Friday, September 12, 2014

The Pharma Social Media Pioneering Era is Over! Long Live the Pharma Mobile App Pioneer!

Today I will chairing CBI's Social Media Compliance Strategies and Benchmarking Summit in Philadelphia. In my opening comments I declared that the pharma social media pioneer era is over. Here's a draft of what I said: Welcome fellow “wonks” to CBI’s Social Media Compliance Strategies and Benchmarking Summit!

I say “wonks” because I assume most of you like Peter Pitts, our first speaker, relish the art of interpreting FDA rules, regulations, and guidances. I know I do!

But before we get to Peter and his wonky views, let me explain why I am wearing this shirt and hat. It’s to remind you that I am PharmaGuy, although it says John Mack on my badge.

For the past 4 or 5 years I have been recognizing pharma marketers who thought – and acted -- outside the “social media box” by handing out the PharmaGuy Social Pioneer Award, which is the shirt you see in the slide here. I wore that shirt at one of the first conferences – actually “unconferences” -- focused on pharma social media. It helped me stand out from the crowd and it’s a fitting symbol for how pharma social media pioneers stand out from the crowd.

This year, I will be making the FINAL presentation of the award.

Why final?

Friday, September 05, 2014

FDA Says Men Who Receive Drugs for "Low-T" Have 30% Increased Risk of Major Adverse Cardiovascular Events

As I reported back in February this year, Public Citizen urged the FDA to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. (see "Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling").

That petition may have lead to the FDA calling for an advisory panel meeting on Sept. 17 to discuss "two controversial issues regarding testosterone replacement therapy (TRT) that have important public health implications. The first issue is identification of the appropriate patient population for whom TRT should be indicated, and the second is the potential risk of major adverse cardiovascular events (or MACE, defined as non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death) associated with TRT use" (see FDA's briefing document here).

More worrisome is the fact that only about one-half of men taking testosterone therapy had been diagnosed with hypogonadism, and 25% did not have evidence of having their testosterone concentrations tested prior to initiating therapy.

And more and more men are receiving prescriptions for so-called "Low-T" drugs such as Androgel. How many more?

Wednesday, September 03, 2014

Craig DeLarge Leaves Pharma to Pursue New Career in Digital Mental Health Outcomes

Craig DeLarge, until yesterday, Global Leader, Multichannel Marketing Strategy & Innovation at Merck, announced his departure from the pharmaceutical industry on his Facebook timeline.

"Yesterday," said Craig, 'was my last day as ‪#‎Global‬ Leader, MCM ‪#‎Strategy‬ & ‪#‎Innovation‬ at ‪#‎Merck‬. It has been a good, highly developmental & productive 2 years at the '‪#‎leadership‬ school', I have fondly come to refer to Merck as. I am grateful for the leaders who brought me in, and the colleagues I co-developed and co-created with during my tenure.

"Moving on, I am furthering my practice in the areas of ‪#‎digitalhealthcare‬, ‪#‎changeleadership‬ and ‪#‎mentalhealth‬ outcomes. I will be taking time to explore how I can best contribute my leadership, ‪#‎creativity‬ and management in these areas in either freelance, ‪#‎consulting‬ or organizational leadership contexts.

"In particular, I will be focusing on a ‪#‎sabbatical‬ research project to map 'digital mental health' over the next 4 months as this brings together my expertise in digital health and my interest in mental health, related to my ‪#‎NAMI‬ Board work. I offer my best wishes to my management and colleagues I am leaving behind. I welcome the good wishes and assistance of any who know of opportunities for me to contribute in the three areas I mention above."

Craig has influenced countless people in his nearly 25 years within and outside the pharmaceutical industry. Let me tell you how he has influenced me.