GSK slams Guardian article
pharmafile | January 31, 2013 | News story | Sales and Marketing | Avandia, FDA, GSK, Guardian
GlaxoSmithKline has slammed an article about its controversial diabetes treatment Avandia in The Guardian newspaper, saying that some of it is ‘wrong’.
Avandia (rosiglitazone) was pulled from the European market in 2010 and limited in the US after it emerged it can cause serious heart problems.
However, the company makes no comment on the thrust of Guardian health editor Sarah Boseley’s article, which is that GSK will not pay compensation in the UK without a court battle.
She writes that “thousands of families in the UK could be deprived of compensation for the death or harm of a relative” caused by Avandia.
“We have every sympathy for people with health complications associated with diabetes and those who care for them,” a statement from GSK says. “However, respecting the UK court process, we are unable to comment on ongoing legal cases.”
The article goes on to say GSK “has admitted concealing data about the damaging side-effects of the drug”.
But in a statement GSK insists: “It is wrong to suggest that we hid or concealed safety data relating to Avandia. We made Avandia clinical trial results available on our website and shared these with regulators.”
However, last year it was announced that GSK would pay $3 billion in fraud charges, the largest fine of its kind in US history – in part for withholding important safety information about Avandia, as well as for off-label promotion of its antidepressants Paxil and Wellbutrin for unapproved uses.
The company admitted legal liability for the off-label promotion and for withholding Avandia data, which are recognised as criminal misdemeanors in US law.
In its statement on yesterday’s Guardian story, GSK explained this by saying: “The settlement reached in 2012 following a US Department of Justice investigation related solely to the inadvertent omissions in certain FDA regulatory reports of information regarding the initiation and status of certain studies.
“We continue to believe that the company acted appropriately and responsibly in its management of Avandia,” it added.
At the time of the US fine, chief executive Sir Andrew Witty was contrite, saying the penalty was for bad behaviour from a ‘different era’ and had resolved ‘difficult, long-standing matters for GSK’.
“Whilst these originate in a different era for the company, they cannot and will not be ignored,” he went on. “On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.”
GSK has always defended its drug robustly and believes European regulators were wrong to remove it from market.
In its statement yesterday the company reiterated: “We continue to stand behind the safety and efficacy profile of Avandia in the treatment of type II diabetes when used appropriately.”
Avandia was the subject of considerable disquiet before it was removed, with GSK facing criticism in 2010 from the BBC’s Panorama programme and the British Medical Journal.
Click here for GSK’s full statement on The Guardian article.
Adam Hill
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