GSK makes another go at failed drug

GlaxoSmithKline (GSK), the drugmaking giant, is making another effort to curb the flagging sales of its blockbuster diabetes drug Rosiglitazone from tapering further.

The British pharma behemoth recently brought out a study, done over a period of five-and-a-half years in over 4,400 patients in 25 countries, which shows that Rosiglitazone has no increased overall heart risks of either death or hospitalisation, compared to other commonly used diabetes medicines like Metformin or Sulfonylurea.

Rosiglitazone, which grossed annual sales of £1.4 billion in 2006, was in the eye of storm after the US Food and Drug Administration (US FDA) in 2007 issued a ‘black box’ warning about cardiovascular risks associated with the medicine.
Black box warning is the strongest type of warning that the US FDA issues about side effects of drugs.

This was followed by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) advising against the use of Rosiglitazone.
Moreover, in November last year, the Drugs Controller General of India (DCGI) asked Rosiglitazone manufacturers in India to print a warning on the drug’s label cautioning its risks, if used by patients with heart problems.

All this led to GSK’s worldwide sales from Rosiglitazone, which is marketed as Avandia globally, and as Windia in India, falling to £877 million in 2007 from £1.4 billion in 2006, and further to £512 million in 2008, as per industry estimates.

So, now by presenting its study called Record (Rosiglitazone evaluated for cardiac outcomes and regulation of glycaemia in diabetes) at the conference of the ADA, the company is trying to convince physicians about the safety drug, said a leading New Delhi-based diabetologist who was present at the ADA conference when the study was presented.

Ellen Strahlman, chief medical officer of GSK, said, “We believe that Rosiglitazone remains an important diabetes medicine for the appropriate patients.”
“Rosiglitazone is an effective drug when used in type II diabetics who don’t have any heart problems. The controversy over its side effects may have been blown out of proportion by the American FDA, could also be because GSK is a British company, so political reasons are at times at play,” said the diabetologist.

According to AK Jhingan, chairman of Delhi Diabetic Research Centre, Rosiglitazone should not be given to patients with pre-existing heart problems, and to older women who are more prone to fractures.

As many as 25-30% of type II diabetics have some form of heart ailments, said A Ramachandran, president, India Diabetes Research Foundation.

“So, in diabetics with heart problems, and also those who are overweight, Metformin is used. For the rest, Rosiglitazone is an effective drug,” says Ramachanrdan.

The Rosiglitazone market in India, which has over 42 million diabetics, is estimated at Rs 28 crore, according to market intelligence provider ORG IMS.

Of this, 20% belongs to GSK, while Indian players like Dr Reddy’s Laboratories, Sun Pharma, Glenmark, Orchid, Cipla, etc make up the rest of the pie.

As per estimates by Grail Research, the overall Indian market for diabetes drugs was approximately $480 million in 2008, growing at 16-20% per year.

According to industry analysts, studies like Record for Rosiglitazone can help to a certain extent in convincing doctors about the effectiveness of the drug.

“There was a significant decline in sales in India also, after the warnings. This kind of a study can make a piecemeal attempt at increasing them,” said a research analyst from an advisory firm in Mumbai.