How Did the uChek iPhone Urine Analysis App "Come to FDA's Attention?"

"An iPhone application that lets users check levels of blood, protein and other substances in their urine is the first target of U.S. regulators seeking boundaries in a burgeoning industry for medical diagnosis on-the-go," reports Bloomberg (here). The app is uChek and it is free -- but you have to buy the test strips and the special "Cuboid" box that positions the iPhone's built-in camera over the test strip (see the video below).

FDA sent the developers, Biosense Technologies Private Limited, a "It Has Come to Our Attention Letter," which is a species of FDA communication not previously known by experts like Eye On FDA blogger Marke Senak, who said "in the wake of issuing its Draft Guidance on Mobile Medical Applications, FDA has shed further light on its regulation over medical apps with this letter" (here).

UChek works with test strips made by Siemens and Bayer, which are only approved for visual reading and require new clearance for automated analysis, the FDA said in the letter. You can find the FDA letter (here).

Another BI "Educational" Game That I Don't Get -- Literally!

Have you heard that Boehringer Ingelheim (BI) and Lilly have "stepped up their joint efforts to raise awareness of diabetes, launching the new educational game Complications Combat?" (see here).

Of course, I had to be the first kid on the block to try it out. OK, maybe not the first ... according to the Leaderboard on the browser version, at least 4 people have tried it. The top 7 scores are owned by "SAI," whoever that is.

The goal of the game or "task" you must perform is to "effectively manage Type 2 Diabetes and its complications before your patient's health level deteriorates. The longer your patient stays healthy, the higher your score." You keep your patient healthy by swiping objects that whiz by into the "Complications" or "Friends" areas. "Friends" include pills and healthy foods, "Complications" include stroke, foot ulcers, etc.

J&J Embraces "Special K" for Depression - Why Not Medical Marijuana?

Current antidepressants take weeks or months to have an effect, and then only in 30% of patients, notes Matthew Herper, Forbes, in a recent post (see here).

Herper reports that J&J is "reinventing" ketamine as a product for the rapid treatment of depression just like your kids have been using it for years as a party drug under the name "Special K".

It is suggested that J&J's embrace of ketamine as a product is courageous and that not many other corporate executives would be afraid of trying to turn ketamine as a product.

Tablet Detailing Evolution According to Roche Italy

I'm preparing for my presentation at the Roche Digital Academy in Milan on June 19, 2013 (see "Pharmaguy to Present at the Roche Digital Academy"). The Roche "Team Italy" (see below) sent me a nice infographic that provides some details about the current and future digital efforts of Roche Italy -- including some data regarding digital marketing spend by various brands.

Should Pharma Do Tumblr?

Peter Houston (@Flipping_Pages) asked "Could Pharma Do Tumblr?" in a guest post to PharmExecBlog (here).

"I’m not suggesting that anyone switch their social media budget to Tumblr today on the strength of Yahoo’s involvement," said Houston. "But it’s worth keeping an eye on what Yahoo does and how the Tumblr audience responds. If they get the content marketing part of the play right and the user base keeps active, Tumblr might just make it into your social media marketing plan."

My question replaces "could" with "should," which is probably what Houston meant to say -- it just got lost in translation from UK English to US English :-)

Of course, pharma "could" do Tumblr, but as Houston himself points out, there are many reasons why it "shouldn't."

First, the Tumblr demographics are not right for pharma. Tumblr, says Houston, is used "mainly by a 13 to 25 age group attracted by its 'social looseness'."

Using Social Media as an Early Predictor of a New Drug's Market Share

According to Gideon Mantel, co-founder and CEO of Treato, social media can predict the success of a new drug launch much faster than traditional methods.

"Many pharmaceutical companies try to measure the success of their launch based on weekly script trends," said Mantel in a blog post (here). "The difference between social media data and data derived from prescriptions is significant: social media data can predict the future, while script data record the past."

To illustrate this, Treato looked at patient-written social media posts on over 2,000 health blogs and forums to find mentions of Tecfidera (formerly called BG-12 during clinical trials), a new multiple sclerosis drug that Biogen launched on April 13. Since the launch of Tecfidera in mid-April, the most talked about MS drug in social media has been Tecfidera, bypassing all other MS medications and growing on a daily basis (see chart below):

Jerome "The Bus" Bettis Promotes Auvi-Q With and Without the Important Safety Information

Celebrity spokespeople seem to be all the rage in pharma marketing circles these days. I wonder, however, how closely the FDA is watching celebrity endorsements such as former NFLer Jerome Jerome “The Bus” Bettis's promotion of Sanofi's talking epinephrine injection, Auvi-Q, which is marketed for the treatment of life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions.

Bettis is not just promoting anaphylaxis awareness on TV shows such as the The Doctors. On TV, Bettis is actively demonstrating how the product works and naming brand names. But he

1. does not disclose that he is being paid by Sanofi to endorse Auvi-Q, and 
2. does not mention the "important safety information" (ISI), which is required by FDA regulations whenever a pharma company or its agents promote brand name products and the conditions they treat.

Will 2013 Be the Year of "Digital Pharma?"

Today, I posted on Twitter "HCP digital spend by pharma to equal that of print this year, forecast says." That tweet is getting a lot of retweets and Mike Young (@Brandshaping) responded "The times they are a changing."

I am afraid my tweet may be misleading. I should have said "HCP digital MEASURED MEDIA spend by pharma to equal that of print this year, forecast says."

My tweet points to a chart I created from data published in a whitepaper from Compas: "Follow the Money-- a Point of View on HCP Media Trends in Pharma" (find it attached to this post). Here's my chart:

Measure Differently for Healthier Returns

This week my friend Shwen Gwee, Chief Digital Officer at Chandler Chicco, volunteered me to lead the ROI "Group Roundtable Discussions" at the Social Media for Pharma Conference in Princeton, NJ. This conference was organized by Advanced Learning Institute, one of my clients.

As always, discussions of "return on investment" in pharma marketing are fraught with difficulties, especially when talking about consumer and patient focused marketing efforts and even more especially when these efforts involve social media.

I came away with two insights from the discussions I led:

1. Other than scripts written, practically everything pharma marketers measure for ROI analyses are surrogates for scripts written, and 
2. pharma brand managers move in and out of brands too frequently to consider alternatives to ROI, such as ROR ("return on relationship"), which some experts propose to measure social media effectiveness.

Pharmaguy to Present at the Roche Digital Academy

PharmaGuy (aka John Mack, me) will present at the Roche "Digital Academy" in June, 2013. The Digital Academy is a project that has enrolled over 80 Roche employees who will participate in a 6-month Master Course of study created in collaboration with the School of Communication IULM in Milan, Italy. Here's my pitch:

Merck in the Mirror: Profits, Not People, Come First. Shame!

"How can Merck look itself in the mirror?", asks Josh Bloom of the American Council for Science and Health (see here).

"This week, Merck, with some questionable help from the FDA, gave more ammunition to industry critics, who typically maintain that the industry contributes little innovation, and is simply concerned with profits," said Bloom.

"For the most part, this criticism is biased and uninformed, but this time I'm siding with the critics. Because Merck is trying something that is as good an example of marketing without innovation as you'll ever see."

Big Inside Joke About Doctor Surveys: 90% of Physicians Believe They Graduated in the Top Half of Their Class

Richard Meyer, author of World of DTC Marketing Blog, is a big believer in physician surveys, including the survey that the FDA intends to do regarding how physicians feel about direct-to-cinsumer (DTC) advertising.

Rich was interviewed on HuffPost Live recently along with a health reporter and former Zyprexa Drug Rep, Shahram Ahari, who now is a consultant for Pharmedout. The 30-minute interview -- see embedded video at the end of this post -- was titled "Big Pharma's Pill Pushing." The description reads: "Big Pharma spends almost twice as much on promotion as it does on research and development. Drug company revenues climbed more than $200 billion in the years between 1995 and 2010 and so did the number of addicts. How can this be better regulated?"

Rich did his best to defend the drug industry in such an obviously biased setup. The part of the discussion I found interesting in light of my recent post about the FDA physician survey (see "Is FDA Doing DTC, Social Media, & Professional Market Research On Behalf of the Drug Industry?") was Rich's comments about a similar survey by CMI/Compas, which I also wrote about (see "Most Physicians Agree That DTC Advertising Leads to Inappropriate Prescribing -- by OTHER Doctors, Not Them!"), and Shahram's reveal of how pharma sales reps view physician surveys. Here are the two relevant excerpts:

Let Us Fear the Price of "Cutting-Edge" Drugs!

I must respond to the opinion piece by Peter Pitts, president of the Center for Medicine in the Public Interest, regarding the high cost of new drugs. The piece. titled "Another Voice: Cutting-edge drugs are worth the cost in the long run," was published in The Buffalo News of all places (here).

"We shouldn’t fear the price tag of these new medicines," says Pitts. "Expensive medicine may be a bitter pill, but these advanced therapies offer hope to millions of patients, keeping them healthier for longer."

Unfortunately, the numbers Pitts cites in defense of that statement suggests the opposite.

Pitts says that the cost to bring a new drug to market – "from the time it is a twinkle in a scientist’s eye, through a decade or more of lab research, to clinical trials and finally FDA approval" – is $1.2 billion. This, according to Pitts, justifies the prices of the most expensive medications, including four biopharmaceuticals approved in 2012 that cost more than $200,000 per year, per patient.

At $200,000 per patient-year, a drug company can recoup the development cost by treating 6,000 patients in just one year! A far cry from offering "hope to millions of patients!"

Even with insurance paying for the bulk of such treatments, only the rich can afford the co-pays for these drugs that "our children and grandchildren will grow up to marvel," according to Pitts. Marvel, indeed.

Legit Online Viagra! Dead Rat, Boric Acid, Etc., Not Included.

Pfizer, the company best known for fighting online purchases of prescription drugs - especially Viagra, has decided on a new approach: setting up its own online site to sell Viagra directly to consumers (see press release here). Pfizer doesn't call it an "online pharmacy" -- wording that might be synonymous with "counterfeit" thanks, in part, to Pfizer's PR efforts such as the famous dead rat commercial (see "Was a Rat Harmed in the Filming of This Pfizer Commercial?"). Coincidentally (?), that commercial is no longer available on YouTube! I guess you won't find any dead rats in Pfizer's "home delivery" of Viagra®.

The "prescription-fulfillment website for Viagra", which is powered by CVS/pharmacy and accessible through Viagra.com, "offers men with erectile dysfunction (ED) an opportunity to purchase Viagra online (with a valid prescription) from a trusted source," says Pfizer.

Pfizer is now in direct competition with other online pharmacies -- legit and otherwise -- that sell Viagra at discounted prices. To distinguish itself from the online rabble, Pfizer continues to dis the idea of buying Rx drugs from such sites:

Pfizer Integrates Daytime TV Spots, YouTube, Facebook, Twitter, Slideshare, & Blogs. Focus is Less on Science, More on Medical Advice.

Over the months I have reviewed several of Pfizer's digital and social media efforts and have said that the company is good at promoting its digital efforts but not so good when it comes to implementation (see, for example, "Pfizer, If You Are So Smart, How Come You Were Hacked By 'Kiddies'?").

In one of my Twitter news feeds, I learned that Pfizer's Chief Medical Officer, Freda Lewis-Hall, M.D., was a guest on The Doctors daytime TV show. The segment is titled "Keep an Eye on Your Blood Pressure" and you can view it here on Pfizer's Corporate YouTube channel. It's part of Pfizer's Get Healthy, Stay Healthy "campaign," which also includes a blog that features Dr. Lewis-Hall but also includes posts from other Pfizer physicians (here).

The Get Healthy, Stay Healthy blog covers a range of health conditions for which Pfizer markets products. No products are mentioned. The blog post about hypertension is entitled "Managing High Blood Pressure Takes More Than Just Medication."

When you clickthrough to the Pfizer Youtube home page, you can see that Pfizer is all over the social media landscape, including Facebook, Twitter, LinkedIn, Slideshare, and Blogs:

The Adherence Problem: Are Patients Just Forgetful, or Are They Rebellious?

This is the adherence season for pharma industry conferences. This Monday and Tuesday was the 12th Annual Patient Adherence and Support Summit produced by CBI. This Thursday and Friday is the Patient Summit USA 2013 produced by eyeforpharma.

I've been following the Twitter stream from the latter. Two of them stood out:

@susanmees (Susan Mees; Director, Community Relations at Wegohealth) reported: "Of every 100 prescriptions written, only 50-70 are filled, 48-66 picked up, 25-30 taken according to directions."

Meanwhile, @StaffordPharmRX posted a link to an eyeforpharma article: "A Post-It Note Solution to Patient Adherence: Achieving Success with Simplicity" (here).

In that article, Anthony Londino, president of Med-Con Technologies, a company providing medication adherence tools, said

"People don’t take their medication because they don’t remember, and they don’t have a method to confirm that they have taken it."

That struck me as being at odds with the information that Susan posted. That data suggests 30% to 50% of the time people simply refuse to fill their prescriptions and pick them up (I doubt they can be so forgetful as to forget to go to the pharmacy after the doc writes a script). Only 20% to 25% of the time are people "forgetting" to take their medications "according to directions."

Most Physicians Agree That DTC Advertising Leads to Inappropriate Prescribing -- by OTHER Doctors, Not Them!

When the FDA announced it was moving a head with yet another study of direct-to-consumer (DTC) advertising, I said:

"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, which they also say does not influence their prescribing habits" (see here).

If a snap poll of 104 physicians by CMI/Compas has any value, nearly two-thirds of both primary care and specialty physicians agree (20% strongly; 45% somewhat) that DTC pharmaceutical advertising leads to inappropriate prescribing (see chart below):

Why Pharma Execs Fear to Follow on Twitter

There are no Big Pharma CEOs that I know of who actively and directly engage with their stakeholders -- investors, physicians, patients -- using social media such as Twitter. There are probably many reasons for this. For one thing, they hire entire PR departments to be their "spokespeople."

But I have suggested that future pharmaceutical C-suite executives will have to have experience "carrying the digital bag" (see here).

Alexandra Fulford (aka @pharmaguapa on Twitter), in an interview today (here), suggested that pharma execs could greatly benefit from having -- and using -- a personal Twitter account.