Thursday, September 27, 2012

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

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

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

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

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

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

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

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

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

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

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

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

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

Tuesday, September 11, 2012

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

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

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

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

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

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

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

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

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

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

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

Saturday, September 8, 2012

States' Rights: Regulation Via Settlement

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

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

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

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

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

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

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

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

Friday, September 7, 2012

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Thursday, September 6, 2012

FDA Caught Speeding. Puts Public Safety at Risk.

"An FDA effort to speed approval of new medicines allowed drugs for stroke prevention, cancer and multiple sclerosis onto the market without proper safety analysis, according to two drug-safety experts," reports the Wall Street Journal in a review (here) of a "viewpoint" recently published in JAMA.

Peter Pitts of Drug Wonks says: "As usual, Janet Woodcock [Director of the Center for Drug Evaluation and Research at FDA] places the matter in the appropriate perspective. 'I'd like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,' Dr. Woodcock said. "The cancer community in particular says we haven't used accelerated approvals enough.'" Pitts adds this zinger:

"Here’s the truth -- there is no such thing as a 'safe' drug. It's the patient who must understand the risks required to achieve the benefit. That’s why the patient voice must be heard during all phases of the regulatory review process."

Unfortunately, I don't think Pitts actually read the piece in JAMA. The drug safety expert authors of that piece (Thomas J. Moore and Curt D. Furberg) did not claim that drugs approved by the FDA should be "safe." They made the argument that accelerated approval by FDA of several powerful drugs with UNKNOWN safety issues were no better at improving outcomes than drugs currently on the market whose safety issues are well-known.

"Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal," said Moore and Furberg, "the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered."

The authors cite several specific drugs that were fast-tracked for approval without adequate safety information available. I'd like to focus on one: Dabigatran for prevention of stroke. Dabigatran is marketed as Pradaxa by Boehringer Ingelheim (BI).

According to Moore and Furberg, Pradaxa benefited from "3 different FDA policies promoting innovation. This drug received both Fast Track and Priority Reviews and was studied in a single large phase 3 trial rather than in at least 2 pivotal trials, as normally required...Within less than a year of approval, 1 survey showed that dabigatran accounted for more serious adverse drug events reported to the FDA during the second quarter of 2011 than any other regularly monitored drug. Risk of hemorrhage was prominent in older patients (median age, 80 years), a subgroup for whom declining kidney function or other factors may have increased bleeding risk. Both a manufacturer package insert revision and the European Medicines Agency have called for closer monitoring of kidney function, a needed step because even moderate kidney impairment increases dabigatran levels more than 2-fold. In addition, unlike warfarin, no antidote is available for use in bleeding emergencies related to dabigatran. Evidence was beginning to emerge that dabigatran-related bleeding— whether from trauma or as an adverse effect—may be more difficult to treat than warfarin-related bleeding."

Couple this safety issue with the promotion of Pradaxa in the media as a "super pill" and a "revolutionary drug" (see "Bad Journalism or Bad Pharma?") and you end up with a real public safety issue that patients should be concerned about. BI itself stoked this Pradaxa-mania (read, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons" and "Full BOEHR(inger) Social Media Reporting of RELY Trial Results").

Sadly, Woodcock may have heard from "patient advocates" paid by pharma companies to testify before the FDA, but who advocates for the patients harmed by drugs like Pradaxa? Their stories are locked in the FDA's adverse event database, which is not generally cited during drug approval Hearings at the FDA.

Not to mention the impact of DTC advertising on the public's willingness to accept greater risk:

Wednesday, September 5, 2012

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!