Weekly Roundup 6-7-13

I have been away on vacation and while I thought I would be posting while on vacay – not so much it appears – and yet lots has happened, so here is a brief attempt at catching up. While I have been rounding up views of the ocean, there has been a lot going on and here are just two of note.

Avandia Restrictions Reconsidered by AdComm – Surely the biggest news of the week is in relation a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.  The two day AdComm was announced for the purpose of discussing the readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemic Diabetes (RECORD).  The meeting was not without its controversy as noted in a blog posting on FDAVoice on the day before the meetings by Dr. Janet Woodcock – “Avandia: Hearing All Sides in Scientific Debate” where she stated that given the enormous effort that went into researching this drug, she felt that every effort should be made in assessing the results of the trial in question.  According to the GSK announcement on the outcome, the 26 panelist vote broke down with 13 members voting to remove any restrictions, 7 voting to modify the Risk Evaluation and Mitigation Strategy program in place, 5 voting to continue the REMS program and 1 voting to withdraw the drug from the market in the U.S.  This will not be the end of the story as FDA will now have to act on the committees’ recommendation.  While a there has been uncertainty expressed on a number of fronts throughout this process – one thing is certain – the situation certainly presents some unique communications challenges for FDA as the story continues.
Majority of Americans Now on Smart Phones – Pew reported this week that a majority of Americans now claim smart phone ownership – 56% this year compared to 46% last year and 35% the year before that.  Wait – isn’t that a technology story?  Yes it is, but it has increasing healthcare implications on a number of fronts.  The most obvious of these is the fact that as increasing numbers of people access information through mobile technologies, sites that want to provide health care information competitively have to be optimized for mobile use.  Secondly, the increasing numbers mean that the role of medical apps stands to increase in importance as more and more people access the technology that, when combined with an app, will let them perform all sorts of self-monitoring never before considered.  And finally, a third factor to consider is that mobile access enhances more frequent use of social media sites as well, meaning that the role of social media in healthcare may see a boost as well.

That’s it for me this week.  I’ll return next week with more regularly scheduled programming!  In the meantime, have a wonderful weekend.

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