Healthy Skepticism Library item: 10812
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Condie B.
'Bone risk' blow for Glaxo diabetes drug
Financial Mail 2007 Jul 3
http://www.thisismoney.co.uk/investing-and-markets/article.html?in_article_id=421955&in_page_id=3
Full text:
Drugs giant GlaxoSmithKline faces a new public relations disaster after a study suggested its diabetes drug Avandia could lead to bone fractures in men as well as women.
Glaxo is still reeling from a report in the New England Journal of Medicine saying the drug increases heart disease risks. Avandia sales slumped after its publication.
Avandia is a cornerstone of Glaxo’s business, with sales of $3.2bn (£1.6bn) – 7% of group revenues – in 2006.
Glaxo tried to play down the latest report. ‘The findings of this study are limited as it involves very low patient numbers and, as a retrospective study, it is not possible to draw meaningful comparisons nor rule out confounding factors, such as age and duration of diabetes,’ a spokesman said.
But analysts at Morgan Stanley said the new data delivered an additional blow to Glaxo. Whatever the significance of the study, it was likely to lead to tougher labelling and more negative sentiment among consumers, the investment bank said.
The study, published in the journal Diabetes Care, is the first to provide evidence that men might be exposed to similar risks as those previously reported in women, with a significant reduction in bone mineral density seen in those taking Avandia.
The bone risk in women was previously highlighted in other trials, including a major one that reported late last year.
However, the issue has been pushed to the background by the New England Journal’s critical study published in May, which claimed that Avandia increased the risk of cardiac-related deaths by 64% and heart attacks by 43%.
US politicians immediately launched a review of Avandia and began quizzing the company and regulator, the Food and Drug Administration, about the approval process and the British Medical Journal weighed into the controversy, calling for a radical overhaul of how drugs are approved and monitored.
Glaxo says a new study of Avandia is at risk because patients have dropped out following reports of healthy risks.
The company’s medical director, Dr Ronald Krall, said he did not know how many of the 4450 patients in the diabetes drug trial had withdrawn but added that Glaxo was worried it may not be able to finish the trial, which is scheduled for completion next year.
The company emphasised that it believes Avandia’s benefits outweigh its risks.
