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."

"The Crowd is My Only Drug," Says GSK Olympics Anti-Doping DTC Ad Campaign

GlaxoSmithKline (GSK) will raise awareness of its role in anti-doping measures at the London 2012 Olympic Games as part of its first consumer-facing corporate campaign in the UK (see here).

Advertisements will appear across a range of media, including television, and outdoor advertising space, commencing July 23. One TV ad is currently available on Youtube:



Obviously, when the athlete star of this video is quoted as saying "The Crowd is My Only Drug," he means illegal drugs that some athletes may use to boost performance, not the drugs sold be GSK for legitimate use. But I wonder if social media "crowds" -- as in "Wisdom of the Crowd" -- can replace some Rx drugs for some people? I'm thinking about GSK drugs such as diet pill Alli and diabetes drug Avandia, both of which have been problems for GSK (see here and here).

JNJ Attempts YouTube Humor to Promote a DTC Advertising Goal

The goal of every direct-to-consumer (DTC) ad is to get people to visit their doctors and ask about the advertised Rx drug. But are these ads effective?

The drug industry often defends DTC ads, claiming they ARE effective in achieving this goal. Some studies, however, seem to indicate that once people visit their physicians, they do not ask for the advertised drug (read, for example, "Advertisers Don't Know How DTC Works. Say wha?").

But the ads may not even be effective in driving people to see their physicians. Maybe that's why Johnson and Johnson (JNJ) recently promoted a YouTube video it uploaded more that two years ago called "The Appointment." It's an non-branded attempt to use humor. JNJ's corporate Twitter account (@JNJComm) recently posted this tweet:

"Afraid to visit the doctor? Don't be! Watch 'The Appointment' for medicinal laughter - and important info > http://t.co/0PQanPNF @JNJVideo"

On the YouTube page, JNJ introduces the video: "Many people are wary of making a doctors visit. In The Appointment, some extreme humor works to make several important points about why you should visit your doctor and most importantly things you should not be afraid to understand and ask. Enjoy and no, there really isnt a needle that big!"

Here's the video:




A few people do not think the video is funny. One commenter (yes, JNJ accepts comments on its YouTube channel) said:

"I'm not one to start a YouTube spitting contest - I'm just saying that this seems to be a bit (not massively!) insensitive to both the clinicians and the patients who are trying to treat each other better. Your ultimate message in the vid is perfect - it just strikes me as missing the mark in its opening approach."

One commenter even said it was "misguided":

"Wow. I'm sure you meant it to be funny, but I have to say, this is the worst-conceived pitch I've ever seen for being an empowered patient. In addition to the patient looking like something of a simpleton, to me it charicatures doctors in the worst possible way too.. I'm sure y'all meant well, but wow, this is misguided."

To which JNJ replied:

"I understand and respect your point of view. It was supposed to be a lighthearted reminder to those who might not be practicing preventive care. You are already an informed, empowered patient who has dealt with, and become educated about, a life threatening disease. Although it uses caricutures of doctors and patients, the video is aimed at those who might have misconceptions or fears about visiting their doctors for annual check ups and other routine care."

What do you think?

EU's EMA Plans to Open Up Proprietary Drug Trial Data to Outside Investigators

European Medicines Agency (EMA) -- the European drug regulator -- "is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information," according to Reuters news (here).

This is big news depending on how EMA makes these large data sets available to outside investigators and which investigators are granted access. Reuters reports that the agency will host a conference in November to determine who has access to what and how fast. As I always said of the FDA, if an agency wants to delay something, its best bet is to hold a meeting to discuss it or sponsor research to study it.

The drug industry has long argued that the clinical data it presents to the FDA and other regulators as part of the drug approval process is proprietary -- ie, closely guarded trade secrets. But critics contend that important safety data about drugs is hidden from outside investigators and the data is critical for maintaining public health.

"It will make a huge difference to public health," said Peter Gotzsche, director of the nonprofit Nordic Cochrane Centre in Denmark, which carries out systematic healthcare reviews. "The pharmaceutical industry routinely exaggerates the benefits of its drugs and plays down the harms or hides them. By getting access to material held by drug regulators we may discover that many drugs are less effective than we thought they were and also more harmful."

In 2011, Gotzsche wrote paper titled "Why we need easy access to all data from all clinical trials and how to accomplish it." In it, he said "Calls for data sharing have mostly been restricted to publicly-funded research, but I argue that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests" (find the full text here: "Call for Easy Access to ALL Clinical Trial Data").

A case in point is Vioxx, whose harmful side effects once were secrets known only to Merck and the FDA.

"Europe used to be behind the FDA in terms of openness and transparency but now Europe is ahead," Gotzsche said. Will the FDA ever follow EMA's lead?

I doubt it. FDA has been very gun shy of the pharmaceutical industry, which pays over 60% of the agency's budget for approving drugs. Also, the drug industry has no qualms about taking the FDA to court to defend itself. Usually, the FDA is sued by pharma for limiting the industry's First Amendment right to free and open speech. In this case, however, the industry would argue that FDA has no right itself to "speak" freely about clinical data provided to it by drug companies.

UPDATE (7/16/2012): While the EU plans to provide access to "confidential" clinical trial data, the FDA is prohibited by LAW to do so. The Wall Street Journal reports that the FDA is monitoring some of its own employees who are suspected of leaking confidential medical device data to the press (read about this here).

“We do things at Pfizer that are best for shareholders of Pfizer." You Gotta Problem with That?

I can't believe a Pfizer "spokesperson" (Corporate Secretary and Chief Governance Counsel, Matthew Lepore) said:

“We do things at Pfizer that are best for shareholders of Pfizer" 

when defending Pfizer's continued financial support of Heartland Institute, an organization whose president Joe Bast claimed that the public health community has a campaign to "demonize smokers" based on "junk science" (find the story here: "Pfizer Refuses To Pull Funding From Anti-Science Front Group").

Among the books authored by Joe Bast is "Please Don’t Poop in My Salad (and other essays opposing the war against smoking)" (see his 2008 resume here).

First of all, it's shameful for a drug company that on one hand promotes campaigns to help people quit smoking (eg, CHANTIX direct-to-consumer commercials) while on the other hand supports an organization that believes anti-smoking campaigns are based on "junk science." How does that resonate with people who are taking CHANTIX?

Secondly, doesn't Mr. Lepore know that Pfizer's trademarked slogan is "Working Together for a Healthier World" and NOT "Working Together for a Profitable Investor"?

Lepore also stated that Pfizer "isn’t concerned" by the decisions of Eli Lilly, GlaxoSmithKline, and Bayer, to disassociate themselves with Heartland. "We can't be very knee jerk on every issue that is brought to our attention," said Marc Scarduffa, Vice President, Government Relations & Public Affairs.

Which reminds me of a typical New Yorker conversation ender: "You gotta problem with that?"

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.

Can Pharma Cure Alzheimer's Disease? A Pfizer Pre-Launch Multichannel Marketing Case Study

Last month I quipped on this blog that "Pfizer's Social Media Initiatives are Getting Old." Actually, that was a review of Pfizer's new "Get Old" initiative, which Pfizer says is a "first-of-its-kind online community" where people can "get and share information, add to the dialogue and contribute to the growing body of knowledge about this important topic."

In that post, I suggested that Pfizer's real goal was to court advocacy groups such as the Alzheimer’s Association in advance of the announcement of results from an Alzheimer clinical trial of its drug ddsigned to treat the disease.

Just a couple of days ago, on the CBS Evening News, I saw an interview of Rae Lyn Burke, "An Alzheimer's researcher who is also a patient." Ms. Burke is participating in a clinical trial of bapineuzumab (bap-ih-NOOZ-uh-mab), a drug with a funny, Irani-sounding name. Turns out that bapineuzumab is a Pfizer/Johnson and Johnson drug.

Ms. Burke's participation in an Alzheimer clinical trial is old news. According to an August, 2011, San Francisco Chronicle story (here), "Burke worked on some of the initial research into bapineuzumab" (her LinkedIn profile indicates that she is "senior Director at SRI International," a CRO that is likely running the Pfizer Alzheimer clinical trial).

The 2011 story also revealed that "Burke has been in the trial for almost two years, and should find out shortly whether she's been receiving the active drug or a placebo. If she's on the placebo, she intends to switch to the active drug as soon as possible.

She obviously was in the bapineuzumab arm of the study, or switched, because in her recent CBS interview she said that she taking the drug and it was "slowing the decline, but I don't think it's making me better." That's too bad.

Is this all part of Pfizer's multichannel marketing of bapineuzumab prior to its approval by the FDA (if indeed it ever does get approval)?

It's no coincidence that Burke's story was resurrected shortly before results from key studies of two Alzheimer's drugs -- including bapineuzumab -- are to be released. But the journalism stinks: the CBS Evening News story is practically the same, word-for-word as the 2011 San Francisco Chronicle piece cited above. Maybe CBS owns the San Francisco Chronicle or maybe it's becoming more like a blog rather than a primary source of news.

There are also stories in newspapers about these trials, such as this one from the Mercury News: "Alzheimer's drugs could be pharmaceutical industry's last-gasp efforts to cure disease" and this one from the Denver post: "Alzheimer's cure may lie in three drug (sic) tested over past decade." Both of these stories are based on the same AP story, which does NOT mention "cure" but says the drugs are meant to "slow the course of Alzheimer's disease."

I always find it odd that reporters often overstate the efficacy of drugs, sometimes in collusion with drug companies (see, for, example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons"). Perhaps the local news reporters were influenced to use the word "cure" by Pfizer, JNJ, Lilly, and/or Baxter PR parrot trainers?

As I mentioned in my "Get Old" post, institutional investors doubt that treatments for Alzheimer's disease being developed by Pfizer (and Lilly) will "achieve the main goals of their ongoing late-stage trials." Those goals certainly are NOT to CURE Alzheimer's, but only "aim to clear the sticky plaque gumming up patients' brains."

"Everybody in the field is probably holding their breath that there is something positive to come out of these trials," said Dr. Ronald Petersen, director of the Mayo Clinic's Alzheimer's Disease Research Center. "It may not be a home run" in terms of improving memory and cognition, but if brain imaging or spinal fluid tests show the drugs are hitting their target, "they will be regarded as successes," he said.

Next week, at the 4th Annual Social Communications & Healthcare: Case Studies and Roundtables confernce in NYC, I hope to discuss this with Pfizer's Andrew Topen (VP of Global Media Relations and Digital Communications), Caroline Roan (VP of Corporate Responsibility and Reputation), and/or  Bob Libbey (Senior Director of Global Colleague Communications). These exceutives led the GetOld.com site project and will present the Get Old Case study ("Pfizer Starts a Conversation about Aging") at the conference.

NOTE: Pharma Marketing News is aMedia Partner for this conference. You can get a $20 discount off registration if you have the secret word, which you can find here.

Multichannel Marketing: Easy to Brag About, but Difficult to Do

"Multichannel pharma marketing [see PMN glossary definition: MCM] is conceptually relatively simple to understand, but incredibly difficult in practice," says Len Starnes, former Head of Digital Marketing & Sales, General Medicine at Bayer Schering Pharma. "That said, multichannel is not a transient phenomenon, it’s here to stay," according to Starnes, who is a candidate for this year's Pharmaguy Social Media Pioneer Award.

Len is well-known for his LinkedIn surveys, such as a 2009 survey that asked "Will doctors’ social networks radically change pharma marketing & sales?" Thirty-one percent of respondents to that survey thought this would happen within 2 years (by 2011) and 38% said within 5 years (2014). For more on that, read "Socially Challenged Pharma" (PMN Reprint#84-03; pdf). I think it hasn't happened yet, but multichannel marketing (MCM) to physicians these days must surely include social media "channels" and even more importantly mobile.

But given the "incredible difficulty" of implementing MCM, Starnes is hosting another survey on LinkedIn (here), which asks "Will pharma marketing become de facto multichannel marketing in future?" The results to date are shown in the chart below (click on chart for an enlarged view).

There seems to be overwhelming sentiment that MCM will be de facto for pharma within 5 years.

Starnes' survey also has generated a good number of comments, some of which I include below. My own opinion, however, has to do with the difficulty of implementation vs. the ease with which pharma marketers talk about MCM, which used to be called "Customer Relationship Marketing (CRM)."

I've attended many pharma marketing conferences in the past that focused on "CRM." These days, however, I don't see any CRM presentations included in conference agendas, whereas there are conferences dedicated to "Multichannel Marketing." More often than not, these conferences actually focus on digital marketing. The upcoming Pharma Marketing Show (Europe) is a good example (note: Pharma Marketing News is a Media Partner for the conference; however, I have not been paid to write about it on Pharma Marketing Blog). It's description includes this observation:

"The pharmaceutical marketing sector is fast moving with new marketing techniques developing to meet the wider challenges of the industry. Over recent years, pharma has learnt what emerging technologies such as online and mobile can offer to a marketing campaign."

There are somd very interesting presentations on the agenda; even a couple that address the "difficult" part of MCM: data collection and management (propeller head stuff) such as:

• Managing and analysing vast amounts of data
• How can pharma utilise data to enhance strategic marketing?
• Using big data to integrate multiple sourced customer information and improve quality of customer engagement

In my mind, pharma marketers are "old school", meaning they believe marketing is more of an art than a science (see, for example, "Are Marketers Artists or Mathematicians?").

When I talk to my nephew who sells digital media advertising, it's all about numbers and esoteric measurement terminology, which is way over my head. These numbers, I bet, cause many pharma marketers' eyes to glaze over. But for MCM to be successful, more pharma marketers must become "propeller heads" or hire, enable, and listen to them, IMHO.

OK, enough about my opinion. Here's a sampling of what experts are saying in relation to Len Starnes' LinkedIn survey:

Christopher Wade said: Len - good question! It's not surprising that the consensus is that MCM will become the norm - in terms of aspiration if not actual reality - over the next few years, but I suspect that like other tech-dependent initiatives it will remain the preserve of the few if it sits in the same marketing organisations that exist today. My opinion is that one of the key points on which pharma trips time and again is that sales are nowhere to be seen. Marketing's role as understanding the product / customer / need space and formulating tactics is no less important, but the group that has the information, resources and experience in executing complex activities is the sales force, or more specifically the SFE / SFO group. I would hope that marketing has access to a level of analyst support that helps them to identify key segments and understand their behaviour and preferences, but implementing is where sales excels - they just need to realise that their competence spans more than the rep/territory model.

Robert Nauman said: Excellent discussion. Thanks for asking the question. I honestly have to say no. My rational is born from the assumption that good Multi-channel marketing requires some interaction on the part of the other party. We all suggest it is the marketing paradigm that has to change here. I am growing skeptical in my belief that will occur anytime soon on the patient or the HCP side, can industry create a real two way dialogue. And given the recent US case with GSK and there $3Billion whistleblower settlement, My opinion is that other entities (not supported by pharma dollars) will be producing the content that meets the needs of healthcare consumers and professionals today. And pharma marketing will not be paying for that content creation. I believe that if truly tested, pharma produced content scores very poorly to content produced via other healthcare entities. In terms of the multi-channels, it adds a level of complexity that in the silo'd world of pharma marketing today, may not be operational. The grow of mobile and video's use in that channel is tremendous. And in developing nations, SMS messaging is making great strides in improving health care yet the industry is not leading in either of these approaches. It is sad, but I believe this is pushing marketers into similar roles that we see in the medical device industry today. Very few marketing dollars, very little innovation.

Paul Simms said: Great question, Len. You're good at these! Rob, hope you're well (haven't spoken in ages...) I wanted to respond to your point, which unfortunately saddened me. I see every industry in the world, with the exception of pharma, investing in 'content' as a way of engaging its audience - because it works.Yet pharma still seems reluctant to engage those who can speak in the doctor's language (the medical affairs / liaison folks) fully as a communication device. These days we have simply moved from physician access to now worrying about payer access and soon it will be fretting over patient access. To me it feels like pharma continues to create the equivalent of a TV channel that plays only commercials - and that's never going to create high engagement or trust. Stuck on the one blaring channel, night and day. Yes, you are right, pharma is starting from a difficult position and news like that from GSK doesn't help. But are you resigning us all to eternal oblivion? To me the only way to dig ourselves out of this rut is to begin to produce content of value (let alone services of value) and to build those bridges. Otherwise pharma, and by default, healthcare will never reach its true potential. It is possible for GSK et al to produce content of value and to build trust that way. As for multichannel, I can't believe we're talking about it like it's something revolutionary (yes I'm guilty of running events on the topic but that's only because it's what everyone tells me they want...). I'm personally astounded we're even bothering to distinguish between the channel at all. Indeed it's a gross manifestation of the focus on the medium rather than the message. As some have said, we should simply provide valuable wisdom in whatever convenient format our customers request, and use technology to adapt to multiple channels in a semi-automated fashion. Again, that's what other industries do. Can you imagine FMCG or other B2C industries having a big debate about multichannel???

Len Starnes: Reflecting on the comments from both Rob and Paul I am fully convinced that pharma is capable of providing ‘content’, via whatever channel is necessary, and that HCPs want the industry to deliver it – but it must be on their terms. Using Paul’s TV analogy this would be a shift from airing commercials to running full-on documentaries. I state this having recently spoken to a leading doctors’ social network here in Germany, Esanum, who’s CEO confirmed that 80% of its 33,000 members want to access pharma ‘content’ and engage with pharma peers (aka Medical Affairs, MLOs). This once again reconfirms my research with similar networks globally which indicates that the majority of community members welcome industry engagement of all types. What astounds me is that pharma largely continues to ignore these networks in its multichannel efforts - snail mail and email still appear to be brand managers’ favourites.

More here...

Are Pinterest Women & Virality Worth It to Pharma Marketers?

Once again I am responding to a Pharmaforum guest blogger post that was promoted by the author (Kelley Connors) on Twitter: "How Pinterest Creates the Love for #Healthcare #Marketers #hcsm #pharma #womenshealth #socialmedia @pharmaforum ow.ly/c8jiF"

Connors' post, entitled "Understand the rules of engagement with Pinterest" (here), starts out with this observation:

"Since healthcare is such a personalized experience, and 90% of healthcare decisions are made by women, I find it interesting that more healthcare marketers aren’t exploring Pinterest."

She forgot to add that 82% of Pinterest users are women (see data in this infographic).

Pinterest, according to Connors, beats Twitter hands down in terms of "engagement" and "virality."

"Remarkably," says Connors, "over 80% of pins are repins, demonstrating the impressive level of virality at work in the Pinterest community. By contrast, a study conducted by HubSpot at a similar point in Twitter’s history found roughly only 1.4% of tweets were retweets."

From my experience, Twitter drives much more traffic to websites than does Pinterest. I learned about Connors and her post, for example, via Twitter, not Pinterest. What's the purpose of "virality" if it doesn't drive people to your website where you can "close" the deal (ie, get subscriptions, distribute coupons, etc.)? Maybe it's different for shoes than for Rx drugs or B2B pharma marketing news items.

There is one other very important reason why pharmaceutical marketers do not use Pinterest: they cannot turn off or moderate comments like they can with Facebook and YouTube. The only Pinterest comment editing option -- as far as I know -- is to delete the pin and repin it without the comments. That is draconian (it deletes ALL comments, not just offending one) and labor intensive. Pharma is not only worried about possible adverse events mentioned in comments, but also off-label claims. For more on this, read "What's Your Infographics Strategy?" (use discount code 'pgpin4').

These problems may never arise if pharma pins only innocuous images and videos on Pinterest. That is, pins whose purpose is to generate goodwill, share disease information, promote corporate responsibility, and broadcast other non-branded messages. All of which are of no interest to pharmaceutical marketers who want to promote brands.

For some reason, however, Pinterest is of interest to a few pharma corporate communicators and PR preople. Therefore, you do see a few Pinterest sites that obviously are corporate PR campaigns. Unfortunately, however, the demographics of Pinterest (82% women and mostly consumers) is NOT the target demographic of PR people who want to reach mostly reporters and investors.

Ergo, IMHO, as long as Pinterest does not have a pharma-friendly commenting policy, it will not interest pharma marketers even though its "women's world"/consumer demographic and virality is enticing to them. In addition, Pinterest will not generate much ROI on pharma PR investment. Eventually, the pharma Pinterest pioneers, few though they may be, will drop out even though, as Connors surmises, the Pinterest net "attrition rate" overall is "close to 0%."

Blaming the FDA for Pharma's Tepid Use of Social Media

A tweet by Paul Tunnah (@pharmaphorum) caught my attention this morning:

"…the FDA social media regulations for pharma marketing are extremely strict…" bit.ly/NaPU7h #pharma #socialmedia

This linked to a blog post "Social media challenges and benefits for pharmaceutical companies" by Rodica Ceslov, president of Wild Frog Studio, "a dynamic full-service firm helping companies create go-to-market strategies and execute product launches for new products, new product line extensions and re-packaging existing products."

The full quote from Ceslov is "the FDA social media regulations for pharma marketing are extremely strict, and at the same time still somewhat ambiguous, lacking clear structural boundaries that are needed to prevent unwarranted issues."

How can FDA social media regulations be "extremely strict" when there are NO such regulations (ambiguous or otherwise)?

What the drug industry is looking for is "guidance" regarding how the FDA will interpret existing regulations, which are media agnostic. Even if FDA does issue such guidance, it is not legally binding. Some pharma companies -- eg, Pfizer -- are looking for new regulations, which would be legally-binding (read "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").

So, it's more a matter of how pharma INTERPRETS existing regulations without guidance from the FDA. Some pharma companies are more comfortable than others when it comes to doing this as they launch social media marketing campaigns. Pfizer even claims to have a "Social Media Playbook" (read "Is This Pfizer's Social Media 'Playbook?'")

So far, however, no pharma social media communication/campaign has been cited by the FDA for violating any regulations unless the communication overstates efficacy or understates risks (ie, says things that are against regulations no matter what the medium).

The FDA has come out with guidance on responding to unsolicited requests, which include guidance on how to handle off-label drug information requests via social media such as YouTube and blogs (read "FDA Guidance on Responding to Unsolicited Requests for Off-Label Infnrmation Via Social Media").

This guidance is actually neither very strict nor very ambiguous. So stop blaming the FDA for preventing pharma companies from using social media!

P.S. Ms. Ceslov works for an agency that obviously wants more pharma clients. Her blog post promotes a "3 Step eBook" called "How to Succeed in Social Media." My advice to pharma on how to succeed in social media is this: pick your outside agencies with care. For more on that, read "PR vs Interactive: Agencies Vie for Pharma Social Media Campaign Crumbs."

The 3rd Annual Pharmaguy Social Media Pioneer Award

If you are a regular reader of Pharma Marketing Blog, you know that I generally do not like awards sponsored by pharma trade publications (see “Awards. What Are They Good For?”). Such awards are somewhat suspect because of the inherent conflicts of interests involved -- the winners tend to be the agencies that advertise the most in the sponsoring publication or that purchase big page ads announcing that they won the award.

The Pharmaguy Social Media Pioneer Award
Defenders of pharma “social media” site awards insist that we must reward even the most elementary attempts that pharma is making to have online conversations despite all the regulatory obstacles that they face. I agree. But instead of having awards for the work product, why not give awards to the pioneers who have lead the way to create these sites? We can learn more from how these pioneers overcame the obstacles to launch a social media project than from the end result – even if the end result is flawed or faux.

Sometimes, pioneers work "behind the scenes," making it possible for their colleagues to develop customer-facing social media projects. We must recognize these efforts as well. Marketing campaigns and Web sites come and go, but pioneers move on to new positions and continue to spread their influence far and wide.

To better recognize the value of these pioneers, I launched the Pharmaguy Social Media Pioneer Award in July, 2010. The first award went to Alex Butler (see here) and the second award went to Tony Jewell (see here).

The Pharmaguy Social Media Pioneer Award is meant to recognize pioneers who work (or have recently worked) within regulated drug and device companies. The award recognizes courage in the face of regulatory and corporate culture boundaries!

What's With the Hawaiian Shirt?
Let me explain the Hawaiian shirt motif of the award. Around the time that the FDA announced it would hold a public hearing regarding regulation of pharma’s use of the Internet and social media, I started appearing at conferences in a yellow Hawaiian shirt, which was left over from a Hunter S. Thompson Halloween costume (see “Pharma Social Media Crips vs. Legal/Regulatory Bloods: Call for a ‘Peace’ Conference” for a sighting of me in the shirt at the 3rd Annual Digital Pharma East Conference). I also considered wearing the shirt when I made my presentation to the FDA at the November, 2009 meeting (see “Fear and Loathing in Washington, DC”), but out of respect for the FDA and the audience, I opted for a traditional suit and tie.

Although I didn’t wear my Hawaiian shirt at the FDA hearing, it became an emblem for standing out from the crowd, which is a necessary trait for a social media marketing pioneer. I think a Hawaiian shirt motif befits, therefore, what the Pharmaguy Pharma Social Media Pioneer Award stands for.

The Nominees Are…
I have several people in mind as contenders for this award (see the end of this post), but first let me discuss what I consider to be the qualifications for nominees.

What are the qualifications to be nominated to receive this prestigious award?

First, a nominee must work or have worked within an FDA-regulated pharmaceutical, medical device, or biotech company when he or she pioneered in social media marketing or non-branded communications or was an advocate for such. Although there are many people in agencies that are true social media pioneers and who have been involved in many pharma social media projects, only the insider has the experience and courage I am looking for. The insider has to contend with many stakeholders inside the organization and is ultimately responsible for the project. Consultants and agencies do not have nearly as much skin in the game as do insiders.

Although some pharma social media pioneers have subsequently moved on to other positions in non-pharma companies (see, for example, "Is There an Upward Career Path Within Pharma for Social Media Pioneers?"), they are still eligible for consideration as nominees for the Pharmaguy Social Media Pioneer Award.

Second, a nominee must have been a true social media pioneer. By that I mean someone who has been involved from the early days in marshaling the forces necessary to ultimately build a social media campaign. No matter if the campaign has been a failure. We often learn more from our failures than from our successes. Above all, we want nominees who have learned and who can share their learnings with us.

Third, although it is not necessary that a nominee to have experienced a “Mack Attack” such as that experienced by Novo Nordisk’s Ambre Morley (see “Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!”), it can’t hurt, especially if that person has survived and gone on to be interviewed by me (eg, “Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter”).

The type of social media that a nominee has been involved with is immaterial as long as it is one or more of the following: a blog, a Twitter account, a Facebook page, a network (community), a YouTube channel, etc.

That’s about it for qualifications.

Who Will Nominate Candidates and Determine Who Wins an Award?
Since this award has my Twitter name associated with it, I take ultimate responsibility for who to consider for this award and who wins an award. I already have several candidates in mind (see below).

However, I also depend upon my readers and colleagues to assist me. You can vote for my nominations and write-in other candidates using the online form here (sorry, voting is closed; see a summary of the results here). Not only your vote, but the comments you add will go a long way awards influencing me, especially if you offer details that back up your choices. I especially need help identifying former pharma people who may be working at agencies, but who did a lot of their social media pioneering while employed at a pharmaceutical company.

Ultimately, I will use my best judgment and experience to decide who is qualified to enter the contest and who wins an award. My decision is final.

NOTE: It occurs to me that many pharma marketing initiatives – including social media initiatives – are the result of teamwork within the organization. For example, a SM Pioneer may operate behind the scenes to support a pioneering product manager who makes the decision. Both are pioneers and should be rewarded. It is possible, therefore, that several people may share the same award. I also recognize the fact that outside consultants and agencies may have played a critical role. When appropriate, these pioneers will also receive honorable mention when the awards are announced.

Let me start the process by nominating several people that I know and have interacted with listed in alphabetically by last name. You can click on each name to learn more about this person and add comments. More names will be added as the nominations continue. Please add your nominations and/or votes here.

Nominees
For the most up-to-date list, see Nominees for The Pharmaguy Social Media Award.

NOTE: Every nominee for the Pharmaguy Social Media Pioneer Award is a winner and deserves recognition. But only 1 individual will be awarded the coveted Hawaiian shirt. This is NOT a popularity contest. "Winners" will be chosen solely by Pharmaguy (me) based on my evaluation of merit. Your votes, however, will also count to influence my decision. Also, I need your comments about the people you nominate so that I can profile each and every nominee in recognition of his or her pioneering effort.

Positive or Not, Pediatric Drug Trials Pay Off: Cymbalta and Oxycontin Case Studies

Very few people may know that drug companies can get an additional six months of market exclusivity from FDA as an inducement for them to study the efficacy and safety of drugs in children. Fewer people realize that no matter what the outcome of such tests, FDA will still grant the additional 6 months of exclusivity before generic copies of the tested drug can be introduced.

A case in point is Cymbalta, an antidepressant marketed by Lilly.

As reported in the Wall Street Journal (here), Cymbalta will have an additional six months of U.S. market exclusivity -- through December 2013 -- because the company studied the drug's effects on children. "Lilly said, however, that it won't seek regulatory approval to market Cymbalta for pediatric use because study results were inconclusive regarding Cymbalta's efficacy in children."

Cymbalta is the "duct tape" of drugs; i.e., it has many approved indications for use in adults.

Cymbalta was originally approved in 2004 for adults with major depression. Later the FDA granted Lilly approval to market Cymbalta for treating nerve pain in diabetics, GAD (ie, "generalized anxiety disorder"; see "eGAD! How I Learned to Stop Worrying and Love Cymbalta!") and fibromyalgia, a condition characterized by chronic fatigue and muscle and joint pain.

With each new indication comes the potential to increase sales significantly. In 2010, for example, Cymbalta was approved for chronic lower back and knee pain, an indication that may have increased sales by $500 Million, a 16% increase over the $3.07 Bn in sales for Cymbalta in 2009 (read, for example, "Cymbalta: A Sweet ROI for Chronic Pain Indication").

But a 16% increase in sales is paltry compared with a 50% increase in sales that is possible when the FDA approves a drug for use in children under the Best Pharmaceuticals for Children Act, a statute that created the incentive for drug makers to test the products in young patients. For Lilly, a 6-month extension of market exclusivity for Cymbalta could give Lilly more than a $2 Billion windfall (in April, 2012, Lilly reported that first-quarter sales of Cymbalta rose 23% to $1.11 billion).

I'm sure the intent of the law was to make it possible for physicians to prescribe drugs for children based on evidence that the drugs worked in children. To offset the cost to drug companies to run trails to prove efficacy, Congress allowed 6 months of additional exclusivity during which those costs could be recouped. In the case of Cymbalta, children do not benefit and Lilly more than recoups the cost of pediatric trials, which involve perhaps only a few hundred subjects.

Purdue Pharma, however, claimed it lacked resources in 2004 when it abandoned a pediatric Oxycontin clinical trial requested by the FDA. Only now -- when Oxycontin is a mere year away from losing market exclusivity -- is Purdue pursing such a trial (see "After Delay, OxyContin’s Use in Young Is Under Study"). Sales of Oxycontin reached $1.7 billion (in the U.S.?) in 2004.

It is too soon to know if the Oxycontin pediatric trial will demonstrate any effectiveness in treating children under 12. One thing that is certain, however, is that street use of Oxycontin by children and young adults is deadly. If extended market exclusivity can help prevent illegal diversion of even cheaper generic versions of Oxycontin, then I am all for it no matter what the clinical trail results!