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.

Pharma Support of CME at Lowest Level Ever Recorded!

According to data maintained by the Accreditation Council for Continuing Medical Information (ACCME), in 2011 the percent of accredited CME revenue attributed to the pharmaceutical/medical device industry (i.e., grants, advertising, and exhibit fees) was 33.2% of total revenue received from all sources.

This is the lowest percentage attributed to commercial sources since ACCME began reporting these data in 1998 when the percent was 34.0%.

Refer to the infographic on left (find a full size view on my Pinterest page here).

These data refer to CME offered primarily to national or international audiences of physicians and other health care professionals by provider directly accredited by ACCME. It does not include data from state-accredited providers.

For the first time, the 2011 ACCME Annual Report Data features separate data sets about the CME delivered by ACCME-accredited providers and by state-accredited providers, offering an overview of the CME system at both the national and state levels.

Whereas the total commercial support for direct ACCME-accredited providers was $1.033 billion ($736 million in grants and $296 million in advertising and exhibit fees) in 2011, state-accredited providers received only $28.5 million from the drug industry ($16 million in grants and $12.6 million in advertising and exhibit fees).

As the last chart in the infographic shows, the trend in the percent of physicians opting for online CME continues to decrease. About the same number of physicians participated in ACCME-accredit CME programs in 2011 as in 2010 (approx. 11.4 million), but a lower percentage (37.8%) participated in online CME (not including live sessions and search learning). That compares to 40.1% in 2010 and a peak of 41.9% in 2009.

Why are fewer physicians participating in online CME activities? There were 25,000 online CME activities offered by ACCME-accredited providers in 2011 vs. 23,300 in 2012. The decline, therefore, cannot be attributed to fewer available activities.

UPDATE: Hat Tip to Mario Nacinovich (@nacinovich), Managing Partner, AXON, for pointing out to me that the CME numbers I quoted above should be bolstered after implementation of the FDA opioid safety plan (see "Drugmakers must pay for opioid continuing medical education programs for physicians").

The FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (find it attached to above article) calls for "education for prescribers of these medications, which will be provided through accredited continuing education (CE) activities supported by independent educational grants from ER/LA opioid analgesic companies." Unfortunately, the training is voluntary and won't begin until March 2013. The grants may or may not impact the 2012 ACCME data and reverse some of the trends noted above.

War on Counterfeit/Illegal Drugs Hobbled by Same Demons as Real War

Pfizer Intelligence Uncovers $200 of Counterfeit Viagra In Manila Raid!

"Armed with a tip from pharmaceutical company Pfizer Inc., several dozen government investigators carried out a series of rapid fire raids one day last month on what were supposed to be the key suppliers of counterfeit drugs in the city [Manila]," reports the Wall Street Journal (read the story here).

"The net result of the raids, touted beforehand as likely to be one of the largest counterfeit drug busts in the city this year, was $200 worth of fake Viagra, Pfizer's erectile-dysfunction drug."

This intelligence gaffe reminds me of the Bush-era Iraqi weapons of mass destruction intelligence gaffe that propelled us to war in Iraq. I'm wondering if the "war on counterfeit drugs" is similarly based on faulty intelligence?

Another similarity between these two types of war is the unbridled optimism expressed by those in charge. "I think we are making a dent in the problem, but it's a slow process," said Scott Davis, senior director for global security in the Asia Pacific for Pfizer and a former special agent for U.S. Customs. Smells or sounds like victory, but it's no where near actual victory.

Here's yet another analogy: the war on counterfeit (or illegal) drugs seems to be as hobbled by rampant corruption of officials as is the war in Afganistan (or Iraq). In the case of the Manila raid, an owner of a couple of the target warehouses "bragged that he knew the NBI's [the Philippine's National Bureau of Investigation; i.e., the country's FBI] lead investigator on the counterfeit drug case and the deputy director who authorized the raid." After the raid turned up practically nothing, "the owner and the government agents walked a block away to lunch at Maxim's Tea House, a Chinese restaurant, according to people close to the investigation." That lunch probably cost more than $200!

It was interesting that the raiders found what they thought was counterfeit Cialis -- an ED drug marketed by Eli Lilly. Unfortunately, they did not have a search warrant for that illegal product, so no one was arrested.

It appears that Pfizer and Lilly did not share their intelligence data in this case, otherwise the NBI could have had a more inclusive search warrant.

This begs the question: Is the drug industry working together as allies in the war on counterfeit/illegal drugs? Are they sharing intelligence? Or is this also "proprietary" information that each company wants to keep close to its vest?

Days of Live Pharma Reps are Numbered: M&A's and Outsourcing - the "Bain/Bane" of the U.S. Pharma Industry

Last night, my sons and I attended a NJ BioPharma Networking Group (NJBPNG) meetup at the Princeton Sports Bar and Grille. NJBPNG is an ad hoc LikedIn group, which you can join (here).

This group is mostly comprised of senior pharmaceutical executives in the research side of the drug industry (click on infographic on the right for more NJBPNG demographics).

It was a good night out with my sons, but not so upbeat for most of the people I met there, many of whom are out of work -- including PhDs, organic chemists, and project  managers.

When meeting new people I usually ask "What do you do?" The most frequent answer I received last night was "I'm in transition," which is one of those "Awkward Euphemisms" for out of work and looking for a job (see other euphemisms listed by Michael Spiro, a professional recruiter, on his blog here).

When I asked "Why?", the response was either mergers and acquisitions or outsourcing, which, I note, was the specialty of Bain Capital in its glory years. Sorry, I just had to throw in a Romney reference and relate "Bain" to "Bane" (i.e., the super-villain nemesis of Batman).

Seriously, outsourcing in the pharmaceutical industry is on the rise. Clinical research is being outsourced to countries like India, and China. Basic research is also being outsourced to startup companies and academia and maybe even overseas.

I also met a few people who are doing very well, thank you. One was the owner of a sales outsourcing agency that specializes in non-personal pharma sales and marketing; i.e., sales calls done by phone via a call center.

"This year has been my best year ever," said this person. He's been doing this for several years. In fact, his prediction for the future of live sales reps is dire: "they will disappear."

Frankly, I had hoped that my son -- a recent Penn State Smeal College of Business graduate -- would make some connections at the meetup that could help him find a job. He doesn't have any pharmaceutical experience, which is what a young recruiter attendee was looking for. Perhaps my son should become a recruiter -- if you aren't qualified for a job, maybe the next best thing is finding a qualified person.

But we learned of one job that my son IS qualified for: one of those people on the phone at the call center mentioned above. It turns out that this is a low-paying, entry-level job paying about $20 per hour. You don't have to be a nurse or former pharma sales rep. In fact, such people are over qualified for this sort of non-personal sales and marketing.

Just like young, entry-level commercial airline pilots bunk together in small apartment nearby airport hubs, young call center employees relocate near the call center and share low-rent apartments. Sounds like Penn State to me!

What advice should I give my son? Should he apply for a job at the call center?

Meet “Ceyockey,” an Astrazeneca Pharma Wikipedian

The most visible and most accessed example of crowd-sourced “creative commons” information is Wikipedia where “wikipedians” – i.e., people who write and edit the pages for Wikipedia – create drug information pages such as the one about rosuvastatin (“marketed by AstraZeneca as Crestor”).

“Nearly 75% of US physicians going online for professional purposes are visiting Wikipedia for medical information according to Manhattan Research,” says Eileen O'Brien, Director, Search & Innovation at Siren Interactive. “And 36% of US consumers searched for health info on Wikipedia according to Rodale's DTC Study. This is because Wikipedia dominates the search results for health. As Wikipedia plays such a key role, I think it's essential that pharma help to provide accurate information.” O'Brien made her comment in response to the this survey: Should Pharma Edit Wikipedia Articles? You can take the survey here -- afterward you will be able to see a summary of the results to date.

There may in fact be several “wikipedians” responsible for a single page of drug information on Wikipedia. The rosuvastatin page, for example, was edited by over 175 people as of 21 July 2012. The top three “editors” were:

1. “Ceyockey” (who made 35 edits),
2. “Jfdwolff” (who made 29 edits), and
3. “MALvis” (who made 23 edits).

The person who is number 4 on the list with 15 edits is "anon."

Who are these “wikipedians” and what credentials do they have as credible sources of drug information? We may never know who "anon" is, but we have some information about identified contributors.

“Jfdwolff” is a a "Dutch doctor living and working in the United Kingdom." “MALvis” is a US physician, "specializing in preventive, non-invasive and invasive cardiology and internal medicine in San Antonio." Both seem to be well-qualified to write about rosuvastatin, but their Wikipedia profiles tell us nothing about possible conflicts of interest (COI).

“Ceyockey,”  however, does have a COI. He is Courtland Yockey, an “informatics scientist” who lives in Delaware and works for a “top-10 multi-national pharmaceutical company,” according to his profile on Wikipedia.

Yockey has nothing to hide. You can find his Wikipedia profile here,  his LinkedIn page here, his Twitter account  here, and his Facebook page here.

According to his LinkedIn page, the pharmaceutical company that Yockey works for is Astrazeneca, which markets rosuvastatin as CRESTOR.

“I believe that my editing of Wikipedia is generally beneficial,” says Yockey in his Wikipedia profile, “and I have no regrets or concerns about anything that I have or will create or revise here, which is why I am willing to provide my real name.”

Whether or not it is “beneficial” for individual pharma company employees such as Yockey to be editing Wikipedia information about their own company’s products is difficult to know for certain. Transparency, however, is crucial for judging credibility of drug information on Wikipedia. Yockey addressed transparency head on in a straight-forward fashion, although he failed to state unambiguously  in his Wikipedia profile that he works for “Astrazeneca.”

Did Astrazeneca empower Yockey or give him permission to edit Wikipedia pages about AZ drugs? That is, is Yockey an "official" Wikipedia spokesperson appointed by Astrazeneca to perform all Wikipedia article edits on behalf of the company? I doubt it. Yockey's profile specifies that he works on edits from home.

Official pharma employee Wikipedia editors and related issues were discussed during a recent Pharma Marketing Talk podcast titled “Pharma Wikipedians: The Pros and Cons of Pharma Employees Editing Wikipedia Articles” (listen here).

It's possible to determine the exact edits Yockey has made to the Wikipedia rosuvastatin page, but I do not have the time or resources to find that needle in a haystack of thousands of edits Yockey has made to Wikipedia articles over the years. Wikipedia is not user-friendly enough to allow ordinary citizens to ferret out that kind of information, IMHO. For all I know, Yockey could have written or edited the section titled "Debate and criticisms."

Another problem with Wikipedia drug information pages is that they are not consumer-friendly -- i.e., not written at a level that is understandable by non-physicians. The Wikipedia rosuvastatin page, for example, says "as with all statins, there is a concern of rhabdomyolysis, a severe undesired side effect." Unfortunately, the article does not explain what rhabdomyolysis is in layperson terms.

Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite.

A little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA, pdf), which was signed into law by president Obama on July 10, 2012, simply states:

SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE INTERNET.

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

Does that mean the FDA will deliver? If not, it wouldn't be the first time that a government agency missed deadlines imposed by Congress.

Usually, Congress specifies that regulatory agencies must issue regulations that spell out how to comply with the laws it passes. Regulations, therefore carry the weight of law. FDA Guidance (guidelines), however, is just FDA's current thinking on a topic. "It does not create or confer any rights for or on any person and does not operate to bind FDA or the public."

So, if FDA misses the deadline set by PDUFA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

The only thing interesting about this provision of the PDUFA act is why it was included and who lobbied to have it included? It couldn't have been Pfizer (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"), but it could have been PhRMA (see "PhRMA Statement on FDA Social Media Guidance Delay").

OMG, LCOI! Open Source Pharma: Creative Commons Coming To Pharma

I had an interesting phone conversation yesterday with Jerry Matczak, Community Manager, Lilly Clinical Open Innovation, Eli Lilly and Company. Yes, "Open" and "Innovation" together in the same phrase from a pharmaceutical company - OMG! LCOI is the acronym for Lilly Clinical Open Innovation, a venture that Lilly hopes "can transform clinical research and development." How will they achieve this? "We look to engage in the open for insight, innovation, talent and wisdom to drive new capabilities to fight disease and meet patient needs." There it is again, "open" and "innovation" in the same sentence.

The devil is in the details and I hope to interview Mr. Matczak soon on my Pharma Marketing Talk show.

It's was a happy coincidence that my conversation with Matczak followed yesterday's show about "Pharma Wikipedians: The Pros and Cons of Pharma Employees Editing Wikipedia Articles" (use the playback widget below to listen to that podcast).

Listen to internet radio with Pharmaguy on Blog Talk Radio

An even happier "coincidence" was an audio commentary from my friend Brad Pendergraph (@bradatpharma), former Senior Manager, Consumer Digital and Social Engagement at Novartis, in response to a question raised during my show.

Brad posted his commentary to Audioboo, which is "a simple way of recording audio while on the move and adding as much useful data to it as possible, such as photos, tags and location." Audioboo is the audio equivalent of Twitter -- you can record as many 3-minute audio messages from your smartphone as you like. I signed up immediately so that I can post Auioboo comments while on the road at drug industry conferences.

In his audio commentary, Brad touched upon how pharma deals with proprietary information. "Is pharma really going to let some of its information 'go general'?," Brad asked. He mentioned "creative commons" and "taking a look at what material you [pharma] have and figuring out how you can distribute it to people in the social media space in ways that they can understand and work with that are still compliant." Brad was suggesting pharma use creative commons rather than the more restrictive copyright when distributing information. Listen to his comments using this Audioboo playback widget:

listen to ‘A quick response to a question raised during @pharmaguy blog talk on Wikipedia.’ on Audioboo

Meanwhile, back at LCOI, here's their take on "open Innovation" published on the LCOI website (here):

There’s plenty of evidence that drug development is broken. The estimated efficacy rate of drugs for many common illnesses comes in at 50% or below, and a recent Forbes article by Matt Herper suggests the cost of bringing a new drug to patients is twice the already-big-number commonly used – over $4 billion per drug.

Patients need better.

The Lilly Clinical Open Innovation team exists to make it better. We believe 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.

We’ll explore challenge driven innovation and gamification to tap into expertise which might otherwise be missed. We embrace open source development to maximize technical contribution and benefit, and will Work Out Loud to assure transparency on our projects. To manage rights in a distributed digital age we leverage Creative Commons licensing. In the open, with no strings attached.
That’s a lot of buzzwords, and even more to actually try to do. Too much for the smallish Lilly COI group for sure – but that’s kind of the point. Open Innovation promises that we can all play bigger than we are, and enables greater innovation than any individual or organization can accomplish on it’s own.

Keep tuned for an announcement of an upcoming show where I will interview Jerry and Brad about "Open Source Pharma."