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.