Weekly Roundup 9.19.14

Argh!  It is International Talk Like a Pirate Day! Fear not Matey!  I’m not gonna write my whole posting in pirate-speak, though it be a tempting morsel to ponder.

There were lots of approvals this week and finally a wee bit of action from the Office of Prescription Drug Promotion (OPDP) which so far this year has produced very little output in the way of warning or untitled letters.  The one sent out this month brings us to a grand total of 7 for the year, far below any rate of production recorded on these humble pages.

  • New Type 2 Diabetes Drug Approved - FDA gave Lilly’s Trulicity (dulaglutide) a green light this week.  Trulicity is a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with Type 2 diabetes.  The drug is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels and comes with a Boxed Warning regarding an increased risk for thyroid C-cell tumors based on studies in rats. FDA will be looking for some post-marketing studies for the compound – studies in pediatric patients on efficacy and safety as well as others.  According to the company release, Lilly plans to make Trulicity available in single dose pens in two doses.
  • Treatment for Opioid-Induced Constipation Approved – A common side effect faced by patients using opioids to control pain is constipation as the drugs reduce the motility of the gastrointestinal tract. This week the agency approved a new oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.  According to FDA’s release, the results of the trials measured two doses – 25 mg and 12.5 mg – and found that 44 percent of study participants at the first dose and 41` percent at the second dose experienced an increase in bowel movements compared to 29 percent who were on placebo.  The agency is looking for a postmarketing study related to cardiovascular adverse events.  The company said it expects to have the drug available to patients during the first half of 2015.
  • AdComm Vote on Testosterone Replacement Therapy Candidate – A joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met this week to consider approval of Testosterone Undecanoate – brand name REXTORO, put forward for consideration by Clarus Therapeutics.  The committee against the overall risk/benefit ratio by a large margin.  As is well-known, FDA is not required to follow the recommendation of the advisory committee.

That’s it for me today, matey.  To celebrate the day, I’ll be having a nice seafood lunch!  Argh!

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Talking Points for When People Who Don’t Get Social Media as a News Platform

Someone asked me the other day something to the effect of this – what is the point of social media when it comes to news – isn’t CNN just as fast?

It occurred to me that many of us in healthcare communications may face this question from people outside of the communications profession who, as a consequence of being professionally focused elsewhere, may not have a grasp of the how’s and why’s with respect to why social media is important in the overall communications picture.  In other words, there are many people outside of communications who may not have grasped all of the ways social media has changed the way we communicate.

So here are a few talking points to help in the event that, or a similar question, is posed to you.  There is nothing breathtaking here and it represents things I have said in this space previously, but I thought it might be handy to have them in a list – for when you need them.

  1. Not all social media are equal news platforms – some – like Facebook –  are more social platforms where news is spread, while some may perceive that Twitter has evolved as a major news platform.
  2. In any case, social media platforms offer people the ability to get news from personal sources who they trust and from people who are interested in the same or similar things and with whom they share outlooks on many topics.
  3. Social media also allows people to comment and spread news to their own networks – making it more participatory.
  4. Social media allows you to reach an audience who is likely already pre-disposed to be interested in your topic (e.g., people concerned about a specific disease or condition) rather than relying on a general publication that will reach a less enriched audience.
  5. In addition, social media allows instant reporting from almost any venue.  For example, medical meetings are very important for new medical products and the twitter traffic at these meetings increases every year, comprised of doctors, patient advocates, scientists as well as journalists.  As we have seen on the world stage, sometimes social media is the only means by which reporting even can occur – such as in areas of heavy conflict.
  6. Almost every journalist is on Twitter
  7. Social media in general and Twitter in particular allows a reporter to report several times a day instead of filing a single story (micro-reporting).

Feel free to add your own talking points, either yourself, or by leaving a comment!

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Weekly Roundup 9.5.14

After a surprisingly mild August, September begins with summer in full force – heat, humidity and a mosquito rally that is immensely annoying.  Forecasts however predict that we only have one more day of this and then a break to temperatures that appear to be much closer to the gentle welcome of autumn.  I hope.

I also hope that you enjoyed the short week as a result of the Labor Day holiday.  In the meantime, here is a bit of what happened this week (short week – short roundup):

  • Approval of Keytruda (pembrolizumab) for Advanced Melanoma - FDA announced this week the accelerated approval of Merck’s new treatment for patients with advanced or unresectable melanoma who are no longer responding to other drugs.  Keytruda is a humanized monoclonal antibody andis the first approved drug that works by blocking a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells, but is the sixth melanoma drug approved since 2011.  Keytruda was granted breakthrough therapy designation by FDA based on the agency’s assessment that Keytruda may offer a substantial improvement over existing therapies.  The company’s press release can be found here.
  • First Test for Assessing Risk of Developing Acute Kidney Injury - The NephroCheck Test System was cleared for marketing by FDA - a first-of-a-kind laboratory test to help determine if certain critically ill hospital patients are at risk of developing moderate to severe acute kidney injury.  Currently tests can only assess if a patient may already be experiencing acute kidney injury, however this test assess the patient’s risk of developing the condition within 12 hours of the administration of the test.

Have a good weekend everyone.  Next week is a long one!

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Tracking 10 Healthcare Beat Reporters on Twitter

It is not news that social media has fundamentally changed the way we communicate. Today, we share news, we don’t just read it.  A news cycle is every moment of every day. We rely on people to pitch news to their own networks of other people.  You get the picture.  The fact that communications has changed is not really news anymore.

Twitter, more than any other social media platform, is a news platform.  It is a news feed that is constant and on-going.  It is less social than it is media.  It even sometimes provides us with news and pictures from places and events where there is no other way to get news out.

And since the nature of the way we communicate has changed, so has journalism.  Ever since 2009 when news events started generating pictures of breaking events over Twitter every reporter realized “I need to be on Twitter” (and some realized it before that) .  A reporter who used to file maybe one story a day, can now file several mini-stories.  A reporter who used to have to cast a wide net with a story or a report can now report on something very granular.  And a reporter can drive traffic back to his or her story with a link to followers and the follower’s followers.  There used to be only macro-reporting – now there is micro-reporting.

So I wanted to get a feel for the environment around Twitter and healthcare reporters.  I picked 10 reporters who I consider to be those who would regularly report on significant data milestones or on FDA advisory committee outcomes or FDA decisions.  They spanned broadcast, print, wire/news service, magazine and newspaper.  I think what I found was interesting.

Of the ten I examined (no I am not telling you who they were) – they ranged quite a bit in terms of frequency of tweets and number of followers.  Some had a rather anemic output on Twitter – sending out a tweet only every other day or so and rarely re-tweeting.  You could tell that they don’t embrace the medium fully.  Others were prolific, sending out as many as several tweets a day.

Followings ranged quite bit as well, with some having only a few thousand followers while others went into the stratosphere.  Some had relatively low KLOUT scores, while others had very high ones – though not quite in the Lady Gaga realm.

And I was surprised to find that many of them re-tweeted others and in fact, some were prolific re-tweeters.  Moreover, not only were some prolific re-tweeters, but some retweeted others regularly from other outlets, not just their own.  High profile reporters re-tweeted material from other high profile healthcare reporters.

So what, you may ask?  The so-what is this.  While it may be very important to get a print story above the fold in a traditional paper, or even to get a nice mention in an online edition, there is something to be said for knowing your beat reporters and their Twitter profile. I have said before, a media list that has the name, phone number, email and outlet name on it is yesterday’s list.  Just as one might prepare for a news milestone by doing some macro-analysis of the media environment, it is probably important to be doing some micro-analysis as well.

I think it is time that today’s media list includes a Twitter profile that includes following, KLOUT score and that you have an understanding of who they follow and who they retweet.  It is good to be above the fold in print – but it is also good to be in the know on the digital side.  Cover the macro.  Cover the micro.

I have created a Twitter list of some key healthcare reporters and if you like you can follow it here.

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FDA Looking for New Head of CDER Communications

For those who have had the pleasure of working with Julie Zawisza in the past, the news is that she has moved on to a new role at FDA.  That means her former position in communications at the Center for Drug Evaluation and Research is open and FDA is looking for someone to fill it.  Wishing Julie well in her new position, here are the deets on her old one in case you, or someone you may know, is interested and note – the official job posting will be up next week.

Description of Duties:

FDA’s Center, for Drug Evaluation and Research (CDER) is searching for exceptional candidates for the position of Director of the Office of Communications (OCOMM). The Office currently has over 100 employees. OCOMM is the central hub for communication expertise, in CDER, focused on the development of consistent messaging to inform and educate the multiple audiences. The Office has a variety of responsibilities including the planning, coordination and evaluation of the policies, procedures, programs in the strategic outreach and communication about drug-related requests.

The incumbent serves as Director, Office of Communications (OCOMM) for the Center for Drug Evaluation and Research (CDER). The Director provides leadership and direction for all Center internal/external communications. The Director is responsible for the creation of a climate for cooperative work relations, and support and understanding of the CDER program objectives. Additionally, the Office of Communications Director advises and counsels the Center Director and CDER leadership on external and internal communications relative to the exchange of information and is the liaison external groups.


Applicants should possess an advanced degree in Communications, Marketing, Public Relations, or Public Affairs.

Successful candidates are those that have experience working closely with highly-credentialed people. They must have substantial experience in Communications, Marketing, Public Relations, and/or Public Affairs. Knowledge of pharmaceuticals is a plus. The candidate should be persuasive, influential, and have the ability to ask the right questions.

Location: Silver Spring, Maryland

Salary: GS-15, $124,995-157,100 Salary is commensurate with qualifications and experience. A full Federal benefits package is also available including: leave, health and life insurance, retirement, long term care insurance, and Thrift Savings Plan (401K equivalent).

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