Weekly Roundup – 4.18.14

There were audible gasps all over the Internet from people experiencing yet more snow this week – the week of Easter break for many.  Freeze warnings here threatened my young herbs planted only a few days before over a warm and languid weekend.  But at last, it appears that Spring has made its arrival, just lacking a little in confidence.

But there hasn’t been much of a thaw at FDA.  Not many press releases, no speeches, no testimonies and very little warning letter action.  Still, here are a few tidbits from the week that I thought would be of interest:

  • New Type 2 Diabetes Drug Approval - FDA announced approval of GSK’s Tanzeum (albiglutide), a once-weekly subcutaneous injection to improve glycemic control for adults with Type 2 diabetes.  The agency said that the drug was being approved with a Boxed Warning and a REMS program as well as a requirement for several types of post-marketing studies, including dosing, efficacy and safety in pediatric patients and a cardiovascular outcomes trial.  According to the company release, albiglutide has been approved in Europe in March and expects to launch in the U.S. sometime in the third quarter of this year.
  • FDA Approves New Allergen for Ragweed - Earlier in the month FDA approved the first sublingual allergen extract for the treatment of grass pollen allergies and this week approved the first sublingual product to treat short ragweed pollen induced allergic rhinitis (also known as hayfever).  The newly approved product, called Ragwitek, is to be used 12 weeks before the beginning of the ragweed season with the first dose being administered in the physician’s office and the balance at home.  There is a Boxed Warning for the product informing that severe allergic reactions, some of which can be life threatening, can occur and the product will come with a MedGuide.
  • IMS Report on Medicine Use – The IMS Institute for Healthcare Informatics released the report – “Medicine Use and Shifting Costs of Healthcare:  A Review of Medicines Used in the U.S. in 2013″.  Among other things, the report finds that after a decline in 2012, drug spending increased in 2013 once again, new products were launched and fewer patents expired.  It is filled with a wealth of information from the fact that prescriptions for pain meds dropped by 1 percent to an increase in contraceptive medications by 4.6 percent.  The release of the report includes videos overviewing the key findings and if you want the report you can download it from the IMS Institute site or you can get the IMS Health App on an iPad and get it there, which is pretty neat.
  • FDA Discourages Use of Procedure for Removal of Uterine Fibroids – FDA made a safety related announcement yesterday that made the front page of some papers today.  The agency announced this week that the use of laparascopic power morcellation – a procedure that is one of several available for treatment for fibroids – was discouraged as a treatment by the agency after finding that approximately 1 in 350 women who are undergoing a hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer.  The procedure works by dividing the tissue into smaller pieces or fragments that can be removed through laparascopy. FDA said there dis a risk the procedure could spread the cancerous tissue, thus posing a risk.

That’s it for me this week folks.  Please have a good weekend.

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Release of CMS Medicare Payment Data a Sunshine Dress Rehearsal

There were two major healthcare stories last week.  One involved the announcement that Health and Human Services Secretary Kathleen Sebelius would be leaving and the nomination by President Obama of Office of Management and Budget Director Sylvia Mathews Burwell to replace her.  But also last week CMS made an unprecedented release of Medicare payments data.  For the first time since 1979, the public had access to information regarding which physicians received what kind of sums under Medicare. Media stories were extensive and primarily focused on the amounts of money that went to providers.

For some time now, preparation has been underway for full implementation of The Sunshine Act, incorporated into the provisions of the Affordable Care Act.  Under that law, there will be a similar release of information, only this will focus on payments made from the pharmaceutical, biotech, and medical devices industries to physicians and teaching hospitals.  CMS has been in the process of implementation of the Sunshine Act for some time now and the culmination will be in the first scheduled publication set for the end of September, 2014.

There were many angles to the CMS story to explore in the stories.  But perhaps one of the most important aspects of CMS Medicare announcement for the medical products industry is the fact that it served as a media “dress rehearsal” for the publication of data under the Sunshine Act provisions later this year.

Coverage of the CMS news was broad – spanning many national outlets.  It was both a national story with headlines focused on the top grossing physicians as well as those specialties that saw the highest payments, and a regional one – where local physicians were assessed as seen in this piece from Arkansas Business.

The primary focus was squarely on the amounts of money received by physicians. While many reports carried caution that the whole story did not end there – that there were reasons behind the numbers – the fact that large amounts went to a small group of physicians stood out.  Beyond the individual physicians, there were reports profiling particular physician specialities – oncologists for example.  Some of the messaging around the “behind the numbers” issue worked, some of it did not.  That is something to look at.

There is every reason for one to expect the same type of coverage for the release of information under the Sunshine Act coming in the autumn of 2014.  Again, a good deal of the focus will likely be on the numbers, and there will be some additional messaging about the story beyond the numbers, but the stakeholders may be broader.

First, of course, will be individual physicians who will see a focus on amounts they received.  Second will be the medical societies of particular physician practices where there may have been more interaction with industry than others.  And third will be industry with a focus on everything from comparative amounts expended to exploration of the relationships between the funding and product marketing.

In the field of issues management, it is rare that one gets the opportunity to look at a blueprint and to have the luxury of time to develop messaging ahead of an event. This is one of those rare times.

On their websites, many medical societies have given members overviews and tools to learn about how the Sunshine Act works.  But it may also benefit the membership to have a framework for how to talk about their participation in various industry programs once it is released. There is a story beyond numbers. Members may also face regional stories if they stand out in a particular region or state.  A webinar on the topic may for members might benefit many.

Similarly, industry has been working to aggregate and submit data – it is also time for companies and their trade organizations to examine the coverage from this release of data with an eye for preparation:

  • Begin with both messaging and strategy regarding the release of numbers, decide what worked, what didn’t.  What is the story beyond the numbers?
  • What does it mean to sit on an advisory board?  What are the benefits to patients from the relationships that are developed with physicians?
  • And, given the benefit of time for planning, in addition to preparing for responding to inquiries, stakeholders need to assess to what extent some proactive efforts might be a good idea.

There is a good deal of time between now and the time the Sunshine data is released. Developing and assessing messaging now – considering strategy and possible tactical execution – is probably time and effort well spent.  In the end, preparation will not do away with the negative connotation associated with money, but it can help to paint more of the background picture so that there is greater context associated with the coverage of the release of data.

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Weekly Roundup 4.11.14

A few weeks ago it was snowing.  Today, a walk around the neighborhood yields views of piles of mulch near driveways ready to be loaded into wheelbarrows and spread into the garden beds.  Bags of topsoil are lined up.  Grass seed is nearby and already the grass appears to be putting forth bright green shoots.  The birds are noisy.

Transitions happen before we know it.  One minute we are complaining about snow and the next, there is a pollen alert.  Here are some news items to mark our way down the path:

  • FDA Expands Indication for Some Pacemakers and Defibrillators –   FDA approved an expanded indication for two pacemakers and eight defibrillators for use in patients with less severe heart failure.  The devices had been approved for severe heart failure use.  The agency spokesperson stated this could delay the occurrence of heart failure related urgent care for people who meet the new criteria.  The devices are manufactured by Medtronic.
  • Internet Ad Spending Beats Broadcast TV Last Year - For the first time it was reported by Mashable that revenue spent on advertising on the Internet surpassed that spent on broadcast television.  Not sure if that is true for the pharma industry or not, but it certainly signals that if not yet, it will likely be soon.  And for FDA, it signals that enforcement efforts, long centered by OPDP on broadcast, need to be approaching their efforts in new ways, taking into consideration a lot of new factors.
  • Predictability and Transparency in DEA and FDA Regulation - On April 7, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, provided a statement before the House Subcommittee on Health, Committee on Energy and Commerce that outlines and explains some of the massively complicated situation regarding the regulation of sunscreens.  One might not think that the oversight of sunscreens could possibly be so involved, but if you want to gaze into the labyrinth, by all means, take a look.
  • And a Timely Alert About Lillies – In time for the Easter Season, FDA has provided an alert about the fact that kitties and lillies may not mix very well. According to the agency, the entire plant – leaf, pollen and flower – are all toxic to our feline friends.  Symptoms can include lethargy, vomiting and loss of appetite which can worsen as kidneys are affected and can prove fatal and early treatment is extremely important.

That’s it for me this week.  I am finally for the first time in many weeks not on the road, so I will be more regular in this space.  Have a good weekend everyone.

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Sunset on the ROI of Social Media and Pharma Discussion

While many pharma companies have developed a wide and deep footprint in social media, many others have not.  When exploring the issue of whether or not to involve a brand, there are several questions to consider.  Some are very important considerations – for example – what is your communications goal and will social media help you achieve it?  And another perennial question is – what of the return on investment?  What is to be gained for a pharma brand by being involved in social media?

For those who face those discussions, here are a few considerations that I think might indicate that the days of having the ROI discussion are essentially over.

  1. Participatory Media is Here to Stay – Some considering whether or not to engage in social media will wonder – even still – if social media is here to stay. Whether or not the individual social media platforms that are popular today – Facebook, Twitter, YouTube, continue in their current form or maintain their levels of popularity – they stand for something bigger.  Social media is representative of a seismic shift in the way we communicate.  Just as television fundamentally changed the way we communicate by bringing the camera into the equation and eclipsing the spoken word of broadcast radio, social media ushered in an era of participation in communications and the balance of power between the communicator and audience shifted forever in favor of the audience.  We, the audience, can now take your message, comment on it and pass it along in the public discourse of things.  We now participate in communications and we are not likely to give that up.
  2. Social Media is Bigger than Patient Engagement – Many will wonder what value there really is in engaging with patients, their communities and their advocates.  It is doctors, after all, who write the prescriptions.  But, for many categories of drugs, it is the patients who ask for them.  Granted, in areas of medicine that involve high expertise a patient may rely more heavily on their physician.  But for a large range of medications, the patient will engage in conversation with the doctor, make suggestions or even demands for specific medications.  Beyond that, today’s media environment includes journalists – many key ones in the pharma space – who are heavily involved in social media on a daily basis and who have large followings.  Mainstream media has migrated to digital media in general and to social media in particular.  And so have doctors, who are integrating social media into the practice of medicine more and more and for whom social media is increasingly important in medical meeting venues.
  3. Social Media is Now Installed in the Wall – What that means is that social media is no longer something that is added on to a communications set of tools.  It is like the wall socket in the wall.  It is there.  It is part of the structure.  True, whether or not you plug into it or not is up to you.  But the fact that houses are now wired for electricity kind of diminishes the power of the question – what is the return on investment for my using electricity?  Likewise, social media has become part of the fundamental communications infrastructure.  Not utilizing it is an option, but it may not be a competitive one.
  4. Everyone Has Moved OnPerhaps nothing is more symbolic of the way that communications has changed than with the uptake of the smart phone.  Remember when you used your phone to call people?  Now, your phone is probably used as a phone less often than it is used to access the Internet or to use an app to get directions, measure my bike ride or count my calories.  Your phone is an entirely different communications device than it was just a few short years ago.  It has become practically ubiquitous (though I do know people without a smart phone) and we don’t even think about the way that it allows us access to constant communications and very few of us would entertain the discussion – what is the return on investment for using my smart phone?  You just do it.

So, all that is to say that in my opinion, the question on ROI has gone the way of the question of the shape of the planet.  It may still be worth having the discussion if for no other reason than to actually get grounded in your goals and objectives.  But in fact, we have all moved on and we are not turning back.  It is probably as much good to ask what the ROI is on social media in the same way you might ask what the ROI was on your press releases, your web site, or the electronic socket in wall.  In the end, it may not be a question about the return on investment as much as the cost of not doing business.

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Weekly Roundup 4.4.14

Dumbfounded by another week packed with business travel.  It was a week that truly involved planes, trains and automobiles.  I wish I could say that it will be a while before I am once again in an airport, but it would not be so.  In any case, home today for the first time in a week, and here is a bit of what happened that was pretty newsworthy that came out while I was standing in one line or another.

  • Approval of Sublingual Allergen Extract - FDA announced approval on April 3 of a new tablet called Oralair manufactured by a French company called Stallergenes.  Oralair is a once-daily dose and indicated for the treatment of hay fever induced by grass pollens and is the first under the tongue (sublingual) extract approved in the United States.  The first dose is administered in the physician’s office and thereafter can be taken home for use.  Oralair contains a mixture of freeze-dried extracts of pollens of five different grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.  One interesting note for those of us in the pharma communications trade – FDA’s press release came out two days after the company announced approval with its own release dated April 1 and hence the unusual language in the FDA release that was dated April 3 which stated that the agency had “recently approved Oralair”.
  • Opioid Overdose Treatment – It is an unfortunate circumstance that drugs meant to alleviate the serious pain of people suffering from disease are not only often abused, but in a way that puts a life in danger from overdose.  In fact, drug overdose deaths are not the leading cause of injury death in the United States, according to FDA, suppressing motor vehicle crashes.  This week FDA approved a new hand-held auto injector to be used in an attempt to reverse the effects of an opioid overdose treatment that can be used by families or law enforcement for emergency treatment called Evzio.  Evzio contains a single dose of naloxone that is administered by a hand held auto-injector.  This is a step forward over what had been the status quo which involved administration by syringe from trained medical personnel.  The announcement was accompanied by a statement from Commissioner Hamburg regarding FDA efforts to combat prescription drug abuse.
  • Battlefield Wound Dressing - More successful innovation emerged this week when FDA announced it would allow marketing of an expandable sponge that could be used under emergency circumstances to control bleeding for “certain types of wounds received in battle.”  FDA’s release notes that the U.S. Army says that nearly half of all combat deaths are due to bleeding out and that approximately half of those could be saved if appropriate care – presumably something to stop the bleeding – could be available.  The sponges are administered by syringe and expand into the wound and are later removed from the body.  To support the removal process, each sponge contains a marker that is visible when X-rayed.

That’s it for me this week.  I am working today to produce a few think pieces for next week so that there are some more postings outside of the Weekly Roundup – due to the really busy schedule I have had since the New Year started.  Have a wonderful weekend everyone.

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