Tuesday, August 31, 2010

YouTube Fixes Problem I Pointed Out Months Ago: Update on YAZ Case Study

In January, I pointed out that drug companies that place product videos on YouTube leave themselves open to association with other videos that poke fun at them, or worse, encourage consumers to join class action lawsuits against the company. The case that I pointed out was the YAZ Birth Control Channel (see "The Trouble with YouTube: YAZ Case Study").

The problem is that you cannot control what other videos may be highlighted by YouTube when your video is played OUTSIDE the channel. In the case of YAZ, for example, when you click on "related videos," what you see are many videos from law firms suing Bayer and spoofs of YAZ TV commercials. Even though Bayer has turned off comments, it cannot prevent viewers from seeing these related videos.

According to an article in AdAge, YouTube may have fixed this problem.

"Enter YouTube's latest feature, 'target excludes,' launching as part of the site's Video Targeting Tool, which gives advertisers the choice to exclude as few as one video they don't want their product associated with as well as specific genres and channels. The feature addresses the most often-criticized aspect of YouTube: You can buy video there, but you never know what you'll get" (see "YouTube Launches Brand Protection Feature").

Today, I revisited the YAZ channel and was greeted with "YazBirthControlPill has no videos available." See image of blank channel below.


It may only be a coincidence that this channel is now blank. Perhaps Bayer has taken down the videos as it looks into using YouTube's new feature? Considering ALL the anti-YAZ videos on YouTube, it must be a monumental task to track them all down and add them to the exclusion list one-by-one. I wonder if there's a app for that?

See More advertiser control on YouTube for the official announcement regarding "target excludes."

OTC Drugs and Children

Recently, the news media and Congress focused our attention on the recall of contaminated over-the-counter (OTC) children's medication manufactured by McNeil Consumer, a division of Johnson & Johnson (see "Despite Its Social Media Expertise, J&J Fails to Use It Effectively to Communicate to Consumers").

But there's an even more dangerous problem than contamination relating to OTC medication for children: incorrect dosing.

"There is an urgent need to review the use of children's over-the-counter medicines by parents," said Dr Rebekah Moles, University of Sydney, as part of her research, which concluded that many parents are incapable of giving their children the correct dose of liquid medicines.

The Australian study, presented in Lisbon, tested 97 adults and found 61% measured the wrong dose - 17% measured an overdose and 44% did not give enough (see "Many parents are incapable of giving their children correct dose of liquid medicine").

As reported by BBC: "Dr Moles said that almost half of the 119,000 calls received by the New South Wales Poisons Information Centre, which handles emergency calls from across Australia, concerned accidental overdose in children, with 15% needing hospitalisation."

I covered this topic last year when I interviewed the principals of a company that invented a solution for the problem of incorrect dosing of children's OTC medicine. Listen to this Pharma Marketing Talk podcast: "A Solution to the Problem of Inaccurate Dosing of OTC Pediatric Medicines."

Monday, August 23, 2010

Alex Butler's Signature Says It All -- Well, Almost All.

I am getting excited about presenting at the upcoming DigiPharm Europe 2010 conference in London at the end of September mostly because I will be meeting several pharma people who are doing digital marketing in Europe! One of these people is Alex Butler who is Digital Strategy and Social Media Manager at Janssen-Cilag.

You can tell that Alex is immersed in communication and social media just be looking at his email signature, which I reproduce below (without revealing his personal phone and email address):


I need to update my sig file to look more like this!

I first learned about Alex when I asked people to nominate candidates for the Pharmaguy Social Media Award (learn more about that here).

Alex's signature says it all, or ALMOST all. There is a lot more to learn about Alex and what he is doing over there in the UK! To learn more about Alex and the other speakers at the DigiPharm Europe 2010 conference, I invited them to participate in my Pharma Marketing BlogTalkRadio show on September 8, 2010. See "DigiPharm's EU ePharma Pioneers: Doing More with Less" for more information about listening to and participating in that show.

My presentation, entitled "New Rules for New Media: A Funny Think Happened While Waiting for FDA Guidance", will be on Thursday, September 30 (see here).

My newsletter -- Pharma Marketing News -- is a Media Partner for this conference.

Movie "Love and Other Drugs" is More an Ad for Viagra Than an Expose of Sales Tactics

If you were expecting the movie "Love and Other Drugs" to be a hard-hitting expose of pharmaceutical sales tactics as was the book it's loosely based on -- ie, "Hard Sell," by Jamie Reidy (see review here; use code 'JAMIE' to get it FREE! -- then you are in for a surprise. The trailer (see below) exposes that this is just another "love story" that happens to feature pharmaceutical sales reps and their shenanigans.

"[Anne] Hathaway portrays Maggie, an alluring free spirit who won’t let anyone - or anything - tie her down. But she meets her match in Jamie ([Jake] Gyllenhaal), whose relentless and nearly infallible charm serve him well with the ladies and in the cutthroat world of pharmaceutical sales. Maggie and Jamie’s evolving relationship takes them both by surprise, as they find themselves under the influence of the ultimate drug: love."

The "ultimate drug" may be "love," but the movie seems to focus on how great a drug Viagra is!

Thursday, August 19, 2010

Do We Really Need a Date Rape Drug Marketed for Fibromyalgia?

Xyrem -- Jazz Pharmaceuticals Inc.’s narcolepsy drug -- is safe and effective, said FDA, which is weighing whether to approve the drug for treating fibromyalgia. Xyrem's active ingredient is Gamma hydroxybutyrate (GHB), a chemical linked to date rape (see "Date Rape Drug May Soon Be Approved for Fibromyalgia!").

Just what the world needs -- another drug to treat Fibromyalgia! Fibromyalgia is "a poorly understood pain condition which is believed to affect three to six million Americans, mostly women," according to an article in the Wall Street Journal.

There are already several drugs on the market in the US for treating fibromyalgia, including Lilly's Cymbalta (see "Cymbalta: A Sweet ROI for Chronic Pain Indication") and Pfizer's Lyrica (see "Battered Woman Imagery in Pfizer's New Fibromyalgia Ad").

It appears that PAIN -- even "poorly understood" pain -- is the holy grail of indications for a variety of drugs seeking a boost in sales. Not only are we becoming a nation of people suffering more pain than any other, we are allowing dangerous drugs onto the market and NOT adequately policing their illegal use and abuse.

You only have to look at how Oxycontin is being abused by our children to realize that these drugs are very profitable to physicians who are engaged in illegal trafficking. Because there will always be unscrupulous physicians who distribute these drugs illegally, no "restricted distribution program," no matter how onerous, will prevent these drugs from reaching our children.

We certainly don't need GHB (aka Xyrem) promoted heavily on TV as are Cymbalta and Lyrica. It won't be long before every college kid realizes that there is a new and easier way to obtain the date rape drug. It's not easy to obtain a drug to treat narcolepsy from a physician. That condition is so rare and confined to a specific group of people that even an unscrupulous physician would not risk prescribing it too freely. But it is easy to prescribe a drug for fibromyalgia, that anyone can complain to suffer from.

Luckily, fibromyalgia is currently thought to affect mostly women and if many college-age men try to get prescriptions, red flags might go up. However, men's pain is an overlooked marketing target and I predict it won't be long that you'll see men in commercials who suffer from fibromyalgia and encouraged to "see their doctors."

IMHO, the unintended (?) consequence of marketing Xyrem under that scenario is more abuse, more date rape, and more college kids being swept up into our prisons.

Wednesday, August 18, 2010

Cymbalta: A Sweet ROI for Chronic Pain Indication

One new indication for pain = $500 Million in additional sales!

Once a drug is developed for a single indication, gaining approval for additional indications can be sweet icing on the profit cake.

As an example, take Cymbalta, which was originally approved in 2004 for adults with major depression. Later the FDA granted Lilly, the company that manufactures Cymbalta, approval to market Cymbalta for treating nerve pain in diabetics, GAD (ie, "generalized anxiety disorder"; see "eGAD! How I Learned to Stop Worrying and Love Cymbalta!") and fibromyalgia, a condition characterized by chronic fatigue and muscle and joint pain.

Now, as reported in this Bloomberg article ("Lilly’s Cymbalta Helps Chronic Pain in U.S. Review"), Cymbalta may be approved for chronic lower back and knee pain, an indication that would increase sales by $500 Million, a 16% increase over the $3.07 Bn in sales for Cymbalta in 2009.

Currently, it is estimated that 7% (about $215 Million) of Cymbalta sales comes from "off-label" prescribing for "diseases of the musculoskeletal system, including arthritis and back pain." No doubt this is due in part to stories published two years ago with these headlines:

* "Cymbalta Found To Reduce Chronic Lower Back Pain"
* "Patients Taking Cymbalta Experienced Reduced Chronic Low Back Pain in New Study"
* "Anti-depressant drug shown to help people with low back pain"

For more on that, see "The Cymbalta Buzz Machine is at Full Throttle!"

Getting a 7% in sales from off-label prescribing is sweet, but sweeter still is getting an additional 17% from being able to market the drug for a new indication.

This got me to thinking about how much it costs to get a drug approved for a new indication. First of all, it has to be lot less expensive than getting the first indication because no new safety trials have to be run. Of course, new efficacy trials have to be run to "prove" that the drug works to treat the new condition. But these trials are much smaller -- hundreds of patients -- compared to the initial trials that involved thousands of patients.

As I learned when I wrote "The Cymbalta Buzz Machine is at Full Throttle!" the the back pain study, which Lilly may have submitted to the FDA to support Cymbalta's use for chronic pain, involved ONLY 236 patients. That's a pretty small study compared to the size of clinical trials needed for initial approval of a drug for marketing.

Searching Google, I found the cost per patient of running a clinical trial to range from $5,000 to $26,000. I suspect the former number is closer to what Lilly paid for its back pain trial. That would mean that Lilly paid only $1.3 Million to run this trial, for which it stands to gain $500 Million in additional sales.

Now that's some sweet ROI icing!

Friday, August 13, 2010

Are Pharma Marketers Using Viral Social Media Techniques to Promote Products?

Subtitle: This Bayer Sexy Youtube Video is Popular, but Will It Help Levitra Sales?

Is viral, peer-to-peer pharma marketing an effective tactic? Jeff Chester, who heads up the Center for Digital Democracy (CDD), thinks so. Speaking on NPR's All Things Considered show (summarized on NPR's blog), Chester commented on Bayer's funny "InBedStory" series of YouTube videos and claimed that "the drug company marketers are counting on you to forward the funny video. And," he says, "that's the idea behind all these techniques."

By "all these techniques," Chester includes techniques like the infamous Novartis Share button that recently was dinged by FDA (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'").

First of all, there was nothing "funny" about the Novartis button, which included this message: "Home - Tasigna (nilotinib) 200 mg capsules." I can't imagine a more uninspiring, absolutely non-viral message! Why would I bother to share that unless I was working for Novartis?

Ah! I think I really hit upon pharma's viral social media strategy -- get your agents, acting like real patients, to spread the word. By agents I mean ad and pr agencies who hire ordinary people to do the dirty work. I believe that this is happening (see "Professional 'Hired Gun' Pharma Tweeters. Is It a Good Idea?").

But Chester's point was that funny, sexy stuff like Bayer's InBedStory videos are popular and easily spread far and wide by ordinary Joes like me. Well, not like me. I am not among the "one in four men" who have ED, which is a claim made in one of Bayer's videos; in another video, the male character claims that "maybe there's a whole army of men out there needing to put more balls into the cannon, so to speak" (BTW, I have issue with these exaggerated ED prevalence claims; see "40over40: Lilly's DTC ED Awareness Campaign in the UK").

The funny thing is, Bayer has shut down practically ALL of the social media, viral functions on its InBedStory Youtube channel. You can't submit comments and you can't embed any of the videos in blogs like this one. So I can't embed Episode #9 ("Sex Tape"), which is by the far the MOST popular video in the series, in this post. But here's a scene from it, which you can click on to get to the Youtube site.


 
View the Video


I should mention that you can "Share" InBedStory videos by distributing links to them in Twitter, Blogger, email messages, etc. I guess that counts as viral. It seems, however, that not many people are doing this EXCEPT for the "Sex Tape" video, which has been viewed more than 126,000 times! This video really has no message other than hinting at various ways of having kinky sex (go ahead, have a look!) All the other videos, which are at least educational and have the message to go talk to your doctor, have been viewed only about 1,000 times -- less than 1% of the views racked up by "Sex Tape." In contrast, "Macks' Osso bucco recipe" Youtube video has over 1,100 views (see embedded version at the end of this post).

BTW, there's also an InBed web site. "See one man's journey from droop to Don Juan" is how the site describes the series of videos. You can "Share This Site," but not by using any nifty social media tool -- you just enter some one's name and email address and Bayer sends them a message like this: "Hi, John Mack sends you the following recommendation http://www.in-bed.info/en/index.php" which is pretty enticing. NOT! I spent all morning entering email  addresses of everyone I know and I hope they will do the same. Yeah for the latest in viral marketing!

Curiously, the InBed website does NOT include Episode #9 ("Sex Tape"), which is the most viral of all videos in the series!

Even if Bayer allowed viewers to comment on and embed its videos, I doubt that it would help the sales of Levitra. The whole effort is UNBRANDED, except for the Levitra flame logo off to the right of the screen. You'd have to be pretty savvy to know that Bayer markets Levitra. The fact is, these videos may get more men to ask their doctors about ED treatments, but it's likely that the doctor will prescribe Viagra, the number one ED drug, and NOT Levitra (#3 in most markets).

But getting men to see their doctors about their erectile dysfunction problems is a good thing whether it sells more Levitra or not. Maybe some of these men have real underlying, untreated medical problems such as diabetes or hypertension that is causing ED. Unfortunately, only one of the 9 InBed videos I viewed mentioned possible underlying medical conditions (ie, high blood pressure).

So, the most viral aspect of InBedStory (video #9) is the least effective in promulgating Bayer's cause (get men to see their doctors about ED) and is the least promoted video on the official website. This hardly seems like a case in support of Chester's contention that pharmaceutical marketers are "counting" on the viral nature of social media to spread their drug messages.



Thursday, August 12, 2010

Is Phil Mickelson Shilling for Enbrel?

The golf world was stunned by Tiger Woods' recent poor performance. Another bit of "stunning" news hit the golf world yesterday when the #2 ranked duffer Phil Mickelson announced that he suffers from Psoriatic Arthritis and is being treated with Enbrel. See "Phil Mickelson Arthritis: Will Play At PGA Whistling Straights".

The New York Times also ran a story: "Immune Disorder Could Be an Enduring Test for Mickelson".

Both these articles mentioned that he was being treated with Enbrel, a drug jointly marketed by AMGEN & PFIZER. The first article I cited includes the subtitle "PGA Championship 2010, Whistling Straits: Phil Mickelson Has Psoriatic Arthritis - Uses Enbrel To Help Manage Condition" and includes this quote from Phil: "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been."

Quite an "unsolicited" celebrity endorsement! Amgen/Pfizer could never quote what Phil said on its Enbrel website as in the following completely fabricated (by me) screen shot:


By the way, although you probably cannot see it in Phil's press conference image shown above, his eyes are completely BLOODSHOT, which indicates to me that he is taking something other than Enbrel to ease the pain (see larger image here).

The New York Times helped Enbrel's cause by supplying the following dire statistics about this medical condition: "As many as 7.5 million people in the United States have psoriasis, according to the National Psoriasis Foundation, and about 30 percent of those with psoriasis develop psoriatic arthritis. While psoriasis often appears between the ages of 15 and 25, the arthritis symptoms usually appear later, often between 30 and 50. When it does, there is no rhyme or reason as to which joints will hurt at any given time."

I am willing to bet that this bit of information came straight from AMGEN/PFIZER's PR people.

It probably did NOT come from the "nonprofit Psoriasis Cure Now" group, which issued a press release entitled "Phil Mickelson's Arthritis Shocks Golf World, Psoriasis Cure Now Says a Reminder That Psoriatic Arthritis Is a Serious Disease." That group, which includes Amgen and Pfizer as sponsors, claimed ONLY 1 million people (less than half the number cited in the NYT article) in the US have psoriatic arthritis. "... cases range from mild to what Phil Mickelson described this week. Fortunately, the man on the edge of being ranked the world's number one golfer is taking Enbrel, a biologic treatment that has transformed the lives of many people with psoriasis, psoriatic arthritis, rheumatoid arthritis and other immune system diseases."

My question is this: Is Phil Mickelson being paid as a spokesperson by Amgen or Pfizer either directly or through Psoriasis Cure Now?

I have surveyed readers about the "Use of Patient Testimonials in DTC & Social Media Advertising" (see survey here) and have also written about it in Pharma Marketing News (see "Real Patient Testimonials: An Effective Social Media Marketing Strategy"; use code 'SMOD239' to download it FREE).

P.S. Does Phil have a Twitter account? Will he do branded tweets like racecar driver Charlie Kimball has done for Levemir? (see “Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!”).

P.P.S. Before you go off on a rant, let  me just say that I admire Phil Mickelson -- unless, of course, he is having an extramarital affair we do not know about! I also like Charlie Kimball and Sally Field and each and every pharma celebrity product endorser!

Wednesday, August 11, 2010

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.

Monday, August 09, 2010

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."

Friday, August 06, 2010

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.



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.

Thursday, August 05, 2010

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."

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?

Wednesday, August 04, 2010

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.
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