Thursday, November 29, 2012

Dear Santa from Pharma: "Please, Sir, May I Have More?"

In the "Pharma's 2011 Christmas Wish List for Santa" survey, I had a list of items for Santa to deliver to the pharmaceutical industry. Naughty or nice, the drug industry did receive quite a few of their most wished-for presents, including:

Make sure Congress passes the PDUFA reauthorization act WITHOUT those "additional provisions that could create unintended burdens on the regulatory process." I'm pretty sure Santa delivered that present. As an extra-added bonus, Santa somehow convinced lawmakers to add this to the legislation:
"The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says. Abrams outlined the offices priorities at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C. The social media guidance is of critical importance because the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates the agency produce the guidance by July 9, 2014." However, see the list of presents Santa did not deliver below.
I'd like a copy of Steve Jobs's biography so I can learn why every sales rep needs to have an iPad! It's official! Practically every pharma sales rep now has an iPad. The question is, is the device improving the sales call? For the answer to that, see: "How is the iPad an Effective Delivery Platform for Medical Sales Professionals?" (Subscription -- free -- required.)

Please stop all this talk about "GoSoMo," which mashes together global, social, and mobile. At most, I can manage only two of these at one time! On the basis of my own anecdotal evidence, I think Santa delivered this present. I haven't seen or heard "GoSoMo"at any of the conferences I've attended this year!

Please make sure the Supreme Court decides that drug companies do NOT have to pay their sales representatives for working overtime hours. Yep, got it! Thank you, Santa!

Talk to CMS and get them to issue reporting standards for payments to physicians. They need to do this before January 1, 2012, when the Physician Payment Sunshine Act takes effect. OK, this didn't happen. However, CMS extended the data collection deadline to January 1, 2013, and has just recently provided a final rule (standards) to the White House Office of Management and Budget for review. This is usually the final step before its release. Better late than never!

That's it for the presents that Santa more or less delivered as requested by the drug industry. The following are items on the wish list that Santa did NOT deliver:

Repeal "Obamacare!" The industry doesn't have the money to subsidize the Medicare Part D doughnut hole AND to fund research into new drugs. The Supreme Court was only able to declare a small part of the law unconstitutional. And since the Republican presidential candidate who vowed to get "rid of it" -- and Big Bird too -- lost the election, I think the industry will have to wait for Christmas Future to try again for this gift.

Bring a "free" commercial speech case to the Supreme Court so that we may talk to doctors and patients about off-label uses of our products. That didn't happen, but FDA did issue guidance on how to respond to unsolicited requests for off-label information (see here).

Make the FDA get off its ass and issue those social media guidelines -- better yet, let's get new regulations to make the guidelines legally binding. Didn't happen, but see my "open letter" to FDA's Megan Clark Velez, MPH, Office of the Commissioner (here).

Put an end to FDA's "Bad Ad" program. It's the "Phoniest Thing Ever." Also didn't happen. In fact, the program is great big success and I've heard rumors that the FDA is considering allowing ordinary citizens to report bad ads. I think this was in response to my letters (see here).

Please find Pfizer's "Social Media Playbook" so we can all learn from it. I haven't seen it. Have you? Some think this is it.

Naughty or nice, pharma always wants more. What do you think should be on pharma's list this year for Santa?

FDA's "Social Media Guidance Cliff": An Open Letter to Megan Clark Velez

FDA will communicate its progress towards accomplishing the requirements of the FDA Safety and Innovation Act (FDASIA) by updating an online chart/database on a regular basis. This database/website is called FDASIA-TRACK.

Currently, the chart includes only those requirements with specific statutory dates set by Congress. "Additional deliverables will be added to the chart over time as FDA continues to advance its implementation planning efforts," says the FDA.

Of course, I am laser-focused on ONLY one "deliverable": Draft guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA. Congress has set 9-JULY-2014 as the deadline for this guidance.

In order to be in step with current Congressional media jargon, I refer to this date as FDA's "Social Media Guidance Cliff" although this "cliff" -- and, IMHO, the "Fiscal Cliff" as well -- is more like a slippery slope (see here).


If you are a regular reader of Pharma Marketing Blog, you know that I am not content to report the news. I also attempt to influence the people who make the news and goose things along by being a bit provocative.

So, I have decided to send an email to the person listed as the contact for this deliverable -- Megan Clark Velez, MPH, Office of the Commissioner -- and ask her for a bit more transparency. I decided to make this an "open" email by publishing it below in the hopes that some of you may also contact Ms. Velez with your own questions. Her contact info:

Megan Clark Velez, MPH
Food and Drug Administration
10903 New Hampshire Ave., WO1, Rm. 4316
Silver Spring, MD 20993
Phone 301-796-4830
Email: megan.velez@fda.hhs.gov


My email to Megan Clark Velez:
Dear Ms. Megan Clark Velez, 
Your email address was listed as the contact on the FDASIA-TRACK site for draft guidance regarding internet promotion, the deadline for which is 7/9/2014 (I call this the "Social Media Guidance Cliff").

The deadline seems far off, but FDA has supposedly been "serious" about issuing this guidance since the November, 2009, public hearing.

Maybe you can answer a few questions:

FDA has said that there may be several guidances in this category. "What had been envisioned as a massive, all-encompassing guidance on Internet promotion is being retooled as multiple guidances to address specific issues in the online realm," Tom Abrams said (see http://bit.ly/SgS21f). Recent guidance for unsolicited requests for off-label info, for example, included some guidance for responding to such requests via social media. Will there be other guidance documents like this issued BEFORE the "Social Media Guidance Cliff"?

If not "hidden" within other guidances, will there be any guidance SPECIFIC for social media prior to the deadline?

If such "mini" guidances ARE issued prior to the "Social Media Guidance Cliff," what question/area posed at the November, 2009, hearing will the first such guidance document address?

Whatever you can tell us -- the general public and the pharma industry -- about what the FDA is doing behind closed doors and progress being made to develop these guidances will be appreciated.

Thank you for your attention to this matter and your much anticipated response!
John Mack, Editor & Publisher
Pharma Marketing News/Pharma Marketing Blog

Wednesday, November 28, 2012

Pharma's Adherence Revenue Pipe Dream

You've seen the headlines:

"Pharmaceutical Market Fails to Capture $188 Billion U.S. Revenue and $564 Billion Global Revenue Annually Due to Medication Non-Adherence"

"Poor adherence costs pharma $564 billion per year"

These numbers come from a study conducted by Capgemini Consulting with HealthPrize Technologies: "Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence."

On the cost side, the New England Healthcare Institute estimated that medication non-adherence is responsible for $290 billion in "otherwise avoidable medical spending" in the US alone each year.

"On the pharmaceutical revenue side, however, the impact of medication non-adherence had yet to be accurately quantified," said Capgemini in the executive summary of its report. "The market assumption relied upon to date, and quoted extensively, has been $30 billion globally, which we felt was a gross underestimate-prompting this project."

"Interventions to improve medication adherence should be top priority for the pharmaceutical industry," said Capgemini. It's not likely that the drug industry can capture all the revenue "lost" dues to non-adherence.

"While achieving 100% medication adherence is not possible," said Capgemini, "even a modest 10 percentage point increase in adherence could lead to a significant rise in pharmaceutical revenues, accompanied by improved health outcomes and decreased healthcare spending."

Is improving adherence -- even a "modest" 10 percent improvement -- a "pipe dream?"

Pipe dream or reality?
It's a pipe dream
It could happen
It depends

  

U.S. Brand Drug Prices Take Flight While Generic Prices Plummet

Express Scripts just published its "Inaugural Drug Trend Quarterly," which provides the "first comprehensive overview of U.S. prescription drug spending for 2012 (see press release here). The key findings include:

  • The Index shows that since September 2011, price inflation for the most highly utilized brand-name medications was more than six times greater than overall economic price inflation for consumer goods.
  • The price gap between brand-name and generic medications widened an additional 35.2 percentage points from September 2011 to September 2012, the largest one-year increase Express Scripts has recorded (see chart below).
  • Year-to-date spending on specialty medications is up 22.6 percent, underscoring the nation's need for an accelerated pathway for biosimilars.

Here's the chart that tells it all (click on it for a larger view):


In other words, brand drug prices INCREASED 63% since 2008, while generic drug prices DECREASED 39%. Overall prices in the U.S. increased 9% during that time.

The 35.2 percentage point net inflationary difference is the largest gap between brand and generic prices since Express Scripts began calculating its Prescription Price Index in 2008.

"The big takeaway from this for me is actually not so much that we have ongoing brand inflation, because we've always had that, though it's larger than usual," said Steve Miller, chief medical officer for Express Scripts. "What's really remarkable is the gap (between branded drug prices and generics) is getting larger because of the number of generics and the discounts on those generics are steep."

I would call the "larger than usual" brand-generic price gap in 2012 the LIPITOR EFFECT, meaning that the shift from branded Lipitor to generic versions may have played a big role in widening that gap. As an aside, recall another LIPITOR EFFECT: on DTC advertising (see "Lipitor Holds Key to DTC Ad Spending in 2012").

Tuesday, November 27, 2012

What Pharma Can Learn from Dexter

Pharma marketers are often urged to learn from other industries. Well, I have something that pharma marketers/communicators can learn from Dexter, "America's favorite serial killer."

No, I'm not suggesting that marketers adopt Dexter's "Code of Harry" (i.e., kill only bad people). Pharma already has codes. It's arguable whether or not pharma follows its codes as scrupulously as Dexter follows his, but that's not what I want to talk about now.

Actually, it's not Dexter that pharma marketers should learn from -- it's Showtime, the cable TV network that created Dexter. Specifically, I'm talking about integrating a creative mobile/iPad app with a live event. The app I am talking about is Showtime Sync.

Showtime Sync allows fans of Dexter (and Homeland) to interact with exclusive content while watching the show. It has polls (e.g., How many times will Deb drop the "f-bomb" in the current episode?), quizzes, etc. You get immediate feedback on your iPad as other viewers answer questions (43% think Dexter should not have trusted Isaak).

The most interesting feature of the app, however, is how it syncs up with the show. It knows where you are in the show by LISTENING! That's right. The app listens and is able to tell where you are in the show -- even if you are watching it On Demand!

My first idea for what pharma can learn from the Showtime Sync app is to include a similar listening feature into interactive iPad detail aids that reps can use in sales calls with physicians. The app can "listen" to the physician while he/she is being detailed by the rep and automatically serve up relevant content when it hears key phrases or questions. The rep doesn't have to lose eye contact with the doc to fiddle with clicking this or that icon on the iPad to access the content!

OK, that sounds simple enough. But what about the social aspect -- e.g., comparing data from other users in real time? I don't see how this would work in one-on-one sales calls. But suppose there was an app that synced up with live presentations made at medical meetings or satellite symposia or key opinion leader presentations? About 100% of docs attending such meetings will already have iPads. If they had a syncing app on their iPads, they could interact with other attendees the same way I can interact with other Dexter fans using the Showtime Sync app. Attendees could be polled at appropriate times during the presentation and see the results. Of course, there are special audience polling companies that do this sort of thing, but apps like this will soon put them out of business, I'm afraid.

Anyway, that's enough free ideas for the pharmaceutical industry for today!

Monday, November 26, 2012

How Many Sales Reps is One Key Opinion Leader Worth?

Remember Marcia Angell, former editor in chief of the New England Journal of Medicine? She wrote the book "The Truth About the Drug Companies: How They Deceive Us and What to do About It," which I reviewed back in 2004 here in Pharma Marketing News

Angell was recently quoted in a Scientific American article where she estimated the worth of one good "Key Opinion leader" (KOL) as equal to 100,000 pharma sales reps: “To buy a distinguished, senior academic researcher, the kind of person who speaks at meetings, who writes textbooks, who writes journal articles -- that's worth 100,000 salespeople,” said Angell. The article is titled "How Drug Company Money Is Undermining Science" (find it here).

Obviously, Angell is just pulling a number out of nowhere for its sensational value. But it would be interesting to calculate the return on investment (ROI) for a KOL and compare it with the ROI for a sales rep. Just for fun, let's do the math.

First let's calculate the investment side of the ROI analysis. 100,000 sales reps, which is somewhat greater than the current total complement of reps in the U.S. (see "further thoughts" at end), would cost the pharma industry about $10 billion in salary & benefits alone (not counting travel & entertainment expenses). Actually, I've seen estimates that the total investment in sales reps, including all expenses, is about $17 million per year. Let's use that number.

Let's say that sales reps are responsible for 75% of drug sales in the U.S. I use that percentage because most reps sell the top 20 or so drugs and direct-to-consumer advertising must account for some sales. I've seen estimates of yearly Rx drug sales in the U.S. of about $320 billion (2011). Using my 75% estimate, $240 billion of that is due to a salesforce that cost $17 billion per year. The ROI is 225/17 or about 14:1.

Robert Lindsay, a physician/researcher who is the kind of "distinguished, senior academic researcher" Angell is talking about and who is featured in the Sci Amer article, was said to receive more than $124,000 from Eli Lilly in 2009 and 2010; much of it for speaking fees. So, let's say that the average high calibre KOL might get  $100,000 per year from a pharmaceutical company.

For such a KOL to be worth ONE sales rep, he/she would have to be responsible for about 14 X $100,000 or $1.4 million in drug sales per year. That's a pretty good sales number (you would have to spend about $700,000 in DTC advertising to generate that level of sales; DTC ROI is said to be about 2:1). But for a KOL to be worth 100,000 sales reps, the ROI would have to be astronomical -- about 2.4 million:1! That is, every dollar spent on the KOL would have to generate $2.4 million in sales!

My conclusion? If my estimates are correct or close to reality, then one KOL might be worth maybe ONE or LESS sales rep in terms of drug sales. What do you think?

Further Thoughts
According to ZS Associates, the current U.S. pharma sales force total stands at 64,000 (see chart). So, I really should redo the math to get a more accurate estimate of the worth of a sales rep.

If 64,000 reps are responsible for 75% of the $320 billion in U.S. Rx drug sales, then each rep accounts for $3.75 million in sales!

By some estimates, it costs the pharma industry $150,000 per year per sales rep. This includes travel and other expenses. Using that number, the ROI for a sales rep today (2012) is about 23:1!

Ergo, one KOL is worth much less than one sales rep. Caveat: Without the KOLs to legitimize claims made by sales reps, the sales rep ROI might be much less than it is, whatever the exact number may be.

Wednesday, November 21, 2012

Pharma COPD Campaigns Abound, Yet Public's Awareness of COPD Declines

According to the U.S. Department of Health and Human Services, awareness of chronic obstructive pulmonary disease (COPD) has been rising gradually in recent years, but the results of a national survey show current awareness levels have returned to those of 2008 (see press release here). Sixty-five percent of adults reported that they have heard of COPD, compared to 71 percent in 2011. Among people most at risk for COPD, awareness stood at 74 percent for current smokers and 73 percent for former smokers; in 2011 these values were 78 percent and 76 percent, respectively.

This must be discouraging news to Boehringer Ingelheim (BI) and GSK, which have been running COPD awareness campaigns for several years. They are spending money, for example, on search ads such as the ones shown in the screen capture on the left.

BI and GSK have also used social media such as Twitter and Facebook to raise awareness about COPD and treatments for the disease.

BI has been especially active in COPD awareness campaigns since at least early 2010 when I first blogged about its "DRIVE4COPD" campaign, which involves posts to Twitter, Facebook, Flickr, and YouTube (see "Danica Patrick: NASCAR Driver, Super Model, Superbowl Lingerie Ad Model, & COPD Spokesperson All Rolled Into one!"). BI, however, recently dropped its sponsorship of DRIVE4COPD, which claims that 2,629,925 people have taken the COPD screener featured on its website.

"Although these current numbers do not indicate a trend, we are concerned that the awareness level has not continued to increase. We plan to use this as an opportunity to mobilize and re-energize our efforts." said James P. Kiley, Ph.D., director of the NHLBI Division of Lung Diseases. "COPD is the only major chronic disease where deaths are not decreasing, which makes it critical for people to understand whether they are at risk for it and recognize its symptoms as early as possible. COPD can be treated - but the challenge is that more than 1 in 3 Americans do not know what it is or what its health outcomes are."

Tuesday, November 20, 2012

Merck May Know How to "Engage," But It Certainly Does NOT Know How to "Disengage"!

"Here’s your first weekly e-mail from MerckEngage®" was the subject line of an email message I received today. The introduction says: "Whether it's eating healthier, being more active, taking medicine, or learning about a specific health condition, MerckEngage can help you stay motivated—now with weekly e-mails. As requested, you'll be receiving health information and tips that are right for you, even mouthwatering recipes based on foods you like and any dietary requirements you may have. Simply log in to select your meal preferences."

I don't remember opting in to join the merckEngage email list, but I assume I did. It must have been a long time ago though. Probably in 2011 sometime because that's when MerckEngage won a Gold MM&M award for "excellence from online programs, including CRM programs that support patients that are already taking a particular therapy or using a particular medical device" (see here).

Also, in July, 2011, my blogger colleague Rich Myer -- a "big fan of Merck" -- wrote a blog post titled "Merck engage is not engagement at all" (here) in which he said "To me engagement is not a website with tools and information for patients. Engagement = conversation."

Well, I don't know if merckEngage now offers conversation or not, but I do know that Merck is trying to "engage" with me via email. The problem is, it comes a bit late; I have forgotten why I wanted to "engage" with Merck in the first place.

So, I decided to "opt out" of receiving further emails from merckEngage. That's when I began to have problems.

At the bottom of the email message from merckEngage is this statement: "You may have elected to receive e-mails and other online communications from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. If you no longer wish to receive these e-mail communications from Merck, please click here to provide Merck your e-mail address for the sole purpose of this opt-out request. If you have trouble accessing this link, please send an e-mail to merck_privacy_office@merck.com with the subject line of E-mail Opt Out Request."

I thought by simply clicking on "click here" as instructed I would be immediately removed form the list. Silly me! It seems I have to log in first to be able to unsubscribe (see screen shot below). Whaaa?


For the past few weeks I have been clicking "unsubscribe" links in dozens of spam email messages in order to get off lists I somehow got on just by visiting Websites. Most of the time this works fine - I click and wham, bam, thank you spam, I'm off the list and my email inbox now is manageable.

I have never encountered an opt out process such as the one merckEngage seems to be using. So, I went back to the opt out instructions at the end of the merckEnage email to see if I had other options. It was then that I noticed the link for "click here" is "https://www.merckengage.com/login.aspx?ReturnUrl= f99_Admin funsubscribe_email.aspx", which is what led me to the page above. The code includes: "funsubscribe_email" which is either a combination of "f" and "unsubscribe" or "fun" and "subscribe." Hmmmm! Does Merck think I'm having fun?

The opt out statement also says "please click here to provide Merck your e-mail address for the sole purpose of this opt-out request..." Dear Merck: You sent a message to my email address. Ergo, you must know my email address! Why should I have to provide you with my email address to unsubscribe? I've opted out of dozens of email lists and never had a problemlike this. Your "engagement" technology stinks.

So, because I forgot my username and password to this site a long, long time ago, I decided not to go through the convoluted process of retrieving that info just to opt out. Instead, I decided to send an email to merck_privacy_office@merck.com as instructed. I never received any email confirmation that my message was received nor that my email address was removed from the list. Perhaps my email ended up in Merck's spam filter!

Maybe it's me that has a problem? Maybe I'm just too stupid to figure this out? Nah! It's Merck!

FDA Pulls “Plug” on PATANASE Detail Aid

Subtitled: Alcon Caught Illegally "Plugging" PATANASE Nasal Spray to Docs The FDA's Office of Prescription Drug Promotion (OPDP) sent a "untitled" letter to Alcon Research regarding a PATANASE "detail aid", which the FDA claims is "misleading because it implies that Patanase has been shown to be effective in the treatment of the specific symptom of nasal congestion, when this has not been demonstrated by substantial evidence or substantial clinical experience."

Language in FDA's letter regarding graphic images and the product logo appearing in the detail aid caught my attention:
  • Graphics of a woman and child with a cork in each nostril [my emphasis] on the front of the sales aid and the contrasting image of the same woman and child without corks in their nostrils on the back of the sales aid.
  • The tagline “Unplug with” in conjunction with a graphic of two loose corks  [my emphasis] and the Patanase logo
FDA is not known for its humor, so I had to see if these images were actually in the detail aid. Fortunately, FDA linked to a pdf version of the aid here. Below is the first page:


Of course, the "after" image shows the mom and boy without the corks up their noses and smiling:


Usually, FDA's letters often tell pharma marketers who overstate efficacy to "put a cork in it"; i.e., stop making false claims. But, in this case, FDA would rather that Alcon just get rid of the corks altogether!

Doctors Miss Their Free Lunches Says Survey

Medscape's 2012 Ethics Report survey revealed that 72% of 23,710 physician respondents answered "Yes" to the question "Do you feel that you could be unbiased with prescribing habits if you accept lunches from pharmaceutical representatives?"

First, it's interesting that this question was included in a survey that purports to investigate "Physicians' Top Ethical Dilemmas" along with questions involving insurance fraud, physician-assisted suicide, and abortion. But it certainly has generated buzz and blog posts such as this one and this one.

Limiting free lunches to physicians is part of PhRMA's Code of Interaction with Physicians. According to my own survey of pharmaceutical marketers, however, the code has had little impact on "Lunch and Learn" activities in which sales reps offer free lunch in physicians' offices while making a presentation (see "Impact of PhRMA Code of Interaction with Physicians").

Some states, however, have enacted laws that are more prohibitive than PhRMA's code. But these laws have had an impact on local businesses (i.e., restaurants that serve the meals). In response to pressure from pharma, physicians such as the 72% above, and local businesses, Massachusetts recently decided to "scale back" it's anti-free-lunch-for-physicians law. Instead of outright banning of gifts like free lunches, Massachusetts now allows physicians to receive "modest meals," which is more in line with PhRMA's code.

The physician payment sunshine provision of the Affordable Care Act, however, will eventually reveal just how much pharma companies spend on feeding physicians. "Food" is one of the 15 or so "categories of payment" that pharma must report.

Some of the comments from physicians in the Medscape survey include:
  • Voted Yes: "A dedicated lunch offers a chance to ask questions and actually ruminate on how the product might work for your patients. The alternative is doing what we do -- a bit of reading and trying it out patient after patient." Why, however, do physicians need a free lunch to ask reps these questions?

  • Voted Yes: "I am outraged at the notion that a lunch or a pen or a book could be felt to be inducement for me to prescribe certain drugs." There are studies that show what doctors think and what they do are two different things (see, for example, the study attached to this post: Pharmaguy's Picks for 20 November 2012).

  • Voted Yes: "If you accept lunches from ALL reps, that levels the playing field and you make your own choices." Ha ha! This guy/gal just loves to eat, IMHO.

  • Voted No: "I want to believe I can be, but the evidence says I'm kidding myself." An evidence-based physician! How refreshing!

Monday, November 19, 2012

New Fangled Cardio Drugs: Good Lab Results, Little Benefit to Patients

In a story about the struggle of Amarin Pharmaceuticals against a "Fish Oil Backlash," Forbes blogger Matthew Herper said "the idea that some drugs may improve laboratory values without helping patients is now popular among cardiologists" (read here).

Herper suggested that this "popular" belief has hurt prescriptions for niacin, sold by Abbott, for Merck’s blockbuster cholesterol pills Zetia and Vytorin, and now for Lovaza, marketed and sold by GSK.

At first, GSK's marketing "prowess" seemed to overcome common sense; i.e., that you might as well get your fish oil from less expensive OTC supplements or from fish itself (see "Proof That Pharma Marketing Works: Lovaza sold more than $1 B in 2010!"). But as the following Lovaza Rx data shows, the blockbuster days may be over for Lovaza:


It turns out, however, that marketing "prowess" may have had less to do with the rise of Lovaza than ancillary "unsavory and aggressive" tactics such as "hiring doctors with little expertise in heart disease to talk up Lovaza’s cardiovascular benefits, paying one primary care doctor $45,000 over a three-month period to speak about the medicine," according to an expose cited by Herper.

Is this another incidence of GSK inappropriately influencing prescribing decisions?

According to a Pharmalot blog post (here) that exposes other GSK unsavory marketing practices associated with Advair (here), a Glaxo spokeswoman said that “it is absolutely against GSK’s policies and practices to inappropriately influence prescribing decisions.” The spokeswoman added that such practices do not reflect “the company we are today.” That, IMHO, remains to be see.

Physicians' Healthy Skepticism About Pharma-Funded Research

"Is Big Pharma getting too much flak from doctors?" That's the title of a recent Reuters article (find it here) that reviews a Harvard study published in the New England Journal of Medicine (NEJM). The study found that physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials of equal scientific rigor.

In an editorial response, editor-in-chief Dr. Jeffrey Drazen listed the steps the journal has to improve the reporting of clinical trials such as publishing study protocols and posting the financial associations of study authors. Drazen also noted that "NIH-sponsored studies also have substantial incentives, including academic promotion and recognition, to try to ensure that their studies change practice."

Pardon me if I don't believe the career incentives of NIH scientists are on par with the huge financial incentives of pharma companies, some of which have been found guilty of "spinning" unfavorable data (e.g., the Merck VIOXX scandal; see here and here) and hiding important safety information (e.g., GSK and Avandia; see here).

"A trial's validity should ride on the study design, the quality of data-accrual and analytic processes, and the fairness of results reporting," said Drazen. "Ideally, these factors — not the funding source — should be the criteria for deciding the clinical utility."

The study authors, however, had this to say about that: "Financial disclosure is important, but more fundamental strategies, such as avoiding selective reporting of results in reports of industry-sponsored trials, ensuring protocol and data transparency, and providing an independent review of end points, will be needed to more effectively promote the translation of high-quality clinical trials — whatever their funding source — into practice."

The steps taken by the NEJM and other medical journals may address some of these concerns, but nothing they do can unearth situations where drug companies and their paid researchers criminally hide safety data or selectively report positive results. How is a journal going to discover that? And since there is past incidents where this has happened, IMHO physicians SHOULD be skeptical of trial results sponsored by pharma companies and perhaps not prescribe new drugs to their patients until there is independent confirmation that the results are valid.

The drug industry, however, also plays a big role in this "validation" process AFTER trial results are published. "Key Opinion Leaders," paid by pharma companies, are often deployed to spread the word and influence other physicians to prescribe the product*. But at least physicians can get other, less biased, opinions from their colleagues. This may be where "gated" online physician forums can be helpful (see here).

*Speaking of physicians deployed by pharma to spread the word, A recent Journal Sentinel/MedPage Today investigation found the growth in Advair sales followed new asthma treatment recommendations that were written largely by doctors who received money from GlaxoSmithKline and other companies that market the drugs. The picture of how a potentially dangerous drug became commonly prescribed comes from a Journal Sentinel/MedPage Today review of transcripts of FDA hearings, financial disclosures, medical journal articles and a U.S. Department of Justice complaint against GlaxoSmithKline. Read more here...

Saturday, November 17, 2012

Measuring Online Communities: Pharma vs. Other Industries

The pharmaceutical industry "would benefit from studying and judiciously adopting some of the more innovative ways that other industries interact and build band affinity through their community models," says ComBlu, a firm which builds online and offline communities. Comblu's fourth annual study, "State of Online Branded Communities," offers a view of how some of the biggest and most respected brands approach online community broadly defined as "an engagement ecosystem that has no walls. Community includes offline conversations, social networks, review sites, gated brand communities and content hubs," says Comblu.

Comblu specifically looks at the community and social marketing programs of 92 companies, all of which are major brands, across 15 industries. Comblu mentions several pharma "communities" in its study and singles out Johnson & Johnson’s My Coach Sleep -- TYLENOL® PM branded app/site -- as a "great example" of mission-appropriate engagement.

The report also mentions Pfizer's "Lipitor app," which Comblu says, "integrates" with its online community. I guess Comblu is referring to "Recipes 2 Go," an app that was linked to a Lipitor for You program, which offered a $4 co-pay card. That app, however, was quickly retired, perhaps because it was a marketing failure (see "Pfizer's Short-lived LIPITOR Branded Mobile App: Was It a 'Bad Ad' or Just a Bad Idea?").

The study also mentions Pfizer's unbranded Get Old community, which I reviewed here, Novartis’ CML Earth community, also unbranded, and Eli Lilly's Lilly Pad, a corporate blog (see "Eli Lilly's LillyPad Blog: To Whom Does It Speak?").

Comblu rates the communities of major industries according to how well they follow 33 "best practices" that relate to content and engagement. It also discusses "worst practices." What's the #1 worst practice? "Moderating comments, stories and photos before posting to the community site." Overcoming that is something the pharmaceutical industry cannot "judiciously adopt" from other industries due to many factors (mostly regulatory). It's no surprise, therefore that the pharma score falls in to the "Lights Out" category, which is to say it scored less than or equal to 21 points. Of the ten lowest-performing brands, eight are in a regulated industry, including four pharmaceutical companies and four OTC brands. Here's the chart:


It's no surprise that the Rx pharma industry would score low. Many of the  community"best practices" advocated by Comblu are nearly impossible for the pharmaceutical industry to score highly on. Pharma industry best practices must incorporate "lowered expectations" commensurate with a highly regulated industry. That being said, I am surprised that the OTC drug industry fared worse than the Rx drug industry according to Comblu. If low scores are directly related to greater regulatory pressure, then the OTC industry, which faces less stringent regulations than Rx, should have a better score than the Rx industry. Whatever.

The pharma industry, however, does somewhat better in terms of "Integration with Mobile" as shown in this chart:


Friday, November 16, 2012

If Negative Political Ads Work, Would "Negative" Pharma Ads Also Work?

According to the Wesleyan Media Project, which tracks political advertising, over 80% of the two presidential campaigns’ television advertising was negative. Greg Kirsch over at Intouch Insights Blog asks: "So if the public ... hate the negative discourse, why does it continue?" and then answers: "Because it works."

Kirsch thinks pharma marketers should learn from political advertising and "avoid automatically defaulting to the positive — e.g, 'If you take this drug, you can be like this happy couple walking on the beach.'" Instead, suggests Kirsch, "what if we defined the offer as a way to prevent health loss? As in, 'If you don’t take this drug, you won’t be able to do the things you love.'" (Read all his comments here.)

Here's a typical "positive" pharma direct-to-consumer (DTC) ad that you might find in a woman's magazine:


Imagine this ad remade to be slightly more "negative" like this:


Of course I'm limited in my ability to use Photoshop. The people on the left are supposed to represent what you would look like WITHOUT Stelara. Obviously, they should not be smiling like the people on the right who have been treated with Stelara. Anyway, I think you see where I am going with this.

There are a host of reasons why pharma would or should never do something like this -- primarily because of FDA regulations. Even if my make-believe ad did not illustrate before and after treatment, but just used the "before" image on the left, I imagine that the FDA would have something to say about the ad.

But a more important reason why pharma should NOT use "negative" ads, IMHO, is because patients don't want to be reminded of how bad they look or feel. We are conditioned to view OURSELVES as the people depicted in ads no matter if they are ads for soap suds or for drugs. Clearly, however, people featured in negative political ads are specific persons that are being targeted and are not supposed to represent the typical viewer.

Now, I imagine the print portion of ads could talk about the negative implications of not being treated. In fact, that is done very often. Unfortunately, print does not have the same impact as do images.

Just some of my thoughts about what pharma should not learn from political ads.

Pharma "eBooks": Imagining what COULD be, not what IS

"Should Pharma companies be developing eBooks for patient education?" That's another pharmaHOTSPOT online "debate" that I am currently having with Zomega's Mike Spitz (@spitz). You can view both sides of the debate here. My view was summed up thus: "Interactivity in eBooks is crucial to help patients. If the pharmaceutical industry is using eBooks as a marketing resource, they should be used as well-documented tools to help physicians pass content onto their patients."

As usual, the debate spilled over into Twitter and now to this blog post :-) @MaverickNY said "iBook format offers a wonderful way to integrate useful content rich disease information in text, audio & video." I will say more about that below.

First, let's make a distinction between "eBook" and "iBook" because there's some confusion. An "iBook" is actually a special form of eBook that can be created with Apple's FREE iBook Author. iBooks are what you find in the iTunes Store and read with the iBooks reader on your iPad or iPhone.

"eBooks," on the other hand, are more general and can actually be "apps" that run on iPads or iPhones. eBooks can be quite complex and limited only by the programming ability, imagination and creativity of the developer. Pharma eBook developers #FAIL in the last two attributes, IMHO.

Two examples of pharma eBooks that I talk about in my video (see below) are (1) "Diabetes and You" by Novo Nordisk, and (2) "Understanding Plaque Psoriasis" by Janssen Biotech.

"Diabetes and You" is an iBook. It's easy to download and navigate just like any other iBook; just flip the pages.


"Understanding Plaque Psoriasis" is actually one "issue" in a serialized publication called "Your Journey to Healthier Living." You must download the special "viewer" app before you can read it. This is similar to my New Yorker Magazine viewer/app. Presumably, when the next issue is released, it will appear in my Journey to Healthier Living library section and available for me to view.

Whereas  "Diabetes and You" is a simple, linear page turner that was probably "repurposed" from a print version, "Understanding Plaque Psoriasis" is like a very beautiful, well-designed customized magazine. You don't simply "turn pages" to read this eMagazine. You can scroll and push buttons to see recipes and take a quiz.

If you combine the first two pages of "Understanding Plaque Psoriasis," what you get is a typical magazine-style ad for Stelara, a Janssen drug for the treatment of "moderate to severe plaque psoriasis..." etc.


I have nothing against this except what I mention in my HOTSPOT video; i.e., this type of branded "hard sell" in an eBook might make it more difficult for "ethical" physicians not on Janssen's payroll to "prescribe" this eBook to their patients who may be taking another drug. So it loses its appeal as a true patient education piece that many physicians might like to see in the hands of their patients.

Anyhoo, back to interactivity and what could be.

As I mentioned, "Diabetes and You" is just a repurposed print book. It has no interactivity to speak of. In fact, it has "faux" interactivity. Here's an example of what I mean by that:


The print version is more interactive than this! In the iBook version, I cannot write anything into the boxes that invite me to do so. And there's no link to an online form that would allow me to use this "tool."

This is is what it is. But what COULD it be?

Just a short review of iBooks Author gives me some ideas of what iBooks could be like. Here are a few features that could make pharma iBooks MUCH more interactive and engaging and, hence, educational:
  • Add text, shapes, charts, tables, and media anywhere on the page 
  • Choose from a variety of widgets that add Multi-Touch interactivity to your book 
  • Add a photo gallery, chapter review, movie, audio file, 
  • Keynote presentation, scrolling sidebar, dynamic pop-over, interactive image with callouts, 3D object, or custom HTML anywhere in your book 
  • Add accessibility descriptions to any widget so that it can be used by sight-impaired readers easily with VoiceOver
None of these features is in Novo's iBook OR Janssen's customized "eMagazine." I am especially miffed that some graphic labels in Novo's iBook are practically impossible for me to read, such as this one:


I invite you to click on this graphic for an enlarged view that you MIGHT be able to read. Unfortunately, Novo's iBook does not allow you to even do this, much less have "voiceovers" to help vision-impaired readers such as people with diabetes... DOH!

Here's my HOTSPOT video:

Tuesday, November 13, 2012

Physicians Need Better Guidelines for Disclosing Conflicts of Interest Via Social Media

It is well-known that space constraints inherent in search ads and social media applications such as Twitter prevent the pharmaceutical industry from disclosing FDA-required important safety information (ISI) in ads/messages that promote Rx drugs for indicated uses. There may be ways around this (see here and here and here), but without specific social media guidelines from the FDA, the drug industry is reluctant to use the workarounds.

It turns out that space limitations may also be a factor in preventing physicians from disclosing conflict of interest (COI) ties to the pharma industry when they use Twitter and other social media to communicate with patients, especially about medical research.

In a commentary published online in the Journal of General Internal Medicine, Matthew DeCamp, M.D., Ph.D., a postdoctoral fellow in the Johns Hopkins University School of Medicine’s Division of General Internal Medicine, "argues that some physicians use social media to give advice to patients and the public without revealing drug industry ties or other information that may bias their opinions," reports HealthCanal.com (here). "Without serious efforts to divulge such information - standard practice when publishing in medical journals and recommended in one-on-one contacts with patients - DeCamp says consumers are left in the dark."

"As physicians and patients increasingly interact online, the standards of appropriate behavior become really unclear," says DeCamp, who also holds a fellowship at the Johns Hopkins Berman Institute of Bioethics. "In light of norms of disclosure accepted throughout medicine, it’s surprising that major medical guidelines fail to adequately address this issue."

Decamp notes that one reason for this may be difficulty in in disclosing within the space constraints of social media. A generic disclosure such as "The author has no conflict of interest to report related to this tweet" uses up 70 of the allotted characters and leaves little room for other content such as patient support messages or research information.

In other cases -- such as in medical journals and in office settings -- physicians must disclose conflicts, although sometimes they don't. And such lacks of disclosure CANNOT be blamed on "space limitations."

Speaking of disclosures in the office setting, according to the article "when doctors prescribe a blood pressure medication, professional guidelines say they are ethically bound to tell patients if they have any financial relationship - such as receipt of consulting fees - with the company that manufactures the drug."

I have some personal experience with physicians that do not reveal possible conflicts when prescribing drugs to patients: my Doctor -- who has received payments from Pfizer in 2010 -- wanted to switch me to from a generic Pravachol to brandname Lipitor to control my high cholesterol level (see "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE").

"While some professional guidelines do recommend disclosure in social media," DeCamp says, "they don’t lay out how it should be done, while many ignore the topic altogether. The history of conflict of interest in medicine is such that you don’t want to be late to the table," DeCamp says.

I agree that guidelines for physician use of social media should lay out how to disclose conflicts of interest. I'd love to see the guidelines that do this (see below) because they may be the model for FDA guidelines on how pharma should disclose ISI via social media/search ads that promote Rx drugs. The problem is, will physicians adhere to such guidelines any better than they have adhered to "real world" disclosure guidelines?

P.S. I've looked at one example of guidelines for physicians use of social media that addresses COI: The Federation of State Medical Boards "Model Policy Guidelines for the Appropriate Use of Social Media and Social Networking in Medical Practice" (find it here).

Regarding disclosure of COI, this document states: "At times, physicians may be asked or may choose to write online about their experiences as a health professional, or they may post comments on a website as a physician. When doing so, physicians must reveal any existing conflicts of interest and they should be honest about their credentials as a physician."

This comes no where close to helping physicians figure out how to actually do this in a social media setting such as Twitter. DeCamp, at least, provides some specific examples of ways that physicians might accomplish disclosure on Social Media (click for a larger view):


Monday, November 12, 2012

Public Citizen Tracks "Bad Pharma" Financial Settlements

Public Citizen, the citizen "watch dog" group, has documented all major financial settlements and court judgments between pharmaceutical manufacturers and the federal and state governments since 1991. Its latest report (here) covers the time frame from its last report (November 2, 2010) through July 18, 2012. According to this latest report:
"A total of 74 additional settlements, totaling $10.2 billion in financial penalties, were reached between the federal and state governments and pharmaceutical manufacturers between November 2, 2010 and July 18, 2012, with the first half of 2012 alone already representing a record year for both federal ($5.0 billion) and state ($1.6 billion) financial recoveries. Since 1991, a total of 239 settlements, for $30.2 billion, have now been reached (through July 18, 2012) between federal and state governments and pharmaceutical companies."
The following chart shows the yearly trend since 1991:


These data include Federal and State settlements. Between November 2, 2010 and July 18, 2012, state settlements were $2.5 billion vs. Federal settlements totaling $7.7 billion. "2012 already represents a record year for state financial recoveries," says Public Citizen,  which notes that this 2012 state windfall was "largely due to a single court judgment in Arkansas in 2012 that required Johnson & Johnson to pay the state $1.2 billion for the unlawful promotion of the antipsychotic Risperdal. To our knowledge, as of the publication of this report, the company has not yet paid the fine and plans to appeal the judgment." Hopefully, JNJ will eventually pay up and help AK balance its budget and then some!

I created the following pie chart showing which types of penalties were responsible for generating these massive Federal and State settlement amounts:

"Unlawful Promotion" -- off-label and other "deceptive" marketing practices -- represents largest slice of the pie. This is probably a low estimate because the category "multiple violations" must also include unlawful marketing violations. If only 25% of these were marketing related, then "Unlawful Promotion" would account for the MAJORITY of settlement fees.

The following table shows the TOP TEN settlements between November 2, 2010 and July 18, 2012:


Congrats to GSK for being at the top of the list!

One other piece of information I found interesting is that "qui tam" cases involving "whistle blowers" account for the vast majority of the financial settlements in recent years. In terms of percent of the settlement dollar amount, here's how it looks for the past few years:

  • 2009: 96%
  • 2010: 97%
  • 2011: 33%
  • 2012: 90% (through July 18)

Whistle blower cases in 2011 didn't result in big financial settlements; consequently, 2011 was a "down" year overall.

Happy Anniversary! First Ever Pharmaguy Social Media Procrastinator Award Goes to...

Today is the third anniversary of the first day of the 2-day November 2009, FDA public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here, here, and here).

Shortly after that hearing, some FDA staffers lead us to believe that FDA would come out with social media regulatory guidance for the pharma industry by the end of 2010 (see here). That never happened.

Instead, FDA kept procrastinating and throwing roadblocks in the way such as proposing further studies (see, for example, "FDA's Proposed Web Study Will Further Delay Social Media Guidelines").

Meanwhile, to add insult to injury, Tom Abrams, head of FDA's DDMAC (now OPDP), keeps showing up at industry meetings where industry leaders were expecting him to announce progress towards issuing draft guidance. At one such meeting in February, 2011, Abrams spent a scant 4 minutes discussing social media guidance (read this). At that meeting, he said FDA would NOT "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter. Those things are really big now, but you know what, two years from now who knows what the next thing [will be]?" Well, guess what? It's almost two years later and YouTube, Facebook, and Twitter are still BIG, if not BIGGER and nothing has come along that's bigger. [BTW, Abrams also pooh-poohed Groupon, which now seems prophetic! And Google eliminated sidewiki, which was a big concern at the 2009 public hearing (read this).]

In recognition of the role Abrams has played in all this procrastination regarding social media guidance from FDA, I hereby present to Abrams the first ever Pharmaguy Social Media Procrastination AwardTM.

This award, as you may notice, is the antithesis to the famous Pharmaguy Social Media Pioneer Award, which was recently given to the sanofi US diabetes team (see here).

The iconic Hawaiian shirt in the "Procrastinator Award" is dark, symbolizing the negative implications of procrastination versus the bright yellow, positive Hawaiian shirt image used in the "Pioneer Award."

Abrams continues to show up at industry meetings promising that social media guidance is a high priority at FDA and it will be coming soon -- perhaps as "soon" as July, 2014 (see here). Yet, we've heard it all before. That's why I think it is fitting that Abrams receive the the "Procrastinator Award."

If Abrams lives up to his latest promise -- which is doubtful, IMHO -- it would have taken the FDA only 4 years and 8 months to issue draft social media guidance. In terms of Internet/social media timeframes -- in which 2 years can bring BIG changes -- this is procrastination on an epic scale. But in terms of FDA guidance timeframes, 4 years and 8 months is par for the course (see, for example, "A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon").

Saturday, November 10, 2012

Mobile Apps vs. Mobile Optimization: Which Offers Pharma the Best ROI?

According to the "Mobile Health 2012" survey on the use of cellphones for healthcare that was just been released by the Pew Internet and American Life Project, "half of smartphone owners use their devices to get health information and one-fifth of smartphone owners have health apps."

Pharmaceutical marketers who wear "rosy glasses" may take away from that top line synopsis, which appears as the subtitle of the survey report (find it here), that it is time to develop Rx branded health apps -- such as adherence reminders -- for consumers. But if you look more deeply into the survey results, which I am sure you will do after reading this, you will find that only about 9% of U.S. Adults over the age of 18 (19% of the 45% of smartphone owners) "happen to have" apps that help them track or manage their health. Keep in mind that "having" does not equate to "using." We know from other surveys that the majority of these apps may have been used just a few times and then forgotten.

Also, 81% of those 9% have health apps for:
  • Exercise, fitness, pedometer or heart rate monitoring (includes specific types of exercise like running, ab workouts, yoga, etc.) - 38%
  • Diet, food, calorie counter - 31%
  • Weight - 12%
Other "uses" include "period or menstrual cycle" (7%), "blood pressure" (5%), and WebMD (4%).

So, on the one hand we have these disappointing numbers regarding mobile health apps. On the other hand, however, PEW reports that "in 2010, when the same percentage of U.S. adults owned cell phones, 17% of cell phone owners reported using their phones to access health information. Today, that number stands at 31%, almost double the previous figure." That's 31% of 85% of all U.S. adults over the age of 18, or 26% of all adults!

"Access health information" more or less refers to using the browser on the smartphone to access plain old web sites. IMHO, this means that drug companies would be better off optimizing their Web sites for mobile access than putting money into the development, distribution, and support of "apps." And, according to Klick Health, which is in the business of optimizing Web sites for mobile, "Google recently reported that 1 in 5 searches on Google are now from a mobile device. [Google] also asserted that ranking priority within mobile search results will be given to sites that are mobile optimized. This further underlines the need to ensure your website is optimized for mobile." For some interesting statistics from Google, see "Mobile-friendly sites turn visitors into customers."

"Sadly," reported Michael Maher, Senior Vice President of Marketing at Digitas Health (here), "a 2011 Mediapost audit showed just 19% of pharma sites are mobile-optimized, and Google estimates only slightly higher at 21%." A Digitas Health December 2011 survey found that of the top 25 pharmaceutical brands of 2010, only three had mobile websites specifically built to display on mobile browsers.

I wonder if the situation viz-a-viz pharma Web site mobile optimization has improved much in the last year.

Thursday, November 08, 2012

Will FDASIA Get FDA Off Its Butt to Finally Issue Social Media Guidance?

I noted with interest the headline in today's FDA News email: "OPDP: Social Media Guidance Will Be High Priority in 2013"." Here's the teaser copy that explains what's going one:
"The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says. Abrams outlined the offices priorities at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C. The social media guidance is of critical importance because the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates the agency produce the guidance by July 9, 2014."
I have three comments regarding this:
  1. I reported back in July 2012 (here), about a little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act", which was signed into law by president Obama on July 10, 2012. This provision simply states: "Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."

  2. This is NOT the FIRST time Abrams has promised that social media guidance was a "priority." At the November, 2009, FDA public hearings on social media, Abrams said he heard "loud and clear from folks in this room" (ie, pharma companies) that "we want guidance on social media... We heard that message. Let me tell you that we are devoting a lot of resources and effort to this" (read this: "Is It Time for Abrams to Leave?").

  3. Although it's nice that Abrams says social media guidance will be "at the top" of FDA's work plan for 2013, I wonder why it was REMOVED from the published work calendar as far back as 2011 (read this: "FDA Drops Social Media from Its 2011 Guidance Agenda").
So, will Abrams keep his promise this time? Pardon me for being a doubting Thomas. You think a "do nothing" Congress that's facing a "fiscal cliff" will spend any energy to make sure the above "provision" is adhered to by the FDA? I said it before and I'll say it again now: If FDA misses the deadline set by FDASIA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

Wednesday, November 07, 2012

Sanofi Accepts Pharmaguy's Social Media Pioneer Award

A few weeks ago -- before hurricane Sandy disrupted life as we know here on the east coast -- I presented the coveted bright yellow Hawaiian shirt/Pharmaguy Social Media Pioneer Award to Dennis Urbaniak, VP, Joan Mikardos, Senior Director, and Laura Kolodjesji, Senoir Manager, Patient Solutions, at Sanofi US Diabetes (see "Dennis Urbaniak, Joan Mikardos, and Laura Kolodjeski of Sanofi US Receive the 3rd PharmaGuy Social Media Pioneer Award").

Unfortunately, Dennis, Joan, and Laura were not available to accept the award personally. Since we're all into "non-personal" communication via email and YouTube, I am happy to post the following award "acceptance" video that Joan and Laura made at their New Jersey-based sanofi Hawaiian set (I am amazed that they found Hawaiian Leis for props!). Too bad that Dennis could not be there with Joan and Laura to strum on his Ukulele :-(

Tuesday, November 06, 2012

Pharma Testimonial Videos Overstate Efficacy More Often Than Other Ads

Mark Senak over at Eye On FDA Blog has analyzed 235 Warning Letters (WLs) and Notice of Violation (NOVs) letters issued by FDA's Office of Pharmaceutical Drug Promotion (OPDP) since 2005. He cataloged 600 violations, including:

  • risk omission or minimization, 
  • superiority claims, 
  • overstatement of efficacy, 
  • unsubstantiated claims and
  • broadening of indication

When Senak specifically looked at letters regarding pharma marketing videos (excluding TV DTC ad videos), he found that 80% of the violations concerned risk minimization (40%) or overstatement of efficacy (40%). Below is the remake of his pie chart of these data (for the original data see "Viewing Video’s Regulatory Profile").


What's interesting is that these videos -- mostly patient and physician testimonials -- overstate efficacy at TWICE the average for all kinds of promotions (40% for videos vs. 21% for all ads, including video). Senak postulates that "when people talk about their own experiences with a treatment, [they] may include reference to outcomes that is not typical or supported by clinical data."

An example of a video that overstated efficacy was a video testimonial featuring Ty Pennington posted on youtube.com by Shire. FDA said "Both the webpage and video overstate the efficacy of Adderall XR; the video also omits important information regarding the risks associated with Adderall XR use."

The problem with FDA letters is they usually are sent well after the cow has walked through the open barn door! See, for example, "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!"

Monday, November 05, 2012

Survey: Should PhRMA Issue Mobile Health App Guiding Principles?

In February, 2012, in a blog post provocatively titled "An App for That, But For How Much Longer?", PhRMA's Kate Connors agreed with a Washington Times op-ed piece 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. In my own blog post, I cited this post as "FDA Mobile Regulatory Fear Mongering." You can read my blog post (here) to see why or you can read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.

More recently, I suggested that The Best Defense Against Zealous FDA Regulation is Self-Regulation (see "My POV Regarding Regulation of Pharma Mobile Medical Apps").

This survey asks your opinion regarding several issues faced by pharma companies when developing mobile applications (apps) for physicians and consumersI wonder how many people feel as I do. So, I posted the Regulation of Pharma Health Apps Survey to find out (see the survey embedded at the end of this post). This survey asks your opinion regarding several issues faced by pharma companies when developing mobile applications (apps) for physicians and consumers. Issues include impact of regulation by FDA, privacy, trust, accuracy, and 3rd-party certification as well as industry self-regulatory guidelines.

I recently interviewed Happtique CEO Ben Chodor who said "There are tens of thousands of medical, health and fitness apps on the market and their sheer number makes it difficult for health care professionals and consumers to locate apps that operate reliably, are based on valid information, and safeguard users' information" (listen to the podcast: "Taming the 'Wild West' of Mobile Health").

Sooner or later, IMHO, Congress is going to be investigating mobile health apps to see if further regulations -- not just FDA regulations -- are required. IMHO, the pharmaceutical industry (i.e., PhRMA) should differentiate itself from the "wild west" developers by being pro-active in issuing Guidelines for Mobile Health Apps Developed by the Pharmaceutical Industry in much the same manner as it developed other self-regulatory guidelines such as the DTC Guiding Principles and the Code on Interactions With Healthcare Professionals. However, this time, PhRMA should act BEFORE Congress or the FDA takes the first step!

What Do You Think?

The Regulation of Pharma Health Apps Survey asks whether or not you agree that it is in the drug industry's best interest to police itself and develop best practices or self-regulatory guidelines for developing trustworthy health/medical apps for consumers and physicians.

It also asks if you agree or disagree with the following statements:
  • Apps must include full disclosure regarding the company that has created the app or the sponsoring pharma company. This includes contact information. BRANDED apps MUST include ISI (important safety information) up front in an easily accessible manner (e.g., on start-up screen).
  • Apps that are BRANDED (i.e., mention drug brand names) must be available ONLY from the appropriate U.S. app site (e.g., Apple App Store) even if all the FDA-required ISI (important safety information) is included.
  • Apps intended to be used by healthcare professionals in the U.S. must be HIPAA compliant.
  • If an app collects personal information, it should include a privacy policy that explains how such data is protected (security), who owns the data, how users can access the data, where data is stored (on device or on remote web site) and instructions for opting out of data collection.
  • The pharmaceutical industry has to police itself with regard to development of all health apps regardless of what regulations FDA may impose.
  • The app should include appropriate disclaimers and terms of use that the user MUST agree to before the app will run.
  • All health/medical apps should be certified by third parties such as Happtique.
  • If an app relies on algorithms or formulas, it must be validated through rigorous testing and documentation to ensure it works properly (i.e,. calculations are correct).
Please take a few minutes to respond to this survey here. The summary of results will be published in a future issue of Pharma Marketing News. You may remain anonymous or you may provide your name and contact information if you wish to be quoted in the published summary. If so, I may contact you for more details and allow you to review your responses prior to publication.

Friday, November 02, 2012

Rodale's Study Cites My Estimate Regarding DTC Ad Spending; I'm Flattered, But...

My friend Richard Meyer over at World of DTC Marketing Blog posted some key findings and charts from the 2012 Rodale DTC Study (see "A new era for DTC marketing").

There's a lot of interesting data in that study, but I will focus on one chart that documents DTC (direct to consumer) ad spending by the pharmaceutical industry from 1997 through 2012. Here is the chart:


I noticed that the "DTC Ad Spend" data (top line) looked familiar. Sure enough, when I searched through my Pinterest "Charts & Data" board, I found a chart that I created back in April 2012 (see "Lipitor Holds Key to DTC Ad Spending in 2012"; the chart is shown below):



All the numbers regarding DTC Ad Spending are the same in the two charts. In other words, Rodale copied my data to the "penny," but did not credit me as the source. In fact, Rodale did not cite any third party as the source!

OK, I didn't get credit. Big deal. I'm not complaining because I didn't get my 15 minutes of fame. The problem is that my original post did cite the source of my data and the last two columns (for 2011 and 2012) were estimates based on a few assumptions. Here's what I said:
"This chart actually plots measured media data (excluding Internet display and search advertising) through 2010 from AdAge, which got the data from TNS Health. I calculated the 2011 total based on the 1% decrease reported by Nielsen (sorry, I don't have TNS data for 2011).  
"The final bar of the chart is my estimate for 2012, which is based on the premise that DTC ad spending for Lipitor will be less than half of what it was in 2011."
So, thank you Rodale for repeating my estimated data for 2011 and 2012, but you should have included the above information about how those estimates were calculated!

P.S. BTW, it is possible -- but not probable -- that my estimates were right on and the Rodale chart is based 100% on new data from AdAge/TNS/Nielsen.

Thursday, November 01, 2012

FDA's "Mobile Medical Apps" Scope of Oversight Pyramid: Confusion Abounds

"Consider the 'Mobile medical apps Proposed Scope for Oversight' issued by CDRH [FDA's Center for Devices and Radiological Health]," said DrugWonk Peter Pitts (here). "It’s a pyramid divided into three parts":



Pitts describes these parts of the pyramid:
  1. The top of the pyramid includes mobile medical apps that are traditional medical devices or a part or an extension of a traditional medical device. Clearly within the scope of being regulated as medical devices. 
  2. The middle section includes patient self- management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by CDRH, for enforcement discretion 
  3. The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.
So, FDA has reserved the term "Mobile Medical App" (MMA) to mean a medical app that meets its medical "device" definition. From now on I will have to be careful NOT to use that term/phrase when talking about mobile apps that clearly are NOT medical devices. I guess we should use "Mobile Health Apps" instead.

I notice that many reporters and drug industry people refer to "mobile medical apps" when describing apps that are CLEARLY at the bottom of CDRH's pyramid. An example is the article titled "11 Super Mobile Medical Apps" that offers these examples of apps, which clearly should NOT be called MMAs:
"Among the innovative mobile medical apps we found is one that lets doctors use interactive diagrams to show patients what's happening with their bodies, where procedures will be done, and exactly what will happen during different procedures. Alternatively, patients can use this app to get doctors to provide detailed visual answers to their questions."
Unfortunately,  FDA's co-optation of "mobile medical app" to refer to health apps requiring regulation as medical devices confuses the discussion, which up until now used the term to describe any health-related app that a physician or patient might use. This may be why PhRMA and other drug industry spokespeople are so fearful of FDA regulations hampering innovation within the "mobile health app" arena (see, for example, "FDA Mobile Regulatory Fear Mongering by PhRMA").