GlaxoSmithKline (GSK), one of the world’s largest pharmaceutical companies, has been issued with a subpoena by the US Department of Justice.
Avandia chemical Structure
The American government is pursuing information regarding the company’s development and marketing of the diabetes drug rosiglitazone, marketed by GSK as Avandia.
The subpoena, issued on 21 October is the latest instalment in an increasingly damaging affair for GSK. The decade old drug has been suspended by the European Medicines Agency (EMEA). In a statement the EMEA said: “Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone.” The statement continued: “the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.” The American Food and Drug Administration (FDA) has also acted, placing stringent restrictions on its sale.
GSK profits fell 3.5 per cent in the third quarter of this year because of declining prices paid for drugs by government agencies and the announcement of the subpoena. US healthcare reform and European governments’ frugal spending plans have reduced the price companies like GSK can charge for their products.
Patients already in the ‘at risk’ category for heart disease are particularly affected by Avendia’s cardiac side effects. As the contributory factors for developing type-2 diabetes and heart disease can overlap –obesity is a prime example – this is thought to be a serious problem for many of the two million people worldwide who take the drug.
This unfolding story has incorporated wider concerns over the actions of big pharmaceutical companies. GSK has been forced to defend itself from allegations that it hid negative study data for Avandia.
The credibility of the industry regulators has also been called into question. BBC’s Panorama alluded to the lack of transparency in the workings of the EMEA and suggested a certain deceptiveness. Shelley Jofre’s film implied that the FDA, which held an open committee meeting on the future of Avandia, is a more credible regulator. However the FDA has yet to pull Avandia from US pharmacies and the EMEA has recommended the European Commission suspend sale of the drug. This was an echo of directives from the UK’s drug advisory body, the Medicines and Healthcare products Regulatory Agency.
Analyses published in the British Medical Journal (BMJ) have highlighted concerns over how publication bias can affect health policy. An example is the story of the antidepressant drug reboxetine, manufactured by the US pharmaceutical giant Pfizer. Marketed as Edronax, it has been found to be ineffective and potentially harmful by the German Institute for Quality and Efficiency in Healthcare. Reboxetine received approval for sale in Europe in 1997. However, it was declined in the USA in 2001.
A systematic review of the drug’s study data has shown the published trial results overestimate the benefits and underestimate the harm of the drug when compared with unpublished data.
It has been alleged that such selective publication of study data may be a common practice – a marketing strategy, even – throughout the pharmaceutical industry. It is not yet clear whether the US Department of Justice will pursue civil or criminal proceedings against GSK for the Avandia controversy. What is sure is that the Avandia stories, and the troubles for GSK, are not going to disappear.
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