Report Highlights GSK Avandia Heart Attack Risk Again
GlaxoSmithKline's Avandia diabetes drug was the source of fresh concern on the 12th September 2007, when two new reports appeared in the US medical publishing sphere concerning its heart risk side effects. The reports appeared in the Journal of the American Medical Association, and focused on a side-by-side assessment of Avandia and Actos - the sole significant competing diabetes treatment on the market.
One study affirmed that Actos seemed to act as a protective barrier against future development of cardiovascular conditions or strokes. Avandia, on the other hand, was again associated with an increased risk of heart attacks. Importantly, though, Takeda Pharmaceuticals - the manufacturer of Actos - provided funding for one of these studies, with three of the authors behind it receiving financial support for their efforts.
GlaxoSmithKline issued a statement in response to the JAMA's findings, in which it asserted: "We believe conclusions drawn from the most recent meta-analyses... do not confirm a difference in the safety profile of Avandia and Actos".
It continued: "These analyses reflect limitations that are common to all meta-analyses, by the authors' own admission. These analyses do not yield data robust enough to guide doctors in selecting appropriate diabetes treatments."
However, it is likely the studies will impact further on Avandia's already shattered reputation. When, four months ago, the pivotal New England Journal of Medicine article highlighted that it could be linked to heart attacks, sales of the blockbuster drug plummeted. In July 2007, the US Food and Drug Administration assessed Avandia in context with the latest findings. At the time, the regulatory body decided against withdrawing Avandia from the market completely, but it is contemplating enforcing a "black box" warning, or limiting its sales.
A market withdrawal could, of course, still take place. If this did occur, it would be an unprecedented action against a high profile pharmaceutical treatment.
Avandia's sales shed 22 per cent in the first quarter, to rest at approx 349 million pounds. Industry experts now describe any hopes that the diabetes drug's sales figures could climb again as unlikely.
Source - Pharmaceutical International's US Correspondent
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