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!

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.

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:

Social Media and the Future of Adverse Event Reporting

View more presentations from Pharma Marketing Network.

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.

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!"

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?

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.