Thursday, March 28, 2013

Is This the Typical Mobile Health App Developer Hired by Pharma?

In testimony before the U.S. House of Representatives Energy and Commerce Committee Subcommittee on Communications & Technology, several expert witnesses alluded to "garage entrepreneurs" as the driving force behind the "trajectory of innovation" in the development of mobile health apps. They worry that such "small" enterprises do not have the money or knowledge to deal with FDA regulation, especially when it is uncertain which mobile health apps the FDA will or will not deem to be medical devices subject to regulation.

"The development and availability of mobile health apps has, quite simply, skyrocketed. Approximately 27,000 unique health apps are available for consumers and healthcare professionals," said Robert Jarrin, Senior Director, Government Affairs, Qualcomm in his testimony. "About 500 new mobile health apps launch every month, which is up from about 400 health apps that launched every month this time last year. Over 7,000 apps are specifically intended for use by medical students, physicians, nurses, clinicians and other healthcare professionals."

"Unlike other aspects of the healthcare marketplace, there is little to no barrier to entry into the health app market -- so basically anyone with an idea and programming skills can build a mobile health app," said Ben Chodor, CEO of Happtique in his written testimony. "While this has exposed the healthcare industry to an influx of technologically sophisticated and innovative developers who are eager to make positive transformations, it has simultaneously made the industry vulnerable to a new breed of inventors who are novice to its regulatory landscape. Thus, the easy entry into mHealth offers incredible opportunity for innovation in healthcare; however, the open market comes with certain concerns, namely, 'how credible are the apps I am (or my patients are) using?'"

The availability of so many mobile health apps and the low economic and technical barriers to entry in this market begs the question: Who is the typical mobile Health App Developer?

The closest I could come to the answer to that question is this graphic in an article ("The Messaging Apps Taking on Facebook, Phone Giants") published in today's Wall Street Journal:

(click on image for an enlarged view)

It's a well-known fact that pharma companies and their agencies typical outsource the development of their digital applications and usually the supplier is a lone developer in a garage or unassuming Brooklyn brownstone apartment (see, for example, here).

So, is the typical developer of mobile health apps sponsored by pharma a lone, young man 29 years or less old? Hmmmm... if so, I hope he's not anti-social, armed and on anti-depression drugs!

Monday, March 25, 2013

Money Talks, Social Media & Games Walk, Say Docs re: Healthy Behavior Incentives

"An offer of money is often the most persuasive argument in getting someone to do what you want. The saying can be traced back to G. Torriano's 'Italian Proverbs' (1666). First attested in the United States in the 'Saturday Evening Post' (September 3, 1903) Anoter (sic) common modern variant is 'money talks, bullsh*t walks' From 'Random House Dictionary of Popular Proverbs and Sayings' by Gregory Y. Titelman (Random House, New York, 1996)." -- found here.
According to the 2013 Deloitte Survey of U.S. Physicians, financial incentives (such as direct payments, reduced insurance premiums or reduced co-pays) and "rewards, perks, and points" top the list of incentives that might work best with consumers to achieve better treatment compliance. LAST on the list was "social networking and games to build a peer support community." Over 70% of physicians cited financial rewards whereas only 13% cites social media and games (see chart below; access the report here):

(click on chart for enlarged view)

This is interesting because for years now the pharma industry has been hearing from their agencies and consultants that social media and especially games ("gamification") can improve adherence to medication and other "healthy" behavior (see "The Role of Social Media in Managing Chronic Diseases" and "Cure by Gamification: Science or Wishful Thinking?," for example).

Who should the industry believe? Physicians or consultants? I know, I know... sometimes they are the same (i.e., paid physician consultants). If physicians' views matter, then SM & games are "bullish*t" when it comes to incentivizing patients.

This should be good news, however, for companies like Healthprize, which offer cash, rewards, and points for treatment adherence. I interviewed Tom Kottler, CEO of HealthPrize, about the company's online and mobile platform that leverages rewards, behavioral economics and gaming dynamics to motivate people to stick with their prescription medications. Here's a snippet of that conversation:

Yes, games are part of the incentive. But games that results in real-life rewards such as points that can be redeemed for goods and services. You can listen to the entire interview here.

FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate

In testimony at the March 21, 2013 House Subcommittee on Oversight and Investigations regarding Health Information Technologies: Administration Perspectives on Innovation and Regulation, Christy Foreman, Director of FDA's Office of Device Evaluation, Center for Devices and Radiological Health, "promised" that FINAL guidance regarding the regulation of Mobile Medical apps (MMAs) will be released by the end of the current fiscal year; i.e., before October 2013 (read her words here).

There's been quite a lot of fear mongering regarding the types of health apps that FDA will seek to regulate. PhRMA, for example, agreed with an editorial that suggested 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"). Foreman specifically excluded such apps in her answers to questions from Rep. Henry Waxman (D-CA):

"Just as important as what the policy proposes is what the policy does not  propose," said Foreman in her written testimony. "FDA’s proposed mobile medical apps policy would not regulate the sale or general consumer use of smartphones or tablets. FDA’s proposed mobile medical apps policy would not consider entities that exclusively distribute mobile medical apps, such as the owners and operators of the 'iTunes App store' or the 'Android market,' to be medical device manufacturers. FDA’s proposed mobile medical apps policy would not  consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA. FDA’s proposed mobile medical apps policy would not  require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes. FDA’s proposed mobile medical app policy would not  apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system."

Near the end of the hearing, Rep. Morgan Griffith (R-VA) asked Foreman if the FDA could regulate these kinds of apps "if it had a change of heart." Foreman reiterated that the FDA would only regulate apps that were considered medical devices under the FDA Act and only if "strong safety signals" indicated that the FDA was not regulating a device appropriately:

In her written testimony, Foreman said:

"FDA recognizes the importance of implementing a balanced, transparent approach that fosters the development of health IT solutions and innovative products like mobile medical apps, while ensuring appropriate patient protections. Like traditional medical devices, mobile medical apps may in some cases present significant health risks to patients. FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended. Consistent with this balanced approach, FDA would not regulate the sale or general consumer use of smartphones or tablets."

You can see the entire hearing and download the testimony here.

Thursday, March 21, 2013

FDA Urged to Take "Small Steps" in Developing Final Guidelines for Mobile Medical Apps. Good Advice for Social Media Guidelines As Well

In July 2011, the FDA proposed regulating mobile medical apps as medical devices (see "FDA Issues Long-Awaited Guidance - for Mobile Medical Apps").

FDA has reserved the term "Mobile Medical App" (MMA) to mean a medical app that meets its medical "device" definition. Which mobile health apps will qualify as true MMAs requiring FDA approval?

That is a question left open by the FDA's draft guidance. At least that's the view of most of the experts who testified yesterday before the House Energy and Commerce Subcommittee on Communications and Technology. The session was titled "Health Information Technologies: Harnessing Wireless Innovation" and was chaired by Rep. Greg Walden (R-OR).

Bradley Merrill Thompson, General Counsel for the mHealth Regulatory Coalition, spoke about the need for FDA regulations of mobile health apps that obviously should be classified as medical devices. As an example, he cited an "innovative app" that allows you to do urinalysis with your iPhone.

To use the app, you do NOT pee on your iPhone! "You do the test mostly the old-fashioned way of collecting urine in a cup and then inserting a test strip," said Thompson. "All the app does is objectively read the results using the camera on the phone."

"The company website presents the app as able to help patients understand and manage diseases like diabetes, urinary tract infections and pre-eclampsia, a high blood pressure pregnancy complication," said Thompson.

"But here is the problem," said Thompson, "this app falls within longstanding FDA regulation for urinalysis. It seems to me that the company must be aware of the potential for FDA regulation, because on its home page, at the very bottom, after extolling the clinical uses of its product to monitor disease, the company tries to simply disclaim FDA medical device status."

That was an interesting point that confirms what I have been saying about certain pharma-sponsored health apps that also try to disclaim FDA medical device status (see "Checking Under the Hood of Pharma Mobile Apps").

However, what I found most interesting about Mr. Thompson's testimony was his idea for how FDA can get off its ass and develop and publish its final guidance on mobile medical apps. It is exactly the same idea I had for how the FDA should develop guidance for regulating pharma advertising via social media. Listen to this segment of Mr. Thompson's testimony:

As I said in my post FDA Social Media Guidelines Best Done in Baby Steps, "If FDA decides to bite off more than it can chew, it will take a long time to issue any guidance and whatever it comes up with will be out of date as soon as it is published."

Wednesday, March 20, 2013

Lazy IT "Nazis" Thwart iPad Use by Sales Reps

In a recent post, Rich Myer asked "how can pharma avoid the 'IT Nazis'"? Of course, he meant "Nazi" in a "good" sense, akin to the "Soup Nazi" on Seinfeld, the old TV sitcom.

Myer was talking about faulty IT policies that disallow pharma employees -- including marketers -- from accessing "a whole range of sites" on company computers while at work.

"There comes a time when some IT policies could hurt pharma marketers and prevent them from learning what is going on around the health conditions they market in and treatment options they market," said Myer (here).

But this may not be the only way that the Pharma IT "Nazis" are hurting pharma marketers. They may also be standing in the way of more widespread adoption of iPads by sales reps.

While at CBI's Sample Management and Mobile Sales conference yesterday in Princeton, NJ, I heard from some pharma people about the "limitations" of iPad use by sales reps in a roundtable discussion. In one case, IT took away all the iPads from reps and replaced them with MS Surface Tablets so that reps can use MS Excel and Word desktop applications without switching to a laptop.

Someone at the table called this "The Excel Spreadsheet Hurdle."

Now, I'm not going to get into the fact that Microsoft Surface Tablet Sales are "Nothing to Brag About" (see here, for example) and the folly of betting on a dead horse in the tablet race.

But taking the iPads away from sales reps to run desktop programs like Excel is so old school! It's an example of how legacy systems are putting pharma on the wrong side of the digital divide.

What do sales reps use Excel for? The major use seems to be travel and expense reporting. Why isn't there a mobile app for that? Pharma IT people should be able to create these or buy them from vendors pretty easily. Are they "Nazis" or just lazy or too cheap?

Another "hurdle" to iPad adoption I heard was that many Web pages sales reps need to access on mobile devices like smartphones and iPads do not display very well on these devices. Duh! I've already explained how pharma could greatly benefit by optimizing their web sites for mobile (see "Mobile Optimization Offers Better ROI Than Mobile Apps").

When I pointed out these and few other "technical" tips to the people at the table, you would have thought I was a technology genius! One woman asked me if I had any other good ideas. That's when I handed out my infamous @Pharmaguy card with the QR codes (see here). That, of course, lead to another discussion -- about QR codes -- What are they? How do I read them?, etc.

Some day this stuff will be as simple as pie for pharma marketers. Right now, however, I am a big fish swimming in a small pond, if you know what I mean.

Friday, March 15, 2013

Victoza, Januvia, and Other Diabetes Drugs Under FDA Scrutiny: Marketing's "Ethical Concerns"

"Facing growing evidence that some of America's top-selling diabetes medicines could lead to pancreatic disease, federal regulators [see FDA notice here] on Thursday opened an unusual review of drugs from Merck & Co., Bristol-Myers Squibb Co. and other pharmaceutical makers," reports the Wall Street Journal (here).

Some of the "evidence" may have come from Public Citizen in a petition it filed in 2010 with the Food and Drug Administration (FDA). That petition called on the agency to "immediately remove from the market the increasingly prescribed diabetes drug Victoza because it puts patients at higher risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure that outweigh any documented clinical benefits."

The Public Citizen press release states the case regarding pancreatitis:
"Even in the small numbers of patients in clinical trials, pancreatitis was increased 3.7-fold in patients getting Victoza over that seen in patients getting other diabetes drugs; additional cases of pancreatitis continue to be reported to the FDA in alarming numbers, considering how few adverse events are ever reported. In the first 17 months of Victoza being on the market, 200 patients were diagnosed with acute pancreatitis, according to Public Citizen’s review of the FDA’s adverse event database. Because only an estimated 10 percent of cases are reported, potentially as many as 2,000 patients or more have suffered a painful and serious outcome as a result of taking Victoza."
At the recent Selling Sickness conference in Washington, DC, Wolfe gave a rousing keynote presentation in which he spoke about the "selling sickness" aspect of marketing Victoza in spite of its dangerous side effects:

Here are his slides related to Victoza:

Appealing to the "ethical concerns" of models and modeling agencies is not, IMHO, going to get very far. Instead, Wolfe should focus on Novo's use of celebrities, caregivers, patients, and contests to sell this drug (see, for example, "We Do Hope Y'All Will Enter! Contests Guarantee ROI for Diabetes Drug Marketing"). Some celebrities might have "ethics" to appeal to, but more importantly, they have a stake in this issue as do patients and caregivers.

Wolfe surmises that the models were not informed of the dangerous possible side effects of Victoza. But models do not have to be informed if they are not taking the drug. Paid celebrities, on the other hand, must be informed. I am sure, for example, that Paula Deen -- Novo's Victoza celebrity spokesperson -- was duly informed and is followed closely by her physician for any signs of side effects.

It would be very damaging to Novo's marketing efforts if Deen developed problems related to Victoza. That would not be so easy to cover up as it is to ignore the thousands of Victoza users who may be suffering from side effects in silence because they are not being so closely monitored by their physicians as is Deen. Also, the adverse event reporting system in the U.S. is so dysfunctional, as much as 90% of adverse events go unreported, as noted by Public Citizen.

Thursday, March 14, 2013

FDA and Sugar: One Lump or Two?

"The U.S. Food and Drug Administration announced that a federal judge has approved a consent decree of permanent injunction against Butterfly Bakery Inc., a bakery based in Clifton, New Jersey, and its president, Brenda Isaac, for unlawfully distributing misbranded food products, such as muffins and snack cakes."

It all started with one oven, one mixer and a whole lot of love!

"In 1998, I started experimenting with Sugar Free desserts that my mom could enjoy," says Brenda. "See, she has diabetes and the choices at the time were limited. I set out on a mission to satisfy her sweet tooth. This was no easy task, as she is an exquisite baker and very tough critic."

"I kept experimenting with sugar free recipes, baking cakes and muffins - even creating my own buttercream frosting... until one day, my Mom took a bite of my cake and declared it, “Simplesmente perfeito!” (’Just perfect’ in Portuguese)."

"I knew I was on to something when I started to get requests from friends and family who didn’t even have diabetes. 

And The Butterfly Bakery was born."

Usually, I don't blog about the food side of the FDA, but I found this announcement from the FDA interesting (find it here). I was thinking - "What the heck can a seemingly small, mom and pop brakery be doing to catch the FDA's attention and be shut down for it?"
"Samples tested by both FDA and state officials over several years show that Butterfly Bakery’s product labeling was false and misleading. For example, laboratory analysis showed that foods labeled as 'sugar free' contained sugar, and that certain products contained as much as three times the amount of labeled/declared sugar, two times the amount of labeled/declared fat, and two times the amount of labeled/declared saturated fat."
It appears that George Costanza ratted out poor old Butterfly Bakery, which I imagine was frequented by several of my New Jersey pharma friends.

Then I received an email from the Center for Science in the Public Interest (CSPI). That organization placed an ad in the Hollywood Reporter calling out Nickelodeon’s owner, Viacom, for "impersonating a responsible media company while aggressively marketing obesity to kids" (see ad below; click on it to enlarge).

According to CSPI:
"Nick characters are on fatty, salty Kraft Macaroni & Cheese and Cheese Nip crackers and sugary imitation-fruit snacks, Pez candy, and Popsicles. Unilever's Popsicle brand sells ice pops in the shape of SpongeBob SquarePants and Dora the Explorer. The SpongeBob SquarePants bar is made from water, several forms of sugar, and a long list of preservatives, artificial food dyes, and other additives."
CSPI has also petitioned the FDA to Determine Safe Limits on High-Fructose Corn Syrup and Other Sugars in Soft Drinks.

FDA is getting two lumps: On the one hand, FDA is ridiculed for shutting down a small family bakery because it's "sugar-free" products contained some sugar. On the other hand, it is accused of doing nothing to reign in dangerous sugar consumption in children.

Besides asking the FDA to reduce levels of added sugars in beverages, CSPI's petition urges the FDA to encourage industry to voluntarily reduce added sugars in breakfast cereals, baked goods, and other foods, though beverages are the biggest problem. CSPI says the agency should add a separate line for added sugars on Nutrition Facts labels and mount, perhaps with the Centers for Disease Control and Prevention, education campaigns aimed at curbing consumption of added sugars.

Big Sunshine Law Data

More than half of physicians surveyed by MMIS -- a technology company that supplies data management services to the pharma industry -- did NOT realize that the new Sunshine Law, which is part of the Affordable Care Act, requires pharmaceutical and medical device companies to report annually to the government payments to physicians as low as $10 WITHOUT physician review of the data to correct any inconsistencies or errors prior to submission. 63% were deeply concerned that a record of these payments will be available in a publicly searchable database.

Although the Sunshine database won't be available to the public before September 30, 2014, some data are already available publicly thanks to Propublica, which launched the third update of its popular Dollars for Docs project (see "Dollars for Docs Mints a Millionaire"). ProPublica’s database, however, only includes data from 15 pharma companies that were required by law to make the data public. Although this represents more than $2 billion in payments to doctors, other medical providers and health care institutions since 2009, it's just the tip of the iceberg. Imagine the size of the Sunshine Act database containing data from thousands of companies. We're talking BIG DATA.

Here's what Michaeline Daboul, CEO of MMIS, had to say about it (listen to the full Pharma Marketing Talk interview here):

To get an idea of the minutiae of data that will be available for analysis, take a look at the data I found in Propublica's database for my family physician:

(click on image for enlarged view)

The payments range from $4 to $1500 and cover meals, gifts, and speaking fees. There were several big meal payments ($388, $324, and $504), which I suppose are for the entire year?

This database does not get into the details of these payments such as the subjects or locations of the doctor's speaking engagements or the number of people at the meals or which drug was promoted during meals and at speaking engagements. The Sunshine Law may require such details as part of its Big Data collection (see "Finally, Sunshine Rules!" for access to the final rules determining the scope of the data to be collected).

The odds are that my physician is one of the 50% who are unaware that these data are in the public domain. If she is aware, did she get a chance to review the data before it was released?

Although the regulations specify that the Centers for Medicare and Medicaid Services (CMS) provide physicians a 45-day "review and correction" period after publication to ensure the accuracy of any disclosures, pharma companies may want to be pro-active and work directly with their physicians prior to submitting the data to CMS. To do that effectively requires BIG DATA expertise.

Despite opinions to the contrary (see here), Big Data is not "dying." It's just lying dormant within individual pharma companies and soon will be coalesced into one BIG CMS database in the government "cloud" accessible by every Tom, Dick, and Grassley!

Wednesday, March 13, 2013

Are You Demented? There's an(other) App for That!

"A team of clinicians from Australia and the UK have translated one of the most commonly used dementia screening tools into app form to speed up patient assessment," reports PMLive (here).

"The ACEmobile app uses the paper-based Addenbrooke's Cognitive Examination (ACE-III) as its starting point and will be made available free of charge in forms for Apple and Android devices in the next couple of months."

This is not the first "dementia" (known as Alzheimer's Disease here in the US) diagnostic app aid for physicians. This video describes another app (for the iPad) currently in use in the UK.

"This new medical app is so accurate," says the voiceover, "that it spots problems while symptoms are still mild" and  "It's software that so sophisticated that it can distinguish normal forgetfulness from more serious medical problems in just ten minutes!"

When the app tells the patient that her symptoms are "normal for her age," she says "it's like a black cloud lifting."

The big questions are -- are these apps accurate? If not, will they do more harm than good (e.g., cause patients NOT to seek medical treatment when they should)?

I've written about this issue before. See, for example, "Some Unregulated Physician Smartphone Apps May Be Buggy" and "Reigning in the "Wild West" of Mobile Health Apps" and "Study Reveals Inaccuracy of Smartphone Health Apps."

IMHO, you must be "demented" to rely on the accuracy of smartphone health apps such as these without having assurances that they are properly documented and TESTED. Even apps supplied by reputable pharmaceutical companies (e.g., Pfizer) may be prone to errors (see "The First Ever 'Dear Doctor' Letter Regarding a Mobile Medical App Recall").

OMG, FTC Says "One-Click Rule" OK for Twitter Ads. Will FDA be a Copy Cat?

The Federal Trade Commission (FTC) just released new guidelines to expand its decade-old rules on Web ads to the world of social media and smartphones, reports the Wall Street Journal (guidelines attached to this post).
"Short-form ads on Twitter and Facebook have the same basic requirement as any old-fashioned ad: They can't mislead consumers, federal regulators said Tuesday. Whether it is including the average effectiveness of a weight-loss shake or noting that a celebrity was paid to push a product in a Twitter post, marketing company need to apply the same standards to online ads as they long have to older media, according to guidelines released Tuesday by the Federal Trade Commission."
"That means making room for full disclosure even in a 140-character tweet on Twitter." [my emphasis]
"If a company can't find a way to make its disclosure fit the constraints of social or mobile ad, it needs to change the ad copy so that it doesn't require a disclosure, the agency said, making that point explicit for the first time," reports WSJ.

But Wait! The FTC also codified a version of the infamous "one-click rule" in its guidelines. Principle/guideline # 4 states:

"To make a disclosure clear and conspicuous, advertisers should:
  • Place the disclosure as close as possible to the triggering claim." 
  • When a space-constrained ad requires a disclosure, incorporate the disclosure into the ad whenever possible. However, when it is not possible to make a disclosure in a space-constrained ad, it may, under some circumstances, be acceptable to make the disclosure clearly and conspicuously on the page to which the ad links.
That, my friends, is a version of the "one-click rule" that has haunted pharma marketers for years -- a "rule" that wasn't really sanctioned by the FDA, which also shot it down with those April 2009 warning letters (see Overcoming Space Limitations in Social Media Bring Out the Old ("One-Click Rule") and Ring in the New Ideas). Up until that point, pharma marketers believed they could create short branded ads -- such as Google adwords and Tweets -- that did not include the FDA-required important safety information (ISI) as long as that information was one click away (on the landing page summoned via a link within the ad).

Certain Circumstances
Yes, there are certain circumstance under which this "FTC One-Click Rule" applies. Namely:
"If a product or service promoted online is intended to be (or can be) purchased from 'brick and mortar' stores or from online retailers other than the advertiser itself, then any disclosure necessary to prevent deception or unfair injury should be presented in the ad itself — that is, before consumers head to a store or some other online retailer."
What the FTC is saying is that it is OK to use its "one-click rule" if the product or service can only be purchased from the advertiser. Purchasing of Rx drugs is a special case in that pharmaceutical companies do not sell drugs directly to consumers. We have to go to "brick & mortar" agents of the drug industry -- doctors and drug stores -- to "purchase" the product. Surely, these "learned agents" are qualified -- and even required by law -- to educate consumers about the ISI associated with Rx drugs. Therefore, the above "circumstance" would not apply if this rule were applicable to pharma (i.e., if FDA adopted the rule as its own).

Of course, FTC advertising guidelines do not apply to Rx pharmaceutical products because of an agreement between FDA and FTC. FDA still has not come out with any guidelines for drug ads on social media such as Twitter and it may never do so  (see FDA's "Social Media Guidance Cliff": An Open Letter to Megan Clark Velez).

But FTC's guidelines may provide a hint as to how the FDA might craft its own guidelines should that every happen; not that the FDA is an FTC copy cat, mind you. But still, FTC's release of these guidelines can be used to embarrass the FDA into action, which I hope is the result of this and other posts.

FOLLOW-UP: In a post made AFTER FDA published its social media guidelines, I clarify some issues, including the following: "Some circumstances" do NOT include disclosures of health and safety information: "Hyperlinks should not be used to communicate disclosures that are an integral part of a claim or inseparable from it, including important health and safety information," says FTC. Please read "The 'Risk-Only' Landing Page Requirement: Can We Get FDA to Adopt FTC's Thinking and Drop This Rule?"

Tuesday, March 12, 2013

Quantified Self-focused Narcissism

South by Southwest (#SXSW) is in full swing in Austin, TX. The conference organizers wouldn't give me a comp press pass, so I am following the health track from afar via Twitter using the #sxswh hash tag.

There's seems to be a lot of talk right now at SXSW about the "Quantified Self" as mentioned by NPR (here): "Technology has made it easier than ever to track your activity levels, your sleep cycles, how you spend your time, and more. The self-trackers who near-obsessively capture and analyze their own data are part of a growing 'Quantified Self" movement. Self-tracker Peter Zandan, an executive at Hill+Knowlton Strategies headed up a panel on Quantified Self this year at SXSW."

"Interested in giving self-tracking a try?", asked NPR. Yes, I am, but only because I received an UP bracelet by Jawbone as a Christmas present. UP is "a uniquely trendy wrist-worn pedometer" that communicates with my iPhone. It resembles a black Livestrong-style bracelet except that it is an ugly black thing:

I've been wearing this thing now for a few weeks because I think it's cool -- I believe billionaire Walden Schmidt on Two and a Half Men wears one (see his left wrist).

But then I read this comment from "Eric Larson" on the NPR site:

"Self-examination and self-awareness via all this tech-driven tracking are great at some level, but not too useful unless they are linked with motivation to change whatever behaviors are problematic or reinforce those that are healthy. Otherwise they're a sign of self-focused narcissism if one fixates and gloats over the results, or self-flagellating low self-esteem for failing to meet whatever standards one is using. Either way, it's pretty self-absorbed to be tracking all that data without a clear purpose, and a surrender to technology for technology's sake. Just sayin'"

I think that's a pretty good assessment of the "Quantified-Self" movement. The movement could capitalize on "self-focused narcissism" by designing better looking gizmos. For example, how would Steve Jobs redesign my UP thingee? Maybe the Apple "Watch" will break new ground here because I keep glancing down at my UP on my left wrist expecting to see the time!

Monday, March 11, 2013

OPDP Reorganization: Will It De-emphasize DTC Ad Review?

FDA's Office of Prescription Drug Promotion (OPDP) is being re-organized. Instead of separate divisions for consumer promotion (direct-to-consumer or DTC promotion) and professional (HCP) promotion, there will be two divisions focused on ALL advertising but organized around therapeutic categories.

"We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions," said Woodcock's statement (reported via MM&M here).

"The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising. The new structure will improve efficiency in our program area and our ability to meet the health needs of the American public."

I don't really see how this reorganization improves the efficiency of reviewing DTC advertising. It seems, rather, to de-emphasize oversight of DTC by mixing it with oversight of physician promotion. I'd like to hear your opinion on this.

Pharma Dollars for Docs Millionaire Club

Pharma Mints Millionaire Doc: This is America, But Is It Marketing?

Dr. Jon W. Draud, the medical director of psychiatric and addiction medicine at two Tennessee hospitals, "earned more than $1 million for delivering promotional talks and consulting for seven drug companies," according to ProPublica’s Dollars for Docs database, which has been updated to include more than $2 billion in payments from 15 drugmakers for promotional speaking, research, consulting, travel, meals and related expenses from 2009 to 2012 (see here).

Paid speaking "is perfectly legal, and if people want to work for drug companies, this is America," said Dr. James H. Scully Jr., chief executive of the American Psychiatric Association. "But everybody needs to be clear — this is marketing."

Vladimir Maletic. Jain, of Lake Jackson, Texas, has not yet made the Pharma Dollars for Docs Millionaire Club. He has earned only $582,049 from pharma to date. “I am not a marketer, I am an educator,” Jain said. Reminds me of Nixon's claim: "I am not a crook!"

Meanwhile, a survey of 1,000 physicians revealed that more than half admitted they didn't know that the new Physician Sunshine law (part of Obamacare) requires pharmaceutical and medical device companies to report on expenditures annually, without physician review of the data to correct any inconsistencies or errors, prior to submission to the government. 63% were deeply concerned that a record of these payments will be available in a publicly searchable database such as ProPublica's.

Physicians Unprepared for Sunshine ActYou can learn more about this survey by listening to a conversation with Michaeline Daboul, CEO of MMIS, about her company's third annual survey of doctors and their knowledge of the Sunshine Act. The survey found that physicians are actually less informed than they were one year ago.

Airs LIVE on: Wednesday, March 13, 2013 * 2:00 PM (Eastern US)

Listen during or after the show here.

Meanwhile, PhRMA is beginning to put a positive spin on this. "There seems to be an increased curiosity these days about interactions between biopharmaceutical research companies and healthcare professionals," says PhRMA on The Catalyst blog (see here). "If you’re interested in learning how these collaborations lead to better patient care and contribute to the discovery and development of new, innovative medicines, check out the Partners for Healthy Dialogues website," urges PhRMA.

Facebook Likes Pharma. Pharma Likes Facebook. So Why Doesn't FDA Like "Likes"?

Much fanfare and "sky is falling" comments have been made by bloggers regarding FDA's recent warning letter to a dietary supplement maker that used Facebook to “Like” an unapproved claim regarding one of its products (see, for example, "FDA Wants to Regulate Drug Firms on the Internet and It's Targeting Facebook 'Likes'" and "What’s Not To Like? Facebook And The FDA").

Scott Gottlieb -- Forbes' conservative commentator -- claimed that FDA is "ramping up its regulatory activity over the use of Internet tools by regulated companies" (op cit). But as my friend Eileen O'Brien said in a recent post: "This warning letter isn’t really about Facebook or blogs, but about following existing guidelines," specifically guidelines about making unsubstantiated product claims (see "FDA Warning Letter: Don't Make Unsubstantiated Claims, Even on Facebook").

But I'd like to point out that the FDA singled out Facebook "Likes" at the exactly the same time that Facebook announced a revision to its News Feed design.

As pointed out by the Wall Street Journal (here and in the video below), "Changes to the feed -- the key channel on Facebook's service where users post and consume content -- include a more minimal design, larger images and new types of sub-feeds. The revamp reflects a big push to prod users to spend more time on the site and curry favor with brands hoping to be noticed by Facebook's users."

The new News Feed design also allows for MORE text in the summaries. Bigger photos and more room for text are good news for pharma marketers who have struggled with complying with FDA regulations regarding "fair balance" when using online ad services such as Google's adwords that have limited space (see "Overcoming Space Limitations in Social Media").

Most of the items in your Facebook News Feed comes from friends and sources related to pages and posts you "liked." Pharma marketers can take advantage of that and target ads to people based upon their likes. Better yet, if you "Friend" a pharma Facebook page -- to download a coupon, for example -- new posts to that page may show up in your News Feed.

I may not understand all the technical details of how pharma advertisers can now target specific people via ads in News Feeds, but I see that there is a definite connection between "Likes", "Friends", and the "News" you will be served on Facebook. FDA, in my opinion, has also seen the possibilities and its recent letter highlights the fact that it will be looking not only on what pharma "likes" but what messages pharma places in Facebook News Feeds.

Pharma now has more incentives than ever before to accumulate "Friends" and "Likes -- it's not just a numbers game. It's a targeted advertising game.

While Facebook is offering pharma advertisers the means to create FDA-compliant social media "News," Google is not doing much to please pharma. For example, it's new search result format seems to exclude direct content from pharma companies (see "Google's New Drug Search Result Format: A 'Knowledge Graph' that doesn't include pharma!").

With regard to the "space limitation" issue, Google devised a new adword format that allowed pharma advertisers to include important safety information (ISI) within the ad. This format was tested by Bayer (see here) and the FDA did NOT issue any warning letters.

So, why haven't we seen more of these new Google adwords by pharma? That's exactly the question I asked people at the recent Digital Health Coalition workshop during ePharma Summit in NYC.

One of the issues the workshop was trying to address is how to solve the space limitation problem of social media and Internet advertising so that FDA regulations can be followed (i.e., display ISI). Google's beta adword format seemed to have solved this as far as search was concerned, so why haven't we seen more pharma companies use the new format? I have some ideas about that; i.e., the bad blood between Google and HHS/DOJ (see "A Pharma Social Media Conspiracy Theory: Were Guidelines Held Hostage as Part if FDA's and DOJ's Criminal Investigation of Google?").

So far, Facebook has avoided alienating the FDA by encouraging illegal drug sales, which is what Google did. Now that Facebook is cozying up to advertisers and competing with Google for ad dollars, it should proceed carefully with drug advertisers, especially the ones that FDA doesn't like: the online drug stores.

Friday, March 08, 2013

More Biologic Rx's Mean Less DTCA Spending, But Not More Internet Ad Spending

By now you should be familiar with charts like the following, which documents the decline in  direct-to-consumer advertising (DTCA). [Please read "Pharma DTC Ad Spending Took a Nosedive in 2012!" for details regarding the last 3 bars of the chart.]

What are the causes of this decline?

As many experts have pointed out, there are several likely causes, including the recession of 2007-2008 (see here), shrinking pipeline (fewer new drugs means fewer ads), and the rise of generics (which are not advertised).

But have you noticed that the sales of biologics have taken off? And that means there is less need for the type of DTCA that pharma has traditionally relied upon; i.e., BROADCAST DTCA (TV and print).   Could this be a factor in the most recent 22-26% drop in DTC spending (2012 compared to 2011)?

Forbes published a list of "Best Selling Drugs of All Time" (see here). I created the following chart from the data cited (click on it for a larger view):

Many of these are biologics. But many biologics have not yet reached the all-time sales records of DTC-advertised pills. Given time, we are likely to see an even higher proportion of biologics on this list.

Here is a table of the top US-selling biologics (in 2010) along with product-specific expenditures and promotional spending toward consumers and providers (taken from PLOS research article: "Promotion of Prescription Drugs to Consumers and Providers, 2001–2010").

(Click on image for an enlarged view)

Although these are 2010 data, we can see that relatively little was spent on DTC advertising for these 25 top selling biologics -- a total of $185.5 million compared to $4,371 million for total 2010 DTC spending, according to data from this source.

"Declining promotion may also reflect the increasing biologics share of the market," suggest the authors of the PLOS study cited above. "Declines in DTCA may accelerate as biologics make up a greater share of new therapies. Biologics often have unique routes of delivery and storage and can be very costly compared to small molecules, with costs for one cancer drug, Avastin, exceeding $100,000 per year. Given that use of new biologics is concentrated among a smaller number of patients with relatively rare conditions treated primarily by specialists, we would expect promotion to providers and consumers to also be highly targeted."

What's the best medium for "targeted" advertising? The Internet. Duh! However, as the authors note, "Although relative increases in DTCA through media such as the Internet and social networking have occurred, these expenditures remain a small fraction of overall consumer-targeted promotion." From the authors' data, I calculate that Internet DTC spending in 2010 (not including search advertising) represented only 4.6% of the total DTC spend for that year.

What about 2011 and 2012? Has the percent of Internet spending versus total DTC spending increased significantly? I have some data from 2011 that suggests this percent was 4.7% - no increase (see pie chart below).

So, pharma marketers either don't have to do much DTC marketing of any sort to sell biologics or they haven't figured out how to use the Internet to do targeted marketing of biologics to consumers.

Thursday, March 07, 2013

We Do Hope Y'All Will Enter! Contests Guarantee ROI for Diabetes Drug Marketing

"Hey y'all, I'm Paula Deen and these are my sons Bobby and Jamie," says Paula Deen, Novo Nordisk's Victoza diabetes drug spokesperson, in a new video designed to solicit personal stories for a chance to "walk in Paula's footsteps this year." It's the launch of the Seeing Diabetes in a New Light® contest. Here's a screen shot from the video (I couldn't find a way to embed it -- too bad; y'all go find it here):

There are so many similar contests soliciting diabetes stories from patients that you can hardly swing a cat on the Internet without hitting one, if y'all get my drift.

Here's a contest for you:

How many times do Paula Deen and her sons say "y'all" in the Seeing Diabetes in a New Light contest video?
Only 1 time
About 3 to 5 times
More than 5 times but less than 10
10 times or more
I didn't bother to count
I didn't bother to view the video

The winner will be invited to spend a day with Pharmaguy™ in his home office in Newtown, PA. No expenses will be paid.
And these contests must be VERY popular! My podcast interview of Bruce Braughton, Vice President, Insulin Franchise for Sanofi U.S., about the "Diabetes Co-stars Casting Call" contest (here) has been listened to over 21,000 times since December 6, 2012. It gleaned more listens than any of my other 200 or so podcast interviews (see here).

It seems that y'all don't have to be too creative or worry too much about targeting and such when marketing in the diabetes arena. Just find a celebrity with diabetes, pay her (and her children or spouse) well, launch a contest where the winner can schmooze with the celebrity, and voila! Y'all got ROI! By which I mean lots of responses, page views, video views, etc. Sales? I dunno...

Tuesday, March 05, 2013

Pharma Advertising Sequestration! DTC & Physician Ad Spending Cut 20% Across the Board!

According to MM&M: "Ad pages in medical/surgical journals fell precipitously in 2012, with companies buying 16,100 fewer pages than they did in 2011 (a 21.2% decline). Ad dollars, similarly, were down to $328 million, a $77.7 million drop (19.2%) from 2011 (see "Journal Ad Report 2012: In a Bind"). The data comes from Kantar Health. Here's the trend in Medical/Surgical journal ad revenue from 2007 through 2012:

It's interesting that medical journal ad revenue from pharma decreased about the same percentage amount as did DTC advertising as reported by CSD (see "Pharma DTC Ad Spending Took a Nosedive in 2012!"). It's as if "sequestration" has spread to pharmaceutical marketing.

Here's a pseudo infographic showing how the TOP 5 medical journals ranked by ad revenue did in 2012:

Saturday, March 02, 2013

Pharma DTC Ad Spending Took a Nosedive in 2012!

According to data from cegedim Strategic Data (CSD), DTC spending decreased by 22% in 2012 compared to 2011 (see chart below and here):

(click for an enlarged view)

Boy, was I wrong when I predicted that Direct-to-Consumer (DTC) advertising by the pharmaceutical industry would decrease by about 3.3% in 2012 compared to 2011. I made that prediction back in April 2012 and based it SOLELY on the loss of Lipitor advertising (see "Lipitor Holds Key to DTC Ad Spending in 2012").

CSD bases its analysis on surveying a panel of 2,455 physicians and other healthcare professionals. But I like to use "measured media" data from Nielsen to plot the trend in DTC spending over the years. The Nielsen numbers are somewhat higher than the CSD numbers. The more important thing is the trend in the numbers (% increase or decrease).

Here's my chart that I have used many times before and which has been copied by others (see, for example, here):

(click for an enlarged view)

Notice that there are 3 different bars for 2012. These are different estimates that I have made for what Nielsen will eventually report as the measured media DTC spend for 2012 (I don't have that data right now):

The BLUE estimate ($4.16 Bn) is my April 2012 estimate based on the loss of Lipitor advertising as explained above. This is obviously too optimistic -- it only takes into account Lipitor's contribution.

The PINK estimate  ($3.35 Bn) is based on CSD's estimate of a 22% decrease in spending in 2012 compared to 2011 ($4.30).

The ORANGE estimate is based on Nielsen data comparing Q2 spending in 2012 vs 2011 ($0.896 Bn vs 1.137 Bn, respectively). You can find that data here. That's a 21% decrease. However, I did not assume that the 2012 total would also be 21% less than 2011. What I assumed was this: Q2 spending in 2012 is to the 2012 total as Q2 spending in 2011 is to the 2011 total. The equation is: (Q2-2012/x) = (Q2-2011/Total-2011). I know all the Nieslen numbers in this equation and calculated x = $3.15 Bn, which is about 27% less than the total DTC spending for 2011. That's quite a nosedive!

The last time DTC spending decreased by double-digital percentage points was in the recession of 2008, which saw a 10% drop in DTC spending compared to 2007.
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