Is FDA Playing "Bait & Switch" with Pharma Marketers?

Sensing that there are a lot of pharma marketers out there who are "angry as hell and don't want to take it any more," I decided to host a short, VERY anonymous survey seeking opinions about FDA's recent letter to Novartis regarding its use of metatag text in a Facebook Share button (for background,  see "Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget", "Who's in Charge of Your 'Invisible' Metadata? WARNING: Don't Invoke the 'Invisibility Rule'", and "Update on FDA Regulation of Pharma Metadata & Impact on Search").

My timing could not have been better!

Yesterday, the big story coursing through social media was NOT FDA v. Novartis, but the story of how JetBlue attendant Steven Slater decided he had had enough. He cursed off his passenger nemesis via his plane's PA system, grabbed a beer, and exited via an emergency escape chute. I, among many other people, tweeted about it positively:

"Wouldn't we all love to pull the shute (sic) lever & escape into adventure like this JetBlue flt attendant? http://nyti.ms/bh2deF"

This plus the Tea Party movement may signal a new era of "had enough bullshit!" Which is good way to describe the comments I have collected so far in my little survey. The following is just one example:

"It's bullshit. The issue is not the metadata but the truncating of the data that will occur through any number of sources - and one that you correctly point out is natural search. This is a very slippery slope where the FDA should provide some options. It's a bait and switch that they listen to us and then crush us. What do they have against Novartis? Feels like they've been picking on them lately."

You can find this comment and others here and take the survey yourself here (it's completely ANONYMOUS; no names or IP addresses are collected).

Needless to say, I have my own opinions on this and have stated a few in the posts I have cited. But the responses to my survey open up new issues that I plan to use in a future debate to be aired LIVE on my Pharma Marketing Talk Blog Talk Radio Show. More on that later.

Update on FDA Regulation of Pharma Metadata & Impact on Search

Since writing about FDA's letter to Novartis regarding the content of a Facebook Search Button -- see "Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget" and "Who's in Charge of Your 'Invisible' Metadata? WARNING: Don't Invoke the 'Invisibility Rule'" -- several other experts have offered their analysis and recommendations. I already have referred to "Digitas Health Facebook Regulatory Alert" in a previous post. Here I'd like to focus on what Jonathan Richman and Bridge Worldwide have to say.

Specifically, Jonathan addresses my thoughts on how this may affect search engine marketing by pharmaceutical companies. Jonathan comments, in the Bridge Worldwide Digital Alert-Facebook Sharing Warning Letter (find it here),

"While there may be a simple way to allow for compliant Facebook sharing by using Facebook tags, the larger issue that the FDA is citing really focuses on the use of META tags [my emphasis]. In fact, this latest ruling seems to indicate that FDA doesn’t necessarily have an issue with Facebook or any other type of social sharing, but rather how META tags are written by companies. Since manufacturers control the content of the META tags, it is subject to the same regulations as every other piece of content on their sites [my emphasis]. Since the content of these META tags is being used in search engine results and now with social sharing, these tags are being taken out of the site and out of context. This means that the content of the tags now appears without fair balance. This is a violation of DDMAC guidelines. Therefore, DDMAC may be suggesting that META descriptions be written to either include fair balance or written without the drug indication (i.e., a generic, non-product related statement) [my emphasis]."

The problem is this: while it is easy to write a fully compliant META description that includes fair balance, search engines will reproduce only the first 160 characters when displaying that description as part of the natural search result. Facebook share buttons are even worse: they ignore everything after the first 50 characters.

"What this means," notes Bridge Worldwide in its Alert, "is that if you created a META description that included full fair balance what is displayed in search results and social sharing will not include the full text, however, the liability of companies could be reduced or eliminated. Consider the case where someone copies only a portion of your content and republishes it. The company is not liable since they did not create the copied version and do not control how people use their content. The corollary to the current situation would be when someone shares (or Likes) a page on Facebook, companies are not responsible for how the content is displayed, but rather what the original content was. This is a matter for each company’s legal and regulatory teams to determine, but likely has risk because due to intent."

Bridge Worldwide reminds us that META descriptions have "very little, if any, impact on search engine rankings. However, excluding META descriptions or creating unrelated, generic ones, may impact clickthrough rates in search results. Many people read the descriptions in search results to determine which results to click, as they help inform what the site is about before they visit."

When there are space constraints to deal with, as is the case here, what's a pharma company to do in order to remain compliant with FDA regulations AND provide useful information to consumers searching for information? Bridge Worldwide has some suggestions, which you can find in its alert, but the ultimate authority is the FDA, which I hope addresses this problem in new guidance regarding the answer to the question it posed at the November, 2009 hearing:

"Are there proposed solutions that may help address regulatory concerns when using social media tools associated with space limitations or tools that allow for real-time communications to present product information?"

For more on that with results from a PMN survey on this issue, see "Regulatory Solutions to Overcoming Space Limitations in Pharma Social Media Communications."

Medium vs. Message vs. FDA

Dedicated to the Twitter "debate" about which comes first for the FDA: The Medium or the Message?

"It's the message NOT the medium! This content did not follow existing FDA guidelines, it just so happened it was to be shared on FAcebook." says Eileen O'Brien (@EileenObrien).

Meanwhile, @ddwebster, cancer survivor and student of social media quoted me and inspired this graphic image (I didn't go with a chicken v. egg visual, but yin v. yang is close enough):

"Ah, chicken or egg debate? RT @pharmaguy: FDA lttr 2 Novartis: Is it msg or medium? w/o medium-specific metadata, FDA wuld not hv seen msg."

Who's in Charge of Your "Invisible" Metadata? WARNING: Don't Invoke the "Invisibility Rule"

My Twitter pals are all atwitter over FDA's recent letter to Novartis citing violative content in a Facebook "Share Widget" that Novartis created (see "Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget" for the back story).

At the center of the controversy is "metadata." If you are a pharmaceutical marketer asking yourself, "What the hell IS metadata?", then you need to read this because some junior web developer on your team (internal or agency side) may be playing fast and loose with your metadata unbeknown to you and your legal/regulatory people. The Novartis letter is a warning that FDA, however, is looking at metadata.

Metadata is usually "invisible" content inserted within the header of the HTML code that creates a Web page. This includes a "description" of the page or Web site and keywords. Some of this information is used by search engines to find the page and include a description of the page in the natural search result.

When you do a Google search on "Viagra," for example, you will find a "sponsored" link (ie, paid search ad) like this:

You will also find this unpaid natural search result:

BOTH the paid ad and the search result contain content that is written and controlled by Pfizer. The natural search result content that begins with "Learn about..." is exactly the content that Pfizer included in its "description" meta tag within the HTML code for the viagra.com home page. Google just lifted that content. Users cannot control this content, only Pfizer can -- by editing the meta tag.

This was exactly the point that the FDA made in its letter to Novartis regarding the Facebook Share widget. That widget includes meta tag content created and controlled by Novartis. It's not content that users of the Facebook widget can change.

Let's look at Viagra.com's meta tag content. You can easily do this by choosing "Page Source" in the View menu of your browser (eg, Firefox). It may be called something else in other browsers. Here's what you can find in the source within the "description" meta tag:

"Learn about prescription VIAGRA ® (sildenafil citrate), an erectile dysfunction (ED) treatment option that may help your ED."

This content is exactly the same content you see in the natural search result above.

The problem is that this content is in violation of FDA regulations that require fair balance -- ie, presentation of major risk information -- whenever a pharma company controlled communication to consumers includes a product trade name and its indication. The meta tag does NOT include this fair balance.

The lack of fair balance was one of the violations that FDA cited in the Novartis letter that concerned the Facebook widget.

Pharma people have often invoked what I will call the "Invisibility Rule" with regard to metadata. According to the "Invisibility Rule," meta tag content is NOT intended to be visible or read by consumers; its function is to provide information to search engines and improve the visibility of the site in search engines. Consequently, meta tag content should not be regulated by the FDA.

The problem with the "Invisibility Rule" is that metadata is not really invisible to consumers searching the Internet or using social media because both search engines and social media make the metadata visible.

Digitas Health made this recommendation (see previous post):

"Because website metadata is used both by search engines in generating organic search listings and by social media channels, such as the Facebook Share functionality, Digitas Health advocates that all site metadata should be included in internal medical/legal/regulatory review and as part of mandatory FDA submissions."

While many pharma marketers may claim not to know about metadata and who creates it -- it's "too technical for me" may be the excuse -- the metadata content is carefully crafted by someone on the team as is evident in the Viagra.com example. And that content is directed to the consumer; why else begin with the words "Learn about..." and end with the words "...may help your ED."?

It is more important than ever that the FDA come out with some guidance relating to this issue, which falls under the heading "Regulatory Solutions to Overcoming Space Limitations in Pharma Social Media Communications" (read more about that here).

Without specific guidance, pharma marketers must rely on "received precedent" and the Novartis letter is such a precedent. It clearly warns pharma advertisers that the FDA is looking at metadata content when that content is controlled by the marketer AND becomes visible to consumers as in Facebook Share widgets. It's only a short step from widget to natural search result as in the Viagra.com example above. BOTH make metadata content visible and render the "Invisibility Rule" defense questionable.

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P.S. Back in the day (prior to 2001) when I worked as a consultant helping pharma companies design and build product Web sites, I had a personal experience with a pharma client who attempted to manipulate meta tag content. Specifically, someone on the client side suggested that competitor product trade names be included within the "keyword" tag of their product's web page in order to "hijack" searches on their competitor's trade names. That is, if someone searched for "Brand Y," the search engine would dutifully offer up the client's site as a result. I pointed out that this may be illegal and certainly was unethical. The scheme was never enacted and I soon found myself out of work as a consultant.

I tell this story for two reasons:

(1) It offers some evidence that as far back as 2001 at least some pharma marketers knew how to craft metadata content to their benefit; and

(2) It demonstrates how difficult it is to point out that the Emperor has no clothes when you are paid by the Emperor.

Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget

You know you are getting old when the FDA knows more about Facebook than you do! In a July 29, 2010 letter to Novartis, FDA cited violations with regard to a "Facebook Share" social media widget that generates Novartis-created information for Tasigna that can be shared with Facebook users (i.e., “shared content”). FDA said: "The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug."

To help the recipient of the letter -- Lisa Drucker, Director, Regulatory Affairs -- understand what a Facebook Share social media widget is, the letter includes several footnotes that supplied technical details and explanations:

"Facebook Share is a way for users of Facebook to share articles, pages, video, or flash content of a site with other Facebook users. Over two billion pieces of content are shared each week through Facebook. With two clicks, visitors to a website can share any page of that website through Facebook by generating a link to the page, along with a thumbnail image and a brief description (i.e., 'shared content') that will appear on the users’ profiles and, depending on privacy settings, in the home page stream of all of the users’ friends. Each time a link is shared by one user, potentially hundreds of new people may see and/or click through on the link."

and

"As described below, the shared content for Tasigna generated by the Facebook Share social media widget was developed by Novartis and, although Facebook users can add additional comments that are displayed separately from the Tasigna information, the shared content cannot be modified by Facebook users who use this Facebook Share social media widget."

and

"We also note multiple Tasigna web pages contain widgets that allow users to share content via other social media applications offered via the “Share This” tool (http://sharethis.com). Some of the content available to share through these other social media applications raise similar issues to those discussed in this letter."

In a separate document, FDA included a screen shot showing what one of the widgets looked like before Novartis edited its Facebook page:

This looks very much like one of those infamous Google bAdwords (see Lunesta, Google, and "bAdWords")!

Luckily, Digitas Health published a "Facebook Regulatory Alert" that clarified a few issues and sheds some light on how this widget was created.

"The descriptive content displayed by Facebook on the user's page via the Share feature pulled from the [Tasigna] website metadata [my emphasis], which is invisible to most users but relied on by search engines, such as Google, Yahoo!®,and Bing™, to provide a description of the page's content," notes the Digital Health document.

I Warned This May Happen!
In a previous post, I warned that the FDA may cite certain content generated from metadata (see "Are Organic Search Results Next on FDA's Chopping Block?"). While the Novartis example is not exactly what I was talking about, it's pretty close because the FDA is now citing content that is usually hidden but made visible by widgets. If it can do that, why not cite natural search content that is also picked up from metadata tags?

Possibly thinking along the same lines as I am, Digitas Health ended its Alert with this recommendation:

"Because website metadata is used both by search engines in generating organic search listings and by social media channels, such as the Facebook Share functionality, Digitas Health advocates that all site metadata should be included in internal medical/legal/regulatory review and as part of mandatory FDA submissions."

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P.S. Novartis has updated its meta tag on the Tasigna Web site. It now reads: "Tasigna (nilotinib) 150-mg and 200-mg capsules from Novartis is a treatment for Ph+ Chronic Myeloid Leukemia in newly diagnosed adult patients in chronic phase or patients in chronic or accelerated phase who are resistant to Gleevec."

FDA had complained about the previous wording: "These statements of Tasigna’s indication are incomplete, and misleadingly imply that the drug is approved to treat all individuals with Ph+ CML, when this is not the case. At the time this shared content was originally disseminated, Tasigna was only approved as a second-line option after failure or intolerance to prior therapy that included imatinib. Furthermore, Tasigna is only approved for use in patients with Ph+ CML in the chronic or accelerated phases."

Pharma Symptom Quiz Goes to the Dogs!

I have often criticized the "symptom quizzes" that are found on many drug.com sites for not being very useful to patients. In fact, they are more useful to marketers (see, for example "OMG! Do I Have ED or 'Low T?' Or Both?! Pharma 'Symptom Quizzes' Are NOT in the Best Interest of Patient Health!").

These tests are promoted as a way to measure your "risk" of having a medical condition such as congestive heart failure (CHF). The tests are often designed in such a way that practically everyone who completes the quiz is told they have some level of risk. For an example of how this works, see: "You Must Score Better than 84% on Viagra's Sexual Health Quiz to NOT Have Signs of ED."

Now, Boehringer Ingleheim (find out how to pronounce it here) alerted me via its @boehringerus Twitter account to a new CHF risk quiz: "Is Your Dog at Risk of CHF? Visit http://ht.ly/2lpvJ for helpful information." Yes! A CHF risk quiz for your dog!

Of course, my dog can't fill out the form (maybe some day there'll be an app for that). So, I filled it out. You can choose from a number of dog breeds or just choose the politically correct choice for "mutt," ie, "Mixed breed/None of the above," which is what I did.

For symptoms, you can choose:

• coughing
• lack of energy or depression
• reluctance to go for walks
• poor appetite
• difficult or fast breathing
• fainting
• weight loss

Finally, you choose the age of your mutt, er, dog:

• 1–6 years
• 7–12 years
• over 13 years

Now, my dog is pretty old -- over 13 years -- and consequently, it is not surprising that he is depressed and lacks energy. So I checked off that symptom. For the same reason he is reluctant to go for walks and I checked that off. Sometimes he has difficult or fast breathing, like when he is FORCED to go for a walk. But I didn't check that symptom. Neither did I check off any of the other dire symptoms because, frankly, if my dog had those, I would not need this silly test to know that I should bring him to the Vet, which  is EXACTLY what BI suggested I do anyway in the evaluation results, which said:

Your dog is at moderate risk of developing CHF.
Please visit your veterinarian for more information.

I must admit that I cheated :-( I do not actually have a dog. I just imagined I had one so I could take the quiz for him and see if he was at risk for CHF. If I did have a 13-year old dog, however, I would already know he is at risk for CHF. Thirteen dog years is equivalent to, what, 91 human years? What animal -- human or dog -- would NOT be at risk for CHF at 91 years of age?

It used to be that old dogs were most often given the Kevokian option of dying with dignity. Now that there are medicines for dogs that can treat conditions like CHF, will there be laws against dog euthanasia?

Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?

At the recent 6th Annual Public Relations & Communications Summit at Pfizer Headquarters in NYC, Chris Loder, Pfizer's Head of US Media Relations, cited World Health Organization data that says 1% of worldwide sales of Rx drugs are counterfeit. Loder claimed that number is between 10 and 50 percent in "developing" nations. Pfizer defines counterfeit as "products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product."

Loder spoke of Pfizer's all out campaign to bring attention to the counterfeit drug problem, which obviously hurts sales, especially of Pfizer's flagship drug, Viagra. He focused on the PR effort, including the "dead rat" movie Pfizer distributed in the UK in movie theatres and on television (see "Was a Rat Harmed in the Filming of This Pfizer Commercial?"). Loder's efforts are part of Pfizer's "Get Real, Get a Prescription" campaign (find the web site and dead rat video here).

"Counterfeit medicines are a risk to patient health and safety," said Loder. "That's the one message we send."

While there is no known cases of someone being poisoned by counterfeit Viagra -- which is what Pfizer's film is all about -- "up to 149 Americans died in 2007 and 2008 after taking heparin, a blood thinner, contaminated during the manufacturing process in China," according to the 2010 "Drug Safety and Accountability" bill recently introduced in the Senate by US Senator Michael Bennet, a Colorado Democrat (find that bill here).

It wasn't the active ingredient in Heparin that caused the problem, it was a contaminant that was deliberately added to heparin batches that were processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. The contaminant mimics the in-vitro properties of heparin, but is much cheaper than heparin, which is obtained from pig intestine. It seems that there was a shortage of pigs in China at the time, perhaps due to efforts to curtail swine flu.

So, yes, counterfeiting was the problem, but not counterfeiting done by renegade "bad guys" selling product through the Internet, which Loder focused on as the main problem. It was contamination at the facility responsible for producing product for sale in the US. And the product found its way into the normal drug supply chain unnoticed by regulatory authorities.

Therefore, another message that consumers should be getting is that the drug supply chain is also a risk to patient health and safety. This was most recently demonstrated in the problems Johnson and Johnson's McNeil division had with over-the-counter children's drugs (see, for example, "Trouble in the House that McNeil Built: Why Drug Company Silos are Useful").

According to a Pew Prescription Project poll ("American's Attitudes on Prescription Drug Safety"), Americans are confident that drugs produced and sold in the US are safe, but those produced in China and India are not (see chart below).

Perhaps what the poll did not tell respondents is that "up to 80 percent of the active ingredients in drugs used in the United States are made overseas" (see Drug Safety and Accountability Act).

The story about how drug companies may or may not be monitoring the drug pipeline for adulterated -- counterfeit or not -- products is NOT being told. Perhaps this is because the PR people cannot think of dramatic images such as dead rats and sleazy criminals to represent the problem with drug supply chains. Or perhaps focusing on the supply chain hits too close to home.