Pfizer and Janssen Halt Alzheimer Drug Development: Why Not Try Gamification?

Pfizer and Janssen Halt Alzheimer Drug Development: Why Not Try Gamification?

"In the wake of another negative trial with the anti-amyloid biologic drug bapineuzumab, Pfizer and Janssen said they were halting development of the product for mild to moderate Alzheimer's disease," reports medpage today (here).

Pfizer may have had high hopes for this drug because it already launched a multichannel marketing/PR campaign centered around "getting old" (see "Pfizer's Social Media Initiatives are Getting Old") and this drug in particular (see "Can Pharma Cure Alzheimer's Disease? A Pfizer Pre-Launch Multichannel Marketing Case Study").

I'm not sure what other Alzheimer products Pfizer is currently working on, but maybe it's time for it think out of the box. Perhaps it should look into gamification as an alternative strategy.

You might ask, "Are you serious John? Just yesterday you pooh-poohed gamification as an alternative to ADHD drugs" (see "Cure by Gamification: Science or Wishful Thinking?").

True that. I still believe that games will never be approved by the FDA for treatment of a medical condition and doctors won't prescribe them even if they were approved. But that doesn't mean games cannot be effective in the treatment of Alzheimers Disease by slowing its progression, which has been the goal of clinical trials of drugs like bapineuzumab.

There is actually some SCIENCE published in a peer-reviewed medical journal (JAMA's Archives of Neurology) that purports to have found a link between “brain-stimulating activities” and levels of protein -- ie, β-amyloid -- thought to cause Alzheimer’s disease (see "Brain Games May Help Thwart Alzheimer’s: Study"). The authors of the study state:

"We report a direct association between cognitive activity and [11C]PiB uptake, suggesting that lifestyle factors found in individuals with high cognitive engagement may prevent or slow deposition of β-amyloid, perhaps influencing the onset and progression of AD."

At least one patient support group supports the idea that games might be helpful in thwarting Alzheimer's Disease (see this LivingStrong web site page: "BRAIN GAMES FOR ALZHEIMER'S").

For anecdotal evidence, I have been solving 2-3 crossword puzzles per day (as recommended by LivingStrong) for a couple of years and am happy to say that I have not been diagnosed with Alzheimer's -- yet. Unfortunately, I did not have a brain scan before starting nor do I have a control group so as to scientifically prove or disprove that I am not slowly developing the disease.

Nevertheless, I still think it's unlikely that any drug company would get into the business of "drug gamification" -- ie, developing games approved by the FDA for treatment of medical conditions. For one thing, it's much more expensive getting games approved by the FDA than it is to develop the games themselves -- an economic reversal of the typical pharma drug development model.

As a consequence, it would be very easy for competitors to develop therapeutic games of their own and get them approved by the FDA, which is likely to consider such games as medical devices (they are not consumed by patients). I believe that the way FDA approves medical devices makes it easier for competitors to get similar games approved without having to finance new clinical trials. "Me too" game developers can use existing clinical data paid for by the "innovator" company as evidence of safety and efficacy.

Then there would be "over the counter" competition from games that do not have to be approved by the FDA as long as they are not marketed as being effective in treating a disease like Alzheimer's (the marketers, however, can say things like "helps improve cognitive ability").

Hey, I'm sorry to break your bubble -- ie, hype -- about the potential of gamification for the pharmaceutical industry in so far as treatment modality goes. It's not that games may not be effective in the treatment of certain medical conditions -- they could be. My point is that it is unlikely that traditional pharma companies will develop games for that purpose for the reasons cited above and in previous posts. That's my opinion and I'm sticking to it!

Cure by Gamification: Science or Wishful Thinking?

Cure by Gamification: Science or Wishful Thinking?

Last week, I wrote about a video game -- Akili, meaning "wisdom" in Swahili -- that the developers plan to submit to the FDA for approval in the hope that "clinicians will turn to before prescribing medicines for ADHD" (see "The Next New Drug: An FDA-Approved Video Game").

"We would aim to have efficacy and tolerability that outstrips any of the drugs," said Dr. Martucci, an associate at PureTech Ventures, which formed the start-up company that is developing the game.

I expressed strong doubts that the FDA would ever approve a game to treat a medical condition. Even if the FDA did approve such a game, I doubt insurers and other payers would pay for it. I also doubted that physicians would prescribe it.

This morning, James Ellis (@digital_pharma), a "digital strategist" at closerlook tweeted:

"Gamification is laughable, says @pharmaguy? I'd rather listen to what science says. bit.ly/NjIo9G"

In his blog post ("Who’s Scared of Gamification? (Besides pharma, I mean)"), Ellis says:
"But last week, Pharma Guy decided to stomp all over the idea of gamification like it was irritating pest. A game that helps kids with ADHD train their brain to not need Ritalin? Laughable! Now, I’m not picking a fight with John Mack (oh, wait. Yes I am), but he seemed to take actual joy in pointing at it and calling it names."

Let's start with the "laughable" crack. I certainly did not call this game or even the idea of developing FDA-approved games "laughable." And I did not call it a "name" other than what it's called by its developers! I also did not "stomp all over the idea of gamification" -- my post was simply about one particular game and not a critique of gamification. If you want that, Ellis, I suggest you read "A Drug is Developed:" Easier than Launching an Educational Facebook Game about Drug Development?

As for the science, I have no idea what Ellis is referring to in this case. There certainly is NO SCIENCE -- ie, clinical trials -- that I know of that proves a video game can treat ADHD. And certainly no scientific data that has been submitted to the FDA. Nor does Ellis offer ANY science in support of his thesis, which is nothing more than wishful thinking.

In the end, Ellis makes this wise crack: "maybe Pharma Guy thinks washing one’s hands before an operation is lunacy."

I have no idea where that came from! Maybe Ellis thinks wishful thinking -- ie, that science WILL one day prove Akili helps kids with ADHD so they will "not need" ritalin -- is enough for the pharma industry to go out and hire "digital strategists" to develop games. Now that's "lunacy!"

The Next New Drug: An FDA-Approved Video Game

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.

Gamification's Brave New World Circa 1984: Operation Frog

Gamification's Brave New World Circa 1984: Operation Frog

There's a lot of brouhaha these days in pharma circles about "gamification" as if it were the newest thing since sliced bread. What is "gamification," you ask? According to the Gamification.org wiki (here):

"Gamification typically involves applying game design thinking to non-game applications to make them more fun and engaging. Gamification has been called one of the most important trends in technology by several industry experts. Gamification can potentially be applied to any industry and almost anything to create fun and engaging experiences, converting users into players."

You might find this "Gaming Goes Mainstream" infographic interesting.

An example of an attempt to apply gamification to the pharmaceutical industry is the "Syrum" Facebook game being developed by Boehringer Ingelheim. The release of that game, however, has been delayed for nearly a year (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!" and "'A Drug is Developed:' Easier than Launching an Educational Facebook Game about Drug Development?").

I know from first-hand experience how difficult it is to develop educational games. I started my career -- such as it is -- back in 1984 designing an educational life science personal computer-based game. It was a simulation of a frog dissection. The objective was to use the keyboard or joystick to move a simulated hand, pick up simulated instruments, and "dissect" a simulated frog and identify its organs. At the end, the user (usually a high school biology student) was challenged to reverse the process by putting the frog back together (the game aspect). If successful, the user was rewarded with a fun animation of the (simulated) frog dancing off in a top hat and cane -- no harm done (except to the frog I dissected doing research for the simulation). The codename was "Defrogger" but it was published by Scholastic as "Operation: Frog".

Operation: Frog ran on the Apple II computer, which at the time had the most advanced graphics of any personal computer on the market. It was an 8-bit computer with a screen resolution of 280x196. You could get 16 colors using a technique called "dithering." Here's a screen shot showing the frog's digestive system:

You can count the pixels without a magnifying glass! To get this level of detail from an 8-bit 16-color computer display was quite a challenge requiring planning and storyboards (I also created the graphics and wrote the screen text and user's manual). Here's the storyboard for the dissection screen, which is evidence that I actually did this more than 28 years ago (OMG!):

In my proposal to Scholastic I said that "dissection of a living animal or one stewed in formaldehyde is an unpleasant experience for many biology students and teachers alike. Not only does it require the sacrifice of many animals, it is also expensive and potentially dangerous. Consequently, many children never carry out a dissection."

Okay, I was playing it up a bit too much. However, the program was a hit. It was  featured in the October 15, 1984 issue of Newsweek Magazine and played a role in a 1987 California court case in which Jenifer Graham, a brave 15-year-old high school girl, defended her right to refuse to dissect a frog. Ms. Graham suggested "she could learn just as much from models or computer graphics as her fellow students learn from the dissection of a frog. It seems incredible," said a Los Angeles reporter at the time (here), "that a school would resort to a dead frog, formaldehyde, forceps and scalpels in this age of computer graphics."

At the time, Ms. Graham was vilified. Unfortunately, although we've come a long way in terms of computer graphics and gaming, students who refuse to dissect real frogs are still vilified (see, for example, "Middle school student claims teacher bullied her over refusing to dissect frog").

For more Operation: Frog screen shots, see my Pinterest Gamification Board.

"A Drug is Developed:" Easier than Launching an Educational Facebook Game about Drug Development?

"A Drug is Developed:" Easier than Launching an Educational Facebook Game about Drug Development?

About six months ago in December, 2011, Boehringer Ingelheim (BI) teamed up with the Mainz Natural History Museum in Rhineland-Palatinate, Germany, to create "Ein Medicament Entsteht" ("The development of a medicine"), which was an educational exhibit seen by more than 30,000 visitors who "marvelled at the story of a drug's development cycle from the first project outline through to market authorisation." Here's the YouTube video:



Meanwhile, back in October, 2011, BI's @johnpugh was tweeting about a "kick-ass [Facebook} game" called Syrum, in which "a player must first investigate molecular compounds at a research desk before putting them to the test in the laboratory, then conduct clinical trials and, if successful, advance a treatment to market." For more about this game read "BI's Facebook Game Syrum to be Launched 'When It's Ready'."

It turns out that Syrum has been much more difficult to "bring to market" than the Mainz Museum exhibit. Syrum is still not ready to be played and is "Coming Soon" (see screen shot below taken today when I clicked on the "How to Play" button).

I'm supposed to be a "beta tester" -- someone who reviews the game before it is launched to the public -- but, so far, I haven't been given anything to test. I'm afraid this game might take longer to develop and bring to market than an actual drug!

Meanwhile, John Pugh continues to talk about Syrum at industry conferences. Most recently, Pugh presented at "Doctors 2.0 & You™" and he is scheduled to provide "A Detailed Update on the Development and Continued Use of Syrum" at ExL's 6th Annual Digital Pharma East Unconference on October 17, 2012. Of course, that depends on the gamiification development process, which we know can take years!