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Diabetes
Diabetes: Avandia No Longer Has a Place in the UK Market
‘Avandia no longer has a place in the UK market’. I must admit, I felt a huge surge of relief when I read that news headline this week.
But as we all know, nothing is cut-and-dry anymore, especially when you’re dealing with top selling pharmaceuticals raking in near-billions of pounds and their equally unscrupulous manufacturers...
Path of destruction
With Avandia, this certainly is the case.
In 2003, HSI was the first to tell you about a link between Avandia and an increased risk of congestive heart failure. Since then we’ve brought you regular updates about the dangers of Avandia... dubbed the ‘Killer Drug’ by some.
In 2007, the New England Journal of Medicine (NEJM) made headlines with a study that illustrates just how expansive this danger really is and how an increased risk of suffering a heart attack is only one part of Avandia’s risk profile.
Astonishingly, the drug stayed on the market despite the findings of a report in 2007 - published by the Journal of the American Medical Association (JAMA) - that demonstrated it was killing around 19 per cent of patients, and was causing non-fatal heart problems in a further 8 per cent.
In 2008, a segment of a major type 2 diabetes trial was halted when the number of deaths (257) in the aggressive intervention group far exceeded deaths (203) in the standard care group. One of the drugs used in the aggressive care group was Avandia... at that point, the consensus was that Avandia was not to blame for the deaths in the trial...
Earlier this year, it was revealed that the UK’s biggest drugs company, GlaxoSmithKline (GSK) – the pharmaceutical giant behind Avandia, tried to intimidate independent scientists and deliberately misrepresented medical data to deny safety concerns over their top-selling diabetes treatment, Avandia.
Finally, after nearly 10 years of risking patient’s lives it looks as if things are catching up with Avandia...
Benefits still outweigh the risks?
This week, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) dealt GSK a blow by saying that the risks associated with Avandia outweigh its benefits and that it no longer has a place in the UK market where 220,000 patients receive the drug.
Bravo to the MHRA, for acting much quicker than the American Food and Drug Administration (FDA), who voted to keep Avandia on the American market earlier this year.
In spite of the MHRA’s opinion on Avandia, GSK has pledged to stick by its controversial blockbuster diabetes drug, saying that it still believes the drug's positive effects are greater than its risks. A spokesperson for GSK said that studies have shown that Avandia does not increase the overall risk of heart attack, stroke or death compared with other diabetes medicines. He added, “We continue to believe that Avandia is safe and effective when it is prescribed appropriately.”
Tug of war
It’s almost as if GSK can’t see what the big kafuffle is all about. Which astounds me, because in the last quarter of 2009 Avandia has been linked to 304 deaths during the – the same year in which the drug turned global profits well-over £771 million... and we wonder why GSK is sticking with their precious killer drug despite all the evidence quickly mounting against it.
Recently the FDA also produced a report, showing this shocking estimate: Over the past decade, 48,000 people experienced stroke, heart failure, or death because they used Avandia... That’s almost 5,000 people a year, suffering adverse side-effects or death at the hands of GSK!
The recent recommendation from the MHRA adds to the mounting international scrutiny of Avandia. In 2007, regulators began restricting its use after studies suggested that it caused a greater incidence of cardiac problems in diabetics than alternative treatments... To make things worse, it transpires that some GSK executives knew about Avandia’s heart risks and suppressed the data for more than a DECADE!
A decade! 5,000 people a year! And you kept your mouth shut?!
In a 2001 internal GSK e-mail, one executive made this comment about a study that linked Avandia to serious heart problems: "These data should not see the light of day to anyone outside of GSK."
Well luckily it did, even if it took 10 years!
Lesson to GSK executives: The truth will always come out...
End of the road for Avandia?
The MHRA recommendation will now shift the focus to European regulators, who are finalising their conclusions on Avandia.
The Commission on Human Medicines (CHM), the MHRA’s specialist advisers, reached consensus on the view that Avandia should be withdrawn, in July. German and Swedish regulators are due to make their recommendations to the European Medicines Agency (EMA) later this month.
The EMA's ruling on the drug is expected to be tougher than the FDA's, given that the treatment already faces harsher restrictions in Europe than it does in the US.
In July the FDA ruled to further restrict the use of Avandia but to keep it on the market, however they still need to make a final decision which is also expected later this month.
European doctors may not prescribe the drug to patients with a history of congestive heart failure. German regulators recommended this year that health insurers should no longer cover the costs of Avandia.
In the US, doctors are prevented from prescribing Avandia when dealing with patients with a more severe history of congestive heart failure.
Doctors in both Europe and the US can still prescribe Avandia to those at risk of heart attacks, although its use is not recommended.
The EMA’s decision on whether Avandia retains its European licence for sale will be made at a final meeting on 23 September. Prof Gale, who chairs the EMA’s scientific advisory group on diabetes, said Avandia should be withdrawn entirely. "How long do you wait? How important is it to be absolutely certain and at what point do you start saying - this game isn't worth it, people's lives may be at risk, something should be done about it?" he said.
So, if you or someone you know is taking this drug, see a doctor immediately to discuss safer alternative treatments...
Hopefully we’ll soon all be able to say, Good riddance!
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Sources:
Avandia Still on the Market Despite Cardiac Deaths, by Debra Manzella, published online 22.02.10, diabetes.about.com
UK watchdog calls for Glaxo’s Avandia recall, by Andrew Jack, published online 06.09.10, ft.com
‘GSK vows to stick by controversial diabetes drug’ by Rob Davies, published online 06.09.10, dailymail.co.uk
"F.D.A. Panel Votes to Restrict Avandia" by Gardiner Harris, published online 07.14,10, nytimes.com
"Diabetes Drug Maker Hid Test Data, Files Indicate" by Gardiner Harris, published online 07.12.10, nytimes.com
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