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Jonathan Richman (@jonmrich) writes:
'The FDA has released some guidance for using one aspect of social media. We created a handy flow chart that dissects all the requirements.'
[AS: a helpful and thorough analysis from Jonathan Richman on fhe recent FDA social media guidance. I'll confess to not having made a study of the document myself yet, but if Jonathan's analysis displays the rigour I associate with his work (as I'm sure it does) how useful is guidance that counsels the industry to respond privately to queries made in a public forum?
Are broader questions raised here pertaining to the viability of applying thinking around off-label information designed for offline settings within online, public, discursive settings? I would welcome further insight into the volume of conversation undertaken online that refers to off-label usage of medication compared to that which discusses approved uses and dosages. If the former massively exceeds the latter, this guidance would be speaking to a minority rather than a majority of instances.]
In February 2012, Facebook unveiled Facebook Timeline that threw social media marketers for a loop. The new layout practically took away the capability to have a great landing page in order to have individuals to “Like” a brand page.
Instead, Facebook provides a framework in which companies are given the opportunity to boost engagement with fans. In order to properly take advantage of the timeline function, a content strategy is required.
[AS: This article somewhat misleadingly bills itself as 'Content strategy: the backbone of a facebook timeline for pharma', but actually offers two tactical examples of individual facebook posts from Pharma accounts. Even the most generous gloss couldn't really call that a 'content strategy' per se, but no matter :)] 
Gaining internal consent for an online community-based strategy requires “explanation and reassurance, lots and lots of it”, according to Claire Derbyshire, Sanofi’s UK & Ireland market research manager. http://PharmaStrategyBlog.com Preview of American Society of Clinical Oncology (ASCO) 2012 annual meeting in Chicago from Sally Church, PhD (@MaverickNY)
[AS: These video summaries from Sally just get better and better. Fantastic! Looking forward to seeing yet more growth in discussion on Twitter from ASCO this year, too.] 
In a recent survey of 250 mobile executives from around the world, 78 percent of respondents said that they considered the healthcare vertical had the most to gain from 4G connectivity. 
With the proliferation of mHealth apps, it was only a matter of time before healthcare providers would start prescribing apps as soon as apps proved to be as or more effective than prescription drugs.
Anecdotal evidence has circulated that some apps have been more effective at addressing some chronic conditions than drugs. As more hard data is available, this represents a major threat to lucrative drug franchises.
[AS: What if pharma is creating/commissioning the apps? A threat, or an opportunity?] 
There will be 44 million mhealth app downloads by the end of 2012, which will rise to 142 million by 2016.
[AS: About 2.2 million of them will be used more than once...] 
Social factors influence behavior, to a larger degree than most people recognize. By identifying the structures of social influence among physicians, and targeting the most influential docs, brand marketers can do more with fewer sales reps.
[AS: Plenty of references to trust in this article, but less interest in exploring the need to align strong revenue generation with a demonstrable commitment to social good and a commitment to evolving socially across the enterprise. 'Trust' isn't an abstraction; it is evidential. Trust can't be gamed. Trust can only be built, one opportunity at a time.]
Thinking of having a website as the hub of your next campaign to educate doctors? Don't bother
Just 10 percent of doctors prefer to receive information via pharma websites.
A slide excerpted from a Doctors.net.uk presentation by Jo Bell and Tim Ringrose, available here (PDF):
A new manhattanResearch report suggests that physicians who touched a sales rep's iPad were more likely to have a satisfactory experience, and more likely to say the experience influenced their clinical decisions.
However, only one-quarter of the 30 percent of physicians who saw a sales rep with an iPad actually touched the device during the meeting.
[AS: a new chapter in the mythologising of the arcane, totemic qualities of the iPad as an influencer of physician behaviour is written with the release of this data.
What exactly is it about the way that content is presented by iOS which leads doctors to feel as though they have been more influenced than they would have done were it presented on either another tablet, or perhaps a laptop?
Is it the tactile nature of the experience? The ability of iOS to render graphics? Or a conditioned response on the part of the audience that associates the tablet with other experiences?
It is also interesting to note that reps seem unwilling to let the tablet out of their hands, and let the doctor 'drive' the detail. I would have thought '1. pass the iPad to the clinician' was the first item on the Successful Digital Detailing 101 training program.] 
Dominic Tyer (@Dominic_Tyer) writes:
The new Group is made up of representatives from the ABPI, PMCPA, ABPI member companies and healthcare communications agencies.
They had their second meeting in March and, while the process is still in the very early stages of development, the Group is expected to produce a list of core principles and case studies, possibly by the autumn.
The PMCPA itself produced ‘informal guidance’ on digital communications in April 2011, but it seems pharma companies want more information and advice before they feel fully comfortable using digital channels.
[AS: a thankless task, for certain. But is it also a pointless one? Will current non-participants ever 'feel fully comfortable'? Does anyone?
Isn't the truth of the matter that there is no short cut to social, and that the aptitudes and abilities that need to be understood and owned in order for the industry to function effectively in social environments are hard-earned, and gained only through experience and participation?
More guidance is not going to get the industry any farther down this road, nor will it make it any easier for it to traverse. The two - note: only two - breaches to date mentioned in the piece both arose (IMO) through a lack of competency on the part of the transgressors, not a desire to mislead, which (again, from my POV) was entirely incidental.
Practice may not make perfect, but it can move us farther away from imperfection. Regulations encourage the seeking out of loopholes, not the ownership of responsibilities] 
The Ad Age DataCenter's agency report, which covers nearly 1,000 U.S. agencies, networks and holding companies, indicates that:
- The 2011 revenue of the big four holding companies (WPP, Omnicom Group, Publicis Groupe, and Interpublic Group of Cos.) is almost twice as large as the revenue of the rest of the top 50 combined -- $45 billion to $23.7 billion. - Digital media jobs are up 37,400 since the start of the recession and 49,400 since the post dot-com-bubble low - 286 agencies listed social media revenue, totaling $493 million, up 53.7% from 2010. - Worldwide revenue for the top 10 public-relations networks grew 10.4%, nearly twice the growth rate seen in the U.S. for 241 agencies reporting PR revenue. Those U.S. agencies' revenue rose 5.3%. 
Pharmaceutical brand teams are generally dissatisfied with their outsourced digital marketing, according to a study by Cutting Edge Information. However, the need to make agency relationships successful is more important than ever as digital media rapidly becomes a key part of the pharmaceutical marketing media mix.
In surveys and interviews, executives acknowledged the challenges that their industry presents to external communication agencies, not the least being the lack of clear regulatory guidelines for pharmaceutical digital marketing. Despite that, pharmaceutical brand teams' opinions of agency performance are generally negative.
Providers were rated for their competency in:
- Developing digital marketing strategy - Moderating interactive forums - Understanding the regulatory environment - Maintaining regulatory compliance - Executing digital marketing strategy - Demonstrating digital marketing ROI
Across all activity categories:
- Just 21 percent of responses considered the services they received to merit categorisation as being 'good' - 35 percent of responses ranked the services they received as 'poor' - ***No*** respondent ranked their experience with outsourced digital marketing as being 'very good.'
Though the overall sentiment is negative, certain activity categories offered more positive signs for digital marketing outsourcing. 'Executing digital marketing strategy' -- the category most widely outsourced -- garnered "good" ratings from 39 percent of respondents, indicating a potential advantage for teams seeking implementation rather than development.
[AS: What a miserable set of responses. Time to change agencies, people!] |
Mark Senak (@eyeonfda) writes:
Pharma has put Twitter to use on many fronts.
One is jobs and recruitment, both within the U.S. and outside of the U.S. There are now at least 21 [recruitment-related] pharma-sponsored Twitter feeds set up, some with more activity than others. 
Google is bulking up on patents to protect its new augmented reality glasses project from legal attack, with at least nine new patents issued in the past week to cover various aspects of the futuristic devices. The patents provide a glimpse into what a heads-up display from Google could provide to real-life users beyond what we learned when Google unveiled Project Glass last month.
Perhaps most interestingly, one patent shows Google is working on a system to help hard-of-hearing and deaf users detect and interpret nearby sounds. The glasses' heads-up display would show arrows and flashing lights to indicate the direction and intensity level of the sound, and even display the words nearby people are speaking. 
Forbes' Matthew Herper suggests:
* De-emphasising drugs * Innovation toward disruption * Making more research “pre-competitive” * Changing the way patents work
According to a recent report by the Health Research Institute at PwC US, nine distinct uses of social media are helping companies to have an impact on the healthcare business, and to take a more active and engaged role in managing individuals' health:
1. Communication is shifting to public, more open forums. 2. Patients (or consumers) are taking a more active role in their healthcare. 3. Increased access to information means patients are demanding more transparency. 4. More instant feedback is helping both consumers and organizations. 5. Social information is impacting how and when patients select treatment and providers. 6. Social media allows for higher levels of trust. 7. Social media is evolving from a marketing tool into a business strategy. 8. Providers can use social media as an outcomes-based measurement. 9. Health insurers can use social media to help focus on population health. 
Infographics (graphic representations of data) can be a effective tool for biopharmaceutical companies to use to visually express complex ideas. 
Support is growing for increased collaboration between pharmaceutical companies and patients in research processes worldwide, according to a new report by GBI Research 
The usual effortless good sense from Phil Baumann (@PhilBaumann):
'I understand the concerns – and fears – executives and managers of Healthcare organizations. Their concerns are rational, while the fears are not. Unfortunately, organizational fear often holds more sway than rationality.
But history has shown, over and over, how so many companies that faced changing conditions simply refused to step back, brave self-critical analyses, and profoundly apprehend and exploit a changing world.
In the end, patients will bear the costs of fearful leadership in today’s participatory communications – safety belongs at the bedside, not the boardroom.
The problem of Healthcare and Social Media Marketing is within you. So is the solution.
More crudely: You are the problem.
Good news (maybe): You are the solution.'
[AS: For the record: I don't share everything Phil publishes, because you should have his content delivered to your in box or add him to your RSS feed. Provocative, uncomfortable, and highly recommended reading for all interested in healthcare as an evolutionary practice rather than an exercise is lift rock-move rock-drop rock.] A short presentation from pharmaphorum (@pharmaphorum) addressing:
0:12 – What is changing the landscape for SFE? 
In the relationship era, sales tactics may drive consumers away.
[AS: Marketing is so steeped in the 'unshakeable wisdom' of a set of precepts forged in an offline world, that it seems to have forgotten that people aren't cattle, and brands are called brands for a reason. People don't want to be branded. I suspect that cows aren't too keen on it, either. Brands don't want people; they want what they have, not who they are. More encouraging grist for the #postmarketing mill here. Keep thinking.] |
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Thank you for your opinion Jon!
Just adding one more aspect: I miss from this document how unsolicited allegations/opinions/statements (as opposed to queries)about off-label use should or could be handled by pharma. Can it be the same? E.g. how about a misinterpretation of clinical study data published on wikipedia? - where the FDA proposed standard public answer does not seem a good or even viable solution to me.
Referring to the interesting issue Alex Butler tweeted ( http://bit.ly/AEY26K ) it is also a good question whether there is a possible situation where an open, public answer from the corporation about the issue is more ethical and provides more benefit short and long term than the FDA proposed short public answer? E.g. handling popular and spreading misbeliefs?
I'm with DRPJ on this one.
The reality is that this direction is far from ideal. I'm sure companies would like to post a public answer to a public question. However, I definitely see the FDA's thought here. If you allow companies to post off-label information in response to questions online, you're inviting a flood of what will amount to off-label promotion. Companies would go out of their way to find questions just to get the information out there. Broadcasting off-label information in this way isn't really good for anyone in many cases. The information is off-label for a reason. The FDA hasn't approved it because the evidence is strong enough in most cases. This means that the data and information might change (and change dramatically). It might suggest that something is safe based on data from a small trial only to find it's dangerous in a larger one. I doubt that companies would then be willing to go back and hunt down all of the places where they shared the outdated (and now potentially dangerous) information.
I see this position of answering public, off-label questions with a private answer as being a good compromise.
What's missing from the document is how to handle on-label questions. Can companies answer these publicly and if so, how do they do it in a compliant way? For example, how do you answer someone who is asking about the approved dosage for an approved indication? I think the company should be allowed to post the answer with some fair balance (which can be done in forums, but not in places like Twitter), but we don't have this direction yet. I find it strange that this wasn't addressed.
Jonathan
Dose of Digital
"How useful is guidance that counsels the industry to respond privately to queries made in a public forum?"
Since these queries in question are queries about off label use, I think the _public_ answer they recommend serves transparency and quality of publicly available official information (as well as precludes the chance of off label promotion). E.g. in case a new indication is cleared for a drug, it would be impossible to go back and hunt down every place where the "this is off-label..etc" info, based on a previous and now outdated SmPC ended up, originating from the official corporate account.