2014 Edition of The Pharmaguy Social Media Timeline™

Now that the FDA has finally published a bit of its long-awaited social media guidelines for the drug industry, I thought it would be a good idea to update The Pharmaguy Social Media Timeline™ The drug industry has come a long way despite the long wait. This 2014 edition of the Timeline documents some of the key events in pharma's social media quest, including its triumphs and tribulations. For a more complete and up-to-date timeline with links to source documents, see my Google Docs version here.

The Pharmaguy Social Media Timeline™ from Pharmaguy

Is Pharma Working with Wikipedia to Ensure Its Drug Information is Accurate and Up-to-Date?

We all know that Wikipedia is the leading single source of healthcare information for patients and healthcare professionals. We didn't need the IMS Institute for Healthcare Informatics to tell us that, which it did in its recent report (find it here).

But IMS also said "information gathering occurs not only at time-points where treatments are started or changed, but rather throughout the entire patient journey, including adherence to the medication."

"This finding," said IMS, "should encourage providers of online information, as it indicates that patients not only focus on the treatment initiation or the dynamic treatment phase within the patient journey, but require information, tools and insights that relate to the entirety of the treatment process."

IMS also found a correlation between information searching on Wikipedia and prescription volumes.

Finally, IMS reminded us that Wikipedia articles on health issues are "in flux" and that there is a need for knowledgeable editors to keep the information as current and unbiased as possible.  

"There is yet to be established a broad approach to funneling the vast resources of healthcare institutions, the pharmaceutical industry, regulators and patient groups into the information that is being used by millions of patients," said IMS.

Recall that back in June, 2012, Dr. Bertalan Meskó (@Berci), in an open letter to pharma, urged the pharmaceutical industry to employ Wikipedia editors and thus "funnel [their] vast resources" to help. You would think that the pharmaceutical industry would have jumped at the chance to establish a liaison with Wikipedia to help edit articles about their products. Did they?

"Leaky" Pharma Mobile Apps and the Brave New World of Big Data

I read with interest this morning a ProPublica/NY Times/Guardion story about how spy agencies - e.g., the National Security Agency - take advantage of "leaky" mobile apps to collect a range of data about users (see "Spy Agencies Probe Angry Birds and Other Apps for Personal Data").

According to ProPublica, the N.S.A. and Britain’s Government Communications Headquarters "have traded recipes for grabbing location and planning data when a target uses Google Maps, and for vacuuming up address books, buddy lists, phone logs and the geographic data embedded in photos when someone sends a post to the mobile versions of Facebook, Flickr, LinkedIn, Twitter and other services."

"Some personal data, developed in profiles by advertising companies, could be particularly sensitive," says ProPublica "A secret 2012 British intelligence document says that spies can scrub smartphone apps that contain details like a user’s 'political alignment' and sexual orientation."

Which leads me to wonder: What kinds of data can "leak" from Pharma mobile apps and who besides spies are likely to "scrub" pharma apps for these data?

DTC Melee–a-Trois: Pradaxa, Xarelto, and Eliquis. Women Only Marginally Involved.

Why does it always seem that pharma direct-to-consumer (DTC) advertising competition for market share comes in threes, or as I like to say, "DTC Melee-a-Trois"?

Click on image for larger version.

Last year around this time, I wrote about three companies competing for diabetes market share (here). The diabetes drugs squaring off in that melee were Januvia, Onglyza, and Victoza. To win over consumers, each implemented an online content marketing campaign that featured recipes from celebrity chefs.

My thought at the time was that none of the drugs had an efficacy advantage, so each had to engage in a battle reminiscent of Food Network's Iron Chef.

Today, I read about Pradaxa, Xarelto, and Eliquis, which are fighting for a share of the atrial fibrillation (AFib) market (see "The Warfarin Replacement Ad Fight").

Unlike diabetes, AFib cannot be mitigated via change in lifestyle. Therefore, there isn't much opportunity in this therapeutic area to engage in any kind of popular content marketing. There's only so much content you can create and curate that is relevant to AFib.

So how are marketers at Boehringer, Janssen (J&J), and BMS positioning their respective expensive anti-AFib Rx drugs -- Pradaxa, Xarelto, and Eliquis, respectively  -- to compete with warfarin -- an inexpensive generic drug?

Johnson and Johnson Out Ranks All Other Pharma Companies in Social Media Engagement, According to IMS

According to a new report released today by the IMS Institute for Healthcare Informatics, nearly half of pharmaceutical companies are now actively using social media -- specifically Facebook, Twitter and YouTube -- to "engage with patients on healthcare-related topics" (see press release here).

Before those of you who see the glass half full get too excited, however, IMS points out that only ten companies utilize all three of these major social networking services for healthcare topics. "Many companies are using social media primarily as a unilateral broadcasting channel to physicians and patients, with limited interaction or fostering of discussion," says IMS.

These results are based on the IMS Health Social Media Engagement Index, which assesses reach, based on the total number of individuals exposed to a message via likes, shares or re-tweets; relevance, the degree that content is found useful and shared across social networks; and relationship, the level of direct interaction around specific content.

"Smaller manufacturers with narrower therapeutic focuses -- UCB, Boehringer Ingelheim and Novo Nordisk -- and consumer health companies typically have the highest levels of social media patient engagement," notes IMS.

According to the data shown in the above table, Johnson and Johnson is by far the most socially engaged pharma company. Its overall Engagement Index is 70, which is almost 3 times GSK's second-highest score of of 25!

How is it that J&J's score is so far and away above the others?

"Pfizer Meds for iPhone": A Useful Mobile App, Except for One Problem...

There are over 2,500 posts from various sources in the "Mobile Health and Pharma Applications" Forum. Most of these originate from POCKET.MD, which is the world's "first and only free online service focused exclusively on providing the most comprehensive directory of mobile applications created by healthcare companies for medical professionals, patients, caregivers, and consumers." POCKET.MD is created, owned, and operated by Fabio Gratton, aka @skypen on Twitter.

Every day I get notified of new posts about pharma apps. Today, for example, I learned of "Pfizer Meds for iPhone," which is an app designed for people taking Pfizer prescription medications.

"By simply scanning or entering the barcode on your prescription medicine pack," says the app description on iTunes (here), "you will be able to access helpful information about your medicine and/or medical condition."

Other useful features include:

• Hear the name of your Pfizer prescription medicine and for some medicines, other helpful information
• Watch videos and read information that may help you understand how to correctly take or use your Pfizer prescription medicine and/or better understand your medical condition
• Set reminders to take your Pfizer prescription medicine as instructed by your doctor 
• Keep a log of your Pfizer prescription medicines 
• Access the current Consumer Medicine Information for your Pfizer prescription medicine

This sounds like a great app that would help patients adhere to their treatment. If I were taking a Pfizer med, I would like to have this app.

There's just one problem…

The New MedAdNews Will Focus on Old School "Narcissistic Advertising"

This is the week of "sort of's."

First, FDA published draft guidelines that "sort of" fulfilled the requirements of Section 1121 of the Food and Drug Administration Safety and Innovation Act (see "FDA Says It Has & Will Release Bits and Pieces of Long-Awaited Social Media Guidance Before July 2014 Deadline").

Then, it was announced that MedAdNews would return, "sort of" (see "MedAdNews Lives Another Day!").

As reported by MM&M—a competitor of the "old" MedAdNews—"rather than its usual monthly format, the magazine will publish two issues a year—the October Top-50 Pharma Company issue and April's Annual Healthcare Communications Agency issue. Both are big reference editions. The award show, “The Manny Awards,” now in its 25th year, is also returning, according to the announcement."

Speaking of format, the magazine will retain its large broadsheet print format. This was according to Daniel Becker, formerly brand director of MedAdNews, and now founder of Outcomes LLC, which is the new owner.

Why keep the larger-than-life and expensive print format? Why not go all digital?

FDA Says It Has & Will Release Bits and Pieces of Long-Awaited Social Media Guidance Before July 2014 Deadline

I just got off the phone with Stephen King, a Public Affairs Specialist at FDA's Center for Drug Evaluation and Research (CDER), who confirmed that the recently released draft guidance on "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics" (see here) is actually PART of the long-awaited guidance that was promised after the 2009 public hearing and required by section 1121 of the Prescription Drug User Fee Act (PDUFA).

According to King, it is the just the first of several additional social media guidances that FDA plans to release before the July 9, 2014 deadline.

Recall that section 1121 states: "Not later than 2 years after the date of enactment, FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA" (see here).

"The new guidance that just came out actually addresses some sections of 1121," said King. "However, we're planning on issuing additional guidances before July. It will be in several different parts, but it will all come together before the July deadline. This is just the first little piece."

According to King, CDER plans to publish in the Federal Register its "Guidance Agenda" by the end of January. "That will give you an idea of how many documents that will be coming out addressing social media," said King.

So, my apologies to @pharmaguapa -- it seems like the right time to "pop open the bubbly!"

UPDATE (3 FEB 2014): "FDA's 2014 Social Media Guidance Agenda Published: Space Limitation, Correcting Third Party Misinformation, & Use of Links Included"

Analysis of FDA's Draft Guidance Relating to Postmarketing Submission of Interactive Promotional Media

The FDA just issued "Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics."

You can find it here.

"This draft guidance describes FDA’s current thinking on what the Agency considers to be interactive promotional media and outlines the considerations taken into account in determining if product communications using interactive technologies are subject to FDA’s postmarketing submission requirements. Furthermore, this draft guidance provides FDA’s recommendations for how firms can fulfill the regulatory requirement to submit postmarketing promotional materials to the FDA in a practical manner to address the potential volume of real-time information that is continuously posted and shared through various interactive promotional media platforms."

Usually, drug companies must submit every promotional piece -- print ad, TV ad, or drug.com web page -- to the FDA at the time of "initial dissemination" (e.g., when the TV ad first airs). "However," says FDA, "for some interactive promotional media, submission 'at the time of initial dissemination' may pose a challenge for firms, particularly when these media communicate information that is displayed in real time."

This may sound like the much-anticipated guidance for how the FDA will regulate drug promotion on the Internet and social media sites, but it really describes when and how pharma companies should submit forms to the FDA to fulfill regulatory requirements for post marketing submissions. Nevertheless, it does give us some insight into FDA's thinking about how it intends to regulate interactive promotions

I'll just summarize what I consider to be a few interesting comments made in this draft guidance.

What Makes a "Memorable" DTC Ad? The Restasis Case Study

Back in 2005, when then Senate Majority Leader Bill Frist (R-TN) called upon the drug industry to impose a two-year moratorium on drug advertising, he pointed out that all Americans remember these ads because "we've heard them over … and over … and over again" (see "To Ban or Not to Ban DTC, That is the Question").

One drug ad -- for Restasis -- has made it to Nielsen's "Top 10" Memorable ads in 2013 (see here).

To determine the most memorable new ads (aired from January 1, 2013 through November 30, 2013), Nielsen determines a "memorability score," which is the percent of viewers able to remember the ad and correct brand.

The "new thing" pharma marketers are enthusiastic about these days is "telling a story" that viewers relate to.  But is the success of the Restasis ad campaign due to story telling or to repetition?

Is FDA Seeking NSA Capabilities?

As reported by @AlecGaffney in Regulatory Focus (here), the "US Food and Drug Administration (FDA) recently issued a notice indicating that it is seeking the services of a company to help it monitor online sentiment, keep abreast of social media conversations and even determine 'influencers' to better target its outreach."

It's interesting that the FDA seems to think social media is very important for conducting and monitoring its communications with consumers and healthcare professionals, but has problems issuing guidance to help the pharmaceutical industry do the same. In this respect, I agree with Republican Tom Coburn (R-OK), who said "maybe federal agencies should take some time away from figuring out what people think about them and spend more time just doing their job."

Here's a summary of what the FDA is looking to accomplish by hiring an outside agency (before spending millions hiring an external agency, however, FDA should contact the National Security Agency, aka the NSA):