UK headlines this week have been in uproar about the safety of GlaxoSmithKline’s (GSK) Avandia (rosiglitazone) diabetes drug, following an article in the British Medical Journal (BMJ), which claimed that the drug should never have been approved in the first place, as well as a television programme aired in the UK that highlighted cardiovascular safety concerns associated with the drug.
The BMJ article claims that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) voted unanimously to withdraw Avandia from the UK market earlier this year. In particular, the article questions why the drug was ever approved in Europe in the first place given the “paucity of evidence” submitted to the EMA.
“When rosiglitazone was approved, even clinicians who were normally supportive of the drug remarked about the poor evidence base and lack of long-term clinical detail,” said the article.
A member of the EMA panel is also quoted in the article as saying that Avandia is “an example of what happens for drugs that have large commercial interest such as the antidiabetic drugs”.
Naturally, GSK is a little unhappy about the article. “GSK has carried out an extensive research programme involving more than 50000 patients to analyse the safety and benefits of rosiglitazone. No other diabetes medicine introduced in the last 10 years has such an extensive safety database,” said GSK in a statement released in response to the article.
But it’s not just the article that GSK has to worry about. On 6 September, the UK’s BBC aired a documentary entitled A risk worth taking? The programme looked at the history of Avandia and also interviewed patients who believed they may have suffered side effects from the drug, as well as another patient who was happy with the treatment. However, the programme’s key aim was to draw attention to the trustworthiness of regulators and their ability to put patient interests first, particularly as regulators such as the EMA draw most of their funding from industry.
Again, GSK released a statement in response strongly rebutting “any allegations that our actions have put patients at risk”.
The controversy surrounding the blockbuster drug is nothing new — the FDA slapped a black box warning on the drug back in 2007 because of evidence linking the drug to the increased risk of heart attack. In July this year, the FDA looked again at Avandia’s safety but a panel of experts ultimately decided not to withdraw the drug from the market.
In Europe, including the UK, Avandia’s fate is still undecided. Earlier this week the EMA’s Committee for Medicinal Products for Human Use (CHMP) met to discuss the benefit–risk review of rosiglitazone. CHMP said that it expects to finalise its review at its next meeting, which will take place 20–23 September.
“The CHMP identified a number of further questions that it is putting to the marketing authorisation holder, GlaxoSmithKline,” said a press statement. “The responses to these questions will help the Committee to reach its opinion on whether the marketing authorisations for rosiglitazone-containing medicines should be maintained, changed, suspended or revoked.”