Pharma's Friend: Social Media
With a friend like that, who needs enemies?!
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I am seeing a lot of these tweets and wonder if they violate FDA regulations.
Back in October, 2009, I criticized such a tweet by Boehringer Ingelheim (BI), which I thought did violate FDA regulations (see "Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did"). The tweet is shown below:
In it's comments to the FDA, PhRMA, the US drug industry trade association, included a section about “Responsible Microblogging of Newsworthy Events.” PhRMA stated that the “FDA has set a responsible example in its use of Twitter to broadcast newsworthy events such as new drug approvals. Given the limited space constraints (e.g., 140 characters) of such media, and consistent with FDA's own use of such media [emphasis added], the Agency should allow biopharmaceutical manufacturers to microblog about significant scientific and regulatory events (e.g., approvals, new indications, recalls) for a medicine, provided that (i) all information provided in the initial entry is truthful and accurate, and (ii) the landing page contains a comprehensive description of product risks and benefits. As FDA’s regulations recognize, scientific exchange of information which is neither advertising nor promotion can and should exist, and manufacturers should serve as responsible stewards of such information about the products they develop.”
PhRMA cited this example of a FDA tweet announcing the approval of a new product: “FDA Approves Votrient (pazopnib), a New Treatment for Advanced Form of Kidney Cancer. http://bit.ly/Votrient” A more recent example from the FDA Twitter people is shown below:
I must say I agree with PhRMA's logic: if it's OK for the FDA to do it, then it should also be OK for pharma companies to do it. I note that the FDA has not sent one warning letter to any drug company regarding this issue. FDA has not even sent a letter to Novo Nordis for its Levemir-branded tweet (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!").
[UPDATE: See "Bone-Loss Drugs Linked to Increased Risk of Thigh Fracture - FDA May Act"]
As written in wikipedia, "Break a leg" is a well-known saying in theatre which means "good luck." It is typically said to actors and musicians before they go out onto stage to perform.
I doubt, however, that anyone would say this to Sally Field before filming one of her BONIVA TV commercials. BONIVA, after all, is a drug designed to PREVENT bone fractures in women with postmenopausal osteoporosis.
Actually, the patient information page (on Genentech's site) linked to from the BONIVA Web site says "Boniva helps reverse bone loss in most women who take it, even though they won't be able to see or feel a difference. Boniva may help lower the chances of breaking bones (fractures)."
The part about preventing broken bones, however, is merely conjecture propagated by the marketers of BONIVA. They know that women with osteoporosis are prone to bone fractures and that's what gets them to take the drug.
But does BONIVA and other similar drugs such as Merck's FOSAMAX, Procter & Gamble’s ACTONEL, and Novartis' RECLAST actually INCREASE a woman's chance of breaking a bone?
Where do I get a crazy idea like that? Well, from patients via social media! You know, the crowd that has all that wisdom. In a blog post entitled "Pharma and New York Times are 'Puzzled' by Bone Drug Fractures -- But Patients Aren't," the author cites patient testimonials seen on askapatient.com, a social network site where people can rate the medicines they are taking.
On a scale of 1 to 5 (1=LOW, 5=HIGH), BONIVA gets a score of 1.3 based on 1084 ratings.
Patients also posted stories about how they broke bones while taking BONIVA and similar drugs:
I noted before that relying on the "wisdom of the crowd" to decide which drugs to take was a mistake (see "Crowdsourcing Vs. Science"). So, I don't believe in patient ratings of drugs when you don't even know the N -- the number of people voting, which was the case with the iGuard ratings I criticized.
But 1084 is a pretty impressive N! Also, I might look to the crowd's negative experiences to help inform me of the risks of drugs I am taking or about to take.
Like all Rx drugs, BONIVA has risks. One of them is increase bone brittleness, according to this report cited in the blog post I mentioned above:
That conclusion was based on 12 such "rare types of fractures near the hip." Meanwhile, there a total of 284 hip and leg fractures in the study group.
This is reassuring, although the study cannot rule out risk, said Dr. Dennis Black, the study's leader, who consults for makers of osteoporosis treatments. There was a trend toward more of these unusual fractures among bisphosphonate users, but the difference was small enough to have occurred by chance. "There are too few fractures for definitive proof. But what it does show is that these are very, very rare," Black said.
The study was designed to counteract case reports that have tied these drugs to the unusual fractures of the upper thigh bone, just below the hip, that seem to occur without provocation or injury. But I don't think the results warrant the glowing NYT headline "Study Adds Evidence That Bone Drugs Work, Are Safe."
Another problem with the study was it was a "meta-analysis" of several different studies. I think GSK has balked at using such analyses when Dr. Steven Nissen cited the heart risks associated with AVANDIA. Just another example of the drug industry having its cake and eating it too!
Anyway, back to Sally. She's been a spokesperson for BONIVA since 2006. So far, she hasn't broken a leg that I know of and I hope she doesn't break any bones in the future. It would be a devastating event both for her and for BONIVA, which is my focus here.
The problem with celebrity endorsements is that the celebrity may experience a side effect and become disgruntled and turn on the brand (see "Andy Behrman, Now an Anti-BMS Spokesperson, Says 'Ask Your Doctor If Abilify is Wrong for You'").
Sally has been taking BONIVA now for 4 years. Perhaps it is time for GSK to drop her before she becomes a liability. But, I wish her good luck. Break a leg, Sally!
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P.S. Meanwhile, Novartis uses "real" women to tell their Reclast stories.
That's "Rhoda" on the left. "Age 65 • Senior citizens program director • Widowed • Plays a mean game of bridge, bakes the best brownies, knits one, purls one (scarf is a work in progress)" is how the site describes her on the Meet Rhoda page.
Is she a real patient?
Before you find yourself in a social media crisis, you should have a Social Media Implementation Plan. I'm not certain that many pharmaceutical companies are doing systematic planning. Many may be launching apps without any plan at all!
Several months ago at an industry conference focused on ePharma marketing, I led a small group discussion about what pharmaceutical companies need to do BEFORE they engage in social media promotion or disease awareness or patient support programs. The group came up with the following list, which is a pretty good outline of a social media implementation plan:
The first item on the list seems the simplest, but it was only recently that Pfizer, for example, implemented this. Eileen Obrien (@EileenObrien), Director, Search & Innovation at Siren Interactive, tweeted about Pfizer opening the firewall to allow Facebook after hearing it from per Pfizer's VP of Communications Ray Kerins at a recent CMI eMarketing event.
A little while ago, Len Starnes, Head of Digital Marketing & Sales, General Medicine at Bayer Schering Pharma, polled his LinkedIn colleagues asking "Does your pharmaceutical company permit social media monitoring?" The chart below shows the results.
There are plenty of restrictions to access. Without access how can your employees learn enough about social media to follow your social media plan let alone design one and implement it?
In my "Rate Your Social Media Readiness Self-Assessment Survey" I asked respondents how often they used social media applications. The pharma respondents answered the question as shown in the following chart:
Less than 40% say they use social media frequently.
Instead of going through the plan items one-by-one, I ask my readers -- you -- to post a comment about your favorite item on the list or add your own. No doubt, we'll have more to say about this in my conversation with Dennis Urbaniak.
Also, regarding "guideposts, internal standard operating procedures," many pharmacos expressed their ideas on this in their official comments to the FDA. I will be reviewing those ideas in the March issue of Pharma Marketing News (see the preview here).
Meanwhile, in today's #hcsmeu Twitter discussion, Manu Field (@manufield) asked "How can Pharma Snr Mgt best be briefed on SM, and what r the barriers we need to overcome? Who already 'gets it'?"
Some responses:
I never expected to see "branded drugs" and "pushed" used in the same sentence by a non-critic like Ehrlich. I suggest that he edit that sentence -- at least put "pushed" in quotes. It elicits an image in the minds of readers that I don't think Ehrlich would approve of.
Ehrlich was speaking about direct-to-consumer (DTC) advertising critics, who have been known to use the word "push" when describing DTC ads as well as how drugs are marketed to physicians. See, for example, the book "Confessions of an RX Drug Pusher" by Gwen Olsen who "spent more than a decade as a sales rep in the pharmaceutical industry working for health care giants such as Johnson & Johnson, Bristol-Myers Squibb and Abbott Laboratories."
I searched Google for images to use in this blog post using the search term "drug pusher" and found three versions of Olsen's book cover art on the first page of results!
If it wasn't for Bob's post and use of the word "push," I never would have come across Olsen's book. Now I simply must read it!
Is it fair to call Rx drug marketers "pushers?" It all depends on how you define "pusher." Of course, the term is almost always used in relation to the sale of illegal drugs, not Rx medications. But since Bob has used it to describe promotion of legal drugs, we'll leave legal vs. illegal out of the equation.
I've always envisioned "pushers" as unscrupulous drug dealers who attempt to "hook" school kids on drugs by first offering them "free" samples. "Try it Johnnie! If you like it, I can get you more and give you a good deal." Hmmm... this is exactly what "free" samples given to docs by drug sales reps are designed to do. It's a form of "pushing" using the physician as the middleman -- the ultimate drug user being the patient. Of course, for this whole process to work, you need to get the patient into the doctor's office, which is the role of DTC advertising.
In the world of illegal drug sales, the pusher has direct contact with the user and seeks them where they hang out; eg, school yards. In the world of Rx drug "pushing," the "users" (ie, consumers) are found where THEY hang out: the living room!
Jeez! When you think of DTC advertising that way, it feels way creepy! Thanks Bob for planting that image in my brain!
Take a look at the Juvederm XC ad, which I found in this week's New Yorker Magazine, which (coincidentally) includes an article about treatment of wrinkles ("Face It: The Truth About Wrinkles"). The article does not mention Juvederm and hardly has anything at all to say about injection of gels into the skin.
Do you think this ad is "fair and balanced"; ie, presents risk information that is "comparable in depth and detail with the claims for effectiveness or safety" as required by the Federal Food, Drug, and Cosmetic Act?
FDA issues "notice of violation (NOV)" letters to drug companies when it feels that promotional pieces overly minimizes risk information.
Should FDA send a NOV letter to Allergan, which markets Juvederm?
"Promotional materials are misleading," said FDA in a recent letter to Meda Pharmaceuticals regarding an Astelin promo piece (see "FDA Warns Meda Pharmaceuticals that Astelin Isn't Approved as a Cure for House Cleaning!"), "if they fail to present information about risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug."
With regard to the Astelin promo piece, FDA noted "the only risk information contained on the sign (a disclosure of common adverse events) is presented at the bottom of the sign after the indication for the drug in extremely small font size and in a single-spaced format that makes this information very difficult to read."
Clearly, the Juvederm ad also presents risk information in hard to read "mouse typeface." But let's take a more scientific, quantitative approach. I compared the area devoted to risk information versus benefit information in both the Astelin and Juvederm ads. My thesis is that there is a similar quantitative de-emphasis of risk information in the latter as in the former and that Allergan should also receive a letter from the FDA.
I've collected benefit vs. risk information data for a number of print DTC ads and have found that, on average, Rx drug print ads devote 65.3% to benefit information (includes image area) and 11.8% to risk information (not including information on back of the ad). See "Print DTC: How Does It Measure Up?: A Quantitative Analysis of Risk vs. Benefit Information." Clearly BOTH the Astelin and Juvederm ads devoted MUCH less of the ad space to risk information than the AVERAGE print DTC ad.
I don't know if the FDA will send a letter to Allergan or not. FDA has sent letters regarding violations that seem as trivial as this one may be. I'll be keeping an eye out.
Bnet journalist Jim Edwards cites the Seroquel professional ad shown on the left and suggests that it is implying that "If Calling Mom Makes You Hear Voices, Then AstraZeneca Has a Pill for You." That's the headline of his article (see here), which is what all the search engines and blogger critics are going to pick up (ie, this PhamaGossip post).
Edwards immediately waffles and says the ad may be making one of these two claims: "...calling your mom [can] worsen your symptoms if you're a schizophrenic... Or ... taking antipsychotic medicine [can] help you to remember to call your mom more often." The headline clearly underscores which of these Edwards favors.
Further down in the article, Edwards says "The ad shows a chart with two variables, 'Calling mom?' and 'Dosing.' The line between them indicates that more you call her, the more Seroquel you’ll need to deal with the mental fallout." He does admit an alternative, which he "guesses" was AZ's intent; namely, "the chart shows that the more Seroquel you take, the more you’ll be psychologically stable enough to call her."
Anyone with a decent knowledge of science and math -- such as physicians to whom this ad is directed -- will understand that there are NO two "alternative" ways to interpret this chart. Mathematically, there is only one way to interpret this and similar charts: the dependent variable -- the one that depends on changes in another variable -- is always plotted on the vertical Y-axis and the independent variable -- the one you change to determine the dependent variable -- is plotted on the horizontal X-axis. Therefore, the chart means that the higher the dose, the more often you are likely to call mom.
Small point. But if you are going to write about the pharmaceutical industry, you need to understand the science before you start criticizing. Fortunately, I have a graduate degree in biochemistry and am a math buff.
You cannot blame Edwards for not being mathematically astute enough to properly interpret this chart. He probably had the same "excellent" grade and high school education in science and math as my kids. A case in point: my son, the mechanical engineer. In a grade school math homework assignment he was asked to plot a series of "ordered pairs," which look like these: (1,1), (2,8), (3, 27), etc. How would YOU plot these? Which number in each pair is plotted on the Y-axis and which on the X-axis?
Answer: The first number in any "ordered" pair is the INDEPENDENT variable, the second number is the DEPENDENT variable. As I said above, there is only one way to plot these: independent on the X-axis and dependent on the Y-axis.
My son was plotting it the "alternative" way, which I indicated was the wrong way. He countered that his teacher said either way was OK! I blew up and ordered my poor son tell his teacher that she was wrong. I don't know if he ever did muster up the courage to do that. But form that point forward I pushed him to take AP math in high school to keep ahead of the math dummies being churned out by our schools.
Enough of my ranting about our educational system!
The thing that I find interesting about the chart in this ad is the question mark ("?") attached to the dependent variable (ie, "Calling mom?"). I suppose this was added to appease the FDA regulators who might otherwise object that the chart is making an unsubstantiated, off-label, claim; ie, taking Seroquel will lead to more calls to mom. The question mark emphasizes that this is just conjecture. However, perhaps the FDA reviewer may be mathematically inclined to ignore that "?" and slap AZ with a warning letter anyway.
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
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!
Seventy (70) different entities submitted one or more comments to the docket. These submitters can be organized into the following eight general categories:
I also compared the types of entity that submitted comments to those that made presentations at the November 2009 public hearing. Of course, there was some overlap because many did both. Here is the bar chart showing the comparison:
(See "Industry Groups will Eat Consumer Advocates' Lunch at FDA Social Media Public Hearing" for my analysis of entities that made presentations at the public hearing.)
It's immediately obvious that there is a more even distribution among commentators than among presenters. Whereas only 7% of presenters at the public hearing were pharma companies, 21% of commentators were pharma companies. Pharma obviously played it close to the vest and many companies decided not to be in the limelight at the public hearing but waited until the very last minute to submit comments to the docket.
Consumer Advocates also stepped up to provide comments, whereas very few made presentations at the public hearing. As I suggested at the time, it cost money to attend these hearings and individuals simply cannot afford it.
My "Consumer Advocate" category of commentators is comprised of these 12 organizations and individuals:
I compared my follower profile with that of @pfizer_news (Pfizer's official Twitter account) and a few of my Twitter pals (@shwen, @jonmrich, @maverickNY, and @swoodruff; except for @shwen, these people are consultants to the pharmaceutical industry or work in agencies servicing the industry; @shwen is employed in a pharma company as a new media expert). The charts are shown below (click for an enlarged view).
In each case, I share MORE followers with Pfizer than the other people. For example, @jonmrich and I share 480 followers with @pfizer_news, but I uniquely share 720 additional followers with @pfizer_news, whereas @jonmrich uniquely shares only 122 additional followers with @pfizer_news (see chart on upper left). Or to put it another way, I share a total of 1,200 followers with @pfizer_news whereas @jonmrich shares only a total of 602 followers with @pfizer_news.
What does this mean? Well, if more Pfizer Twitter followers also follow me than follow the other "experts," I guess what I have to say is more relevant to these people. The people who follow me and Pfizer are in the pharma mainstream. I have been surveying my followers and have put together a profile, which you can find in this Pharma Marketing News article: "Pharmaguy's Twitter Followers: What Do They Want and How Is It Relevant to You?"
Let me restate it this way: I made a comparison between me and the best of the best on pharma's "team." By which I mean that @jonmrich, @MaverickNY, and @shwen are very "pro" pharma and have been known to support many pharma marketing practices that I have been critical of. In that context, it was interesting to ME and probably ONLY to me to compare who follows these people with who follows me. The fact that I can compete with these industry advocates to reach the same audience that follows the world's largest pharma company means a lot to ME because it proves I am not of marginal influence among industry watchers. From time to time it is nice to toot one's own horn, which is what this is all about.
You can see from the comments that I may have offended some of my colleagues. I am truly sorry for that and hope we can move on.
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:
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."
According to an MM&M story, "Ex-Extra host and broadcast journalist Dayna Devon will dispense personal tips to Facebook fans each week, and is sharing her experience with Juvederm through the social networking site."
But why open up a Facebook page, which looks like just another product website (see screen shot below), especially if you are not going to accept and publish comments to the Wall?
IMHO, Allergan and other pharma companies are not launching Facebook pages to "engage" consumers in "dialogue." First, there is no "dialogue." Of course, the excuse is that pharma is waiting for the FDA to publish guidelines that will allow them to use ALL the nifty social networking features of Facebook, including online dialogue. Here's an example of how the FDA is being blamed for not "allowing" comments on pharma Facebook pages:
The REAL reason for launching Facebook pages is because of Facebook's POPULARITY and the number of "eyeballs" it can deliver, not the the number of conversations. According to the latest Hitwise analysis, Facebook has surpassed Google in terms of Web site traffic (see figure below and "Facebook More Popular Than Google? Let the Ad Wars Begin").
In comments to the FDA, Johnson & Johnson (JNJ) stated "Flexibility in regulatory approach is crucial in the evolving digital world." The comment was part of an 8-page document submitted to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).
JNJ especially would like FDA to be as flexible as the FTC in regards to disclosure of important drug safety information within the context of space-limited digital applications.
"Technology," says JNJ, "can help companies provide information about products in convenient and easily accessible ways, particularly for applications with limited space options. In such cases, links, rollover and scrolling functions can enable direct connections to safety and efficacy information about regulated products."
JNJ cites FTC's "reasonable man" as a model (see "Dot Com Disclosures: Information About Online Advertising (2000)"). From that source, JNJ offered this quote:
"Website are interactive and have a certain depth--with multiple pages linked together and pop-up screens, for example--that may affect how proximity [of required disclosures] is evaluated." Therefore, "[a]dvertisers have the flexibility to be creative in designing their ads, so long as necessary disclosures are communicated effectively and the overall message conveyed to consumers is not misleading" given that "[i]n reviewing their online ads, advertisers should adopt the perspective of the reasonable man."
Arnie Fried, former Pfizer Counsel, has already brought up the issue of "reasonable man" in context of FDA regulation of the Internet (see "Arnold Friede Blasts FDA's Right to Define "Reasonable Man" Without External Input").
What JNJ and Friede omitted to mention is this quote from the same FTC report: "On a Web page, the disclosure is more likely to be effective if consumers view the claim and disclosure together on the same screen. Even if a disclosure is not tied to a particular word or phrase, it is more likely that consumers will notice it if it is placed next to the information, product, or service to which it relates."
And this:
Admittedly, I have not studied the FTC document thoroughly, but I do note that it was written at least 10 years ago, long before space-limited social media emerged within the "evolving digital world." It's utility as a model in today's world, therefore, is limited.
The FTC, however, did address one case where space is limited: banner ads.
Which leads me to think about how technology will evolve 10 years from now. Perhaps all this fretting about "space-limited" social media (eg, Twitter) will be as irrelevant as space-limited banner ads are today. Flexibility, therefore, is required from the FDA when it issues regulations regarding social media. However, that does not mean that it should not issue any guidelines at all. As the technology evolves FDA should also revise its guidelines to keep up (see "FDA Social Media Guidelines Best Done in Baby Steps"). Some day, even TV technology may evolve that would require new broadcast regulatory guidelines.
Novartis made many interesting proposals on how FDA should regulate the use of social media by drug companies, but I'd like to focus on one of particular interest to me: special FDA-sanctioned short URLs and hashtags that make it easy for consumers to find product-safety information and for the FDA to review social media communications for compliance.
Novartis first recommended using a "new short URL, essentially a bit.ly for the FDA , that points to drug information on an FDA controlled website... Our recommendation is that the URL include mention of 'safe' or 'safety.' This website could then contain prescribing information and important safety information wholly controlled and approved by the FDA, removing the need for multiple, additional reviews by an FDA committee of language used on the Internet." [My emphasis.] Novartis calls this "One review, many uses."
The second recommendation was for the FDA to consider "establishing a set of search terms that are in the interest of public health and the FDA's compliance agenda. These terms can be assigned a hastag ('#'). Widely recognized by Social Media users, hashtags communicate and make it easier for people to find information."
I mentioned the use of hashtags in my presentation to the FDA during the November, 2009, public hearing: "If each product was assigned a unique hashtag by the FDA and all product tweets were required to include that hashtag, then the FDA, consumers, and healthcare professionals could easily review all the product tweets and ensure they obey regulations regarding fair balance presentation" (see "FDA Social Media Guidelines Best Done in Baby Steps").
Actually, the hashtag idea was submitted in at least two comments to my survey of readers (see "WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media"):
"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:
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:"
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!"
In defense of the "one-click rule" for space-limited "generic" search ads and "Rich Ads in Search (RAIS)," Yahoo! presented a study that purports to prove that "When it comes to side effects... the patient mindset appears to be ambivalent until research for an ailment is needed" (see Exhibit A (pdf)). The following chart was offered in evidence:
The question, which was posed to 2,540 Online Americans in the study, was "As you may or may not know the FDA (Federal Drug Administration) mandates companies to lay out side effect information or risk factors in advertising. Using the scale below please tell us how much you agree with the following statements when it comes to medication advertising online."
It's not clear from Yahoo!'s comments whether or not respondents to their survey were asked to look at specific online ads. Recall that Merck, in its defense of the "one-click rule," did a study that asked respondents opinions about specific ads they were shown (see "Merck Says FDA Should Approve the 'One-Click Rule'").
A bigger problem I have with these data is that they do not support Yahoo!'s conclusion. Although 23-26% of respondents claim they agreed or strongly agreed with the statements, twice as many (43-45%) must have said they disagreed or strongly disagreed! I contend, therefore, that these results DO NOT prove the point that Yahoo! was trying to make. In fact, the data prove just the opposite: patients DO pay attention to medication side effects in online advertising BEFORE they ask their doctors or research it more online!
Am I not seeing something that I should be seeing in these data? Take a look at Exhibit A (pdf) yourself and tell me what you think.
FDA is considering issuing new guidelines regarding regulation of pharmaceutical use of the Internet for promoting drugs. The drug industry and online service providers like Google and Yahoo! hammered into the FDA's head how important the Internet is for health information seekers. Speaker after speaker made the point: the Internet can no longer be ignored if you are serious about protecting the public health. "The trend towards Americans seeking health information online generally is considered to be positive from the standpoint of improved healthcare," said Yahoo! in comments submitted to the FDA.
A new study, however, offers evidence suggesting that "using the Internet for health purposes [is] associated with increased depression," which doesn't sound like a health and wellbeing improvement! "The increase [in depression] may be due to increased rumination, unnecessary alarm, or over-attention to health problems," said the researchers (see "Effects of Internet Use on Health and Depression: A Longitudinal Study"; Bessière K, Pressman S, Kiesler S, Kraut R; J Med Internet Res 2010 (Mar 12); 12(1):e6).
"It may be that one source of the increase in depression is the misinformation people get from factually incorrect websites," say the researchers. "This may lead to inaccurate self-diagnosis, poor health behaviors (eg, herbal remedies), or potentially unnecessary worry (for both healthy and ill populations)." This is similar to the argument used by the drug industry in support of more lax regulation by the FDA. If consumers and patients had easier access to FDA-approved information, it would counterbalance the bad information, claims the industry.
Use of Social Networks May Decrease Depression
The study also found that "using the Internet to communicate with friends and family was associated with declines in depression." Although not studied in this research, perhaps online social networking with other patients also is associated with declines in depression.
This study was conducted between 2000 and 2002 and the researchers recognize that the Internet and access to it have changed dramatically since then, especially the rise of social networking resources. "The quality of health information and support online may have improved," say the researchers, "and Internet users today may no longer use Internet resources in the same fashion as they did during the time period of our study..."
Perhaps if drug companies could more easily supply hopeful messages about effective treatments via the Internet, online health information seekers may be less depressed. Online health information seekers may even be the opposite of depressed -- ie, joyful -- if drug companies were to support open and authentic social networks where patients can exchange personal information and share stories.
Beware of the Disgruntled Patient!
Drug companies, however, should NOT OWN or CONTROL these kinds of social networks because of DPS -- the "disgruntled patient syndrome," which was most recently brought to light by the sanofi-aventis VOICES Facebook Fiasco (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"). As I have said previously, Pharma Should Leave Unmoderated SM Discussions to 3rd Parties (see here).
"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.
Regular readers of Pharma Marketing Blog are familiar with Emily Jameson, aka "FDA Intern" and "PhRMA Intern." Emily has moved on to accept a position with a leading pharma interactive media agency and is now Social Media Intern!
We've watched Emily's career progress from her internship at PhRMA, which hired her fresh out college because she was related to one of PhRMA's VPs, to her stint at FDA where she was instrumental in nudging that organization to call for a public hearing on the regulation of social media.
It's only natural, therefore, that Emily has ended up on the agency side of the business where she will be able to directly serve the interests of the pharmaceutical industry, which seems to need all the help it can get these days in terms of avoiding social media faux pas.
It is precisely a recent faux pas that caught the attention of Social Media Intern in the first episode of the Adventures of Social Media Intern, which I am please to present here.
Ask Social Media Intern Your Question
"I enjoy changing the course of social networks, fixing an errant Facebook page faster than a speeding bullet, and jumping over the highest hurdles of any pharma legal/regulatory department," says Social Media Intern (SMI). "As an intern I do not make much money. My job is to find pharma social media "dummies" who launch social media campaigns without thinking! You can help me find these dummies by answering my 'Ask Social Media Intern' survey/questionnaire. CLICK HERE to submit info about your favorite social media dummy!"
Tell SMI about:
Become a fan of Social Media Intern on Facebook: visit her Facebook page here: www.facebook/com/socialmediaintern
Follow Social Media Intern on Twitter: @SM_Intern
Shirley Ledlie, aka "Ann Adams", "Julie Kahn", "Jasper Boon", and who-knows-how-many-more-phony-FB-aliases -- the patient who claims sanofi-aventis (S-A) mislead her about the side effects of cancer drug Taxotere (see "sanofi aventis Feels the Social Media Pain. But Is It Authentic?") -- is laying siege to S-A's VOICES Facebook page. Maybe some of these other people are real friends of Shirley and not just fake FB accounts. Only Shirley knows for sure. She has recruited at least one real person-- her daughter -- to post for her:
The VOICES FB page is a legit S-A page, which focuses on support of Deep Vein Thrombosis (DVT) prevention and awareness. [CORR: This S-A FB page is NOT focused on DVT. It's more vague than that: it's a corporate communications effort to "..[e]mpower employees, retirees, friends, families and communities to educate, engage, and mobilize with our grassroots network as we focus on healthcare industry priorities." DVT was just mentioned as one of these priorities in a post to the Wall]. In any case, this is an unbranded site. VOICES is an acronym for Vitalize, Organize, Involve, Communicate, Educate, Serve.
This attack smells to me like an organized campaign designed by professional PR people who might be employed by a law firm representing Shirley in a current or planned lawsuit against S-A. I asked Shirley:
Probably the papers have not yet been served, therefore no "lawsuit"!
Where's the Terms of Use Policy?
In any case, S-A has made a faux pas and has NOT taken its own advice about posting a Terms of Use policy on its VOICES Facebook page. In comments to the FDA, S-A stated that
Where is S-A's Social Media VOICE?
S-A sure is getting a lesson on how to handle social media communications! What it needs to do quickly is to get vitalized, organize its response, involve its legal and PR people, communicate with Shirley, and educate themselves about social media so that they better serve their FB community!
P.S. I was just informed that all the posts I mentioned are now gone from the VOICES FB page. I, however, still find the comments posted to the site's Wall. In case you think I made all this up, I took a screen shot of the top few posts this morning. Here it is:
As I mentioned above, you can find all the posts copied here.
MicroBlogging About "Newsworthy" Events: Should Pharma Follow FDA's Lead?
Many pharmaceutical corporate Twitter accounts are devoted to posting news about the company, including news about new research results relating to one of its products. In these tweets, product names are mentioned as well as the research results, but no fair balance information is included. Such tweets include links to press releases, which include all the necessary risk information.I am seeing a lot of these tweets and wonder if they violate FDA regulations.
Back in October, 2009, I criticized such a tweet by Boehringer Ingelheim (BI), which I thought did violate FDA regulations (see "Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did"). The tweet is shown below:
In it's comments to the FDA, PhRMA, the US drug industry trade association, included a section about “Responsible Microblogging of Newsworthy Events.” PhRMA stated that the “FDA has set a responsible example in its use of Twitter to broadcast newsworthy events such as new drug approvals. Given the limited space constraints (e.g., 140 characters) of such media, and consistent with FDA's own use of such media [emphasis added], the Agency should allow biopharmaceutical manufacturers to microblog about significant scientific and regulatory events (e.g., approvals, new indications, recalls) for a medicine, provided that (i) all information provided in the initial entry is truthful and accurate, and (ii) the landing page contains a comprehensive description of product risks and benefits. As FDA’s regulations recognize, scientific exchange of information which is neither advertising nor promotion can and should exist, and manufacturers should serve as responsible stewards of such information about the products they develop.”
PhRMA cited this example of a FDA tweet announcing the approval of a new product: “FDA Approves Votrient (pazopnib), a New Treatment for Advanced Form of Kidney Cancer. http://bit.ly/Votrient” A more recent example from the FDA Twitter people is shown below:
I must say I agree with PhRMA's logic: if it's OK for the FDA to do it, then it should also be OK for pharma companies to do it. I note that the FDA has not sent one warning letter to any drug company regarding this issue. FDA has not even sent a letter to Novo Nordis for its Levemir-branded tweet (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!").
What If, God Forbid, Sally Field Broke Her Leg?
As written in wikipedia, "Break a leg" is a well-known saying in theatre which means "good luck." It is typically said to actors and musicians before they go out onto stage to perform.
I doubt, however, that anyone would say this to Sally Field before filming one of her BONIVA TV commercials. BONIVA, after all, is a drug designed to PREVENT bone fractures in women with postmenopausal osteoporosis.
Actually, the patient information page (on Genentech's site) linked to from the BONIVA Web site says "Boniva helps reverse bone loss in most women who take it, even though they won't be able to see or feel a difference. Boniva may help lower the chances of breaking bones (fractures)."
The part about preventing broken bones, however, is merely conjecture propagated by the marketers of BONIVA. They know that women with osteoporosis are prone to bone fractures and that's what gets them to take the drug.
But does BONIVA and other similar drugs such as Merck's FOSAMAX, Procter & Gamble’s ACTONEL, and Novartis' RECLAST actually INCREASE a woman's chance of breaking a bone?
Where do I get a crazy idea like that? Well, from patients via social media! You know, the crowd that has all that wisdom. In a blog post entitled "Pharma and New York Times are 'Puzzled' by Bone Drug Fractures -- But Patients Aren't," the author cites patient testimonials seen on askapatient.com, a social network site where people can rate the medicines they are taking.
On a scale of 1 to 5 (1=LOW, 5=HIGH), BONIVA gets a score of 1.3 based on 1084 ratings.
Patients also posted stories about how they broke bones while taking BONIVA and similar drugs:
"After six years of taking Fosamax, I slipped in ice in my driveway and broke my femur (thigh bone). Two years later, still taking Fosamax, I fell in the snow and my other femur snapped before I hit the ground."The site is a virtual treasure trove of adverse events reported by patients! You can find the BONIVA stories here. Oh, the humanity!
"I am filling this out because my Mom took Boniva for many years. I now realize her death was in part due to her taking Boniva. She had so many of the side affects listed and I wish I had known while she was alive that they were caused by Boniva, so I could have taken her off of this poison.I suggested that she go on this-I feel so guilty. I hope this report helps others recognize what this drug does to your body. It certainly did not make my mother's bones stronger. She had so much muscle pain all over, but especially her back, broke her pelvis and had fratures in 4 vertebrae while taking Boniva."
I noted before that relying on the "wisdom of the crowd" to decide which drugs to take was a mistake (see "Crowdsourcing Vs. Science"). So, I don't believe in patient ratings of drugs when you don't even know the N -- the number of people voting, which was the case with the iGuard ratings I criticized.
But 1084 is a pretty impressive N! Also, I might look to the crowd's negative experiences to help inform me of the risks of drugs I am taking or about to take.
Like all Rx drugs, BONIVA has risks. One of them is increase bone brittleness, according to this report cited in the blog post I mentioned above:
"Bisphosphonates preserve and remineralize bone by turning off bone remodeling– creation of new bone–that would normally occur. But as early as 2004, Gordon Strewler, MD in the New England Journal of Medicine and Susan M. Ott, MD in the Annals of Internal Medicine warned the remineralized bones could become brittle and fracture-prone and that the drug may actually cause what it is supposed to prevent."In a study sponsored by Merck and Novartis, in which 14,000 women were given Fosamax, Reclast or dummy treatments for three to 10 years, these drugs do not "significantly raise the risk of a rare type of fracture near the hip" (see "Study Adds Evidence That Bone Drugs Work, Are Safe").
That conclusion was based on 12 such "rare types of fractures near the hip." Meanwhile, there a total of 284 hip and leg fractures in the study group.
This is reassuring, although the study cannot rule out risk, said Dr. Dennis Black, the study's leader, who consults for makers of osteoporosis treatments. There was a trend toward more of these unusual fractures among bisphosphonate users, but the difference was small enough to have occurred by chance. "There are too few fractures for definitive proof. But what it does show is that these are very, very rare," Black said.
The study was designed to counteract case reports that have tied these drugs to the unusual fractures of the upper thigh bone, just below the hip, that seem to occur without provocation or injury. But I don't think the results warrant the glowing NYT headline "Study Adds Evidence That Bone Drugs Work, Are Safe."
Another problem with the study was it was a "meta-analysis" of several different studies. I think GSK has balked at using such analyses when Dr. Steven Nissen cited the heart risks associated with AVANDIA. Just another example of the drug industry having its cake and eating it too!
Anyway, back to Sally. She's been a spokesperson for BONIVA since 2006. So far, she hasn't broken a leg that I know of and I hope she doesn't break any bones in the future. It would be a devastating event both for her and for BONIVA, which is my focus here.
The problem with celebrity endorsements is that the celebrity may experience a side effect and become disgruntled and turn on the brand (see "Andy Behrman, Now an Anti-BMS Spokesperson, Says 'Ask Your Doctor If Abilify is Wrong for You'").
Sally has been taking BONIVA now for 4 years. Perhaps it is time for GSK to drop her before she becomes a liability. But, I wish her good luck. Break a leg, Sally!
--------
P.S. Meanwhile, Novartis uses "real" women to tell their Reclast stories.
Is she a real patient?
What's Your Social Media Implementation Plan?
Last week I posted "Where's Your Social Media Crisis Management Plan," which received some good responses from readers, including Sanofi-Aventis (S-A). Dennis Urbaniak, VP U.S. Diabetes and former VP of Innovation and New Customer Channels at S-A called and I will be interviewing him in my Pharma Marketing Talk Show on April 6 (see "What Has Sanofi-Aventis Learned from Its Facebook Experience?").Before you find yourself in a social media crisis, you should have a Social Media Implementation Plan. I'm not certain that many pharmaceutical companies are doing systematic planning. Many may be launching apps without any plan at all!
Several months ago at an industry conference focused on ePharma marketing, I led a small group discussion about what pharmaceutical companies need to do BEFORE they engage in social media promotion or disease awareness or patient support programs. The group came up with the following list, which is a pretty good outline of a social media implementation plan:
- Unblock corporate access to social media so employees can monitor and use applications such as Facebook while at work
- Have a sustained vision/goal
- Become a dialogue company - learn how to listen and respond, not just push messages out
- Get everyone - including marketing - on board
- Develop guideposts, internal standard operating procedures
- Training
- Develop a moderation strategy
- Marshall necessary resources - use the best tools available
- Hire a social media Tsar
The first item on the list seems the simplest, but it was only recently that Pfizer, for example, implemented this. Eileen Obrien (@EileenObrien), Director, Search & Innovation at Siren Interactive, tweeted about Pfizer opening the firewall to allow Facebook after hearing it from per Pfizer's VP of Communications Ray Kerins at a recent CMI eMarketing event.
A little while ago, Len Starnes, Head of Digital Marketing & Sales, General Medicine at Bayer Schering Pharma, polled his LinkedIn colleagues asking "Does your pharmaceutical company permit social media monitoring?" The chart below shows the results.
In my "Rate Your Social Media Readiness Self-Assessment Survey" I asked respondents how often they used social media applications. The pharma respondents answered the question as shown in the following chart:
Less than 40% say they use social media frequently.
Instead of going through the plan items one-by-one, I ask my readers -- you -- to post a comment about your favorite item on the list or add your own. No doubt, we'll have more to say about this in my conversation with Dennis Urbaniak.
Also, regarding "guideposts, internal standard operating procedures," many pharmacos expressed their ideas on this in their official comments to the FDA. I will be reviewing those ideas in the March issue of Pharma Marketing News (see the preview here).
Meanwhile, in today's #hcsmeu Twitter discussion, Manu Field (@manufield) asked "How can Pharma Snr Mgt best be briefed on SM, and what r the barriers we need to overcome? Who already 'gets it'?"
Some responses:
@andrewspong I thought about COs inviting SM specialists after "the Nestle situation" in my blog http://bit.ly/9C8Cjp
@manufield Not a Q of 'when', but 'how'. Pharma needs to suppress its organizational immune system. Cf. analogy http://bit.ly/9sDqYz
@blogaceutics To create a group of digital natives to guide an internal process and recommend to snr mgt to use SM internally to better adapt
@chibbie: q2 how about invite outside experts that don't have pharma associations #hcsmeu Best digi practice from other industry
@SM_Intern I heard that @pharmaguy asks his fees when working w pharma be donated to favorite charity. http://bit.ly/bf6pgP
Are Pharma Marketers Drug Pushers?
"Critics may not like branded drugs pushed [my emphasis] directly to consumers but it is clear that it brings people in the doctor's door," wrote Bob Ehrlich, Chairman of DTC Perspectives (see "DTC Supported By Ad Critic"). Note to Bob: Please attach your name to your blog posts. I know this was written by you, but new visitors might not realize that these are your opinions. Also, since I am a bit dyslexic, it will help me remember how to spell your last name!I never expected to see "branded drugs" and "pushed" used in the same sentence by a non-critic like Ehrlich. I suggest that he edit that sentence -- at least put "pushed" in quotes. It elicits an image in the minds of readers that I don't think Ehrlich would approve of.
I searched Google for images to use in this blog post using the search term "drug pusher" and found three versions of Olsen's book cover art on the first page of results!
If it wasn't for Bob's post and use of the word "push," I never would have come across Olsen's book. Now I simply must read it!
Is it fair to call Rx drug marketers "pushers?" It all depends on how you define "pusher." Of course, the term is almost always used in relation to the sale of illegal drugs, not Rx medications. But since Bob has used it to describe promotion of legal drugs, we'll leave legal vs. illegal out of the equation.
I've always envisioned "pushers" as unscrupulous drug dealers who attempt to "hook" school kids on drugs by first offering them "free" samples. "Try it Johnnie! If you like it, I can get you more and give you a good deal." Hmmm... this is exactly what "free" samples given to docs by drug sales reps are designed to do. It's a form of "pushing" using the physician as the middleman -- the ultimate drug user being the patient. Of course, for this whole process to work, you need to get the patient into the doctor's office, which is the role of DTC advertising.
In the world of illegal drug sales, the pusher has direct contact with the user and seeks them where they hang out; eg, school yards. In the world of Rx drug "pushing," the "users" (ie, consumers) are found where THEY hang out: the living room!
Jeez! When you think of DTC advertising that way, it feels way creepy! Thanks Bob for planting that image in my brain!
Is This Juvederm XC DTC Print Ad "Fair and Balanced?"
Do you think this ad is "fair and balanced"; ie, presents risk information that is "comparable in depth and detail with the claims for effectiveness or safety" as required by the Federal Food, Drug, and Cosmetic Act?
FDA issues "notice of violation (NOV)" letters to drug companies when it feels that promotional pieces overly minimizes risk information.
Should FDA send a NOV letter to Allergan, which markets Juvederm?
"Promotional materials are misleading," said FDA in a recent letter to Meda Pharmaceuticals regarding an Astelin promo piece (see "FDA Warns Meda Pharmaceuticals that Astelin Isn't Approved as a Cure for House Cleaning!"), "if they fail to present information about risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug."
With regard to the Astelin promo piece, FDA noted "the only risk information contained on the sign (a disclosure of common adverse events) is presented at the bottom of the sign after the indication for the drug in extremely small font size and in a single-spaced format that makes this information very difficult to read."
Clearly, the Juvederm ad also presents risk information in hard to read "mouse typeface." But let's take a more scientific, quantitative approach. I compared the area devoted to risk information versus benefit information in both the Astelin and Juvederm ads. My thesis is that there is a similar quantitative de-emphasis of risk information in the latter as in the former and that Allergan should also receive a letter from the FDA.
I don't know if the FDA will send a letter to Allergan or not. FDA has sent letters regarding violations that seem as trivial as this one may be. I'll be keeping an eye out.
A Little More Math and a Little Less Jingo Pharma Journalism Please
Edwards immediately waffles and says the ad may be making one of these two claims: "...calling your mom [can] worsen your symptoms if you're a schizophrenic... Or ... taking antipsychotic medicine [can] help you to remember to call your mom more often." The headline clearly underscores which of these Edwards favors.
Further down in the article, Edwards says "The ad shows a chart with two variables, 'Calling mom?' and 'Dosing.' The line between them indicates that more you call her, the more Seroquel you’ll need to deal with the mental fallout." He does admit an alternative, which he "guesses" was AZ's intent; namely, "the chart shows that the more Seroquel you take, the more you’ll be psychologically stable enough to call her."
Anyone with a decent knowledge of science and math -- such as physicians to whom this ad is directed -- will understand that there are NO two "alternative" ways to interpret this chart. Mathematically, there is only one way to interpret this and similar charts: the dependent variable -- the one that depends on changes in another variable -- is always plotted on the vertical Y-axis and the independent variable -- the one you change to determine the dependent variable -- is plotted on the horizontal X-axis. Therefore, the chart means that the higher the dose, the more often you are likely to call mom.
Small point. But if you are going to write about the pharmaceutical industry, you need to understand the science before you start criticizing. Fortunately, I have a graduate degree in biochemistry and am a math buff.
You cannot blame Edwards for not being mathematically astute enough to properly interpret this chart. He probably had the same "excellent" grade and high school education in science and math as my kids. A case in point: my son, the mechanical engineer. In a grade school math homework assignment he was asked to plot a series of "ordered pairs," which look like these: (1,1), (2,8), (3, 27), etc. How would YOU plot these? Which number in each pair is plotted on the Y-axis and which on the X-axis?
Answer: The first number in any "ordered" pair is the INDEPENDENT variable, the second number is the DEPENDENT variable. As I said above, there is only one way to plot these: independent on the X-axis and dependent on the Y-axis.
My son was plotting it the "alternative" way, which I indicated was the wrong way. He countered that his teacher said either way was OK! I blew up and ordered my poor son tell his teacher that she was wrong. I don't know if he ever did muster up the courage to do that. But form that point forward I pushed him to take AP math in high school to keep ahead of the math dummies being churned out by our schools.
Enough of my ranting about our educational system!
The thing that I find interesting about the chart in this ad is the question mark ("?") attached to the dependent variable (ie, "Calling mom?"). I suppose this was added to appease the FDA regulators who might otherwise object that the chart is making an unsubstantiated, off-label, claim; ie, taking Seroquel will lead to more calls to mom. The question mark emphasizes that this is just conjecture. However, perhaps the FDA reviewer may be mathematically inclined to ignore that "?" and slap AZ with a warning letter anyway.
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!
Consumer Advocates Step Up and Submit Comments to FDA Regarding Regulation of Social Media
The deadline has come and gone for submitting comments to docket FDA-2009-N-0441 regarding "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." You can find ALL of the comments here at Regulations.gov and easily download MOST of them here at fdaSM.com. Unfortunately, the latter does NOT include text comments that were submitted by individuals. You can find these at the end of this post.Seventy (70) different entities submitted one or more comments to the docket. These submitters can be organized into the following eight general categories:
- HCP Org - Health Professional (HP) or HP Assn
- Search Engine - Google and Yahoo!
- Trade Media - Blog, newsletter, publication focused on drug industry news
- Pharma Company - Drug, device, or diagnostic company
- Consumer Advocate - Individual or consumer advocacy group
- Industry Advocate - Trade association or ad hoc group
- Health Website - Patient, physician, or health activist focus
- Industry Service Provider - Marketing, communications, ad or PR agency that provides services to drug industry
I also compared the types of entity that submitted comments to those that made presentations at the November 2009 public hearing. Of course, there was some overlap because many did both. Here is the bar chart showing the comparison:
(See "Industry Groups will Eat Consumer Advocates' Lunch at FDA Social Media Public Hearing" for my analysis of entities that made presentations at the public hearing.)
It's immediately obvious that there is a more even distribution among commentators than among presenters. Whereas only 7% of presenters at the public hearing were pharma companies, 21% of commentators were pharma companies. Pharma obviously played it close to the vest and many companies decided not to be in the limelight at the public hearing but waited until the very last minute to submit comments to the docket.
Consumer Advocates also stepped up to provide comments, whereas very few made presentations at the public hearing. As I suggested at the time, it cost money to attend these hearings and individuals simply cannot afford it.
My "Consumer Advocate" category of commentators is comprised of these 12 organizations and individuals:
- Anonymous, Individual
- Bruce Overman Jr, Individual
- Center for Digital Democracy, Consumer Advocacy Group
- Consumers Union, Consumer Advocacy Group
- Kathryn Rowerdink, Individual
- Kathy Lambert, Individual
- Melvin Flowers, Individual
- Michael E. Bailey, Individual
- National Organization for Rare Disorders, Consumer Advocacy Group
- Randall Pecsek, Individual
- Michael E. Bailey, Individual
- PEW Prescription Project, Consumer Advocacy Group
"I think the implications of this can get out of hand. Social media and the internet allows for too much false, partially true, information which can harm the lay people who do not know the difference. It may lead to unapproved/remakes of devices that are not safe." -- AnonymousThe two "PRO" commentators expressed these opinions:
"I and many, many others are very much against any further promotion or advertising of Food and Drug Administration-Regulated Medical Products, particularly prescription drugs. I am very much in favor of outlawing the existing practice of advertising prescription drugs. Billions of dollars are spent by pharmaceutical companies to advertise drugs, confusing and misleading the public, most of whom do not have the expertise needed to make proper judgments where these drugs are concerned. This massive amount of money should, instead, be used to reduce the cost of these drugs." -- Bruce Overman Jr
"By using an array of new digital marketing tools -- including behavioral targeting, social media, online video, and mobile -- pharmaceutical companies now have unprecedented abilities to take advantage of consumers." -- Center for Digital Democracy
"The experience with DTC ads from 1997 to the present should be a cautionary tale and compel the agency to carefully examine its options and the appropriate mechanisms to assure against widespread and unbalanced promotion of drug products via online media." - Consumers Union
"I do not want Rx drugs advertised or promoted on TV or through media to the public." -- Kathy Lambert
"This is surely helpful use the FDA regulatory authority. There need to be control on the Internet advertisements epically when it relates to medical devices and labeling." -- Melvin Flowers
"The manufacturers of medications and their representatives must be held accountable for each claim they put on any online media concerning their products because the public health and safety demands it. There maybe some online media that are not suited for drug advertising because of the space limitations involved. There may not be enough space for the important risk information that needs to come with the claims. It is too risky and dangerous to allow the drug company claims alone without the risk information. It is not enough to put in a link that you can click on to take you to another site to get the risk information because many people won't do that and will only read the claims of the drug company that it puts up on the social media. But they should always provide a link to the FDA website for people who want an unbiassed and fair assessment of the drug, and so people can report bad reactions to the drug. Thank you and best wishes, Michael E. Bailey."
"The last thing this country needs is MORE advertising by drug companies. Prescription drugs need to be administered by doctors acting in the best interest of their patients. Patients need to talk to their doctor about a medical "problem", and let the doctor determine the best treatment. Drug ads serve only to feed hypochondria in the public. Marketing of drugs and the costs of advertising serve only to drive up prescription drug costs in America. Our capitalist system is out of control, driving Americans to spent money frivolously. Let's not expand advertising opportunities, let rein them in and recind the rules which allow drug companies to advertise anywhere except medical journals intended for doctors. How many more erectile dysfunction ads do we need to be subjected to?" -- Randall Pecsek
"[W]e urge caution in promulgating rules that could effectively establish new and pervasive modes of industry marketing. It is important that current FDA guidance on the presentation of risk information not be compromised to the detriment of the public health in favor of accommodating evolving industry marketing practice. If a marketing tool, such as a space-limited microblog, or tweet, is unable to satisfy basic consumer protective measures such as the fair balance requirement, that tool should be considered inappropriate for the promotion of pharmaceutical products." -- PEW Prescription Project
"To reduce demand and help curb online diversion, we urge FDA to more stringently regulate pharmaceutical companies' advertising of controlled prescription drugs to physicians and consumers." -- The National Center on Addiction and Substance Abuse, Columbia University
"Patients and patient organizations increasingly are using the social media as an important communications tool. We expect this trend to continue. Patients and families affected by rare diseases have a great need for information since they typically have a greater-than-usual participation in their own, or their loved one?s, disease management and treatment. There is opportunity for the social media to perform a helpful role in facilitating the exchange of information for rare-disease patients and families. There also is significant potential for misuse of the social media or for the circulation of inaccurate or misleading information. It is NORD?s recommendation at this time that FDA continue its deliberation of how best to provide guidance regarding manufacturers? participation in the social media, since the use of social media for sharing of medical information is widespread and growing. We understand that FDA?s resources are limited. However, it is our sense at this time that clear guidance from FDA, similar to that which is currently being provided for traditional advertising modalities, would help to define appropriate ways for manufacturers to participate in this newest of the new media. If NORD, as the primary representative of the rare disease patient community, can assist FDA with defining what the guidelines should be, we would be happy to work with FDA on that process." -- National Organization for Rare DisordersWith individuals such as "Kathryn Rowerdink," it's not clear if they have a bias based on whether or not they receive funding indirectly from the drug industry (eg, are employed by an ad agency that has drug company clients).
"I believe transparency is requested for all of the healthcare industry. Prior to twitter, facebook etc. the public was posting comments on drugs (pros and cons). I have googled drugs by their marketed and generic names to read about other peoples' experiences. I had some reactions to a steroid medication I was prescribed and wanted to find others who might have experienced the same. Doing a search and finding the right forum was extremely difficult and time consuming. A drug makers facebook page or a separate page for each drug was available, it would have made life much easier. A Facebook etc with non-censored updates, stories and comments etc. would have helped me and been faster. If the drug companies and insurance companies (although this is not the topic for the FDA)agree not to censor comments and stories, this is e a great avenue for information exchange. The pros and cons of a drug are more easily assessed through other peoples experiences and comments. Regulations and laws have forced the drug industry to use very complex wording in the packaging (in good faith of full disclosure) however this not helpful to the consumer but overwhelming. I would much rather go to a social media site and view what the possible tangible experiences are so that I may weigh my options and assess the risk. If the FDA chooses to regulate social media I do not see how this is a move toward transparency. The more the FDA represses communication avenues the less people feel informed. Regulating the censoring of comments etc. should be enforced but there are too many loopholes in trying to prevent the healthcare industry from engaging in new communication avenues. The FDA should encourage communication between patients and drug makers. Not only will this help the drug companies to assess needs and fill gaps but consumers are more likely to make their voices heard and feel empowered." -- Kathryn Rowerdink
According to Follower Wonk, I Have More Followers in Common with Pfizer Than Other "Experts"
This morning I learned about "Follower Wonk," a neat Twitter application that creates Venn diagrams showing the overlap among followers of up to three different Twitter accounts. It does other stuff, but I was mostly interested in looking at the follower overlap.I compared my follower profile with that of @pfizer_news (Pfizer's official Twitter account) and a few of my Twitter pals (@shwen, @jonmrich, @maverickNY, and @swoodruff; except for @shwen, these people are consultants to the pharmaceutical industry or work in agencies servicing the industry; @shwen is employed in a pharma company as a new media expert). The charts are shown below (click for an enlarged view).
What does this mean? Well, if more Pfizer Twitter followers also follow me than follow the other "experts," I guess what I have to say is more relevant to these people. The people who follow me and Pfizer are in the pharma mainstream. I have been surveying my followers and have put together a profile, which you can find in this Pharma Marketing News article: "Pharmaguy's Twitter Followers: What Do They Want and How Is It Relevant to You?"
Let me restate it this way: I made a comparison between me and the best of the best on pharma's "team." By which I mean that @jonmrich, @MaverickNY, and @shwen are very "pro" pharma and have been known to support many pharma marketing practices that I have been critical of. In that context, it was interesting to ME and probably ONLY to me to compare who follows these people with who follows me. The fact that I can compete with these industry advocates to reach the same audience that follows the world's largest pharma company means a lot to ME because it proves I am not of marginal influence among industry watchers. From time to time it is nice to toot one's own horn, which is what this is all about.
You can see from the comments that I may have offended some of my colleagues. I am truly sorry for that and hope we can move on.
Where's Your Social Media Crisis Management Plan?
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:
- How should Sanofi aventis have dealt with their Facebook problem? (submitted by Sam Walmsley; @sammielw)
- 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)
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."
Drug Companies Are Flocking to Facebook for Eyeballs, Not Conversation
More and more pharmaceutical companies are launching Facebook pages that promote their products. The latest is Allergan, which launched a celebrity Facebook campaign for Juvederm, a dermal filler used for "long-lasting correction of moderate to severe facial wrinkles and folds." Allergan also makes Botox.According to an MM&M story, "Ex-Extra host and broadcast journalist Dayna Devon will dispense personal tips to Facebook fans each week, and is sharing her experience with Juvederm through the social networking site."
But why open up a Facebook page, which looks like just another product website (see screen shot below), especially if you are not going to accept and publish comments to the Wall?
IMHO, Allergan and other pharma companies are not launching Facebook pages to "engage" consumers in "dialogue." First, there is no "dialogue." Of course, the excuse is that pharma is waiting for the FDA to publish guidelines that will allow them to use ALL the nifty social networking features of Facebook, including online dialogue. Here's an example of how the FDA is being blamed for not "allowing" comments on pharma Facebook pages:
@RosettaHC tweeted: Juvederm launches Facebook page. No open comments allowed. (FDA: when's guidance coming?) http://bit.ly/aPpC8v #hcsm #fdasmIf it looks like a Web 1.0 site and acts like a Web 1.0 site, why not just stick to a Web 1.0 site and forget about Facebook?
The REAL reason for launching Facebook pages is because of Facebook's POPULARITY and the number of "eyeballs" it can deliver, not the the number of conversations. According to the latest Hitwise analysis, Facebook has surpassed Google in terms of Web site traffic (see figure below and "Facebook More Popular Than Google? Let the Ad Wars Begin").
Johnson & Johnson Urges FDA to Be As Flexible As FTC in Its Regulation of Social Media, But...
JNJ especially would like FDA to be as flexible as the FTC in regards to disclosure of important drug safety information within the context of space-limited digital applications.
"Technology," says JNJ, "can help companies provide information about products in convenient and easily accessible ways, particularly for applications with limited space options. In such cases, links, rollover and scrolling functions can enable direct connections to safety and efficacy information about regulated products."
JNJ cites FTC's "reasonable man" as a model (see "Dot Com Disclosures: Information About Online Advertising (2000)"). From that source, JNJ offered this quote:
"Website are interactive and have a certain depth--with multiple pages linked together and pop-up screens, for example--that may affect how proximity [of required disclosures] is evaluated." Therefore, "[a]dvertisers have the flexibility to be creative in designing their ads, so long as necessary disclosures are communicated effectively and the overall message conveyed to consumers is not misleading" given that "[i]n reviewing their online ads, advertisers should adopt the perspective of the reasonable man."
Arnie Fried, former Pfizer Counsel, has already brought up the issue of "reasonable man" in context of FDA regulation of the Internet (see "Arnold Friede Blasts FDA's Right to Define "Reasonable Man" Without External Input").
What JNJ and Friede omitted to mention is this quote from the same FTC report: "On a Web page, the disclosure is more likely to be effective if consumers view the claim and disclosure together on the same screen. Even if a disclosure is not tied to a particular word or phrase, it is more likely that consumers will notice it if it is placed next to the information, product, or service to which it relates."
And this:
"In reviewing their online ads, advertisers should adopt the perspective of a reasonable consumer. They also should assume that consumers don't read an entire Web site, just as they don't read every word on a printed page. In addition, it is important for advertisers to draw attention to the disclosure. Making the disclosure available somewhere in the ad so that consumers who are looking for the information might find it doesn't meet the clear and conspicuous standard.When it comes to this precedent, pharma can't have its cake and eat it too. Somehow it doesn't seem right to selectively quote the FTC only when the quote bolsters your case.
"Even though consumers have control over what and how much information they view on Web sites, they may not be looking for -- or expecting to find -- disclosures. Advertisers are responsible for ensuring that their messages are truthful and not deceptive. Accordingly, disclosures must be communicated effectively so that consumers are likely to notice and understand them."
Admittedly, I have not studied the FTC document thoroughly, but I do note that it was written at least 10 years ago, long before space-limited social media emerged within the "evolving digital world." It's utility as a model in today's world, therefore, is limited.
The FTC, however, did address one case where space is limited: banner ads.
"Disclose required information in the banner itself or clearly and conspicuously on the Web site it links to. In some cases, a required disclosure can be incorporated into a banner ad easily. Because of the space constraints of banner ads, other disclosures may be too detailed to be disclosed effectively in the banner. In some instances, these disclosures may be communicated effectively to consumers if they are made clearly and conspicuously on the Web site the banner links to and while consumers are deciding whether to buy a product or service. In determining whether the disclosure should be placed in the banner itself or on the Web site the banner links to, advertisers should consider how important the information is to prevent deception, how much information needs to be disclosed, the burden of disclosing it in the banner ad, how much information the consumer may absorb from the ad, and how effective the disclosure would be if it was made on the Web site." [My emphasis.]It seems to me that this would have been a better quote for JNJ to cite. Perhaps it's because the drug industry has long ago figured out a way how to use rich media banner ads to supply all the necessary balance within the ad itself. That technology may not have been around in 2000.
Which leads me to think about how technology will evolve 10 years from now. Perhaps all this fretting about "space-limited" social media (eg, Twitter) will be as irrelevant as space-limited banner ads are today. Flexibility, therefore, is required from the FDA when it issues regulations regarding social media. However, that does not mean that it should not issue any guidelines at all. As the technology evolves FDA should also revise its guidelines to keep up (see "FDA Social Media Guidelines Best Done in Baby Steps"). Some day, even TV technology may evolve that would require new broadcast regulatory guidelines.
Novartis Proposes Use of Unique FDA-Approved Short URLs & Hashtags to Overcome Space Limitation Issues of Social Media
Novartis submitted 6 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).Novartis made many interesting proposals on how FDA should regulate the use of social media by drug companies, but I'd like to focus on one of particular interest to me: special FDA-sanctioned short URLs and hashtags that make it easy for consumers to find product-safety information and for the FDA to review social media communications for compliance.
Novartis first recommended using a "new short URL, essentially a bit.ly for the FDA , that points to drug information on an FDA controlled website... Our recommendation is that the URL include mention of 'safe' or 'safety.' This website could then contain prescribing information and important safety information wholly controlled and approved by the FDA, removing the need for multiple, additional reviews by an FDA committee of language used on the Internet." [My emphasis.] Novartis calls this "One review, many uses."
The second recommendation was for the FDA to consider "establishing a set of search terms that are in the interest of public health and the FDA's compliance agenda. These terms can be assigned a hastag ('#'). Widely recognized by Social Media users, hashtags communicate and make it easier for people to find information."
I mentioned the use of hashtags in my presentation to the FDA during the November, 2009, public hearing: "If each product was assigned a unique hashtag by the FDA and all product tweets were required to include that hashtag, then the FDA, consumers, and healthcare professionals could easily review all the product tweets and ensure they obey regulations regarding fair balance presentation" (see "FDA Social Media Guidelines Best Done in Baby Steps").
Actually, the hashtag idea was submitted in at least two comments to my survey of readers (see "WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media"):
"Also, products can be assigned hashtags by FDA, for a Twitter example (eg #Chillax), and be required to use that hashtag in all Twitter communications related to that product, so that FDA can easily review the public tweets. Not sure how the DMs would be monitored. Similar rules for other specific SM sites." [This comment was submitted by someone who indicated that he or she was "Physician, nurse, other healthcare professional (currently practicing or retired) or medical student".]and
"Twitter doesn't allow for more than 140 characters. Perhaps companies should have a hashtag that can go on the end of tweets. So if a company is having people tweet about a campaign, it would read something like "Great campaign called Cure Diabetes @ (link) #Merckcmpns. "#Merckcmpns would be the hash tag for Merck Campaigns and perhaps audiences would soon learn that these hash tags are equivalent to disclaimers on platforms where more copy is allowed." [This comment was submitted by someone who indicated that he or she was "Employed at a marketing/marketing research/advertising/communications agency/company/consultancy having pharmaceutical companies as clients."]Novartis issued this warning: "Having these search terms added should not, however, be permitted to become an undue burden on the message itself. The benefit of a short message can become somewhat lost if it is buried in a stack of agency-required hash tags."
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.
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:"
- Development of search terms (product/disease specific) and timeframes
- Development of process for identifying and transferring potential adverse events to the company's Pharmacovigilance department
- Training monitoring staff (in-house and/or vendor) on the aforementioned process
- Training vendors on company standard operating procedures (SOPs) for adverse event reporting
- Internal/vendor audits to assess compliance
Sanofi-Aventis Updates Facebook Site with Disclaimer, But Shirley Still Posting About Her Side Effects
"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!"
Yahoo!'s Claim That Patients Are "Ambivalent" When It Comes to Side Effect Information in Search Ads Is BS!
Yahoo! submitted 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).In defense of the "one-click rule" for space-limited "generic" search ads and "Rich Ads in Search (RAIS)," Yahoo! presented a study that purports to prove that "When it comes to side effects... the patient mindset appears to be ambivalent until research for an ailment is needed" (see Exhibit A (pdf)). The following chart was offered in evidence:
It's not clear from Yahoo!'s comments whether or not respondents to their survey were asked to look at specific online ads. Recall that Merck, in its defense of the "one-click rule," did a study that asked respondents opinions about specific ads they were shown (see "Merck Says FDA Should Approve the 'One-Click Rule'").
A bigger problem I have with these data is that they do not support Yahoo!'s conclusion. Although 23-26% of respondents claim they agreed or strongly agreed with the statements, twice as many (43-45%) must have said they disagreed or strongly disagreed! I contend, therefore, that these results DO NOT prove the point that Yahoo! was trying to make. In fact, the data prove just the opposite: patients DO pay attention to medication side effects in online advertising BEFORE they ask their doctors or research it more online!
Am I not seeing something that I should be seeing in these data? Take a look at Exhibit A (pdf) yourself and tell me what you think.
Use of Internet to Obtain Health Information Can Make You Depressed
A new study, however, offers evidence suggesting that "using the Internet for health purposes [is] associated with increased depression," which doesn't sound like a health and wellbeing improvement! "The increase [in depression] may be due to increased rumination, unnecessary alarm, or over-attention to health problems," said the researchers (see "Effects of Internet Use on Health and Depression: A Longitudinal Study"; Bessière K, Pressman S, Kiesler S, Kraut R; J Med Internet Res 2010 (Mar 12); 12(1):e6).
"It may be that one source of the increase in depression is the misinformation people get from factually incorrect websites," say the researchers. "This may lead to inaccurate self-diagnosis, poor health behaviors (eg, herbal remedies), or potentially unnecessary worry (for both healthy and ill populations)." This is similar to the argument used by the drug industry in support of more lax regulation by the FDA. If consumers and patients had easier access to FDA-approved information, it would counterbalance the bad information, claims the industry.
Use of Social Networks May Decrease Depression
The study also found that "using the Internet to communicate with friends and family was associated with declines in depression." Although not studied in this research, perhaps online social networking with other patients also is associated with declines in depression.
This study was conducted between 2000 and 2002 and the researchers recognize that the Internet and access to it have changed dramatically since then, especially the rise of social networking resources. "The quality of health information and support online may have improved," say the researchers, "and Internet users today may no longer use Internet resources in the same fashion as they did during the time period of our study..."
Perhaps if drug companies could more easily supply hopeful messages about effective treatments via the Internet, online health information seekers may be less depressed. Online health information seekers may even be the opposite of depressed -- ie, joyful -- if drug companies were to support open and authentic social networks where patients can exchange personal information and share stories.
Beware of the Disgruntled Patient!
Drug companies, however, should NOT OWN or CONTROL these kinds of social networks because of DPS -- the "disgruntled patient syndrome," which was most recently brought to light by the sanofi-aventis VOICES Facebook Fiasco (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"). As I have said previously, Pharma Should Leave Unmoderated SM Discussions to 3rd Parties (see here).
Disgruntled Patient Shuts Down sanofi-aventis Facebook Page
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.
Social Media Intern is Here to Help Pharma Avoid Social Media Faux Pas!
We've watched Emily's career progress from her internship at PhRMA, which hired her fresh out college because she was related to one of PhRMA's VPs, to her stint at FDA where she was instrumental in nudging that organization to call for a public hearing on the regulation of social media.
It's only natural, therefore, that Emily has ended up on the agency side of the business where she will be able to directly serve the interests of the pharmaceutical industry, which seems to need all the help it can get these days in terms of avoiding social media faux pas.
It is precisely a recent faux pas that caught the attention of Social Media Intern in the first episode of the Adventures of Social Media Intern, which I am please to present here.
EPISODE 1: Social Media Intern Searches for Her First Client!
Yes, it's Social Media Intern! Strange visitor from an Ivy League school who came to a leading interactive agency with powers and ability far beyond those of Jonathan Richman or even Fabio Gratton!Social Media Intern! Who can change the course of social networks, fix an errant Facebook page faster than a speeding bullet, jump over the highest hurdles of any pharma legal/regulatory department, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great interactive agency, fights a never ending battle for pharma authenticity, transparency, and the ePharmaPioneer way!
Ask Social Media Intern Your Question
"I enjoy changing the course of social networks, fixing an errant Facebook page faster than a speeding bullet, and jumping over the highest hurdles of any pharma legal/regulatory department," says Social Media Intern (SMI). "As an intern I do not make much money. My job is to find pharma social media "dummies" who launch social media campaigns without thinking! You can help me find these dummies by answering my 'Ask Social Media Intern' survey/questionnaire. CLICK HERE to submit info about your favorite social media dummy!"
Tell SMI about:
- A competitor's feeble effort to leverage social media. Maybe they are pushing the regulatory envelope or not being transparent ... whatever! SMI will find something that's not quite right and she will expose here on Pharma Marketing Blog!
- Maybe you are thinking of launching your own social media initiative, but you want an outside opinion, a critical eye to review it and make sure it doesn't end up as a case that SMI exposes because your competitor reported it to SMI (see above).
- You may be a social media "newbie" -- if you don't know what that means, you are one! -- and have a question. Don't waste SMI's time with stupid questions like what are FDA regulations regarding social medi use by pharmaceutical companies? SMI is interested in questions like I want to use social media to promote a drug off-label, how do you recommend I do that? Now that's a question SMI can sink her teeth into!
Become a fan of Social Media Intern on Facebook: visit her Facebook page here: www.facebook/com/socialmediaintern
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Patient "Unadvocate" Lays Siege to sanofi-aventis VOICES Facebook Page. Where's S-A's Social Media VOICE?
"Hello John," Shirley posted to my FB Wall yesterday, "just to tell you your freind (sic) was right. The SA voices is the real deal. I posted and the same day my post had vanished and i was blocked. So i posted again and within 5 mins my other name was blocked and removed. I think they have someone sitting there waiting for me - so my daughter is going to post for me while i open another account."Today, the VOICES page is flooded with messages from Shirley et al similar to this one posted by "Julie Kahn":
"If your company is typical of the blinkered attitude that big drug companies take when faced with genuine grievances from the poor people that have suffered by using your products - well no wonder that intelligent people are so cynical about the merits of the huge pharmaceutical machine.You can find all the posts by visiting the VOICES FB page, but in case they are removed by S-A, I've collected them here.
"Just because things test fine on the poor animals that are... See More... See more used does not mean that humans will also do well on them. You need to modify certain things with Taxotere and you should be falling on your knees thanking some of these women who have information that will help you. Surely feedback like theirs is vital to your organisation. If you truly cared about improving people's lives through your product you would contact these women and find out about their stories - not just delete their posts and pretend that all is fine in the Sanofi-Aventis garden"
The VOICES FB page is a legit S-A page, which focuses on support of Deep Vein Thrombosis (DVT) prevention and awareness. [CORR: This S-A FB page is NOT focused on DVT. It's more vague than that: it's a corporate communications effort to "..[e]mpower employees, retirees, friends, families and communities to educate, engage, and mobilize with our grassroots network as we focus on healthcare industry priorities." DVT was just mentioned as one of these priorities in a post to the Wall]. In any case, this is an unbranded site. VOICES is an acronym for Vitalize, Organize, Involve, Communicate, Educate, Serve.
This attack smells to me like an organized campaign designed by professional PR people who might be employed by a law firm representing Shirley in a current or planned lawsuit against S-A. I asked Shirley:
"Don't you think you are going too far? While you may have a legitimate issue with S-A, is flooding its FB page ... (VOICES) ethical on your part? I suppose you have a lawsuit against S-A brewing. If so, why don't you reveal that in your posts? Let me know -- I am blogging now!"She responded almost immediately: "Hi John, no lawsuit that we know of. They refuse to answer my registered posted letter and emails so............"
Probably the papers have not yet been served, therefore no "lawsuit"!
Where's the Terms of Use Policy?
In any case, S-A has made a faux pas and has NOT taken its own advice about posting a Terms of Use policy on its VOICES Facebook page. In comments to the FDA, S-A stated that
"It is advisable for company sites to include clearly-stated Terms of Use ... For unbranded (non-promotional) sites, such as those devoted to disease awareness, sanofi-aventis recommends the following Term of use:I searched the VOICES FB page and could not find any Terms of Use statement.
'This site is not intended as a forum for discussing specific products or other treatments. It's best to talk to your doctor about specific treatments. You may want to contact our Medical Information Department for product specific questions at 1-800-xxx-xxxx.'"
Where is S-A's Social Media VOICE?
S-A sure is getting a lesson on how to handle social media communications! What it needs to do quickly is to get vitalized, organize its response, involve its legal and PR people, communicate with Shirley, and educate themselves about social media so that they better serve their FB community!
P.S. I was just informed that all the posts I mentioned are now gone from the VOICES FB page. I, however, still find the comments posted to the site's Wall. In case you think I made all this up, I took a screen shot of the top few posts this morning. Here it is:
As I mentioned above, you can find all the posts copied here.
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