Envisioning 2.0

For many years, pharmaceutical companies and advertising agencies have been producing text advertisements that link to Websites promoting medications.  Generally, advertisers used what what was dubbed the “one click rule” – i.e., if information about the risks associated with a medication was included via a hyperlink, they would be fulfilling requirements to post information about prescription medication side effects.

No more.  Recently, the FDA issued 14 warning letters to various pharmaceutical companies demanding that they start including risk information in text advertisements.  According to the New York Times:

“When the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.”

Today, attendees at a panel with the FDA at the Direct to Consumer National Conference expressed disappointment (via Twitter) that the FDA was not more forthcoming about the warning letters.  In addition, Peter Pitts who is working for the Public Relations firm Porter Novelli said (in a comment he left on the Wall Street Journal blog):

“Guidance? What guidance? DDMAC letters should help companies understand what “in compliance” means. These letters do not. In fact, they make things more muddled. After all, “sponsored links” are by no means a new phenomenon.”

Ken Johnson, senior vice president at the industry trade group PhMRA had this to say: “Rather than regulate through warning letters, FDA could help patients and serve the public health by initiating a public dialogue and FDA guidance outlining clear standards.”

While industry executives are perplexed by the new warning letters, one can look at this situationa as a glass half full.  Demands on the FDA to issue clear and unabigious guidance on Internet and social media marketing will only increase.  I understand that people inside FDA are open to dialogue.  In my opinion it can’t happen fast enough.

Today, my e-mail box has been burning up with astounding news from the FDA regarding social media marketing.  In a press release, which is starting to be widely distributed online, the FDA is said to be developing draft guidance on social media marketing! First, my mouth fell open in shock.  Then I remembered what day today is, April 1.  Here’s the “release”:

“New FDA Draft Guidance Aims to Improve Health Information Obtained via ‘Social Media’ Websites

The Food and Drug Administration today issued a draft guidance document designed to improve communications to consumers and health care practitioners about health conditions and medical products that they obtain on ’social media’ Websites such as Facebook, YouTube, Twitter and online bulletin boards. The guidance is the result of FDA research and policy development, and was influenced by the success of the recent social media based peanut recall program (see http://tinyurl.com/d3lvag).”

This is a clever ploy by my fellow blogger John Mack of the Pharma Marketing Blog to drive traffic to his Website and get folks buzzing about the new “guidance.”

I took some time to call one of my contacts in the FDA’s media relations department today about this release, Rita Chappelle.  She is aware of every FDA release that crosses the wire.  She told me: “We have not issued any releases today.”  Check out the FDA’s newsroom to confirm her statement – as of 1:30 p.m., Eastern.

Also, careful examination of the “release” reveals that the telephone number listed regarding media contracts is incorrect.  In addition, FDA always provides specific contacts on all releases who can field media requests.  Finally, the FDA does not use TinyURL links in its official communications.

So, stop distributing this release to your colleagues.  You’ve been had.  April Fools!

A significant part of the recently signed stimulus package (at least for people in the health industry) is comparative effectiveness research.  Now that the bill has become law, government agencies will be required to conduct large-scale head-to-head clinical trials to determine which prescription medications are truly superior.

Some pharmaceutical industry stakeholders and physicians do not like comparative trials, and their experience with the ALLHAT trial illustrates some of the reasons why.  The ALLHAT trial demonstrated that generic blood pressure medications are better than more expensive alternatives.  The results sounded good until prominent physician thought leaders began to take the data apart and suggested that the government skewed the study results.

More troubling is that some doctors said the government based the study on poor outcomes experienced by African American patients taking certain types of blood pressure pills.  Differences in how people from various ethnic and racial backgrounds respond to medications is one reason minority advocacy organizations are resisting the push to launch more comparative effectiveness studies.

The Congressional Black Caucus expressed concern that “comparative effectiveness research will be based on broad population averages that ignore the differences between patients.”  While House and Senate negotiators inserted language in the final bill requiring government-funded trial to include adequate numbers of minorities (and women), some are still concerned that this isn’t enough.

The issue of differences in how people of various racial and ethnic groups respond to medications was a major topic of the interview series I conducted a few years ago focusing on race and medicine.  You can read one scientist’s comments about this issue here.

This week, the New York Times and other outlets reported that Bayer has taken the rare step of producing and distributing corrective advertising for its Yaz brand name birth control medication.  Yaz is indicated for the prevention of pregnancy, management of moderate acne and premenstrual dysphoric disorder.  Bayer produced an advertisement that the FDA requested be removed because viewers could interpret it to mean that Yaz helps women remedy a larger array of acne symptoms and can help treat PMS.

The Times reported that the FDA and a group of states attorney generals forced Bayer to spend $20 million to air a series of commercials correcting the record and stating that the company’s previous advertisements were “unclear.”

John Mack who writes the Pharma Marketing Blog wondered if Bayer “shouldn’t use its power” to ask an actress (Desiree Hall) who appeared in the TV commercials to remove the advertisement from YouTube.  It is worth mentioning that Hall has also published a number of her other commercials on YouTube, indicating that she is using the Website for self-promotion.

Based on my understanding of FDA regulations, unless Hall was acting as an agent of Bayer when she posted the commercials, the drug firm has no responsibility or obligation to ask her to remove the spot.  Although Bayer employed Hall, the company does not have direct or indirect control over the content Hall chooses to upload to YouTube.  Of course the situation would be a little bit different if Bayer (or one of its agencies) had uploaded the video to to the video sharing Website.

In the end, it all comes back to control.  If a drug firm is responsible for the social media content, then the relevant marketing regulations apply.

Over the past few years, attacks on pharmaceutical industry direct to consumer (DTC) advertising have steadily increased.  Once critics blasted it for increasing sales of medications that have limited usefulness.  Today, these individuals have been joined by some within and without the industry who have suggested that it is not a very effective marketing tactic.

I am very used to seeing scathing critiques of DTC advertising, but I must admit I was a little shocked when I learned that the CEO of Roche Pharmaceuticals, William Burns, said it was the “single worst decision for the industry.”  I have not been able to locate Burns’ full remarks, but his statement made me wonder whether:

o    Roche is going to discontinue its DTC advertising:  Perhaps not as commercials featuring Sally Field are currently appearing on television

o    If Roche is going to aggressively experiment with other marketing channels that help it build robust and authentic connections to patients

Somehow, I think that unless the FDA bans DTC advertising – which is unlikely – we are going to see companies continue to use it.  Although some may doubt its effectiveness, commercials do have their uses.  In crowded disease areas like osteoporosis, advertising can do a good job alerting people to new medications.  Roche likely believed that advertising about Boniva made sense because it only needs to be taken once a month unlike other osteoporosis drugs.

Despite Burns’ critique, I expect DTC advertising to be with us for a long time to come.

Ever since I conducted a series (partly) focusing on antibiotic resistance a couple of years ago, I have been keeping tabs on the antibiotic marketplace. Mainly, I am interested in whether new products will emerge that will help us manage bacteria that are resistant to all but the most powerful medications.

Today, I learned that a federal advisory panel has decided to ask the FDA to approve a new antibiotic designed to manage MRSA, a serious and life threatening skin infection. MRSA is resistant to many antibiotics and those that are effective are rapidly growing less effective.

I was also pleased to see that a number of companies are developing medications designed to manage MRSA and related bacterial infections. We need new drugs – and prevention – in order to ensure that we go forward and not backward in the fight against Super Bugs.

A new study published in the British Medical Journal indicates that many US physicians regularly prescribe sugar pills or other drugs that are ineffective.  The study authors surveyed 673 physicians and found that while very few gave patients placebos, other prescribed aspirin and other medications not designed to specifically treat the condition patients were suffering from.

When asked whether this behavior is ethical Farr Curlin of the University of Chicago told Health Day News: “It’s a gray zone. It is not ethical to actively deceive patients. But when doctors give something which they think will help but don’t think it helpful to explain the full reasoning about why it will help, that’s a gray zone.”

This study must anger some of those tasked with measuring clinical outcomes.  After all, how can one be certain patients are being managed appropriately when it is not clear they are being provided with effective medications?

Personally, this study confirmed what I have always believed: placebos are big business.  I’m just waiting for the “Placebo Manufacturers of America” to convene a conference.

Source: Pharmalot

Today, the Wall Street Journal has an article focusing on how unbranded advertising (or commercials that don’t mention a specific product) is gaining traction. The Journal writes:

“Unbranded . . . advertising is gaining popularity among drugmakers, which in recent months have come under renewed fire from lawmakers for the ways in which they promote drugs directly to consumers.”

The Journal also suggests that companies are using this type of advertising in order to avoid talking about the side effects associated with their medications.

The Journal’s focus on unbranded marketing is certainly interesting, but this strategy has always been popular — at least with some drug firms. Pharmaceutical companies (especially in non-US markets) regularly use this type of advertising to educate and raise awareness about issues related to a product.

In addition, I doubt Pfizer has aired these advertisements to avoid talking about drug side effects. It just makes good marketing sense. In a market where your product stands virtually unchallenged (Chantix is only one of two drugs approved by the FDA for anti-smoking uses – the other, Zyban, has lost patent protection), it makes a lot of sense to run unbranded advertising First, there is less likelihood that you are building a market for a competitor. Second, by pushing people to an unbranded Website, you get that much closer to driving them to a online property focusing on the drug.

Since early this year, Abbott Laboratories and the PR firm Fleishman Hilliard have been producing a contest designed to encourage young people to enter the clinical laboratory profession.  According to Abbott, the program, Labs Are Vital, was a smashing success.  It reached more than 1.8 million students interested in the sciences.

Students participating in the contests were asked to develop videos, T-shirts and advertisements encouraging people to start a career in laboratory medicine.  A key part of the programs’ success was the fact that Fleishman Hilliard was heavily engaged with the Facebook community surrounding the contest.  With a few exceptions, the contest sponsors were very responsive to community members’ needs and quickly answered questions.

Intimate interaction with community members was critically important, as Abbott changed the program’s various deadlines a few times over the past few months to give students more time to participate in the contest.  These changes confused community members.  In addition, Fleishman did a good job defusing negative commentary about the contest by quickly and honestly addressing criticism about the effort.

This contest illustrates that social networks have the power to “seed and grow” online communities around a common cause.  “Seeding” means providing the community with an online home.  Growth entails giving the community room to evolve at its own pace and constantly making adjustments as its needs change.

To learn more about the contest, click here.  To view the Facebook group, please click here (Facebook account required to view site).

A bit of a buzz has been going around the pharma blogosphere about a new marketing campaign for the over the counter allergy medicine (OTC) Zyrtec.  Jack Friday at PharmaGossip has wondered whether it’s legal.  Yes, as John Mack, author of Pharma Marketing Blog, noted. The marketing campaign is perfectly legal as Zyrtec is now an OTC pill.

However, Mack wondered whether it is true, as Adrants reported, that Zyrtec flyers were seen on telephone poles in Boston.  He said: “I doubt this is a true story — more likely a Web 2.0 plant by crafty Zyrtec marketers.”

Well, shortly after I read these two blog posts, I left my windowless cubicle for a dose of fresh air and sunshine and what did I see?  Well, I caught a glimpse of a flyer taped to scaffolding near my office in New York’s East Village.  So, yes the rumors are true.  McNeil has instituted a clever guerilla marketing campaign once reserved for consumer packaged goods companies and underground musical acts.  I took a moment to scan in the flyer.  As you can see, someone was curious enough to respond to the marketing campaign by ripping off a section of the flyer with the Zyrtec 800 number.

Overall, this is a very, very clever campaign that’s sure to generate a lot of buzz for Zyrtec.