That’s the way Merrill Goozner analyzes the Avandia story – a terrific analysis focusing on the fact that “The Food and Drug Administration today slapped new restrictions on GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone), while the European Union suspended its marketing entirely.”
Read the entire column – a GoozNews gem.
Opinions on other issues in news, journals, PR, advertising, marketing
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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JS
September 25, 2010 at 9:42 amI think that analysis is naive at best.
“What we’re seeing emerge — remember there are now about 30 of these programs in existence — is a new class of drugs. They are not exactly safe, but not so dangerous that we would deny them to physicians or patients who really want to have them.”
There are no “safe” drugs and there never have been, there are only drugs with acceptable and unacceptable risk, and the acceptability of the risk depends on the nature of the potential benefit conveyed, which in turn depends on the circumstances and even the values of the individual for whom the drug is being prescribed. Where’s the moral high ground in complaining categorically that there should be no effort to try to accommodate these complexities?
There are problems with the REMS strategy, and it’s worth discussing how it can be improved. But bemoaning that the FDA is even attempting to move away from black and white decisions into a middle-ground that can be more flexible is just foolish.
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