Glaxo’s Avandia – exposed much as Vioxx was exposed

Will someone out there please tell me how much longer we are going to have to put up with stories like this?

“A meta-analysis of the clinical trial data shows that GlaxoSmithKline’s diabetes blockbuster, Avandia, increases the risk of heart attacks and cardiovascular related deaths. Once again the FDA is shown to be asleep at the helm-its approved drug label and cannot be trusted to protect the public from unsafe drugs that kill.

Anna Wilde Matthews of The Wall Street Journal reports: “Dr. Nissen started his quest to gather data about Avandia’s risks last year, after he spotted what he thought were hints of trouble in published studies. Along the way, he set congressional investigations into motion, and, last month, hit pay dirt with a Google search that pointed him to a trove of study data. Brushing aside the arguments of Glaxo executives who rushed to Cleveland, he pushed his concerns into one of the world’s top medical journals in just a few weeks.

One issue coming under congressional scrutiny is whether the Food and Drug Administration should have acted faster to alert the public about possible risk from Avandia. Glaxo performed its own meta-analysis, which also showed a potential danger. It shared an early version of it with the FDA in September 2005 and a more complete one in August 2006. The findings weren’t reflected on the U.S. label, which is supposed to give a comprehensive review of the drug’s risks.” About one million Americans-7 million world-wide people-are affected by Avandia whose world-wide sales were above $3 billion.”

The full story can be read at Vera Sharav’s AHRP blogspot.

I note many other news stories about this latest Glaxo safety scare.

GlaxoSmithKline’s shares suffered their biggest one-day fall in four years yesterday as a safety scare engulfed the drug company’s blockbuster diabetes treatment, Avandia.

The US food and drug administration issued a formal alert on Avandia last night, warning doctors to be aware of a study suggesting that the medicine could increase patients’ risk of heart attacks.

The drug is Glaxo’s second biggest seller, behind its asthma treatment Seretide. In London, Glaxo’s stock plunged 81p to £13.83 and in late New York trading, the shares fell by as much as 8%.

Doctors at the Cleveland clinic in Ohio analysed 42 historic clinical trials. They found that those taking Avandia were 43% more likely to have heart attacks – and 64% more prone to die from heart failure – than those on a placebo.

Investors in Glaxo are keenly aware that any hint of a health risk could cause patients to switch to competing products. Two rival firms – Eli Lilly and Merck – saw their shares edge upwards yesterday on hopes that their diabetes drugs would gain from Avandia’s woes.

So Glaxo has unleashed another potentially dangerous drug onto the market – it has to be said that Glaxo’s record isn’t really that good when it comes to producing safe, effective medicines that do not attract controversy and lawsuits once they have been in use for some years.

I written about big pharma and new drug discovery before here and here.

The age of the truly innovative blockbuster drug is over – drug companies know this and so continue to market sub-standard products to the public. This is the reason why we have seen marketing and advertising spend leap ahead of (by two to three times) the R&D spend at every major drug maker in the world.

This simple fact shows where Big Pharma’s priorities lie – science and discovery have taken a back seat and the salesmen are driving.


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