Novartis Wines -- er, Beers -- and Dines Docs at Hooters!

The U.S. Justice Department announced yesterday that it has filed a second civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers (read the details here).

DOJ claims that Novartis violated the Anti-Kickback Statute by paying doctors to speak about certain drugs, including its hypertension drugs Lotrel and Valturna and its diabetes drug Starlix, at events that were often little or nothing more than social occasions for the doctors. The payments and lavish dinners given to the doctors were, in reality, kickbacks to the speakers and attendees to induce them to write prescriptions for Novartis drugs, says DOJ.

Many speaker programs were held in circumstances in which it would have been "virtually impossible for any presentation to be made, such as on fishing trips off the Florida coast," the suit claims.

"Other Novartis events were held at Hooters restaurants."

Stories like this are why I love my job! It's a great excuse for me to Google images of Hooters' girls -- even with Mrs. Pharmaguy peering over my shoulder -- to come up with the following interview of a Hooter's Waitress of the Month who was present on several occasions when Novartis reps and their clients held "educational" events at her Hooters restaurant:

BTW, do pharma sales reps take female physicians to Chippendales? Just askin'

Your Aging Problem: Is It [LowT]? Take this Quiz and Find Out. Or Just Chalk It Up to Clever Marketing. Adriane Fugh-Berman, MD, Explains

Have you noticed a recent deterioration in your ability to play sports? Are you falling asleep after dinner?

Those are just two of the questions in the "Is it Low T?" symptom quiz "Supported by AbbVie," the pharma company that markets Androgel -- testosterone replacement therapy -- for the treatment of androgen deficiency, a condition that AbbVie marketers have renamed "LowT."

(click on image for enlarged view)

"If you answered 'yes' to questions 1 or 7, or to at least three of the other questions," says AbbVie, "your symptoms may be caused by Low T."

Jeez! I answered "Yes" to 7 out of 10 of these questions? What about you? Did you take the quiz?

Regardless of whether or not you have taken the quiz, just asking these questions may set up expectations that treatment of "LowT" will solve all these problems and give you stronger erections, allow you to stay awake after dinner regardless of your otherwise boring life, and enable you to be a better baseball umpire -- as seen on Androgel's TV ads -- despite the fact that you never played sports in your entire life.

According to Adriane Fugh-Berman, MD, Associate Professor at Georgetown University Medical Center and Director of PharmedOut, who I recently interviewed, this is just clever marketing for a treatment of a natural life condition. Listen to a snippet of her interview here:

listen to ‘Adriane Fugh-Berman, MD, Talks About Low T Treatments’ on Audioboo

You can listen to the complete interview here. 

PharmedOut will have more revelations about Low T marketing -- including the confessions of a reformed "ghostwriter" -- at its "Medical Behavior in a Commercial World: Who is Responsible?" conference in June 2013.

I'm "sad and/or grumpy" (#6) and will experience a "decrease in my enjoyment of life" (#5) because I will not be able to attend this conference!

Sorry Charlie! Novo's Race with Insulin "Chain E-mail" Sweepstakes Campaign is Spam

I once characterized a @Racewithinsulin Levemir branded tweet as "Sleazy Twitter Spam" (search Google on "race with insulin spam" and you'll find this post). That got a lot of comments from people arguing that the tweet wasn't technically "spam."

Today, however, I learned about the new Novo Nordisk Race With Insulin sweepstakes campaign that is truly a spam e-mail campaign. In fact, it is a "chain e-mail spam campaign," which is something I've never seen before.

As explained in this PMLive article, "the campaign features a website www.RaceWithinsulin.com hosting a competition inviting entrants to build a 'pit crew' by enrolling two friends by e-mail and be in with a chance of winning a VIP trip to the 2013 IndyCar finale and a Twitter feed."

"Invite" is not the proper way to describe the entry rules (find them here), which REQUIRE entrants to provide "two (2) of your friends’ valid e-mail addresses." The online entry form has four (4) fields for "friends" e-mail addresses (only 2 are required).

The "friends" receive e-mail "invitations" to "join the crew" by also filling out the entry form and providing two e-mail addresses of THEIR friends who will also receive e-mail "invites" so that those friends can apply and also "invite" two more friends, etc. etc. In other words, this is a "chain e-mail" campaign similar to the chain letters of yore, many of which were shady scams. In fact, in the United States, chain letters that request money or other items of value and promise a substantial return to the participants are illegal.

But the Novo Race With Insulin chain e-mails do not request "money or other items of value and promise a substantial return to the participants." However, they DO advertise Novo's FlexPen diabetes treatments and are thus UNSOLICITED commercial e-mail; i.e., SPAM.

Of course, I signed up to enter the sweepstakes and provided two e-mail addresses of "friends." I could have entered any one's e-mail address WITHOUT their permission! But I entered two of my own alternate e-mail addresses so that Novo's spam e-mail would only end up my e-mail inbox. Here's what that e-mail message looked like:

(click on image for an enlarged view)

As you can see, this message is basically an advertisement for Levemir and NovoLog. It has all the fair balance/safety information required by the FDA for DTC ads, but as far as the recipient is concerned, it is unsolicited. The FDA doesn't care about that, but maybe the FTC should review the legality of this campaign (i.e., whether it violates the CAN-SPAM law).

“This programme is a great way for people to show support, especially for friends and family affected by diabetes, and encourage them to share my story,” says Charlie.

Sorry, Charlie! This program is also a great way for people to participate in what I call a "chain e-mail spam campaign" that is designed to promote products, NOT to help people share stories.

P.S. One other troubling item: When you sign up and supply your friends' e-mail addresses, Novo does not tell you that the e-mail "invites" that your friends will receive "MAY CONTAIN MATERIAL MARKETING OR ADVERTISING NOVO NORDISK PRODUCTS, GOODS, OR SERVICES." The entry screen (see below) only refers to the e-mail messages YOU receive.

(click on image for an enlarged view)

Why Big Pharma Can’t Battle Big Bugs

A critical shortage of antibiotic drugs threatens to "derail efforts to fight the so called superbugs," according to a new report by the Infectious Diseases Society of America (IDSA), reports CNBC (here). You can find the IDSA report here.

New systemic antibacterial agents approved by the US Food and Drug Administration per 5-year period, through 2012, is shown in the chart below:

"At one time," reports CNBC, "11 big pharmaceutical companies were involved in antibiotic research and development. But the ISDA report says that figure is down to four: GlaxoSmithKline, Pfizer, AstraZeneca and Merck... Johnson & Johnson has gone on record saying it is no longer involved in antibiotic research and development, citing a high cost/benefit ratio and FDA rules. Even though Pfizer continues some R&D in the area, it closed its main antibiotic center in 2011."

"Big pharma has downsized so much. It's reflective of the fewer businesses opportunities they see," said Dr. Henry Chambers, an ISDA member.

FDA has been identified as the culprit because it "hasn't always made it easy to get antibiotics approved," Chambers added. But as an IDSA letter to Congress points out, antibiotics "provide less financial reward for companies as they are used for a short duration, typically are priced low, and must be held in reserve to protect against the development of drug resistance, rather than used widely as most other drugs are."

In other words, antibiotics do not fit the current Big Pharma "blockbuster" model demanded by institutional stockholders and Wall Street analysts.

Instead of looking to fast track FDA regulatory processes to make antibiotic drug development more profitable for Big Pharma -- as advocated by IDSA -- big pharma companies should follow the lead of smaller bio-pharmaceutical companies like Cubist, which focuses "exclusively on the superbugs of today and other types of anti-resistant bacteria."

OK, I don't mean that Big Pharma should "focus exclusively" on anti-superbug drugs. But if they want to improve their public image as recommended by former president of Pfizer Global Research, John LaMattina (see here), they should at least emulate Cubist and "[take] the long view in the battle to find new drugs," as Steve Gilman, chief scientific officer and executive vice president of Cubist, said. "It's not just a bottom line issue," Gilman said. "We want to provide for our shareholders, but we want to do something for the public as well. This is a very serious problem and it's important for us to go home at night knowing we've done something for the world. That's how we look at this."

This sentiment is seldom heard from Big Pharma these days. But back in the day, it was George W. Merck, founder and CEO of Merck, who famously said: "We try never to forget that medicine is for the people. Not for the profits. The profits follow, and if we have remembered that, they have never failed to appear."

Fixing Pharma's Reputation: IMHO, the Train Has Left the Station

In an "open letter" to PhRMA CEO, John Castellani, Forbes Blogger and former president of Pfizer Global Research, John LaMattina, offers several suggestions for improving the reputation of the pharmaceutical industry. You can read the "letter" here.

Unfortunately, IMHO, the "train has already left the station" as they say. In fact, the train has crashed!

You might recall that LaMattina famously called for the end of DTC (direct-to-consumer) advertising in his book, Devalued and Distrusted (see "Bad, Devalued, Distrusted & Defensive Pharma: A Tale of Two Books").

In his open letter, however, LaMattina focuses on the R&D side of the pharma enterprise. Specifically, he calls upon PhRMA to "put more of a human face on the R&D process."

"Why not put together a group of PhRMA scientists who were key members of the teams that produced these [newly FDA-approved] drugs?," LaMattina asks. "Then, pair them up with patients who have personally benefited from these breakthroughs and ask that they give talks or meet with the media in cities throughout the U.S. I have found that, while many members of the pharma industry are viewed with skepticism, scientists still have a good deal of credibility."

That's a good idea. In fact, I suggested almost the same thing repeatedly as far back as 2007 and earlier when that train was still in the station. In a 2007 post to this blog, I said: "God bless the dedicated researchers and scientists of the pharmaceutical industry! They are truly the unsung heroes of the pharmaceutical industry! Too bad they are sequestered in their labs!' (see "God Bless R&D, but Marketers May Go to Hell!").

The "guys" in the labs are "isolated from public view, locked away in cages like lab rats!," I said.  "And that's a problem I have always railed against. Time and again, I point out to any industry executive who will listen: give these people a voice!. Instead, the industry gives sales reps a voice among the public (see, for example, the section "Clarence," GSK's R&D Guy, Trumps "Jamie," Pfizer Viagra Guy! in this 2006 post: "GSK's 'Plain Talk' Flawed").

But that train may have left the station and crashed in 2008 when the "dark side" of pharma's R&D leaders was exposed  (see "Pharma R&D Succumbs to the Dark Side"). R&D is succumbing to the demands of the commercial side of pharma. I said, "It's not quite under the thumb of the dark side, but it's tainted, which is one conclusion I came to after reading the EHNANCE story" (op cit).

LaMattina also addresses the issue of "clinical trial transparency" in his open letter. Lack of transparency about negative clinical trial data is another, more recent, manifestation of the "dark side" of pharma R&D. Dr. Ben Goldacre, author of Bad Pharma, has written and lectured extensively about this (see "Bad, Devalued, Distrusted & Defensive Pharma: A Tale of Two Books").

On this issue, LaMattina recommends that all pharma companies follow GSK's lead and make all clinical trial data available for 3rd-party analysis. Recently, Roche agreed to release all of the trial data for its controversial influenza drug Tamiflu to the Cochrane Collaboration (see here). Roche did this kicking and screaming and may have put limits on the data revealed. To the public, this sounds like "too little, too late"; i.e., another way of saying "the train has already left the station."

Fewer Teens on Facebook - Good News for Pharma

Active US users of Facebook have declined 7.37% in the last six months and the average age of a Facebook user in 2012 was 41 years old whereas in 2010 it was 38 years old (65% of Facebook users are over 35 years old). It seems teenagers in particular are leaving Facebook because their parents are now on Facebook keeping track of them, not to mention the FBI and other law enforcement agencies. As Yogi Berra's great grandson might say, "I don't go there any more, it's too old." Here's a piece of an infographic showing the trends (find the entire infographic here):

Another reason cited by teens for leaving Facebook is "too many ads."

Of course, this is good news for pharma marketers who may now be interested in placing ads on Facebook to reach the older demographic they usually target with DTC ads. So far, however, based on my limited experience with Facebook, I haven't seen many Rx drug ads. Still, Facebook is becoming a more pharma-friendly place.

Is FDA Doing DTC, Social Media, & Professional Market Research On Behalf of the Drug Industry?

The FDA is planning on spending $364,588 to field the "Healthcare Professional Survey of Prescription Drug Promotion" (see "FDA Gets Go-Ahead for Study of DTC Advertising and Social Media"). According to the FDA public notice (here), this survey is designed to "explore the opinions and perceptions of physicians, nurse practitioners, and physician assistants with regard to the promotion of prescription drugs to consumers and healthcare providers."

In 2002, FDA considered this form of promotion "sufficiently important as a force in the physician-patient interaction" that they surveyed both patients and physicians regarding their perceptions of DTC advertising (see results here). Now, nearly a decade later, the FDA says "there are critical reasons to return to the field to gather more evidence on the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients." The major "critical reason" is the role now played by various "physician extenders": i.e., nurse practitioners and physician assistants. Physician extenders can also prescribe drugs and the drug industry would love to learn more about THEIR attitudes.

Over the years the FDA has proposed and run several such studies (see, for example, here, here, and here). Each time it asks for public opinion to assess "whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility."

I don't recall seeing any comments that questioned the necessity of these studies and that is the case with the current study. In fact, most comments are "supportive" of such studies. Merck, for example, says it is "supportive of FDA's efforts to gather more evidence on the influence of direct-to-consumer (DTC) advertising and prescription drug promotion on interactions between patients and their healthcare professionals." Other comments from healthcare professional societies simply complain, hey, why aren't our members (e.g., pharmacists) included?

And why wouldn't these stakeholders be "supportive?" Most results of FDA studies such as this one yield more positive results for the drug industry than negative ones. Very few healthcare professionals are going to admit that advertising ADVERSELY affects their clinical decisions. Most would say it has no effect at all and many would say it has a positive effect; don't forget all the money many physicians have received from the drug industry (see "Pharma Pays Out $327 per Doc in UK vs. $302 per Doc in US"), which they also say does not influence their prescribing habits.

So, is the FDA spending our "sequestered" tax dollars on research that benefits patients or the drug industry? It's not just the $364,588.99 cash spent -- it also involves numerous FTEs and time to manage the study and promote the results. Factor in the labor costs and this study could cost us a cool million! BTW, I don't think the FDA collects any "user fees" from the drug industry to cover these costs.

Another effect of studies like this is to delay any real regulatory action such as the issue of new guidance (see, for example, "FDA's Proposed Web Study Will Further Delay Social Media Guidelines"), which is the REALLY IMPORTANT job of the FDA.

Hey, FDA: Enough studies already! Do your job!

U.S. e-Detailing Spending Up 74% in 2012. Yet Pharma Still NOT "Digitally Mature."

According to the latest Promotion Audit by Cegedim Strategic Data (CSD), the U.S. pharmaceutical industry increased its professional digital marketing spending by 65% from $534 million in 2011 to $879 million in 2012. For the top 5 EU markets, the trend is much less dramatic: a 39% increase from $65 million to $90 million. (see charts below and this press release):

Obviously, despite digital pharma being "alive and well" in the EU (e.g., see here), the total pharma digital marketing spend in the EU is only a fraction -- about 10% -- of the spend in the U.S. I'm not sure if non-digital spending in EU is also 10% of what it is in the U.S.

According to CSD, the pharma industry spends about $17 billion on physician promotion: $15 billion on detailing and $2 billion on meetings (see here). I assume these numbers include digital. Digital is only 879/17000 = 0.0517 (5.2%) of that. This means that the U.S. pharma industry, which spends nearly $1 billion on professional digital marketing, has a long way to go before it reaches "digital maturity" on a par with other industries. I estimate that "par" to be 20%.

"Digitally Mature" or not, this shift to digital detailing must be part of the reason for the 10% to 12% sales force reductions in the US and EU Top Five countries. For more on that see: "Pharma Sales Jobs Take A(nother) Tumble! Digital's Slow But Relentless Impact."

Speaking of "digital maturity," Capgemini/MIT Sloan Center for Digital Business categorize 33% of global pharmaceutical companies as "Beginners" -- i.e., they "do very little with advanced digital capabilities, although they may be mature with more traditional applications" (see chart below).

By this qualitative measure, however, pharma is about on a par with the packaged goods industry, which is much more of a "Digirati" -- "truly understand how to drive value with digital transformation" -- than is pharma. "Fashionistas," BTW, are companies that have "implemented or experimented with many sexy digital applications." I'm not sure what "sexy" means to the people at MIT, but I can't say that I've seen many "sexy" pharma digital applications, unless you count Pfizer's "Facebook Fiasco: Chapstick Slapstick Ad Uses Woman's Ass as a Prop."

I'll stick to my quantitative measure of "digital maturity," thank you very much.

The pharma industry often blames FDA regulations for its lack of "digital maturity." I'll buy that when it comes to the patient/consumer side of the business (see "Lack of FDA Clarity Regarding Internet Rules Leads to Greater Pattern of Enforcement Against Digital Pharma Promotion"), but, IMHO, it lacks credence for the professional marketing side. I haven't seen, for example, any NOV letters regarding e-Detailing, e-Meetings, or e-Mailings.

The FDA Director Man Who Cried “Soon!”

There once was an FDA-OPDP Director man who was besieged whenever he spoke to conference attendees and the press. “When will you publish the social media guidance you promised?”, he was asked. To save himself from further shame he took a great breath and sang out, "Soon! Soon! The social media guidance is coming … soon!"

The pharma social media hopefuls & pundits & consultants came running up the Hill to visit the Director man to drive all doubt away. But when they arrived at the Hill, they found no guidance. The Director man laughed at the sight of their angry faces.

"Don't cry 'soon,’ Director man," said the pundits et al, "when there's no guidance coming!" They went grumbling back down the Hill.

Later, the Director man sang out again, this time to Pharmalot, "Soon! Soon! The social media guidance is coming … soon!" To his naughty delight, he watched the pharma social media hopefuls & pundits & consultants run up the Hill to ask him to drive all doubt away.

When the pharma social media hopefuls et al saw no looming guidance they sternly said, "Save your hopeful song for when there is really some guidance coming along! Don't cry 'soon' when there is NO soon!"

But the Director man just grinned and watched them go grumbling down the Hill once more.

Later, he saw some REAL social media guidance being developed by his OPDP flock. Overjoyed, he leaped to his feet and sang out as loudly as he could, "Guidance! Guidance!”

But the pharma social media consultants et al thought he was trying to fool them again, and so they didn't pay him any attention.

At sunset, everyone wondered why the Director man hadn't returned to the FDA with his OPDP flock. They went up the Hill to find the Director man. They found him weeping.

"There really was guidance here! The OPDP flock has scattered! I cried out, ‘Guidance!’ Why didn't you come?"

An old wise Pharmaguy tried to comfort the Director man as they walked back to the FDA.

"I'll help you look for your lost OPDP flock and the guidance they wrote in the morning," he said, putting his arm around the Director man, "Nobody believes a liar...even when he is telling the truth!"

FDA's Abrams Repeats Same Old (Empty) Promises Regarding the Issuing of Social Media Guidance

According to a Pharmalot headline, FDA's Tom Abrams -- who heads the Office of Prescription Drug Promotion -- promises that "Long-Awaited Social Media Guidance Is Coming" (see here).

Despite Ed Silverman's valiant attempts to pin Abrams down to a specific time frame, all he was able to get from Abrams was "It’s hard to anticipate the time, because there are many steps involved."

Abrams wouldn't even commit to the July 9, 2014, deadline mandated by Section 1121 in FDASIA. "Our intention is to make that," said Abrams. "Any chance you can make it sooner?," asked Silverman. "We are striving to make it as soon as possible," said Abrams.

Abrams emphasized the "many steps" involved in the process and that his peeps "are working very, very thoroughly and very hard – people are putting in extra hours."

So what progress has FDA made? What actions have been completed? Surely, after all the extra hours there must be some progress to report.

According the FDASIA-TRACK site, through which FDA "will communicate its progress towards accomplishing the requirements of the FDA Safety and Innovation Act," the agency has completed NO actions with regard to "issuing guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA." Here's the section of the FDASIA-TRACK showing the lack of progress as of March 29, 2013:

I stand by my prediction that the FDA will prevaricate and delay the issuance of social media guidance until it reaches the very edge of the July, 2014, "Social Media Guidance Cliff" and Beyond! For more on that, see here.

Rare Disease Sufferers in US Worse Off Financially & Medically Than Those in UK

An interesting Shire Pharmaceutical survey compares the health, psycho-social, and economic impact of rare diseases on patient and medical communities in the United States (US) and United Kingdom (UK). According to patients surveyed, it takes on average 7.6 years in the US for a patient with a rare disease to receive a proper diagnosis, whereas it takes 5.6 years in the UK.

This is interesting because the US pharma industry claims that single payer systems, which drive drug prices down, have longer wait times for essential medical care.

Here are a couple of data tables from the report (find it here) that highlight other differences between the two countries regarding rare disease cost of care and the economic plight of patients:

In the US, 37% of patients surveyed said they had to borrow money from friends and family to help pay for care, whereas in the UK, the figure was 21%. 34% borrowed from charity in the US, whereas only 18% did so in the UK.

The report claims that there are 30,000,000 people with rare diseases in the US and 3,500,000 in the UK. If true, that means there are 100 rare disease sufferers per thousand people in the US and only 51 per thousand in the UK. Why the difference?

Pharma Sales Jobs Take A(nother) Tumble! Digital's Slow But Relentless Impact.

Two stories in today's Wall Street Journal caught my attention. The first article reported that Eli Lilly will lay off 30% of its U.S. salesforce (see here). Why? Generics, of course, was mentioned first. But if you read on, you will find this tidbit:

"Also, the influence of sales representatives has shrunk, as many physicians no longer have the time to take the calls and some doctors refuse to see pharmaceutical representatives out of concern about improper promotions. Growing numbers of doctors prefer digital marketing. Lilly's U.S. sales force "will move to a smaller structure that is more directly aligned with our business realities—along with the realities our customers face, and the way they want to interact with us," a spokesman said."

Here's the trend in pharma sales rep jobs that I was able to piece together from this and previous articles (the data come from ZS Associates - other sources might have somewhat different numbers, but the trend is the same):

(Keep reading for more about "Jack & Jill Rep"; see end of post for notes about data sources)

I have previously noted that visits by sales reps that include free drug samples are also in a downward plunge (see "Will Drug Samples Soon Be a Thing of the Past?").

The second article reported that Pfizer and GSK (#1 and #2) are cutting back on payments to physicians related to marketing (see here). Again, if you read past the first few paragraphs of this article, you will find that digital is having an impact on this as well:

"Pfizer reduced spending on meals for doctors because the company's sales force is smaller and is conducting more 'virtual' meetings between doctors and company representatives, said spokeswoman Sharon Castillo."

Yesterday, I predicted that future pharma C-suite executives will come from digital pioneers who have personally "done digital" rather than "carried the bag" as do sales reps of yore (see "Fifty Ways to Do the Digital: Pharma CEOs Must Start 'Carrying the [Digital] Bag'").

Now, back to Jack and Jill:

Jack vs. Jill, Two Different Kinds of Pharma Sales Reps

Jack, the traditional pharma sales rep, drove his Ford Taurus all around town,
To detail and distribute free samples to his physician clients.
Jack banged his head against a doc’s door and broke his crown,
Because physicians would not let him in to see and feed them.

Meanwhile, Jill the virtual pharma sales rep, opened her iPad,
To Skype & email her physician clients and offer them free sample coupons.
She “visited” many docs this way, made a bundle, and was glad,
Because busy physicians prefer to get drug info & samples "virtually."

Source of data: 2006 - 2012 data come from ZS Associates as shown in the chart here. The 2012 number is an estimate through Q3 of that year. The 2013 datum comes from the WSJ article cited above regarding Lilly Layoffs. The 2003 datum comes from this Deolitte white paper.

Fifty Ways to Do the Digital: Pharma CEOs Must Start "Carrying the [Digital] Bag"

After posting about "Pharma C-Suite Social Media Dummies," I got into a Twitter discussion with my friend Paul Tunnah (@pharmaphorum) who asked "do C-level need to use social media directly, or just see value within their org and ensure others manage?"

I answered "Yes: Used 2 b CEOs rose from ranks 'carrying the bag' as they said. They now need to 'do the digital' - I say :-)"

It used to be that most pharmaceutical company C-suite executives started at the "bottom"; i.e., as sales reps, carrying the bag and learning the business. Some still do.

But the days when face-to-face customer interaction was the best way to learn the business may be coming to an end. These days and going forward "non-personal" -- i.e., digital -- communications may be the way to learn the business and executives need to have experience "carrying the digital bag." Maybe so, said Paul, "guess before too long all C-level will know #sm anyway as they grow up with it!"

But why wait for those youngsters to grow up? There must be "Fifty Ways to Do the Digital," which I put into lyrics based on the song “Fifty Ways to Leave Your Lover” by Paul Simon:

Fifty Ways to Do the Digital
(Sung to the tune “Fifty Ways to Leave Your Lover” by Paul Simon)

"The problem is all inside your silos", said my consultant Michael
The answer is easy if you have less FDA concern
I'd like to help you in your struggle to be modern
There must be fifty ways to do the digital

He said it really IS my habit to intrude
Furthermore, I hope my meaning won't be lost or misconstrued
But I'll repeat myself, at the risk of being crude
There must be fifty ways to do the digital
Fifty ways to do the digital

You just post a tweet, Marguerite
Get a page on Facebook, Brook
You don't need to be a lawyer, Lloyd
Just get yourself digital
Hop on the YouTube, Rube
You don't need to discuss much
Just drop off the 2253 form, Norm
And get yourself digital

He said it grieves me so to see you in such pain
I wish there was something I could do to make your marketing shine again
I said I appreciate that and would you please explain
About the fifty ways

He said why don't we both just sleep on it tonight
And I believe in the morning you'll begin to see the light
And then he took me golfing at the Doral and I realized he probably was right
There must be fifty ways to do the digital
Fifty ways to do the digital

You just post a tweet, Marguerite
Get a page on Facebook, Brook
You don't need to be a lawyer, Lloyd
Just get yourself digital
Hop on the YouTube, Rube
You don't need to discuss much
Just drop off the 2253 form, Norm
And get yourself digital

Sales Rep "Free Speech" Does Not Include Important Safety Information: I Call this "Free Non-Speech"

Everyone is talking about the 2-to-1 split decision by the 2nd U.S. Circuit Court of Appeals in New York, which threw out the conviction of a sales representative for promoting off-label use of a prescription drug. Many pundits believe that the court decision will allow pharma sales reps to exercise their right to freely talk about off-label uses of the products they are selling.

"From our vantage point as digital health communicators," says Michael Spitz of Pixels&Pills Blog, "the ruling has the potential for transforming how the industry connects with its targets, perhaps some day getting us all closer to using the incredible power of digital to deliver the most patient benefit" (see "Free Speech, Fair Balance, and the Future of Pharma").

That's all very well and good. But did you know that even when sales reps are "staying on label" in discussions with physicians, they almost never mention serious adverse events as required by law, not to mention required for "patient benefit"?

A study published online in the Journal of General Internal Medicine shows that sales representatives "failed to provide any information about common or serious side effects and the type of patients who should not use the medicine in 59 per cent of the promotions" (see here).

According to the study abstract:

Serious adverse events were rarely mentioned (5–6 % of promotions in all four sites), although 45 % of promotions were for drugs with US Food and Drug Administration (FDA) “black box” warnings of serious risks. Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 %) of promotions, and indicated readiness to prescribe 64 % of the time.

I call this "Free Non-Speech."

A Mobile App for Crowdsourcing Vaccine Refusal Data: A Model for Improving Drug Adherence

A mobile app for tracking vaccination refusal was recently released by the University of Iowa Computational Epidemiology Group. It's called simply "vaccine refused."

According to the developers, "vaccinations are one of the most important interventions for preventing the spread of several infectious diseases. Refusing recommended vaccinations puts communities at greater risk for outbreaks of vaccine preventable diseases. This app enables pediatricians and other health care providers to very quickly document and track instances of vaccine refusal."

I downloaded the app and used it even though I am NOT a healthcare provider. In fact, I think the app would better be targeted to consumers than to physicians who are less likely to use it, although it is quite easy to use -- you only need to enter a name, email address, and profession to register.

Regarding privacy issues, I notice that there is no privacy policy per se, just a statement that says "Your information is kept completely private and will be used for verification purposes." I did not receive any email attempting to verify that I was indeed a healthcare professional.

Whatever!

To submit a refusal you enter the patient's sex, zip code (of hospital or clinic), and age. Then you select the vaccine that was refused (or all of the vaccines listed) and the reason the patient gave for refusing the vaccine.

On behalf of my 23 year old son, I submitted a flu vaccine refusal. He believes that the flu vaccine doesn't work, which may be a reasonable assumption  (see "Does the Flu Vaccine Work? What 62% 'Effective' Really Means"). He may also have thought that he is not at risk for the flu, but I could select only one reason.

What I found interesting about the app is the Map function, which shows the distribution of refusals as pins on a map such as the ones shown below (the one on the right shows my refusal; I am relieved that this app does not use geo-location to show more precisely my location!):

It looks like most of the refusals to date are close to the University of Iowa. And most refusals are flu vaccine refusals -- you can use a filter to display only certain vaccine refusals (RV, DTaP, Tdap, Hib, PCV, IPV, MMR, HepA, HepB, VAR, HPV, MCV4, or Flu or All Vaccines). It looks like one patient (#318) in Orgeon refused ALL vaccines! I am not sure what the numbers in the black circles refer to -- the app is poorly documented.

Anyway, I will be interested in viewing the data as more and more "healthcare professionals" (or whoever) use the app.

More importantly, however, is how crowdsourcing apps like this may be useful for tracking why patients refuse other medications such as statins. The pharma industry knows that "Poor medication adherence costs pharma $564 billion per year." From surveys of patients and physicians, the industry also knows the major reasons for this, but it has struggled to come up with a solution.

If the vaccine refusal app were targeted to consumers it could go one step further by adding an educational component so that when a patient submits a refusal, the app displays a screen that addresses the reason for the refusal by offering a counter argument based on evidence, of course.

For example, if my son entered his own refusal, the app could have informed him of the data regarding flu complications among people of his sex and age in his local area. It also could have provided evidence of the effectiveness of the vaccine for men of his age. That may have influenced him to change his mind. But he most likely would not be persuaded any longer no matter the data -- he did not get the flu!

Pharma C-Suite Social Media Dummies: Can They Be Trained?

Ask any digital expert to name the key factors to successful social media communications and the number one item on the list will be "senior management support." But what do senior managers and C-suite executives know about social media? Do they use social media?

In a 2012 report by Stanford University's Rock Center for Corporate Governance titled "What Do Corporate Directors and Senior Managers Know about Social Media?" the authors detail the results of a survey of more than 180 senior executives and corporate directors of North American public and private companies. The findings reveal a disconnect between companies' understanding of social media and the actions they are taking to apply it to their business.

Key findings include:

• While 90% of respondents claim to understand the impact that social media can have on their organization, only 32% of their companies monitor social media to detect risks to their business activities and 14% use metrics from social media to measure corporate performance.
• Only 24% of senior managers and 8% of directors surveyed receive reports containing summary information and metrics from social media. Approximately half of the companies do not collect this information at all.
• Nearly two-thirds of respondents (65%) use social media for personal purposes, and 63% for business purposes. Of those who use social media, 80% have a LinkedIn account and 68% have a Facebook account, demonstrating that executives and board members are familiar with this medium.

Still, only 59% of companies in the survey use social media to interact with customers, 49% to advertise, and 35% to research customers. Approximately 30% use social media to research competitors, research new products and services, or communicate with employees and other stakeholders.

Find a link to the report here.

What applies to corporations in general is probably even more true of corporations in the pharmaceutical sector, which have traditionally lagged behind other sectors in adoption of digital tools.

My friend and feminine Twitter alter ego Alexandra Fulford (@pharmaguapa on Twitter -- Alex tells me that this handle is derived from the Spanish word "guapa," which means "lovely") developed a comprehensive, global social media training program while working as a consultant for Novartis in Basel, Switzerland. Alexandra will be my guest on an April 30 Pharma Marketing Talk show/podcast where she will discuss the need for social media training of pharmaceutical senior managers:

• Why should senior management get social media training?
• What should training incorporate?
• How should they learn about social media?
• When should they learn?

Listen to the audio podcast archive here:

More Mobile Health App Guidance from FDA for Pharma to Worry About

The more I dig into FDA regulation of mobile health/medical apps, the more I worry that many pharma health apps aimed at consumers may be in FDA's crosshairs.

At first, I thought that PhRMA and other industry spokespeople were engaging in a bit of fear mongering when they suggested that the FDA "will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices" (see "Mobile Regulatory Fears: PhRMA Raises an Alarm").

Then I interviewed Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green and General Counsel to the mHealth Regulatory Coalition. We discussed the prospects for FDA's final guidance on regulation of mobile medical apps (MMAs) and other regulatory issues that the mobile health community and FDA will need to face after publication of the "final" guidelines. In his closing remarks, however, Thompson revealed that there is ANOTHER FDA mobile guidance that the drug industry should be concerned about: new guidelines regarding FDA's regulation of clinical decision support (CDS) software.

listen to ‘FDA's Upcoming CDS Guidance’ on Audioboo

You can listen to the full interview here. FDA has been regulating many different types of CDS for the last 20 years, but -- surprise, surprise -- it has never published a guidance document regarding its CDS regulatory program.

What is CDS? Here's FDA's definition:

• Uses an individual’s information from various sources (electronically or manually entered) 
• Converts this information into new information that is intended to support a clinical decision 
• Could be a mobile application, web-based service or desk top application

Converting data could include the use of algorithms or formulas such as the Janssen's PASI calculator and other pharma apps (see "Checking Under the Hood of Pharma Mobile Apps" and "Some Unregulated Physician Smartphone Apps May Be Buggy").

These days, CDS software is increasingly being run by mobile apps. Hence, the importance of determining which apps are likely to be regulated as CDS devices.

What are examples of CDS? Some examples that FDA lists as examples of CDS include mobile apps that remind users to take their medication:

• calculates creatinine clearance or BMI
• gives reminders for tests, consults or medications
• checks for drug-drug interaction
• checks for allergies directs where to biopsy 
• suggests cancer treatment based on proprietary algorithm, not widely accepted
• provides radiation treatment recommendation from combines multiple physiological inputs
• interprets complex information to an untrained user

FDA says its regulation of CDS apps depends on the clinical impact of medical decisions made on the basis of such apps (see this FDA PPT and figure below).

(click on image for an enlarged view)

Younger Physicians Less Engaged in Social Media Than Their Elders

Kantar Media just launched a new healthcare insights blog at www.kantarmedia-healthcare.com. Hopefully, many of the posts will include key data points from the company's professional and consumer studies that I can analyze here on Pharma Marketing Blog. In fact, there is one piece of data that caught my attention: i.e., the types of social networks used by physicians for professional purposes. Specifically, this chart:

"Looking at the data by physician age, those in the 35+ group are nearly twice as likely to participate in a professional social network versus those in the under 35 group," says Bernadette Cognac, who writes for the Insights Blog. "Surprisingly, physicians ages 45-59 are the most likely to use any social network for professional purposes overall" (read the post here).

Yes, this is surprising given all the hype about how younger physicians are leading the way to digital and thus future pharma marketing to physicians should focus a lot more on digital channels as these physicians become mainstream.

It is also surprising that the headline for the Kanter Media blog post reporting these data -- "Social Media Usage Increasing Among Physicians -- is a bit misleading. A better title, IMHO, may be "Social Media Usage Increasing Among Older Physicians Compared to Younger Ones," which is another way of expressing the title of my post.

Unfortunately, this is not good news for pharma marketers (or their ad agencies) who wish to convince their bosses to invest in more social media marketing aimed at physicians.

Pharma Pays Out $327 per Doc in UK vs. $302 per Doc in US

The Association of the British Pharmaceutical Industry (ABPI) released aggregate totals of payments its member pharma companies made last year to doctors, nurses and other healthcare professionals.

ABPI said pharma companies in the UK paid healthcare professionals £40m in sponsorship and support during 2012, reports PMLive (here). This estimate is "based on information received from, or published by, 35 out of the top 44 companies based on UK sales in 2012."

In comparison, pharma companies paid $150 million dollars to U.S. physicians in the first 8 months of 2012.

These payments are for attending medical education events, training and speaker fees.

Just for fun, I calculated what this comes out to PER physician in order to get an idea of the value of physicians to the pharmaceutical industry in each country.

First, I assume 100% of the money went to physicians, not to nurses (ha! that will be the day!). From Kaiser Health data, I learned that there are 24 physicians per 10,000 people in the US, which has a total population of about 310 million. There are 27 physicians per 10,000 people in the UK, which has a population of 69 million. Thus, there are approximately 186,000 physicians in the UK and 744,000 in the US. I converted £40m to dollars: $60.9m. Doing the math, I find that if the pharma money was equally distributed to all physicians in each country, each UK doc would get $327 whilst each US doc would get only $302.

It's surprising how similar the numbers are given the margin of error. On the one hand, I would have expected UK docs to be less valued as KOLs, paid consultants, etc. because of the single-payer system in the UK where supposedly docs have less say in which drug to prescribe than do docs in the US. On the other hand, because pharma spends so much on direct-to-consumer (DTC) advertising in the US, I would have thought less would need to be spent on schmoozing, er... educating, docs.

But pharma money is not distributed equally among docs -- at least one physician in the US became a millionaire from the money he received from pharma (see "Pharma Mints Millionaire Doc"). I don't know if any UK doc was as fortune-ate.

DTC Down the Drain

"Direct-to-consumer advertising, as we've known it, at least, is not the be-all and end-all of marketing prescription drugs to patients anymore," says Matthew Arnold in a new MM&M report with the provocative title "DTC Drain" (find it here). Yes, and the spending trend shows it -- DTC ad spending decreased 12% in 2012 compared to 2011 (see "DTC Not As Dead As We Thought... But Digital Ad Spending Down One-Third!")

I took MM&M's title a step further and increased the alliterative appeal by adding "Down" as in the following photo, which appeared in the MM&M report (sans the words):

The tubs image, of course, recalls DTC ads for Cialis. According to Nielsen data, which you can find in the MM&M report, Cialis ranked #2 in DTC ad spending in 2012, just behind Cymbalta. That's an increase in 13% over the 2011 spend (those tubs aren't drained just yet!). The Viagra ad spend, on the other hand, decreased 15%. Oh well, one man's Viagra is another man's Cialis!

Physicians Growing Cool Toward ePromotion

The percentage of physicians who believe that e-promotion -- video details, online events, and virtual details -- is inferior to face-to-face promotion increased from 33% in 2011 to 38% in 2012, according to Encuity’s 2012 eAnswers Annual Study (here). "Physicians age 45 or older are more likely than their younger peers to feel that e-promotion is inferior to face-to-face promotion (41% vs. 28%)." Meanwhile, only 14% of physicians find e-promotion to be superior to face-to-face promotion, down from 16% in 2011.

(click on image for larger view)

Why the colder shoulder despite the fact that the industry has been scaling back on their field forces in recent years while simultaneously increasing investment in e-promotion? Perhaps there has been TOO MUCH e-promotion. According to a cegedim Strategic Data report published in February 2012, e-detailing has "risen steadily since 2009 both in net details and in the proportion of online details to total details. The total number of e-details grew by almost 50 percent in 2011 and by over 80 percent the previous year" (see chart below).

(click on image for larger view)

Encuity notes that younger physicians have a "more positive view" of e-promotion and that may suggest that pharma is "ahead of the curve." Ha! That's the first time I've heard of pharma being ahead of a technology curve! It's more likely that younger physicians have not reached the saturation point, are not as busy as older physicians, or feel the need to absorb more information from whatever source. In addition, the proportion of "younger" physicians must be increasing as the baby boom physicians retire. If so, I would have expected an uptick in e-promotion approval, not a "downtick."

Meanwhile, in terms of actually driving prescriptions, e-promotion lags behind events and face-to-face details, according to Encuity. "Forty-four percent of physicians surveyed in 2012 are somewhat or extremely likely to prescribe a product highlighted during an e-promotion activity, compared with 45% in 2011. By comparison, 67% of physicians surveyed in 2012 are somewhat or extremely likely to prescribe a product highlighted at a meeting or event, compared with 61% who would do the same for a product highlighted during a face-to-face detail." Here's the chart for that:

(click on image for larger view)

Nalts Has Low T! Asks Internet for a Diagnosis Based on His Brain MRI Images. Isn't There an App for That?

Nalts (aka "ADHD Boy", aka Kevin Nalty, Marketing Strategist, former Merck/Janssen-Cilag employee) posted a new YouTube video of his brain -- which includes a series of MRI scans. It seems he has "Low T" (low testosterone) and his doctor recommended the scan to see if his Low T is caused by a "pituitary issue." I hope he is OK and just growing old like the rest of us.

As Nalts himself admits, he has no privacy when it comes to his health issues. I've blogged about his ADHD years ago (see "ADHD Boy").

His brain scan video is his latest revelation about his health-related problems. In the video Nalts asks for some "wisdom of the crowd" to help him/his doctor? interpret the image and arrive at some kind of diagnosis. Here's the video -- see if you can help:


"Low T" is a phrase invented by AbbVie, which markets Androgel, a "hormone replacement" gel for men. AbbVie's “Drive for Five” campaign urges men to know their testosterone levels, in addition to lipid, BP, blood sugar and PSA numbers. On the website (http://www.driveforfive.com; "Mens Health | Learn about 5 risks to mens health") is an animated "gear box" that shifts from high cholesterol (first gear) to high blood pressure (second gear) to high blood sugar (third gear) to high PSA (four gear) and, finally, to low testosterone (fifth gear). AbbVie's "Low T" agencies are Digitas Health for consumer ads and AbelsonTaylor for professional ads ; More...

The driveforfive.com website encourages men not to be "embarrassed to talk to your doctor about any health problems you may be having, such as:

• Reduced sex drive
• Problems during sexual activity
• Feelings of sadness
• Bladder or bowel control
• Weight gain
• Drug abuse

I don't know which, if any, of these symptoms drove Nalts to his doctor. What I do know is that Nalts is a father of 4 children, is a comedian, has male-pattern baldness, and is pretty thin -- all of which do not fit the symptom profile promoted by AbbVie. I'm not sure, however, if he currently has problems of a sexual nature or if he is abusing drugs (although he once said, in jest, "Not taking drugs is like not drinking water when you are thirsty").

Perhaps his doctor just routinely measures testosterone levels in men of a certain age because AbbVie sales reps suggested he/she do that as part of the "Drive for Five" campaign.

Speaking of Marketing of Low T, I will interview Adriane Fugh-Berman, MD, Associate Professor at Georgetown University Medical Center and Director of PharmedOut, about this subject in an upcoming Pharma Marketing Talk show.

This show is a live streaming audio podcast that airs on Thursday, April 25, 2013, at 2:00 PM (Eastern US). You can listen live or to the archived podcast afterward here.

We will discuss how the marketing of Low T drugs uses ghostwriting, celebrities, symptom quizzes, and numbers to convince men and physicians that "low testosterone" is a medical condition that should be treated.

I invite Nalts to participate in the discussion and tell us more about his experience and possibly debate the issues with Dr. Fugh-Berman. Topics/Questions for discussion include:

• How does the marketing of Androgel and other testosterone gels and patches use ghostwriting, celebrities, symptom quizzes, and numbers to convince men and physicians that "low testosterone" is a medical condition that should be treated?
• Do you see this as a problem akin to "disease mongering?" What's the harm in making more men aware of "low testosterone" and urging them to treat it?
• Are the same tactics used for other products?
• How do direct-to-consumer (DTC) ads for these products differ from professional ads aimed at physicians?

Lack of FDA Clarity Regarding Internet Rules Leads to Greater Pattern of Enforcement Against Digital Pharma Promotion

Mark Senak, author of EyeOnFDA blog, assembled a database of FDA/OPDP Warning and NOV letters spanning the years 2004-present and wrote an informative white paper review of the data (find it here).

"Lacking any sort of formal guidance from the agency [regarding regulation of digital media], the only peek into FDA’s point of view is to examine enforcement patterns," says Senak. "So I have used the data base to compare enforcement patterns vis a vis digital communications."

Here are a couple of charts from the white paper showing the breakdown in violations cited and warning letters sent according to type of media - digital vs. nondigital:

On the left is the breakdown of violations. There were a total of 676 violations and 173 letters. "Of all the violations cited," notes Senak, "a majority involved nondigital media. A comparison shows that 57 percent (n=385) of the vehicles cited for violations were nondigital properties compared to 43 percent (n=290) involving digital-based communications vehicles."

How many of these violations are serious? Senak looked at the distribution of Warning Letters for that. "Of 45 WLs [Warning Letters] issued by OPDP during this period," wrote Senak, "only 12 cited digital communications vehicles while 33 were based on nondigital (traditional) communications, meaning that a Warning Letter was almost three times more likely to be based on a traditional media communications vehicle than on a digital one."

Senak cites an obvious limitation of his data: one cannot say whether or not digital is over or under represented. The reason, claims Senak, is that "we do not know what proportion of communications by industry is divided between digital and non-digital efforts." Senak contends that "the lack of clarity respecting the rules around Internet and social media use does not appear to translate into a greater pattern of enforcement against digital media."

I disagree.

I believe we DO have some data that suggests digital is very much OVER REPRESENTED in terms of violations and warning letters. As I pointed out in a previous post (here), only 2% of pharma's DTC budget is devoted to digital (not counting search advertising). Now I know that Senak's data also includes professional promotion and is not limited to consumers promotion. Even taking all that into account, it's impossible that pharma spends 27-43% of its promotional budget/effort on digital channels.

Maybe, however, it's not the money spent but the number of communications created that we should look at. Let's look at the "Total 2253 pieces (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use) received" by FDA for fiscal year 2011 (the latest full year of data; here):

(click on image for enlarged view)

The percent of "non-Internet" pieces varies from 72% to 80%, which means the % of Internet pieces is in the 20-28% range (I would say the average was 24% for the year).

So 24% of promotional pieces reviewed by FDA gets 43% of the violations cited and 27% of serious warning letters sent. From this I would have to disagree with Senak and say the lack of clarity respecting the rules around Internet and social media use by pharma DOES appear to translate into a GREATER pattern of enforcement against digital media.

DTC Not As Dead As We Thought... But Digital Ad Spending Down One-Third!

Based on early data from cegedim, it appeared that direct-to-consumer (DTC) ad spending by the pharmaceutical industry declined by 22% in 2012 compared to 2011 (see here). New Nielsen data, however, indicates that the overall decline in DTC spending was only 11-12%.

My fellow blogger, Rich Meyer (World of DTC Marketing), sent me the data from which I created the following table showing the "measured media" DTC spending for 2011 and 2012 broken down by medium (TV, Magazines, Newspapers, Internet, radio, and Outdoor):

The numbers for 2011 were calculated from the percent increase/decrease (inc/dec) reported by Nielsen for each channel. The Nielsen data I have do not include the percent change of total DTC spending. I calculated that number (-11.48%) from the two totals.

Using these data, I updated my Pharma DTC Ad Spend (Measured Media) trend chart:

(click on image for an enlarged view)

Previously, I estimated that the 2012 DTC spend would be in the range of $3.15 to $3.35 billion. This estimate was based on the 22% drop that cegedim reported. Nielsen, however, says the number is $3.47 billion, which is 11.5% less than the $3.98 billion spent in 2011.

Why the difference?

Cegedim and Nielsen get their data from different sources. Cegedim polls physicians and Nielsen gets data from ad buyers, I believe.  For me, I value Nielsen data more than cegedim data.

You can't put too much stock in the absolute value of these numbers because they are based on list pricing for ads. But you can put some stock in the trends. The 2012 drop is NOT the biggest decrease in DTC spending since 1998 as I had previously said. The drop in spending in 2008 was bigger: about 17%.

Meanwhile, TV ad spending decreased only a modest 10% whereas Internet display ad spending (excluding search) decreased 33%! This confirms my January 2012 prediction of a "recession" in pharma digital (see this slideshare presentation). Also note from the pie chart above that Internet measured media spending is only 2% of the total! This is a number that hasn't changed much since 2000 when I started tracking it.

Why is Internet advertising by pharma taking such a huge hit?

Meyer asks basically the same question: "With so many people going online for health information one has to wonder why the love affair with TV and magazines at the expense of the Internet?" Meyer believes that DTC marketers are not up to the task of analyzing the data from Internet ad campaigns to confirm the superior ROI that can be had. "The problem," says Meyer, "is that you need someone who can actually mine these numbers and present the results to DTC marketers. Obviously that doesn’t seem to be happening" (see "2012 DTC Media spending breakdown-Web neglected?").

Some experts HAVE attempted to mine the numbers and inform DTC marketers. At least one (biased) expert claims that digital ROI can be as high as 5:1; i.e., for every dollar spent on digital advertising, you can gain $5 in sales. But I contend that this number may be OK for small $60,000 campaigns, but it may not be scalable and apply to bigger campaigns (see "Is Online Pharma Promotion ROI Scalable?").

What is the cause of the downward spiral of DTC ad spending? Practically every expert points to the "patent cliff," over which the industry has already fallen. There must be other factors. I have presented some data that suggests a role for the rise in biologics, many of which are too complicated and have too many serious side effects to be marketed via DTC. It's not as if a consumer can "ask her doctor" for a specific cancer treatment regimen, for example. Although I do see DTC ads for biologics, I believe most biologics marketing dollars will be spent on physician and payer sales and marketing. So, even when biologics are advertised on TV, the ROI is not as high as for drugs with a much bigger potential patient pool. That would mean fewer TV and print ads.

For more on biologics impact on DTC, see the Pharma Marketing News article "Spending on Direct-to-Consumer Advertising Takes a Nosedive" (subscription -- free! -- may be required) and this Pharma Marketing Blog post.

BI Launches Official Version of Syrum Facebook Game in U.S.

Remember Syrum - the social media game developed by Boehringer Ingelheim (BI)?

BI began talking about this game in early 2011, saying it will be launched "when it's ready" (see here and here). A BETA version of the game was launched in September, 2012, but ONLY in Europe! At that time, BI said the game would be launched in the U.S. and globally sometime in 2013. But little did I or anyone else expect Syrum to be launched in the U.S. as soon as April, 2013. But that's just what happened. BI announced today the OFFICIAL launch of Syrum in the U.S. and the world -- and not just a beta version, but a fully-tested and approved version. The following is an excerpt from the official press release.

Ingelheim, Germany and USA, 1 April 2013 - Boehringer Ingelheim has announced the U.S. launch of its first social game on Facebook, called Syrum. Syrum will be a new and evolving platform for the research-driven pharmaceutical company to inspire and educate in a changing digital world. 

In development for more than two and one-half years, Syrum has been specifically designed to demonstrate the complex processes around medicine research and development through gaming mechanics. It aims at promoting science and innovation to the digital community in a fun and engaging way. 

"The use of gaming by the pharmaceutical industry is set to become the next big thing since FDA relaxed regulations to allow direct-to-consumer (DTC) advertising in the U.S., " said Peter Pitty, Ass Marketing Dir at Boehringer Ingelheim. "Syrum is a fantastic example of how fun gaming can be used to mine actionable data about gamers such as what time they wake up in the afternoon, what virtual rewards they like, and what color test tubes turn them on. We're talking BIG DATA here!"  

The goal of Syrum is to discover cures by first creating a stable medicine, conducting a clinical trial and finally bringing the medicine to the market. "The research driven pharmaceutical industry is challenged to develop new, innovative drugs," says John Pugilist, Chief Game Master at Boehringer Ingelheim. "Gaming is an experimental way for Boehringer Ingelheim to gain research insights that we've been unable to gain for one reason or another. The challenge is to find intelligent, awake, and innovative gamers who are willing to help us discover new drugs worth millions/billions of dollars for the sheer joy of gaining points, beating the competition, and receiving no financial compensation whatsoever. The best place to find such people is in the U.S. and every where else in the world except Europe." 

Syrum is built on Facebook, and has already generated a high level of interest, both within the pharmaceutical industry and amongst gamers. More than 100 people have already signed up to play in advance of the launch via the website www.syrum-game.com. 

Happy April Fools Day! Just in case you fell for this.