Diabetes Sufferers Warned That Widely-Used Drug Avandia Can Cause Heart Disease And Death

(Daily Mail) – THE SAFETY of a diabetes drug used by thousands of Britons was called into question again yesterday.

U.S. senators said the makers of Avandia, British firm GlaxoSmithKline, knew it carried a higher risk of heart attack than a rival medicine but had tried to keep evidence of the risk from the public.

Senators Max Baucus and Charles Grassley said GSK executives ‘attempted to intimidate independent physicians and focused on strategies to minimise or misrepresent findings that Avandia may increase cardiovascular risk’.

Now the U.S. Food and Drug Administration, the medicines watchdog, has asked an advisory committee to look again at the drug.

Britain’s equivalent, the MHRA, said it would be ‘continuously monitoring’ the safety of Avandia.

The drug is prescribed for patients with type 2 diabetes and up to 100,000 Britons take it.

In their controversial report, senators Max Baucus and Charles Grassley accused the FDA of not having banned the drug because it is too ‘cozy’ with drugs firms like Acandia maker GlaxoSmithKline.

They quoted a memo written by two FDA reviewers which concluded: ‘The risks of (Avandia) are serious and exceed those for’ rival drug Actos.

The reviewers said there was ‘strong evidence that (Avandia) confers an increased risk of’ heart attack and heart failure when compared to Actos.

It followed a 2007 study published in the Journal of the American Medical Association, which found Avandia puts users at a 60 per cent greater risk of heart failure, a 40 per cent greater risk of heart attack and a 29 per cent greater risk of death than other medication.

But the FDA decided later that year against pulling the product from the shelves.

The senators’ report said evidence showed GSK ‘knew for several years’ that there were ‘possible cardiac risks associated with Avandia’.

Executives ‘attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,’ the report said.

Senator Baucus said: ‘Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them.

‘Patients trust drugs companies with their health and their lives and GlaxoSmithKline abused that trust.’

Today, FDA commissioner Margaret Hamburg said a committee had been asked to look into the safety of Avandia.

‘I await the recommendations of the advisory committee,’ she said. ‘Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.’

A spokesman for the MHRA, the Medicines and Healthcare products Regulatory Agency, said: ‘We look at any new data that comes to light about a medicine and can update the product information if necessary.’

A spokesman for GSK said it rejected the report’s conclusions.

The company said the report ‘cherry-picks information from documents, which mischaracterises GlaxoSmithKline’s comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients.’

It said it had rigorously studied Avandia’s safety and ‘consistently shared this data with regulators around the world’.

The company said it ‘does not condone any effort to silence scientific debate’.