizens have to depend on “common law”, which in non-statutory in nature.
Used in India for almost six years, rosiglitazone was hailed as a panacea as it impacted a lot of body parameters such as lipids, levels of inflammation, coagulation and fat levels in liver, besides blood sugar. But it quickly lost favour among scientists as successive studies revealed an increased incidence of “congestive heart failure”.
“A series of other studies showed that the drug was very effective, reduced diabetes even in pre-diabetic people and faced least resistance in patients even after sustained use,” said Anoop Mishra, an endocronologist who heads the diabetes department at Fortis Hospital here. “It is an extremely useful drug but one that needs to be prescribed, keeping in mind the cardiac condition of the patient.”
A Sun Pharma spokeswoman said there was neither confirmed data nor any complaint that showed increased risk of heart attacks in the users.
“We have never had any safety problems whatsoever, but we will abide by the drug regulator’s orders, if any, on the issue,” said a Glenmark executive. The US drug regulator, in its safety alert, did not confirm the clinical significance of the reported risk, but advised patients on Avandia, who are known to have heart disease or are at a high risk for the same, to consult their doctors.