GlaxoSmithKline has once again jumped to the defence of Avandia amid renewed calls for the controversial diabetes drug to be pulled from the market as a result of its cardiovascular safety profile.
Ahead of a European Medicines Agency meeting later this week to review the safety of Avandia (rosiglitazone), the UK’s Medicines and Healthcare products Regulatory Agency said it believed the risks of taking the drug outweighed its benefits and that “it no longer has a place on the UK market”. The MHRA has sent a statement to PharmaTimes World News this morning noting that it contacted healthcare professionals on July 26 on the need “to provide clear advice on the need to closely follow the current prescribing advice regarding the use of rosiglitazone and to consider alternative treatments where appropriate”.
The MHRA says it has also contacted the EMA “to robustly put forward the UK’s position” and is “pushing hard for these issues to be considered and for a swift European consensus”. The EMA is holding an extraordinary expert meeting on Wednesday to review the drug’s safety before finalising its position at its next scheduled meeting later in September.
The MHRA’s stance has emerged ahead of a BBC Panorama programme, which was aired yesterday evening, which claims that the agency’s advisory body, the Commission on Human Medicines, voted unanimously in July for Avandia’s withdrawal from the UK. However, the recommendation was not made public.
In the programme, Edwin Gale, who chairs the EMA’s scientific advisory group on diabetes, said Avandia should be withdrawn entirely. He is quoted as saying: “How long do you wait? How important is it to be absolutely certain and at what point do you start saying – this game isn’t worth it, people’s lives may be at risk, something should be done about it?”
GSK issued a statement in anticipation of the programme, called A risk worth taking?, saying it is concerned the broadcast “could alarm patients and their families about the use of Avandia. The company said has not seen the programme but “denies any suggestions that it has put patients at risk”.
At the same time, the BMJ has published an investigation of the drug and also called for withdrawal of Avandia. GSK responded by saying that “contrary to suggestions within the article produced by BMJ journalists, GSK has carried out an extensive research programme involving more than 50,000 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”.
The company went on to say that “we reject any suggestion that there is a lack of publicly available trial results related to rosiglitazone for independent scientific scrutiny”. GSK concluded that “we have rigorously shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website”.
In July, 20 members of the US Food and Drug Administration’s Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management advisory committee voted to recommend that the agency keep Avandia on the market, while 12 advisors voted to remove it. Of the panellists who backed Avandia, ten voted for additional warnings and restrictions on use, while seven recommended additional warnings only. Three said that no changes to the label were necessary and the FDA is scheduled to make a final decision later this month.
