Weekly Roundup 10.3.14

Back from a brief vacay to discover that leaves are littering the yard and porch as if it were autumn and then realizing that it is, in fact, autumn.  The year is going by so quickly and there is so much to do.  And with the brief and slight chill that is present in the air, my thoughts whiz right past Halloween to beginning to percolate ideas for the Thanksgiving week menus.

For those of you with your feed more secured to the ground, here is a bit of what happened this week:

  • HHS Publishes the Sunshine Act Data – The very, very long-awaited publication of the data collected under the Sunshine Act designed to provide insight into the financial relationships between the medical products industry and key stakeholders such as physicians and teaching hospitals was published this week on the website of CMS.  To say the least, the data base known as Open Payments is a big piece of machinery and navigating it is not so intuitive or easy as one might think (or hope).  Nevertheless, it is there and ready to be explored.
  • FDA Updates Ebola Page on Website – With the escalation of news regarding the Ebola outbreak in West Africa and the subsequent first case diagnosed in the United States, there is a consequential need for more in-depth information.  This week FDA expanded upon its new Ebola section of the FDA Website that overviews a timeline of events, latest developments, FDA’s involvement, news about treatments – both investigative and fraudulent.
  • More on Cyber Security and Medical Devices – Last week it was noted in the Weekly Roundup that FDA would be holding a public hearing on cyber security and medical devices.  On the same topic, this week the agency announced availability of a guidance – “Content and PreMarket Submissions for Management of Cybersecurity in Medical Devices“.  FDA is recommending that cybersecurity be a component of the design and development of a device and also are inviting manufacturers to submit their plans for patches to be provided to improve security for software.

That’s it for me this week.  Have a good weekend everyone.

Photo Credit:  Anne Becker

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off

Less Characters, More Tweets – A Few Tweeting Tips

It is hard to believe that a service that limits your speech to 140 characters would emerge as an important media platform, but it has.  News travels more quickly, is more granular in nature, can very specific to highly targeted audiences and drives traffic to full stories and sites.  It allows reporters to file micro-stories all day long.  The breadth of what gets communicated drives depth, even in such a short character span.

Last month I posted on tracking the top healthcare beat reporters as a means of keeping up with what is going on in the healthcare space.  You only have to attend a medical meeting to understand how quickly news is being shared out of those venues by attendees and media.  Even FDA has 14 twitter feeds and they are compiled here in a list if you would like to view all FDA tweets at once.

There is no right way and wrong way to post tweets.  But it is important to remember that one maximizes one’s impact on Twitter by providing content that is engaging and newsworthy and gets repeated.  In other words, talking to your followers is one thing – and perhaps an important thing, but talking to your followers’ followers is much more effective from a communications point of view.  It is reaching those networks to which you do not have direct access yourself.  It is the echo chamber that is Twitter.

In other words, the whole point is to have your tweet re-tweeted.  Retweeting is pretty easy – you click on the icon and poof, you send.  But when you do that, it adds characters to the tweet.  If you go over the character limit, the retweet will be truncated.  Not good.

Therefore, it is important to consider, when composing a tweet, the need to keep it a short and sweet tweet in order to maximize the possibility that it gets retweeted.  If a reader goes to retweet and finds that the retweet is now too long, it will require the user to modify the tweet.  At that point you are likely to experience a drop-off in retweeting.

So in the end, don’t make re-tweeting a chore.  If you force your reading public to modify the tweet, then you are going to experience a drop-off in re-tweeting.  Drop unnecessary words like “a” and “An” and “the” – abbreviate when possible – and use short cuts like & and $ when you can.  Putting your readership against the wall with the 140 characters is not doing them or you a favor.

Checklist for finishing a tweet – look it over and ask yourself

  • What words can be dropped entirely?
  • What terms can be abbrevicated?
  • What can be replaced by a symbol such as substituting “&” for “and”
  • Can I use other shortcuts – substituting risk/benefit for the “risks and benefits”

Shaving characters from your tweet will increase the likelihood of getting re-tweeted and minimize the chances of someone mangling the meaning of your tweet by modifying it.

Happy Tweeting People.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in New and Social Media | Comments Off

Weekly Roundup 9.26.14

I bring you the Weekly Roundup today from Cape Cod where there is a lovely sense of autumn in the air, but blue skies and lovely shoreline allowing us to still remember the summer’s most pleasant days.

And here is what happened this week in reality-based Washington, D.C.

  • Ebola Candidate Treatment Emergency Use - Reuters reported this week that FDA was allowing the emergency use of Tekmira’s investigative compound TKM-Ebola being studied as a treatment for Ebola. Canada also issued a similar authorization.  And the company announced this week that it would be joining an international consortium to conduct clinical trials for new treatments in West Africa.
  • FDA Warns Purveyors of Ebola Treatments – On a related but entirely different note, FDA issued warning letters to 3 companies that the agency said were marketing preventions and/or cures for Ebola.  The letters were issued on September 22 and 23 and represented a range of types of products.  FDA has put up a web page on Ebola and overviews distinctions between investigative compounds and fraudulent products.
  • CyberSecurity and Medical DevicesFDA announced a public workshop for October 21 and 22 to be held in Arlington, Virginia entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity” and the purpose of the meeting is to identify barriers to promoting cooperation and to consider strategies to overcome various challenges.
  • Social Media Guidance Comment Period Extended - FDA announced that it would be extending the time period for comment from the public regarding the two social media guidances issued in June.  The agency took five years to produce the guidances and is seeing fit to give the public a bit more time to provide input. According to the notice sent by FDA, the time period will be extended from September 29 to October 29.

That’s it for me.  Back to vacation.  Have a good weekend everyone.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off

Here Comes the Sun – Communications Tips on The Sunshine Data Publication

The Sunshine Act will peek out from behind some, but not all, of the clouds on the horizon soon, leading to a new day in transparency on payments between the medical products industry and those who provide care.  Data will be published by HHS on payments made to key stakeholders including physicians and teaching hospitals among others.  Much has been written and much will be written.  My own humble contribution has taken place from time to time looking at the issue here in this country and in France; looking at how the release of CMS data this Spring was covered by media as a proxy for what we might see on Sunshine coverage; and a Webinar that was held in June providing tips for preparing for the publication of the data from a communications point of view.

The time is near. For those who have procrastinated, here from the Webinar are a few of those observations and tips.

Observations

  • The first wave of coverage will likely focus on the payments – how much went to where – with comparisons and rankings, the second wave may then focus on how well the implementation of the law is working, or not (reporting errors, e.g.);
  • Focus may well be on which doctors received high levels of funding, which institutions and which companies paid the most, which parts of the medical profession received the most funding – and these stories will likely be on a national and regional/local level;
  • Because of the connection with money – the skew is likely to be negative;
  • Stakeholders will include teaching hospitals, non-teaching hospitals, physicians, research centers, medical societies, CMS and of course, patients.

Tips

  • Messaging will be important for individual stakeholders, not just trade associations and groups and is best developed ahead of time and that takes into consideration not just what stakeholders feel a need to say, but what they think audiences – particularly patients – may want to hear;
  • Understand ahead of time your stake – what are the characteristics and scope of your involvement – what is your individual story and assess strengths and vulnerabilities;
  • Also understand that this is an opportunity to educate people about the relationships that exist so provide a comprehensive picture – don’t just respond to individual snippets of the story or the data – which will appear defensive;
  • That said, be able to define the individual elements of those relationships – help media/people understand what the benefits are to scientific advisory boards, clinical trials, etc.
  • Make sure internal stakeholders help devise messages to provide the most accurate messaging;
  • Have materials ready – FAQ, Talk Points and Backgrounders to help convey the messaging.

With the potential holding back of some of the data, the resulting story may be even more confused than it would have otherwise been and may complicate the ability of media to cover the story of the data publication considerably.  Good preparation will help mitigate some of that circumstance, particularly in messaging, that will allow individual stakeholders to help shape their story, rather than have the story shaped for them.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in FDA Policy, Miscellaney | Comments Off

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!

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | 1 Comment