A spectre is haunting the healthcare system — the spectre of Big Pharma.
Fears over the side effects of a widely used diabetes medication in Australia have revealed the power of big money and its influence on the healthcare system.
The medication — known as Avandia — is under fire for potentially causing heart attacks and strokes in patients. The manufacturer, GlaxoSmithKline (GSK), is accused of hiding evidence of the drug’s harmful side-effects.
A US Congressional investigation in early 2010 released some of the company’s internal correspondence. One such communication said the negative results of one study “should not see the light of day to anyone outside of GSK”, the July 15 Sydney Morning Herald said.
The investigation concluded that the British-based multinational had failed to give proper notice to the US Food and Drug Administration (FDA) about the potential harmful effects of Avandia for a number of years.
A spokesperson for GSK said that the quoted internal documents had been presented out of context.
The company’s reluctance to reveal alleged dangers of Avandia are clearly linked to the drug’s profitability. In the hugely profitable pharmaceutical industry, Avandia was once the firm’s most profitable drug, bringing in US$3 billion in sales in 2006.
Despite evidence suggesting that the drug was unacceptably dangerous, on July 14 a majority of the 33-person panel of experts advised the US FDA to allow Avandia to remain on the market, but to have better labelling and warnings.
The decision gained international attention.
Evidence of the drug’s dangers included a study of 35,500 participants finding that taking Avandia led to an increased risk of heart attack of up to 39%, while a larger study of 227,500 patients found an increase of between 14% and 27% of strokes, heart failure and death.
Earlier reports of the drug’s dangers led to a dip in the share prices of GSK. In-confidence settlements between the company and former takers of the drug has led to reports, not confirmed by GSK, that it has already paid out $460 million to former users. The amount is staggering, but it is small change for GSK; Avandia represents just 2% of the company’s total revenue.
That Avandia has side effects is not denied, but the continued availability of the drug needs to be balanced against the dangers of untreated diabetes and the alleged relative safety of a similar drug launched at the same time, called Actos.
Carrying out impartial scientific investigation into the relative safety of the drug is difficult when such large amounts of money are an integral part of the evaluation process.
The SMH said a European medical regulatory body would evaluate Avandia's safety. The drug is used by about 20,000 patients in Australia.
Diabetes can cause heart disease, stroke, and kidney failure. Outcomes are good if properly treated, which requires access to medication and medical services. Results are poor in countries whose populations can’t afford the drugs, or where access to medical services, such as in some of Australia’s Indigenous communities, are difficult.
The World Health Organisation has estimated that diabetes will affect 366 million by 2030.
The Avandia controversy comes at the same time as it has been reported that GSK has put aside $1 billion to settle claims against birth defects allegedly caused by the anti-depression drug Paxil, known in Australia and New Zealand as Seroxat and Aropax.
People taking Avandia or Paxil should only discontinue their use with medical advice.