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What will be the Heir to Avandia's Troubled Throne?
Washington, DC: While Avandia has proven to be a drag on public relations, and the bottom line for GlaxoSmithKline (GSK), the troubled diabetic drug's propensity for causing heart attack and weight gain is not causing the British drug manufacturer any undue hardship.
In fact, third-quarter (Q3) results released November 6th by Chief Financial Officer Julian Heslop shows that in spite of a decline in GSK's Pharma line--partly impacted by Avandia—such losses are offset by stellar performance in GSK's Vaccines and Consumer Healthcare line.
According to information posted on GlaxoSmithKline's web site, Avandia sales were down USD $299.5 million in the third quarter, while three of GSK's other drugs were off USD $650.5 million (converted from British pounds).
 Avandia's market share in the US had fallen to roughly five per cent by mid-October, down from just under 12 per cent at the end of April. Growth in new pharmaceutical products recently introduced into the marketplace could not offset the decline of Avandia, Zofran, Wellbutrin XL and Coreg, resulting in a loss of USD $130 million in Glaxo's Pharma line for the third quarter.
The good news for GSK—and for anyone thinking of litigating after being harmed by Avandia—is the performance of Glaxo's Vaccine sector, which was up 49 per cent in the third quarter, while consumer healthcare products gained 16 per cent.
What is most certainly fuelling Glaxo's optimism, in spite of the Avandia headache, is the sheer number of new products either already on the market, approved, or under development.
In fact, GlaxoSmithKline reports there are no fewer than 149 new products currently under development.
What does this have to do with Avandia, and Avandia patients? Plenty, given the current regulatory environment in the US that has allowed dangerous drugs like Avandia to continue, and Glaxo's plans to streamline the development process.
In fact, Glaxo reports that a number of functions have either moved, or will soon move offshore, including data management and IT functions.
The most worrisome, is the revelation that Glaxo plans to sponsor clinical trials in so-called 'low-cost countries.' What those countries are is not specified.
However, coupled with a pledge to enhance R&D efficacy and reduce bureaucracy, one can assume that given the number of new products under development the company is looking for ways to speed the process. It identifies a new operational excellence program, and a host of new products as the drivers of future growth, and to offset losses incurred by what it calls 'generic erosion.'
As for Avandia, the graphic used is telling. The arrow it is neither up, nor down—but points both ways. In other words, the company is signaling that Avandia is a wild card, and Glaxo doesn't know which direction it's ultimately going to go.
What they're counting on is a pipeline filled with new products. As for sales in the United States--its largest single market--Glaxo can no doubt count on the US Food and Drug Administration (FDA) as an ally for favorable response.
Just looking at the Avandia debacle gives pause to wonder if a similar faux pas could happen again, in the face of pressure to approve new drugs expedited through the R&D process and tested in some un-named offshore country, only to be given the thumbs-up by a waffling federal agency.
The Avandia debacle could prove as a template. When an expert panel was assembled at the behest of the FDA to debate the merits of Avandia this past summer, the agency's director of surveillance and epidemiology, Dr. Gerald Dal Pan, indicated that he agreed Avandia should be removed from the market completely, and not be sold.
Dal Pan stressed at the time that his position was a personal one, and not reflective of any position taken by the agency which employed him. Still, it is highly unusual for a senior FDA official to offer an opinion about a drug's future in such a setting.
And who can forget the situation that occurred in March of last year when Dr. Rosemary Johann-Liang, then a safety supervisor with the FDA, approved a black box warning for Avandia, relative to concern for congestive heart failure. However, she was directed by her superiors in the FDA to rescind the warning, and was stripped of her authority within the agency. Dr. Johann-Liang has since left the Food and Drug Administration, and the FDA has since added one black box warning—the very warning Dr. Johann-Liang had tried to implement—and is now being urged to add a second.
At its peak, Avandia raked in 3.2 billion dollars in annual sales. While Avandia is no longer performing at that level, GlaxoSmithKline appears to have several newcomers poised to take its place at the altar.
Avandia Legal Help If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] who will review your case at no cost or obligation.
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