What's Right Rx for Pharma Industry's Survival?

What's Right Rx for Pharma Industry's Survival?

Two commentaries caught my attention this morning. Both offered solutions to the drug industry's "fundamental problems."

Each solution, of course, defines the "fundamental problem" differently.

Solution #1 says the problem is the drug industry does not deliver "precisely what the world's health care systems need from it — therapies to materially advance the standards of care." The author blames top-heavy management populated with "protected dimwits and timeservers who fail to grasp the current dynamics."

"The management approach traditionally used by pharma also fails to hone the skills that the industry needs right now," according to the author (see "What pharma needs to evolve" here). "...it makes for a slow pace because, figuratively, everyone learns to raise his hand before going to the bathroom. Pharma, for example, generally frowns on setting up innovative, skunk works projects."

Solution #2 says successful pharma companies must drive revenue growth by acquisitions. Management is also to blame according to the author.

"The high-growth companies have clearly aligned their capital-deployment strategies with growth investments. They have done this instead of trying to achieve a balanced capital-allocation strategy that sacrifices reinvestment in exchange for greater dividends, buybacks, or cash accumulation" (see "The Prescription for Pharma Is Revenue Growth" here).

The first solution could be categorized as a "patient/customer" focused solution, whereas the second one can be said to be an "investor/stock holder" focused solution.

Which approach do you think can help pharma in the long run?

Which approach do you think can help pharma in the long run?
	Patient-focused approach: improved health outcomes
	Investor-focused approach: improved revenue growth
	I'm wishy-washy: Both
	I'm a pessimist: Neither
	I have no friggin' idea!

A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon

A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon

If you think waiting over two years for FDA to issue guidelines it promised for regulation of "Promotion of Prescription Drug Products Using Social Media Tools," then you should take a look at the following timeline and weep.

This timeline documents the major steps in FDA's process of developing guidance for direct to consumer television (DTC) and radio ads; ie, "standards that would be considered in determining whether the major statement in direct-to-consumer television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner":

• 1 November 2005: FDA convenes a 2-day public hearing to discuss the issue (see "FDA DTC Hearings: Snippets from Day 1" and "DTC Pros and Cons Presented at Public Hearing"). Sound familiar?


• 21 August 2007: FDA announces it will conduct a study of "consumer evaluations of variations in communicating risk information in direct-to-consumer (DTC) prescription drug broadcast advertisements." It opens a 90-day period to submit comments regarding this study. This study used the latest cognitive science technique called Affect Misattribution Procedure (AMP), in which participants are asked not to judge the TV ads' imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. I suggested FDA NOT use Chinese characters because that would be discriminatory, but they did not listen to me (see "FDA at a Mall Near You: The Manchurian Connection"). With regard to social media guidelines, the FDA has also announced it will do some studies before issuing guidance (see "FDA's Proposed Web Study Will Further Delay Social Media Guidelines"). Deja vu all over again!


• 29 March 2010: FDA finally publishes the draft guidance, more than 4 years after the public hearing (see Federal register ref: 75 FR 15376). FDA was goosed along by an act of Congress: the Food and Drug Administration Amendments Act of 2007 (FDAAA), which required that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA was forced into RULEMAKING mode rather than GUIDANCE mode, which is how the pharma industry wants the agency to approach the regulation social media drug promotion as well (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").


• June 2011: FDA published an executive summary of a study of the methodology of the AMP study cited above entitled "A Supplementary Test of Distraction in DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure" (find it here). Maybe FDA read my comments after all!


• 27 January 2012: FDA announced that it added a document to the docket for the proposed rulemaking concerning a study entitled: "Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements" (Distraction Study; see Docket No. FDA–2009–N–0582). This document reopened the comment period (extending the deadline to February 27, 2012) for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards. Way back during the public hearing in 2005 I was unimpressed by research claiming that TV drug ads were designed to "distract" viewers from reading the fair balance (see op cit and "Ruth Day and the Bees Repeat Performance at House DTC Hearing" for an update on that).


• 23 March 2012: FDA reopens the comment period for a second time "in response to a request for more time to submit comments to the Agency." The new comment period will expire on April 9, 2012. According to the FDA, the "Pharmaceutical Research and Manufacturers of America (PhRMA) submitted a letter dated February 20, 2012, requesting an additional 15 days for interested persons to comment. FDA believes that an additional 15 days to comment on the Distraction Study as it relates to the proposed standards is appropriate."

What strikes me are the similarities between the evolution of these DTC guidelines/rules and the long-awaited social media guidelines.

First, there are the delaying studies and studies of studies. It's well-known that if you wish to halt progress, do a study.

Second, I sense that the drug industry pushed the FDA into RULEMAKING rather than issuing guidelines although it took an act of Congress to do that in this case. The drug industry may use the courts in the case of social media (another example of how an "activist" judiciary can work both sides of the aisle).

If it takes the FDA SEVEN or more years to complete this process for TV ads, I imagine it will take them 10 years to finalize guidance or rules (whatever!) for regulation of the use of social media for drug promotion. While TV has more or less stagnated during the seven years since 2005, social media will look completely different by the time those 10 years are up in 2019!

Pharma DTC TV Advertising Is a Joke. Seriously.

Pharma DTC TV Advertising Is a Joke. Seriously.

No wonder CBS refused to run the following "Stoogesta" ad during the NCAA basketball tournament. According to Deadline, network execs were concerned because the spoof, which promotes the forthcoming “The Three Stooges” movie, makes "light of prescription drug ads."

I've seen some pretty funny spoofs of drug DTC ads in my time (eg, see "ADHD Boy"), but this is the best I have ever seen. It convinced me to visit my movie theater & ask for an Rx of silly!



I imagine that pharmaceutical advertisers sent a clear message to CBS that they did NOT find the spoof funny. Rx drugs, after all, are serious and should not be made "light of."

However, it's not the drugs that are being spoofed. It is the drug advertisers who have rolled out the same formulaic DTC TV ads for years and years. Even kids think most of these ads are a joke.

Will the formula ever change? I don't think so. Here's why.

One of the funniest lines in the spoof is "Three in 6 billion people are afflicted by Stoogation (?), a disorder that causes the brain to ricochet and bounce..." That's just slightly more outrageous than some claims made in real drug ads about the prevalence of some "disease" you never heard of before.

I've commented on the topic of DTC ads making outrageous disease prevalence claims before (see "Disease Awareness or 'Disease Mongering'?", for example). In many cases, it is absolutely necessary for drug ads to make such claims to justify the millions of dollars spent on mass media TV ads to reach the "three in 6 billion" people who may suffer from the condition advertised.

So, the tradition of "making light of drug ads" will live on as long as advertising agencies and TV networks rake in millions of dollars to air ads that would be better off targeted to the truly appropriate audience.

BTW, the NCAA basketball tournament audience is PERFECT for the Stoogesta ad! But the ad that was chosen to run in its place is totally wrong; that ad spoofs Christianity! Where's the religious right when you need them?

Sanofi Launches Diabetapedia: "Google" for Diabetes

Sanofi Launches Diabetapedia: "Google" for Diabetes

Laura Kolodjeski (@lkolodjeski), Community Manager for Sanofi US Diabetes, sent me a Twitter DM this morning announcing the launch of Diabetapedia (di-ah-bee-tah-pee-dee-ah), a new site "to help meet educational needs of diabetes community." According to Laura, the goal is to create "a single, comprehensive place where anyone can find and share definitions of diabetes-related terms and phrases." The site's tag line is "Diabetes doesn't define you... so define diabetes."

The name "Diabetapedia" invokes a comparison to "Wikipedia," the online encyclopedia comprised of user-generated content. Diabetapedia does accept contributions from visitors who can use a form on the site to suggest a new term. To use the site, however, you first search for a term as if you were using Google. In fact, the site's home page has the simple look of a "Google" for diabetes site: a single large box for entering a term located under a large logo:

The results of a search also resemble what you would get with Google. It remains to be seen if Diabetapedia will jazz up it's logo and modify it to celebrate certain holidays the way Google does.

The simplicity of the interface also makes the site easy to access from your mobile phone. However, it is NOT optimized for mobile use (eg, the search results, etc., do not line break to enable you to read the entire definition without scrolling side to side).

Of course, there are guidelines. Terms that are appropriate for inclusion in the site include:

• Terms that directly relate to diabetes (e.g. blood glucose meter)
• Diabetes jargon, slang, or abbreviations (e.g. DOC, d-mom, blue Fridays)
• Twitter hashtags that are specific to diabetes discussions (e.g. #dsma, #sweatbetes, #bgnow)
• Diabetes-focused advocacy groups (e.g. The American Diabetes Association, The Diabetes Hands Foundation)

The most important guideline as far as pharmaceutical companies are concerned is: "do not post terms that are specific to brand names of diabetes management products."

Sanofi previews all suggestions and Sanofi promises to contact users if it requires clarification about submissions.

The site currently comes with 119 common diabetes terms and corresponding definitions. "All of the terms include a general definition from the online version of the Merriam-Webster dictionary (when available), a more specific diabetes-related definition, and any alternate uses of the term that might apply. For some," says Laura in her post introducing Diabetapedia (here), "we even included an example of a tweet or a post that demonstrates how the term is commonly used."

I hope to have Laura as a guest on my Pharma Marketing Talk show and get some more details about the site and how Sanofi hopes it will grow. One question I would ask: "Do you plan to release a Diabetapedia mobile application?"

See the questionnaire at the end of this post where you can suggest improvements for Diabetapedia and ask your own questions for Laura to answer.

P.S. Laura points out that Diabetapedia visitors' "Likes and Tweets" "may help create" a program called Diabetes Advocates run by the Diabetes Hands Foundation (DHF). The purpose, says Laura, is to "connect individuals and small organizations that have taken a leadership role in improving the world for people touched by diabetes. In 2012, Sanofi US Diabetes is proud to sponsor the Diabetes Advocates program to help empower its members to have a greater impact by helping them improve their reach and effectiveness."

A discussion of this post on Twitter:

ddwebster: Little disappointed. All definitions from Merriam-Webster RT @pharmaguy: Sanofi Launches Diabetapedia http://t.co/8R3jjYbf #diabetes #hcmktg8:57am, Apr 02 from Visibli

pharmaguy: @ddwebster All? Including "d-mom"? Whatever, good way to start. #diabetes9:00am, Apr 02 from HootSuite

ddwebster: @pharmaguy Yet to find one w/a comprehensive definition. Even A1c doesn't explain ranges, just says a test performed every 2-3 mos#diabetes9:06am, Apr 02 from TweetDeck

pharmaguy: @ddwebster Admit strange to use defns frm MW instead of National Diabetes Information Clearinghouse http://t.co/HO1IMNSX #diabetes9:13am, Apr 02 from HootSuite

ddwebster: @pharmaguy Agreed! I love the idea of the site-find info to be too generic. Pts need more detail-diabetes is complicated9:21am, Apr 02 from TweetDeck

pharmaguy: @ddwebster This could develop into good resource - what happens, however, when it is no longer sponsored by S-A? #diabetes9:32am, Apr 02 from HootSuite

ddwebster: @pharmaguy Yes, that begs a good question. Impressed by efforts by @SanofiDiabetes@Roche_USA in reaching pts in digital space#diabetes9:53am, Apr 02 from TweetDeck

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