Pharma's Friend: Social Media

With a friend like that, who needs enemies?!

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?

[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:

"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."

"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."

The site is a virtual treasure trove of adverse events reported by patients! You can find the BONIVA stories here. Oh, the humanity!

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!

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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?

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 order of items in this list is more or less the order in which the group shouted them out to me as I was compiling the list. It may or may not be the order in which a plan would be implemented in the real world by your typical pharma company.

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:

@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.

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!

Is This Juvederm XC DTC Print Ad "Fair and Balanced?"

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.

A Little More Math and a Little Less Jingo Pharma Journalism Please

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.