Thursday, April 30, 2009

Social Media: Opportunity or Nightmare?

There’s nothing like a little FDA letter writing campaign to stir the pot! Yes, I’m talking about the 14 letters FDA sent out on April 2, 2009, informing 14 pharmaceutical companies that their paid search ads violated FDA regulations regarding fair balance. That really stirred the simmering Internet guidelines pot that many people want to bring to the front burner!

To mark this special occasion, the April 2009 issue of Pharma Marketing News is focused on social media, patient empowerment (which is powered by social media), and the constraints of regulation.

Paid search ads are old school compared with social media marketing. I can’t help but wonder what kind of trouble pharmaceutical marketers can get into when they really delve into social media. Is the FDA right now working on letters that address current social media activities?

FDA regulation of drug marketing via the Internet in general and social media in particular is a hot topic at industry conferences. Next month I will be participating in a panel discussion on social media hosted by the PharmaSIG of the Philadelphia American Marketing Association (PAMA). The topic will be “Pharmaceutical Marketing Within Today’s Social Media Culture - Opportunity or Nightmare?” (see here for more information and to register).

This Could Be Hell!
Michaelangelo’s nightmarish painting Last Judgement includes the image of a poor soul being dragged down to Hell by the devil’s agents. That image often comes to mind when I hear proponents of social media trying to persuade pharma marketers to just “dip their toe” in the social media waters. The other image I see is a shark lurking just below the water’s surface!

There is no doubt, however, that social media and net-working are becoming integral parts of our society and a growing resource helping consumers manage their own healthcare. Where these consumers lead, pharma is sure to follow.

Here’s some data I received from Michele Aranda (Weyth), who is helping organize the PAMA panel discussion:
  • Social Media sites are the fastest growing category on the web--doubling their traffic over the past year (ComScore, 2008)
  • A single word of mouth conversation has the impact of 200 TV commercials (Buzz Agent, 2008)
  • 34% of adult online users (54 million people) in the U.S. said they have connected to others or to the content others created online about health and wellness issues in the past year ("Online Health: Assessing the Risk and Opportunity of Social and One-to-One Media," Jupiter Research, 2007 )
  • 72% of people use social media sites "all or some of the time" to educate themselves about specific medical conditions (iCrossing survey via Greenfield Online, 2008)
  • Nearly half (47%) of online consumers report that user-generated content has at least some impact on their health or prescription treat-ment decisions (Manhattan Research, 7th ePharma Consumer survey, 2008)
  • The average person can share health information with a 50-person network within 30 days (“Influencers and Health Advertising", MedTrackAlert and Interactive Media Studies (IMS) Program at Miami University in Oxford, Ohio Study, 2007)
Source: iCrossing, How America Searches Health and Wellness, January 2008. Click to enlarge.

Pharma marketers are navigating uncharted territory in the social media space. They are just starting to experiment with Facebook pages, corporate blogs and YouTube but they are faced with unknown risks. Regulations have not kept up. When DTC is addressed in DDMAC or PhRMA documentation, the channels discussed are limited to traditional broadcast (TV and Radio) and print. Marketers and regulatory professionals are being forced to apply regulations based on their own ad hoc interpretations.

Should We Go Public?
In the article “Developing Guidelines for Pharma’s Use of the Internet & Social Media” (PMN Reprint #84-01), a case is made to initiate a public process to inform the FDA about social media prior to issuing guidance. Many people feel that informed guidance from the FDA is better than regulation via warning letters.

Many pharma marketers within drug companies and within agencies that work for drug companies are trying to move the needle forward to develop guidelines that the industry can follow. So far, however, they have left patients, physicians and other stakeholders out of the discussion. They have forgotten that patient empowerment built the very social networks that they wish to engage in. Personally, I believe pharmaceutical companies need to become truly patient-centric companies BEFORE they can even consider engaging in social media. And they have a long way to go before they get there.

Don’t Forget the Patient!
The article “The Empowered Patient: What It Means for Pharma” (PMN Reprint #84-02) is a review of a presentation made by Reinhard Angelmar, Professor of Marketing at INSEAD, at the recent eyeforpharma SFE Europe 2009 conference held in Barcelona, Spain. Angelmar makes a case for the drug industry to adopt a patient-centric model in which pharma companies can develop unique expertise in decoding the behavior, needs, motivations of patients. Without a patient-centric focus such as Angelmar suggests, pharma marketers will have little success engaging consumers and patients in social media even if they have FDA guidance and guidelines out the wazoo!

Doctors Too!
Not only will empowered patients radically change pharma marketing and sales, so will doctors who are engaging in social networks, according to a LinkedIn survey by Len Starnes, Head of Digital Marketing & Sales General Medicine at Bayer Schering. Starnes spoke at the recent ExL Pharma Digital Pharma Europe conference.

While experts predict that social media will have a great effect on pharmaceutical marketing, many of us view the drug industry as being “social media challenged.” That’s the view, at least, of contributing author Erik van der Zijden--entrepreneur, marketing professional, new media evangelist and self-styled "autodidactic techno-nerd." His article, “Socially Challenged Pharma” (PMN Reprint #84-03), is a summary of the Digital Europe conference. To support van der Zijden’s thesis, I added recent data from the "Social Media Pharma Marketing Readiness Self-Assessment Survey," which has been hosted online by Pharma Marketing News since December 2007.

To overcome the challenges, proponents of social media pharma marketing are busy collaborating. For example, Shwen Gwee, Lead Business Analyst of Health Informatics and New Media for Vertex Pharmaceuticals, organized the Social Pharmer “Unconference” in which attendees heard from and interacted with some great speakers and vowed to continue the discussion online. Amber Benson, Group Strategy Director for IMC2’s Health & Wellness practice, summarizes key presentations made at this “unconference” (see “Report from the Social Pharmer ‘Unconference’”; PMN Reprint #84-04).

So far, we do not know whether social media will be an opportunity or a nightmare for the pharmaceutical industry. It may be both! Out of adversity comes opportunity. But the one piece of advice that I’d like to leave you with is what was said at the Social Pharmer unconference: Be careful what you wish for.

Wednesday, April 29, 2009

50 Ways to Use Social Media

Sung to the tune “50 Ways to Leave Your Lover” by Paul Simon

"The problem is all inside your head", FDA said to me
The answer is easy if you take it logically
I'd like to help you in your struggle to be AER free
There must be fifty ways to use social media

FDA said it's really not my habit to intrude
Furthermore, I hope my meaning won't be lost or misconstrued
But I'll repeat myself, at the risk of being crude
There must be fifty ways to use social media
Fifty ways to use social media

You just Tweet the right way, GSK
Make a new Blog, Janssen-Cilag
You don't need to be coy, Daiichi Sankyo
Just get yourself free
Hop on the bus, Novartis
You don't need to discuss much
Just drop the key(word), Lilly
And get yourself free

Ooo slip out the back door, Bayer
Make a new plan, Allergan
You don't need to be wiser, Pfizer
Just listen to me
Hop on the grid, Orchid
You don't need to discuss much
Just drop the search ad, Gilead
And get yourself free

FDA said it grieves me so to see you in such pain
I wish there was something I could do to make you smile again
I said I appreciate that and would you please explain
About the fifty ways

FDA said why don't we both just sleep on it tonight
And I believe in the morning you'll begin to see the light
And then FDA sent me a warning letter
Boy, that didn’t make me feel any better!
Still, there must be fifty ways to use social media
Fifty ways to use social media

[See here for some REAL ways to use social media; warning, not all of these may be FDA friendly.]

The Swine Supply Chain: Food, Drugs, Disease

If Off-label Use of Anti Swine Flu Drugs are OK, Why Aren't Reminder Ads that Lack Fair Balance Also OK?

This week, the world is all a-Twitter about the outbreak of Swine Flu. Two stories caught my attention:
  • FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans, and
  • MedImmune Cited for FluMist Reminder Ad
You can find the FDA press releases here and here, respectively.

In the first case, FDA is allowing vaccines to be used to treat populations (ie, children as young as 1 year) or to be "distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs" (eg, without a physician's prescription and by volunteers). This applies to Relenza (GSK) and Tamiflu (Roche).

Previously, FDA had issued a MedWatch warning regarding pediatric use of Relenza (see here). And previously FDA added an "abnormal behavior" precaution to the Tamiflu label (see here).

FDA noted that its Emergency Use Authorization of off-label use of Relenza and Tamiflu was made possible by Project BioShield, which became law in July 2004 (see "Bioshield Boondoggle").

This is a classic case of balancing PUBLIC health benefit versus PERSONAL risk. That is, some small segment of the population may be at increased risk, but the general public may benefit. This would be a great topic for another discussion.

Right now, however, I would like to talk about drug advertising, which is the focus of this blog.

In the second FDA action mentioned above, Medimmune, the pharma company that makes and markets Flumist, was cited for a "reminder ad" that violated FDA regulations. "Specifically," said FDA, "the 'FluMist Now Available' advertisements make such representations or suggestions about the use of FluMist, they are not considered reminder advertising and, therefore, are required to contain a true statement of information in brief summary relating to side effects and contraindications."

It's odd that this FDA action against a Flumist ad campaign was reported today by FDANews Drug Daily Bulletin. The date on the FDA "Violative Advertising and Promotional Labeling Letter" is February 23, 2009, which is probably the date the letter was sent to MedImmune. At the bottom of the Web page where this letter is reproduced, however, I find this: "Updated: April 24, 2009." That's probably the date that FDA made this public or posted the letter to its site. That probably triggered the FDANews report I received by email today.

The FDA's timing of publicizing these actions causes me to think about the role of drug advertising during "health emergencies" such as this outbreak of Swine Flu.

If the FDA has authority to dispense with label requirements and allow off-label promotion of two anti-Flu medications, shouldn't it also relax its restraints on broadcast and paid search reminder drug ads? Specifically, should the FDA allow Reenza, Tamiflu, and Flumist ads that mention the product name and what it treats WITHOUT the otherwise necessary listing of risks? After all, it has dismissed the risks to allow off-label use of at least 2 of these products.

Reminder TV ads can be produced quickly and at low cost and inform a large segment of the population -- at least let them know about the availability of treatments. This might be useful in a health emergency.

PhRMA's DTC guidelines, however, prohibit reminder TV ads. Even so, maybe PhRMA should give GSK and Roche dispensation allowing them to run reminder ads. (Medimmune, which obviously has NOT signed on to those "voluntary" guidelines, needs no dispensation.)

What about paid reminder search ads?

When I search Google for Relenza or Tamiflu, I find ads sponsored by Canadian pharmacies that claim "Protect Yourself from Swine Flu" (see below). If GSK or Roche sponsored these ads, the FDA would surely cite them as being violative, especially after it already cited 14 companies for running such ads back on April 2 (see "The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!").



Luckily, in this case, the brandname drug sites are top of the list in the natural (unpaid) search results, so this may be a moot point. But allowing third parties like Canadian pharmacies to get top billing on search pages AND to make outlandish claims such as "Protect Yourself from Swine Flu" doesn't seem right. What do you think?

Tuesday, April 28, 2009

Is UW's Smoking Cessation CME Course Effective Promotion of Chantix?

I generally believe that, on balance, the drug industry gets pretty good press. That is, there are more favorable stories about Rx drugs (especially new drugs) than unfavorable stories. Unfortunately -- as most PR people will tell you -- it takes an average of seven favorable stories to counteract one unfavorable story.

An unfavorable story about Chantix appeared in yesterday's Milwaukee-Wisconsin Journal Sentinel. The story, entitled "Ads, class ignore drug's downside," was about Pfizer's support for a smoking cessation continuing medical education (CME) course offered through the University of Wisconsin-Madison.

The article claims "None of the side effects are mentioned in the UW continuing education online course, which is paid for by Pfizer. The course directly mentions only Chantix as a first-line treatment, even though the drug is one of seven first-line treatments, according to national guidelines."

There are several problems with this. First of all, I found it difficult to believe that a CME course would mention any drug by brand name as this article implied was done in the UW course. Luckily, I was able to pose as a doctor and register to take the course. The relevant section of the course that mentioned drug treatment options is shown below (please click on it for an enlarged view).

As I suspected, only the generic or scientific names of drugs are used. There is no mention of "Chantix," only "Varenicline," which is the scientific name.

It is true that none of the other first-line drugs approved for smoking cessation was mentioned and the course did not mention side effects. The Clinical Practice Guideline, which the course suggested time and again that I review, does include extensive information about side effects.

The article starts out with "A Pfizer promotional campaign for the controversial drug Chantix - which includes financing a course for doctors through the University of Wisconsin-Madison - has helped the drug dominate the prescription smoking-treatment market while burying mention of its serious side effects."

I suppose the CME course could be part of Pfizer's plan to make physicians more aware of Chantix, and perhaps the ads do not mention the serious side effects that the journalist who wrote this article wished they would mention: "such as suicidal behavior and blackouts." Unfortunately, the FDA does not require Chantix ads to mention these "unproven" side effects, which are "under investigation."

The article also focuses on the amount of money Pfizer has donated for CME at UW: "UW's smoking cessation course is being paid for as part of a $3.5 million grant from Pfizer."

At first, I thought this meant that the entire $3.5 million was spent on this one course, which so far has been taken by 100 physicians plus me. That would mean $35,000 to promote Chantix to each of the 100 physicians who have taken the course to date! Of course, that is ridiculous. Especially when any Tom, Dick, or John (Mack) can register for the course. It would be a lot less expensive to send a sales rep to see each of the 100 doctors 10 times!

But how much of that $3.5 million grant was used for this course?

According to the article, "At UW, drug companies spend about $13 million a year to fund its doctor education courses..." I looked at the CME course catalog (here) and found about 24 courses listed. If each course received an equal slice of the pharma funding pie, then the smoking cessation course would have gotten about $550,000. That means Pfizer has paid ONLY $5,500 per "doctor" taking the course so far. That's still a lot more money than would be needed to send sales reps to each physician ten times!

It seems to me that this kind of CME is not as effective a promotional tool as this article would like us to believe. If every pharma company spent its promotional resources like this, they would all be bankrupt!

Monday, April 27, 2009

Science, College Undergrads Agree: Adderall is Da Bomb for Performance Enhancement!

Finally, all those college kids who have engaged in the ADHD stimulant drug (Adderall, Ritalin etc.) black market on campus have had their anecdotal evidence vindicated by a scientific study that proves that Adderall, et al helps students score higher on tests! This was reported by Reuters (see "Children who get ADHD drugs score higher on tests").

If you think this study was funded by the drug industry, you are wrong. "The study was government-funded and did not have links to companies that make the drugs," claims Reuters.

Strangely, a subhead of the article states "Tutoring, parental involvement also called key elements." Whew! For a minute I thought all my dinner discussions with and rewriting of essays for my sons were in vain!

However, the article included no data to support the parental influence claim. All we have is this quote from Richard Scheffler of the University of California, Berkeley, one of the researchers: "Drugs are part of the answer. But we need parent involvement, understanding what this is and how to work with the kid. We need the school to be involved. We also think that special services like tutoring need to be made available."

I mean, this sounds more like a personal opinion than a fact backed up by data.

In fact, this is strangely reminiscent of the statements often made by the drug industry in its drug promotions as in "along with a healthy diet and exercise," etc. Just kind of an afterthought to ease our consciences. "We're not promoting drugs as the answer. But we did find medication does improve standardized math and reading scores in the long term," said Scheffler.

Meanwhile, ponder these data (source: The NSDUH report).

Friday, April 24, 2009

Pharma Agency Awards for Web 1.0, None for Blogs or Other Social Media

There were two major awards events in the past week. The first was the 2009 DTC National Advertising Awards presented by DTC Perspectives Magazine at the conference of the same name held in Washington, DC on April 15 to 17 (see results here). The second was the Manny Awards presented by Med Ad News on April 22 (see press release here).

Neither of these awards had a category for Best Social Media Campaign or Agency despite all the recent focus on social media by drug industry agencies at industry conferences and on Twitter (see, for example, Social Pharma Unconference).

The Gold winner in DTC National's "Best Digital Media Campaign" category DID go to a "social media" campaign; ie, Gardasil Facebook Fan Page: Take a step against cervical cancer, but I would hardly call that a "truly social" social media campaign. Despite the fact that there are over 100,000 fans of the page, the wall contains only ONE comment, which was submitted by the Merck agents and not a fan. In fact, I see no way that I or any other fan can submit a comment!

That's the way it is with pharma's use of social media - it's false (see "Faux Social Marketing: Have Your Cake and Eat It Too!").

I am not a fan of awards, as you may know. Traditionally, trade publications give out rewards to their best advertising clients or do not necessarily reward what's really important. The Gardasil Facebook campaign reward, for example, did not reward Merck's agency for creating a truly interactive social media site that carried on a conversation with its fans. The only thing "social" about it is that it's on a social media site. It could just have well been any web site.

A really useful pharma marketing/advertising reward category, IMHO, would be "Best Truly Social, Social Media Campaign." I think that would help pharma companies compete to create actual useful conversations with consumers and patients online.

What about it DTC Perspectives, MM&M, Med Ad News? Will you do that? Or do you believe, like the FDA does, that social media is just another form of media not needing any special consideration?

If these prestigious publications do not take up my challenge, perhaps I once again will have to take up the slack and do it myself via Pharma Marketing News!

Better idea! Instead of writing a white paper, maybe the attendees of the Social Pharma "unconference" should develop this award program. What do you think?


Should there be an award for Best "truly social" Social Media Pharma Campaign?
Yes, great idea!
No way, we got enough rewards!
Whatever, maybe, couldn't hurt

Thursday, April 23, 2009

Is Pharma Socially Challenged?

Stacy Reese, Associate PRA Director at AstraZeneca, speaking on "Managing the Risks Associated with Online Discussions” at CBI's 8th Annual Forum on eMarketing for the Pharmaceutical Industry noted that when the FDA is doing more than pharma companies with social media, "we need to figure out how to get in there."

But Erik van der Zijden, author of an article to be published in the April 2009 issue of Pharma Marketing News (see preview here), thinks pharmaceutical companies are socially challenged.

In fact, many pharmaceutical marketers may have this view of the challenge posed by social media compared to that of Internet 1.0:

What Good Can Come from a Public FDA Hearing on Social Media?

"The reality of that actually happening is very small..."

"Does the public even want to talk with pharma companies?"

"If the FDA opened hearings to the public they would get an earful of what they don't want to hear or acknowledge..."

"Another reason the FDA is not going to get into social media as a marketing tool is that the evolution of social media is continuing at a very fast pace..."

"...at this time I'm sure the FDA wants to try and head to calmer waters."

"With an anemic forecast for pharma sales for 2009 and more layoffs expected I also can't see pharma hiring more people to manage online social media initiatives."

Wow! Fellow blogger Rich Meyer really dissed my call for a public hearing hosted by FDA on use of social media (or Internet in general) by pharmaceutical companies in his post "Why the FDA will not conduct a public hearing on social media."

[See my call here: "FDA, Tear Down This Wall! A Draft Petition Calling for a Public Hearing"]

Never mind that 88% of respondents to a survey agree that before issuing any draft guidance on the use of the internet by pharmaceutical companies, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns. That includes 63% who "strongly agree." Even 56% of US Pharma respondents strongly agree!

What Rich fails to see is that the pharmaceutical industry is getting into social media marketing whether consumers want a conversation with pharma or not. And the industry is devising its own guidelines behind closed doors WITHOUT any input from patients, consumers, physicians, or other stakeholders.

And whether or not the FDA wants to hear it or will even develop guidelines for the industry, a public hearing will inform them, the drug industry, and ourselves about how the public views pharma's entry into THEIR world!

I will also remind Rich that the last time the FDA held a public hearing on the Internet a lot of good came from it even though the FDA did not issue specific internet guidelines.

One result of that hearing was the birth of a grassroots coalition I helped organize to develop a set of ethical principles guiding the use of the Internet for health information.

But because the FDA did not issue specific guidelines left the drug industry able to read the tea leaves and come up with their own interpretation of what was within regulations and what was not. The folly of that was demonstrated when the FDA issued its "14 letters."

Rich is right that the Internet is evolving at a very fast pace. But that is NO reason not to have a public hearing. In fact, it is the BEST reason to have such a hearing now. Only the FDA can do this in order for the results to be heard round the world. All our little Tweetups and white papers won't amount to a hill of beans because it is just the industry and its agents speaking for the public, not with the public!

Wednesday, April 22, 2009

How to do Social Media Pharma Marketing without Getting Blown Up

That's my re-interpretation of Josh Bernoff's presentation "How to do a social application in life sciences without getting fired" at yesterday's Social Pharmer Boston Unconference organized by @Shwen.

Bernoff is the co-author of the book "groundswell - winning in a world transformed by social technologies" and is Vice President and Principal Analyst at Forrester Research.

Bernoff's title speaks to corporate politics. My re-interpretation tries to bring in the target audience of marketers -- especially consumers and patients. If not approached correctly, SM denizens can really "blow up" any marketer's carefully laid plans to engage them in conversation.

Stuart Foster, an attendee of the SocPharm unconference, summed up Bernoff's presentation in his blog post:
"It came down to this: Your customers are going to talk and you can provide the space or you don’t. But conversation will continue with or without you. It’s just harder to facilitate once ball gets rolling in order to launch self serving community.

"Josh then laid out the basic model of: Consumers want to help. Pharmaceuticals want to help. FDA in the middle."

Benoff's presentation, which you can find here, includes the following graphic to illustrate his concept of FDA blocking pharma companies from connecting with consumers and physicians via social media:


This image resonates with my previous post, "FDA, Tear Down This Wall! A Draft Petition Calling for a Public Hearing."

Neither Bernoff nor I expect the FDA to get completely out of the way. I think we are in agreement that the FDA must show pharma a clear path around the wall, which should only inhibit the "bad guys" from getting through. Right now, however, some "bad guys" have a clear path to social media to promote all sorts of elixirs and worthless information about dangerous products.

How can FDA help pharmaceutical companies provide useful, balanced product information via social networks? Guidelines, guidelines, guidelines! Guidelines are the path around the wall.

But there are many possible paths around the wall -- not just any path will do. It must be the correct path and especially a path that EMPOWERED PATIENTS -- part of the groundswell that INVENTED social media -- decide is appropriate or at least acceptable. Consumers want to help, but not if they are kept out of the loop when it comes to developing the ground rules of engagement.

That is why I believe a PUBLIC HEARING that will include patient advocates and other stakeholders is important BEFORE FDA and the drug industry decide among themselves what the path will be.

If guidelines are developed with input from all stakeholders, the drug industry will begin its journey around the wall and find the citizens there greeting them with flowers, not roadside bombs!

SURVEY: Should FDA Convene a Public Hearing on Use of Social Media by Pharma?
SURVEY: Should FDA Convene a Public Hearing on Use of Social Media by Pharma?

Tuesday, April 21, 2009

Thanks to My Twitter Pals I Donate $50 to Nothing But Nets!

Last week I decided to test the power of Twitter to advance social causes by offering to donate $50 to a charity if I had 1,000 followers by Monday morning. I encouraged people who were already following me to "retweet" (aka RT) my message so that THEIR friends/followers would see it and possibly continue the retweet chain throughout Twitterdom.

Several of my friends DID RT and Xavier Petit, an ePharma Pioneer Club member, even pledged to match my contribution.

Currently, I have 985 followers and although this is short of the goal I set, I decided to make the contribution as a thank you to everyone who helped me out and also because it was the right thing to do.

The charity I chose was Nothing But Nets, which is a grassroots campaign to save lives by preventing malaria, a leading killer of children in Africa. It uses donations to buy anti-malaria bed nets. My $50 donation will buy 5 nets.

I got the idea when Ashton Kutcher challenged CNN to become the first Twitter user to reach one million followers. At stake was a pledge from the winner to donate 10,000 anti-malaria bed nets. Kutcher won!

Perhaps I should have challenged Xavier, but I am glad he volunteered to match my donation. Of course, I didn't reach my goal, but I still hope Xavier will donate his $50 anyway.

Here's part of the receipt from Nothing But Nets just to allay any skepticism. After all, nobody really knows what you are doing just by following you on Twitter!

Gardasil Sales: One $ Less (out of three)

Merck's cervical cancer vaccine, GARDASIL, posted total sales as recorded by Merck of $262 million for the first quarter of 2009, a 33 percent decline from the same quarter in 2008 (see "Merck Worldwide Sales Decrease 8%"). This continues the same decline in sales reported in October 2008 for the July/August 2008 v 2007 period reported by IMS (see here). Thus, this current decline cannot be considered seasonal and may not even be related to the bad economy.

It is speculated that as more girls get the shot, its remaining market declines. Merck must target increasingly larger populations (see "Merck's Goal: 'One Less' Gardasil Marketing Problem").

Recently, Gardasil ads re-appeared in TV, which is obviously an attempt to maintain sales or prevent further decreases.

Will this marketing succeed?

TV ads can only increase awareness in the general population. Perhaps there are some women out there who are not aware of Gardasil or who need another reminder about its benefits. But unless and until Merck gets approval for a larger patient population -- it is seeking FDA approval to market Gardasil to women through age 45 -- no amount of marketing can overcome a sustained 33% decrease in sales.

Monday, April 20, 2009

Want to See Adverse Events of Drugs You are Taking? Try This Site

New to me is the site FDAble, which says it is "A fast, simple search engine for all drug and vaccine Adverse Event information reported to the FDA."

I entered these search parameters: "Drug Names: viagra OR sildenafil AND Reaction Names: death AND the outcome of the event was DE AND the person reporting the event was MD"

I got 140 hits. Is that a lot?

I'll leave it up to you to search for yourself and report back to me.

Cialis Ads Make a Splash, But Sales are Down

Although Lilly's profits rose 23% primarily due to a 27% decrease in sales costs (see "Eli Lilly Profit Rises 23%"), "Q1 sales of Cialis, Cymbalta, Zyprexa, Humalog, Gemzar all DOWN from Q4 to Q1," reported CNBC Pharmaceuticals Reporter Mike Huckman on Twitter (see @mhukman).

Meanwhile, Lilly continues to spend hundreds of millions of dollars on DTC (direct-to-consumer) advertising for Cialis, its erectile dysfunction (ED) drug.

According to IndyStar.com, "Cialis was the seventh-most-advertised drug in the country in 2007, with $152 million spent."

Although sales of Cialis are down recently -- possibly reflecting less discretionary income spending on life-style drugs during this recession -- Cialis is catching up to Viagra. Worldwide sales of Cialis last year increased by 26 percent, to $1.4 billion, and Cialis commands nearly one-third of the U.S. market for ED drugs.

The IndyStar article tries to attribute all this good news about Cialis sales to DTC ads for the product, but neglects to mention the recent decrease in sales despite the continued presence of these ads on TV. In fact, the advertising for Cialis seems to have increased over the last several months.

Perhaps the decrease in Cialis sales Q1-2009 v. Q4-2008 would have been much worse were it not for the advertising, which leads me to wonder if cutting back on DTC advertising during a recession is a good idea for pharma companies. Alas, we can never be sure what influence DTC advertising has on sales.

Sunday, April 19, 2009

FDA, Tear Down This Wall! A Draft Petition Calling for a Public Hearing

FDA, tear down this wall! The wall between pharma and the Internet.

For too many years the FDA has neglected to issue guidance to the pharma industry on how it will enforce its regulatory authority over Internet-based promotions. Instead, FDA seems to depend entirely on formulating policy by issuing warning letters. In contrast, FDA has often issued specific guidance with regard to TV and print advertising.

The FDA defends its lack of Internet guidance by saying that the same principles apply to the Internet as apply to other media. That argument is not rational nor is it an extension of how the FDA treats other media, such as broadcast TV.

The FDA, for example, has long recognized that there are limitations inherent in a 60-second TV commercial that required it to issue guidance on how to comply with fair balance regulations when using that medium. Similarly, there are limitations inherent in a 70-character Google adword. Yet the FDA refuses to issue any specific guidance for the use of adwords by pharma marketers.

Let's continue to focus on adwords as just one specific example of how lack of guidance from the FDA has caused problems.

Without specific guidance from the FDA, pharma marketers came up with their own rules for how to use adwords and remain compliant with FDA regulations. One such "rule" was the one-click rule. The recent issuance by FDA of 14 letters against that practice, however, proved how slippery the slope is when pharma marketers are left without specific guidance on what's acceptable and what's not acceptable on the Internet (see here).

Now, pharma marketers have come up with another "rule" or work-around: the use of "redirect" URLs in adwords (see here). The question remains, however, how will FDA interpret this practice in the future? Is FDA right now drafting warning letters against this practice?

There are probably many other examples that could be cited demonstrating how the Internet is unique from other media and deserves special guidance from the FDA. This is especially true when considering Web 2.0 applications such as social media.

We may not know all the possible unique ways in which pharma marketers can get into regulatory gray areas on the Internet. It's possible that the FDA itself cannot foresee all these gray areas. Maybe that's why it is reluctant to issue guidance.

Lack of knowledge of new technology and how it is being used by consumers, pharmaceutical marketers, health professionals and other stakeholders should NOT be an excuse for FDA's lack of guidance in this area.

That is why it is necessary for the FDA to convene a PUBLIC HEARING where ALL stakeholders can participate in a discussion of the issues and provide the FDA with a good understanding of the Internet as it exists today and tomorrow. That understanding and knowledge can then be the basis for issuing guidance that will allow the pharmaceutical industry to contribute to the conversation online.

More and more patients are seeking health information online and through social networks of their peers. Guidance from the FDA on the use of these media by pharmaceutical companies will help empower these patients with accurate information from manufacturers rather than relying upon unsubstantiated claims made by anonymous online sources.

It is proposed, therefore, that the FDA convene a public hearing similar in structure to the public hearing it convened in 1996 (see FDA and Internet). At that hearing dozens of experts were organized into several panels and participated in Q&A sessions with representatives from the FDA and attendees. Panelists included representatives from organizations such as the following:
  • Advertising Agencies
  • Consumer Advocacy Groups (eg, AARP, Public Citizen, etc.)
  • Health Web Sites
  • Interactive Media Agencies
  • Legal Firms
  • Medical Communications Companies
  • Medical Journal Publishers
  • Medical Journalists
  • Pharmaceutical Companies
  • Physician Organizations (eg, American College of Cardiology)
  • State Attorneys General
  • Technology Companies
Any public hearing today would have to include health and medical bloggers and other citizens engaged in social media that reaches out to patients and consumers. It would also have to include technology companies that did not exist in 1996 (eg, Google!).

Only through such a diverse group of stakeholders can the FDA get a well-rounded picture of the importance of the Internet -- and especially social media -- in improving the health literacy and well-being of patients. That is the best basis upon which to develop draft guidance for use of the internet by pharmaceutical marketers.

Survey Results Support Call for Public Hearing Involving ALL Stakeholders
(N=120)

Saturday, April 18, 2009

Health Literacy Worse Where There is DTC Advertising than Where There is No DTC!

One of the issues raised at the recent DTC National conference in Washington, DC was the impact of direct-to-consumer (DTC) advertising on health literacy.

Mark Senak -- blogger at EyeOnFDA, who participated in a panel discussion -- raised the ante on DTC's educational merit and suggested that we "Look abroad (where there is no DTC), and measure the health literacy to see the potential impact" (see these tweets).

I did some research and found a report that compared health literacy in the US (where there IS DTC) and in Canada (where there is no DTC advertising). The report, entitled "Health Literacy in Canada," cited research that used the same point system as the US to measure health literacy in Canada and compared it's results to the US data:

"Canadian men outperform their American counterparts by roughly 12 points. Canadian women outperform their American peers by roughly 15 points. These differences are larger than the differences in the underlying cognitive skills such as literacy and numeracy, which raises questions about the underlying causes of the differences and their impact on population health."

This was summed up in the chart on the left.

So much for DTC improving health literacy!

Proponents of DTC advertising often defend it by saying that it is educational. Does this data destroy that argument?

Not necessarily. There is a difference between health literacy and being "educated" about a drug. DTC proponents may need to place an asterik next to "education" in their argument about the utility of DTC so we all understand that they mean the latter and not the former.

Wednesday, April 15, 2009

New FDA Data: Adverse Event Reporting Increases Dramatically

The FDA received nearly half a million (496, 412) adverse event reports (AERs) in 2008, which is nearly a third (32%) more than it received in 2007 (376,902). By comparison, the 2007 number was only 20% higher than the 2006 number.

The definition of "adverse event" for both nonprescription drugs and dietary supplements is "any health-related event associated with the use of a [nonprescription or dietary supplement] that is adverse" (see source). This could include any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease, and, more seriously, death.

The chart below shows AER data from the FDA for the period 1998 through 2008, as updated on April 6, 2009.

Click on image for an enlarged view.

"These data," says FDA, "describe information about the reporter – the person who submitted the report to FDA, or the person who submitted the report to the manufacturer (who then sent the report to FDA). Physicians and pharmacists are the healthcare providers (HCP) who submit reports to FDA most frequently. Other Healthcare Providers include nurses, dentists and others. Consumer refers to any reporter who is not documented in the report as a healthcare provider. This figure includes only data where reporter information is known, and some adverse event reports may contain more than one reporter."

Why did the number of AERs increase so dramatically in 2008?

"Other Healthcare Professionals" may be partly responsible for the increase. AERs submitted by this group increased by 47% in 2008 v. 2007 (data not shown but available here). This compares to a 27% to 33% increase in AERs received from other reporters.

The FDA's use of technology to reach out to the public (see "FDA's Use of Social Media"; PMN Reprint#83-03) may also have made it easier to submit adverse event reports.

Whatever the cause, the drug industry is concerned and often cites AERs as a major reason why it has not engaged in social media as aggressively as it could.

But adverse event reporting requirements are just the tip of the iceberg that is the barrier to pharmaceutical use of social media for healthcare marketing and communications. For more on that and some ideas for overcoming this barrier, listen to this ePharma Pioneer Club roundtable discussion (podcast).

Tuesday, April 14, 2009

Viagra Boxers: An Example of Proto-Nostalgia tchotchke

"[Pfizer] has initiated an internal investigation following the dispatch to GPs of pairs of boxer shorts, bearing a Pfizer logo to mark the tenth anniversary of the erectile dysfunction medication Viagra in Ireland," reports IrishTimes.com ('Viagra boxers' to GPs cause quite a stir).

"One GP who received the boxers said he 'hadn’t had such a good laugh at a time when there weren't many opportunities to do so', while another said she had no intention of returning the item and only regretted that a Viagra-equivalent for women wasn’t on the market."

I searched and searched Google to see if I could find an image of these boxers online, but was unsuccessful.

I did find, however, a site that sells T-shirts, boxers, and thongs emblazoned with "I (heart) Viagra."

The image on the left is my interpretation of how a Viagra-logoed thong might look.

Here's the catalog description of the actual I (heart) Viagra thong:

"Panty-minimalists love our casual thong that covers sweet spots without covering your assets; putting an end to panty-lines. This under-goodie is 'outta sight' in low-rise pants. Toss these message panties onstage at your favorite rock star or share a surprise message with someone special ... later."

"Surprise message" indeed! I'm not sure how a man might receive that message coming from his partner just before sex.

Although Pfizer claimed “This should not have occurred and only did so through the poor judgment of a Pfizer employee,” it did not explain why Pfizer would create boxers embossed with the Viagra logo and who the intended audience was if not physicians.

The boxers may have been part of Pfizer's left-over "tchotchke" inventory that the company distributed to its employees rather than shred for scrap (distribution of tchotchkes -- free gifts -- to physicians is now forbidden by PhRMA's guidelines; also forbidden in Europe).

Perhaps drug-industry logoed tchotchkes will become nostalgia items in the future, reminding pharmaceutical sales reps of the "good old days."

Monday, April 13, 2009

Twitter Lobbying Effort Calls Upon FDA to Convene a Public Hearing

The effort to get the FDA to hold a public hearing on the use of the Internet and social media for the promotion of drugs and medical products has moved onto a new stage: Lobbying legislators via Twitter (called "twilobbying").
"John Mack's Saturday blog post, http://pharmamkting.blogspot.com/2009/04/fdas-actions-speak-louder-than-its.html, calls on the FDA to hold a public hearing on the use of the Internet and social media for the promotion of drugs and medical products," says KrÅ« Research. "This is an excellent and reasonable request. And I’d make one other suggestion, send a tweet to all the Senators and Congressmen and women who are on Twitter. Maybe they 'get' social media better than the FDA and will see the sound reason of a request for a public hearing."

"Get the full list of legislators on Twitter here: http://www.congressional140.com/tweeting.php. Send them this tweet, 'FDA acts against Pharma on e-marketing, yet offers no guidelines! Please force public hearing. Details: http://tinyurl.com/cwqfza'"
Survey Results
Meanwhile, a survey of nearly 100 pharmaceutical professionals reveals that a vast majority of respondents are in favor of the FDA convening a public hearing before issuing draft guidance and respondents are divided about issuing draft guidance for public review ONLY after consulting privately with pharmaceutical companies (see chart below, click on it for an enlarged view).


Respondents included representatives of the following companies:
  • KC Healthcare Communications
  • Devine + Powers
  • Group DCA
  • Cline Davis & Mann
  • AMS Inc.
  • SMI Health Media
  • Thomson Reuters
  • Fleishman-Hillard Clinical Trials Division
  • Trusted.MD Network
  • Good Health Advertising
  • Dr. Reddy's laboratories
  • KnowledgePoint360 Group
  • HyGro Group, Inc.
  • e-Healthcare Solutions
  • BioPharma Advisors
  • GSK
More details of the survey results will be published in the April 2009 issue of Pharma Marketing News. You can still take the survey and give me your opinions. After you complete the survey, you will be able to see the summary yourself. No comments or other identifying information is included in the summary. Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.

TAKE THE SURVEY HERE

PhRMA Supports a Public Process But Stops Sort of Calling for a Public Hearing
During a recent roundtable discussion (listen to podcast here), Jeff Francer, Assistant General Counsel, PhRMA, said:
"We just want to echo what [Mr. Mack] said, which is it would be helpful for the FDA to have some sort of public process about a guidance document. Without commenting on specific enforcement actions, it's clear there's some lack of clarity by companies and it would benefit public health, it would benefit public policy to have a public dialogue especially given the fact that the public is going to the Internet for healthcare information and that there are so many studies that report significant under diagnosis and under treatment of serious diseases in the United States. So that’s why we want to echo your call for a public process."
PhRMA should issue a public statement and clarify what it means by "some sort of public process." Usually, the pharmaceutical industry is more comfortable with FDA using a process that includes consultation with the industry and then issuing draft guidance subject to public comment. That, IMHO, is not adequate because the NEW FDA should embrace a more transparent process. A public hearing that is simultaneously streamed live to the Internet would be much more inclusive, transparent, and eduactional.

Sunday, April 12, 2009

Botox: Medicine's Answer to Duct Tape

“We see it as a molecule that keeps on giving. As we understand it more, it gives us new ideas of how to use it,” says Dr. Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker (see NYT: "So Botox Isn’t Just Skin Deep").

"In the hunt to discover the next blockbuster medical use for Botox, doctors have injected it experimentally into muscles and glands all over the body, making it medicine’s answer to duct tape," says the New York Times. "According to recent medical journals, physicians have used it to treat chewing problems, swallowing problems, pelvic muscle spasms, drooling, hair loss, anal fissures and pain from missing limbs."

Of course, these are all off-label uses of Botox, meaning that the FDA has not approved the marketing of Botox for these purposes.

But now, with the poor economy, and sales of Botox for approved cosmetic uses down, off-label uses of Botox "are poised to outstrip the cosmetic treatment in both revenue and prominence."

No wonder that Allergan has not signed on to PhRMA's DTC advertising guidelines and continues to run "reminder ads" (see "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway").

BTW, it isn't likely that Allergan will EVER want to get official FDA approval for ANY of the above-mentioned uses of Botox. Can you imagine what the reminder DTC ads might look like for "drooling" and "anal fissures?" Wait..hair loss. That one MAY be possible!

Saturday, April 11, 2009

Redirect URLs in Adwords: Who Knew What When?

In previous posts, I discussed the use of "redirect" URLs in Google adwords for pharmaceutical product websites (see The Next FDA Concern May be the Use of "Redirect" URLs).

This practice is USUALLY forbidden by Google policies: "Your display URL must accurately reflect the URL of the website you're advertising," says this policy. "It should match the domain of your landing page so that users will know which site they'll be taken to when they click on your ad."

It appears that Google has granted pharmaceutical companies an exception to this policy AND has been doing so for a number of years:
"We just heard back from Google this morning," said Jeff Hill of MedThink Communications. "Their 'policy board' ruled that they will make an exception just for pharmaceutical companies and allow non-branded URLs in paid search ads to be redirected to branded websites."

"For years it has been standard practice for Google to make this exception for our pharmaceutical clients," said Eileen O'Brien of Compass Healthcare Communications.
This raises more questions than it answers:

If Google was making this exception for years, how come so few experts knew about this? Many members of the ePharma Pioneer Club that I've been talking to, at least, had not heard of this and like Jeff had to call Google to confirm it.

Was Google making exceptions on a case-by-case basis up 'til now, but now is making the exception the rule for ALL pharma?

If some pharma companies were already taking advantage of the exception, why didn't the 14 companies cited last week by the FDA do it? It's hard to imagine that not a single one of these companies would NOT have known about the exception to the rule that O'Brien claims was going on for years.

If the 14 companies KNEW that Google would give them an EXCEPTION, then what was their motive in using the brand name in the adwords if they could have used a redirect URL instead? Did they knowingly use the "one-click" rule -- which everyone knew was not a rule at all -- as an excuse to get an extra bonus by linking the brand name to the benefit WITHOUT including the risks?

Did the FDA know that pharmaceutical companies had the option of using redirect URLs in their ads? If so, the FDA may have said to itself, "These guys could have easily used a redirect URL but they decided to use the brandname URL instead. Let's show them that we are not dummies and quash this practice right now!"

Many questions...not the least of which is the use of redirect URLs at best a bad user experience and at worst false advertising? That's a question raised by Robert Kadar of GoodHealthAdvertising.com



Follow me and see the reaction to this on Twitter...

Thursday, April 09, 2009

St. Google Slays the FDA Dragon?

There once was a dragon -- called FDA -- much feared by the citizens of the tiny pharma e-marketing community.

The dragon usually made its nest in TV or print land, but it soon devoured all the denizens of those places and decided to build its nest in Internet land where many pharma e-marketing citizens were wont to do business.

Soon the dragon lashed out and prevented the good pharma e-marketing citizens from doing business as usual in the search engine district of their village. The citizens tried to placate the dragon with user fees, to no avail.

All feared that the dragon, if allowed to get his way, would ruin all business, everywhere in Internet land.

Then there appears Saint Google on his travels. The citizens beseech St. Google to help them rid their land of the dragon.

"I cannot allow this beast to ruin business in the search engine district or anywhere else that I hold sway in Internet land!," he cried.

St. Google then faced the dragon, and protecting himself with the sign of the "one-click rule," slays it -- or at least thwarts its plans to prevent the pharma e-marketers from doing business in the search engine district -- by declaring "redirect" URLs OK in pharma marketing adwords!

From then on, all the pharma e-marketing citizens felt safe and were able to place their adwords all over Internet land!

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This story is based on the rumor swirling in Twitterville that Google has created an official exception for paid search for Pharma and URL redirects. See The Next FDA Concern May be the Use of "Redirect" URLs and follow me and see the reaction to this on Twitter...

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FOLLOW UP

It appears that Google has granted pharma this exception AND has been doing so for a number of years:

"We just heard back from Google this morning," said Jeff Hill of MedThink Communications. "Their 'policy board' ruled that they will make an exception just for pharmaceutical companies and allow non-branded URLs in paid search ads to be redirected to branded websites."

"For years it has been standard practice for Google to make this exception for our pharmaceutical clients," said Eileen O'Brien of Compass Healthcare Communications.

This raises more questions than it answers:

Was Google making exceptions on a case-by-case basis up 'til now, but now is making the exception the rule for ALL pharma?

If some pharma companies were already taking advantage of the exception, why didn't the 14 companies cited last week by the FDA do it? It's hard to imagine that not a single one of these companies would NOT have known about the exception to the rule than O'Brien claims was going on for years?

If the 14 companies KNEW that Google would give them an EXCEPTION, then what was their motive in using the brand name in the adwords if they could have used a redirect URL instead? Did they knowingly use the "one-click" rule -- which everyone knew was not a rule at all -- as an excuse to get an extra bonus by linking the brand name to the benefit WITHOUT including the risks?

Did the FDA know that pharmaceutical companies had the option of using redirect URLs in their ads? If so, the FDA may have said to itself, "These guys could have easily used a redirect URL but they decided to use the brandname URL instead. Let's show them that we are not dummies and quash this practice right now!"

Many questions...



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The Next FDA Concern May be the Use of "Redirect" URLs

FDA's recent "untitled" letters notifying 14 pharmaceutical companies that their search engine paid search ads violate FDA regulations (see "The 14 Letters. Who at the FDA Knew What and When?") has opened a can of worms that is rapidly becoming a snake pit for pharmaceutical marketers. FDA's actions and the resultant analysis by bloggers, ad agencies, and consultants has opened several questions about the current search engine marketing practices of pharmaceutical companies.

On example concerns the use of "vanity" or "redirect" URLs in Google adwords (paid ads). According to Wikipedia "URL redirection, also called URL forwarding, domain redirection and domain forwarding, is a technique on the World Wide Web for making a web page available under many URLs."

There are good and legitimate reasons for using redirection, but when used in a paid search ad for an Rx product, redirection is always used to mask the fact that you will be going to a branded Rx site.

As Robert Kadar of GoodHealthAdvertising.com says in a comment to my previous post, "your example does seem to violate Google rules but they obviously have made an exception for Pharma as a large percentage of pharma brands are masking the url's of their brand sites with generic names like depressionhurts.com [which takes you to www.cymbalta.com]. I believe that at the minimum this is a bad user experience and at worst is false advertising."

Usually, as I pointed out in yesterday's post, Google does not allow redirect URLs in adwords. Google's public policy states: "Your display URL must accurately reflect the URL of the website you're advertising. It should match the domain of your landing page so that users will know which site they'll be taken to when they click on your ad."

It appears, however, that Google has carved out an exception to this policy to allow pharmaceutical marketers to create adwords that mention the drug's benefits WITHOUT having to include the drug name as would be the case if the URL accurately reflected where the consumer would be sent if he or she clicked on the ad.

Consumer might be "fooled" into thinking they were going to an independent site and NOT to a pharmaceutical company site. Would they be harmed? Probably not.

But another commenter to my post, enkil76, pointed out that this practice may be another sort of "one-click rule" destined to cause trouble for pharma: "Is this like the one-click rule? At this point, I would say [FDA] haven't been enforcing a rule. What says tomorrow they won't?"

GOOD QUESTION!

Tomorrow's FDA might not be as friendly to pharma as today's FDA is:



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Wednesday, April 08, 2009

PhRMA Says FDA Should Initiate a Public Process Rather than Regulate by Warning Letter When it Comes to the Internet

"FDA should initiate a public process, which could take the form of a meeting or draft guidance, rather than regulating by warning letter in an area where there is now a lack of clear standards," said Jeffrey K. Francer, Assistant General Counsel, PhRMA.

His comment was made during a recent 45-minute ePharma Pioneer Club conference call that I hosted. Several other ePharma Pioneer Club members, including Fabio Gratton, Jonathan Richman, Rich Meyer, and Rob Nauman were also on the call and had comments.

The subject of the call was Overcoming Barriers to Pharma's Engagement in Social Networks. I expect a podcast audio archive to be available shortly.

Meanwhile, here are the opening comments I made during the call:
As all of you probably know, the FDA just sent off 14 letters to different pharmaceutical companies about pay-per-click search engine ads that violated FDA regulations regarding fair balance. Although some of us felt in the past that these ads were perfectly kosher because of a so-called “one click rule,” it turns out that this is not the case.

Mark Senak expressed our concerns well when he said in an Advertising Age article:

"The FDA is of the mind that they don't need to issue guidance specific to digital media because their current regulations cover that," said Mark Senak, senior VP at Fleishman Hillard and author of blog Eye on FDA. "Technically that's true. However, the internet presents a lot of situations that are somewhat nuanced and would lead to question in the mind of any reasonable person. Those questions deserve some answer. Formulating policy by issuing mass warning letters is not a valid way to set that policy or express it."

I think most of us agree that there are several other ways in which pharmaceutical companies can get into trouble with the FDA when they use social media. Right now, there is NO guidance from the FDA on how they may look at social media marketing in the future. As recent FDA actions have shown, companies can be in for some bad publicity and risk losing sales if they are caught unawares. It is perfectly reasonable, therefore, for the drug industry to insist that the FDA come up with some guidelines for use of the Internet and social media.

Before the FDA goes off and creates guidelines, however, it is important that it understand the position of all stakeholders on this issue. 84% of respondents to my survey agree that before issuing any draft guidance, FDA should convene a public hearing in which ALL stakeholders – including pharma, agencies, patient advocates, healthcare professionals, web site owners, etc. – can put on record their suggestions and concerns.

Some of us have already approached the FDA on this and have been rebuffed. One goal of this conversation, therefore, could be to approach the FDA as a stronger coalition of concerned stakeholders and demand at least a private meeting.

Although it would be helpful for the FDA to release guidance for the industry on the use of social media, there is also a need to develop “best practices” that go beyond what the law requires. Some pharma companies are currently discussing this and that is perhaps what we can also do starting with this roundtable discussion.



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When it Comes to Pharma Marketing on the Internet, be Careful of the Advice You Get from "Experts"

In the wake of DDMAC's "Curious Case of the 14 Letters" (see, for example, "The 14 Letters. Who at the FDA Knew What and When?"), many so-called "expert" consultants are coming out of the woodwork and offering advice on how to comply with FDA's newly "received precedence" concerning sponsored (ie, paid) search engine advertising (eg, adwords on Google).

Be careful whose advice you accept. It could be worthless!


Take, for example, this piece of advice from Ropes & Gray partner Alan Bennett published in the "The Pink Sheet" DAILY April 7, 2009 (see the reprint here).

"The citations will likely result in substantial rewriting of the search-result messages," said the Pink Sheet. "One solution for firms would be to insert a 'fanciful' name in place of a product name in a search engine link that leads to a company-sponsored product Web site, offered Ropes & Gray partner Alan Bennett."

Is this a good piece of advice?

Without any other information to go on besides the PUBLIC policies of search engines like Google, you might think this advice goes against Google's policy on the use of "redirect" URLs in adwords, which states that display URLs in sponsored ads "must be accurate." Even more specific: "Your display URL must accurately reflect the URL of the website you're advertising. It should match the domain of your landing page so that users will know which site they'll be taken to when they click on your ad."

If you want your ads to bring searchers to www.brandname.com, then the link URL in the sponsored ad must be "www.brandname.com" and NOT some "fanciful" name like www.bestdrugever.com or www.depressionhurts.com (which takes you to www.cymbalta.com)

It appears, however, that Google has carved out an exception to its link URL JUST for pharmaceutical companies (see "Redirect URLs in Adwords: Who Knew What When?")

Some experts -- maybe Mr. Bennett included -- knew about this for years, whereas many others DID NOT. This is just one example of how CAREFUL pharma marketers should be when taking the advice of "experts."

Although OK with Google (and maybe, just maybe) the FDA, should pharmaceutical companies be using redirect URLs in paid search ads?

As Robert Kadar of GoodHealthAdvertising.com says in a comment to this post, "your example does seem to violate Google rules but they obviously have made an exception for Pharma as a large percentage of pharma brands are masking the url's of their brand sites with generic names like depressionhurts.com. I believe that at the minimum this is a bad user experience and at worst is false advertising."

In response, enkil76 said "Is this like the one-click rule? At this point, I would say they haven't been enforcing a rule. What says tomorrow they won't?"

GOOD QUESTION!

See followup post: "St. Google Slays the FDA Dragon?"

Follow me and see the reaction to this on Twitter...

Tuesday, April 07, 2009

The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!

"My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters," says Peter Pitts, author of Drug Wonks, which is widely read by the pharmaceutical industry (see "Sponsored Links: Implications & Applications").

"What does this mean? Does it expose the probability that this important social media issue was not discussed at higher levels? You be the judge – but you can bet they will be now. In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee."

MY sources tell me that FDA Intern is tracking down who discussed these letters at higher levels in the FDA.
Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even former FDA commish Andy von Eschenbach!

FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!

(Click for an enlarged view. Print it and show your friends!)

"In fact," says Pitts, "[the issue] should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion."

Better be careful Mr. Pitts! You might just get what you wish for and MORE -- ie, Sydney Wolfe sitting on that advisory committee!



Continue the discussion via Twitter...

Monday, April 06, 2009

Protection from Brand Infection: Research Survey


On behalf of the CMO Council, I am pleased to pass along to my readers an announcement of the formation of a new thought leadership initiative titled "Protection from Brand Infection." Protection from Brand Infection is a new area of exploration to determine the degree to which senior global marketers are sensitized to, and concerned about, brand hijacking, product piracy, cyber fraud, and other Internet reputation risks.

I emphasized "Internet reputation risks" because that is often my focus in discussions on this blog.

According to Donovan Neale-May of the CMO Council, "the program will focus on Enterprise Brand Protection and take a deep dive into the brand image and integrity issues, implications of online counterfeit sales, gray market knock-offs, phishing attacks, cyber squatting, email scams, online brand and trademark abuse, domain kiting, pay-per-click fraud, copyright and patent infringements, as well as product piracy and fakes."

As part of this initiative, CMO Council is currently hosting the Protection for Brand Infection survey, which I encourage my readers to take. In return, CMO Council will give us an exclusive look at the results of interest to the pharmaceutical industry.

Here are some finding so far:
29.4% of respondents (so far) see cybersquatting, or the illegal use of trademarks or brands in domain names online, as the most prevalent infringement on business and reputation. However, only 18% are plagued by replication of goods, fashion labels, apparel or products.
Where do you fall? Are you among the nearly 40% of marketers who are leaving this brand problem up to legal? Or are you one of the marketers with an eye on those who are looking to profit from your brand’s reputation?

We are nearing the end of our research for a CMO Council initiative, Protection From Brand Infection, and are looking for your insights to round out our peer-led audit. You can access the survey at http://www.brandsecuritycenter.org/survey/protection/

The CMO Council is closing this research within the next week, so time is of the essence. All participants will receive a free copy of the report upon publication.

Take part in this benchmark of how marketing is taking control and securing the trust in our brands!

There's a New Crop of Pharma People Who Are Not So Savvy About Social Media!

This morning I posted some results from the "Social Media Pharma Marketing Readiness Self-Assessment" survey that seemed to indicate that Pharma's "Social Media Readiness" Score had improved (see post here).

But looking at the data from three different time periods, I find something perhaps interesting: the score increased from Dec-2007 to Nov-2008, but decreased afterwards as if there were some kind of "Social Media Readiness Recession" going on in the pharmaceutical industry.

Here's the chart (click on it to enlarge):


The chart reflects data collected during the following 3 time periods:
  • Period 1: 26-Dec-2007 through 31-May-2008
  • Period 2: 1-Jun-2008 through 30-Nov-2008
  • Period 3: 1-Dec-2008 through Today (6-Apr-2009)
The "Knowledge" category is the most telling. The new crop of respondents don't seem to have as much social media knowledge as the 1-Jun-2008 through 30-Nov-2008 respondents, who were much more knowledgeable than the first group.


Continue the discussion via Twitter...

Pharma's "Social Media Readiness" Score Improves

The "Social Media Pharma Marketing Readiness Self-Assessment" survey has been hosted by Pharma Marketing News since December 2007 and to-date about 390 people from pharmaceutical companies, pharma vendor companies and other interested parties have taken the survey and compared their scores with the average score.

The survey asks respondents several questions to gauge readiness in 3 categories:

Regulatory Environment of respondents company
Their company's Corporate Culture viz-a-viz comfort with social media
Respondent's personal Knowledge & Opinion of Social Media

You can read more about the details of the questions and get a summary of the results through 26 March 2008 by downloading this Pharma Marketing News article reprint: PMN Reprint #73-05.

At the time I last reviewed the data (March 2008), only about 108 people had taken the survey. Today, approximately 400 people have responded.

It occurred to me that I could compare the responses collected during the last 12 months (ie, 1-APR-2008 through 31-MAR-2009) and compare them to the first set of responses (ie, 26-DEC-2007 through 31-MAR-2008) and see if the scores improved.

They have! See the following chart (click on it for an enlarged view):


These data are from PHARMA respondents only (ie, people who claim they are employed at FDA-regulated Pharmaceutical/Biotech/Medical Device companies). The "2008" data were based on 46 responses and the "2009" data are based on 86 responses.

I should really look at 6-month chucks of responses and see if there really is an upward trend. Come back after lunch for an update!

Sunday, April 05, 2009

Overactive Bladder: "Pharmacia instrumental in creating new disease" says Former VP

I just received a link to an old Powerpoint (PPT) presentation that was featured at an October, 2002, Pharmaceutical Marketing Research Group (PMRG) conference. The presentation was entitled "Positioning Detrol (Creating a Disease)" and the presenter was Neil Wolf who, at the time, was Group Vice President at Pharmacia, the drug company purchased by Pfizer. As you may know, Pfizer is preparing Toviaz, a follow-on drug to Detrol, for marketing (see "Detrol v. Toviaz: Marketing Replaces Innovation at Pfizer!").

The presentation outlines the strategies used to convert a "niche product into a Mass Marketing Opportunity." Download it here.

I was gratified to get my hands on this PPT because I remembered being present at the 2002 meeting and how shocked I was that a pharmaceutical VP would actually be so transparent in discussing how "overactive bladder" was a "new" disease that he and his company created specifically to increase the sales of Detrol! Often, I wished I had a copy of that presentation to prove that I wasn't imagining things and now here it is.

The introductory notes state:
How many have seen
How many have heard of overactive bladder?
How many have overactive bladder???

Overactive Bladder now a lexicon in American culture
-cocktail parties / media / sitcoms / talk shows

Most importantly, routinely discussed between patients and their physicians
Not the case 4 years ago

Pharmacia instrumental in creating new disease
-improving lives of millions around world
Some critics of the pharmaceutical industry say that overactive bladder (OAB) is an example of "disease mongering," a term that was coined by the late journalist Lynn Payer to describe what she saw as the confluence of interests by some doctors, drug companies, patient advocacy groups and media in exaggerating the severity of illness and the ability of drugs to "cure" them (see "Disease Mongering -- Is it real or not?").

I believe this presentation is a classic "disease mongering" case study.

Slide #20 shows how by creating a "new" disease, the potential market for Detrol could be increased 2.7-fold!


Slide #22 states the "Critical Success Factors" for the Detrol launch in the US:

This is now the classic formula for creating greater demand for an Rx product than would normally be the case. As you can see, "education" of PCPs (primary care physicians) is a critical component as is DTC and PR (public relations).
NOTE: Influencing Prescribers
The American Medical Women's Association (AMWA), which is cited as a resource on the Detrol product Website, is currently promoting an "Overactive Bladder Initiative," which includes a "comprehensive continuing medical education curriculum" that provides "primary care providers with the latest discoveries concerning etiology, epidemiology and treatment of urinary incontinence, with particular emphasis on practical management strategies of overactive bladder, particularly as it affects women." AMWA lists Abbott, Novartis, Astrazeneca, and Wyeth (recently purchased by Pfizer) as corporate sponsors.
Slide #30 in the deck clearly shows that Pharmacia understood the need to achieve the "confluence of interests by some doctors, drug companies, patient advocacy groups and media" as well as REGULATORY people to achieve its aims:


To get payors (ie, insurance companies) to place Detrol on their formularies and pay for OAB treatments, Pharmacia convinced them that OAB was "a serious medical condition, not just a 'lifestyle' disorder" citing "Skin and soft tissue infection," "Falls and fractures," "UTIs," and "Significant co-morbidity with depression and sleep disorders" (slide #39).

Interestingly, none of these "serious" conditions was ever mentioned in the DTC marketing of Detrol. That might be just too much education for consumers to swallow!

Continue the discussion via Twitter...

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Listen to this WHYY radio segment, which aired Monday, April 20th, 2009:

"Inventing a disease"
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