Glaxo’s Avandia Increases Heart Risks

An US Food and Drug Administration (FDA) reviewer who worked on the study said government scients had analysed Avandia, GlaxoSmithKline Plc’s controversial diabetes drug and found it to increase heart risks, including deaths compared to a rival pill.

Known for opposing now-withdrawn painkiller Vioxx, Dr. David Graham and other government staff reviewed data on Medicare health insurance programme for the elderly patients taking Avandia or competitor Actos (Takeda Pharmaceutical Co Ltd.)

The yet to be published findings come barely weeks before a highly anticipated public meeting on the safety risks of Avandia is to be held next month. It was in a 2007 study that concerns were first raised about the drug’s cardiovascular effects.

Graham calls for Avandia’s removal from the market, since it is more dangerous to the heart than Actos.

Graham and his colleagues from the FDA and the Centres for Medicare & Medicaid Services for their latest research, studied data from 230,000 Medicare patients, finding Avandia increased the risk of stroke by 27%, heart attack by 25% and death by 17%.

Overall, Graham said between 1999 and June 2009, around 48,000 excess complications with Avandia use in older patients occurred, however, since Medicare patients are 65 plus, with over 60% of Avandia users under 65 years of age, ‘the national impact is probably 100,000 or more’.

Concern over Avandia’s risks have sen its sales decline sharply, with the drug losing its US patent protection in 2012, and liability claims remain an issue.

Global sales of the drug topped $3 billion in 2006 but fell to $1.2 billion in 2009.

According to Graham's email, the government scientists are seeking to publish their findings in the Journal of the American Medical Association (JAMA), a peer-reviewed medical publication. A spokeswoman for JAMA said the journal does not comment or confirm any submissions before publication.

Graham, an outspoken safety reviewer who is often at odds with official FDA positions, voiced concern that FDA officials were blocking the study from becoming public.

But the FDA's Riley said "senior management did not seek to suppress this study." It was reviewed "expeditiously" and has been submitted to JAMA, she said.

A known whistleblower, Graham has drawn attention to a number of other prescription drugs since the 2004 withdrawal of Merck & Co Inc's Vioxx. Some of those medicines were later withdrawn or saw strict new warnings.

A study Graham had done looking at the heart risks of Vioxx in late 2005 using data from a private insurer was also repressed, he wrote, "so you can understand that I am very sensitive to anything that remotely smells like suppression or censorship."

Glaxo has defended Avandia, known generically as rosiglitazone, saying there is no scientific evidence that Avandia increases the risks of cardiovascular problems like heart attacks.