“This is here to stay.”
“This” refers to what outgoing GlaxoSmithKline CEO JP Garnier sees as a vicious cycle of safety signals damaging blockbuster brands--the phenomenon that he says caused a $1 billion decline in sales of GSK’s Avandia. (See diagram.)
Garnier’s message: the safety-first regulatory climate of 2007 is not going away. “This is long-lasting. This is not a bad year and then the statistics even out.” And the need to adapt to that reality was a major theme of Garnier’s final year-end presentation as the company’s top exec on Februay 7.
Here is how Garnier sees the new reality:
“In the past these meta-analyses were conducted among scientists with not much interest from the media. Things have changed. Those kinds of desk researchers want their publications to get some play. So the news is then digested by the media, and I can’t expect the media to know the subtle points about hazard ratios and confidence intervals and the like.”
“If you think about Avandia, the signal was if you compare Avandia to placebo out of 10,000 patients, five more in the Avandia group will have some kind of cardiovascular event, versus not treating a patient—which is not exactly realistic. When you compare Avandia to other type 2 diabetes agents the signal goes away.”
“That is what the FDA put in the labeling.”
Nevertheless, “that signal was publicized by the newspapers in America as saying there is a 43% increase in the risk of heart attacks if you take Avandia.”
In case you missed it, that was a dig at Steve Nissen, the Cleveland Clinic Cardiologist whose meta-analysis triggered the Avandia safety scare, along with a healthy dose of blame-the-media, always a popular explanation for unexpected safety disasters.
But the more important point is Garnier’s assertion that, like it or not, the Nissen effect is not going away anytime soon. And as we wrote here, industry has no choice but to adapt.
Or, as he put it, “It’s always going to be with us, because as you can see the fundamental parts of mechanisms are with us now. And we better be ready as a company to deal with this.”
Check back later today for six lessons Garnier learned from GSK’s unwitting experience as the guinea big for the new meta-analysis driven safety model.