Deconstructing Pitts' Guiding Principles for Pharma Social Media

Peter Pitts over at DrugWonks Blog has put together 11 "principles that must serve as the basic substrate of regulated social media participation" (see here). Pitts offered these principles because he is urging the pharma industry to participate in social media and not wait for FDA guidelines "not because of its potency as a marketing vehicle – but because it’s the right thing to do." Let's take a closer look at "Pitts' Principles."

Principle  1. "We engage in social media to help improve the lives of patients and advance the public health of our nation."

"improve" is the key word here. We all have different definitions of what it means to "improve  the lives of patients and advance the public health of our nation." I, for example, think it is very important to make sure all Americans have affordable healthcare insurance and support efforts to close the gap in Medicare Part D coverage (ie, the "doughnut hole"). The drug industry may not agree with me 100% on this. Lilly, for example, hosted a Twitter "chat" that tried to convince people that Medicase isn't broken, so don't fix it, but I asked "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?" (read this post). Also see "More Pharma Twitter Chats: Medicare is Topic."

Even if we agree on how to improve patient lives, it has not been proven that social media actually can help in this effort. There are plenty of other ways that the drug industry can -- and does -- do things to help improve patient lives. Perhaps social media can help in those efforts (see, for example, "Boehringer Ingelheim and Ashoka Make More Health via Social Media."

Principle 2. "We will thoughtfully engage in social media while remaining in compliance with both the letter and the spirit of FDA regulations."

The word "thoughtfully" requires definition, IMHO. There have been many occasions when pharma companies have seemed to put little thought into their social media activities (see, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons"). 

Seriously, however, "thoughtful" implies best intentions as in showing consideration for the needs and sensibilities of other people (eg, "how thoughtful of you!"). Perhaps Pfizer lacked "thoughfulness" when it promoted on FaceBook a Chapstick ad that angered quite a few women (see "Pfizer's Facebook Fiasco: Chapstick Slapstick Ad Uses Woman's Ass as a Prop").

Principle 3. "Our social media engagements will have both strong public health themes and appropriate marketing communications."

IMHO, "appropriate marketing communications" is the big elephant in the room that cannot be dealt with UNTIL the FDA says what is and what is not "appropriate." This requires more than being compliant with the "spirit of FDA regulations" as noted in Principle 2. It requires being compliant with the "letter" of FDA regulations. Of course, without the "letter" being written by the FDA, there can be no compliance with it.

Principle 4. "All social media messages and partnerships must be accurate, appropriate and transparent."

Pitts said "One principle that runs as a red thread throughout all of these 11 principles is transparency. Real, honest transparency – not the usual translucency that 'in compliance' often brings." I can't agree more. But this is where the drug industry will have problems. I can cite many instances of lack of "transparency" in pharma's social media activities that I have blogged about. For example, during a Lilly-hosted Twitter chat about Medicare, I suspect an employee or agent hired by Lilly posed as an ordinary citizen (@ellsbelles3) who posted "I keep hearing that Medicare Part D is working and not to change it. what does that mean?" This sounded suspiciously like a setup from a phony ordinary citizen similar to "Joe the Plumber" (see "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?"). Although I suspect that Lilly was not being transparent about this, I cannot prove it. That's the problem with transparency in social media -- nobody can prove you are not a "real patient" and it's very easy for unscrupulous players to manipulate the game (ie, conversation).

Principle 5. "We believe that social media presents multiple opportunities to learn more about how our products impact the lives of patients."

Sounds good to me. I hope that pharma is actually listening and learning. It would be interesting to know exactly what the industry is learning about its products from monitoring social media. However, very few companies will even admit they are monitoring social media for fear that FDA will learn that they are not reporting adverse events they hear about (see Principle 7).

Principle  6. "We believe that social media engagement allows us to correct errors and misperceptions about both our company and our products."

"correct errors and misperceptions" is really a slippery slope. Who defines what is "correct" and "not correct"? There are many scientific studies and clinical trials whose results are challenged by the drug industry but that are accepted as correct by other experts. All sides of a debate involving scientific evidence should be discussed with the (transparent) participation of the industry. But if the goal of the drug industry is to "correct" other points of view, then the industry will not be engaging in discussion but trying to manipulate it. Also, keep in mind that the industry itself has often been caught make false statements about its own products -- hence all the warning letters from FDA!

A little pedantic aside: "misperceptions" is a curious word choice. Since Pitts is known to choose his words carefully, the distinction deserves some analysis in the present context of "misperceptions" of drug products by the general public.

According to Grammarist: "To perceive is to become aware of something directly through the senses. To conceive is to form something in the mind or to develop an understanding. So to perceive is merely to see something, and to conceive is deeper. But perception often involves passive evaluation, and this is where the line between the verbs perceive and conceive becomes blurred. Think of perceptions as relatively shallow interpretations, and conceptions as more creative interpretations involving substantial thought or imagination. Think of a misperception as a mistaken impression... and a misconception is a mistake of imagination or interpretation." A simpler distinction: Misperception, means to not understand, misunderstand; Misconception means a mistaken thought.

It's possible that patients, for example, might believe that a muscle ache after being prescribed a statin for high cholesterol is a side effect of the drug. This could be a "misperception" (not a a true pain) or a "misconception" (a real pain but not caused by the drug). Another example: some patients may believe the risks of a drug outweigh the benefits and then decide not to adhere to the treatment regimen prescribed by their doctors. Is this a "misconception" or a "misperception?" Of course, it may be neither: the risks may actually outweigh the benefits!

Anyway, perhaps a better word to use in this context would be "misunderstandings."

Principle 7. "We believe in using social media to discover adverse drug experiences, which will then be addressed off-line."

I like this, but would like to see more real-world examples. I recall only one example of a pharma company that has publicly embraced discovering AEs via social medias: ie, UCB, which partnered with PatientsLikeMe  to create an online, open epilepsy community that includes a pharmacovigilance program to monitor the site for adverse events and report directly to the FDA adverse events associated with UCB products (see "Finally, a Drug Company Embraces Social Media, AEs Included!"). I haven't heard much about this lately -- did UCB find many adverse events and what else did they learn (ie, re Principle 5)? I've seen several studies by agencies that work for the pharmaceutical industry that suggest very few reportable AEs are found on social media sites. PatientsLikeMe, however, reported that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (see "PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members"). Also see: "The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting."

Principle 8. "We will strive to interact in a timely manner, appropriate to the general expectations of social media."

I expect there's a difference in opinion of what is meant by "timely." As has been demonstrated many times, pharma can get into trouble when it does not respond in a timely fashion to social media crises as was the case with Sanofi's response to a disgruntled patient (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"). The ultimate decision of whether a response is "timely" or not is up to the customer (ie, patient, physician, or payor). Whether "striving" is adequate or if "succeeding" is better, remains to be seen.

Principle  9. "We believe that social media must be regularly monitored and our programs measured in real time to gauge effectiveness."

See my comments under Principle 5. The industry also is struggling with how to "measure" social media campaigns. There is also a question whether or not social media should even be campaign-oriented, which implies a beginning and an end.  We've already seen pharma companies shut down Facebook pages and abandoning their social media audiences (see "Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?"). Companies are blaming new Facebook rules for the shut-downs, but I think "campaignitis" has hit -- new marketers come on board and want to run their own "campaigns" or the "campaigns" were not as successful as expected. Which leads me to ask, How do you measure social media success?

Principle 10. "We respect but are not responsible for user-generated content that resides on sites we do not control."

This should not be a principle. It's just common sense. Duh! But wait! The word "control" needs to be defined. Comments to FDA by several drug companies addressed this.

Principle 11. "We believe the path to engagement is through useful and thoughtful content and commentary."

I've already commented on "thoughtful" (see Principle 2). "engagement" is a key word here. What do pharma marketers really think of when they think of "engagement?" Is it the same as what you or I think of? If pharna social media programs are controlled by marketers or corporate communications people, it's difficult for me to think the goal is not just "engage" but also to "convince." That was my criticism of the Lilly chat regarding Medicare (see "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?"). Also see "Will Patients Find Value in Discussions with Pharma Marketers on Social Media Sites?" 

A book can be written about this stuff and I suspect someone out there is already finished with the first draft. I thank Peter Pitts for drawing up these 11 principles around which we can organize an ongoing discussion. I invite your comments.

What's On Pharma's 2011 List for Santa?

At this time every year, the good "boys and girls" of U.S. pharmaceutical industry send a letter to Santa that includes a list "presents" they would like to receive. Help me create this list.

I've put together a list as a starting point. Please select the items you think are appropriate to include in Pharma's letter to Santa. Feel free to add an item if it's not on the following list. Also: @PharmaSanta is putting together his "naughty" & "nice" list of pharma companies. Help him! See Q2.

Results of this poll will be summarized in a future  post to Pharma Marketing Blog.

Pfizer, World's Most Innovative Drug Company - Not!

Pfizer is the world's most "innovative" drug company, not in terms of developing new drugs to treat, for example, high cholesterol -- which it failed at spectacularly (see "Why Pfizer Flopped"), but at keeping old drugs on the market beyond their patent expiration date and competing with generic drug companies. I am referring, of course, to its efforts to keep Lipitor on the market competing with generic versions after Lipitor's Nov 30, 2011, expiry date. Lipitor Won't Go Gentle Into that Good Generic Night! as I commented on in a previous Pharma Marketing Blog post (see poem here).

The first phase of Pfizer's innovative "Save Lipitor" plan was an unprecedented level of direct-to-consumer (DTC) marketing of Lipitor. In 2010, Pfizer was the biggest DTC spender -- it's $967.5 million DTC budget for that year was more than double the DTC spend of its closest rival, Eli Lilly (see "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"). Of that amount, approximately $251 million was spent to advertise Lipitor to consumers. An additional $410 million was spend promoting Lipitor to physicians ($1500 of which went to "wining and dining" my physician; see "Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year") and supplying free samples (see chart below).

Just a week or so ago, I learned that Pfizer reached a deal with several PBMs -- middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers) -- that would compel many drugstores to block prescriptions for a generic version of Lipitor (see "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE").

Now, according to this WSJ article, Pfizer is planning to sell Lipitor at generic prices directly to patients. "If successful," says the WSJ, "the risky move could rewrite the industry's playbook for selling medicines." So, THAT's the "Playbook" Pfizer is writing (see back story on that here).

All this sounds like good news for patients like me who have been advised by their physicians to switch to Lipitor because "it's a second generation statin that will be available in generic form." But wait! First of all, my drug plan has to be in cahoots with Pfizer to offer it to me at the generic price (actually, to request pharmacies and PBMs it works with to NOT substitute a true generic version of Lipitor when my doc writes "Lipitor" on the script).

But the savings will not be passed on to employers who will pay higher rates to keep Lipitor on their plans' formularies. What are employers likely to do in that case? They'll pass the added expense on to their employees by requiring them to contribute more to their health coverage!

Calling Merck: Help Save the Honey Bee!

The European Parliament has called on the pharmaceutical industry to play a role in finding a solution to halt the rapid decline of the honey bee (see "Can Big Pharma Halt Honey Bee Decline?"). There may even be(e) monetary incentives in the works for any drug company that agrees to develop new medicinal products designed to combat bee diseases.

Merck, which famously uses a honey bee as its Nasonex drug icon (see left) and which is famous for developing vaccines, should be(e) the first to step forward, support this resolution, and announce it is willing to take on the challenge, IMHO. Provided, of course, it gets a major share of those monetary incentives!

Think of the possibilities!

First, Merck would earn the undying love of Europeans facing economic disaster should its honey bee population disappear; did you know that "Albert Einstein once said that without bees, man would live no more than four years"? Thus spoke Hungarian Socialist Csaba Tabajdi, who drafted the resolution.

Whaaa?? A socialist wants to give the capitalist drug industry monetary incentives? This bee problem must really be(e) serious! However, given Europe's current man-made financial crisis, many Europeans may have fewer than 4 years left regardless of the fate of honey bees.

Second, Merck is committed to animal health: "Our Animal Health business is an industry leader and delivered strong revenue growth in 2010 in both companion and production animals, as well as all geographic regions. Merck remains committed to the animal health business and the diversification it brings. We intend to continue to capitalize on growth opportunities in our broad and innovative portfolio" (2010 Annual Report).

Third, imagine the direct-to-consumer (DTC) marketing opportunities should Merck launch a full-bore attack on honey-bee-disease-causing agents that threaten every honey bee, INCLUDING Merck's famous Nasonex icon. I'm thinking that Merck can use that icon to promote its efforts to save the honey bee. It can use Twitter to reach out to Europeans (but, of course, NOT the branded fake @Nasonex_Bee account). I'm also thinking that this non-branded DTC effort would not violate EU restrictions on promoting brand drugs to consumers.

Merck would have an easy time convincing EU parliamentarians to approve laws REQUIRING all flowering-plant farmers to use the Merck anti-honey-bee-disease-causing agent vaccine or whatever. Heck, it could extend the law to require ALL farmers -- even those who grow crops that do NOT require honey bees for pollination -- and even home owners with lawns or other plants, to apply its product. Better yet, the state can take over completely and send out helicopters to spray whole swaths of the countryside!

Of course, you wouldn't want to eliminate COMPLETELY the honey bee scourge! That would not help Merck "continue to capitalize" on its investment, assuming those government subsidies do not cover 100% of the research and development. You must continue to have high sales to recoup those costs!

One fly (or is it a bee?) in the ointment: part of Merck's plan to "diversify" may include developing other agricultural products such as pesticides (see, for example, this Merck EPA Application to Register Pesticide Products).

"Research has shown that pesticides made by the pharmaceutical industry are a cause for the weakening of bees. But instead of asking them to stop producing those pesticides, the European Parliament now asks that same industry to develop medicines against the effects of their pesticides," says Bas Eickhout, Dutch green member of parliament, who presented the house with an alternative resolution asking for a moratorium on the use of harmful pesticides.

Given that 25% of members of the EU Parliament support Eickhout's resolution, I'd say it's time for Merck to send to Brussels its lobbyists left over from its push to get U.S. state legislatures to pass bills requiring ALL children to be vaccinated with Gardasil (see "Gardasil: To Be Mandatory or Not To Be Mandatory -- That is the Question")!

Cancer Drugs: Greener Pastures for Pharma R&D and Wall Street

Two news items regarding medical/pharmaceutical research caught my attention today. Both involve stem cells.

The first item was about research results revealed at the American Heart Association's annual conference. US researchers found stem cell therapy in humans has been "surprisingly successful in replacing damaged muscle and getting the heart to pump better" (see "Stem cells give new hope to heart attack survivors").

This is indeed "promising news for people at risk of heart failure" and is squarely focused on unmet patient need.

The other news item was about Geron, the "pioneering" stem cell therapy biotech company, that decided to withdraw entirely from the field and to dismiss nearly two-fifths of its employees (see "Geron withdraws from stem cell research"). The reason? According to the company's CEO, "By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital" (my emphasis).

near-term value inflection points for shareholders

I guess Geron's CEO could be using shareholder value as an excuse instead of revealing a basic research failure despite good intentions to meet patient needs. Stem cell research must be difficult and payoff too long term. It's probably much better to focus on cancer-drug research. That's a proven cash cow that every pharma company seems to be chasing these days. Yet I don't expect many cures, just treatments that keep the cow on greener pastures.

Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE

"I'm mad as hell and I'm not going to take this any more!"

I love that line from the 1976 movie Network. The whole scene in which fictional news anchor Howard Beale goes on a "rant" is even more appropriate today. You can watch the YouTube version at the end of this post.

Today, however, I'm mad as hell at Pfizer in particular and plan to boycott its products or even "occupy" its corporate headquarters in NYC -- or maybe symbolically "occupy" it here on the Social Media Network and urge my readers -- much as Beale urged his fictional UBS Evening News viewers -- to at least stand up and say to Pfizer "I'm mad as hell and I'm not going to take this any more!"

Why am I mad as hell at Pfizer? I just read a story in the New York Times that explains how Pfizer has reached a deal with several PBMs -- middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers) -- the results of which is that "many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins" (see "Pfizer-PBM Deal Means Many Drugstores Will Delay Sales of Generic for Lipitor").

That's why I just issued my Howard Beale "call to action" via a Twitter post: "Pfizer-PBM Deal Means Many Drugstores Will Delay Sales of Generic for Lipitor: ow.ly/7sEkz @pfizer_news: I'm mad as hell!"

Recall that I wrote a recent spoof about Pfizer's plans to keep Lipitor alive in the market (see "Lipitor Won't Go Gentle Into that Good Generic Night"). Little did I realize, however, that the PBM-Pfizer deal would result in drug stores refusing to substitute the generic version when filling prescriptions for Lipitor or to give patients Lipitor even when the prescription is for a generic version. The reason is that because of the rebates Pfizer offers to the PBMs, the co-pay for Lipitor scripts will be lower than the amount the patient would have to pay for the generic! The PBMs pocket the profits, wheres the payers (taxpayers like me and employers like me) get stiffed with the higher bill for Lipitor scripts.

"Raymond F. Kerins, a Pfizer vice president and spokesman, issued a statement saying Pfizer was committed to supporting patients’ continued access to Lipitor. He declined to answer further questions Friday afternoon," reported the NY Times. Typical of Kerins, who does not like to reveal much (see "Pfizer, Show Us Your Social Media 'Playbook'").

Most patients taking Lipitor won't even know what's going on except that their out-of-pocket co-pay will be decreased. But as more patients pay a portion of their employer-sponsored healthcare coverage, they should be concerned that employers may pass along the added expense (to them) to their employees. And even though the Pfizer-PBM deal will end in six months and Lipitor co-pays will rise back up, it would still hurt employers who will remember the shakedown when they adjust their employee benefit plans!

I also have a personal stake in this because my Doctor -- who has received payments from Pfizer in 2010 (see "Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year") -- wants me to switch from a generic of Pravachol to brandname Lipitor to control my high cholesterol level. Just on the basis of the above story and the fact that my doctor was wined and dined by Pfizer, I feel that I should boycott Lipitor until I can truly get a generic version.

Am I putting my health at risk by refusing Lipitor? I don't think so. When I think how mad and helpless I would feel while taking Lipitor because of this PBM-Pfizer deal, my blood pressure would rise and I would be at greater rise of having a heart attack. I wouldn't, however, be at a greater risk of committing suicide as Howard Beale did in the movie Network, unless, of course, I was also taking Chantix!

I urge you to post a note to Pfizer on Twitter (@pfizer_news) and say that you oppose its PBM kickback plan and that you are now "occupying" Pfizer by sending out daily tweets with a similar message until Pfizer backs down. Use the hash tag #OccupyPFE (PFE is Pfizer's stock symbol -- a fitting acronym considering Pfizer's deal will mainly benefit its investors).

Here's the "mad as hell" scene from Network:

Your Wife, Your Choice - Diapers or Detrol (now Toviaz)?

Pfizer's @pfizer_news Twitter account just posted this tweet:

"Toviaz top-line primary endpoint results positive in overactive bladder study of nocturnal urinary urgency http://t.co/OU60l6oZ" (see here). 

The link is to a press release that reports the results of a study that purports to show that Toviaz (a reformulation of off-patent Detrol) is "statistically significantly superior to placebo" in treating OAB (Over Active Bladder). The "statistically significantly superior" results were "based on patient self-reporting," which is a very subjective measure of efficacy to say the least.

OAB is one of those "medical conditions" that has been refurbished by the drug industry so that more people -- especially women -- can believe they have a problem requiring treatment by a pill rather than by some other, less invasive, means. I wrote about this before -- see "Overactive Bladder: 'Pharmacia instrumental in creating new disease' says Former VP." Pharmacia was purchased by Pfizer after that post was made.

An anonymous commenter to that post said:

"In the case of OAB, Pharmacia (and later Pfizer and others) provided an acceptable name for the condition, increased awareness, and provided access to effective treatment for a large group of patients (women especially) suffering a hugely difficult condition. Your wife, your choice - diapers or Detrol?"

I thought the last sentence was worth immortalizing in the title of this post because it is said that OAB is one of those conditions that "women especially" suffer from.

The Pfizer press release claims that "approximately 33 million Americans are estimated to suffer from overactive bladder symptoms." It doesn't say how many of these Americans are women, but the Toviaz Web site features a woman posing as a patient ("Not an actual patient") as in this banner:

Yesterday, I asked "Do Women Take More Drugs Than Men Because They Need To or Because They Are Targeted by DTC Advertising?" (see here). Toviaz ads (eg, the Toviaz.com Web site) demonstrate how women are targeted by direct-to-consumer (DTC) advertisers. As I mentioned in yesterday's post, I plan to discuss this in an upcoming Pharma Marketing Talk LIVE podcast discussion tomorrow (see "How to Score With Women (as a Marketer) via Social Media").

One other thing I have to say about the @pfizer_news tweet is that it is an example of a branded tweet that may not comply with FDA regulations because it mentions a brand name drug plus its indication but does not include any "fair balance" (ie, major side effect information) as required by law.

Most pharma social media initiatives such as company blogs and twitter accounts (including @pfizer_news) are managed by corporate communications people who are increasingly taking on the role of brand marketers. These people tend to think of themselves as outside of FDA's purview. Consequently, Pfizer may claim that the Toviaz-branded tweet is notice of a press release, not advertising, and that the press release contains the necessary fair balance (albeit one click away).

In the post about OAB mentioned above, I included slides from a Pharmacia VP that demonstrate the importance of PR and the media in "creating a new disease." One slide said "Drive potential patients to physician offices by using DTC and PR with symptom recognition." Another slide (see below) shows that the Media are an important component in creating consumer demand: