Thursday, April 29, 2010

NAMI's Pharma Funders - Serial Off-label Promoter Astrazeneca Tops the List

The National Alliance on Mental Illness (NAMI) until recently was reluctant to reveal the source of its funding. But thanks to Sen. Grassley we now can learn NAMI's sources for Major Foundation and Corporate Support, which you can find here.

I downloaded the list of "funders" for 2009. Fortunately, unlike pharmaceutical companies who have revealed monies paid to physicians (see, for example, "Transparency Vs. Translucency in Reporting Physician Payments"), NAMI's numbers are easy to copy into Excel spreadsheets and analyze.

In 2009, NAMI received 84 payments over $5,000 from different sources. Payments total $4,737,610.00 of which $3,836,750.00 (81%) came from major pharmaceutical companies. The following pie chart shows how the $3,836,750.00 was divided among major pharma funders (click on the chart for an enlarged view).

The biggest pharma funder in 2009 was AstraZenca (AZ), which donated $1,255,000.00. Recall that AZ is forced to pay about 400X that amount ($520 million) to resolve allegations that it illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (see HHS press release here). I guess you might say AZ got a large NEGATIVE ROI for its NAMI investment!

Lilly was next on the list having donated $750,500.00 to NAMI in 2009. Recall that Lilly markets Cymbalta and that it recently received a warning letter from the FDA about misleading a Cymablta print ad -- ie, re: "omission of risk information." Cymbalta is indicated for treatment of depression among many other things these days (see "The Cymbalta Buzz Machine is at Full Throttle!").

The third biggest NAMI pharma "funder" for 2009 was BMS, which donated $506,250.00. Recall that BMS markets the drug Abilify for bipolar disorder. Some time ago, Andy Behrman -- BMS's patient spokesperson for Abilify -- went on a campaign against the very product he endorsed for money (see "Andy Behrman, Now an Anti-BMS Spokesperson, Says 'Ask Your Doctor If Abilify is Wrong for You'").

It's a crazy, crazy world out there in the marketing of mental illness drugs!

Wednesday, April 28, 2010

How NOT to Solicit Adverse Medical Event Reports

My Twitter and real-life pal Fabio Gratton (@skypen) -- Co-founder & Chief Innovation Officer of Ignite Health -- sent out this tweet today:
New Web Site Invites Patients To Report on Adverse Medical Events: http://bit.ly/bp7EGx #fdasm #hcsm
Where Fabio tweets, I follow!

So I clicked on the link and found this article:
The Empowered Patient Coalition and Consumers Union's Safe Patient Project have launched a Web site that invites patients to fill out a 40-question survey about their experiences with an adverse medical event, Modern Healthcare reports.

The survey asks respondents to provide details on the incident, such as:

* The state where the error occurred;
* The type of health care provider involved;
* The procedure or treatment associated with the incident;
* Factors contributing to the error;
* Whether the affected patient considered legal action; and
* How the health care provider responded to the incident.

Patients have the option of submitting the survey anonymously.

The coalition said it plans to aggregate the information and use it to identify patterns that could lead to adverse medical events.
At first, I thought this survey was the one developed by Dr. Basch mentioned in my previous post: "If Patients Know Best, then Patient Social Networks Can Help Capture and Report AEs". Not the case. The article linked to this Empowered Patient Coalition web page.

I wanted to fill out the survey, but it quickly dawned on me that I had better things to do with my life than to wade through a Survey Monkey survey consisting of 43 (not 40) questions, many of them open ended.

This survey is no easier than the FDA's MedWatch Voluntary Reporting Form.

I don't see very many patients filling out the Empowered Patient Coalition form, which is too bad because I believe in the Coalition's cause: "We want the public to know that they can and must be the cornerstone to improving health care quality and safety and that their experiences are being counted. Sharing your story will ensure that your experiences will assist us in collecting data to be used to identify the sources of medical harm and to look for ways to keep patients safe in the future."

As far as "sharing stories" goes, patients are already doing that on sites like PatientsLikeMe, which can be mined for adverse events as I discussed here.

Wednesday, April 21, 2010

Social Media and the Future of Adverse Event Reporting

I am speaking tomorrow at the World Drug Safety Congress in Washington, DC. The title of my presentation is "Social Media and the Future of Adverse Event Reporting." You can view the presentation here:

Pharma's ObamaCare Math: It All Adds Up, But...

Drug companies are already claiming a loss of income due to costs related to the new U.S. health-care overhaul (aka, "ObamaCare"). First, Lilly claimed costs associated with higher rebates to the Medicaid government health program for the poor, etc. will reduce its 2010 revenue by $350 million to $400 million. Then, Johnson & Johnson said its 2010 revenue would be cut between $400 million and $500 million (see "Pharma Sales Set to Grow 5%-8%; Overhaul Effects Unclear").

It seems that the top 20 pharma companies got together and decided how to divvy up the $80 Bn that Billy Tauzin promised the drug industry would kick in to help pay for health care reform over 10 years. If each of these 20 companies claim losses of about $400 million per year for ten years, it all adds up to -- you guessed it: $80 billion!

Not included in these calculations is the 5%-8% annual increase in global pharmaceutical sales over the next five years predicted by IMS Health, which also predicted that the health system overhaul may “spur fundamental change in the market” [due to new sales of drugs to previously uninsured Americans] starting 5 years from now.

Tuesday, April 20, 2010

Pharma "Social Networks": Close But No Cigar Award

If you are a regular reader of Pharma Marketing Blog, you know that I generally do not like awards that are given to pharmaceutical marketers by trade publications. Such awards are very suspect because of the inherent conflicts of interests involved -- the winners tend to be the agencies that advertise the most in the sponsoring publication or purchase big page ads announcing that they won the award.

Recently, Dose of Digital, which maintains a wiki list of pharma and healthcare organization social media initiatives, hosted the "2010 Dose of Digital Dosie Award" to be given to the most deserving sites on the wiki list. You can find the finalists here. The winners will be announced at the upcoming 2nd Annual Social Communications & Healthcare Conference in New York City. Unfortunately, I won't be able to attend that conference. I am sure attendees will have fun despite my absence ;-)

The Dosie award process was a bit unique in that the finalists were determined solely by soliciting votes among Dose of Digital's Twitter followers and blog visitors. The voting process did not require any identifying information, so we will never truly know much about the population who cast votes. I am sure everything was on the up and up, but contenders were allowed to promote themselves to their followers on Twitter and game the system in other ways.

It's safe to say, however, that most of the people who cast votes for the Dosie were pharma professionals, marketing agency people, and social media activists. In other words, people who should know what constitutes a "winning" or outstanding social media application or social networking site.

The finalists in the Best Brand Sponsored Patient Community (Communities created by a pharma or healthcare company for a brand or corporate effort) are:
  • Accu-Check Diabetes Link (Roche)
  • Children with Diabetes (J&J Lifescan)
  • Crohn's and Me (UCB)
  • Diabetes Handprint (J&J Lifescan)
  • Voices of Diabetes (Novo Nordisk)
Wow! This list is completely dominated by diabetes sites! That's not surprising. People with diabetes have long engaged in online social networks.

Between 1996 and 2000 I was the owner of the DIAB-EHLB listserv, which was an email-based discussion group for people with diabetes, diabetes educators, caregivers, and endocrinologists. It was sponsored by Hoechst Marion Roussel, a pharma company that later merged with other companies that eventually formed Sanofi-Aventis. "EHLB" was short for "Electronic Highlights Bulletin," which was a source of highlights from medical conferences such as the annual meeting of the American Diabetes Association. Highlights, which were produced live at the meeting, were pushed out to the list of subscribers (see here) during the conference. Subscribers could also post their own comments to the entire list and anyone in the list could respond to those comments (see this sample discussion thread about Hemoglobin A1c). It was a lively community.

Most of the "social network" Dosie finalists, with the exception of Children with Diabetes, are "Faux Social Media" sites that cannot hold a candle to even my primitive diabetes listerv in terms of real conversation! I am not trying to get praise for DIAB-EHLB. I am pointing out that these modern-day pharma-sponsored networks actually represent a step BACKWARD along the path toward true pharma-sponsored conversation with stakeholders.

Let me use  Novo Nordisk's Voices of Diabetes to illustrate my point.

I just registered with Voices of Diabetes, which publishes stories submitted by registered users. The registration form is nothing more than a market research ploy. No self-respecting, truly social network would require information that this site requires such as your name, physical address, age, when you were diagnosed with diabetes, and what drugs you are taking. You are also REQUIRED to agree to have information from Novo Nordisk sent to you (see registration confirmation screen below)!

I was not permitted to complete my registration unless I checked off one of the boxes to receive information from Novo Nordisk. If I were a real person with diabetes wishing to share my story on this site, this would stop me in my tracks! But, I am a sucker for punishment and opted to receive information in English.

I wanted to submit a comment about a story already published, so I clicked on "If you would like to comment on this story, click here to share your voice..." I expected to start a discussion about Catherine M's "Finding Motivation" story ("It has taken me years to come to grips with my diabetes. Talk about denial. Then I went on insulin and my sugars are coming down, which is motivating me. It definitely is a day-by-day adventure.").

But, instead of being able to post a comment like "Good luck with managing your diabetes, I hope my sister finds motivation to deal with her condition too.", I was only asked to Share Your Story and presented with these rules, aka "Guidelines":
Please use the following form to submit your story. You will first have to pick the "category" of your story. This may place your story in one of the many areas of this website.

Voices of Diabetes Story Guidelines:

1. Stories must be no less than 1 paragraph and no more than 8
2. Stories must not contain any drug or device names (neither Novo Nordisk nor any other company)
3. Stories must not contain information on any "reactions" or adverse events relating to the use of insulin or other types of therapy

Please note: The submission of your story does not guarantee its publication on the website.
Also, I had to agree to the following "Individual Release and Waiver of Rights":
I hereby irrevocably grant Novo Nordisk and those acting with its authority the following:


1. All rights to use my name (first name, last initial only), voice, likeness, age, city, state and/or image;
2. The unrestricted, absolute, perpetual, worldwide right (but not the obligation) to use, copy, modify, edit, create derivative works, display, transmit, perform, distribute, publish, exhibit and otherwise use the submitted materials ("the Materials") in any and all media or form of communication, whether now existing or hereafter developed, including on Novo Nordisk's Web sites or those Web sites owned by Novo Nordisk affiliates or anyone acting with Novo Nordisk's authority (the "Web Sites"), all for the purpose of publicizing Novo Nordisk's programs (the "Purpose").
I waive any right to royalties or other compensation arising from or related to the use of the Materials.
I acknowledge Novo Nordisk's right to crop, splice, treat and edit the Materials at its sole discretion. I waive my right to inspect or approve the finished product, now and in the future, whether that use is known or unknown to me.
Novo Nordisk reserves the right to discontinue the use of the Materials without notice to me.
I represent and warrant that I have full power and authority to execute this Individual Release and Waiver of Rights (the "Release"). I hereby waive all rights and release Novo Nordisk from any claim or cause of action, whether now known or unknown, for defamation, invasion of right to privacy, publicity or personality or any similar matter, or based upon or relating to the use and exploitation of the Materials as contemplated herein, including but not limited to any reuse, distortion, blurring, alteration, optical illusion, or use in composite form, either intentionally or otherwise, that may occur or be produced in production of the finished product.
*I have read this Release before checking this box, and I fully understand the contents, meaning, and impact of this Release. (Check box must be clicked for your story to be submitted.)
No wonder that the latest story was dated January 9, 2010! This site is dead to me and probably dead to every person with diabetes who would like to share his or her story. Which leads me to ask: Why is this site on the Dosie list of finalists? Sure, there are very few "Brand Sponsored Patient Communities" to choose from. But we need to have some MINIMUM requirements for sites to be classified as "communities." My opinion is that this minimum should be "real conversation."

So, that's why I don't like awards. Defenders of these awards will say that we must reward even the most elementary attempts that pharma is making to have online conversations despite all the regulatory obstacles that they face. Well, then maybe we should call these the "Close But No Cigar Awards!"

Monday, April 19, 2010

Voltaren "Adherence Email" Gets FDA Warning Letter: Is It Justified?

As of April 15, 2010, FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) sent out 5 "notice of violation" (aka "warning") letters to drug companies regarding various promotional pieces. One letter is of interest because it concerns a direct-to-consumer (DTC) adherence "wave 5 e-mail" ("Adherence Email") for Voltaren, an NSAID topical gel marketed by Novartis. This may be the FIRST FDA warning letter issued for an email promotion. But is it justified?

Among other violations, the letter cites "minimization of risk information." The letter (find it here) states:
"The Adherence Email prominently presents efficacy claims in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space. In contrast, the risk information is relegated to the bottom of the email and is presented below the indication for use in extremely small black font, and in single-spaced paragraph format that makes the information very difficult to read. Furthermore, while the Adherence Email presents efficacy claims for Voltaren Gel in language that is easily understandable to consumers, it presents risk information using complex medical terminology that is not likely to be comprehended by the same audience (e.g., “cardiovascular thrombotic events” and “hematological effects”). The overall effect of this presentation undermines the communication of important risk information, minimizing the risks associated with Voltaren Gel, and misleadingly suggesting that Voltaren Gel is safer than has been demonstrated."
"For me, that is a little out of left field," said Mark Senak over at EyeOnFDA Blog. "To my knowledge," said Senak, "FDA/DDMAC has not issued any standards on how to do this [present risk information] aptly." I disagree with Senak. The FDA has issued "standards" about presenting risk information.

In my previous analysis of DDMAC warning letters (see "An Analysis of DDMAC Warning Letters Regarding Risk Information in Broadcast Drug Ads"), I noted that the FDA Amendments Act (FDAAA), which was signed into law in 2007, requires that the FDA issue new regulations regarding the presentation of risk information in broadcast (TV and radio, specifically) drug ads directed to consumers (DTC ads). On March 29, 2010, the FDA published the proposed regulations in the Federal Register (see here).

FDA had issued guidance relating to presentation of risk information previously and most experts agree that the proposed regulations pretty closely resemble that guidance (see "Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion"; pdf file). Specifically, the regulations focus on determining whether a drug ad's "major statement" (ie, disclosure of the major side effects and contraindications of the drug) is presented in a "clear, conspicuous, and neutral manner" as required by FDAAA. FDA says that a major statement would be considered to be presented in this manner if:
  1. Information is presented in language that is readily understandable by consumers;
  2. Audio information is understandable in terms of the volume, articulation, and pacing used;
  3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
  4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.
The Voltaren Adherence Email (find it here) seems to violate "rules" #1 and #3 above. That is, it would violate those rules IF it were in the category of "broadcast" DTC. FDAAA requires FDA to enforce "clear and conspicuous" risk information in TV and radio ads that are broadcast to a mass audience. The Voltaren Adherence Email does not seem to fit in that category of ad because it was not a TV or radio ad and it was likely sent to a select group of consumers, not a mass audience.

However, in the draft guidance mentioned above, FDA states: "Unless otherwise specified in this draft guidance, the principles set forth below apply to all promotional pieces, regardless of the medium used or the target audience."

So I am a bit confused as to whether or not, in the case of the Voltaren letter, the FDA has overstepped the authority given it by Congress to regulate risk information in non-broadcast media. What do you think?

Wednesday, April 14, 2010

Pre-Screening, Post-Screening, or No Screening at All - What's the Best Moderation Practice for Pharma Social Media?

As more and more pharmaceutical companies launch social networking platforms associated with their brands, some will allow users (consumers, patients, physicians, and the anonymous rabble) to post comments as part of ongoing discussions about drugs and/or the conditions they treat. Recent pharma experience with social media discussions (see "What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now") demonstrate how important it is to properly manage online communities. Perhaps the most important management tool is moderation.

Basically, there are three options for moderation:
  1. Pre-screening comments BEFORE they are posted
  2. Post-screening comments AFTER they are posted
  3. NO screening/moderation at all
I am already on record as being against no moderation (see "Pharma Should Leave Unmoderated SM Discussions to 3rd Parties"). But I am on the fence regarding pre- vs. post-screening.

A few organizations that submitted comments to the FDA in response to its questions about regulating pharma's use of social media addressed the issue of moderation (see, for example, "Accountability for Pharma Content on Social Media Sites"). LiveWorld, Inc. -- a social marketing agency with 20+ years creating, operating, and moderating online communities -- submitted the most detailed comments regarding moderation (find LiveWorld's comments here).

In tomorrow's Pharma Marketing Talk LIVE podcast ("Online Community Management Moderation Best Practices & Other Tips for Pharma Social Media Managers"), I will be interviewing Jenna Woodul, who is the co-founder and Chief Community Officer of LiveWorld. Jenna and LiveWorld believe that the FDA should not issue specific regulations about moderation of comments on pharma-owned and operated social networks. The questions I have for Jenna are:
  • What's wrong with how many pharma companies are currently managing their social media campaigns?
  • What's your opinion of moderation? Should pharmacos moderate posts BEFORE they are published on their social media sites? Or should they only remove posts that violate the terms AFTER they are posted automatically?
  • Can you explain what kind of moderation is possible for social networking sites such as Facebook and Youtube? Are there limitations that pharma companies should be aware of? How can these limitations be overcome?
You can listen to this podcast live via the Web at 2 PM Eastern time, April 15, 2010 (or listen to the archive afterward). You can also call in during the show to ask questions or participate in discussion: (347) 996-5894. See here for more details.

SURVEY
To help me prepare for the show, please respond to the "Moderation of Social Network Sites Operated by Pharma Companies" online survey that I prepared. It will only take a few minutes of your time. Let me know whether you think pharma moderation best practice is pre-moderation, post-moderation or no moderation at all. What are the benefits/drawbacks of each? Take the survey here.

Tuesday, April 13, 2010

If Patients Know Best, then Patient Social Networks Can Help Capture and Report AEs

A recent article published in the New York Times caught my attention. The article -- "In Reporting Symptoms, Don’t Patients Know Best?" (find it here) -- suggested that doctors tend to "downgrade symptoms" (ie, adverse effects of drugs) reported to them by their patients because of "wishful thinking" or, worse, because they do not want to document problems they failed to act on for fear of being sued.

That being the case, there is little hope that widespread use of electronic medical records will capture useful adverse events that the FDA can analyze. Garbage in, garbage out as they say.

Speaking of garbage, the article criticized FDA's MedWatch program that allows doctors and patients to report problems that they think are adverse events from drugs already on the market. "But it’s a passive system that waits for reports instead of actively surveying patients," says the article. "Many people don’t know about it, and it has failed to catch some important adverse events," said Dr. Ethan Basch, an oncologist who treats men with prostate cancer and does research at Memorial Sloan-Kettering Cancer Center in New York.

"A better approach," says Basch, "would be to have large numbers of patients filling out questionnaires before and after drugs are marketed. For example, in the postmarket setting we could ask 5,000 selected patients starting Bextra to report monthly."

Of course, Bextra has been taken off the market by the FDA. Dr. Bach's point is that if post marketing surveys of patients were done soon after Bextra entered the market, the problems may have been noticed much earlier.

Meanwhile, Dr. Basch is working on his idea: "Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events" is National Cancer Institute funded outcomes Research project that began in October 2008 (see here). As part of that research, Dr. Basch and his co-investigators initiated development of an electronic patient-reported system for monitoring and reporting symptomatic AEs that patients may experience during treatment.

I imagine that this system would be pretty expensive to implement on a large scale across many different drug treatments. But there is a cheap (ie, FREE) electronic system already available for capturing adverse events from patients: patient-focused social media sites such as PatientsLikeMe (PLM) and others.

PLM found that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (an identifiable patient, a specific medication, an identifiable reporter and a reaction). This is 35 times the rate in the frequently cited Nielson study, which found only one such message in its random sample of 500 posts. (See "PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members".)

I'm not sure how Dr. Basch is getting his questionnaire out to patients, but he might look to social media sites like PatientsLikeMe to perform a public service and place the form on its site so that patients can easily access it. Just a thought on how social media can help expedite outcomes research!

NOTE: I will be speaking on this topic next week at the World Drug Safety Congress. The title of my presentation is "Web based AE reporting; is it the future?" I will specifically address how social media can be incorporated into a drug’s safety strategy and the challenges involved. If you have any solutions, ideas, or comments I can incorporate into my presentation, please tell me about them (you can email me at editor@news.pharma-mkting.com).

Monday, April 12, 2010

New Omnaris TV Ad is Less Freudian, Still Amateurish

There are plenty of negative comments on various Internet forums about the first generation of Omnaris TV commercials, which began to air last year. These ads featured military-style "Orkin" men sticking an Omnaris bottle up some unseen woman's nose. "It's so Freudian! Men sticking a phallic symbol up some woman's orifice, saying they have what she NEEDS! Then saluting each other. Gawdawful. Eww." That comment was found here.

The new Omnaris TV ad, which I saw last night during 60 Minutes, had less of the sticking the bottle up the nose animation and showed the full face of the woman, which makes the commercial less creepy. But it still lacked some of the messaging that Omnaris sales reps would like to see advertised.

You can find sales rep comments about the Omnaris ads on Sepracor's CafePharma message board. Most of these comments claim the ad doesn't mention the main selling points of Omnaris. "Where is the stick and stay messaging... won't run down the back of your throat?" asked one anonymous CafePharma poster. "Stick and stay is not a proven benefit," retorter another anonymous poster, "it has not been shown to have clinical relevance. You just proved why you are a rep and not anyone in charge of the marketing...you don't know anything. Leave the big decisions to the adults and you keep trying to do what you are supposed to do."

It appears that "stick and stay" is a benefit these reps are taught to mention to physicians. "we know most of the omnaris claims we tout to doctors have no clinical relevance, since when does that stop us, in fact, the fda does have a say in detail content and mva content so if we'd be pushing past supportable claims in we mentioned the products alleged attributes on TV they we're doing same in details," said another poster. Obviously, this rep does not know that FDA DOES have a say in detail content. I wonder if FDA reads CafePharma.

But the main complaint is how "amateurish" the ads are. "Hello? Anyone want to talk about the crap quality of the commercial too?" said a CafePharma poster. "It makes us look like a bunch of amateurs... no mention of the company (not that we need wonder why) and the damn army men are a joke. At least the Nasonex bee was memorable AND cheesy. This is forgettable and our Omnaris sales will be forgotten because of it. Nice quality agency we got ourselves."

At least one commenter blamed the ad agency and claimed it was hired by friends within the company: "This is once again an example of the company hiring one of their friends or relatives's agencies. There is no way a real ad agency designed that stupid commercial. this goes back to one of the main reason this company has done so poorly, you can not make this organization a vehical (sic) to help friends , return favors or other crooked schemes. you need to hire the best person for the job not your friend or a favor for a friend. An outside auditor should audit the contracting of that company and what relation that princiles (sic) of the ad agency and sepracor managemnt (sic) have."

The new commercial appears almost as amateurish as the old ones. Near the end of the NEW commercial, after the woman snorts her dose of Omnaris, she exclaims "I can smell the roses again!" I think this is a reference to an unsubstantiated benefit claim mentioned by one CafePharma poster: Omnaris has "no smell" that can interfere with the joys of smelling the aroma of roses.

But there are NO roses in the commercial, only a bunch of red daisies in the planter outside the woman's window! At least I think they were daisies -- the flowers looked just like the ones shown here. They definitely were not roses!

Either this is a diabolically clever buzz marketing scheme or the ad agency couldn't tell the difference between daisies and roses. Maybe the animators were not paid enough to create roses, so they created daisies instead (render one daisy petal, copy and paste to create an entire flower). Daisy, rose... same thing, right? I'm not an expert, but I don't think daisies are known for their nice smell.

"Bottom line, the commercial WORKS," said a CafePharma poster who sounded like he/she had some inside information. "Hits to the website are up 7 fold. Omnaris now has a higher brand recognition than Veramyst. It has a higher website generated coupon redemption rate than Veramyst. It has faster growth numbers." That comment was made a year ago. Since the "Orkin man" style ads are still running, I assume they are still working.

Friday, April 09, 2010

The iPad as a Pharma Marketing Platform

"DTC marketers can't afford the luxury of waiting to see how many people purchase an iPad they have to start experimenting with app development and marketing NOW," says Rich Meyer over at World of DTC Marketing Blog.

The best example of an iPad DTC app Meyer could think of, however, was a cookbook for people with diabetes. As if the world needed a new diabetes cookbook!

I have an iPad and am enjoying it. I have even used it when cooking -- propped up on my kitchen counter next to the chicken parts. But I used the browser to find a recipe for BBQ ribs -- there were hundreds to choose from. I don't need an app for that. I assume the Internet is also full of recipes suitable for people with diabetes.

But Rich was probably thinking of something more useful. Something like Sanofi-Aventis's GoMeals app developed for the iPhone/iPod.

MM&M noted that "Sanofi-Aventis [S-A] is promoting it through outreach to diabetes bloggers as well as tactical advertising, such as banners on diabetes sites, and to the patient community through third-party orgs. As of [December 2009] it was the seventh-most-popular app in the free health and fitness section of Apple's iTunes Store."

I downloaded GoMeals for my iPod and used it to find restaurants in my area. You can compare the nutritional value of different restaurant menus and keep track of your own meals. It's very useful for all of us, not just for people who have diabetes. BTW, I  "forgot" to use the GoMeals app to calculate the nutritional value of my BBQ ribs.

When I used GoMeals on my iPad to find restaurants in my area, it crashed. At first I thought it was because my iPad was not GPS-equipped, but "Mic" said that iPad does have GPS (see comments) -- and he's right! Google Earth knows where I am! At least within 100 yards of where I am. Anyway, S-A needs to fix this problem and develop an iPad version. But is it worth the effort?

The GoMeals app has absolutely no marketing ROI for S-A. It may only be one part of an overall marketing plan to position S-A as a player in the diabetes area. Dennis Urbaniak, S-A's new VP of U.S. Diabetes, was previously Vice President of Innovation and New Customer Channels. No doubt Urbaniak was involved in developing the GoMeals app. BTW, listen to my Pharma Marketing Talk interview of Urbaniak: "What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now."

Geoff McCleary, a mobile and tablet computing expert and vice president of strategy for imc2 health & wellness, suggested these consumer-oriented apps for the iPad that pharma marketers should develop:
  • Weekly/monthly health eMagazine for disease state information
  • 3D, touch interactive MOAs for disease or treatment education
  • Branded support program materials delivered weekly or daily
  • Social media-based content for brands or disease groups
How much disease state information can a monthly eMagazine publish and how would an iPad app be better than opening your email and a browser? We don't need an app for that. Same with branded support programs and social media-based content.

How about a "3D, touch interactive" MOA animation for Viagra or YAZ? Now those are pharma apps I'd like to see on my iPad!

You can find McCleary's white paper, "Considering the Apple iPad™ for Pharma Marketing," which has other ideas for apps -- including physician-oriented apps -- here.

P.S. The real marketing value of iPad is iAds, just announced by Apple's Steve Jobs (see "Apple Unveils iAd, iPhone 4.0"). iAds are "in-app" ads served up while you are using a "free" app like GoMeals, which does not have any advertising. Personally, I believe in-app ads are annoying, but if the app is valuable, I will put up with them. For pharma, the hard part will be coming up with truly useful apps.

Thursday, April 08, 2010

An Analysis of DDMAC Warning Letters Regarding Risk Information in Broadcast Drug Ads

The FDA Amendments Act (FDAAA), which was signed into law in 2007, requires that the FDA issue new regulations regarding the presentation of risk information in broadcast (TV and radio) drug ads directed to consumers (DTC ads). On March 29, 2010, the FDA published the proposed regulations in the Federal Register (see here). FDA had issued guidance relating to presentation of risk information previously and most experts agree that the proposed regulations pretty closely resemble that guidance (see "Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion"; pdf file).

Specifically, the regulations focus on determining whether a drug ad's "major statement" (ie, disclosure of the major side effects and contraindications of the drug) is presented in a "clear, conspicuous, and neutral manner" as required by FDAAA. FDA says that a major statement would be considered to be presented in this manner if:
  1. Information is presented in language that is readily understandable by consumers;
  2. Audio information is understandable in terms of the volume, articulation, and pacing used;
  3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
  4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.
FDA's Kristin Davis, deputy to Tom Abrams, head of FDA's Division of Drug Marketing, Advertising and Communication (DDMAC), reminded attendees of a recent industry conference that the FDA is "using the principles of the draft guidance virtually every day in both pre-reviews and Warning Letters," according to John Kamp, Executive Director, Coalition for Healthcare Communication.

I was curious to learn if recent Notice of Violation (NOV) letters (aka "warning letters") issued by DDMAC actually cited violations of one or more of the 4 rules for the presentation of the major statement in DTC ads. I looked at all of the 16 NOV letters that DDMAC issued in the first quarter of 2010. Of these, only 10 included violation warnings related to consumer promotional pieces/ads.

Many NOV letters include warnings about several different types of violations, including
  • Broadening of Indication
  • Failure to State Full Indication
  • Failure to Submit Under Form FDA-2253
  • Minimization of Risk Information
  • Omission of Material Facts
  • Omission of Risk Information
  • Overstatement of Efficacy
  • Promotion of an Unapproved Drug
  • Unsubstantiated Claims
  • Unsubstantiated Comparative Claims
  • Unsubstantiated Effectiveness Claims
I counted a total of 22 such violations concerning promotional pieces intended for consumers and/or patients in the ten letters.  These promotional pieces included print and TV ads, web sites, videos, patient brochures, waiting room signs, and co-pay brochures. That is, not all of these were "broadcast" print and TV ads, which is the focus of the draft guidance and proposed regulations. In fact, ONLY 4 letters included violations relating to broadcast DTC ads!

These 4 letters included 6 such violations, only 33.3% (2) of which were about risk communication. One concerned Cymbalta, a drug promoted by Eli Lilly. The FDA letter stated:
"We note that the Print Ad contains the statement, 'See left page for Important Safety Information, including Boxed Warning.'  at the bottom of the page and that risk information is presented on an adjacent page, but this is not sufficient to provide appropriate qualification or pertinent information for the claims made in the body of the ad or to mitigate the overall misleading presentation. This risk information is placed in a single column in a single-spaced paragraph on a page with unrelated advertisements or magazine content. It appears unconnected to the main body of the Print Ad and is not likely to draw readers’ attention."
This seems to violate "rule" number 3 above (ie, "Textual information [should be] placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily").

The second broadcast DTC risk-related violation concerned Truvada, a drug marketed by Gilead Sciences, Inc. The FDA letter stated:
"The Print Ad is false or misleading because it fails to present the risks associated with Truvada with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug. Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. In the Print Ad, claims pertaining to efficacy and benefits of Truvada are conveyed through headlines, colorful text, illustrations, bullets, and eye-catching graphics and images. In contrast, the risk information is presented in several long, single-spaced paragraphs in small font/text type in a single column along one side of the Print Ad."
Again, a violation of "rule" number 3.

At least one letter cited language in an OraVerse patient brochure that "presents efficacy claims for OraVerse in language that is easily understandable to consumers, it presents risk information using complex medical terminology that is not likely to be comprehended by the same audience." This would violate "rule" number 1 above, except that patient brochures are not "broadcast" media and hence are NOT covered by the newly proposed rules.

Even when you look at ALL the 52 violations cited in ALL 16 letters, only 34.6% (18) are concerned with risk information. So, FDA may not be overly focused on risk. It is, however, focusing on much more than broadcast TV and print ads in its warning letters. Increasingly, FDA is focusing on Web-based promotions, for which there is no guidance and no proposed rules.

Tuesday, April 06, 2010

Pfizer Reveals (Almost) All Payments to Physicians

Pfizer recently published its list of physician payments it made during the last half of 2009 (Q3 and Q4). The list, which is presented on this web page using javascript, includes these categories of payments:
  • Professional Advising
  • Expert-Led Forums
  • Research, including Phase I-IV clinical trials and investigator-initiated research
  • Meals, business travel expenses and educational items that are greater than or equal to $25 in value, and where the aggregate amount paid to an individual health care professional is greater than or equal to $500 in a calendar year.
Pfizer is the only pharma company to reveal how much it pays healthcare physicians and/or institutions for research. GSK and Merck, whose payments I analyzed in a recent Pharma Marketing News article ("Pharma Begins to Reveal Payments to Physicians"), only revealed payments for educational activities (speaker fees) and consulting. Neither Merck nor GSK revealed payments related to clinical research, or travel and entertainment expenses. None of these companies included payments for continuing medical education (CME) activities.

I asked Pfizer last Wednesday for the data in Excel format, but so far they haven't sent it to me, although they said they are looking into it. Meanwhile, Eric Milgram, author of Pharma Conduct Blog gave me his copy of the data in Excel format. Eric has looked into which physicians and organizations got paid the most. I looked at how the money was distributed on a state-by-state basis and by category of payment.

For my analysis, I used these categories:
  • Pfizer Research (Pfizer Sponsored Research)
  • Speaking (Expert-Led Forums)
  • Consulting (Professional Advising)
  • Travel & Meals (Business Related Travel and Meals)
  • IIR (Investigator-initiated Research)
  • Unknown
  • Educational Items (ie, tchtockes given away by sales reps)
The breakdown is illustrated in the following pie chart (click on it for an enlarged view):


Payments for educational items totaled only $12,275 out of a total of $35,436,797. This is too small to be picked up in this chart, which round to the nearest whole percent. Keep in mind that Pfizer is only reporting items with a value of $25 or greater and that the new PhRMA physician marketing code limits "gifts" to physicians (ie, the code prohibits distribution of non-educational items such as pens, mugs and other “reminder” objects typically adorned with a company or product logo). "Educational" items are supposed to be for the education of patients or healthcare professionals and should not exceed a value of $100. Such items include anatomical models that physicians may use to show patients what their insides look like.

It could be that Pfizer is giving away lots of educational items worth less than $25 and therefore not reporting this expense, but I doubt it. The physician gift (educational item) industry is essentially dead.

How much is spent on marketing vs research activities? "Consulting" fees may be paid for either type of activity, but most often physician consultants are paid by the marketing department to help it position the product with physicians. Let's say 75% of Pfizer's consulting fees were for marketing purposes.  Investigator-initiated research (IIR) is also often just a marketing ploy designed to get key physicians to prescribe more of the product. Let's put 50% of that into the marketing bucket. Travel and meals is a substantial category. Let's also say 50% of that goes to the physician marketing consultants. Pfizer has an "unknown" category that totals $899,688. Let's say 25% of that should be in the marketing bucket. And all of the $12,275 worth of "educational" items I consider marketing related.

The total amount of payments Pfizer made to physicians for marketing purposes in the 2nd half of 2009 was $17,390,969 or 49.1% of the total ($35,436,797). This is the first time I have been able to analyze how much a pharmaceutical company pays for physician marketing versus research. Of course, this does not include direct-to-consumer marketing expenses or research that is done in Pfizer's own labs or by research contract organizations. The latter could be a huge research expense.

The other analysis I did was a state-by-state breakdown, which is shown in the following bubble chart (click on it for an enlarged view):


Each bubble's size is proportional to the amount of money physicians/institutions in that state received (for a comparison with GSK and Merck, see "Why Does GSK Prefer New York Physicians & Will Governor Patterson Ruin It for Them?").

The five states receiving the most money from Pfizer are represented by red bubbles. North Carolina (NC) is one of the top five states receiving money from Pfizer. This was primarily because Duke University received over $1 million for research. That represents about 44% of all the money Pfizer paid physicians and other institutions in that state.

Thursday, April 01, 2010

WLF & Pfizer Ask Court to Block FDA Guidance on Social Media

Yesterday, in a move that is sure to delay if not completely halt FDA efforts to issue guidance on the regulation of drug promotion on the Internet and social media, the Washington Legal Foundation (WLF) and Pfizer filed a brief with U.S. District Court in Washington, DC.

I was so pre-occupied getting the March 2010 issue of Pharma Marketing News out to my 7,300 subscribers that I completely missed this press release that came in my email inbox last night around 7 PM.

The press release (find it here) states:
COURT URGED TO ENJOIN FDA FROM BARRING SOCIAL MEDIA FREE SPEECH
(Pfizer, Inc. v. United States, No. 10-223)

"The Washington Legal Foundation (WLF) today urged the U.S. District Court for the District of Columbia to uphold First Amendment rights by limiting the authority of the Food and Drug Administration (FDA) to issue guidance barring the free speech of drug manufacturers on social media sites such as Facebook, Twitter, etc.

"In a brief filed in support of a motion by Pfizer, Inc. for a preliminary injunction against FDA enforcement action, WLF argued that FDA has not provided sufficient justification for interfering with such speech when directed to consumers on social media sites.

"For FDA to regulate in this sensitive area through guidance instead of rulemaking inherently raises First Amendment concerns because of the nature of the process used to develop guidance, and the nature of the Agency pronouncements that result. A particular concern here relates to vagueness. A law “must be carefully drawn or be authoritatively construed to punish only unprotected speech and not be susceptible of application to protected expression.” Gooding v. Wilson, 405 U.S. 518, 522 (1972). “Because First Amendment freedoms need breathing space to survive, government may regulate in the area only with narrow specificity.” NAACP v. Button, 371 U.S. 415, 433 (1963); see also Baggett v. Bullitt, 377 U.S. 360, 366 (1964) (holding a loyalty oath unconstitutional on vagueness grounds).

WLF argued that guidance documents purporting to regulate speech have engendered extensive litigation. Perhaps the best-known First Amendment litigation against FDA involved a trio of guidance documents that Agency personnel developed in the 1990s. WLF v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998), appeal dismissed sub nom. WLF v. Henney, 202 F.3d 331 (D.C. Cir. 2000). There, as here, FDA was confronted with entirely new types of communicative activity. Rather than undertake notice-and-comment rulemaking, FDA sought to establish a new set of regulatory expectations through guidance documents, leading to years of litigation and uncertainty. Pfizer believes it would be imprudent for FDA to repeat this pattern of seeking to address an entirely new field of conduct, where First Amendment rights are clearly at stake, without the discipline that comes with a rulemaking proceeding.
Let me interrupt here to say that I am NOT not surprised that Pfizer would do this because the world's biggest drug company telegraphed its intention in the comments it sent to the FDA in response to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"). In those comments Pfizer called upon the FDA to develop new regulations for the Internet and social media rather than issuing guidance that puts an "interpretative gloss" on existing rules.

The March issue of Pharma Marketing News is 100% devoted to a masterful summary of the drug industry's comments to the FDA that compares comments from different drug companies with one another, extracting nuggets of information, opinions, and novel ideas. It includes the following articles:
You can download all these FREE when you subscribe here.

Here's the remainder of the WLF press release (find it here):
"Further, WLF argued that FDA cannot use statements contained in guidance documents as the basis for enforcement action. See Gen. Elec. Co. v. EPA, 290 F.3d 377 (D.C. Cir. 2002) (holding agency guidance was legislative rule subject to APA where it imposed binding obligations on agency and applicants). Guidance also cannot be used to allow manufacturer communications in online media that would contravene existing regulations. Even if regulations already in effect could be read to permit particular activities, FDA would have to engage in new rulemaking in order to alter its interpretation of an existing rule. See, e.g., Alaska Prof’l Hunters Ass’n v. FAA, 177 F.3d 1030, 1033-34 (D.C. Cir. 1999).

"In its brief urging the court to enjoin FDA efforts to regulate truthful speech through guidance, WLF argued that the First Amendment fully protects the right of Pfizer employees to engage in conversations with consumers on social media sites and via Twitter.

"WLF filed its brief on behalf of several organizations representing patients that have a significant interest in encouraging open communications between themselves, their doctors and Pfizer -- the National Periodic Idiotosis Association and the National Flagrant Flatulence Foundation. WLF also filed its brief on behalf of itself. WLF filed its brief with the pro bono assistance of Coleen Schmucksky, Paul Eatmyshorts, and Brad Klassaction, attorneys with the Washington, D.C. office of Snidely Awesome LLP.

"WLF is a public interest law and policy center with supporters in all 50 states. WLF has appeared in numerous federal and state courts in cases involving FDA efforts to restrict the First Amendment speech rights of manufacturers, doctors, and patients. As a result of a successful WLF challenge to FDA speech restrictions, FDA is permanently enjoined from attempting to restrict certain types of manufacturer speech on social media sites"
I hope you enjoy the remainder of your April Fool's day!

NOTE: The legal language quoted in this "press release" was copied verbatim from comments that Pfizer sent to the FDA. It is not unreasonable, therefore, to assume Pfizer and/or WLF may ACTUALLY take the sort of action described here. It probably would not happen, however, until AFTER the FDA issues guidance and ONLY IF Pfizer and other drug companies are not satisfied with it.
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