Sanofi Says Proposed FDA DTC Guidelines Would Effectively Kill TV Drug Ads

Sanofi Says Proposed FDA DTC Guidelines Would Effectively Kill TV Drug Ads

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, arguing that recent "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads" (find it here) violates the Free Speech Clause of the First Amendment because pharmaceutical marketing is a form of free speech (see "PhRMA Demands that FDA 'Cabin' Its Discretion to Regulate DTC Ads").

Sanofi, on the other hand, in a comment submitted to FDA (see here) argues that "the process presented in the draft guidance would potentially require the sponsor [ie, Sanofi and other pharma companies] to cease the use of TV ads as a vehicle to educate consumers due to significant production challenges as a result of the draft proposed process."

The "process" that Sanofi is talking about is the requirement to submit a "final recorded version [of the ad] in its entirety." Sanofi is concerned that if the ad needs to be changed -- reshot and re-edited -- as a result of FDA pre-review, it be too costly and "resource intensive" for the sponsor.

Not all ads, however, will require FDA review before airing (see "Focus on Drug Safety Communication & TV DTC Advertising" for details) and it is not clear how much it would actually cost to redo the production to comply with FDA comments. Sanofi should have included some specific estimates of these costs and "resources" to bolster its case.

Sanofi offered a compromise. Instead of submitting a "final recorded version" of the TV ad "in its entirety," Sanofi suggests that sponsors submit an "annotated storyboard or animatic [animated?] version of the advertisement."

FDA already reviews storyboards submitted prior to ads being run. In at least one case, however, a violative ad was aired months after FDA had a storyboard in its possession. Only after the ad had run its course did the FDA issue a notice of violation (see "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?").

Sanofi also submitted a comment regarding FDA's requirement for "verification that a spokesperson who is represented as a real patient [in a TV ad] is indeed an actual patient." Sanofi asked that FDA clarify what type of verification would be needed. Would a "signed testimonial from an actual patient" be enough?

Snaofi may be planning to use more real patients in its TV ads as have other pharma companies (eg, Pfizer use of real patients in Chantix TV ads). I've documented one instance where Sanofi has used a real patient in a video ad on YouTube (see "Method Acting for Real Patients Who Play Themselves on Pharma YouTube Channels") but do not recall any TV ads for Sanofi products that used real patients.

Regardless of what verification FDA requires for TV ads, the guidelines only apply to TV ads and NOT to ads that run on YouTube. Hence, although these new guidelines may "kill" TV drug ads, they may be a boon for YouTube ads such as the Sanofi YouTube video mentioned above.

Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Some time ago, I pointed out that certain mobile apps developed by pharmaceutical companies for use by physicians lack adequate disclaimers. Specifically, I was concerned about the software used in these apps that perform calculations to generate data to aid in medical diagnoses. A Psoriasis/PASI app by Janssen Pharmaceutica is an example (see "FDA Promises Still More Guidance! This Time It's Mobile. Janssen's Psoriasis iPhone App May Need It"). I pointed out that this app does NOT include any information about the clinical validity of the PASI calculator nor does it warn the user not to depend on the accuracy of the data.

Today, I found out about AFib Educator 2.0 developed by Sanofi-Aventis (I seemed to have missed 1.0!). The app is intended to be an "interactive way for healthcare providers to illustrate atrial fibrillation and its pharmacologic management for patients and families" (see review on iMedicalApps blog). The "pharmacologic management" is not what you may think; that is, there is no mention of any AFib drug either by trade name or generic name. The app only mentions that "there are treatments available."

Let's look at the disclaimers for these two apps (click the image for an enlarged view):

On the left is the disclaimer for Sanofi's AFib Educator 2.0 and on the right is the disclaimer for Janssen's PAS calculator (updated since I last reviewed the app).

Both disclaimers mention that the app is "not a substitute for medical advice/professional medical care". But only the AFib disclaimer mentions that "Persons using the data within for medical purposes should not rely solely on the accuracy of the data herein." It also mentions that data might be updated periodically -- meaning, I suppose, corrections or more accurate data.

Why doesn't Janssen's Psoriasis/PASI app, which is MUCH more data driven (it calculates a PASI score!), include a similar warning? Obviously, I think it should include that warning.

But more importantly, Janssen's app should include information about the source of the equation it uses to calculate PASI. As I pointed out previously (op cit), there is some difference of medical opinion regarding how PASI should be calculated and which formula should be used by healthcare professionals.

Obviously, ANY healthcare professional can download and use the PASI app. You don't have to be a dermatologist who may be more familiar with PASI calculations than is a general practitioner. In fact, you don't have to be a physician at all! That's fine, but the audience should be made more aware of what's operating "behind" the app to generate the PASI scores.

Be Aware of What's Behind the App
What's going on "behind the app" is a hot topic these days. Recently, major news outlets have reported that there is software running in the background on virtually all smart mobile devices that record every keystroke, supposedly merely to "monitor performance" (see "Is Your Smartphone Tracking Your Keystrokes, Texts and Location?" and the YouTube Video embedded at the end of this post).

It's interesting that part of Janssen's NEW disclaimer HINTS that data are being collected when people use its Psoriasis/PASI app (see screen shot below).

Janssen claims that it is monitoring clicks for performance purposes. However, since it is possible to collect and record ALL keystrokes, there is the possibility that data other than icon clicks are being collected by Janssen. I'll have to see if Trevor Eckhart -- who made the video below -- will take a look at exactly what data the Janssen apps records.

Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?

Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?

August is the cruelest month, especially for pharmaceutical company Facebook pages.

No doubt you've heard that as of August 15, 2011, Facebook will be opening up comments on ALL pharma pages with some exceptions (listen to these podcasts: "Implications of Facebook's Page Commenting Changes: Turning Off Comments May Be a Problem" and "Pharma Facebook Commenting Changes: The 'Final' Story"). That means that the pharmaceutical industry will no longer be able to shut off comments on their Facebook pages. This has lead to speculation that many pharma FB pages will be shut down come August 15.

A couple of pharmaceutical companies have already taken down their Facebook pages or announced they will do so. These include Janssen's ADHD Moms page, which was the first pharma Facebook page, launched in June, 2008, by McNeil Pediatrics (see The Pharmaguy Social Media Timeline™).

"A new Facebook policy, scheduled for Aug. 15, will specifically impact communities that are formed to help people learn more about disease conditions, such as ADHD Moms™, which we sponsor," says a note on the ADHD Moms page. 

"This new policy will alter our ability to consider the appropriateness of comments before they are posted which is important to us as a company in a highly regulated industry." 

"As a result, our ADHD Moms%reg; community will not be available after Aug. 14. Additionally, as of Aug. 9, our Moments™ tab will no longer be available. We want you to know that we value the community formed on this page and this was a difficult decision, but necessary given the Facebook policy change. We apologize to anyone in our community who may be disappointed by this decision."

Sanofi-Aventis said it would discontinue its VOICES page, which became infamous when it was attacked by a "disgruntled" patient (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page").

"Please note that we will be discontinuing the sanofi-aventis VOICES page, effective August 9. We would like to continue this conversation with you, so we ask that you go to the Sanofi US Facebook page to do so."

This marks a turning point in pharma social media. Janssen effectively abandoned 23,725 (more or less) people (including 28 0f my Facebook friends) who "liked" ADHD Moms. It offered no alternative to these people other than third-party resources. Sanofi-Aventis, on the other hand, directed its 859 friends (including 22 of my friends) to its Sanofi US Facebook page, which currently is liked by 360 people (including 11 of my friends).

On the Sanofi US Facebook page, the company states that "To comply with applicable Laws and regulations, we do not use the standard Facebook wall for discussion." It does, however, allow comments on a special "Discussions" page where it previewsthem before being posted. "Just a friendly reminder that all posts are being moderated to ensure they comply with our Terms of Use," said Sanofi.

I had problems finding the Terms of USe, so I posted a question asking where I could find them. I received a reply within 2.5 hours (see screen shot below). The time stamp is odd - I actually posted my question around 3 or 4 PM Eastern US, but the time stamp says 2:20 AM; perhaps my Twitter pal @jonmrich can explain this discrepancy. Another thing Jon might be able to explain is how come Sanofi can still have comments shut off on its wall?

Did the new Facebook policy actually cause these companies to shut down their pages? Janssen seems to put all the blame on Facebook whereas Sanofi seems to blame "Laws and regulations," implying government interference. Of course, there are NO federal Laws or regulations specifically prohibiting Sanofi or any other pharma company from using the "standard" Facebook wall for discussions.

Blaming Facebook or "Laws and regulations" for this reminds me of the final scene of King Kong where the beast is lying dead at the foot of the Empire State Building:

Police Lieutenant: Well, Denham, the airplanes got him.
Carl Denham: Oh no, it wasn't the airplanes. It was beauty killed the beast.

I think there are other reasons why these pages are being shut down -- (1) one (ie, ADHD Moms) may have outlived its usefulness, and (2) one (VOICES) may have been ill-conceived in the first place, giving no benefit to the company and having a tainted history. In these cases, it's just best to shut them down and move on.

Unfortunately, Janssen doesn't seem to have an alternative FB page. It just "abandoned" its 23,725 FB friends. In the scheme of things, this is not a big number considering that Janssen claims ADHD "impacts five million children in the United States, while nearly eight million adults have been diagnosed with the condition" (see here). 23,725 represents only 0.47% of the children's ADHD market. In other words, ADHD Moms was a dismal failure in terms of reaching this market - maybe.

Over the next few days I will maintain a vigil over the pharma Facebook death march. Help me by letting me know of other pharma Facebook pages that announce their demise.

Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance

Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance

Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis filed a "citizen petition" with the FDA yesterday, urging the agency to "establish comprehensive, clear and binding regulations [my emphasis] to guide the industry" in communicating off-label drug information to physicians and payers. You can find the petition here.

Greg Kuetreman, writing about this petition in a post to Lilly's corporate blog (LillyPAD), said "we’re not asking for a change in the regulations -- just clarifications that will help us communicate in a better way." But this is not what the petition says. As I quoted above, the petition is asking for "comprehensive, clear and binding regulations."

In addition to specifically asking for regulations, rather than non-binding guidelines, there are a few other interesting points to make about this "petition" that are relevant to whether or not FDA will be able to issue social media guidance this year (or ever):

The petition asks for regulations regarding manufacturers responses to "unsolicited requests" from physicians for off-label information.

The word "Internet" and the phrase "social media" do not appear in the petition.

"Patients" and "consumers" also are NOT mentioned.

I find these points to be interesting because I recently reported that the FDA 2011 guidance calendar includes guidance for "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet" (see "FDA Drops Social Media from Its 2011 Guidance Agenda"). Whether or not such guidance would satisfy the 7 pharma petitioners with regard to "unsolicited" requests is open to debate.

According to the FDA (see here), a citizen's petition is a way to "influence the way FDA does business... change or cancel a regulation, or to take other action." The agency receives about 200 petitions yearly. "Ultimately, FDA management decides whether to grant a petition. But first, agency staffers evaluate it, a process that may take several weeks to more than a year, depending on the issue's complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly. If not satisfied, the petitioner can take the matter to court."

Since this petition specifically addresses the unsolicited request issue for which FDA planned to issue guidance (see "First FDA Social Media Guidance to Address Responding to 'Unsolicited Requests' for Off-label Information"), that guidance will have to be delayed possibly more than a year while the agency reviews the petition.

If the petitioners are not satisfied with how the FDA responds to the petition, they are likely to "take the matter to court" further hamstringing the FDA efforts to issue social media guidance. The number one pharma company and one of the petitioners is already on record opposing any social media guidance on first amendment grounds (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").

Last week, at the Pharma Virtual Sales & Marketing Summit, I asked Craig Delarge, Director of Healthcare Professional Relationship Marketing at Novo Nordisk, when he thought FDA would issue social media guidance for the industry. His personal opinion was "not in the foreseeable future." That comment surprised me at the time, but now I understand why he said it.

P.S. STRANGE COINCIDENCE?
Pharma's Citizen Petition was filed on the SAME day (July 5) that DDMAC Director, Tom Abrams, said that "publishing social media guidelines for industry is the division's 'highest priority,' and that the document will be 'published as soon as it's vetted.'" Abram's comments were made at the Drug Information Association’s in Chicago (see here).

Lilly's Greg Kuetreman attempted to answer the question "Why Now?" in his blog statement, saying "Because there continues to be some confusion about what companies can - and cannot - say to health care professionals, payers, and patients about new scientific information." Considering that there's ALWAYS been this confusion, Kuetreman's statement fails to answer the question. I think the answer is that pharma anticipated imminent release SM guidelines by the FDA and wanted to delay that release by filing a Citizen Petition.

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

YouTube Interruptus! Dear WhyInsulin: WHY the Dreadful LANTUS Safety Information Blue Screen and Voiceover?

YouTube Interruptus! Dear WhyInsulin: WHY the Dreadful LANTUS Safety Information Blue Screen and Voiceover?

DigiatlBulldog just tweeted this: "Breaking News: GoInsulin's YouTube replacement WhyInsulin is now live http://bit.ly/eDX0cT #socpharm"

The WhyInsulin Youtube Channel seems to be Sanofi-Aventis' latest venture into social media. Importantly, the site allows visitors to submit comments, which is rarely something pharma companies do.

I submitted this comment, which is "pending approval":

"Why was Shenee's video interrupted by the reading of the LANTUS safety information?"

What I was referring to was a dreadful blue screen and voiceover segment that abruptly ended Shenee's story. "Shenee is an active wife and mother who enjoys bowling, fishing, reading and cooking exotic foods with her husband." The blue screen, which began 55 seconds into the 3.04 minute video, merely showed a still text image (no scrolling or any movement at all) while a voiceover read the "Important Safety Information for Lantus" that was displayed on the YouTube page (see below).

I never did get to see what exotic foods Shenee was preparing! The blue screen completely took over the last 2 minutes and 9 seconds of the video!

The surprising thing is that Shenee NEVER mentioned LANTUS or any other treatment during her brief 55 second "story"! Which leads me to ask, Why was it necessary to interrupt her story with this information?

It just runied my whole experience with the site. I gave it a thumbs down. So far, there are 2 thumbs up and 2 thumbs down. What do you think?

Method Acting for Real Patients Who Play Themselves on Pharma YouTube Channels

Method Acting for Real Patients Who Play Themselves on Pharma YouTube Channels

The InPharm post "Sanofi shifts video focus to YouTube" confirmed my belief that the pharmaceutical industry saves money by using almost FREE social media tools like Twitter, Facebook, and YouTube for its online communication needs. It can scrap expensive, custom-designed, standalone video Web sites, post videos to YouTube instead, and save money.

"[T]he size of YouTube’s community (some 490 million unique users per month) and the potential to trim costs – however slightly - following recent warnings that 2011 revenues could fall by 10% are likely factors [for why visitors to Sanofi's standalone video website -- www.sanofi-aventis.tv -- are now sent to a new YouTube channel.]"

I decided to visit the "sanofi-aventis TV" English YouTube channel (here).

The first video I played was titled "Living in the Shadow of Atrial Fibrillation." The first scene showed a man painting his living room. Suddenly, he falls off the ladder and for several seconds we see him breathing with difficulty, sweating, and grabbing his chest on the floor. Pretty dramatic. The full video is embedded at the end of this post. I assume it's still available when you read this.

I'd like to focus on a couple of frames, however, from the first scene here:

Maybe you think this acting is a bit over the top or too dramatic.

It turns out that the "actor" is actually a real patient whose name is Bob. In other words, Bob plays himself in this opening dramatic scene of the video. The part of Bob's wife, Samantha, however, "was played by an actress and based on her testimonial" says S-A in the closing screen of the video.

I've seen real patients in commercials sitting on a couch and talking and then appearing in other scenes cutting vegetables, planting flowers, riding bikes, taking baths, whatever, while a voiceover talks about the side effects. But these appearances require very scant acting skills. They certainly don't require the "method acting" skills that Bob displays in the Atrial Fibrillation video!

I wonder: Did Bob get paid extra for this acting role? Obviously, S-A saved additional money by hiring a novice rather than a skilled actor such as the woman who played Bob's wife.

I wonder: Did Bob learn his direct-to-consumer method acting skills from an as-yet-to-be-famous reincarnation of Lee Strasberg?

I wonder: Will further falls in pharma earnings lead to more patient method actors like Bob?

It's a fascinating social media era we are living in. Not only are newspaper reporters being replaced by bloggers, but professional actors are being replaced by people playing themselves in online videos! We have Nalts to blame for this!

The iPad as a Pharma Marketing Platform

The iPad as a Pharma Marketing Platform

"DTC marketers can't afford the luxury of waiting to see how many people purchase an iPad they have to start experimenting with app development and marketing NOW," says Rich Meyer over at World of DTC Marketing Blog.

The best example of an iPad DTC app Meyer could think of, however, was a cookbook for people with diabetes. As if the world needed a new diabetes cookbook!

I have an iPad and am enjoying it. I have even used it when cooking -- propped up on my kitchen counter next to the chicken parts. But I used the browser to find a recipe for BBQ ribs -- there were hundreds to choose from. I don't need an app for that. I assume the Internet is also full of recipes suitable for people with diabetes.

But Rich was probably thinking of something more useful. Something like Sanofi-Aventis's GoMeals app developed for the iPhone/iPod.

MM&M noted that "Sanofi-Aventis [S-A] is promoting it through outreach to diabetes bloggers as well as tactical advertising, such as banners on diabetes sites, and to the patient community through third-party orgs. As of [December 2009] it was the seventh-most-popular app in the free health and fitness section of Apple's iTunes Store."

I downloaded GoMeals for my iPod and used it to find restaurants in my area. You can compare the nutritional value of different restaurant menus and keep track of your own meals. It's very useful for all of us, not just for people who have diabetes. BTW, I  "forgot" to use the GoMeals app to calculate the nutritional value of my BBQ ribs.

When I used GoMeals on my iPad to find restaurants in my area, it crashed. At first I thought it was because my iPad was not GPS-equipped, but "Mic" said that iPad does have GPS (see comments) -- and he's right! Google Earth knows where I am! At least within 100 yards of where I am. Anyway, S-A needs to fix this problem and develop an iPad version. But is it worth the effort?

The GoMeals app has absolutely no marketing ROI for S-A. It may only be one part of an overall marketing plan to position S-A as a player in the diabetes area. Dennis Urbaniak, S-A's new VP of U.S. Diabetes, was previously Vice President of Innovation and New Customer Channels. No doubt Urbaniak was involved in developing the GoMeals app. BTW, listen to my Pharma Marketing Talk interview of Urbaniak: "What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now."

Geoff McCleary, a mobile and tablet computing expert and vice president of strategy for imc2 health & wellness, suggested these consumer-oriented apps for the iPad that pharma marketers should develop:

• Weekly/monthly health eMagazine for disease state information
• 3D, touch interactive MOAs for disease or treatment education
• Branded support program materials delivered weekly or daily
• Social media-based content for brands or disease groups

How much disease state information can a monthly eMagazine publish and how would an iPad app be better than opening your email and a browser? We don't need an app for that. Same with branded support programs and social media-based content.

How about a "3D, touch interactive" MOA animation for Viagra or YAZ? Now those are pharma apps I'd like to see on my iPad!

You can find McCleary's white paper, "Considering the Apple iPad™ for Pharma Marketing," which has other ideas for apps -- including physician-oriented apps -- here.

P.S. The real marketing value of iPad is iAds, just announced by Apple's Steve Jobs (see "Apple Unveils iAd, iPhone 4.0"). iAds are "in-app" ads served up while you are using a "free" app like GoMeals, which does not have any advertising. Personally, I believe in-app ads are annoying, but if the app is valuable, I will put up with them. For pharma, the hard part will be coming up with truly useful apps.

What Has Sanofi-Aventis Learned from Its Facebook Experience?

What Has Sanofi-Aventis Learned from Its Facebook Experience?

NOTE: This interview has been rescheduled for Tuesday, April 6, 2010 at 2:00 PM EDT.

Dennis Urbaniak, VP U.S. Diabetes and former VP of Innovation and New Customer Channels, Sanofi-Aventis, called what's happening on the Wall of his company's VOICES Facebook page a "key learning experience." He made this comment in a call to me last week. To explain what he meant by that, I invited Mr. Urbaniak to be a guest on my Pharma Marketing Talk show this week (click here for details).

---

What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now

A conversation with Dennis Urbaniak, VP U.S. Diabetes at sanofi-aventis, about the recent activity on S-A's VOICES corporate Facebook page. We'll discuss the lessons learned and hear advice from independent experts. Urbaniak is willing to answer questions and consider advice from listeners.

A FREE Pharma Marketing Talk LIVE Podcast and Online Chat!
Tuesday, April 6, 2010 * 2:00 PM Eastern US

This will be the FIRST time that Dennis Urbaniak/S-A will speak on this issue to the "press" (me) and in an open forum.

---

I warned Urbaniak that this is a LIVE interview and that people can call in with questions or post questions in a live chat window. He responded by saying that he welcomed the discussion and would listen to any recommendations from experts and critics alike. This is the best way to really learn something from the experience and help the industry do a better job in the future.

So, I welcome all the "experts" out there who think they can contribute to the "learning experience" to not only listen in, but to call in and join the discussion. The number to call is (347) 996-5894. Talk to you then!

Where's Your Social Media Crisis Management Plan?

Where's Your Social Media Crisis Management Plan?

According to Chris Kenton of SmartMarketers.com's Inspire Blog, "Surprisingly few companies... have protocols in place to manage social media disasters as they unfold -- even those that have sophisticated crisis management protocols in place for non-social media issues."

Many pharmaceutical companies may be guilty of that lapse in their crisis management strategy. This topic came up today in the #hcsmeu Twitter discussion around Sanofi-Aventis and its VOICES Facebook fiasco (for the story background, see "Patient "Unadvocate" Lays Siege to sanofi-aventis VOICES Facebook Page. Where's S-A's Social Media VOICE?"). The specific questions under discussion were:

1. How should Sanofi aventis have dealt with their Facebook problem? (submitted by Sam Walmsley; @sammielw)
2. How should a pharmaco "engage" a "disgruntled" patient postings AEs on its social media (eg, Facebook) site? Are Terms of Use adequate? (submitted by me - @pharmaguy)

You can find a complete archive of the discussion here. I want to focus on the crisis management aspect. Please read. A bit of free advice ahead!

One type of social media crisis should be easy to manage; eg, someone has set up a Facebook page that uses your logo to make it look like an official corporate site. A case in point may be the "Sanofi Aventis" Facebook page described in the post "sanofi aventis Feels the Social Media Pain. But Is It Authentic?" The site looks authentic, but is it? It uses the SA logo, which makes it look real. But it allows comments, some of which are not complimentary to SA. That seems unusual for an authentic corporate FB page. Some people who should know about these things say it is a fake or at least not "official."

To which I commented: If its is not official, why hasn't SA taken any action to prevent the use of its brand logo on the site? Surely, it could send a "nice" letter from its legal department to the FB people and ask then to cease and desist serving this site that is using the SA logo without official permission.

@xbrochart said: "Agree w/ you John. But when, as a corp, you still consider SM as a playground for your children, why wld u care?"

That comment caused me to Tweet this in reply:

Mack's #1 Social Media Maxim: "Social Media. Not Your Children's Playground Any More!"

That should be in the preface to your SM Crisis Management Plan.

BTW, FOUR years ago I was involved in a case of unauthorized use of a corporate logo on a social media site (blog). Because of my notification to the drug company, its lawyers sent the Blogger/Google people a letter and viola! The logo/site was taken down. See "Cialis Blog Shut Down."

So that's a no-brainer in social media crisis management: protect your brand online so that no crisis that you can't control becomes associated with the brand.

The SA VOICES FB page, however, is an authentic SA campaign and it's in crisis. Many commentators in the #hcsmeu Twitter discussion group offered solutions for how SA should address this particular crisis.

More importantly, SA and other pharmaceutical companies should have a Social Media Crisis Management Plan, which is a set of internal policies that map out EXACTLY what tactics should be employed to deal with every possible scenario. New scenarios should be added based on lessons learned by you or by your competition. Social Media changes rapidly and so should your social media crisis management plan!

Having such a plan will allow you to realize:

Mack's #2 Social Media Maxim: "Yea, though I walk through the valley of the shadow of Social Media, I will fear no patient (un)advocate."

Should Sanofi-Aventis Submit an Adverse Event Report Based on "Disgruntled Patient's" Comments to VOICES FB Page?

Should Sanofi-Aventis Submit an Adverse Event Report Based on "Disgruntled Patient's" Comments to VOICES FB Page?

Sanofi-Aventis (S-A) submitted 14 pages of comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

"As part of routine monitoring of online discussions hosted, or with participation, by a company, postings that contain potential adverse event reports should be addressed according to established company policies and procedures for handling and reporting spontaneous adverse event reports according to current FDA regulations," said S-A in its comments. "This includes, when appropriate [my emphasis], to follow-up to obtain the necessary elements needed to report an adverse event."

Considering the problems that S-A is experiencing on its VOICE Facebook page with regard to "disgruntled patient" Shirley Ledlie (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"), I was wondering if it is appropriate for S-A to follow up with her reports of permanent hair loss side effects of the drug Taxotere.

First, what is an adverse event and is what Shirley's reporting an adverse event?

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.

FDA defines Adverse drug experience as "Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action." (See here)

Shirley reported hair loss, which is known side effect of Taxotere. Are known side effects, especially those listed in the drug labeling (as is hair loss for Taxotere), considered "reportable" adverse events? I found nothing from searching FDA AE reporting pages to indicate that manufacturers are NOT responsible for reporting adverse events if the event is listed as a side effect in the labeling. Besides, Shirley is reporting permanent hair loss, which is not specifically mentioned in the labeling.

In my opinion, therefore, what Shirley has reported in comments to S-A's VOICE Facebook page is a "potential" adverse event report that requires S-A to follow-up.

Shirley's adverse event also satisfies the FDA' guidance on postmarketing adverse reporting, which S-A cites in its comments to FDA: "Before considering any clinical incident for submission to the FDA in an expedited or periodic safety report, applicants, manufacturers, and licensed manufacturers should have knowledge of the following four dats elements:

• An identifiable patient;
• And identifiable reporter;
• A suspect drug, biological product, or device; and
• An adverse event or fatal outcome.

S-A has all four data elements in this case. IMHO, therefore, it is appropriate for S-A not only to follow-up with Shirley, but to submit an adverse event report to the FDA. Has it done so? According to Shirley, S-A refuses to speak with her. if that is true, then S-A is not following its own recommendations it suggested in its comments to the FDA.

Does having a disclaimer about adverse events on its FB page mean that S-A does not have to report this adverse event to the FDA?

The disclaimer states: ""This page is not intended as a forum for discussing sanofi-aventis’ or other companies products including the reporting of side effects associated with the use of prescription drugs. As such, Postings that contain product discussions may be removed by sanofi-aventis... If you, or someone you know, have possibly experienced a side effect while taking any sanofi-aventis product, please contact our Drug Safety department at 1-800-633-1610, option 2, or via fax at 1-908-203-7783. You are also encouraged to report negative side effects of prescription drugs to the FDA. To do so, visit www.fda.gov/medwatch or call 1-800-FDA-1088. Postings may be reviewed by sanofi-aventis and may be subject to removal if they are deemed to be inappropriate or inconsistent with the intended use of this site. We reserve the right to block users who violate the terms of use."

S-A suggests the same kind of wording in its comments to FDA, but does NOT say that having such a disclaimer makes it unnecessary for S-A or other drug companies from fulfilling their obligations to report AEs according to FDA law. I think the FDA would agree that it is still necessary to report adverse events found in comments submitted by an identifiable reporter.

In terms of processing AEs on company-owned social media sites, S-A says that "drug sponsors should monitor (through active participation) their own websites for potential adverse events and report according to existing internal standards. It recommends the following monitoring "parameters:"

1. Development of search terms (product/disease specific) and timeframes
2. Development of process for identifying and transferring potential adverse events to the company's Pharmacovigilance department
3. Training monitoring staff (in-house and/or vendor) on the aforementioned process
4. Training vendors on company standard operating procedures (SOPs) for adverse event reporting
5. Internal/vendor audits to assess compliance

Has S-A implemented these monitoring parameters? About 26% of pharmaceutical companies may not have any social media adverse event monitoring standard operating procedures according to my recent survey (see "WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media" and figure below):

Sanofi-Aventis Updates Facebook Site with Disclaimer, But Shirley Still Posting About Her Side Effects

Sanofi-Aventis Updates Facebook Site with Disclaimer, But Shirley Still Posting About Her Side Effects

Recently, Sanofi-Aventis has been having problems with its VOICES Facebook page (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"). I previously suggested S-A made a faux pas because it did NOT take its own advice about posting a Terms of Use policy on its VOICES Facebook page (see "Patient "Unadvocate" Lays Siege to sanofi-aventis VOICES Facebook Page. Where's S-A's Social Media VOICE?"). I guess someone at S-A read my post because the site now has a disclaimer, which says, in part:

"This page is not intended as a forum for discussing sanofi-aventis’ or other companies products including the reporting of side effects associated with the use of prescription drugs. As such, Postings that contain product discussions may be removed by sanofi-aventis."

The VOICES Wall is now back up with posts and is accepting comments, including the following from Shirey, aka the "disgruntled patient":

"I have just read your disclaimer... Not intended is not the same as not allowed in my eyes."

Shirley's friends are also posting comments like "if this site is not meant for discussions why call it "voices" suggests to me you dont like hearing what is written!!!!!!!!!!"

It will be interesting to see how this all plays out and who will win this "Pharma Social Media Standoff!"

Disgruntled Patient Shuts Down sanofi-aventis Facebook Page

Disgruntled Patient Shuts Down sanofi-aventis Facebook Page

"I actually think i did a very good job in closing down the FB page of Europes largest drugs company, something i am very proud of and something i havent finished with yet," said Shirley Ledlie in a comment made to Social Media Intern's "Ask Me a Question" survey.

In a previous post I documented how Ms. Ledlie -- a cancer survivor who had permanent hair loss after taking Taxotere, a drug marketed by sanofi-aventis (S-A) -- was laying siege to S-A's VOICES Facebook page (see "Patient 'Unadvocate' Lays Siege to sanofi-aventis VOICES Facebook Page. Where's S-A's Social Media VOICE?")

In a quick visit to the VOICES page, I found that all the posts to the Wall had been deleted and have been replaced by this statement: "sanofi-aventis VOICES has no recent posts." No further comments can be posted to the VOICES Wall. It appears that S-A could not stand up to the onslaught waged by Ledlie's solitary "voice" and just decided to call it quits!

A precedent has been set by this experience, which does not bode well for the future of pharma social media.

"So you think it was terrible what i did to SA facebook page do you?," said Ms. Ledlie to Social Media Intern (SMI), who actually expressed no opinion on the matter. "Well you should try living with the disfiguration they have caused me! Thats terrible.

"You want transparancy? so do i," continued Ms Ledlie. "I want SA to be transparent with the data they recieve. If you think SA did such a bad job with FB maybe you should contact Madeline Malia, the director of communication for SA. You can tell her what a rubbish job she did dealing with my FB attack.

"Maybe you could use my skills in finding the weaknesses," finished Ledlie in her comments to Social Media Intern.

"I have no idea why Ms. Ledlie thinks I think what she is doing to S-A is terrible," said SMI in a personal communication. "But I welcome her quixotic campaign for pharma transparency. All she has achieved, however, is a complete blackout!"

UPDATE: S-A has re-opened its FB Wall page for posting: Sanofi-Aventis Updates FB Site with Disclaimer, But Shirley Still Posting About Her Side Effects.