The verdict is in. GSK’s diabetic drug Avandia is effectively dead, and appropriately so. Avandia will be suspended entirely in Europe and limited in the U.S. only to instances where all other diabetes medicines have been tried, resulting in virtually the same impact as the European withdrawal.
As recently as 2006 sales of Avandia were more than $3Billion, then the house came down on GSK for their actions. Deception, vagaries and half truths from GSK were the strategies GSK used to mask the fact that knew the serious cardiac risks to diabetics who took the drug (including yours truly), and yet chose to bury the data. And pharmaceutical companies wonder why we don’t trust their motives? Actions like these unfortunately tarnish the reputations of all big pharma, not just the wrong doers. For more background the following is a reprise of the July 15, 2010 Struming called, Shame on you GSK. Here it is…..
“Do more, feel better, live longer, hide the truth”.
The first three phrases are part of the theme line of GlaxoSmithKline (GSK). I added the fourth phrase. As a former ad guy, I’d have rejected the theme line– too long & not memorable. But it’s accurate.
I know I am not a pharma expert, but as a diabetic I have spent much time understanding the disease and its treatments. However, I am (humbly) a pretty sharp marketer; I know deception, half truths, and shady PR when I see it. I am aggravated and upset by the actions of GSK and its corporate predecessor, SmithKline Beecham, in regards to its diabetic drug Avandia.
Avandia (Rosiglitazone) is an oral medication used by Type 2 diabetics and is a member of the thiazolidinedione class of drugs. Thiazolidinediones act as insulin sensitizers. They reduce glucose, fatty acid, and insulin blood concentrations, critically important for diabetics. I was an Avandia user. It was and continues to be effective an effective drug for its objective.
So what’s the issue?
As reported in 2007, there are significant heart risks to the users of Avandia and GSK knew about these risks and chose not to tell us. Since cardiac and stroke issues are the leading cause of death among diabetics, and diabetics are 2-4 times more likely to experience these than the population at large, this was no small oversight. This was act of deception at the highest levels.
As a type 2 diabetic whose father was a Type 1 diabetic who died at age 46 of a heart attack, on a personal level this is information I would have desperately wanted to know when I was taking the drug. If I had known, I wouldn’t have never taken the drug, and that’s just what GSK feared. While Avandia is an effective drug in glucose control, there are many other effective drugs, so in essence GSK put people’s lives (including mine) at risk, while burying the knowledge that it had of the cardiac issues.
In the July 13, 2010 New York Times is a lead business story titled, Diabetes Drug Maker Hid Test Data on Risks, Files Indicate. It was reported that SmithKline as far back as 1999 secretly began to do a study on Avandia and whether it was safer than Actos, a competing product. The results showed clear information that Avandia was far riskier than Actos. What did they do with these results? Nada. They buried them and worse yet it has spent the next 11 years covering up the data. “These data should not see the light of day”, said an exec in an internal email.
GSK is probably celebrating yesterday’s F.D.A. advisory panel’s decision not to yank the drug entirely. Of the 33 members, 12 members voted to withdraw Avandia, 10 voted to restrict its sales with enhanced warnings, 7 voted for enhanced warnings only, and only 3 said the drug should continue to be sold with no changes, and one member abstained. GSK no doubt “celebrated” that a minority of the panel voted to withdraw the drug entirely, but the reality is that 30 of the 34 panel members recognized that GSK didn’t represent the risks fairly. The final step is that the F.D.A. will soon rule based on this split panel.
How does this work that corporate America puts profits before the health and lives of people? When did we become the Roman Empire? Was it always this way and I’m just catching on? Something is deeply wrong that Toyota can bury data that shows its cars sometimes unexpectedly accelerate and kill its passengers, and GSK can knowingly sell products hiding the knowledge of increased cardiac risks to its users, are then they both run ads about how they much they “care”.
How’s this for a new GSK theme line:
GSK. Profits before People
At least it would be truthful. It’s shorter and more memorable too.