The Next New Drug: An FDA-Approved Video Game

Imagine my surprise when I read this in today's Wall Street Journal: "Akili Interactive Labs Inc. of Boston, formed by start-up-creating firm PureTech Ventures, and San Francisco company Brain Plasticity Inc. are seeking Food and Drug Administration approval for a video game treatment they hope clinicians will turn to before prescribing medicines for ADHD" (read the story here).

I've been writing a lot about "gamification" and the pharma industry (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!" and "Gamification, Then and Now", for example), but never from the perspective of games designed to compete with drugs such as Novartis' Ritalin, a stimulate indicated for the treatment of ADHD.

Akili -- meaning "wisdom" in Swahili -- is the name of the video game that Akili Interactive Labs hopes will be the first ever video game "treatment" approved by the FDA. The game is designed to run on smartphones and iPads. The company also hopes clinicians will recommend the game to patients before prescribing medicines for ADHD.

Fat chance!

First, fat chance that the FDA will actually approve a video game as an effective treatment for a medical condition. Second, fat chance that even if approved, health insurers/patients will pay for a game treatment after being conditioned all these years to think only of drugs as treatments. Third, fat chance that physicians will prescribe the game to their patients. That would require overturning the entire drug-physician industrial complex!

Nevertheless, Akili co-founder Eddie Martucci said "his company's research shows that people want choices other than today's powerful medicines. 'We would aim to have efficacy and tolerability that outstrips any of the drugs.'"

Wow! Are these guys anti-drug industry? NOPE! Senior Partner, Chairman of PureTech Ventures is Dr. Ben Shapiro who was previously Executive Vice President, Worldwide Licensing and External Research for Merck. Another Senior Partner at PureTech is Dr. John LaMattina, who was previously President, Pfizer Global Research and Development and Senior Vice President, at Pfizer Inc.

LaMattina, who also writes the Drug Truths Blog at Forbes, was once enthusiastic about torcetrapib, a drug that Pfizer hoped would replace LIPITOR. "We believe this is the most important new development in cardiovascular medicine in years," said LaMittina. That was before Pfizer halted development of torcetrapib and after it spent more than $800 million on its development (read "torcetrapib: $800 Million Failure but Kindler Safe"). Hopefully, Akili isn't costing nearly as much to develop as a new drug.

With such experienced drug industry veterans as partners, Akili might have a chance of making it to the FDA. Unless, of course, clinical trials reveal dangerous side effects.

It's not likely such side effects will be similar to those that torcetrapib caused; i.e., death. Some video game critics, however, fear that "electronic media might improve visual attention but impair the ability to sustain attention on a hard or boring task," notes the WSJ article. "The latter type is what teachers need from students, according to ... Douglas A. Gentile, a developmental psychologist at Iowa State University." What teachers DON'T need, however, is for students to claim that playing video games during school is part of their medical treatment!

It's interesting to speculate how FDA-approved video games would be marketed, assuming any will actually be approved by the FDA. Akili, for example, might splurge on exhibits at medical meetings and lure physicians into its booth to play the game. And maybe it would hire physicians to be "consultants" and "speakers" to promote the game to their peers. I'm betting that direct-to-consumer (DTC) TV ads would be out of the question -- much too expensive for a product unlikely to reach "blockbuster" levels of sales.

I do, however, envision that DTC social media could be very cost-effective for marketing FDA-approved video game treatments.

Sermo Physicians Use Telephone, Eschew Social Media, to Communicate with Patients

The third edition of "What Physicians Want!," a biennial survey conducted by Publicis Touchpoint Solutions and Sermo, offers evidence that tech-savvy physicians are not embracing social media to communicate with patients. The survey questioned more than 250 Sermo physicians, sixty-two percent of whom were primary care providers (FP, IM, Ped), while the remaining 38% comprised more than 20 surgical and nonsurgical specialties.

Only 19% of the surveyed physicians use Twitter. That compares with 22% of respondents to the 2010 survey. These physicians, however, are flocking to LinkedIn, Facebook, and Google+ for personal and professional use (see chart below). LinkedIn showed rapid growth in users, from 18% in 2010 to 40% in this year’s survey. Google+ is surging quickly, with 38% using this site.

As for communicating with patients, physicians prefer the good old telephone and email rather than Facebook or Twitter (see chart below). Only 15% of respondents are currently using Facebook or plan to use it in the near future to communicate with their patients. Less than 10% of respondents use or plan to use other social media -- including Twitter -- to communicate with patients.

Given that these are tech-savvy registered SERMO physicians, I would have expected them to be more interested in using social media to communicate with patients. There are obvious privacy and other issues involved. The American Medical Association (AMA) warns physicians that "Social networks, blogs, and other forms of communication online ... create new challenges to the patient-physician relationship" (see "AMA Policy on Use of Social Media Sees the Glass Half Empty").

Despite such concerns, physicians use email to communicate with patients. Why not social media like Twitter and Facebook? Both allow private messaging between parties. I don't expect a lot of physicians to do this, but I expected to see a trend in that direction. These surveys, however, reveal no such trend.

One trend that the survey DOES clearly show is physician interest in iPads! 82% of survey respondents want to see “more” or “significantly more” use of iPads or other tablets by pharma representatives calling on their practices. Over half of the survey respondents (54%) are using iPads/tablets for personal and/or professional use. And of the 46% who don’t yet use tablets, nearly three-quarters plan to use one for personal and/or professional use in the near future.

Perhaps with the NEW iPads, more physicians will communicate with some of their patients via FaceTime -- a nifty Skype-like app that allows you to talk to and view friends, colleagues, patients.

You can read more about this survey as well as download a white paper summarizing all the results here: New Survey: Physicians Ask Pharma, Help Me, Help My Patients

Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Some time ago, I pointed out that certain mobile apps developed by pharmaceutical companies for use by physicians lack adequate disclaimers. Specifically, I was concerned about the software used in these apps that perform calculations to generate data to aid in medical diagnoses. A Psoriasis/PASI app by Janssen Pharmaceutica is an example (see "FDA Promises Still More Guidance! This Time It's Mobile. Janssen's Psoriasis iPhone App May Need It"). I pointed out that this app does NOT include any information about the clinical validity of the PASI calculator nor does it warn the user not to depend on the accuracy of the data.

Today, I found out about AFib Educator 2.0 developed by Sanofi-Aventis (I seemed to have missed 1.0!). The app is intended to be an "interactive way for healthcare providers to illustrate atrial fibrillation and its pharmacologic management for patients and families" (see review on iMedicalApps blog). The "pharmacologic management" is not what you may think; that is, there is no mention of any AFib drug either by trade name or generic name. The app only mentions that "there are treatments available."

Let's look at the disclaimers for these two apps (click the image for an enlarged view):

On the left is the disclaimer for Sanofi's AFib Educator 2.0 and on the right is the disclaimer for Janssen's PAS calculator (updated since I last reviewed the app).

Both disclaimers mention that the app is "not a substitute for medical advice/professional medical care". But only the AFib disclaimer mentions that "Persons using the data within for medical purposes should not rely solely on the accuracy of the data herein." It also mentions that data might be updated periodically -- meaning, I suppose, corrections or more accurate data.

Why doesn't Janssen's Psoriasis/PASI app, which is MUCH more data driven (it calculates a PASI score!), include a similar warning? Obviously, I think it should include that warning.

But more importantly, Janssen's app should include information about the source of the equation it uses to calculate PASI. As I pointed out previously (op cit), there is some difference of medical opinion regarding how PASI should be calculated and which formula should be used by healthcare professionals.

Obviously, ANY healthcare professional can download and use the PASI app. You don't have to be a dermatologist who may be more familiar with PASI calculations than is a general practitioner. In fact, you don't have to be a physician at all! That's fine, but the audience should be made more aware of what's operating "behind" the app to generate the PASI scores.

Be Aware of What's Behind the App
What's going on "behind the app" is a hot topic these days. Recently, major news outlets have reported that there is software running in the background on virtually all smart mobile devices that record every keystroke, supposedly merely to "monitor performance" (see "Is Your Smartphone Tracking Your Keystrokes, Texts and Location?" and the YouTube Video embedded at the end of this post).

It's interesting that part of Janssen's NEW disclaimer HINTS that data are being collected when people use its Psoriasis/PASI app (see screen shot below).

Janssen claims that it is monitoring clicks for performance purposes. However, since it is possible to collect and record ALL keystrokes, there is the possibility that data other than icon clicks are being collected by Janssen. I'll have to see if Trevor Eckhart -- who made the video below -- will take a look at exactly what data the Janssen apps records.

In Memory of Steve Jobs Will Novartis Sales Reps Really Embrace iPads?

Pharmalot reported today that "In a memo this morning, David Epstein, who heads Novartis Pharmaceuticals, wrote that before the end of next year, more than 80 percent of the sales reps will give up their PCs and switch all detailing and related work to iPads.'' The memo, which can be found here, is reproduced below:

Posted on 9:52 AM, 06 October 2011
In memory of Steve Jobs - a role model 

"Today a great man has died - one who has forever changed the world. A great innovator, a corporate leader and a visionary who would not take no for an answer. A man who could perceive customer desire in a very clear way, marry it with technology and compel an organization to execute at the highest level to deliver customers a truly unique and compelling experience. A man I adopted as a role model as we began to galvanize our organization to launch Afinitor at a meeting of our Oncology leadership held in Mexico in 2008. 

"Ultimately, after a long fight, he succumbed to the ravages of PNet (pancreatic neuroendocrine tumor), a cancer for which Novartis now has two approved medicines: Sandostatin LAR and Afinitor. With Steve Job's death it is clear that we cannot rest as we work to discover, develop and commercialize still better medicines. It is medical intervention - great doctors, surgery, medicines and more - that allowed us to enjoy having Steve on this planet just a little bit longer so he could inspire a new generation and give us great inventions like portable digital music, the iPhone, the iPad and iCloud. 

"In his memory we commit today that more than 80 percent of Novartis Pharmaceutical field forces around the world will give up their PCs and be executing their call planning, detailing, emailing, and communicating with each other and physicians via iPads before the end of 2012. Please help me to make this a reality. As a result we will be able to make more impactful calls thus better able to ensure that every patient who should be on one of our medicines has access. Our marketers will be empowered to more quickly update digital detail aids and interactive apps with the latest information. Our marketers will better understand almost instantly what our field forces find helpful in their daily work and what is useless. Our field forces will be able to get more of their work done during the day while waiting for their next appointment rather than doing administrative work later in the day. And there are many other possibilities. Let’s use our positive memory of Steve to do some more good in the world. I know we can."

Not so long ago, I was hearing that pharma companies bought iPADs without having a clear strategy for how they were going to be used. It was believed that thousands of these iPads were housed in warehouses and not deployed.

It seems that Epstein is using the "in memory of Steve Jobs" memo as a tool to empty his warehouses of iPads and encourage reps to use them "to get more of their work done during the day" and "do some more good in the world."

But what are Novartis reps saying about the iPad? Here are some tidbits I found on the Novartis board over at Cafe Pharma:

• We are the laughingstock. 'Oh look, there goes the reps that are so incompetent in getting their message across, they are replaced by an iPad!' Hey doc, wanna play Angry Birds with me? 
• Next step in e-detailing is downloading "e-rep" app (doc gets to pick male/female e-rep to interact with,,need samples? click!, need a quick product review? click, heard the latest about managed care in your area? click! 
• Actually...with iPads why do we need high priced reps? The managers will be fine...you...I wouldn't be too sure. 
• I'm going to record all calls with the ipads camera & upload to youtube & publish live as soon as the next severence (sic) is paid out

At least pharma reps are not "selling sugar water to kids" as Steve Jobs once said of John Scully when he hired him to run Apple. Scully promptly ran it into the ground.

Does this memo violate FDA Regulations?

P.S. Epstein's memo was posted to a site called FreePDFhosting.com, which allows anyone to upload PDF files for free (duh!). I am not sure who posted Epstein's memo to this site, but I doubt it was Epstein, who probably intended it to remain an internal document. 

However, now that it is a PUBLIC document, easily accessible by any one, is it subject to FDA regulation regarding branded communications?

I notice that the memo refers to Novartis anti-cancer drugs by brand name and includes the FDA-approved indication: pancreatic neuroendocrine tumor. However, the memo does NOT include any fair balance (major side effect information). Technically, therefore, this memo -- as it appears on FreePDFhosting.com -- violates FDA law. Since FreePDFhosting.com has a rule against uploading PDFs that are "illegal or violates any laws," the memo should be removed from the site (hopefully before the FDA sees it).

How Sales Reps Can Use Tablets to Fool Their Sales Manager Overlords

While reading "How Pfizer Uses Tablet PCs and Click-Stream Data to Track Its Strategy" (see here), I was struck by two thoughts:

1. Pfizer's use of technology to collect sales analytics seems pretty basic; eg, David Kreutter, a Pfizer VP of US Commercial Operations, revealed a source of "predictive analytics" to be a simple Web log that shows what physicians click on and what they click through to when they visit a product website. But Pfizer doesn't have "any greater data on how those clicks translate into prescription writing."

and


2. The "real-time" data they get from sales reps using tablet PCs seems pretty easy to falsify. Here's how Kreutter describes it:
   
   "As they click the screens with their styluses to illustrate points, those clicks are recorded. That’s how we’re able to see things like the order of presentations, the messages within a presentation that were presented, if the physician found it engaging. Representatives synchronize their tablets on a daily basis, and we get a data stream back to our data warehouse. Our customer data master now has all of that click-stream data for each representative and each doctor."
   
   Maybe I'm being a cynic or not understanding the technology, but what's to prevent a sales rep from doing all the clicking while waiting in the physician's office hallway just to drop off samples?

This sort of thing is probably not new -- no doubt sales reps have falsified paper-based sales call reports as well. But now the amount of data coming in from 4,000 representatives, each seeing "about seven or eight physicians a day," and each detailing "about two to three products in each of those calls," provides a false sense of knowing in detail what's going on. As has been said ever since computers were invented, "garbage in, garbage out."

P.S. I also note that Kreutter only spoke about "tablet PCs" and NOT iPads. I guess Pfizer has not yet progressed to using that technology.

Point-of-Care Pharma Marketing: When Is It Appropriate?

In the world of smartphone apps for physicians, Epocrates plays a leading role. The Epocrates iPhone app is free (with a $99 PREMIUM upgrade option) to physicians -- and anyone else -- who can use the app to find information on drug dosing, interactions and insurance coverage while seeing a patient. According to a New York Times article (see here), 70% of Epocrates' revenue comes from pharma point-of-care advertising; ie, messages from pharma advertisers that pop up as "DocAlerts" when the app is used to look up drugs, etc.

Some docs complain about the messaging, claiming they don't have time for that "nonsense." A few reviews on the iPhone app store suggest this is a common complaint:

"why must I be badgered with your alerts?"

"Paid for 'premium' subscription, getting nagging pharma clinical alerts that are rarely useful. Alerts don't go away unless you tap through them. If this is the case, should be free app."

According to the NYT article, "Epocrates is betting that the 320,000 physicians who use its apps, much like those who use Google and other advertising-supported data services, will tolerate some marketing to get the information they want at no charge." However, unlike Google, ads delivered directly to doctors while delivering care can have a much greater influence over their prescribing. If you are of the opinion that advertised drugs are usually more expensive and sometimes less safe than generics, then pharma paid DocAlerts (ads) are not in the best interests of patients and payors.

For pharmaceutical manufacturers, Drug information apps such as offered by ePocrates and ePrescribing may offer a new channel to influence physician prescribing at the point of care. “The beauty of the work we do with Epocrates is that we literally put ourselves in the palm of their hand,” said Dr. Freda Lewis Hall, chief medical officer at Pfizer.

Being in the doc's palm is one thing, but interrupting his/her workflow is another. When is it appropriate to "interrupt" physicians with commercial messages at the point of care? There are several more or less disruptive ways to provide messages in apps at the point of care, including:

• Ads appear via a splash screen when doc turns on PDA, smartphone, or iPad. The message not related to any prescribing transaction.
• Specific targeted messages are "triggered" by doc's drug lookup choice, demographic, and/or prescribing history and designed to influence doc's prescribing decision.
• Non-targeted messages delivered before, during, or after the prescribing process.

Which do you think is most appropriate and why? Please take a few minutes to respond to my "Point-of-Care Pharma Marketing" survey (click here). After finishing the survey, you will be able to see a summary review of the results to date. No open-ended results that may contain personal information of respondents will be shown. Also, at the end of the survey, you will find links to these FREE Pharma Marketing News articles:

1. ePrescribing: What Role Should Pharma Play?
2. Ready or Not: Gearing Up for the Expansion of ePrescribing

Thanks!

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Humana's iPhone/iPad "Games for Health": Would You Pay $2.99 to Play?

My Twitter pal @skypen (aka Fabio Gratton) keeps me up to date regarding innovative health apps and games developed by pharmaceutical and other healthcare companies. Today he tweeted:

"Humana develops health game for iPhone http://bit.ly/biQKlQ"

"Besides developing original games for health," said Paul Puopolo, leader of Humana’s Games for Health, "[we] partner with game developers who are open to new business models to offer unique video games that can improve health and wellness."

That's an interesting goal for an iPhone app worthy of further investigation. So I went to the Humana Games for Health Web site and found this promo for the Humana iPhone game app called "Colorfall":

This is a game similar to Tetris. The objective is to arrange and eliminate cascading color squares before the screen fills up. How does this game "improve health and wellness?" Well, you are prompted to get up off your behind and use the iPhone to photograph colorful objects such as a butter dish (shown below):

The app uses the dominant color in the photo to alter the color of squares, which can help you win the game.

In other words, this game improves health and wellness by encouraging you to move around. Huh? Usually, I play games when I'm stuck in the middle seat of an airplane and not able to move around. If I were at home and went into my fridge looking for colorful foods, I might just pause the game and have a snack. Butter, hmmmmm...

Anyway, Colorfall looks like a game worth trying. But I will never download it because Humana has the nerve to charge $2.99! I asked Fabio: "Why would I pay $2.99 for these games from Humana - an insurance company with $bn in assets????" To which Fabio replied: "i agree. Should be free. Who will pay? Probably Pharma cos and competitors to learn/see what others are doing."

If you are working for a pharma company and thinking of developing iPhone or iPad game apps, I doubt you would want to charge people $2.99. People hate the pharma industry about as much as they hate insurance companies and are sure not to pay. So it's a mystery to me why Humana charges people a fee for this game, especially if they believe it will improve the health of the people covered by their plans and thus lower their costs.

A better business model for game apps is to offer free games that include motivational messages or links to useful information as part of the game.

Is Pharma Blocking or Supporting iPad Use by Sales Reps?

"Has anyone had any luck getting the iPad to connect to J&J email system," asks an anonymous sales rep on the J&J IT board of CafePharma. "My iPhone connects perfectly and I believe that the iPad should work just the same way. However, even with exactly the same settings it isn't working for me..."

"I called helpdesk," said another poster, "he said iPads, Android, and a few other things are blocked at a device family level from activesynching. Didn't say why."

On the Eisai Pharmaceuticals discussion board, another anonymous poster said "I heard that we are getting new ipads for e-detailing. Great now we have 2 systems for inventory and 2 systems for account management. I better be able to dowload some games and it better have a decent battery. Prob nope on the last 2 requests."

In response was this post: "Who wants an Eisai neutered iPAD? You know they will block all downloads. No apps, movies, or music. Screw that!"

On the other hand, it seems that Genentech is providing iPads to its sales force: "iPads will be overnighted to the entire sales force next Tuesday," said an anonymous poster to the Genentech board on June 8, 2010.

According to Quang Pham, CEO, LathianHealth - an eDetailing company - iPads definitely have a place in the future of eDetailing. He was speaking at a MedAdNews webinar on sales force effectiveness today. Pham did mention, however, that many eDetailing programs currently use Adobe Flash, which is not supported by iPad. Yet the low price point for iPads is a great incentive for pharma to goose its eDetailing vendors to develop programs specifically for the iPad.

In the same webinar, David Kerr, SVP Business Development at PDI, Inc. (a company that provides outsourced sales and marketing services) wondered whether the iPad was robust enough to be thrown around in a sales rep's bag. I use the iPad Case (see photo) to protect my iPad and have taken it everywhere in my backpack without any worries.

The iPad as a Pharma Marketing Platform

"DTC marketers can't afford the luxury of waiting to see how many people purchase an iPad they have to start experimenting with app development and marketing NOW," says Rich Meyer over at World of DTC Marketing Blog.

The best example of an iPad DTC app Meyer could think of, however, was a cookbook for people with diabetes. As if the world needed a new diabetes cookbook!

I have an iPad and am enjoying it. I have even used it when cooking -- propped up on my kitchen counter next to the chicken parts. But I used the browser to find a recipe for BBQ ribs -- there were hundreds to choose from. I don't need an app for that. I assume the Internet is also full of recipes suitable for people with diabetes.

But Rich was probably thinking of something more useful. Something like Sanofi-Aventis's GoMeals app developed for the iPhone/iPod.

MM&M noted that "Sanofi-Aventis [S-A] is promoting it through outreach to diabetes bloggers as well as tactical advertising, such as banners on diabetes sites, and to the patient community through third-party orgs. As of [December 2009] it was the seventh-most-popular app in the free health and fitness section of Apple's iTunes Store."

I downloaded GoMeals for my iPod and used it to find restaurants in my area. You can compare the nutritional value of different restaurant menus and keep track of your own meals. It's very useful for all of us, not just for people who have diabetes. BTW, I  "forgot" to use the GoMeals app to calculate the nutritional value of my BBQ ribs.

When I used GoMeals on my iPad to find restaurants in my area, it crashed. At first I thought it was because my iPad was not GPS-equipped, but "Mic" said that iPad does have GPS (see comments) -- and he's right! Google Earth knows where I am! At least within 100 yards of where I am. Anyway, S-A needs to fix this problem and develop an iPad version. But is it worth the effort?

The GoMeals app has absolutely no marketing ROI for S-A. It may only be one part of an overall marketing plan to position S-A as a player in the diabetes area. Dennis Urbaniak, S-A's new VP of U.S. Diabetes, was previously Vice President of Innovation and New Customer Channels. No doubt Urbaniak was involved in developing the GoMeals app. BTW, listen to my Pharma Marketing Talk interview of Urbaniak: "What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now."

Geoff McCleary, a mobile and tablet computing expert and vice president of strategy for imc2 health & wellness, suggested these consumer-oriented apps for the iPad that pharma marketers should develop:

• Weekly/monthly health eMagazine for disease state information
• 3D, touch interactive MOAs for disease or treatment education
• Branded support program materials delivered weekly or daily
• Social media-based content for brands or disease groups

How much disease state information can a monthly eMagazine publish and how would an iPad app be better than opening your email and a browser? We don't need an app for that. Same with branded support programs and social media-based content.

How about a "3D, touch interactive" MOA animation for Viagra or YAZ? Now those are pharma apps I'd like to see on my iPad!

You can find McCleary's white paper, "Considering the Apple iPad™ for Pharma Marketing," which has other ideas for apps -- including physician-oriented apps -- here.

P.S. The real marketing value of iPad is iAds, just announced by Apple's Steve Jobs (see "Apple Unveils iAd, iPhone 4.0"). iAds are "in-app" ads served up while you are using a "free" app like GoMeals, which does not have any advertising. Personally, I believe in-app ads are annoying, but if the app is valuable, I will put up with them. For pharma, the hard part will be coming up with truly useful apps.