Saturday, May 30, 2009

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.

Friday, May 29, 2009

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.

Thursday, May 28, 2009

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 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!

Wednesday, May 27, 2009

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...

Tuesday, May 26, 2009

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 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

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.

Sunday, May 24, 2009

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

Saturday, May 23, 2009

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.

Friday, May 22, 2009

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!

Thursday, May 21, 2009

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:


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!

Wednesday, May 20, 2009

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
  

Tuesday, May 19, 2009

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.

Monday, May 18, 2009

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."
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