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.

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").

I 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.

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:

• FDA Issues Long-Awaited Guidance - for Mobile Medical Apps. Janssen, Look Out!
• Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story
• The Problem with Unregulated "Calculator" Apps for Physicians: Buggy Software!

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").

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 care4today.com 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 care4today.com (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."

I Give Lilly's Glucagon Injection Branded Mobile App an A+ But Its Injection Technology a D-

Lilly recently (September 4, 2012) launched the "Lilly Glucagon Mobile App" to support diabetes caregivers. According to the press release (here):

"The Lilly Glucagon Mobile App is a tool to teach how to use Glucagon for Injection, through simulated practice. Glucagon, 1 mg (1 unit), is indicated to treat severe hypoglycemia (low blood sugar). Severe hypoglycemia due to insulin may result in loss of consciousness (insulin coma). The app is designed to help people be more prepared, and also provide an opportunity to store locations and expiration dates of their Lilly Glucagon Emergency Kits. The Lilly Glucagon Mobile App is now available on the iTunes® store as a free download for iPhone® or iPad® mobile devices."

The app includes an animated video showing caregivers how to administer the drug, which is not an easy thing to do.

This is the second BRANDED mobile app that I am aware of. The first was Pfizer's Recipes2Go app launched in May, 2012. The app promoted the Lipitor $4 co-pay card and used recipes to entice users into downloading the app. That app has since disappeared after I reported that the promo page on the iTunes store was, in essence, an direct-to-consumer ad for Lipitor. The page mentioned Lipitor and its indication (treatment of high cholesterol) but failed to include the Important Safety Information (ISI) as required by the FDA (read "Pfizer's Short-lived LIPITOR Branded Mobile App").

I'm not sure if Pfizer removed the app from the iTunes store because of the complaint I sent to the FDA "Bad Ad" program, or because the co-pay program was a failure (see "Pfizer Throws In the Lipitor Marketing Towel").

In any case, Lilly's Glucagon Injection app does not repeat the mistakes made by Pfizer. The iTunes promo page for Lilly's app mentions Glucagon but does NOT mention the indication (see screen shot below; click for enlarged view or go here). The app also clearly features the ISI and does not require users to scroll down several screens to see it as does the Pfizer app.

I rate this app an A+ because of the above, but mostly because it is likely to be well-received by caregivers -- although the same instructions and animations could be seen on the Web. This is one app that physicians might "prescribe" to their patients' caregivers, but I also think physicians should download the app on their own iPads to show to caregivers at the point of care.

While the app may rate an A+, the injection technology that it illustrates gets a D- from me. There should be an easier, more automated, one-step way to prepare and administer this product instead of inventing a new technology app to support an old technology medical device!

Certifying Prescription Grade Smartphone Medical Apps

An article in yesterday's NYT focused on what I call "Prescription Grade Smartphone Medical Apps." The article said the idea of such apps "excites some people in the health care industry, who see them as a starting point for even more sophisticated applications that might otherwise never be built" (read the article here).

"But unlike a 99-cent game, apps dealing directly with medical care cannot be introduced to the public with bugs that will be fixed later. The industry is still grappling with how to ensure quality and safety." I have written about this issue before, although for apps created by the pharma industry and not "Prescription Grade" apps. See, for example:

• Some Unregulated Physician Smartphone Apps May Be Buggy
• FDA Mobile Regulatory Fear Mongering by PhRMA
• Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Lee H. Perlman, managing director of Happtique, a subsidiary of the business arm of the Greater New York Hospital Association, says "he believes that doctors will soon prescribe both clinically tested apps and more modest apps, like those that track physical activity or remind patients to take their pills. The company has established its own set of guidelines to determine the quality of health care-related apps, and helps doctors integrate them into their medical practice."

Happtique, in July 2012, released a draft of standards that it will be using to certify medical, health, and fitness apps under Happtique’s App Certification Program. The purpose of the program is to help users identify apps that meet high operability, privacy, and security standards and are based on reliable content. You can find the Happtique certification draft standards attached to this post.

The Happtique Certification Standards include these categories:

• App Operability Standards
• App Privacy Standards
• App Security Standards
• App Content Standards

My interest at the moment is in the App Content (C1) and Security (S6) Standards because these are most relevant to my concerns about the credibility of some recent pharma apps.

Content Standard C1 states: "The app is based on one or more credible information sources such as an accepted protocol, published guidelines, evidence-based practice, peer-reviewed journal, etc.

Performance Requirements for Standard C1

• C1.01 If the app is based on content from a recognized source (e.g., guidelines from a public or private entity), documentation (e.g., link to journal article, medical textbook citation) about the information source is provided.
• C1.02 If the app is based on content other than from a recognized source, documentation about how the content was formulated is provided, including information regarding its relevancy and reliability

I have seen pharma apps that do not comply with C1.01 (e.g., read "Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story").

But more troubling than the lack of documentation regarding content, is the accuracy of the apps software. Happtique Certification Security Standards address some of my concerns.

Security Standard S6 states: "The app owner has a mechanism to notify end users about apps that are banned or recalled by the app owner or any regulatory entity (e.g., FDA, FTC, FCC)."

Performance Requirements for Standard S6

• S6.01 In the event that an app is banned or recalled, a mechanism or process is in place to notify all users about the ban or recall and render the app inoperable.
• S6.02 In the event that the app constitutes a medical device (e.g., 510(k)) or is regulated by the FDA in any other capacity, the app owner has a policy and a mechanism in place to comply with any and all applicable rules and regulations for purposes of handling all aspects of a product notification or recall, including all corrections and removals.

Unfortunately, I do not find a standard for addressing the problem of "buggy" medical app software, which I discussed in a previous post to Pharma Marketing Blog (see "The Problem with Unregulated "Calculator" Apps for Physicians"). Specifically, shouldn't there be some certification standard that specifies how the app software was tested for accuracy? I think so.

Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?

I just learned that Pfizer has developed an iPhone/iPad app that promotes LIPITOR, the drug company's off-patent lipid-lowering drug. The app is "Recipes 2 Go." It is the first pharmaceutical app that I know of that promotes a prescription drug.

Here's what the promo screen on iTunes looks like (click on it for an enlarged view):

The description -- shown here in its entirety -- mentions LIPITOR and the FDA-approved indication, which is managing high cholesterol.

Is This an FDA-regulated Drug Ad?
My question: Does this iTunes page qualify as an prescription drug ad that must comply with FDA regulations regarding fair balance (ie, Important Safety Information or ISI)? If it does qualify, then it violates FDA regulations because the page does not include ANY fair balance or a link to the full prescribing information.

Did Pfizer submit this page to FDA for regulatory review? Did it submit the page to its own MLR (medical/legal/regulatory) people?

I downloaded the app to my iPhone and found the side effect/fair balance information plus a link to the "full prescribing" information on the very bottom of the "About Us" screen. Here's what the screen looks like:

Only when you scroll down to the next screen do you see the notice "Scroll down to see Important Safety Information," which appears about 14 screens further down! Whew! That's a lot of scrolling!

The multi-page End-User Agreement (dated April 20, 2012)  should be read carefully. For one thing, it states that "NO STATEMENTS MADE IN THIS SOFTWARE HAVE BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION."

To which I say, Why Not? The FDA should definitely take a look at this app and decide if it complies with regulations.

Because this app does not present the ISI where it can easily be found (and not at all on the iTunes promo page), I gave it only a single star rating on iTunes :-)

An App for Troubled Sleepers that Lunesta Would Love... Maybe.

What makes a mobile app effective?

That was the question posed by Jim Dayton (@JimDayton), Snr Dir Emerging Media at Intouch Solutions, at the iPharmaCONNECT conference this past Monday. As I suggested in a previous post, Dayton was not able, IMHO, to answer the most important questions about effectiveness; namely, provide truly useful KPIs (see "Pharma Social Media Religion Versus Science").

Today, I can explore what makes an app effective based on my personal experience with an app called "Sleep Cycle." Available in the iTunes store (here), Sleep Cycle is "an alarm clock that analyzes your sleep patterns and wakes you in the lightest sleep phase - a natural way to wake up where you feel rested and relaxed." After setting the alarm to the time you wish to wake up, you put your iPhone under your pillow (actually, next to it as shown in the photo below) and the app collects data about your sleep pattern during the night.

The app uses the iPhone's accelerometer to detect and measure your movements during the night. According to the developers, Sleep Cycle calculates the optimal time to wake you up during a 30 minute window that ends at your set alarm time.

It was amazingly simple to use. That's the first characteristic of an effective app.

But does it work? I must admit I had my doubts. It could be like those pads that draw out bad karma from the soles of your feet while you sleep. Yeah, sure. After my first use last night, I can say that it definitely worked!

Here's the chart showing how I slept last night:

The app DID wake me at a deep sleep point at 4:57 AM - 3 minutes before 5 AM, which was the time I set it to.

But could the chart just be faked? The app could have generated a random series of peaks. How would I know? Here's why I know it is for real. At about 1 AM in the morning we experienced a power failure that lasted only a minute or so. It was enough to wake me and my wife. The red arrow indicates the highest peak in my sleep cycle because I (and my wife) definitely woke up after hearing alarms from other digital devices in the bedroom -- such as beeps from the cable box as it turned back on.

What's the utility of such an app? First of all it's fun! Secondly, it records real data that I can use to help me get a better night's sleep. If I were being treated by my doctor for insomnia, I could send the data by email to my doctor. If I was being treated with a drug like Lunesta, I could determine if it really helped (although I should know it helped or not without charting my movements during sleep).

The third reason why this is an effective app is the most important one. I will use it every night. The novelty won't wear off because it fits into my routine of charging my iPhone every night when I sleep -- right there next to me on the night stand. This is an app that keeps your phone charging while it works instead of wasting battery life!

One last thing. The app is NOT free -- it costs $0.99, which is practically free, but makes me feel that I have a stake in using it. No matter how much money you make, you not likely to toss a dollar bill into the trash.

Sunovion Pharmaceuticals (formerly Sepracor), which markets Lunesta (a sleep aid drug), could have developed this app, but here's a better suggestion: SPONSOR it through advertising. I'm not quite certain how advertising works on smartphones, but I have seen free apps that include ads that pop up when the app is started or during its use. It's not usual for ads to appear in apps that you pay for, but Sunovion can pay the developers $0.99 for each app download that includes its ad -- the app would be free to users.

Sleep Cycle is one the top apps in terms of downloads all over the world. It claims "We are now helping more than 1 000 000 people to wake up rested!

#1 Top Paid app in Japan
#1 Top Paid app in Germany
#1 Top Paid app in France
#1 Top Paid app in Russia
#1 Top Paid app in Netherlands
#1 Top Paid app in Taiwan
#1 Top Paid app in South Korea
#1 Top Paid app in Sweden
#1 Top Paid app in Norway"

While number of downloads is not a KPI for developing a successful app (except for a paid app, that is!), it is a metric that advertisers love to use to judge where they should place ads.

How are branded drug ads within smartphone apps monitored by the FDA? What PhRMA DTC guidelines are applicable? How could this be done in countries that don't allow DTC advertising?

Those are all good questions to ponder. First of all, I'm not aware of any direct-to-consumer (DTC) drug ads running within apps. There are no PhRMA or FDA guidelines for advertising drugs on smartphones. But I can imagine that "reminder ads" would pass muster. For example, a simple ad that just mentions Lunesta with the green moth logo and link to lunesta.com would seem to be OK (in the U.S.) although I personally don't like reminder ads. Another option is to run ads that do not mention the drug at all - like this Google ad that links to lunesta.com:

I'm not sure how much Sunovion pays for this ad every time someone searches for "insomnia." It could be less than $0.99.

P.S. One fly in the ointment: I'm not completely sure that Sleep Cycle measured just MY movements during the night or the combined movements of me and my wife. If it's the latter, that would make the data useless for diagnosis by my physician.

This illustrates a major problem with health apps like this; ie, Garbage In, Garbage Out. It's similar to problems I have already noted in apps that are not vetted by being FDA-regulated or by independent testing (see "Some Unregulated Physician Smartphone Apps May Be Buggy"). I probably can make a lot of money being the "Consumer Reports" of health apps!

Pharma Social Media Religion Versus Science

My goal in attending conferences like CBI's iPharmaCONNECT, which is currently in progress in Philadelphia, is to come away with at least one new topic worthy of discussion. Thanks to yesterday's session on "What Makes a Health App Effective?" presented by Jim Dayton (@JimDayton), Snr Dir Emerging Media at Intouch Solutions, I have a topic I think worthy: Are we getting too much religion (preaching to the faithful) versus science (useful data) at these conferences?

Dayton was reviewing the story and "success" of GoMeals, the iPhone/iPad/Android app developed by Sanofi Aventis that is intended to help people with diabetes count their calories whether at home or eating out at restaurants. I have reviewed this program in a previous post (read "The iPad as a Pharma Marketing Platform").

One piece of data that Dayton presented was the fact that the GoMeals app has been downloaded about 415,000 times since it was launched in November 2009. Of course, it is widely known that nearly 85% of the people who download apps use them maybe once or twice and then never use them again. I did that with GoMeals. I stopped using it when my favorite local restaurants were not included in the database.

Also, like me, maybe many people downloaded the GoMeals app to multiple devices (eg, iPhones and iPads).

Thus, the number of downloads of an app is NOT a useful KPI (Key Performance Indicator), IMHO.

Dayton did mention that GoMeals enjoyed an abandon rate slightly less than the 80-85% average I mentioned above. But he couldn't (or wouldn't) give the audience any hard data regarding that or practically anything else that might be considered a true KPI.

Dayton, of course, is limited in what he can reveal about his client's product. It's obvious, however, that Sanofi considers GoMeals a success because it has continued to update the program and supports it with a web site and a twitter account. All of this requires a certain commitment of resources. But is this commitment justified by relevant data or just because the faithful believe in the program? Do you justify money spent by science or by religion?

Sanofi obviously collects useful data from GoMeals users. For example, the application includes a survey that asks questions such as:

1. Do you or anyone in your household who uses GoMeals have diabetes?
2. How often do you use GoMeals?

Answers to these critical questions would provide some true KPIs. Unfortunately, we don't know what the answers are unless Sanofi chooses to reveal them.

That lead me to ask an unusual question during the panel session yesterday; namely, why doesn't Sanofi reveal these data? The only answer I got was that GoMeals was considered an important part of the marketing plan and therefore that information was proprietary.

I understand that there is a lot of competition among pharma companies in the Type 2 diabetes arena and a lot of this has to do with diets, meals, and menus rather than the benefits of the drugs being marketed (see "Three Companies Compete for Diabetes Market Share Using Recipes Rather Than Product Efficacy"). If competing on helping diabetics with meal planning is the most important part of your marketing plan, then sure, you got to keep this stuff secret.

But how important are mobile apps in pharma's integrated marketing approach? It's got to be a very small part of the pie in terms of resources. If Sanofi revealed what percent of the GoMeals users actually had diabetes, would that be giving too much away?

Why should pharma companies reveal more hard data that can prove (or disprove) the effectiveness of social media and mobile apps? If the SM and mobile evangelists want to convince us that pharma should be doing more in this area, they need to give us some hard data in support of that. If they hide these data and just report "soft," meaningless numbers, I think they are preaching, not teaching.

The Problem with Unregulated "Calculator" Apps for Physicians: Buggy Software!

At this year's ePharma Summit in New York, I spent a lot of time listening to presentations about pharma mobile apps. There was, for example, a session entitled "I Wish I'd Done That! Mobile" during which panel members reviewed mobile applications they liked but that were produced by rival pharma companies. Surprisingly, although at least one panel member -- Jason Appel, Director, Physician Relationship Marketing, Amgen -- was involved in creating mobile apps for physicians, only consumer-oriented apps were featured.

Appel said he hasn’t seen any mobile physician apps that he wished he had done and agreed with a previous presenter that most were a waste of money. But of the literally hundreds of apps created by pharmaceutical companies, many are for healthcare professionals.

My friend @skypen (Fabio Gratton) has created a web site to keep track of them all -- it's called POCKET.MD. Fabio claims it 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." Here's a screen shot (click on it for an enlarged view):

Practically every pharmaceutical company has one or more apps. The ones I am interested in are apps designed to help doctors in their diagnosis of patients. Big among these are the "calculator" apps, which calculate things such as glomerular filtration rate (GFR), Medication Adherence Rating Scale (MARS), Delayed Graft Function (DGF) Risk, creatinine clearance, dosing algorithms, Body Mass Index (BMI), and, my favorite, Psoriasis Area and Severity Index (PASI).

According to POCKET.MD, the most downloaded app is Pfizer's "Pfizer Rheumatology Calculator" - a rheumatology disease activity calculator that Pfizer developed to allow physicians to "quickly and easily measure the disease activity of your patients without having to use manual calculations. The calculator is easy to use -- simply enter clinical data for your patient into the calculator and it will instantly provide you with the score in a variety of disease activity measures, including: ASDAS ESR & CRP BASDAI DAS28 ESR & CRP PASI And more..."

Unfortunately, this free Pfizer app is no longer available -- it had to be recalled because of "a bug in the app ... gives wrong results" (see "Pfizer recalls Rheumatology Calculator smartphone App").

Back in July, 2011, I warned that bugs in such apps could go un-noticed because there is no independent verification of the software -- no "Good App Seal of Approval" and certainly no FDA approval. See "Checking Under the Hood of Pharma Mobile Apps" where I point out this shortcoming in another PASI calculator mobile app.

But how do you recall a smartphone app? You can remove the app from the app stores around the world, which is what Pfizer did, but that only prevents new downloads. Most apps are downloaded to smartphones and it is not possible for the developer to remove these copies of the app from the phones. The users must do that. Considering that the "recalled" Pfizer app was the most downloaded app tracked by POCKET.MD, there must be many many users (physicians) out there who still have the app on their phones. Did Pfizer send these physicians a "Dear Doctor" letter informing them of the problem and advising them to remove the app from their phones? Probably not. Did the app include a disclaimer that protects Pfizer from being responsible for misdiagnoses due to its buggy app? Probably yes.

FDA Promises Still More Guidance! This Time It's Mobile. Janssen's Psoriasis iPhone App May Need It.

"The Food & Drug Administration is planning to release guidance for mobile medical applications in 2011, according to Center for Devices and Radiological Health director Dr. Jeffrey Shuren." That was reported in this story relaying comments made at a "town hall meeting" held March 10 in Irving, Texas.

I don't know nearly as much about Dr. Jeffrey Shuren as I do about Tom Abrams, his counterpart in FDA's DDMAC. But if he's making more promises that the FDA hasn't the ability to keep, then I urge that he resign along with Tom Abrams (see "Is It Time for Abrams to Leave?").

As you probably know, DDMAC first "promised" that it would issue social media guidance for pharmaceutical promotion by the end of 2010. When they missed that date, Abrams "promised" it would be done by the end of Q1 20011, which leaves only about 2 weeks for the FDA to fulfill that "promise."

Most observers, however, believe FDA will not deliver social media guidance before April Fool's Day 2011. Considering the looming budget cuts suggested by some anti-government bloat lawmakers, it could be a cold day in hell before FDA can spare the resources to get the job done as "promised."

Regarding mobile devices FDA has a much, much greater challenge in issuing guidance. The issue has to do with agency approval of Mobile medical applications as medical devices. So far, FDA has approved two mobile applications:

1. MobiUS, a smartphone-based ultrasound imaging application for use in obstetric, gastrointestinal, cardiac andother clinical applications.
2. Mobile MIM, a mobile diagnostic radiology application that facilitates viewing of medical images for diagnostic purposes via Apple’s iPhone and iPad devices.

FDA approval of these devices/applications hinged on image quality (see FDA Press Release). Of much greater concern, however, are applications that involve more complicated software. Whether or not the FDA would regulate mobile software has been an issue for nearly two years.

Is the FDA technologically competent enough to evaluate mobile App software? It's a valid question considering that many people have doubted that FDA was competent enough to understand social media and issue guidance in that realm. Software, which operates behind the scenes, is even more of a challenge.

Faulty software can make medical devices dangerous. Think of "HAL" in charge of millions of pacemakers. That sort of thing.

There is a relation between mobile medical Apps and pharmaceutical marketing. Many pharmaceutical marketers are developing mobile Apps. The latest one I've come across is Janssen's "Psoriasis" app for the iPhone and iPad (see it here on iTunes).

The physician version -- which any non-physician can easily access -- includes a "PASI calculator." PASI stands for "Psoriasis Area and Severity Index," which is a tool for the measurement of severity of psoriasis. According to the wikipedia entry, the following formula is used to calculate PASI:

I won't get into the details here, but I wonder if this is the equation used in the software that calculates PASI in Janssen's Psoriasis App? Does the software implement the equation correctly? Has it been tested and certified as correct? By whom?

Jannsen does include this statement in its disclaimer: "The information provided on this App is not a substitute for professional medical care." This is par for the course when dealing with consumers who may be using the PASI calculator without medical supervision.

But I can't find any information about the clinical validity of the PASI calculator, which is an issue I've often blogged about (see, for example, "Pharma Symptom Quiz Goes to the Dogs!" and links therein).

This is just a simple example of a medical App that depends on the accuracy of its software to function properly. If marketers design the Apps and hire outside tech agencies to develop the Apps, then there is the possibility that the software can be "gamed" to provide desired results (eg, higher PASI score) much like the software of Vegas slot machines are "gamed" to favor the house.

Is the Janssen Psoriasis App a medical device that needs to be approved by the FDA? I think that's a valid question to ask since the App encourages physicians to use it: "This interactive PASI calculator enables you to generate a PASI score for your patients."

P.S. Janssen says that the Psoriasis iPhone App is "Intended for a European audience." But it -- like ALL iPhone Apps -- is available on iTunes, which is a US retail Web site. Does that trump "intention" and does intention matter as far as the FDA is concerned?

P.S. See "Checking Under the Hood of Pharma Mobile Apps" for an update.