Friday, December 21, 2012

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Wednesday, November 14, 2012

Modern Modular Buildings

Modular Buildings create space on the premises and in the budget as they are cheaper than fixed buildings and serve the same purposes. The multiple prefabricated wall sections are called modules and the area of the modular building is determined by the number and size of the modules. These modules allow ease of assembly and quick installation for a novice and a professional. These structures gained popularity as schools expanded and required space for laboratories, sewing classes, woodwork rooms and after-school care. The pre-engineered buildings could no longer cater for the masses and people were looking for a cheaper way to expand than fixed buildings that would be costly and take too long to build. The building sounds of hammers and drilling would disrupt the peace and distract students, so these modular relocatable buildings were constructed off site and delivered to the school or assembled in the parking lot. Apart from the noise, building also causes mess and the labourers are noisy when they are in group and there is inadequate supervision. Most of the construction occurs at the factory and this makes deadlines easier to adhere to and it is more convenient for the client without the noise and hassle. Buildings can even be customised and the floor plan is agreed by client and designer.

Building that can switch.

When you get duty to work beyond city you will hard to move house and build new house. Actually it will not happen if you have portable home. Home relocatable buildings and allows you to carry your house everywhere. You need not buy more to build your home.

Monday, November 12, 2012

Public Citizen Tracks "Bad Pharma" Financial Settlements

Public Citizen, the citizen "watch dog" group, has documented all major financial settlements and court judgments between pharmaceutical manufacturers and the federal and state governments since 1991. Its latest report (here) covers the time frame from its last report (November 2, 2010) through July 18, 2012. According to this latest report:
"A total of 74 additional settlements, totaling $10.2 billion in financial penalties, were reached between the federal and state governments and pharmaceutical manufacturers between November 2, 2010 and July 18, 2012, with the first half of 2012 alone already representing a record year for both federal ($5.0 billion) and state ($1.6 billion) financial recoveries. Since 1991, a total of 239 settlements, for $30.2 billion, have now been reached (through July 18, 2012) between federal and state governments and pharmaceutical companies."
The following chart shows the yearly trend since 1991:

These data include Federal and State settlements. Between November 2, 2010 and July 18, 2012, state settlements were $2.5 billion vs. Federal settlements totaling $7.7 billion. "2012 already represents a record year for state financial recoveries," says Public Citizen,  which notes that this 2012 state windfall was "largely due to a single court judgment in Arkansas in 2012 that required Johnson & Johnson to pay the state $1.2 billion for the unlawful promotion of the antipsychotic Risperdal. To our knowledge, as of the publication of this report, the company has not yet paid the fine and plans to appeal the judgment." Hopefully, JNJ will eventually pay up and help AK balance its budget and then some!

I created the following pie chart showing which types of penalties were responsible for generating these massive Federal and State settlement amounts:

"Unlawful Promotion" -- off-label and other "deceptive" marketing practices -- represents largest slice of the pie. This is probably a low estimate because the category "multiple violations" must also include unlawful marketing violations. If only 25% of these were marketing related, then "Unlawful Promotion" would account for the MAJORITY of settlement fees.

The following table shows the TOP TEN settlements between November 2, 2010 and July 18, 2012:

Congrats to GSK for being at the top of the list!

One other piece of information I found interesting is that "qui tam" cases involving "whistle blowers" account for the vast majority of the financial settlements in recent years. In terms of percent of the settlement dollar amount, here's how it looks for the past few years:

  • 2009: 96%
  • 2010: 97%
  • 2011: 33%
  • 2012: 90% (through July 18)

Whistle blower cases in 2011 didn't result in big financial settlements; consequently, 2011 was a "down" year overall.

Happy Anniversary! First Ever Pharmaguy Social Media Procrastinator Award Goes to...

Today is the third anniversary of the first day of the 2-day November 2009, FDA public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here, here, and here).

Shortly after that hearing, some FDA staffers lead us to believe that FDA would come out with social media regulatory guidance for the pharma industry by the end of 2010 (see here). That never happened.

Instead, FDA kept procrastinating and throwing roadblocks in the way such as proposing further studies (see, for example, "FDA's Proposed Web Study Will Further Delay Social Media Guidelines").

Meanwhile, to add insult to injury, Tom Abrams, head of FDA's DDMAC (now OPDP), keeps showing up at industry meetings where industry leaders were expecting him to announce progress towards issuing draft guidance. At one such meeting in February, 2011, Abrams spent a scant 4 minutes discussing social media guidance (read this). At that meeting, he said FDA would NOT "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter. Those things are really big now, but you know what, two years from now who knows what the next thing [will be]?" Well, guess what? It's almost two years later and YouTube, Facebook, and Twitter are still BIG, if not BIGGER and nothing has come along that's bigger. [BTW, Abrams also pooh-poohed Groupon, which now seems prophetic! And Google eliminated sidewiki, which was a big concern at the 2009 public hearing (read this).]

In recognition of the role Abrams has played in all this procrastination regarding social media guidance from FDA, I hereby present to Abrams the first ever Pharmaguy Social Media Procrastination AwardTM.

This award, as you may notice, is the antithesis to the famous Pharmaguy Social Media Pioneer Award, which was recently given to the sanofi US diabetes team (see here).

The iconic Hawaiian shirt in the "Procrastinator Award" is dark, symbolizing the negative implications of procrastination versus the bright yellow, positive Hawaiian shirt image used in the "Pioneer Award."

Abrams continues to show up at industry meetings promising that social media guidance is a high priority at FDA and it will be coming soon -- perhaps as "soon" as July, 2014 (see here). Yet, we've heard it all before. That's why I think it is fitting that Abrams receive the the "Procrastinator Award."

If Abrams lives up to his latest promise -- which is doubtful, IMHO -- it would have taken the FDA only 4 years and 8 months to issue draft social media guidance. In terms of Internet/social media timeframes -- in which 2 years can bring BIG changes -- this is procrastination on an epic scale. But in terms of FDA guidance timeframes, 4 years and 8 months is par for the course (see, for example, "A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon").

Saturday, November 10, 2012

Mobile Apps vs. Mobile Optimization: Which Offers Pharma the Best ROI?

According to the "Mobile Health 2012" survey on the use of cellphones for healthcare that was just been released by the Pew Internet and American Life Project, "half of smartphone owners use their devices to get health information and one-fifth of smartphone owners have health apps."

Pharmaceutical marketers who wear "rosy glasses" may take away from that top line synopsis, which appears as the subtitle of the survey report (find it here), that it is time to develop Rx branded health apps -- such as adherence reminders -- for consumers. But if you look more deeply into the survey results, which I am sure you will do after reading this, you will find that only about 9% of U.S. Adults over the age of 18 (19% of the 45% of smartphone owners) "happen to have" apps that help them track or manage their health. Keep in mind that "having" does not equate to "using." We know from other surveys that the majority of these apps may have been used just a few times and then forgotten.

Also, 81% of those 9% have health apps for:
  • Exercise, fitness, pedometer or heart rate monitoring (includes specific types of exercise like running, ab workouts, yoga, etc.) - 38%
  • Diet, food, calorie counter - 31%
  • Weight - 12%
Other "uses" include "period or menstrual cycle" (7%), "blood pressure" (5%), and WebMD (4%).

So, on the one hand we have these disappointing numbers regarding mobile health apps. On the other hand, however, PEW reports that "in 2010, when the same percentage of U.S. adults owned cell phones, 17% of cell phone owners reported using their phones to access health information. Today, that number stands at 31%, almost double the previous figure." That's 31% of 85% of all U.S. adults over the age of 18, or 26% of all adults!

"Access health information" more or less refers to using the browser on the smartphone to access plain old web sites. IMHO, this means that drug companies would be better off optimizing their Web sites for mobile access than putting money into the development, distribution, and support of "apps." And, according to Klick Health, which is in the business of optimizing Web sites for mobile, "Google recently reported that 1 in 5 searches on Google are now from a mobile device. [Google] also asserted that ranking priority within mobile search results will be given to sites that are mobile optimized. This further underlines the need to ensure your website is optimized for mobile." For some interesting statistics from Google, see "Mobile-friendly sites turn visitors into customers."

"Sadly," reported Michael Maher, Senior Vice President of Marketing at Digitas Health (here), "a 2011 Mediapost audit showed just 19% of pharma sites are mobile-optimized, and Google estimates only slightly higher at 21%." A Digitas Health December 2011 survey found that of the top 25 pharmaceutical brands of 2010, only three had mobile websites specifically built to display on mobile browsers.

I wonder if the situation viz-a-viz pharma Web site mobile optimization has improved much in the last year.

Thursday, November 8, 2012

Will FDASIA Get FDA Off Its Butt to Finally Issue Social Media Guidance?

I noted with interest the headline in today's FDA News email: "OPDP: Social Media Guidance Will Be High Priority in 2013"." Here's the teaser copy that explains what's going one:
"The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says. Abrams outlined the offices priorities at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C. The social media guidance is of critical importance because the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates the agency produce the guidance by July 9, 2014."
I have three comments regarding this:
  1. I reported back in July 2012 (here), about a little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act", which was signed into law by president Obama on July 10, 2012. This provision simply states: "Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."

  2. This is NOT the FIRST time Abrams has promised that social media guidance was a "priority." At the November, 2009, FDA public hearings on social media, Abrams said he heard "loud and clear from folks in this room" (ie, pharma companies) that "we want guidance on social media... We heard that message. Let me tell you that we are devoting a lot of resources and effort to this" (read this: "Is It Time for Abrams to Leave?").

  3. Although it's nice that Abrams says social media guidance will be "at the top" of FDA's work plan for 2013, I wonder why it was REMOVED from the published work calendar as far back as 2011 (read this: "FDA Drops Social Media from Its 2011 Guidance Agenda").
So, will Abrams keep his promise this time? Pardon me for being a doubting Thomas. You think a "do nothing" Congress that's facing a "fiscal cliff" will spend any energy to make sure the above "provision" is adhered to by the FDA? I said it before and I'll say it again now: If FDA misses the deadline set by FDASIA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

Wednesday, November 7, 2012

Sanofi Accepts Pharmaguy's Social Media Pioneer Award

A few weeks ago -- before hurricane Sandy disrupted life as we know here on the east coast -- I presented the coveted bright yellow Hawaiian shirt/Pharmaguy Social Media Pioneer Award to Dennis Urbaniak, VP, Joan Mikardos, Senior Director, and Laura Kolodjesji, Senoir Manager, Patient Solutions, at Sanofi US Diabetes (see "Dennis Urbaniak, Joan Mikardos, and Laura Kolodjeski of Sanofi US Receive the 3rd PharmaGuy Social Media Pioneer Award").

Unfortunately, Dennis, Joan, and Laura were not available to accept the award personally. Since we're all into "non-personal" communication via email and YouTube, I am happy to post the following award "acceptance" video that Joan and Laura made at their New Jersey-based sanofi Hawaiian set (I am amazed that they found Hawaiian Leis for props!). Too bad that Dennis could not be there with Joan and Laura to strum on his Ukulele :-(

Tuesday, November 6, 2012

Pharma Testimonial Videos Overstate Efficacy More Often Than Other Ads

Mark Senak over at Eye On FDA Blog has analyzed 235 Warning Letters (WLs) and Notice of Violation (NOVs) letters issued by FDA's Office of Pharmaceutical Drug Promotion (OPDP) since 2005. He cataloged 600 violations, including:

  • risk omission or minimization, 
  • superiority claims, 
  • overstatement of efficacy, 
  • unsubstantiated claims and
  • broadening of indication

When Senak specifically looked at letters regarding pharma marketing videos (excluding TV DTC ad videos), he found that 80% of the violations concerned risk minimization (40%) or overstatement of efficacy (40%). Below is the remake of his pie chart of these data (for the original data see "Viewing Video’s Regulatory Profile").

What's interesting is that these videos -- mostly patient and physician testimonials -- overstate efficacy at TWICE the average for all kinds of promotions (40% for videos vs. 21% for all ads, including video). Senak postulates that "when people talk about their own experiences with a treatment, [they] may include reference to outcomes that is not typical or supported by clinical data."

An example of a video that overstated efficacy was a video testimonial featuring Ty Pennington posted on by Shire. FDA said "Both the webpage and video overstate the efficacy of Adderall XR; the video also omits important information regarding the risks associated with Adderall XR use."

The problem with FDA letters is they usually are sent well after the cow has walked through the open barn door! See, for example, "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!"

Monday, November 5, 2012

Survey: Should PhRMA Issue Mobile Health App Guiding Principles?

In February, 2012, in a blog post provocatively titled "An App for That, But For How Much Longer?", PhRMA's Kate Connors agreed with a Washington Times op-ed piece that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. In my own blog post, I cited this post as "FDA Mobile Regulatory Fear Mongering." You can read my blog post (here) to see why or you can read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.

More recently, I suggested that The Best Defense Against Zealous FDA Regulation is Self-Regulation (see "My POV Regarding Regulation of Pharma Mobile Medical Apps").

This survey asks your opinion regarding several issues faced by pharma companies when developing mobile applications (apps) for physicians and consumersI wonder how many people feel as I do. So, I posted the Regulation of Pharma Health Apps Survey to find out (see the survey embedded at the end of this post). This survey asks your opinion regarding several issues faced by pharma companies when developing mobile applications (apps) for physicians and consumers. Issues include impact of regulation by FDA, privacy, trust, accuracy, and 3rd-party certification as well as industry self-regulatory guidelines.

I recently interviewed Happtique CEO Ben Chodor who said "There are tens of thousands of medical, health and fitness apps on the market and their sheer number makes it difficult for health care professionals and consumers to locate apps that operate reliably, are based on valid information, and safeguard users' information" (listen to the podcast: "Taming the 'Wild West' of Mobile Health").

Sooner or later, IMHO, Congress is going to be investigating mobile health apps to see if further regulations -- not just FDA regulations -- are required. IMHO, the pharmaceutical industry (i.e., PhRMA) should differentiate itself from the "wild west" developers by being pro-active in issuing Guidelines for Mobile Health Apps Developed by the Pharmaceutical Industry in much the same manner as it developed other self-regulatory guidelines such as the DTC Guiding Principles and the Code on Interactions With Healthcare Professionals. However, this time, PhRMA should act BEFORE Congress or the FDA takes the first step!

What Do You Think?

The Regulation of Pharma Health Apps Survey asks whether or not you agree that it is in the drug industry's best interest to police itself and develop best practices or self-regulatory guidelines for developing trustworthy health/medical apps for consumers and physicians.

It also asks if you agree or disagree with the following statements:
  • Apps must include full disclosure regarding the company that has created the app or the sponsoring pharma company. This includes contact information. BRANDED apps MUST include ISI (important safety information) up front in an easily accessible manner (e.g., on start-up screen).
  • Apps that are BRANDED (i.e., mention drug brand names) must be available ONLY from the appropriate U.S. app site (e.g., Apple App Store) even if all the FDA-required ISI (important safety information) is included.
  • Apps intended to be used by healthcare professionals in the U.S. must be HIPAA compliant.
  • If an app collects personal information, it should include a privacy policy that explains how such data is protected (security), who owns the data, how users can access the data, where data is stored (on device or on remote web site) and instructions for opting out of data collection.
  • The pharmaceutical industry has to police itself with regard to development of all health apps regardless of what regulations FDA may impose.
  • The app should include appropriate disclaimers and terms of use that the user MUST agree to before the app will run.
  • All health/medical apps should be certified by third parties such as Happtique.
  • If an app relies on algorithms or formulas, it must be validated through rigorous testing and documentation to ensure it works properly (i.e,. calculations are correct).
Please take a few minutes to respond to this survey here. The summary of results will be published in a future issue of Pharma Marketing News. You may remain anonymous or you may provide your name and contact information if you wish to be quoted in the published summary. If so, I may contact you for more details and allow you to review your responses prior to publication.

Friday, November 2, 2012

Rodale's Study Cites My Estimate Regarding DTC Ad Spending; I'm Flattered, But...

My friend Richard Meyer over at World of DTC Marketing Blog posted some key findings and charts from the 2012 Rodale DTC Study (see "A new era for DTC marketing").

There's a lot of interesting data in that study, but I will focus on one chart that documents DTC (direct to consumer) ad spending by the pharmaceutical industry from 1997 through 2012. Here is the chart:

I noticed that the "DTC Ad Spend" data (top line) looked familiar. Sure enough, when I searched through my Pinterest "Charts & Data" board, I found a chart that I created back in April 2012 (see "Lipitor Holds Key to DTC Ad Spending in 2012"; the chart is shown below):

All the numbers regarding DTC Ad Spending are the same in the two charts. In other words, Rodale copied my data to the "penny," but did not credit me as the source. In fact, Rodale did not cite any third party as the source!

OK, I didn't get credit. Big deal. I'm not complaining because I didn't get my 15 minutes of fame. The problem is that my original post did cite the source of my data and the last two columns (for 2011 and 2012) were estimates based on a few assumptions. Here's what I said:
"This chart actually plots measured media data (excluding Internet display and search advertising) through 2010 from AdAge, which got the data from TNS Health. I calculated the 2011 total based on the 1% decrease reported by Nielsen (sorry, I don't have TNS data for 2011).  
"The final bar of the chart is my estimate for 2012, which is based on the premise that DTC ad spending for Lipitor will be less than half of what it was in 2011."
So, thank you Rodale for repeating my estimated data for 2011 and 2012, but you should have included the above information about how those estimates were calculated!

P.S. BTW, it is possible -- but not probable -- that my estimates were right on and the Rodale chart is based 100% on new data from AdAge/TNS/Nielsen.

Thursday, November 1, 2012

FDA's "Mobile Medical Apps" Scope of Oversight Pyramid: Confusion Abounds

"Consider the 'Mobile medical apps Proposed Scope for Oversight' issued by CDRH [FDA's Center for Devices and Radiological Health]," said DrugWonk Peter Pitts (here). "It’s a pyramid divided into three parts":

Pitts describes these parts of the pyramid:
  1. The top of the pyramid includes mobile medical apps that are traditional medical devices or a part or an extension of a traditional medical device. Clearly within the scope of being regulated as medical devices. 
  2. The middle section includes patient self- management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by CDRH, for enforcement discretion 
  3. The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.
So, FDA has reserved the term "Mobile Medical App" (MMA) to mean a medical app that meets its medical "device" definition. From now on I will have to be careful NOT to use that term/phrase when talking about mobile apps that clearly are NOT medical devices. I guess we should use "Mobile Health Apps" instead.

I notice that many reporters and drug industry people refer to "mobile medical apps" when describing apps that are CLEARLY at the bottom of CDRH's pyramid. An example is the article titled "11 Super Mobile Medical Apps" that offers these examples of apps, which clearly should NOT be called MMAs:
"Among the innovative mobile medical apps we found is one that lets doctors use interactive diagrams to show patients what's happening with their bodies, where procedures will be done, and exactly what will happen during different procedures. Alternatively, patients can use this app to get doctors to provide detailed visual answers to their questions."
Unfortunately,  FDA's co-optation of "mobile medical app" to refer to health apps requiring regulation as medical devices confuses the discussion, which up until now used the term to describe any health-related app that a physician or patient might use. This may be why PhRMA and other drug industry spokespeople are so fearful of FDA regulations hampering innovation within the "mobile health app" arena (see, for example, "FDA Mobile Regulatory Fear Mongering by PhRMA").

Monday, October 29, 2012

My POV Regarding Regulation of Pharma Mobile Medical Apps

The pharmaceutical industry has to police itself with regard to development of medical apps. There has to be good documentation of the testing of apps to ensure their correctness.

That's the summary of my point of view (POV) regarding the pharma HOTSPOT topic: "Should Pharma reconsider its mobile application approach with FDA guidance looming?" See the annotated video below:

A "counterpoint" was offered by Dr. Chetan Vijayvergia, PhD, Director of Medical Strategy, Ignite Health, on Ignite Health's Pharma HOTSPOT web site. Dr. Vijayvergia's point was "The apps that are currently being created in the Pharma space don’t have a predicate in the FDA database. Pharma needs to reconsider the mobile approach to actively help the FDA shape industry guidance" (see here).

Vijayvergia contends that the current FDA draft guidance for MMAs "casts a very wide net" and if pharma app developers are not careful, their apps can get "dinged as an MMA [mobile medical application]" and be subject to regulation as a medical device.

The fear that FDA is casting too "wide a net" over MMAs was first expressed by PhRMA (see "FDA Mobile Regulatory Fear Mongering by PhRMA"). IMHO, the FDA was pretty clear about staying away from most health-related apps aimed at consumers such as diet apps, etc.

The Best Defense Against Zealous FDA Regulation is Self-Regulation!

In addition to offering FDA its POV regarding what is and what is not a MMA subject to medical device regulation, the pharma industry, IMHO, should begin policing itself to develop MMAs that comply with standards such as Happtique's App Certification Program; listen to this podcast regarding that:

Listen to internet radio with Pharmaguy on Blog Talk Radio

You may also enjoy reading these previous posts regarding pharma mobile medical apps:

Wednesday, October 24, 2012

Big Pharma Places Its Money on Romney to Win the Election

Here's an update on the political contributions of the health/pharmaceutical industry according to the Center for Responsive Politics.

To date, the total contributions - based on contributions from PACs, soft money donors, and individuals giving $200 or more - is $13,782,133, which is up by about 16% from the $12 million reported in August (see "Is Pharma Republican or Democrat? Follow the Money & Find Out"). 58% of that went to Republicans and 42% went to Democrats. In the 2008 election, it was 51% vs. 49%, Republicans vs. Democrats.

Can it be said that "As goes Big Pharma, so goes America?" Time will tell. But if money is the determining factor, Obama is destined to be a one-term president.

Here are updated charts with details about the donations of the top 20 pharma contributors (click here for source):

To make it easier to see which pharma company employees/PACs are "Republican" and which are "Democrat," I prepared this chart from the table above (click on image for an enlarged view).

There are several decidedly "Republicans" in the Big Pharma group, including Abbott, Astrazeneca, and Eli Lilly and a few so-so "Democrats": Pfizer, Amgen, and Merck.

Tuesday, October 23, 2012

Physicians Prefer Gated Social Media Communities

Research sponsored by Pfizer and published last month in the Journal of Medical Internet Research, found that over 70% of physicians surveyed (N=485) are either "current users" (52%) or "likely/very likely" users (19%) of "restricted online communities" (such as Sermo). In this case, "use" means sharing medical information and staying up to date professionally. The following chart is a remake of Figure 2 from that study (find it here).

Wikipedia is the next closest "social media" site used by these docs (186 oncologists and 299 primary care physicians) -- only 25% of surveyed physicians said they are current users of Wikipedia. As for YouTube, 23% of surveyed docs said they were current users.

This survey was conducted in March 2011.

According to Manhattan Research’s Taking the Pulse® v11.0 study (May 2011), only about a third of all “digital” physicians (24% of all physicians) are using gated physician peer communities like Sermo, Medscape, DrConnect, PhysicianConnect, Ozmosis, etc.

Some experts, such as Bruce Grant, SVP of Strategic Services at Digitas Health, in the past have cited other, conflicting data that suggests physicians interested in using online peer-to-peer social communities outnumber by 2 to 1 physicians who are actually using them (see "Physician Participation in Peer-to-Peer Social Media Sites"; use discount code P2Pfree).

52% or 24%, whatever! The number of physicians using gated social media communities for professional purposes far exceeds the number of physicians using "open" communities such as Twitter or Facebook. Only 7% of surveyed physicians say they use Twitter in order to share medical information and stay up to date and 36% of said they either were not aware of Twitter (3%) or said they would never use Twitter (33%) for such purposes (another 50% said they were unlikely or not sure if they would use it)!

Meanwhile, the use of Twitter by patients/consumers seems to be on the rise. Twitter reports that tweets about health are up 51 percent this year (see "Twitter Courts Healthcare – But Cautiously").

It doesn't seem likely that physicians and their patients will ever communicate using social media. They just don't seem like birds willing to flock together on social media.

Wednesday, October 17, 2012

Dennis Urbaniak, Joan Mikardos, and Laura Kolodjeski of Sanofi US Receive the 3rd PharmaGuy Social Media Pioneer Award

PharmaGuy (aka John Mack) presented the coveted bright yellow Hawaiian shirt/Pharmaguy Social Media Pioneer Award to Dennis Urbaniak, VP, Joan Mikardos, Senior Director, and Laura Kolodjesji, Senoir Manager, Patient Solutions, at Sanofi US Diabetes. The award was made at the 6th Annual Digital Pharma East conference in Philadelphia on October 17, 2012. Accepting the award on behalf of the winners -- who could not make it in person -- was Wendy Blackburn of Intouch Solutions.

The Pharmaguy Social Media Pioneer Award is meant to recognize pioneers who work (or have recently worked) within regulated drug and device companies. The award recognizes courage in the face of regulatory and corporate culture road blocks!

This is the first time the award was given to a team of people rather than a single person. The first award went to Alex Butler (see here) and the second award went to Tony Jewell (see here).

I felt that this team deserved recognition because they didn't give up on social media even after a "disgruntled" patient caused Sanofi to shut down a Facebook page that did not have comments turned off (read about that here). Urbaniak et al learned a lot from this experience and shared what they learned (listen to this podcast: "What Sanofi-Aventis Learned from Its FaceBook Experience").

Urbaniak and Kolodjeski also received the greatest number of nominations in a poll I ran (see summary of results here). In comments, respondents to the poll described Urbaniak as "the most innovative guy in pharma" and said he "opened new ways of engaging with patients in the diabetes field, with courage and consistency." Kolodjeski was praised because "she keeps the patient at the center of all her efforts. She is a great example of how we should go about our business in Pharma."

My bad that I did not include Mikardos as a contender in the poll. When I informed Laura, Dennis, and Wendy -- who has worked closely with the Sanofi US diabetes business unit -- about the award, they informed me that Joan was also deserving for her contribution to the team's social media efforts.

What's With the Hawaiian Shirt?
Let me explain the Hawaiian shirt motif of the award. Around the time that the FDA announced it would hold a public hearing regarding regulation of pharma’s use of the Internet and social media, I started appearing at conferences in a yellow Hawaiian shirt, which was left over from a Hunter S. Thompson Halloween costume (see “Pharma Social Media Crips vs. Legal/Regulatory Bloods: Call for a ‘Peace’ Conference” for a sighting of me in the shirt at the 3rd Annual Digital Pharma East Conference). I also considered wearing the shirt when I made my presentation to the FDA at the November, 2009 meeting (see “Fear and Loathing in Washington, DC”), but out of respect for the FDA and the audience, I opted for a traditional suit and tie.

Although I didn’t wear my Hawaiian shirt at the FDA hearing, it became an emblem for standing out from the crowd, which is a necessary trait for a social media marketing pioneer. I think a Hawaiian shirt motif befits, therefore, what the Pharmaguy Pharma Social Media Pioneer Award stands for. Read more about the award here.

Is Online Pharma Promotion ROI Scalable?

Yesterday, at the 6th Annual Digital Pharma East conference here in Philadelphia, I met many "old" friends including Bill Drummy, CEO of HeartBeat Ideas.

Drummy's presentation had a long and complicated title -- "Outsize Results on Modest Budgets: Think You Can't Afford World-Class Marketing on Your Limited Budget? Think Again" -- but his message was simple: the ROI of online promotion is an order of magnitude greater than the "typical" 2:1 ROI for non-digital channel promotion.

"With digital you can get way more bang for your buck," said Drummy, "so you HAVE to think of the digital channel. If you have a real insight about your target, use really bold creative, and use a lot of precision targeting and pay-for-performance techniques, you can get dramatically higher and better results."

Drummy then said that ROI for digital ranges from 4:1 on the low end to high double digits on the high end. He's seen digital ROIs of about 29:1 in "a number of different cases." That's return on investment measured by increased sales, not surrogate key performance indicators like ad impressions, clicks and Facebook likes, etc.

Drummy didn't go into too much detail about how these ROI are measured, but he did show a blinded digital promotion case study (paid search and online display) where the ROI was about 5:1 (it was 13:1 for just paid search). The spend on that promotion was $32,000, I believe.

My question is this: Is this scalable to the point where digital promotion gives you a significant bump in sales?

A 5:1 ROI on a spend of $32,000 translates into $160,000 in additional sales. This is a small number as far as Rx sales go. A TV ad campaign spend of $100 million at 2:1 ROI results in $200 million in additional sales -- now we're talking about a real bump. At 5:1 ROI, how much money would you need to spend on search/display ads to realize a bump of $200 million? You would have to spend $40 million! I contend that it is impossible to spend that amount of money in one year on paid search and display advertising. And, if it was possible, would the ROI still be greater than the traditional, non-online ROI of 2:1?

If Drummy knows of a case to disprove this, I'd like to hear about it.

To be fair, Drummy was talking to companies with LIMITED budgets for promotion. In that case, there are probably limited sales opportunities as well. Therefore, putting your limited promotion budget into digital makes sense.

Drummy showed some examples of what he considered online campaigns that had "bold creative." I'll have more to say about this is a later post; right now, I have to get ready to have a chat with BI's John Pugh over coffee and bagels!

Monday, October 15, 2012

Rich Meyer: We Don't Need No Stinkin' Fair Balance! The One-Click Rule Revisited.

My friend Rich Meyer over at DTC Marketing Blog wrote an inflammatory-sounding post titled "Time to eliminate fair balance on DTC ads." With a title like that, this post is sure to be read by a lot of pharma marketing pundits.

But Meyer is not talking about TV or print drug ads directed at consumers. He specifically is referring to online direct-to-consumer (DTC) advertising:

"...fair balance online and in search makes no sense. Patients are not going to see an online ad or search copy without doing more research and the FDA needs to acknowledge this by revising guidelines."

Recall that in DTC advertising, fair balance refers to the presentation of accurate and fair assessment of the risks as well as the benefits of the drug (more here).

"DDMAC needs to come into the 21 century and provide guidelines that are realistic on how patients make healthcare decisions," says Meyer. "Too many online drug ads provide little in the way of benefits because there is so much fair balance. Does DDMAC and the FDA really believe that someone is going to see an ad for a prescription drug and ask their doctor about it without doing more research?"

It sounds like Meyer is urging the FDA to re-instate the "one-click rule," which the agency shot down in those famous 14 NOV letters in April, 2009. That would mean reversing itself and losing face. But wait! DDMAC no longer exists! It was reorganized as the Office of Prescription Drug Promotion (OPDP)! OPDP can reverse the old DDMAC (Division of Drug Marketing, Advertising and Communications) ruling on the one-click rule and the FDA won't lose face! Brilliant!

BTW, Meyer isn't alone in wishing the return of the one-click rule; see "Pharma Prefers '1-Click Rule' for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads" and "Merck Says FDA Should Approve the 'One-Click Rule'".

How Important is Pinterest for Pharma Marketers?

Fard Johnmar of Enspektos posted some data from his company's September 2012 digihealth pulse survey, which revealed that 30% of "active digital health consumers who use Pinterest encountered health and medical content" on that network (see infographic).

"What are the implications of this data?", asked Johnmar. "Well, a number of hospitals, pharmaceutical companies and other organizations are on the site. However, others are on the fence, wondering if experimenting is worth the effort. Our recommendation: The time for fence-sitting is over. It’s time to begin learning the ins and outs of Pinterest -- and how to develop and deliver credible and accurate health information via the platform."

I've been following pharma's use of Pinterest and have commented on this in previous posts and articles. See, for example, "What's Your Infographics Strategy?" (use discount code pgpin4 to get it free).

I have found Pinterest useful for "repurposing" graphics I create for blog posts and newsletter articles as well as for advertising. I hope that by doing this more people will learn about me, read my blog, and subscribe to my newsletter. All those key performance indicators (KPIs) help me determine what my Pinterest ROI is. I imagine that pharma marketers use similar KPIs to measure the effectiveness of Pinterest.

I've been surveying my new Twitter followers and asking them what other social networking applications they use. Pinterest is one of the choices. The bar chart below shows results from followers who responded to my survey between January 1, 2012, and today.

Pinterest is number 6 on the list -- 20% of my Twitter followers also use Pinterest. I'm not sure if they have Pinterest accounts or just look at the nice pictures.

Am I getting new readers and/or newsletter subscribers from Pinterest? To determine that, I looked at Google analytics for my blog and web site to see where referrals are coming from.

For the past 30 days, the top ten referring sites for Pharma Marketing Network include (in decreasing order of visits) Pharma Marketing Blog (ie, people clicking through on links such as the above link to a PMN article), LinkedIn, Google, Pharma Marketing Forums, and Twitter (ie, Pinterest is number 21 on the referral list and is NOT among the top 10 referral sites for Pharma Marketing Blog, whereas Twitter is number 6 on that list.

So, although I'm getting new followers on Pinterest and people are repinning my charts, etc., I'm not yet achieving my KPI goals for Pinterest -- i.e., driving traffic to my sites.

Could this be why the only pharma companies that I can find on Pinterest are Novo Nordisk (137 followers), Bayer (207 followers), and Boehringer Ingelheim (58 followers)?

I will interview Fard Johnmar on my BlogTalkRadio Show this Friday at 3:00 PM. For more information and to listen to this live podcast or the archive afterward, see "Discovering the Active Digital Health Consumer".

Saturday, October 13, 2012

Pharma Marketers Likely to Spend a Lot More on Patient Adherence Mobile Apps

US pharmaceutical companies’ patient adherence budget allocations have increased from $400,000 in 2009 to $1.5 million in 2012 -- a 281% jump. That is according to a patient adherence survey by Cutting Edge Information (here).

The Cutting Edge Information report includes the following chart, which shows the "Patient Outreach Activities Most Likely to Increase in the Next Five Years" according to surveys and interviews of pharma marketers:

So, as I read this chart, nearly 40% of pharma marketers agree that patient adherence activities involving mobile "apps" will increase over the next five years. It appears that the "app" category here includes sending text reminder messages to mobile phones as well as downloadable applications such as the the Care4Today mobile app that was developed and recently released by Janssen Healthcare Innovation (see here).

Currently, 11% of pharma's adherence budget is allocated to mobile "apps." A little more than half of that is dedicated to simply calling/texting mobile phones to remind patients to take their medications, according to a MEDCity News review of the report (here). In five years, it is projected that 33% of pharma's adherence budget will be allocated to mobile "apps." I predict that the lion's share of this -- maybe 75% -- will be allocated to apps like Care4Today with only a minor portion (25%) going to simple reminder text messaging.

If adherence budget allocations continue to increase on a pace similar to the recent past, US pharma companies may be spending nearly $3.3 billion on adherence by 2017 (i.e., the next five years). One third of that -- $1.1 billion -- may be dedicated to mobile "apps" (including simple text messaging) and 75% of that -- $825 million -- could be spent on other mobile apps like Care4Today.

Hopefully, this investment won't be wasted on mobile adherence apps that are EXACTLY like Care4Today, the main purpose of which may be promotion of products rather than promotion of adherence (see "Adherence - Do We Really Need an App for That? Benefits Do Not Outweigh the Risks").

Friday, October 12, 2012

This Ethics Guideline for Pharma CME Support is a Pile of Malarkey!

A news item from a small corner of the world (the Irish Times) caught my attention. "Doctors told not to accept trips from drug firms' is the headline.
"DOCTORS MAY no longer accept direct invitations from the pharmaceutical industry for trips to international medical meetings, funded by drug companies, following the clarification by the Medical Council of its ethics guidelines..." said the article. 
"While accepting that payment of travel and accommodation expenses for doctors to attend meetings, either as participants or speakers, supports the aim of continuing professional development, the updated guideline says 'these payments should go through unrestricted education and development funds made available by the sponsoring company to the institution which is hosting the meeting or the conference organiser'." 
"Unrestricted education and development funds are not linked to or controlled by the organisations that contribute to them and healthcare institutions can choose to spend the funds any way they see fit," the clarification says [my emphasis].
What a pile of malarkey!

Healthcare institutions theoretically can choose to spend the funds any way they see fit THE FIRST TIME AROUND. It's virtually a sure bet that if they choose NOT to pay speakers for travel, they
  1. won't have any speakers and/or 
  2. won't get funded again by the pharmaceutical sponsor.
This is what makes ethics so ineffective in the real world. If the goal -- as expressed by the "Council" -- is to ensure that doctors' "professional judgment is not affected by the hospitality" of pharma companies, then pharma-sponsored CME should be banned outright. Otherwise, stop putting lipstick on this pig!

Did Pharma Online Ad Spending Increase 50% in First Half of 2012?

"Entertainment, automotive, pharmaceutical and healthcare were the fastest growing vertical sectors for online advertising in the first half of the year, according to a new report from the Interactive Advertising Bureau" (IAB) reports ClickZ (here). The report (get it here) utilizes data and information reported directly to PwC by companies generating online / mobile advertising revenues, and publicly available corporate data. The following figure shows the online ad formats tracked and how much was spent on each in the first half of 2012 compared to the first half of 2011. Overall online ad spending was $17.0 billion in the first hlaf of 2012 compared to $14.9 billion in the first half of 2011 (a 14% increase).

Search accounted for 48% of the online ad spend and display-related advertising accounted for 33% (Display-related advertising includes Display/Banner Ads, Rich Media, Digital Video, and Sponsorship).

Here's the data comparing the total online ad spending by major industry category:

Online ad spending by "Pharma & Healthcare" increased by 50% (from 4% of the total to 6% of the total). Keep in mind that not all of this is specifically spending by the Rx drug industry because the category includes "pharmaceutical products, facilities, services, researchers, and biological products. Also comprises establishments providing healthcare and social assistance for individuals as well as personal care, toiletries, and cosmetic products."

6% of $17.0 billion is $1.02 billion. That could pan out to be more than $2 billion for the entire year -- again, not all of that will be spent by the Rx drug industry.

eMarketer has predicted that online ad spending by the health industry in 2012 will be $1.58 billion (see "Bogus Predictions of Pharma Industry Online Ad Spending"), which is significantly different than the IAB guesstimate 0f $2.04 billion based on the data for the first 6 months.

Why the difference? It could be that eMarketer is measuring something different. However, its 2011 number of $1.28 billion is virtually the same as what IAB said the healthcare industry spent online in 2011 (4% of $31.7 billion equals $1.27 billion).

$1.58 billion, $2.04 billion -- whatever. Pharma's share of that ad spend is probably 50% or $0.8 to $1.0 billion. Taking out the 48% attributed to search, we get $0.38 to $0.48 billion spent on other types of online advertising. This compares to about $4 billion pharma spends on all direct-to-consumer (DTC) advertising -- a number that does not include the online spending of any sort. In other words, online ad spending by pharma is still insignificant compared to offline ad spending.

Tuesday, October 9, 2012

It's Official: Doctors Prescribe Adderall to Help Kids Get Higher Grades at School

Dr. Michael Anderson, a pediatrician for many poor families in Cherokee County, north of Atlanta, routinely prescribes Adderall to kids who get poor grades in school. To do that, he first must commit fraud: submit a false diagnosis of attention deficit/hyperactivity disorder (ADHD) to Medicaid and/or private insurer.

The doctor admitted his fraudulent activity in a story published in today's New York Times (here). “I don’t have a whole lot of choice,” said Dr. Anderson. “We’ve decided as a society that it’s too expensive to modify the kid’s environment. So we have to modify the kid.”

He does this believing in his heart of hearts that ADHD is “made up.” His excuse? To prescribe the pills to treat what he considers the children’s true ill — poor academic performance in inadequate schools.
Dr. Anderson’s instinct, he said, is that of a “social justice thinker” who is “evening the scales a little bit.” He said that the children he sees with academic problems are essentially “mismatched with their environment” — square pegs chafing the round holes of public education. Because their families can rarely afford behavior-based therapies like tutoring and family counseling, he said, medication becomes the most reliable and pragmatic way to redirect the student toward success.
This is wrong on so many levels. For one thing, who made Dr. Anderson and other physicians who feel the same way judge and jury regarding what school is "adequate" or "inadequate"?

That, of course is not the main problem, which is prescribing a dangerous, additive drug to children who have no real medical need. This is clearly a case where a drug's benefit does not justify the risks that the patients are subject to. "Reported side effects of the drugs have included growth suppression, increased blood pressure and, in rare cases, psychotic episodes," says the NY Times.

Not mentioned by the Times is the dangers of addiction. ABC News recently ran a story documenting this problem: Dangers of Adderall Addiction Among Moms (see here or view the embedded video below).

If moms can become addicted to Adderall, their children can also become addicted. When they can no longer get Adderall, they will try other drugs easily available from physicians or on the street (see, for example,

This is so egregious that I must ask if Dr. Anderson has received payments from Shire Pharmaceuticals, which sells Adderall XR (the extended release version of Adderall, which Shire sold to Teva Pharmaceuticals). Unfortunately, Shire does not publicly disclose such payments. According to its compliance Web site (here), Shire only reports spending on HCPs (healthcare providers) to a "limited number of states as required by the individual state laws."

Related posts:

Monday, October 8, 2012

Psychiatry "Suicide" by Pharma

British psychiatrist and "Big Pharma gadfly" David Healy argued that his profession is “committing professional suicide” by failing to address its dangerously close relationship with the pharmaceutical industry. He made his argument speaking at an annual meeting of the American Psychiatric Association during a "well-attended session on conflicts of interest" according to this article.

Dr. Paul Appelbaum, a past president of the APA and director of Columbia’s Division of Law, Ethics and Psychiatry cited a study that showed "only 34% psychiatrists believe that receiving food or gifts affects their own prescribing patterns, 53% believe that it influences that of their colleagues... Research shows that this type of thinking — 'Everyone else is prone to biases and social factors, but not me'” — is common and confounds attempts to address conflicts.'At least some of our colleagues are wrong,' Appelbaum said drily of the study."

Healy offered some advice for how his profession can put some distance between it and the pharmaceutical industry.“The key issue in the short term is access to data. We have to insist on that,” he said. “We let industry come to our meetings and let them talk in our programs. I don’t think it’s huge problem that they get paid. The big problem is that if you ask for data, they can’t give it to you. That’s not science, that’s marketing masquerading as science.”

Daniel Carlat, M.D., director of the Pew Prescription Project, organized the session. Carlat once characterized pharma-sponsored Continuing Medical education (CME) as "a new twist on that well-known instrument of corruption, money laundering." Listen to the following podcast interview of Dr. Carlat on that issue:

Listen to internet radio with Pharmaguy on Blog Talk Radio

Friday, October 5, 2012

Who Has Actually Played BI's SYRUM Game? The Silence is Deafening!

During today's #hcsmeu chat session (see archive here) I asked "Truthfully - has any of my EU colleagues actually played SYRUM?"

There's been a lot of hype about Syrum previous to its launch by Boehringer Ingelheim (BI) in the EU (see here), but I've heard nothing post launch from anyone who has actually spent time playing the "game" (I'm told that it's not a form of "gamification").

"Who's the EU 'pharmaguy' who will take on this task and report back?", I asked.

Turns out that one person (Maria Öst, Sweden, aka @mariaatomaca) admitted she signed on to a beta account, but she didn't actually play the game. By signing on, Maria gave Syrum (and BI) permission to "post on [her] behalf" and "read [her] checkins" even if she does not play the game (see here).

According to @fision (Kai Gait, UK) Syrum opens "lots of potential opportunity in the future by accessing the interest graph of players" -- even if they don't actually play the game ("If a user doesn’t ‘disconnect’ the game, they [BI] still have access to data in theory," said @fision).

Felix Jackson (@felixjackson, UK, founder of medDigital) actually has played the game and said "I ... enjoyed it! I liked the way it showed me drug development." I thank Felix for taking the time to give me a live tour of the Syrum via Skype during which I saw a few peculiar things such as a masked avatar that looked like an Al Qaeda terrorist! I guess it was supposed to be a surgical mask. I've worked in a lab and I never saw anyone wear a mask. Maybe drug development labs are different.

One of the features of the game is that you can see friends on Facebook who have also signed on to play the game. You can "recruit" these friends to be members of your drug development team or you can collaborate with them. Unfortunately, none of Felix's FB friends -- including BI's John Pugh -- were able to collaborate with Felix because they didn't have any molecules under development (ie, they currently are not playing the game).

Meanwhile, Helen Harrison (@harrassedmom) alerted me to this "walk through" on YouTube:

By the time you read this, one or two other people I know on Twitter may tell me that they also have played Syrum. These people, however, are mostly like me -- not representative of Syrum's target audience, which is the general public. We won't know very much about how many of those people have signed on to play, how long they have played, etc., unless BI shares that information with us. That make take another 3 years -- I'll wait :-)

Wednesday, October 3, 2012

Shane Victorino: Adult ADHD Poster Boy

Adult ADHD (attention deficit/hyperactivity disorder) is the "next big thing" for pharma companies like Shire, which markets Vyvanse for the treatment of ADHD in adults. So says the author of a Salon article titled "Big Pharma’s newest invention: Adult ADHD."
“Immature adult market continues to offer greatest commercial potential,” read a 2008 press release to the pharmaceutical industry from the market research agency Datamonitor: “Estimated to be twice the size of the pediatric ADHD population, the highly prevalent, yet largely untapped, adult ADHD population continues to represent an attractive niche to target.”
So who might consider themselves part of this “untapped” market?

Well, former Philadelphia Phillies center fielder Shane Victorino for one. The "Flyin' Hawaiian" is now an adult ADHD celebrity spokesperson appearing in magazine ads like the one shown below and in video testimonials like the one you can find on

If you talk to people in the know, Victorino is an ideal adult ADHD "poster boy." I've heard that Victorino was a mile-a-minute talker and often people around him wished he'd shut up. In a Shire-sponsored YouTube video, Victorino himself admits "always interrupting" his teammates and having problems focusing.

Interestingly, Victorino doesn't mention Vyvanse. It's unclear, therefore, if he benefited from Shire's drug, which entered the market in 2007, about 8 years into Victorino's major league career and about the time that Victorino became a starting player for the Phillies.

So it's unclear if Vyvanse -- or any other medication -- helped Victorino play ball as well as he did for the Phillies. Some have speculated, however, that his constant talking and interruption of teammates was one reason why the Phillies traded him. Could the trade be part of a devious Phillies plot to insert a disruption agent within the ranks of a rival team?

I'm just kidding, of course. Like many Phillies fans, I like Victorino and wish hime the best.

Unlike some other pharma-paid celebrities, Victorino is not promoting a brand of drug, but promoting awareness of a medical condition. Some people -- like the Salon article author -- claim that ADHD awareness marketing is a form of "disease mongering," which causes more people to be diagnosed with the condition than is necessary. But that's a whole other issue that I don't have time to get into now. You can read about disease mongering here.

Thursday, September 27, 2012

"Gamification" (eg, Syrum) is Just Another Way for Pharma to Mine Our Personal Data and Wisdom

Everyone I know in Pharma Twitterdom is enamored by the launch of Boehringer Ingelheim's SYRUM FaceBook game, which is available ONLY to European FB users. BI says the game is "educational" for physicians and the public:
"The research driven pharmaceutical industry is immersed in education - whether aimed at medical or pharmaceutical professionals or providing information directly to the public," says John Pugh, Director of Digital at Boehringer Ingelheim. "Gaming is an experimental way for Boehringer Ingelheim to do this. The challenge is to do this in a truly engaging, educational and entertaining way that immerses the player."
Syrum allows players to create and run their own pharmaceutical company, using a virtual laboratory to discover and develop imaginary medicines to improve the health of the world.

But "educating" the public may be a minor goal of Syrum. It surely is not something that can be measured as a key performance indicator (KPI) to justify the years and money invested in developing this "game."

So how does BI justify investing all this time and money to develop a game if it cannot measure how better educated the public is about drug development?

I believe that Syrum is designed to educate BI and NOT to educate us. It's much easier for BI to measure how much better educated IT has become due to Syrum than to measure how much better I have become from playing the game.

What do I mean by BI being "educated" due to Syrum?

Firstly, BI requires everyone who plays the game to open up their FB information for access by the company.

I was able to access the game while in Spain recently. Before I could play the game, however, I had to agree to allow BI to gain access to practically everything I do on Facebook (see screen shot below).

This stopped me dead in my tracks. Perhaps this is a normal permission request for all FB apps, but I was loathe to "allow" this kind of access for a pharma company app. It seems that BI wants to do some market research about the people who opt in to play Syrum. This kind of data could be a valuable KPI for Syrum.
I must admit that I am mystified by FB. For example, what does "Post on my behalf" mean? Whatever it is, it doesn't sound good. "Reading my checkins" also does not sit well with me. 
I'm not the only one who doesn't use apps due to privacy concerns. More than half of mobile application users have uninstalled or avoided certain apps due to concerns about the way personal information is shared or collected by the app, according to a nationally representative telephone survey conducted by the Pew Research Center’s Internet & American Life Project (see "Privacy and Data Management on Mobile Devices"). What applies to mobile apps also applies to FB apps - maybe even more so given FB's bad rep viz-a-viz privacy (see for example: "How Facebook Plans On Using Your Prescription Drug Purchase History, And How To Stop Them").
Another way that Syrum can educate BI rather than educating us is by allowing BI to cash in on "crowdsourcing" WITHOUT financially compensating the crowd!

BI says it has steered clear of therapeutic areas it is involved with as potential areas of interest in the Syrum game, although it has left the door open to change that. Perhaps BI's objective is to test the social aspects of the game and access the "wisdom of the crowd" to help it develop new drugs.

The pharma industry seems ready -- even desperate -- for help from the crowd to develop new drugs. Ten top U.S. and European drugmakers -- including BI -- started a nonprofit organization, called TransCelerate BioPharma, to collaborate on the problem of developing new drugs (see here).

Meanahile, Lilly's Clinical Open Innovation believes that crowdsouring can help fix drug development, which it claims is "broken." Lilly believes that "Open Innovation models – focused on clinical drug development – can result in transformational gains in value-to-patients and efficiency. We also believe that open data, linked, crowdsourced, consumed and curated by experts outside (as well as inside) the walls of pharma will bring innovative insights and wisdom. And that open communities will set and meet objectives to reduce costs and improve outcomes" (see "OMG, LCOI! Open Source Pharma: Creative Commons Coming To Pharma").

Perhaps Syrum is a precursor to that kind of "collaboration" - what I call "semi-open access" drug research. This could be of tremendous educational as well as FINANCIAL benefit to BI. And all it costs is the price of developing a game with very little payback to the crowd other than "fun" and "engagement!" P.S. On KPI I forget to mention was ROI on PR. BI recently retweeted this tweet from the PM Society: "RT @PMSociety: How is PR ROI for Syrum being measured? 50 pieces of press just from launch party. Value in positioning of @Boehringer". 50 easy "pieces of press" -- some kind of "POP"!

Tuesday, September 11, 2012

Mirror Mirror on the Wall, Who's the Most Innovative of Them All? Pharma, Social Media Wise, That Is.

The pharmaceutical industry has consistently promoted itself as an "innovative industry" by which it means it discovers new, innovative drugs through research. No one ever claimed the drug industry was very innovative in marketing in general or in its use of social media. However, consultant and strategist Andrew Spong, just came close to doing that in a post titled "Innovation: the name of the game for Boehringer."

"By dint of the sheer weight of evidence that has accrued over the past three years alone," says Spong, "Boehringer Ingelheim may reasonably be identified as the pharma company that sets the pace for the industry in digital environments...Boehringer merits recognition as the digital leader in the pharma industry not because of what it has achieved, but because of what its activities say about the cultural evolution that has taken place within the company."

Spong and many others are lauding Boehringer's Facebook Syrum game based solely on hearsay evidence -- Syrum won't be officially released until September 13, 2012 (see "BI to Launch Beta Version of its Syrum FaceBook Game on September 13, 2012"). The "weight of evidence" comes almost exclusively from tweets, blog posts, and press releases written by BI PR people and John Pugh, BI's Director of Digital.

I doubt if Spong or any other laudatory commentator has actually played the game. If they did, I am sure they would have mentioned it and actually written something new about it.

I am not sure what kind of "cultural evolution" is going in within BI, but I know that the company has exhibited some PR and marketing behavior that regulatory agencies have frowned upon (see, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons"). This is not indicative of a cultural evolution in pharmaland.

Spong also mentions BI's "experiments with outré humour" and links to this "Famously Unpronounceable" YouTube video as an example.

Spong neglected to mention that the above video is NOT found on the official BI YouTube site, which no longer hosts the video in question. BI yanked it because of negative comments from industry commentators such as myself who are “slow to acknowledge its transformation” (see “BI’s Famously Unpronounceable Video Lives On!”).

With regard to the Syrum game, BI has been milking that for almost a year making it one of the more spectacular examples of “vaporware” I have ever seen (again not culturally evolved). BI, IMHO, would have been much better off sticking with real world exhibits (see “'A Drug is Developed:' Easier than Launching an Educational Facebook Game about Drug Development?").

Before you label me solely as a negative commentator, I offer you this: “Boehringer Ingelheim Shows How to Support Patients via Twitter and Beyond”.

Just like every pharma company, BI has its social media triumphs and failures – or “Trials & Tribulations” as I like to call them. See my latest Slideshare presentation on that here.

Saturday, September 8, 2012

States' Rights: Regulation Via Settlement

"I believe in states' rights.... I believe we have distorted the balance of our government today by giving powers that were never intended to be given in the Constitution to that federal establishment."

Ever since Ronald Reagan said he believed in "stats' rights" that has been the rallying cry of Republicans up to and including Romney-Ryan.

For pharmaceutical companies, however, states' rights to enforce some federal laws via litigation is a problem. Take for example, the the $181 million settlement reached August 29 between 36 attorneys general and Jannsen Pharmaceuticals (a Johnson and Johnson company). According to a Forbes contributor, this settlement "confirmed that state AGs must indeed be reckoned with on off-label issues. What will get medical product companies’ attention is not the financial settlement, though. The real eye-opener was the precision of the settlement’s conduct requirements, most notably one restraint on speech which goes beyond the dictates of federal law" (see State Attorneys General Step to the Fore on Off-Label Drug "Promotion").

Relating to the distribution of off-label information/reprints about Risperdal (or any "Atypical Antipsychotic"; i.e., all of Jannsen's products that are FDA-approved formulations containing risperidone and/or paliperidone), Jannsen agreed that only Jannsen "Scientifically Trained Personnel" may distribute such materials and NOT sales or marketing personnel UNLESS Jannsen has a "pending filing with the FDA for approval of the new indication described in the reprint." "Scientifically Trained Personnel," according to the settlement are Janssen personnel who are "highly trained experts with specialized scientific and medical , usually with an advanced degree scientific degree (e.g., and MD, PhD, or PharmD)."

"While this specific agreement pertains only to antipsychotics, the principles are obviously applicable at a higher level of generality," said Arnie Friede in a interview with Pharmalot (here). And J&J/Janssen has said they won’t use sales or marketing personnel to disseminate any off-label reprints unless they’ve already submitted an application to FDA covering that particular use and they may well apply the same “rule” in the marketing of other FDA-regulated products. This restriction goes beyond a provision in the FDA Modernization Act that has since expired, which obligated companies to certify that they were conducting studies intended to support a supplemental application before disseminating an off-label reprint, even if peer reviewed, but which did not require actual submission of an sNDA."

Why did J&J/Jannsen agree to this settlement rather than fight the case in court? The Forbes writer suggests it was just a matter of money: "the cost-benefit calculus of fighting vs. settling likely led the companies to resolve the claims."

Perhaps, however, this case is not closed and the settlement could be declared null and void if the "Federealists" have their way: "Unless I’m missing something," said a commenter to the Pharmalot post, "it seems a sure bet that the industry, perhaps via its pals at Federalist Society et al, will file a preemption case that these state requirements interfere with DDMAC’s authority to regulate off-label promo and related. Indeed, I do think the case for federal preemption is considerably stronger here than for preemption of state product liability law. In the meantime, friends-on-the-court could use the case as an opportunity to open the wider issue of off-label promo (for a case down the road)."

It ain't over till the fat lady SUPREMES sings!

Friday, September 7, 2012

Adherence - Do We Really Need an App for That? Benefits Do Not Outweigh the Risks.

Adherence, as defined in the Pharma Marketing Network Glossary, is "Percent of doses of a drug taken as prescribed for entire period of study (compliance + persistence)." In short, "sticking to the proper self-administration of treatment." Lots of patients -- even patients taking life-saving medication -- are not as "adherent" as they should be, which means that the treatment does not work as advertised and drug companies lose money. This has been discussed ad nauseum (see the links to articles listed here).

There have been many attempts by the drug industry to improve medication adherence, but it has been a tough challenge. But the industry has not given up. The new battleground for combating non-adherence is the mobile smartphone and the smartphone app is the weapon of choice. An example is the Care4Today "secure mobile app and website" that was developed and recently released by Janssen Healthcare Innovation.

Jannsen claims that this app is more than just a new-fangled way to remind you to take your medicine -- Care4Today "serves as your self directed personal health assistant."

Here are the "key features:"
  • Customizable reminders and alerts on your mobile device:
  • Medications
  • Prescription
  • Refills
  • Appointments
You can also
  • Store key contact information
  • Store and password protect important medical contact information (Doctors, Pharmacies, and other important Care givers)
I downloaded this app on my iPad and was confronted by the screen shown on the left. It appears that I have to register on the website before I can use the app, which I consider a stumbling block -- I hate registering on a pharmaceutical site. The terms are so long, tough to read and onerous that I just say "f**k it! I don't really no stinkin' app to remember to take my meds!"

But I soldiered on and registered. BTW, I could not click on the URL within the app to go directly to the website -- I had to quit the app, bring up my browser and enter the URL (or copy and paste from the app). BTW2, I hate running iPhone apps that are not specifically designed for my iPad as well. Just sayin'

Success! ...I think. I get a "Temporary Numeric Password" that is a 7-digit number. It says "Enter this Temporary Numeric Password into your mobile device." I do that and immediately get the message "The Numeric Password is a 4-digit number."

I guess it's time to call support! Whoops! Silly me - I didn't read carefully the new gray text that appeared in the boxes. It was asking me to "Enter a New Numeric Password," which should be 4 digits. This will prevent someone from gaining access to my data should I forget my iPad on the bus.

It took a couple minutes for the app to "synchronize" my data. In fact, it's still "synchronizing" while I am writing this. I'm guessing the app has crashed, but I will wait. Meanwhile, let me tell you more about this app.

The data you can enter on the care4today web site is very personal. It can be all you medications including dosages. It can include information about your doctor and pharmacist as well as all your appointments.

Whoops! Just got an error message: "Failed to establish network connection...For help go to (code 08017203)." Whoa boy! If I were an 75-year old mensch, forgetaboutit! I'd quit this app in a heartbeat (ie, minute or two). But, I am your fearless pharma mobile app reviewer who will follow instructions.

Turns out I must call support again - that's what the website tells me to do. While I'm on the phone with "Donald," I try entering my numbers again and lo and behold, it syncs in a flash and I'm in!

I'm not going to get into all the features of this app such as how it helps you enter your prescriptions (i.e., it has a complete list of drugs that takes forever to scroll through -- it would be helpful if it found the drug as you begin spelling it out). My main concern is what Jannsen is doing with all this information.

I suspect that Jannsen may be using my information to do some market research and learn more about non-adherence. After reading the Privacy Policy, I see that Jannsen will "sometimes ... provide limited access to your personally identifiable information to our contractors and consultants, including vendors and suppliers that provide us with technology, services, or content for the operation and maintenance of our Application or data and analysis on Application use."

Jannsen will aslo use aggregated data: "We may combine user-inputted information, including personal health information and information regarding your use of the Application, with information from other users to create aggregated data that may be disclosed to and utilized by our affiliates and by third parties."

Jannsen will also use the app to send out ads about their products: "From time to time, we may ask for your consent for us to send other messages to you. For example, these messages may be directed to improving your understanding of the medications that you are taking as well as conditions for which those medications are typically taken. By providing your consent at those times, you will be specifically consenting to receive the types of messages described in the consent request."

Also ads from other companies: "From time to time, we may also ask whether you would like us to share your personal information with another company that may want to send you information about their products or services. If you consent to such transfer by us of your personal information to another company, please note that the information provided will be subject to such company's privacy practices and not within our control."

Which is all very good and fine with me -- except that it is too much possible sharing of personal information for me to trust the app. Or look at it this way: Do the benefits outweigh the risks? I think not.

P.S. I forgot this tidbit from the Terms: "We have no obligation to provide technical support or maintenance for the Application. At any time and for any reason, without notice or liability, we may modify or discontinue the Application or any part of it or impose limits on your use of or access to the Application."