Dear GSK: Precedent Should Not Guide Pharma's New Media Communications Strategy

GSK Blogs About Challenges of Communicating via New Media Channels

"Michael F," writing on GSK's More than Medicine Blog, suggests that critics "take into consideration that there may be much larger issues at stake governing the way we communicate...before making claims that 'Pharma doesn't know how to do this [talk about products on Twitter and other social media channels]'" (see "Communicating to Stakeholders ... Part 2").

I have to say that I'm beginning to really like GSK's blog and am modifying my initial impression that the blog's sole agenda is to "to propagate GSK's and the drug industry's argument AGAINST a government-run health insurance plan that competes with private insurance' (see "The Real Agenda of GSK's New Blog and Why the Authors' Identities are Cloaked"). Since last week, an amazing number of "new" posts on diverse topics have been made to the blog -- or, more accurately, made publicly available.

One category of posts is "GSK People," which highlighted a post about Pete Hare, who heads GSK's HIV and Immunology group. It includes commentary from Mr. Hare plus photos that he took of himself. This is getting close to the kind of drug company employee "blogging" that I recommended a long time ago (see "A Primer on Pharma Employee Blogging") to help improve the image of the drug industry -- probably the main reason why drug companies have blogs these days.

Getting back, however, to pharma's "challenge" communicating information about their products via new media, "Michael F" had a lot more to say, including this:

"Last week we wrote about the challenges of communicating about our products through new media channels," said Michael F. "Two items from this week's news are illustrative of some of the unique issues with which we must contend when writing about our business.

"An NPR story on the rise of pertussis cites doctors' anecdotal reports on "an increase in the number of parents refusing to vaccinate their children against childhood diseases." As a manufacturer of vaccines we have an obvious business interest in pediatric vaccines that we believe aligns with public health interests. The NPR story fairly addresses a significant public health issue so we'd like to highlight it on our blog. But not so fast... we must first ask ourselves whether doing so could be seen as promoting our products. If it is viewed that way, then we have an obligation to include additional information about the product in question.

"So, it isn't straightforward when a vaccines manufacturer communicates about vaccines. There are times when even our disease-oriented communications might be interpreted as promoting our products, thereby requiring that additional information be included along with the mention of our products (approved indication statement, safety information, submission to FDA etc). Many factors, including a pharmaceutical company's position in a particular market (ie, if they are the largest or only manufacturer of a product for the disease under discussion) and the product's approved indication can inadvertently raise the perception that the communication is promotional."

Please edit the above by taking out "new media channels" in the very first sentence. My point is that this is not just a new media challenge. The same could have been said about communicating disease information via "old" channels such as press releases. Interesting, but nothing of interest to new media mavens. Move along.

"When it comes to Twitter," said Michael F, "there isn't much collective experience or precedent for any of us. So it isn't surprising that as one blog pointed out, Pharma hasn't nailed it yet. However, in our view, the FDA's recent communications on sponsored links raises questions about how Twitter can be used to communicate about prescription drug products. For example, FDA has made clear that the short 100 or so character ad copy used in sponsored links cannot be used for anything deemed to represent what the product is used for, without also including the safety information about the product in the sponsored link - a difficult challenge in such limited space. Including a direct link to the product's website where all the important information about the product is spelled out is not sufficient."

Yep, drug companies definitely face a challenge when communicating product information via Twitter and Adwords. AstraZeneca recently failed to adequately meet that challenge (see "Uh, Oh! Will FDA Cite this 'One-Click Rule' Twitter Post by AZ as Violative?").

What bugs me, however, is that drug companies are relying on "precedent" to determine their new media communications strategy! This is ridiculous! First of all, "precedent" is unreliable as the case of FDA's 14 letters proves. The industry thought it had precedent and it even came up with a name for it: the"one-click rule." No matter that anyone with an ounce of brains -- eg, me -- could plainly see that "precedent," in this case, meant only that drug companies were getting away with flouting regulations under a complacent FDA administration.

Now that there is a new FDA administration, the drug industry is waiting for a new precedent before engaging further in social media. So, forgive me for saying this "Michael F," but you already should know how to communicate via new media channels. The stuff you claim is holding you back is not unique to new media. I can think about 5o ways you can use new media without violating FDA regulations (see "50 Ways to Use Social Media"). Why don't you hire me to help with your new media strategy rather than wait for your competition to do something that either does or does not result in an FDA letter (sent about one year after the fact)?

Of course, the first thing I would recommend is that GSK join in the call for FDA to issue guidance on its views regarding the use of new media (ie, the Internet, social media included) for drug and device promotion. That would eliminate reliance on precedent, which is really an excuse for doing nothing.

Disclosure: One person who's involved with creating the GSK blog is a personal friend of mine. I have not discussed this issue with him.

Drug Companies Bedazzle Docs in the Boondocks with Gifts, Free Lunches, and Speaking Fees!

A new West Virginia state report shows drug manufacturers gave thousands of gifts and payments to doctors and nurses in West Virginia last year, ranging from the cost of a lunch to outlays of $20,000 or more (see "Report: Drug Companies Spend Thousands on W.Va. Gifts").

I'm from NYC, so forgive me for referring to West Virginia as "the boondocks." The state only has 5,152 doctors and nurse practitioners who can prescribe medicine. But here's a synopsis of the drug company money spent on wooing them:

• 15,382 gifts, grants or payments
• 42 payments of $20,000 or more
• 574 payments of $2,500 or more
• 14,808 payments between $100 and $2,500

Unfortunately, the report didn't track payments made to each prescriber nor did it give a total amount, so it's difficult to get an average spent per prescriber. But I can always speculate!

Let's start with those 42 payments and estimate that these totaled $1,000,000 (ie, average payment of $23,809). That's probably a conservative estimate.

I assume the 574 payments of $2,500 or more does not include the 42 payments of $20,000. Let's estimate these total $3,000,000 (average payment equals $3,484).

I'll estimate the the average payment in the 14,808 group was $203 (a pretty low-ball estimate, IMHO) so that the total in that group is $3,000,000.

My estimate for the total is $7,000,000 worth of gifts, free lunches, grants or payments. That's $1,359.00 per prescriber, including PAs who -- I am sure -- received bupkis.

If we estimate that 10% of the 5,152 prescribers were PAs who received no gifts, that leaves $7,000,000 divided among 4,637 physicians or $1,510 per physician.

But drug companies do not waste their money on low decile physicians or on physicians in rural areas that are hard and expensive to travel to. Plus, so many physicians these days do not even open their doors to sales reps.

So I would estimate that only half of West Virginia physicians (ie, 2,319 physicians) received the total of $7,000,000 in gifts, free lunches, grants or payments, or $3,019 per physician!

Not too shabby for the boondocks! I wonder what NYC physicians get these days?

Pfizer's Harem Styled Gulfstream G550 for Sale: US $35,500,000 (Lightly Used)

"Looking for a bargain on a corporate jet?", asks FiercePharma's Tracy Staton. "Pfizer is scouting for buyers for two of its Gulfstream aircraft, a Gulfstream V model and a Gulfstream 550. CEO Jeffrey Kindler's aircraft perks cost Pfizer $175,210 in 2008. Ian Read, the company's worldwide pharma president, got $129,850 worth of aircraft use, while CFO Frank D'Amelio's use only amounted to $70,505 and R&D chief Martin Mackay's was $40,834" (see "For Sale: Two Pfizer jets for $65M").

Tracy kindly supplied links to photos of the jets, including interior shots.

The 2003 Gulfstream G550 is definitely my choice. I especially liked the way in which the interior was decorated. I'm partial to those harem-style throw pillows and blankets. I can only imagine what it was like for Jeff Kindler to climb on board (click the image to get an enlarged view).


I also imagine an on board theater where Jeff and the guys could view some old-fashioned stag movies while jetting around. The closest I can get to showing you what I mean is the following YouTube video of the notorious Bettie Page, who told PlayBoy "I never thought it was shameful [ie, her career as a pin-up girl and PlayBoy Playmate model]. I felt normal. It's just that it was much better than pounding a typewriter eight hours a day, which gets monotonous."

Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft Guidance

DDMAC's (FDA) recently-released "Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion" (pdf file here) focuses almost exclusively on print and broadcast promotional ads. It mentions the Internet -- where patients most often go first to find information on health (see, for example, "The Empowered Patient: What It Means for Pharma Marketers"; PMN Reprint #84-02) -- only once by way of example, as in:

"Example 13: If a Web site for a product approved to treat high blood pressure presents information about a product’s benefits in postmenopausal women, any risks specific to postmenopausal women are particularly material."

To illustrate how non-specific this is with regard to the Internet, all you have to do is substitute "Print ad" for "Web site." Perhaps this is FDA's way of saying that the same rules apply to the Internet as to print ads. I agree, but only so far as a Web page or display ad on the Internet is just another static piece of text/graphic. We used to call such Web sites "brochureware."

Although the Internet has evolved to be much more interactive and user-generated, the FDA has evolved much less. We'll have to wait for Obama-era appointees to work their way down the hierarchy at FDA before we see the FDA evolve more quickly. For now, this draft guidance, which was in the works for at least a year, will have to do.

The Internet may have evolved, but most of the drug advertising on it is pretty much the same as it was 5-10 years ago: static display search engine ads. Included in this category are the 70-character Google Adwords that were the subject of FDA's recent 14 notices of violation. These notices cited the lack of adequate fair balance in search engine ads that mentioned the drug name and benefits; ie, they lacked side effect information.

I have always contended that these ads violated FDA regulations (see "Girl from Google"), but pharma marketers thought I was crazy (see "The 'One-Click Rule': Rant or No Rant?") because, as every sane person knew, there was a "one-click rule" that allowed such ads as long as the risk information was just one click away (ie, on the landing page).

That's water over the dam, so let's move on.

It is quite easy to extrapolate from the current FDA draft guidance on presenting risk information in print ads to static Internet ads like Adwords. This may be like reading tea leaves, but since I have a good batting average when it comes to understanding the application of FDA regulations to Internet advertising, you just might want to listen to my POV. It could save you from a NOV letter down the road. And as Arnie Friede, counsel to the law firm McDermott Will & Emery LLP and former Senior Counsel at Pfizer, says, "every warning letter or notice of violation has another life--in a court of law" (see "Ramifications of FDA Regulatory Actions"; PMN Reprint #85-02).

I find the most relevant tea leaves on page 15 of DDMAC's draft guidance. It's under the section "Print Promotion." Just think of an Adword or static banner or box ad as equivalent to a print piece. Yes, you can click on it and get more information, but the FDA probably considers the ad itself as the "main piece" and says:

"For a piece to be accurate and non-misleading, risk information should be included in the main part of a piece. If the omission of risk information in any part of a piece makes that part of the piece false or misleading, the problem cannot be corrected simply by including the risk information in a separate part of the piece [my emphasis]. To be comparably prominent to benefit information, risk information should generally appear in the same parts of the piece as the benefits."

Now, you may not like that the FDA views an Adword as the "main piece" of a promotion, but there it is. I don't think any argument about "reasonable man standard" is going to change DDMAC's mind on this (see "Arnold Friede Blasts FDA's Right to Define 'Reasonable Man' Without External Input").

The draft guidance also states:

"As a general matter, risk and benefit information should be comparably noticeable or conspicuous in promotional pieces, and audiences should be able to read both risk and benefit information with similar ease [my emphasis]."

and

"Complete separation of benefit and risk information (e.g., presenting several pages of benefits before any risks) is one example of a lack of appropriate prominence."

and

"Example 17: Risk information is placed in a thin column along the side of an ad in a different font and color scheme, so that the visuals and benefit information form a complete whole, separate from the risk information. This is not likely to be considered an adequate presentation of risk 582 information." [Although this is about a print ad, it is easy to read the tea leaves here and extend the thinking to Internet display ads.]

I think no matter how you define a "reasonable man," having to click a link in an Adword to get fair balance is not as easy as reading the benefits right there in front of you. Be honest, how often do you just read the first part of a news story in a newspaper without bothering to flip through to the page where it is continued? Even if you are reading the online version? I bet half of you have not even read this far into my post!

And, I'm also willing to bet that more than 95% of people (ie, "reasonable consumers") who view Adwords do NOT click on them (if you have some secret sauce for increasing the clickthrough rates on Adwords, please let me know). Nevertheless, the ad has some value -- building brand awareness as marketers say.

With regard to FDA's view of a "reasonable man," the following excerpt from the draft guidance document is relevant:

"Consumers have preconceived ideas about the amount of scrutiny these ads undergo. Many believe FDA exercises tight regulatory control over the content of these ads and to some extent, believe that all ads have been pre-reviewed prior to airing. As a result, consumers are likely to expect that the most relevant risks have been included in the ad."

Imagine what a "reasonable consumer" would think if they saw a drug ad with NO risk information included in the main piece?

Be reasonable and read the DDMAC draft guidance at least through page 16.

Live Podcast Today at 1 PM. CureTogether: A Social Network for Patients

CureTogether: A Social Network for Patients to Share Symptoms and Solutions to Improve Thier Health

Daniel Reda, Co-founder of CureTogether.com, will talk about this new social network that helps people anonymously track and compare health data, to better understand their bodies, make more informed treatment decisions and contribute data to research.

• Guest: Daniel Reda, Co-founder of CureTogether.com
• Live Streaming Audio Date:
Thursday, May 28, 2009, 1 PM Eastern US time.
• Live Streaming Audio Duration: 15 minutes
  
  
• Go to this Pharma Marketing Talk Segment Page at the time indicated above to listen to the LIVE show via streaming audio on the Web. You will also be able to participate in an online chat with the host and speakers to ask questions!

An audio podcast archive is available after the show here and can be downloaded in MP3 format as well:

MP3 Audio File (available AFTER the show)

This show and ALL Pharma Marketing Talk shows are available as podcasts via PMT on iTunes (FREE!).

Additional Resources

Background
The Wall Street Journal had this to say about Alexandra Carmichael and CureTogether.org (see "The New Examined Life: Why more people are spilling the statistics of their lives on the Web"):

Alexandra Carmichael, the founder of a health research Web site called CureTogether in San Francisco, has been tracking more than 40 different categories of information about her health and personal habits. In addition to her daily caloric intake, her morning weight and the type and duration of exercise she performs, she also tracks her daily mood, noting descriptions such as "happiness" and "feeling fat."

From her initial readings, she concluded that her mood went up when she exercised and went down when she ate too much. "I realized my relationship with food is a distorted, unhealthy one," Ms Carmichael says. She has concluded that she may have an eating disorder and has decided to seek counseling.

Alexandra Carmichael and Daniel Reda launched CureTogether in July 2008 to help the people they knew and the millions they didn’t who live in daily chronic pain. Starting with 3 conditions, it quickly expanded as people wrote in to request that their conditions be added to this ongoing study. CureTogether is currently funded by its founders, and does not host or receive funding from advertising.

Some Questions/Topics to be Discussed

• Please explain how people use CureTogether to improve their health
• You may call +1 (347) 996-5894 during the show to aks a question (or listen if you are not at a computer with Internet access)

Guest Bio

Daniel Reda brings 15 years of experience as a bio-IT entrepreneur to CureTogether. He co-founded Redasoft in 1997 with Alexandra Carmichael to help life scientists visualize complex genetic information and design molecular biology experiments in a simple, visual way, with applications ranging from cancer and AIDS research to potato crop research. Hitachi Software acquired Redasoft's technology in 2006. Daniel also designed the first social web application for bioinformatics.

A former molecular biologist and self-taught programmer, he was named a "Bio-IT Champion" by Bio-IT world and was nominated for MIT Technology Review's Top 35 under 35 award. Daniel believes in the power of listening and bringing people together to better understand disease.

Uh, Oh! Will FDA Cite this "One-Click Rule" Twitter Post by AZ as Violative?

Remember the 14 Notice of Violation (NOV) letters that FDA sent to 14 drug companies citing their Adwords -- paid search engine ads -- for violating FDA regulations? At issue was (and still is) the so-called "One-Click Rule," which states that an online Rx drug ad can mention the brand name and the benefits (indications) without including all or any of the major side effect effects (fair balance) as long as the fair balance is just one click away (ie, on the landing page). See "The 'One-Click Rule': Rant or No Rant?" and "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!" for my long-standing criticism of the "One-Click Rule."

The FDA letters only focused on paid search engine ads where there is a limit of about 70 characters. You can feel some empathy for pharma marketers in that case because of the impossibility of fitting all that fair balance into 70 characters -- impossible!

But what about the 140 characters allowed in Twitter posts? Is the FDA looking at that?

Below is an example of two Twitter posts made by AstraZeneca US on March 29, 2009 -- a few days before the 14 letters were sent (BTW, AZ was not one of the companies that received a letter that day).

(Click on image for an enlarged view.)

These Twitter posts ("tweets" include the brand name of the drug (Crestor) and the indications (eg, "reduce CV risk" and "reduce risk of blood clots in the veins"), but not the side effects. Both tweets link to AZ press releases that contain all the risk information.

BTW, you'll also find links to these press releases on the AstraZeneca (US) web site here. These links also mention the brand name and benefit without mentioning side effects.

This raises a couple of interesting questions:

1. Are Twitter posts considered promotions that are subject to FDA regulations?
2. What about links to press releases on drug company web sites?
   

I guess we'll have to wait for FDA to issue more letters before we can learn what its thinking is on this!

Arnold Friede Blasts FDA's Right to Define "Reasonable Man" Without External Input

Arnold Friede, Counsel to the law firm McDermott Will & Emery LLP, was my guest in yesterday's live Pharma Marketing Talk Show/podcast (see "Towards a Rational FDA Policy Addressing the Internet and Social Media"). At the end of that interview, Friede mentioned FDA guidance on presenting risk information in drug promotion that had just been released (see "FDA Rules are NOT Media Agnostic").

Today, Friede sent me this note regarding that guidance:

"It is true that FDA in the Draft Guidance officially adopts the 'reasonable man' standard for interpreting advertising and promotional claims. That is nice and long overdue. And the agency also says that in interpreting advertising it attends to the First Amendment. Likewise nice and long overdue.

"At the same time, of course, FDA continues to aggrandize entirely to itself the right and the ability to decide what the 'reasonable man', whether physician or consumer, understands in the context of any given promotional piece.

"By contrast, the FTC's Deception Policy Statement, from which FDA explicitly borrows the 'reasonable man' standard, acknowledges that except when the claim is explicit on its face, the Commission will usually consider consumer survey evidence in determining what meaning to ascribe to the advertising.

"FDA's apparent unwillingness to consider anything but its own views in determining what the "reasonable man" thinks suggests that adoption of that standard may amount to nothing more than elevation of form over substance. And it belies the agency's professed attention to the First Amendment."

Friede is attempting to bring together an ad hoc coalition to respond to the FDA's 14 enforcement letters citing violative Adwords (see "The 14 Letters. Who at the FDA Knew What and When?"). He is in favor of crafting a response that hinges on the concept of "reasonable man."

FDA does not use the term "reasonable man," but the more politically correct and accurate "reasonable consumer" or "reasonable consumer standard." FDA cites the FTC definition of this standard:

"[W]e examine the practice from the perspective of a consumer acting reasonably in the circumstances. If the representation or practice affects or is directed primarily to a particular group, the Commission examines reasonableness from the perspective of that group."

Friede argues that when the "reasonable consumer standard" is properly applied in the case of Adwords, the result is that "people understand that if they have an interest in learning the information, they simply click on the link [in the Adword]. There's a more than credible case to make that the linked information -- the information on the landing page -- should be considered a component of the advertising and not distinct from it," said Friede in my interview (listen here).

This is akin, says Friede, to print ads where the complete prescribing information appears on the back side of the ad.

The FDA, however, seems focused on the main part of the advertising piece and NOT what's on the back of a print ad and, by extension, not what's on the landing page of a Web ad. It cites an example of this on pg. 5 of the Guidance using language from a fictitious print ad. FDA clearly is concerned in this case that the risk information is included on the promotional page and is presented in a manner comparable with the benefit information.

If you consider an Adword to be similar to a print ad in a magazine, then you might interpret the FDA guidance to mean that Adwords must also contain risk information that is comparable to the benefit information in the Adword.

But that brings us to another problem that Friede also talks about: the problem of interpreting what the FDA thinks about Internet ads based on its guidance for print and TV ads.

"FDA is applying the same rules to all promotional communications regardless of the medium," says Friede. "This is a serious problem in the context, particularly, of new media, which has different technological capabilities and limitations."

Friede, IMHO, is a "reasonable man" and we should listen to what he says.

"New" Nalts Video Resurfaces: "Enlightened Stupid Marketer"

Kevin Nalts (aka Kevin Nalty, former Merck Marketing Director), self-proclaimed YouTube comedian and "viral video genius," revealed to me a video piece he did about a year ago that remained private (restricted access) until just recently.

The video, entitled "Enlightened Stupid Marketer," was "inspired by some comments from someone that spoke at a Florida conference, but some of my colleagues took offense of it," said Nalts.

In his video notes, Nalts says "This educational video helps you understand the mind of a marketer, and what shapes our decision making, workplace behavior and marketing mix. Can you become a marketer, or are they born? Find the answer you've long sought."

"A non-marketer might be looking at this and saying, 'Stupid Marketer...isn't that an oxymoron," says Nalts in the video.

"I say no, because there are stupid marketers and there are enlightened stupid marketers. Enlightened stupid marketers are at a fork in the road. Keep being stupid or be stupid but conceal that fact. I have several proven strategies for this." He then goes on to share those strategies, which are hilarious. You might just be a enlightened stupid marketer if you employ one or more of these strategies.

Here's the video:

Some of the 274 comments to this video (made a year ago, before the video was pulled) include:

"I too am an enlightened stupid marketer- and this seriously made my day- because I work with way too many people who say and do these things all the time!"

"ooh.. i am getting my business management degree in 3 months.. you discourage me from being a marketer "

"nalts.. your job wears you down.. you need a psychiatrist. damn. marketers are dumb.. all theory and shit.. too much theory "

"Something akin to cultivating ubiquitous methodologies with relation to extending interactive portals - so to speak, scaling killer convergence while proactively seizing viral markets and, with all things being equal, generating revolutionary mindshare. Five out of five!"

"A traveling salesman can always say, "At least I didn't have to live my life in the dreary shadows and quiet desperation of 'marketing' and of attending meetings with 'enlightened' marketeers speaking with the voice of the customer to drive customer value to the dashboard of executive insight.""

"Nalts, my friend, you have the Wallenda Factor of Powerful punditry for growing the product with your ideas of solid benchmarking to achieve best practices. Your core competences will declutter the bottom line."

Nalts will be featured in the upcoming May 2009 issue of Pharma Marketing News. Subscribe today and get it FREE!

Nalts is the John Cleese of Marketing!
Nalts is on his way to becoming the John Cleese (former member of Monty Python's Flying Circus) of marketing. I see his career as a motivational marketing speaker blossoming. He should be hired by Merck and J&J and every other big pharma company to come in and give marketing teams a dose of reality via humor, just like John Cleese does in his business training videos!

P.S. This Just In! Kevin Nalty Appointed Chief Strategy Officer, HITVIEWS

HITVIEWS, the first company to recognize the power of online WebStars to generate positive business results for brands, signs Kevin Nalty as its Chief Strategy Officer. He will be responsible for continuing HITVIEWS' aggressive entry into the marketplace. Sales tactics, marketing rollouts, public relations and industry relations will be his responsibility. More...

FDA Rules are NOT Media Agnostic

FDA has just released a new draft guidance document: "Presenting Risk Information in Prescription Drug and Medical Device Promotion" (find the pdf file here).

I haven't read the guidance yet, but according to a Reuters report, the guidance has some specific to TV ads:

"Television ads for drugs and medical devices should avoid distracting images and music that can reduce viewers' comprehension of potential side effects, U.S. regulators advised in guidelines proposed on Tuesday.

"Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the Food and Drug Administration said."

It seems to me that contrary to public statements by FDA officials and bloggers (eg, "FDA to Online Marketers: Same Rules Apply"), the same rules do NOT apply to all media.

Obviously, voice-overs and moving images, which are a topic of this new guidance, are not found in print ads. If specific guidance is required about TV ads to address that medium's unique messaging traits, then surely specific guidance for use of social media and the Internet that addresses THAT medium's specific traits is also appropriate. Maybe not necessary, though, if you wish to keep your head in the sand and hope that the FDA won't send you a letter.

Live Podcast Today: Towards a Rational FDA Policy Addressing the Internet and Social Media

Arnold Friede, Counsel to the law firm McDermott Will & Emery LLP, talks about organizing a collective response from representatives of the pharma industry to FDA's recent enforcement initiative on the use of sponsored links in search ads and more generally, on FDA's overall approach to regulating social media and the Internet.

• Guest: Arnold I. Friede, Counsel to the law firm McDermott Will & Emery LLP
• Live Streaming Audio Date:
Tuesday, May 26, 2009, 2 PM Eastern US time.
• Live Streaming Audio Duration: 15-20 minutes
  
  
• Go to this Pharma Marketing Talk Segment Page at the time indicated above to listen to the LIVE show via streaming audio on the Web. You will also be able to participate in an online chat with the host and speakers to ask questions!

Background
On April 2, 2009, the FDA issued 14 letters informing drug companies that their search engine ads, which included drug brand names and indications but no risk information or fair balance, were in violation of the law. This caught many in the drug industry by surprise because they assumed the "one-click rule" applies; ie, as long as the fair balance information was just one click away -- on another Web page -- such ads are allowed by the FDA. With the 14 letters, FDA disagreed and quashed the "one-click rule."

Friede believes that there is an opportunity now to make a strong and compelling argument for the adoption of rational regulatory policies by FDA that address the unique features not only of sponsored links, but of other kinds of new communication tools, such as social media and the like. According to Friede (as quoted in Eye On FDA Blog): "Viewing the matter from this perspective, FDA's approach of unilaterally rejecting the contents of the landing page as a component of the advertising is unquestionably wrong as a legal matter. It may also violate the First Amendment, which, as the Supreme Court held in Hustler v. Falwell, requires that information (in that case, a parody) be interpreted using a 'reasonable man' standard. (Every reasonable person knows that clicking on the sponsored link takes you to additional and contextually integrated information. It's like going beyond the front page of the newspaper to get to the rest of the story Everyone knows you've got to the turn the page, and they tell you as much, as do the hot links here). And the principle that context determines meaning has likewise been applied by the Supreme Court in any number of related contexts (e.g. in the Brown & Williamson case, which involved the scope of FDA's statutory authority)."

On Tuesday, May 12, 2009, Friede and Bob Nicholas of the law firm McDermott, Will & Emery, convened a video conference to discuss organizing a collective response to FDA's enforcement initiative on the use of sponsored links in prescription drug advertising, and, more generally, on FDA's overall approach to regulating the internet as a distinct medium of communication. See below for some background on FDA's enforcement initiative.

The meeting was open to representatives from pharmaceutical companies, advertising agencies, internet media companies, trade associations and their individual member companies, and others who have a legitimate interest in the evolution of a responsible FDA approach to internet communication. The meeting, however, was not open to the trade press and other members of the media. This podast will present some insights from that meeting and an update regarding progress towards organizing a collective respons eto the FDA.

Some Questions/Topics to be Discussed

• Explain your view of the legal issues raised by FDA's recent enforcement action
• What sort of collective response do you hope to organize and why is it necessary?
• Have you gotten a good response? What's next?

Guest Bio

Arnold I. Friede is counsel to the law firm of McDermott Will & Emery LLP based in its Washington, D.C. office. Arnie is a member of the Firm's Health Law Department. Arnold I. Friede is a widely respected food and drug law counselor and advocate with significant advertising law, health care law, First Amendment, environmental, and commercial and transactional experience. He has a long history of direct involvement in successfully representing clients in FDA-regulated matters beginning as an Associate Chief Counsel in the FDA Chief Counsel's Office, as well as a broad spectrum of senior in-house legal experience across multiple FDA-regulated industries.

Additional Resources

• The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!
• A Conversation Around the Legal Questions About the FDA's 14 Untitled Letters on Paid Search Ads

Nalts Talks About His Days at J&J, His ADHD, and His Merck Performance Review

Kevin Nalty (aka "Nalts" the YouTube video blogger), who last week decided to quit his job as Consumer Product Director at Merck to "follow his passion" for video, may have been forced into his new career because of videos that were embarrassing to Merck. I mentioned his "ADHD Boy" and "Sucks Away My Will to Live" as examples in a previous post (see "Was Nalty's Fart Video the Straw that Broke Merck's Back or was it Some Other Video?").

Immediately after I posted those videos on this blog, Nalts responded by RESTRICTING VIEWING OF THEM TO A PRIVATE AUDIENCE, BY INVITATION ONLY. That's too bad because "ADHD Boy" was a brilliant spoof of a disease awareness ad that might have been sponsored by a drug company such as Merck.

In my continued effort to dig up more interesting facts about Nalts, I have found two more videos that may have embarrassed his previous employers, including Merck and J&J. The videos also provide more insight into why Nalts left Merck. It seems that his ADHD was a factor.

The first video I found was "Crackberry Blackberry," which was selected as an official honoree at the 11th Annual Webby Awards, an international paid-entry-exclusive award honoring excellence on the Internet, including websites, interactive advertising, online film and video, and mobile web sites. The video is embedded below.



This video is a spoof of brand name drug ads. Nalts' video notes state: "Now there's a pharmaceutical cure for Blackberry addiction." The video was uploaded to YouTube on June 5, 2006.

"Crackberry Blackberry" describes a new syndrome called "Crackberry Addiction," which is a "Problem That Effects (sic) More than 10 Million Americans." In the video, Nalts acts out several scenarios that demonstrate how addiction to use of your Blackberry can impact your work -- ie, Nalts is seen participating in what looks like a product manager's meeting -- your family and loved ones and how it can endanger your life.

The solution? "Talk to Your Doctor About CracklosecER"

After the solution comes the fair balance. Here is where the spoof hits home at the drug industry. The side effects scroll by so quickly that it is impossible to read. Obviously, this video -- had it been a real drug ad -- would be cited by the FDA as violative.

I decided to pause the video during the side effect scroll to see if Nalts put anything interesting in there that would be missed by the typical viewer. Below is a screen shot of one frame of the scroll.


Note that a real drug name -- etanercept (brand name: Enbrel) -- was mentioned in the text, which probably was copied from the drug's labeling.

This is interesting because Nalts (ie, Nalty) at the time this video was made (2006), was working at J&J, which markets Remicade, a product that competes with Enbrel (marketed by Wyeth). I know that Nalty was working for J&J in 2006 because of his own recollection mentioned in another video, "Thoughts on ADHD."

In "Thoughts on ADHD," Nalts talks about his days at J&J. In it, Nalts expresses "Lots of good comments on 'ADHD Boy' video." This video was posted on March 2, 2008, while Nalts was employed at Merck (as Kevin Nalty).

"I'm allowed to make fun of ADD," says Nalts, "because, of course, I totally have ADD."

This video probably was not noticed by many of Nalts' detractors such as Pete Quily (@petequily), an adult ADHD coach and blogger. "@nalts project insults, shame on #ADHD in hopes of distracting other from noticing that he probably has ADHD himself," tweeted @petequily recently. To which Nalts replied "Denial? My ADHD can beat up yours any day. And humor, to the enlightened, doesn't create stigma it dissolves it."



In the "Thoughts on ADHD" video, Nalts says "When I worked at Johnson & Johnson [about March 2006, according to Nalts's recollection in the video] , they used to call me 'ADHD Boy.' My boss at the time was really encouraging about getting treated," says Nalts. "So I started taking Adderall."

At the time Adderall was not approved for use in adults and Shire -- the company that marketed Adderall -- was cited by the FDA for suggesting that it was approved for use in adults (see "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!").

"Some people are really anti medication," says Nalts in the video. "For me, this is like people complaining about being thirsty and then not drinking water. Sure I have ADD, but I'm medicated," says Nalts as he pops a pill into his mouth.

"And then there's the placebo effect of medication," says Nalts. "sometimes when I go into a meeting where I know that I'm going to have to sit quietly, not be impulsive, I'll take an ADHD med beforehand. I know the onset isn't that quick, but somehow it sort of gives me the confidence to just sit still."

It's not surprising that Nalts would have to suppress his "impulsive" thoughts when sitting in a meeting at a Fortune 100 drug company. Perhaps, however, some of these thoughts also may have been creative and offered solutions to problems being discussed. I can see how Nalts would have suffered more because of corporate suppression of creativity than from "impulsiveness" brought on by his ADHD. When you reach the age of 40, as Nalts did last week, you begin to think of escaping any environment that suppresses your "will to live."

Nalts/Nalty also mentions his latest (Merck) performance review in "Thoughts on ADHD" as he did in the now-withdrawn "Sucks the Life Out of Me" video. "My latest performance review at work was all about attention detail and focus. Ironically, about the time they fielded this 360-degree feedback, I accidentally cut my dose of Adderall in half unbeknowst to me. So that, I think, explains it to a degree."

Nalts' final piece of advice is: "Read The Secret. When I listen to that or The Power of Positive Thinking, that brings me to a happier place. It's about redirecting your thoughts so you're not all hyper-critical and you're thinking positively and you're grateful for what you have. It's very easy to slip out of that."

In the video announcing his career change, Nalts expressed his gratitude to his wife for supporting him at this critical point in his life.

Was Nalty's Fart Video the Straw that Broke Merck's Back or was it Some Other Video?

Kevin Nalty (aka "Nalts" the YouTube video blogger) told NewTeeVee's Liz Gannes that "the fact that Merck was recently being unfairly linked to me and fart videos was the ’straw that broke the camel’s back.’”

Nalty recently quit his day job as Consumer Product Director at Merck, where he marketed Propecia, and decided to "follow his passion" full time -- making videos, working with Hitviews, and starting his own consulting practice (see "Kevin Nalty Goes Nalts Full Time! Quits Merck to Become Online Video Marketer").

Yes, Jim Edwards over at BNET Pharma and others linked Nalty's "farting in public video," with his position as a Merck Marketing Director. Embarrassing as it is to be caught farting in public, much more embarrassing to Merck were two other Nalty videos that I was the first to reveal here on Pharma Marketing Blog:

"ADHD Boy" (see "Kevin Nalty, Merck Marketing Director, Exposed as 'ADHD Boy!'") [SORRY! NALTS HAS RESTRICTED VIEWING OF THIS VIDEO TO A PRIVATE AUDIENCE, BY INVITATION ONLY. If you want to view it, contact Nalts through his website: WillVideoForFood.com]



"Sucks Away My Will to Live" (see "Kevin Nalty (aka "Nalts") Says Co-worker Once "Sucked Away His Will to Live") [SORRY! NALTS HAS RESTRICTED VIEWING OF THIS VIDEO TO A PRIVATE AUDIENCE, BY INVITATION ONLY. If you want to view it, contact Nalts through his website: WillVideoForFood.com]



Despite what Nalty says publicly, "Farting in Public" cannot compare to the above two videos in terms of public humiliation for Merck.

What do you think?

Which video was most likely to have embarrassed Merck the most?
	Farting in Public
	ADHD Boy
	Sucks Away My Will to Live
	None of the Above
	All of the Above

Kevin Nalty Goes Nalts Full Time! Quits Merck to Become Online Video Marketer

May 21, 2009: "Today I quit my day job as Consumer Product Director at Merck, where I marketed Propecia," announced Kevin Nalty, aka YouTube comedian "Nalts." "Thanks to all of my Merck friends for tolerating me and teaching me so much."

Nalty decided to "follow his passion" full time -- making videos, working with Hitviews, and starting his own consulting practice that will "help brands engage in social media, especially the most visceral kind: online video."

While Nalty was preparing for his departure from Merck this past Wednesday evening (5/20), I cited him as an example of why pharmaceutical companies are having a difficult time with social media marketing: they cannot tolerate the kind of creative, out-of-the-box, free spirit employees who embrace new media with a passion. Without these pioneers, pharma companies trundle along their well-worn marketing paths.

Speaking at the Philama (Philadelphia American Marketing Association PharmaSIG) panel discussion on "Pharmaceutical Marketing within Today's Social Media Culture -- Opportunity or Nightmare?" I questioned how long Nalty would remain at Merck and suggested that he might be forced out and pursue his passion outside of Merck.

I suspected that something was up with Nalty when he was a no-show on Wednesday at an industry conference where he was scheduled to speak on "How to Efficiently Acquire Qualified Consumer Leads For RM Programs."

Turns out that I was spot on! Here's Nalty's/Nalts' video, entitled "Bikini Girl Inspired Me to Quit," announcing his departure from Merck to pursue his passion:

"Do what you love, peeps," Nalts suggests. "I have an MBA in entrepreneurship and a passion for marketing, social media and video. Time to put it to work."

Obviously, Merck was not a place where Nalty could put his passion to work. Before he quit Merck, Nalty/Nalts produced a video in which he talked about a performance review in which he was criticized for saying that a co-worker "sucked away my will to live!" See my post: Kevin Nalty (aka "Nalts") Says Co-worker Once "Sucked Away His Will to Live".

In his comments accompanying his swan song "Bikini Girl" YouTube video, Nalty posted this note:

"Last night Katrina Darrell sang Mariah Carey's 'Treated Me Kind' on American Idol 2009. Her song inspired me to quit the full-time job as a Product Director at Merck. Thanks to my Merck friends and co-workers for tolerating me! :)" [Sucked-the-Will-to-Live-Guy excepted, I suppose.]

"I was the consumer marketing director on Propecia for hairloss. Shut up, okay? You should see my brother's hairline.

"Gotta do what you love, and trust the money to follow. Should have listened to that advice right out of school. Not too late for some of you."

"Full steam ahead in video 'entertaining,' and helping brands engage in social media and video... via Hitviews and via my own consulting firm to be announced next week!

"Seriously- thanks so much for watching and subscribing, since I couldn't afford to do this without some income from the ads you watch."

One anonymous commenter (perhaps Sucked-the-Will-to-Live-Guy) had this to say:

"you really fucked yourself over here 'mr. nalty'"

That speaks volumes about pharma's view of passionate new media marketers.

The Real Agenda of GSK's New Blog and Why the Authors' Identities are Cloaked

The world's second largest drug company, GSK, has followed the lead of the world's most trusted drug company (J&J) and entered the blogosphere and Twitterdom.

The blog, American Health: More Than Medicine, which was "piloted" since January with a small advisory group of folks inside and outside GSK, was publicly unveiled just this week. It is intended for US residents only.

Why did GSK launch this blog and why is it focused only on US residents? I hope to get answers to these and other questions from "Michael F.," one of the GSK bloggers, in a future Pharma Marketing Talk show/podcast interview. That won't stop me, however, from speculating.

First, let's talk about why "Michael F," "Michael M," and the other GSK bloggers chose to remain "anonymous."

A few bloggers suggested this anonymity contradicts the blog's stated goal of openness. "This is a tricky issue," said "Michael M." in a recent post ("Content is King Here, Not the One Who Posts It").

I submitted a comment to this post, part of which I reproduce here:

"On the one hand, I agree that content is king. On the other hand, blogs are about individuals. On the third hand, you have a right to anonymity. You wouldn't be the first blogger to use an alias or to not reveal his/her identity.

"But, looking at your competition, I see Marc Monseau, JNJBTW blogger. is very visible and he hasn't suffered from it (that I know of).

"It would help for readers to know a little bit more about your background. For example, I know that Marc used to be a journalist and he plays Rugby (I think). Another (former) pharma corporate blogger, let's call him Michael P., has become a friend of mine, especially after he entered his "after pharma" life stage (see "There IS Life After Pharma!")."

Michael F. cited corporate policies and "legitimate privacy and security concerns" as a defense of anonymity. "We're certainly not hiding anything," he added. "but the larger point is that this blog is not about any of us individually; it is about the company as a whole. Adhering to this policy actually allows us to bring wider perspectives from within the company."

Mark Senak of EyeOnFDA blog suggested that the GSK blogger's anonymity is "a little odd given that the About this Blog section indicates that the purpose of the blog is to seem a little less stuffy and formulaic" (see here).

Interestingly, I was contacted by "Michael F." today via e-mail, which included his signature that identified his real identity. I am not revealing his name until he gives me permission to do so, but I immediately searched for his profile on LinkedIn and requested that he add himself to my network.

Whereas Marc Monseau has a journalism background, Michael F. studied history and has an advanced degree in Economics/Foreign Policy! He also worked for a number of years as a Legislative Assistant for the US Senate Committee on Governmental Affairs and as a State Office Staff Director and Special Assistant to a conservative former US senator. Gotta love LinkedIn!

Quite an interesting background for someone who is now part of a pharmaceutical corporate communications function.

Michael F. says healthcare is not just about medicine:

"But healthcare is about more than medicine. It's about trying to make sure that patients have access to the best care, treatment and medicines available. It's about doctors and other prescribers being able to match the right patient with the right medicine."

Indeed! It's also about POLICY!

The agenda of American Health: More Than Medicine, IMHO, is to propagate GSK's and the drug industry's argument AGAINST a government-run health insurance plan that competes with private insurance -- a hot topic in the current debate about US healthcare (see, for example, "Pfizer's Kindler beats pharma's new healthcare reform drum: No Public Plan!").

Although Michael F. claims that "having a chance to improve peoples' health, and therefore their lives, is energizing and rewarding," he's a policy guy/wonk and probably will energize us with posts aimed at defeating the passage of any health-reform legislation that includes a public health plan.

Which isn't necessarily a bad topic to blog about and engage in debate about. I just wish that GSK would be more transparent about its goals and opinions -- a "tricky issue" for most pharma companies, not just GSK. For example, are you for or against a gov't health plan? DUH! I hear ya!

Will the Drug Industry be the Next Auto Industry?

At last night's Philama (Philadelphia American Marketing Association PharmaSIG) panel discussion on "Pharmaceutical Marketing within Today's Social Media Culture -- Opportunity or Nightmare?" I found myself comparing the pharmaceutical industry to the auto industry.

Impossible!, you say. The pharmaceutical industry is at the top of its game with an average 17% gross and 22% net profit margin, according to panelist Thani Jambulingam, PhD, Chair and Associate Professional of the Department of Pharmaceutical Marketing at St. Joseph's University (a great school, BTW).

Let me explain my thinking.

I am interested in the auto industry because my son just graduated with a BS in mechanical engineering and his dream was to work in the auto industry. When the proverbial sh*t hit the fan belt in that industry, I felt my son had no future there. Now, however, with the industry embracing Obama's plan for fuel-efficiency, the auto industry will have the resources and, more important, the will or need to embrace change. I am hopeful that will spur renewed innovation in combustible engine development, which will require the industry to hire new, YOUNG, inspired engineers like my son.

At last night's meeting, we all wondered what would be necessary for pharmaceutical marketers to embrace new technologies like Web 2.0 and social media. Of course, we talked about the usual suspects like overcoming regulatory barriers, but the main conclusion I heard was that it will take NEW, YOUNGER marketers who grew up with these technologies and who are passionate about them and cannot live without them.

You might recall these survey results that I published in the April 2009 issue of Pharma Marketing News, which seem to indicate that the new batch of marketers in pharma have LESS personal knowledge of new media than did the batch who filled out the survey a year ago:

See "There's a New Crop of Pharma People Who Are Not So Savvy About Social Media!" for more details.

It may be that the current crop of marketers within drug companies is a lost cause when it comes to social media. They have a "not invented here" mindset.

In the book "How the Mighty Fall," Jim Collins identifies "Five Stages of Decline" that failed companies go through.

"Our comparative and historical analysis yielded a descriptive model of how the mighty fall that consists of five stages that proceed in sequence," says Collins. "And here's the really scary part: You do not visibly fall until Stage 4! Companies can be well into Stage 3 decline and still look and feel great, yet be right on the cusp of a huge fall. Decline can sneak up on you, and—seemingly all of a sudden—you're in big trouble" (see excerpt here and chart below).

I place the pharmaceutical industry somewhere in the "denial of risk & peril" area of the curve


"As companies move into Stage 3, internal warning signs begin to mount, yet external results remain strong enough to 'explain away' disturbing data or to suggest that the difficulties are 'temporary' or 'cyclic' or 'not that bad,' and 'nothing is fundamentally wrong,'" says Collins. "In Stage 3, leaders discount negative data, amplify positive data, and put a positive spin on ambiguous data. Those in power start to blame external factors for setbacks rather than accept responsibility. The vigorous, fact-based dialogue that characterizes high-performance teams dwindles or disappears altogether. When those in power begin to imperil the enterprise by taking outsize risks and acting in a way that denies the consequences of those risks, they are headed straight for Stage 4."

There are all kinds of risks that the pharmaceutical industry faces. With regard to social media there may be MORE risk in NOT getting involved than staying on the sidelines, according to Philama panelist Stephan Wray, President & CEO of Cadient Group.

Another point made at last night's discussion is that Social media will change marketing!

Currently, marketers PUSH well-honed messages out to TARGETS. It makes no difference if it's called permission marketing or relationship marketing, it's still a top-down approach where the approved message is pushed down to the masses.

In social media, however, the message comes up from the bottom and to be successful in that environment there has to be a revolution in marketing to accept these messages and try and steer the group toward the messages that support your brand. The new marketers are like sailors making the best of the wind they have to get to their destination. That's quite different than today's marketers who steer powerful tankers in any direction they choose. But, like today's real tankers, they can be hijacked by a small, mobile crew of pirates. Just think of Andy Behrman versus BMS (see "Behrman Wasn't the First Patient Spokesperson Paid Big Bucks By BMS").

So, a revolution in marketing needs to occur before the drug industry can successfully engage in social media. How is that likely to happen?

It won't happen until the pharma industry, like the auto industry, reaches Stage 4 where it is "grasping for salvation." It certainly won't happen when profit margins are 22%. With that treasure chest, pharma companies do not have to react to the Andy Behrmans in the social media world. He's just a gnat on the pimple of pharma's ass.

However, as the profit margins shrink -- think comparative effectiveness -- the social media gnat will look more like an albatross. Pharma will carry that albatross around its neck either into Stage 4 (capitulation) or they will embrace change from the top down just like the auto industry and possibly save themselves!

Behrman Wasn't the First Patient Spokesperson Paid Big Bucks By BMS

Andy Behrman -- aka "Electroboy" -- is being raked over the coals for first shilling for BMS' drug Abilify (for which BMS paid him $400,000), then "shaking down" BMS for a new contract and then launching an anti-Abilify campaign when he didn't get it (see "Andy Behrman, Now an Anti-BMS Spokesperson, Says 'Ask Your Doctor If Abilify is Wrong for You'").

While many bloggers are focused on what Behrman has been and is doing, few are focused on what I consider to be the real issues:

* Is it appropriate for pharma companies to pay patients such huge sums to promote their products?

* Is this done often by all pharmaceutical companies or is it just something unique to BMS?

To answer these questions, I will relate a personal story where I was involved with another patient paid huge sums of money by BMS to advocate another product: an anticholesterol drug.

Way back in 1994, I launched a drug information Web site called PharmInfoNet. It was a popular site and we worked with many pharmaceutical companies that placed ads on the site and that provided funding for physician education programs (we summarized presentations made at medical conferences and published them on the site).

I was often contacted by entrepreneurs who wanted to work with us to develop and promote their own websites. One day a young guy -- let's call him Wayne -- called and said he wanted to launch a site related to cardiovascular health and wanted me to help, maybe be a partner.

Wayne had a heart attack not long before he contacted me -- he was maybe 30 years old at that time. It was nearly fatal. After his recovery, Wayne's physician (let's call him Dr. Raider), a key opinion leader paid by BMS, prescribed a BMS anti-cholesterol drug for Wayne.

When I first met Wayne, he told me about how he was hired by BMS to be a spokesperson -- along with Dr. Raider -- for BMS' drug. Wayne was featured on patient brochures and went around speaking about his experience to wherever BMS sent him.

Although Wayne never told me how much he was paid by BMS, I knew it was serious money because he had a lawyer and was spending a lot to build his Website. The site also received major financial support from BMS. At the time, I did not think it was inappropriate for BMS to pay Wayne to be a spokesperson. Kudos to him!, I thought.

Wayne and I were partners for a time -- we exchanged links and content between our sites. Eventually, we both sold our websites to another company and went our separate ways.

I cite this story as anecdotal evidence that "Electroboy" was not the first patient BMS paid to promote a product. Wayne had not even been a famous author when he was paid by BMS to promote its product. I suspect that even today, other non-celebrity patients are being paid by BMS.

Is it just BMS doing this? Or are other drug companies also paying patients to "tell their stories?"

My fellow blogger, Wendy Blackburn, suggests this is a common practice. She wrote in her post "In Defense of Pharma and Patient Spokespeople":

"There are plenty of pharma companies that handle patient relationships responsibly, plenty of patients that behave ethically, and thousands of people who have benefited from other patients sharing their stories in meaningful ways. And of course the WSJ chose NOT to focus on them. In my experience companies are extremely conservative, careful and ethical with these relationships. Patients speak in their own voice and are treated with respect. Yes, their words are edited. But honestly most of the editing-out is of the overly positive ('this drug saved my life' or 'I felt better immediately'), always striving for a more typical and balanced representation."

I also believe that people benefit from hearing other patients' stories and, as Wendy points out, that's what makes social networks so useful for patients. However, when some patients are paid huge sums of money by drug companies to "speak in their own voice," I suspect that this "voice" is not authentic and most often there is a lack of transparency about who pays for the "voice."

Patients want and need to hear "voices" without the slightest chance of bias. Given the odds that this can happen when the voice is paid for, it becomes necessary to ensure transparency. But even transparency is NOT enough. Drug companies simply should NOT pay for these voices. They should certainly not pay hundreds of thousands of dollars!

If pharma really wishes to engage in social media, they need to find voices that are already partial to their products and support them WITHOUT direct payment.

Here's an idea: Instead of handing bundles of money to patient spokespeople, drug companies can donate the money to the patient's favorite charity -- preferably one not set up by the patient (Wayne and his lawyer had set up such an organization through which BMS funneled him his cash).

What do you think?

Should Pharma Pay Individual Patients to be Spokespeople for Their Products?
	Yes, I don't see any problem with it
	Yes, within limits (eg, amount paid)
	Maybe, it depends
	No, under no circumstances

Andy Behrman, Now an Anti-BMS Spokesperson, Says "Ask Your Doctor If Abilify is Wrong for You"

The saga of the Andy Behrman, the patient that Bristol-Myers Squibb (BMS) paid hundreds of thousands of dollars (but balked at paying him millions) to help promote its drug Abilify, continues.

[Note: After writing this post, Xavier Petit (@xpetit) of Shire posted a tweet from an industry conference that relates lack of adherence to lack of transparency about a drug's side effects, one of the main reasons people stop taking their prescribed medicines. Xavier said: "what can we do [to improve adherence]? Don't downplay side effects: remind docs about strategies for addressing side effects," which is precisely what I am saying in this post if you read the commentary at the end.

My thesis is: using patient advocates like Andy Behrman, who obviously was not "reminded" about Abilify's side effects by his BMS handlers, downplays side effects and does not improve adherence.

While Behrman was being paid by BMS, he was happy to focus on Abilify's benefits. Now that he is no longer on BMS's payroll, he is equally happy to talk about the side effects. It all suits his purpose. I contend that many other paid patient (and celebrity) advocates would do the same.

The danger is magnified 10X when paid patient advocates use social networks to promote drugs. In many cases, other members of the community would be unaware that the person speaking about the drug is being paid by a pharmaceutical company. Imagine if Behrman posted messages about Abilify on social networks! He may have done so on his own in order to please his BMS patrons.]

Jim Edwards of BNET Pharma reports that Behrman has resorted to an e-mail campaign that Edwards says is a "long plug" for Behrman's new book (see "Andy Behrman Resorts to Spam in Fight vs. BMS and Abilify").

In reading Behrman's e-mail message I found a link to a 60-second anti-Abilify video ad he posted to YouTube ("Abilify Kills"; see below). This "anti-ad" lists several of the side effects of Abilify and finishes with a twist on the famous "Ask Your Doctor" closing found in all DTC Rx drug ads: "Ask your doctor if Abilify is wrong for you."



Now that Mr. Behrman is getting so much media attention and is going viral on the Internet (he asked the 3,000+ recipients of his e-mail "to forward this e-mail to everyone you know") and YouTube, Abilify's long list of dangerous side effects is being put in the spotlight.

To be sure, these side effects have always been available for everyone to see in Abilify ads (such as the one on the left; click for an enlarged view) or on the Abilify Web site.

However, in the print ads, the side effects are in small type at the bottom of the ad, whereas the benefits are at the top and within the pleasant image area of the ad -- where your eye is naturally drawn.

On the website, the laundry list of side effects is even harder to read -- very small typeface -- and mostly below the "fold" where it is less likely to be seen at all.

Mr. Behrman's "anti-ad" may have been more dramatic if the side effects were presented as text scrolling down the screen silently, in a black box. Here's what that might look like like (please scroll to the end where you find more of my commentary):

IMPORTANT SAFETY INFORMATION:

Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING).

Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient’s healthcare professional right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression (see Boxed WARNING).

Contraindication: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue.

Serious side effects may include:

* An increased risk of stroke and ministroke has been reported in clinical studies of elderly patients with dementia-related psychosis

* Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal

* Abnormal or uncontrollable movements of face, tongue, or other parts of body. These may be signs of a serious condition called tardive dyskinesia (TD), which may be permanent

* If you have diabetes, or risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger, your blood sugar should be monitored. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it

Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY.

ABILIFY and medicines like it can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you.

Medicines like ABILIFY can impact your body’s ability to reduce body temperature; you should avoid overheating and dehydration.

ABILIFY and medicines like it have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.

Tell your healthcare professional if you have a history of or are at risk for seizures, or are pregnant or intend to become pregnant, and about all prescription and non-prescription medicines you are taking or plan to take, since there are some risks for drug interactions.

While taking ABILIFY, avoid:

* Drinking alcohol
* Breast-feeding an infant

Most common side effects (≥10%) from all clinical trials involving adults or pediatric patients include:

* ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety, insomnia, and restlessness

* PEDIATRIC PATIENTS (10 to 17 years): Extrapyramidal disorder (for example, uncontrolled movement disorders or muscle disturbances such as restlessness, tremors and muscle stiffness), headache, sleepiness, and nausea

It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasm or contraction which may be signs of a condition called dystonia.

With such a long list of serious side effects, one has to wonder if it is appropriate for BMS to have hired or continue to hire patient spokespeople who may not be aware of these side effects because they have not "asked their doctor if Abilify is wrong for them."

Personally, I do not think patients -- whether they have been paid or not are good sources of information -- about dangerous drugs, especially those like Abilify, which contain FDA-mandated black box warnings.

Let's Put Social Media to One Side
And this brings me to social media and the dangers that may be lurking there for patients seeking information about drugs.

A well-known Vice President at a Top 10 Pharma company recently spoke to blogger Ged Moore over the phone. Among other things, this VP said: ""Ged, patients think they have gained the upper hand in knowledge about medicine. They come to the doctors with more informed choices about drugs, dosage etc. But this doesn't mean s**t...we need to re-engage with the physician; let's put the social media stuff to one side. The physician is the most important person in this whole equation. We need to make sure our communication is clear to the physician and they relay to the patient in a clear way" (see "What a VP said to me....").

Although the VP was talking about adherence -- "look at our adherence rates, they are just as low as ever" -- he could just as well have been talking about side effects that may not be mentioned in consumer-generated content on social media sites and that are de-emphasized on drug information websites.

The VP says: "It's madness, we as an industry need to make sure clear, transparent information is there." Unfortunately, again, he/she was not talking about being transparent about side effects.

P.S. I admire Pfizer's Celebrex commercials, which ARE transparent about side effects. Abilify has an even longer list of side effects than does Celebrex, yet you won't see Abilify ads as transparent about them as are the Celebrex ads. Why not?

Thank you Andy Behrman for leading me to this topic of discussion, which I hope will continue.

It's a bird...it's a plane...it's PharmExec 50, but what's that molecule?

The May 2009 issue of Pharmaceutical Executive (PE) Magazine is here. It's cover features a 3-D image of a super hero ("50 Man") holding a complex molecule as he flies above a metropolis -- possibly Pfizer headquarters in Manhattan.

"The whole point of 3-D is to get things to jump off the page," says Patrick Clinton in his editorial piece. "And that's a challenge we all face these days. In today's media-saturated world, it has never been easier to get information in front of an audience. When you recall this month's 50 Man, as we hope you will, remember this: He can't save the world if he just sits on the page. He's got to fly."

50 Man also cannot save the world unless he develops new and effective drugs!

And that brings me to the image of the molecule that 50 Man is holding. I suppose it represents the new drugs that the pharmaceutical industry is inventing to save the world, which Sanofi-Aventis believes is an "unhealthy place" according to its new "video news website."

I have a problem figuring out just what kind of molecule 50 Man is holding. It looks like some kind of polymer. But it's not DNA or RNA, which are polynucleotides. It's also not a polypeptide, the basic structure of proteins. Most biologics and biotech drugs are proteins or polypeptides. So 50 Man is not saving the world with that type of drug.

It's also not a polysaccharide.

That just about covers all the main classes of biopolymers. Which leaves some kind of large, non-biopolymer -- not likely to be much use as a drug, unless it's just a proto-molecule that 50 Man is bringing into space so it can interact with cosmic rays and be transformed into a wonder drug!

Anyway, cool graphic and a nice cover.

Distribution of Reprints: Another Example of FDA Flexing Its Enforcement Muscles

Recently, the FDA sent Sanofi-Aventis (SA) an untitled letter requesting that the company cease the distribution of a reprint from the Journal of Clinical Oncology, which describes a study comparing the efficacy of its breast cancer drug Taxotere to that of Bristol-Myers Squibb’s Taxol.

Actually, FDA did not request that SA cease distribution of the reprint itself. It said that the "violative promotional material," which in this case is the "reprint carrier," should no longer be distributed.

The reprint carrier -- the folder or binder in which the reprint is inserted -- was "false or misleading because it presents unsubstantiated superiority claims and overstates the efficacy of Taxotere," according to the FDA.

In January, 2009, the FDA issued new guidance on the the distribution to physicians of medical journal articles (reprints) on "unapproved new uses of approved drugs" by Rx drug marketers (see the "FDA Guidance Document"). The SA letter, however, is NOT related to a violation of this guidance. The claims made on the carrier were the focus of the FDA. Those claims were not substantiated by the results of the study that was the topic of the reprint. In fact, the FDA said it was unaware of ANY evidence in support of those claims:

"These claims misleadingly suggest that Taxotere is superior to paclitaxel in the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and overstate the efficacy of Taxotere. FDA is unaware of substantial evidence to support these claims."

Of interest is the fact that the FDA based its analysis on materials submitted under cover of Form FDA 2253 by SA and obtained at the American Society of Clinical Oncology annual meeting in June 2008 -- almost one year ago! That material was in the possession of the FDA even before the reprint guidance cited above was issued in January, 2009.

I have often complained that regulatory actions of the FDA is akin to closing the barn door AFTER the cows have left (see, for example, "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"). By law, the SA Form 2253 must have been submitted "at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product." Therefore, FDA sat on this for almost 11 months.

Of course, a lot happened during those 11 months -- notably a change in FDA administration. There may be several other pieces of evidence sitting around the FDA that soon will generate new letters as part of FDA's new enforcement muscle flexing. The SA letter is just one of several recent actions by the FDA that demonstrate this new-found regulatory imperative.

In closing, I quote Mark Senak of Eye on FDA Blog (see "Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 1"): "The lesson learned here? It would be prudent for companies to consider whether or not the regulatory environment is shifting based on the evidence of the infamous 14 letters and the Cheerios warning. It may be time to strategically review and take stock all current promotional materials to assess with a new and highly critical eye to question again whether or not there is a potential violation. Because the message so far out of FDA is that just because you have been engaged in a promotional practice for some time, doesn't mean that it won't be the subject of future regulatory actions. There is no statute of limitations on promotional practices and their eventual regulation by the FDA."

Kevin Nalty (aka "Nalts") Says Co-worker Once "Sucked Away His Will to Live"

Recently, Kevin Nalty -- a Merck dermatology marketing executive -- was "outed" as "Nalts," the prolific YouTube videographer who sometimes spoofs medical conditions like Adult ADHD (see "Kevin Nalty, Merck Marketing Director, Exposed as 'ADHD Boy!'").

I've subscribed to Nalts' YouTube page and have been seeking out other videos he produced that might be relevant to the pharma world. Nalts' wildly popular "farting in public" video doesn't qualify as phrama related unless there is a drug for that; and for a drug to be developed for farting in public, some physician would have to give it a serious-sounding medical name like "Public Flatulence Syndrome" or PFS.

But enough about farting!

Today, I found a Nalts video in which he stepped out of his YouTube "Nalts" persona and spoke as the real Kevin Nalty employed by a fortune 100 company, which he does not name. In the video he speaks about a recent job review in which he was criticized for saying something derogatory about a co-worker (ie, another Merck employee, I assume).

"My boss quoted me in my review, which was otherwise very positive," said Nalts/Nalty, "and said that what didn't reflect well about my leadership was the following quote. I said about somebody we work with that he sucked away my will to live!"

"I agree that I probably shouldn't have said that about somebody I work with," admitted Nalty. "I kind of dig the guy now, but at that point [in time] he did suck away my will to live. Sometimes, you got to call it like it is."

"For the most part, people I work with are indifferent or oblivious of my video thing," Nalts admits in the video. "Hopefully, this video won't make it around the office." Whoops! Sorry, Kevin! As you said to me in a comment to the above cited post, "That's not me. That's my evil twin. ... I think this drama will roll over unless Mack gets a hold of it."

In closing, Nalts asks: "Who sucks away YOUR will to live?"

---

P.S. Nalty is scheduled to present at ExL Pharma's 4th Pharmaceutical Relationship Marketing & Sales Congress in Princeton, NJ, on Wednesday, May 20, 2009, at 2:15 PM. His topic is "How to Efficiently Acquire Qualified Consumer Leads For RM Programs." I hope to be there and have a chat with him.

This Survey May Have Influenced Pfizer's Decision to Offer Free Drugs to Unemployed/Uninsured

Advertising Age asks "Will Pfizer's Free Drug Program Give PR Lift to Big Pharma?"

As shown in the chart on the left (click to enlarge), almost 69% of all respondents to the Pharma Marketing News "How to Earn Back the Public's Trust" survey agreed that drug companies should "greatly expand their patient assistance programs to cover more people (eg, the unemployed)."

Even more interesting, 73% of PHARMA respondents agreed!

Thus, I truly believe that Pfizer employees were instrumental in convincing Pfizer to initiate its MAINTAIN program.

Now, Pfizer should address the other two recommendations from this survey's respondents: (1) be much more transparent in reporting clinical trial results, and (2) do more to promote comparative studies to prove the efficacy of prescription drugs.

Consumer Opinion Leaders: Pharma's Secret Sauce for Social Media Marketing

Lately there's been a lot of talk about pharma marketers "joining the conversation" about their products in social networks and blogs (see, for example, "Social Media: Ask Permission to Join the Conversation First or You Just Might Get Your Ass Kicked!").

However, I am not sure that joining the conversation in a completely transparent way is in the nature of pharmaceutical marketers. We only need to look at what happens in the "real world" of pharma-consumer (patient) interaction to understand how pharma is likely to approach online social networks.

The case of "Electroboy" (Andy Behrman) vs. Bristol-Myers Squibb (BMS) offers some insights. According to a story in the Wall Street Journal (see "A Celebrity Patient's Backing Turns Sour for Drug Company"):

"In 2004, Bristol-Myers held a retreat for 1,250 sales representatives, to prepare them to market a powerful psychiatric drug for a new use -- bipolar disorder.

"Pharmaceutical companies have taken to paying patients to help promote their products. In the case of Andy Behrman and Bristol-Myers, the relationship has backfired.

"A video of Mr. Behrman, a 42-year-old bipolar patient, filled a gigantic screen. He recounted how a Bristol-Myers drug, called Abilify, had changed his life. Unlike other medicines he had tried, Abilify had no side effects, he said. The testimonial drew a standing ovation.

"But Mr. Behrman says he had only taken the drug for four days before the video was filmed. He says he later experienced side effects -- including dazed spells and agitation in his legs -- unpleasant enough that he stopped taking the drug within a year. He says he eventually told several company employees privately about the difficulties he was having with the drug.

"Yet, he continued to talk glowingly about Abilify throughout 2004 and 2005, to sales representatives and other company employees, as well as psychiatrists hired by the company as consultants. In all, Bristol-Myers paid him $400,000."

Despite the fact that the relationship between BMS and Behrman backfired, hiring patients, consumers, physicians, and celebrities as spokespeople is still a favorite ploy of pharmaceutical marketers.

Until recently, PhRMA's "Guiding Principles for Direct to Consumer Advertisements About Prescription Medicines" did not address the use of paid endorsements. In the December 2008 revision, this principle was added:

Where a DTC television or print advertisement features a celebrity endorser, the endorsements should accurately reflect the opinions, findings, beliefs or experience of the endorser. Companies should maintain verification of the basis of any actual or implied endorsements made by the celebrity endorser in the DTC advertisement, including whether the endorser is or has been a user of the product if applicable.

This and the other principles, however, do NOT address the use of celebrities at live events or on the Internet. Nor does the "celebrity" principle apply to the use of ordinary citizens/patients who are not "celebrities."

Pharmaceutical companies are free to pay well-respected patient members of social networks to speak glowingly about their products in online conversations. Jacke Barrette, CEO of WEGO, calls these ordinary people who influence the opinions of others "Consumer Opinion Leaders" (COLs; see "WEGO Health: Empowering Health Consumer Opinion Leaders"). Malcolm Gladwell, author of the book Tipping Point, calls such people "Mavens."

COLs are pharma's "secret sauce" for social media marketing. COLs have the benefit of already being part of the "conversation," which neatly solves the marketer's problem of how to "join the conversation."

I imagine there are hundreds of patients out there on social networks who would gladly take thousands of dollars from pharmaceutical companies to be spokespeople as part of online branded drug or disease awareness campaigns. This may be going on right now and we'd never be the wiser -- unless, of course, another "Behrman" with grandiose ideas of his worth arises and tells all!

FTC is well aware of the trend and potential abuse of using COLs as paid spokespeople. On April 13, 2009, Advertising Age reported: "As part of its review of its advertising guidelines, the FTC is proposing that word-of-mouth marketers and bloggers, as well as people on social-media sites such as Facebook, be held liable for any false statements they make about a product they're promoting, along with the product's marketer."

Pfizer Employees Step Up to Help Fellow US Citizens! GSK, a British Company, Turns Away!

Remember the "erroneous" GSK press release that said the company was offering a 50 percent discount on meds for U.S. patients who are uninsured "no matter a patient's income level or whether he or she qualifies for public programs"? Well, GSK, a British company, retracted that promise and blamed "vendor error"(see here).

Pfizer, an American company, seizing a PR opportunity seldom seen in the annals of the drug industry, picked up the mantle and announced today that it will launch an innovative program (MAINTAIN) to help eligible unemployed Americans and their families who have lost their health insurance maintain access to their Pfizer medicines for free (see "Pfizer Launches Free Medicines Program For Newly Unemployed Americans").

Even more astonishing, Pfizer says the idea came from its employees! Employees proposed the idea of MAINTAIN to the company’s senior leadership team just within the last month, said the Pfizer press release. Pfizer employees also asked to be able to do their part by donating their own money to the program, and the Pfizer Foundation will match their donations.

Way to step up and help your fellow Americans Pfizer employees!

Imagine all the other great ideas drug company employees may have that are not heard! That's why I have always said that drug companies should get their employees to contribute to a blog and tell the world their hopes, dreams, and ambitions so that we can see the human face behind the company!

All Surveys Point to a Further Decrease in DTC Spending This Year

I am on record predicting that DTC spending will be "decimated" this year; ie, decrease by 11% (see "DTC Spending Will Be Decimated in 2009, Experts Say"). Compared to the 18% decrease for 2008, that's good news (see "DTC Ad Spending Decreased 18% in 2008. Worse Than Expected!").

There are several polls out there that suggest my prediction might be on the high side.

Forty-five percent (45%) of respondents to a poll I have been running on and off since November 2008 say DTC spending will decrease this year compared to last; Only 12%, however, agree with me and say it will decrease more than 10%. About 35% see spending increasing and an optimistic 22% see it increasing by more than 10%! Here are the results:

You can take this poll right now, add your prediction to the mix, and view the current results.

Predict DTC Spending Growth/Decline in 2009 compared to 2008
	Will grow more than 10%
	Will grow between 5% and 10%
	Will grow between 2% and 5%
	Will be about the same
	Will decline between 2% and 5%
	Will decline between 5% and 10%
	Will decline more than 10%
	I have no freaking idea!

Pharma Marketing News has been running its Future of DTC Advertising Survey since November last year. One question in that survey also asks respondents to predict how DTC spending in 2009 will compare to that of 2008. The results were reported in the January, 2009, issue (see "The Future of DTC Advertising: Is a perfect storm brewing?"; PMN Reprint #81-01) and are shown below:


In this PMN survey, about 55% of respondents see DTC spending declining this year (20% of respondents predict DTC spending will decrease more than 10%) and only about 24% see an increase in spending. You can take this survey here.

Finally, Cegedim Dendrite's 2009 Direct-to-Consumer Industry Check-Up shows a pessimistic trend:

In this study, the percentage of marketers saying they will decrease DTC spending rose precipitously -- from 28% in 2008 to 58% in 2009 (about 43% believe the decrease will be greater than 5%). That 58% is pretty close to the 55% in the PMN survey who also believe spending will decrease. Also, 25% of the respondents to the Cegedim Dendrite survey believe spending will increase compared to 24% in the PMN survey. The other numbers in these two surveys are pretty similar as well. It's almost as it Cegedim Dendrite copied the results of the PMN survey published in January!

BTW, regardless of what the experts say, I'm sticking to my prediction of an 11% decrease in DTC spending this year compared to last year.

Cheerios vs. the One-Click Rule: Are FDA's Priorities "Askew?"

Pharma advocates are all a-Twitter about FDA's recent Warning letter to General Mills regarding Cheerios, the breakfast food. FDA says the labeling on the Cheerios box makes unauthorized health claims, namely "you can Lower Your Cholesterol 4% in 6 weeks."

FDA said to make such a claim, General Mills must submit a New Drug Application (NDA) with clinical trial evidence to support that claim. In other words, FDA considers Cheerios to be a drug when it makes such claims:

"The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease," said the FDA letter. "Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application."

Well, all my Twitter pals are Twittering about this and Mark Senak (EyeonFDA Blog) thinks the FDA has its priorities "askew" because (1) FDA chose to issue a rare Warning Letter rather than an "Untitled" letter:

"When issuing a regulatory letter, the FDA has a choice - either issue a Warning Letter which suggests a violation is so serious that it creates a public health threat - or an untitled letter or notice of violation which suggests something annoying but less severe. Here, the FDA issued a Warning Letter. For Cheerios. Hello?" (See "FDA Issues Warning Letter on Cheerios - Priorities Askew.")

Senak also compares this FDA action with the 14 untitled letters it issued regarding a particular method of pharma search engine marketing (see "The 'One-Click Rule': Rant or No Rant?"):

"Yet," said Senak, "when FDA's DDMAC issued its infamous 14 letters on April 2 which suddenly declared the years' long practice of Search Engine advertising off limits to companies, the FDA removed from the search engine scene notices about drug treatments when a user is doing a health search about a particular condition. That means now, if you search on a term like 'diabetes treatments' as I did this morning, and you may see an ad that suggests that you can cure your diabetes naturally without drugs."

I agree that a Warning letter may have been overkill and that there is a problem when charlatans are free to claim cures with impunity (ie, nothing but "patient" testimonials and bogus clinical trials that have not been reviewed by the FDA). An example is the paid ad for "Natural Diabetes Treatmnt" seen in the screen shot below (click the image for an enlarged view):


When I click on "Natural Diabetes Treatmnt" I am brought to a site that claims "Lower your blood sugar, safely and effectively with absolutely NO SIDE EFFECTS !! GUARANTEED !!"

The other two top ads (in the #1 and #2 positions) are for Lantus.com and Junivia.com, two FDA-regulated products for the treatment of diabetes. One is produced and marketed by Sanofi-Aventis and the other by Merck. Both of these, by the way, are just one degree more balanced in its claims than is the "Natural Diabetes Treatmnt" ad.

Two out three is not a bad score for the pharmaceutical industry! and nobody should imply -- as Senak did -- that the FDA's warning letters to drug companies about search engine ads will result in a "public health threat" because it "takes the drug ads out of the search equation."

Senak's search example proves that drug search ads are not out of the equation.

Senak also claims that the FDA has "declared the years' long practice of Search Engine advertising off limits to companies." That simply is not accurate. The FDA declared a "certain" tactic off limits; ie, using the drug brand name in conjunction with the indication without including side effect information.

I do not think, therefore, it is accurate to portray the FDA priorities as being "askew." Rather, as Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest, said: "the agency is exerting its authority under President Barack Obama" (see here). This is something that everyone -- including Senak -- has wanted the FDA to do ever since it was hobbled by the Bush administration.

65% of Psychiatrists Say "NO" to Pharma on Facebook!

Psychiatric Times (PT), "the forum for the voice of psychiatry," is currently running a poll on its home page that asks readers a simple question:

"Do you agree that pharmaceutical companies should be allowed to join social networking sites, such as Facebook, to promote their products?"

So far, 65% of respondents say "No" and only 25% say "Yes."

Although there are not enough votes cast to make this significant, I am interested in following this poll as time goes on to see if the numbers change. You can find the poll here.

The readers of PT are predominantly psychiatrists (88% of approx. 39,000 subscribers), a group of physicians that up until now have received a lot of money from pharmaceutical companies to help promote new "medical conditions" such as "PGAD" (see "PGAD. EGAD! Another Syndrome/Disorder, Whatever!"). I assume the majority of poll respondents are psychiatrists too.

Of course, this poll allows respondents a great deal of latitude in interpreting the phrase "promote their products." Does this mean placing an ad in the right-hand column of targeted Facebook pages just like every other advertiser does? Does it mean Facebook pages devoted to products created by pharma marketers? Or does it mean pharma marketers posing as patients and posting comments praising products? I would say "No" to the latter, and say "Yes" to the first two. But I didn't have that option. Thus, I was among the 10% who were "Unsure."

And, there is no way of confirming that the majority of respondents are actually psychiatrists, especially now that I am promoting this poll here on Pharma Marketing Blog!

So, I'm sorry about the misleading title of this post. But it would be interesting to know what physicians (and patents) think of pharmaceutical companies engaging in their social networks. Yes, I know that Sermo polled its physician members and claimed that "more than 50% of [poll] respondents were in favor of having some kind of interaction with the industry" (see "Sermo CEO Talks About Pfizer Collaboration" and "Collaborating with Online Physician Communities"). That result, however, was based on only 89 responses -- a self-selected group of less than 0.3% of all Sermo members. According to Daniel Palestrant, M.D., founder and CEO of Sermo, the site also did "extensive focus grouping" to gauge their members’ preferences.

So as not to let a good opportunity to ask your opinion go to waste, I developed the How Should Pharma Engage in Patient/Physician Social Networks? Survey, which I hope you will respond to now.

End All Pharma Freebies to Physicians by Decree or Just Leave it at Caveat Doctor?

Has the time come for physicians to be forcibly weaned away from ALL pharma "freebies," including CME and drug samples? Or should the principle caveat doctor be emphasized?

An editorial in today's issue of Archives of Internal Medicine (Arch Intern Med. 2009;169[9]:829-831), a medical journal published by the American Medical Association, entitled "Time for the Medical Profession to Act," argues that it is time to prohibit pharma companies from providing free gifts, free meals, free CME, and free samples to physicians.

The author, Philip Greenland, MD, of the Feinberg School of Medicine (Northwesetrn University) points out that the new PhRMA Code on Interactions with Healthcare Professionals (see PMN Reprint #77-01) does not prohibit sponsorship of office-based or hospital-based meals, continuing medical education (CME) events, or "other forms of marketing contacts that are also exceedingly common."

"Eliminating small gifts without restricting other pharmaceutical company interactions (eg, industry-funded CME symposia and clinical trials) is unlikely to eliminate the substantial influence of drug company marketing on the practice of medicine," said Dr. Greenland.

Dr. Greenland calls for the prohibition of "all gifts [zero dollar limit], all meals, payment for time and travel at meetings, and payment for participation in online CME from drug and medical device companies to physicians."

In support, he cites research published in the same issue of the Arch Intern Med: "Effect of Exposure to Small Pharmaceutical Promotional Items on Treatment Preferences," which concluded that subtle exposure to small pharmaceutical promotional items influences implicit attitudes toward marketed products among medical students. We observed a reversal of this effect in the setting of restrictive policies and more negative school-level attitudes toward marketing" (Arch Intern Med. 2009;169(9):887-893).

"Many ... policy initiatives have been proposed to limit contact with and influence from drug marketing personnel, whether in the office, the lunch room, or at CME events sponsored by drug firms," said Dr. Greenland. "We believe (1) that the evidence is solid that these events are designed for the purpose of influencing and biasing the physician-patient interaction and (2) that these adverse effects are achieved as a consequence of the interactions. It is imperative that the profession police itself, or it is inevitable that government will step in and create a policing structure that will be punitive and require expensive oversight. Why are most of us still waiting? The evidence is clear, and the path is defined. It is time to act."

I'm not quite sure if Dr. Greenland is calling upon the AMA and other physician organizations to issue such policies or whether he is just talking about medical schools, hospitals, group practices, etc.

I support eliminating drug company interactions with medical students because -- as the study quoted above suggests -- they are susceptible to influence. I'm not sure, however, if the results of that study can be extended to apply to ALL physicians who are more experienced in dealing with pharmaceutical marketers and sales reps. I guess there are other studies that suggest practicing physicians are just as susceptible. Still, these physicians have lots of sources of drug information. Shame on any physician who depends 100% on the drug industry to keep up to date!

Of course, I would rather see the drug industry itself continue to evolve its marketing practices to live up to its own hype about providing unbiased education and service in support of good patient outcomes. There is also clear evidence in support of and a path defined for that approach.

Caveat Doctor
In closing, I quote Chris MacDonald, author of The Business Ethics Blog: "So go ahead, do business with [drug companies]," says MacDondald in a post entitled "Drug Companies Make Other Companies Do Stupid, Unethical Things," which I believe applies to physicians as well. "But be careful," MacDonald continues. "This way danger lies. Take precautions. Ask questions. Doubt what they say. Think twice. And if they suggest doing anything out of the ordinary, be super vigilant. Think carefully about whether you're being used, or manipulated, or drawn into something that is going to end in scandal. Because you probably are."

Some possibly related articles and posts:

• Side Effects | Are Doctors' Loyalties Divided?
• Should Free Drug Samples Be Banned?
• Free Drug Samples: The Sales Rep's Last Great Hope?
• Is Pharma Sponsored CME Biased?

Online Advertising Growth Slows in 2008, Search Declines in 2009

"US Advertising Continues to Imitate a Stone," says eMarketer. It was reporting on TNS data for measured media ad spending, which showed an overage decline of 9.2% for the fourth quarter of 2008 vs. the same quarter of 2007. BUT... "One bright spot in the TNS report was Internet advertising, which grew by 4.6% in 2008, but even that news was dimmed: That was the weakest full-year growth for online advertising since the dot-com bust of 2002."

Click for an enlarged view.
Meanwhile, search ad revenue, the bellwether of online advertising, decreased 11.5% in the first quarter of 2009 compared to the fourth quarter of 2008. And if not for Google, every quarter of 2008 would also have shown Q over Q decreases for this sector (see chart below).


“One takeaway from Google’s strength relative to the other three portals is the strength of search ad spending relative to display spending,” said David Hallerman, eMarketer senior analyst. “Even though Yahoo!, MSN and AOL all get some portion of their revenues from search, the weakness of the display market will continue to drag down total US ad spending results.”

Although there are some articles claim that pharma DTC ad money may be flowing into online social media (see Big Pharma Finally Taking Big Steps to Reach Patients With Digital Media"), based on the above data, I doubt that 2009 will see an overall increase in pharma ad spending online.

Meanwhile, 58% of respondents to the he Future of Rx DTC Advertising predict that overall DTC spending will decrease 2% or more in 2009 compared to 2008. What do you think? Take the survey here, learn more about it here.

Tamiflu, Relenza May or May Not Protect Expectant Mothers from Flu

In a Mother's Day New York Times Op-Ed piece, an Obygn physician and an bioethicist questioned whether the anti-viral drugs Tamiflu and Relenza are effective in easing H1N1 flu in pregnant women because neither of these drugs -- indeed, no drug -- has been tested for safety and efficacy in pregnant women.

"WHEN diseases like swine flu hit, pregnant women are especially at risk," said the authors. "And yet we know surprisingly little about how to treat them. In its guidelines for the antiviral drugs Tamiflu and Relenza, the Centers for Disease Control and Prevention says that pregnant women infected or at high risk for infection should take the recommended adult dosage: 'Pregnancy should not be considered a contraindication' to taking the drugs, because the benefits of treatment 'likely outweigh the theoretical risks of antiviral use.'"

Note the use of the term "theoretical risks" in the CDC statement.

The "Who should not take TAMIFLU" section of the drug's FDA-approved patient information leaflet (PPI) clearly states "Before starting treatment, make sure your healthcare professional knows if you take any other medicines, or are pregnant, planning to become pregnant, or breastfeeding. TAMIFLU is not normally recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are not known."

Practically every Rx drug includes the same warning.

Not mentioned in the PPI is the fact that Tamiflu's efficacy in pregnant women is also "not known" because the drug was not tested in pregnant women, which is the point made by the NYT Op-Ed authors.

These days, drug companies are asking consumers and physicians to weigh the benefits versus the risks of Rx drugs. The newly aired Celebrex TV commercials are a good example of this -- the entire ad is about weighing benefits against risks (see "Celebrex Ad: Let's Dive Deeper").

Unfortunately, pregnant women and breastfeeding mothers and their physicians simply do not have the data upon which to make an informed decision with regard to anti-viral treatment. And public health agencies are sending mixed messages: FDA says not to take Tamiflu (or Relenza) during pregnancy because the risks are not known, whereas the CDC says it's OK for pregnant women to take these drugs because the benefits of treatment "likely outweigh the theoretical risks."

As a result of animal studies, researchers have advised that "Tamiflu should be prescribed to a pregnant woman only if the case justifies the potential benefit of the fetus" (see "Tamiflu And Pregnancy - Can I Take Tamiflu During Pregnancy?"). Nothing about benefit to the woman.

"One pregnant woman in America has already died from the flu," said the Op-Ed authors. "Although other health problems complicated her illness, her death is a reminder that we need to understand how to medicate mothers-to-be. Research should be done now, while pregnant women are already taking antivirals. Studying blood samples from as few as two dozen women would get us a long way toward determining whether the standard dose is effective."

I could not determine if the woman who "died from the flu" was treated with Tamiflu or Relenza or neither. It depends upon whether her physicians followed CDC's or FDA's recommendations or just their own common sense. Whatever. They had not data to help them decide.

Social Media: Ask Permission to Join the Conversation First or You Just Might Get Your Ass Kicked!

My agency friend Wendy Blackburn (CORR: Jim Dayton; see comments) cited "an expert in marketing communications and PR strategy" who compared social media with a high school lunchroom in her post, "Social Media: It's Your Conversation."

"Social media is a lot like a high school cafeteria, each group with their unique interests sitting at their prescribed table discussing what's relevant to them," said Blackburn.

When the conversation turns to your product, Wendy advises pharma clients "it is your conversation. Whether you want to own it or not, it's yours."

Wendy provides good advice for how to engage in the conversation:

1. First, listen.
2. Second, learn.
3. Finally, answer.

IMHO, Wendy left out one important step: Asking permission to join as in "Mind if I join you?"

That, for example, is how Pfizer joined the Sermo discussion (see"Sermo CEO Talks About Pfizer Collaboration" and "Pfizer has a Gold Mine in Sermo!").

In the commercial e-mail world we have a rule called "double opt-in" to make sure that the recipient really intends to get bombarded by commercial e-mail. Double opt-in is kind of like asking for permission and making sure we have it.

Asking for permission should also be a rule for marketers wishing to join in social media discussions. Just as in a high school lunchroom, if you do not ask to join THEIR conversation, you might just get YOUR ass kicked!

When I attend industry conferences, for example, I always follow the proper social etiquette at the luncheon and ask "mind if I join you" when I select a table to sit at. Then THEIR conversation can become MINE.

Pharma marketers who wish to make someone else's conversation theirs should abide by the following rules, which I modified from Wendy's abridged list:

1. First, listen.
2. Second, ask permission to join.
   
3. Third, learn.
4. Finally, join in.

I'm sure Wendy would agree.

GSK, the "Erroneous" 50% Discount Promise, and Consumer Fraud

Wow! GSK just had a PR catastrophe!

FiercePharma and other online news outlets earlier today published a press release from GSK (originally distributed through PRWeb) that said the company was offering a 50 percent discount on meds for U.S. patients who are uninsured "no matter a patient's income level or whether he or she qualifies for public programs" (see archive here).

I immediately tweeted the news via Twitter and a few of my 1200 or so Twitter pals retweeted (RT'd) and a few of THEIR friends RT'd and so on. As a consequence, it appears that GSK was besieged by calls from consumers seeking more information.

Unfortunately, GSK says it was all a mistake!

According to FiercePharma (see here):

"A GSK spokesperson, as well as a PRWeb manager, contacted us to say that the release was published in error," said FiercePharma Editor Maureen Martino. "The release 'was a test publication which was accidentally distributed through PRWeb,' according to the manager. 'We are currently in the process of retraction for Comtex and TradingMarkets.com. Needless to say, GlaxoSmithKline is extremely unhappy about this.'"

You know who is also unhappy? All those consumers who need this price reduction, that's who!

In the "erroneous" press release, Deirdre Connelly, President US Pharmaceuticals at GSK, was quoted as saying:

"It's innovating to help people afford their medications. We are pleased to introduce our Prescription Cost Relief Card, which will help no matter a patient's income level or whether he or she qualifies for public programs. We feel this is simply the right thing to do, especially in this economy."

You may remember Deirdre from a previous post to Pharma Marketing Blog (see "Lilly's Connelly: The Diversity Issue") when she was working for Eli Lilly, I believe. Maybe she'll be out of a job soon herself and seeking help paying for HER medications! I hope not.

So, what is GSK doing? It's back pedaling, that's what! Referring people to its standard Patient Assistance Program, which while laudable, has a lot of restrictions. Many working uninsured people, for example, probably would not qualify.

The idea of offering a 50% discount to all uninsured US citizens is a brilliant one that, if GSK were to keep its promise, would win a lot of admiration from the public and raise awareness of the plight of the uninsured in this country.

Maybe the powers that be -- eg, insurance companies -- got to GSK and threatened to remove GSK drugs from their formularies. Or maybe GSK just was not ready to pull the trigger and it is telling the truth about a "vendor error." I don't know.

All I know is that an official public announcement was made by GSK that promised a deal to consumers of its products. Then that announcement was "withdrawn" due to some kind of "error."

Whatever! I think that GSK should live up to its initial promise or else this whole episode could be what the Federal Trade Commission (FTC) calls "consumer fraud."

What do you think?

If DTC Ads were Allowed in Picadilly Circus

The next big thing, according to some of my Twitter pals, is interactive billboard ads such as this one for McDonald's:

You get the idea...stand across the circle (ie, circus) and strike up an appropriate pose making sure your head is correctly aligned with the action in the ad. Voila! you've got a nice souvenir shot to send home! Uh, I mean post on your FaceBook page.

Now imagine if the UK allowed direct-to-consumer (DTC) advertising of Rx drugs and Pfizer created the first interactive billboard ad for Viagra! Here's my vision of how it might look with someone posing in front -- I can't show you the animated version. Just imagine the Viagra pill growing larger and larger until it reaches the size shown.



I added a little more innovation by including a celebrity endorsement of a sort in an adjoining ad space.

New Sales Force Effectiveness Maxim: "Never Be Closing"

The ABC of sales, according to Alec Baldwin in the movie Glengarry Glen Ross, is "Always Be Closing." Baldwin's character -- Blake -- is from "downtown" (ie, headquarters) and he won't hear about "weak leads" as an excuse for not selling real estate in Florida to retire folk. See the scene in the YouTube clip at the end of this post (WARNING: Explicit language!).

Tuesday, I attended eyeforpharma's Sales Force Effectiveness USA 2009 conference in Princeton, NJ and I heard about some evidence that closing skills may not be that important for pharmaceutical sales reps who "sell" to doctors that are definitely not retired!

Two presentations at this conference impressed me: one about "Getting Control of Email" (see Pharma Sales Rep "Hamsters" Waste Time on Email Treadmill) and the other entitled "The Race for Doctors' Minds. Factors that Drive Sales Rep Success." I'll focus on the latter in this post. The presenter, whose name I won't mention here without his permission (I call him MR Guy), was a market research manager at a subsidiary of a major healthcare/pharmaceutical company.

MR Guy presented some results from his doctoral thesis, which tried to determine what was the ideal balance between "soft skills" and "hard skills" that sales reps should have in order to be successful.

Soft skills were what MR Guy called Emotional Intelligence (EI), which included things like listening skills and dressing and behaving in a professional manner. Hard skills (or Consultative Selling Skills, aka CSS) include knowledge of the product, the medical condition it treats and, of course, closing skill.

[I won't go into the methodology of MR Guy's research here. I hope to cover this in more detail in a future article for Pharma Marketing News.]

Before presenting the findings of his PhD thesis, MR Guy polled the audience of about 75-100 and asked them which from a list of sales rep characteristics had the most influence on physician satisfaction. The results are shown in the chart (supplied by Meridia Audience Response) below (click on it for an enlarged view). The product brand name and specific medical condition are de-identified in the chart reproduced here.


While closing (poll choice "Asked you to prescribe/recommend (BRAND)") was not the audience's top choice, it was #4 out of 10 and far more popular than many of the "soft skill" characteristics such as "Follows up as requested," for example.

In contrast, MR Guy's thesis top 4 results were as follows:

1. Makes good use of my time (EI skill): 51%
2. Knows about the brand's market (CSS skill): 17%
3. Able to answer my questions (EI skill): 15%
4. Behaves in a professional manner (EI skill): 10%

Closing was not among the top five choices in MR Guy's research.

Note on Closed-Loop Marketing
"Follows up as requested" was the #5 choice.

This is a good argument for implementing a "closed loop" sales effectiveness/marketing solution. However, that does not mean trying to implement a technical solution such as using a touch screen computer to present sales aids and seeing which route the physician takes through the screens.

The best closed-loop marketing technique, according to MR Guy, "may be a simple follow-up call." The rep can use sticky notes as reminders or a program on her notebook computer -- whatever system she/he is comfortable with.

At lunch, I heard some criticism of technology-driven closed loop marketing: implementation is a bitch! My lunch mates suggested it may take up to 5 years to fully implement such a system, by which time technology will have advanced so much as to make the solution out of date. For an idea that may be easier to implement and will never go out of date, see "Closed-Loop Marketing: A New Role for eDetailing"; PMN Reprint #73-04).

Back to the study and closing...

MR Guy also studied what sales rep characteristics were most important for getting the physician to prescribe the product being promoted. All other things (both EI and CSS skills) being equal, if one rep asked for the business (closed) and one rep did not, would the "closer" be more successful in selling the physician?

The majority of the audience response (68%) chose the closer, whereas MR Guy's thesis study said it made no difference whether the rep closed or did not close.

MR Guy pointed out, however, that you cannot conclude from this study that closing is not impactful. He did not measure, for example, the "quality" of the closing. A member of the audience suggested that a good sales rep could subtly be "closing" all throughout the sales call. I guess that person took Mr. Blake's point of view: Always Be Closing!



P.S. Coincidentally, someone called me yesterday to ask me some questions about pharmaceutical sales jobs. She had sales experience in another industry and was going on a interview for a pharma job today. She was worried if pharma sales reps were under a lot of pressure to make quotas. She just couldn't take that kind of stress. I didn't ask her if she had brass balls, which Blake in the above video clip assured his salesmen were necessary to close the deal.

Kevin Nalty, Merck Marketing Director, Exposed as "ADHD Boy!"

Merck dermatology marketing director Kevin Nalty has a side job: as a YouTube comedy star, says Jim Edwards over at BNET Pharma. Edwards displays Nalty's talent using the following "sophomoric" farting in public video, which has received about 7 million views so far.



"Until this week," said Nalty, "'Nalts' [Nalty's YouTube personna] has had no association with Merck. But the MediaWeek story 'outed me.' I don't do videos about Merck, and generally keep my online persona far from my day job."

Nalty may not do videos about Merck, but he did at least one video spoofing adult ADHD, a medical condition that one pharmaceutical company thinks is serious. I used this video, entitled "ADHD Boy," in the post "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!" back in October 2008. Little did I know then that the star of that video was a Merck marketing director! While it's still available, take a look at this video:



In contrast to the "Farting in Public" video, "ADHD Boy" has been viewed only about 100,000 times so far!

I missed Nalty's presentation at the ePharma Summit in January. Otherwise, I would have recognized him right away and "outed" him myself!

"My engagement in social media is helpful to understanding how pharma can play appropriately in this critical space," said Nalty. It remains to be seen, however, if Merck thinks videos like "ADHD Boy" is an appropriate use of space by one of its pharmaceutical marketing directors! For the record, I hope they do!

Pharma Sales Rep "Hamsters" Waste Time on Email Treadmill

According to Mike Song, former pharmaceutical sales rep and author of the book "The Hamster Revolution," pharmaceutical companies can cut the time that sales reps spend receiving, reading, and responding to e-mail by 20%. Since sales reps may spend up to 88 eight-hour working days per year on e-mail tasks (21,120 msgs X 2 minutes per msg = 88 hours), that means 18 days per year per sales rep are wasted.

Song made this claim at the eyeforpharma Sales Force Effectiveness USA 2009 conference, which I attended yesterday. He also gave out free copies of his book.

Presenting along with Song was Schering-Plough's Director of Learning and Development whose company benefited from Song's tips that he summarized in a presentation entitled "Get Control of Email! Driving Sales Force Effectiveness with Email Productivity Training."

Here are some of Song's tips:

• Do not automatically click on "reply to all." The list may grow exponentially as other people add to it. (Song cited a survey in which 91% of respondents say that their colleagues often overuse "reply to all." Yeah, but I do not do that!)
• Use NRN ("No Reply Needed") or NTN ("No Thanks Needed") in subject line. (87% of respondents to that survey previously mentioned say they often receive unnecessary e-mail. And 25% actually resent being thanked!)
• Use action words in subject line. These include "Info," "Request," "Confirmed," and "delivery."
• If the subject line IS the message, place "EOM" (End of Message) at the end so that the receiver doesn't waste time by opening up the email.
• Apply the "newspaper test." "E-mail is a public medium," warned Song. You can be sure there is a copy stored somewhere that has not been erased. So, be careful what you say.
• Strengthen the subject line, sculpt the body. You'll have to read the book or listen to my podcast interview, which I plan for the near future, to learn more.

Best piece of advice: Use a phone. In that survey, 80% of respondents said they or their colleagues often use email when the phone would be better.

Usually, all kinds of expensive and difficult to implement technology "solutions" to the "problem" of sales force effectiveness are promoted at SFE meetings. Song's solution was refreshingly non-technical and a no-brainer. Despite that -- or maybe because of it -- Song had the most people surrounding his "non-booth" (a round-top table in the farthest corner of the exhibit area; no sign, no fancy brochures; just a few books) trying to talk to him.

The next time-wasting technology sales reps may have to deal with is Twitter! Also social media sites like Cafe Pharma.

Academics Exaggerate, Journalists Regurgitate. What About Bloggers?

Thanks to my Twitter colleagues, I came across two disturbing pieces of information concerning healthcare journalism in the US.

The first was a WSJ Health Blog post about an Annals of Internal Medicine study of press releases that academic medical centers send out about their research (see "Academic Medical Centers Often Guilty of Research Hype"). The conclusion: The press releases "often promote research that has uncertain relevance to human health and do not provide key facts or acknowledge important limitations."

The second was a March 2009 Survey of American Health Care Journalists (AHCJ), which found -- among other things -- that just under half (44%) of staff journalists participating in the survey say that their organization sometimes (34%) or frequently (10%) bases stories on news releases without substantial additional reporting (see "State of Health Care Journalism").

Hence, my synopsis: "Academics Exaggerate, Journalists Regurgitate"

Only 39% of AHCJ members surveyed feel that the quality of the U.S. news media’s coverage of medical research is “excellent” or “good” (see chart below).

A couple of other key findings:

• A majority of respondents (52%) say there is too much coverage of consumer or lifestyle health, and too little of health policy (70%), health care quality (70%), and health disparities (69%).
• Nearly nine in ten (88%) survey respondents think health care coverage leans too much toward short “quick hit” stories, and two-thirds (64%) say the trend toward shorter stories has gotten worse in the past few years.
• Nearly half (48%) think health journalism in the US is going in the wrong direction.

Do "citizen" journalists (ie, bloggers) do a better job?

It's an important question because more people may read health-related blogs than read traditional news media. Health bloggers include journalists, of course, but many are also ordinary citizens (eg, patients) as well as professionals with ties to the pharmaceutical and healthcare industries. If anything, bloggers may have more bias than traditional journalists and be more susceptible to influence.

If what I just said about health care bloggers is true, then the decline in the quality of health journalism will not be offset by the rise in health "bloggerism."

Quality Healthcare Social Media: Separating the Wheat from the Chaff

"The more things change, the more they stay the same."

That's how I feel these days when the "newbies" talk about guidelines for the use of social media in the healthcare arena.

Back in the day -- 1997, to be precise -- I, along with Denise Silber (@health20paris), Gilles Frydmann (@gfry), and others, founded the Internet Healthcare Coalition to develop ethical guidelines for developing credible, quality health information on the Internet (Web 1.0 version).

In 2000, I published a summary of the Coalition's mission statement in the Journal of Medical Internet Research (see PubMed entry here). I reproduce that article below and substitute modern day social media/networking rhetoric where appropriate in red text as if I were editing it today for a new Social Media Healthcare Coalition:

As individuals take a larger role in managing their own healthcare, more consumers are independently seeking out health information via the Internet [social networking and other Web 2.0 applications]. Health professionals are also turning to the Internet [social networking and other Web 2.0 applications] to keep informed and interact with their patients. Given the vast amount of healthcare data available on the Internet [social networking and other Web 2.0 applications], the Internet [Social Media] Healthcare Coalition was created to promote quality health resources online and to ensure that consumers and professionals are able to find reliable, quality information online.

The Coalition is an international, non-partisan, non-profit organization dedicated to promoting quality healthcare resources on the Internet [social networking and other Web 2.0 applications]. Founded in 1997, the Coalition's membership represents every sector of the Internet [social media] health space, including consumers, patient advocates, commercial developers of health information, health professionals, medical librarians, government officials, and pharmaceutical manufacturers. The goal of the Coalition is to educate healthcare consumers, health professionals, and others about the evolving issues relating to the quality of Internet health resources and information.

The Coalition is dedicated to:

• Educating healthcare consumers, professionals, educators, marketers, and both healthcare and mainstream media, as well as public policymakers on the full range of uses of the Internet [social networking and other Web 2.0 applications] - current and potential - to deliver high-quality healthcare information and services.
• Furnishing clear models, not only of good and bad sources of online [social networking and other Web 2.0 based] healthcare information and services, but of the potentially disparate methods of evaluating disparate sources of information - from product- or disease-information sites developed by regulated manufacturers, to peer-reviewed electronic publications and patient support groups, [to consumer generated content].
• Publicizing and promoting the use of currently available resources and developing new resources that exemplify ethical, innovative, and high-quality uses of the Internet [social networking and other Web 2.0 applications] to deliver healthcare information and services.
• Acting as a representative of our constituencies in areas of mutual concern before public policymakers and with the media.

The Coalition consults with various government agencies including the World Health Organization (WHO), the US Food and Drug Administration (FDA), and the US Federal Trade Commission (FTC) on broader-based efforts to promote credible healthcare information and combat health fraud online. To that end the Coalition formed an Internet Health Fraud Resources Working Group which will work with the FTC to develop, coordinate, and promote a global online health-fraud reporting web site, which will link to authorities with jurisdiction over illegal or fraudulent online healthcare activities. Using this resource, consumers and healthcare professionals anywhere in the world can be sure that their complaints are transmitted to the appropriate authorities for action.

The Coalition holds an annual conference, "Quality Healthcare Information on [Social Media Sites] the Net," each year in October or November for key thought leaders in the healthcare industry and government representatives to exchange their thoughts and opinions about the problems associated with and solutions to healthcare and the Internet [Social Media]. In October 1999, responding to calls from within the Internet Health community, the Coalition launched its ongoing "eHealth Ethics Initiative" to provide a forum for the development of a universal set of ethical principles for health-related Web sites.

The Coalition created ethical principles for quality Internet health information, which formed the basis of at least one major and ongoing health web site accreditation program (see URAC's Health Website Standards). I still have the computer mouse shaped crystal commemorative award for participating in URAC's Health Website Advisory Committee in 2000-2001. As we used to say in NYC, "that and 15 cents will get you on the subway" (a NYC subway ride costs about ten times that now!).

Recently, Shwen Gwee, Med 2.0 host and founder and Lead Business Analyst of Health Informatics and New Media for Vertex Pharmaceuticals, launched Social Pharmer, a social network for "anyone interested or involved with social media in the pharma and healthcare industry." It's fitting that Shwen chose Ning to build the Social Pharmer site, a Web 2.0 application that allows anyone to set up a social network.

Prior to that, Shwen organized the Social Pharmer "unconference" (see "Report from the Social Pharmer 'Unconference': Sowing Seeds of Social Media Change?" PMN Reprint #84-04). To organize the "unconference," Shwen relied almost exclusively on Twitter to get the word out! The idea for the Ning site came from that meeting.

For me this is deja vu all over again. In 1996, I organized an "unconference" to discuss ethical use of the Internet for healthcare using a listserv e-mail discussion group, which was the greatest social networking technology at the time. [An aside: I wonder how many people still use listserv today and how many people will be using Twitter ten years from today?]

Aside from focusing on Web 2.0 health applications, Social Pharmer and Internet Healthcare Coalition share many things in common such as those I just mentioned. Similar sorts of people have also been involved in starting both movements.

There is, however, one unfortunate difference, which is apparent in the names and mission statements of the two grassroots movements. Social Pharmer is obviously driven by the needs of the pharmaceutical industry and their agents (ie, ad agencies, consultants, web sites that depend on pharma advertising, etc.). This focus is inherent in the very name and in the short description quoted above.

It's fine to have Social Pharmer. We definitely need fda-approved pharmaceutical and other healthcare company information to be trusted by consumers on social networks and that is the appropriate goal of Social Pharmer. But maybe we also need to bring into the discussion other constituents -- especially consumers and healthcare professionals. And the discussion should be focused on IMPROVING the QUALITY of healthcare information provided via social networks, no matter WHO is providing that information.

I noted that a NYC subway ride costs 10 times today what it cost when I was a kid. And it's worth it -- it has great value.

Can we say that the quality of health information on social networks -- especially the information that is user generated -- is 10 times the quality of health information we used to get, and still get, from accredited Web 1.o health sites? I don't think so.

Very few people are willing to admit that, for the most part, user-generated content is NOT high quality. To be sure, there is high quality information out there, but it exists within a vast wasteland (same with Twitter messages). Are the social media tools up to the task of separating the wheat form the chaff?

The first question is: How do we define the "wheat" or high quality user-generated information? Does the "wisdom of the crowd" guarantee the sort of high quality information that is necessary for improving health?

Swine Flu Duck and Cover. We've Come a Long Way Baby!

1950 Civil Defense Film:


2009 CDC Video:


Wow! I am amazed at the increase in production quality. We sure have come a long way!

Confession of a KOL: The Perverse Effect of Conflict of Interest Disclosure

"I was also wrong about disclosure," said James Stein, MD at a University of Wisconsin conflict of interest seminar (see video here). Dr. Stein, a cardiologist, was proud to list all his drug company affiliations on his CV in the 90's and admitted he liked the money he got from being on their advisory boards and speakers' bureaus.

"I really felt that if I stood up in front of a crowd and said these are my disclosures, look how honest I am, that I was really managing conflict of interest. The literature tells me it [has] the opposite effect. Although its laudable to disclose your relationships [with drug companies] ... it actually has the perverse effect. The recipient of your information becomes more trusting. Also, professionals who disclose become more biased. That's the perverse effect of disclosure."

The good doctor drew chuckles from the audience when he said "The solution isn't disclosure. If you are doing something that's wrong or unethical, don't disclose it. Just don't do it!"

That's the problem, of course, physicians who disclose do not think they are doing anything wrong or unethical. It's the one who DO NOT disclose who believe they have something to hide. In both cases, Dr. Stein's words are falling on deaf ears.

Listen to the whole 16 minutes here.

Hat Tip: PharmaGossip