Thursday, July 29, 2010

Who Are The Pharma Social Media "Wright Brothers (Sisters)"?

I just received an email from MM&M announcing that the Finalists for its 2010 Awards have been chosen. When I clicked on the link in the email, I was taken to a Web page where a silent video showed the "rigorous judging process" (see screen shot at left).

Looks like a Day at the Museum in which works of dead artists are displayed! Is this any way to judge a person's accomplishments?

Personally, I think people deserve more than a non-personal perusal of images or screen shots of their work. Of course, the MM&M Awards do not claim to be personal: "The only way to get your hands on an award," says MM&M "is to impress the judges with the quality of your work."

I doubt the judges even communicate with the people behind all that paper hanging on the wall.

When the Wright brothers started on their quest to build and fly the first successful motorized flying machine,  their work product would not have won any awards. "The Wright brothers built seven flying machines in their quest for a practical aircraft, each a test bed for untried theories and assumptions. When they guessed wrong, they crashed -- and the Wrights crashed each one of their aircraft more than once. However, knowing what doesn’t work points the way to what does. After each failure, they rebuilt and modified their aircraft, incorporating what they had learned in the new design. In less than a decade they taught themselves to fly" (see "Inventing the Airplane").


The Wright Brothers story is a good metaphor for building the first successful pharma social media campaign. No pharma social media campaign has yet flown without failure. Rather than look at these failures like the villagers looked at the king with no clothes and say how wonderful it is, I choose to look at the people behind the campaigns and reward the pioneers. That is what the Pharmaguy Social Media Pioneer Award is all about.

My award is PERSONAL because social media is personal. Therefore, I plan to personally "meet" each nominee (find them here) and have each one tell me his or her story. I also plan to collect the opinions of their colleagues and ask them why nominees deserve an award. I've already collected many comments.

You can vote for nominees and write-in other candidates using the online form here. Not only your vote, but the comments you add will go a long way towards influencing me, especially if you offer details that back up your choices. Thank you for your help.

Tuesday, July 27, 2010

How DO You Pronounce "Boehringer Ingelheim"?

Yesterday, while at ExL's 6th Annual Public Relations & Communications Summit, I discovered that I was NOT the only person who had difficulty pronouncing "Boehringer Ingelheim," the name of a well-known, but difficult to pronounce German pharmaceutical company. At a roundtable discussion (see here), Kate O'Connor, Executive Director, Public Relations at Boehringer Ingelheim, corrected someone else who mispronounced her company's name. She then told us that she heard of a funny YouTube video that can help us with "Boehringer Ingelheim Pronunciation." Here it is (pretty funny):



Here's a little rebus/word pictogram that may help English-speaking readers better pronounce "Boehringer." Close enough, anyway. You're on your own with "Ingelheim," which seems easier to pronounce anyway.

Using Social Media in a Crisis: Distribute a Product Safety Widget Is One Idea

The "Social Media During a Crisis" roundtable discussion lead by Deborah Sittig (@GreenRoomMedia), Partner at Green Room Public Relations, was one of the most interesting events for me at ExL Pharma's 6th Annual Public Relations & Communications Summit. The question posed for discussion was "How can digital communications be utilized to best support patient safety during a crisis situation."

Also of importance was how to best protect the company's image during a crisis.

Needless to say, Sanofi-Aventis and Johnson & Johnson were the two most discussed case studies during the roundtable (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page" and "Despite Its Social Media Expertise, J&J Fails to Use It Effectively to Communicate to Consumers").

Here's Sittig's summary of the discussion, which she is presenting right now at the conference:

Key Learnings:
Anticipation and preparation are critical
  • No such thing as a “social media crisis plan”; social media should be incorporated as part of a larger crisis plan
  • Create social media infrastructure (dark sites) in advance; have a plan in place so when a crisis happens, you are prepared
Relationships rule
  • The right time to start blogger relations is now; waiting until after a crisis is too late and will make it more difficult
    • Involve bloggers in identifying potential issues and developing a plan
    • Bloggers will report on the facts in real time; treat them as you would a top-tier journalist
Own your space
  • Familiarize yourself with all third party groups’ social media capabilities and cultivate relationships
    • Consider credibility of third party relationships; many times their word is more credible than yours
  • Corporate blogs are a great way to consolidate crisis communications, reach a global audience and minimize rumors/speculation
    • Do not expect readers to “find” your blog but consider widgets and RSS feeds to maximize reach
  • “Own” the conversation; create hash tags; plan before the big moment
    • Compliment traditional news (ex. Press conferences) with a social media element (ex. Tweet during the press conference, engage in conversation)
My contribution was the idea of involving bloggers (like me) when developing your crisis scenario planning and deftly using widgets and RSS feeds to bring readers to your voice rather than relying on the "build it and they will come" strategy. There are plenty of stakeholders such as physician societies, online communities, patient blogs, etc. that would post a pharma company's widget on their sites -- especially if it was devoted to product recalls and drug safety information.

Not too long ago, Fabio Gratton (@skypen) proposed a similar kind of widget that pharma companies could sponsor that allowed patients to easily report adverse events to the FDA (see here).

If the goal of crisis management is to support patient safety and if the time to start managing a crisis is BEFORE it happens, then pharma needs to be more creative in pushing safety information -- even if it is bad news for their products -- out to stakeholders.  A drug safety widget is just one simple idea.

Media Blackout Imposed by Media People!

I spent yesterday at Pfizer headquarters in NYC attending and speaking at ExL Pharma's 6th Annual Public Relations & Communications Summit.

I met some of my Twitter pals there including Ray Kerins (@RayKerins), Steve Woodruff (@swoodruff), Mario Nacinovich (@nacinovich), and Zoe Elliott Dunn (@zelliott), among others. I didn't tweet very much while at the conference, but you can use the hastag #prsummit to see what other people were saying during the conference.

One issue many people Tweeted about was the "off the record" rule imposed by Mike Huckman (@MikeHuckman), SVP, Director of Media Strategy at MS&L, during the panel discussion "Exploring How Increasing Demands Placed on a Shrinking Number of Sector Reporters are Affecting Coverage of Health Care Issues."

Huckman also ordered us to shut off our mobile devices and pay attention, which was difficult to do after he imposed the rule that all comments were off the record.

"No quoting... Does anyone know how bizarre this all sounds?" said Len Starnes (@lenstarnes), a nominee for the Pharmaguy Social Media Pioneer Award (see Len's bio).

Christiane Truelove (@ChristianeTrue) said "Still disappointed media panel here was made off the record. Some interesting things were said." She was being polite, as always.

During the Q&A, I noted that all my Twitter buddies were all atwitter about the blackout Huckman imposed and I asked him a simple question: "Why?" His answer was: XXXXXXXXXXXX (redacted).

In a followup tweet to Nacinovich, Huckman said: "Apologies ... 2 those disappointed it was off the record."

"Does 'off the record' exist now a days?!" asked Paulo Machado (@pjmachado). I guess it does for Huckman, who, BTW, is not a candidate for any SM Pioneer Award that I know of.

Monday, July 26, 2010

Professional "Hired Gun" Pharma Tweeters. Is It a Good Idea?

Pixels & Pills Blog's recent post, "Pharma Jobs of the Future: Professional Tweeters", got me thinking of a way to supplement my income. That is, hire myself out as a "professional Tweeter" to a pharmaceutical company.

Of course, freelance or contract professional pharma Tweeters is not what Pixel & Pills had in mind. They were talking about an employee of a pharma company assuming the role of professional Tweeter. Such a person, said P&P, "likely ... understands the company and its culture, the complaints and compliments shared by customers and, quite frankly, is invested in the success of the organization."

But this leads me to ask "Is there, right now, a professional pharma Tweeter who has been hired from outside the company to manage and write for the company's Twitter account(s)?"

I suspect that there are such people.

When @pfizer_news first started, many industry watchers wanted to know who was the person behind the Twitter wall so to speak. We were beginning to suspect that it was a hired gun.

At a conference last year I was glad to be introduced to the real person behind Pfizer's Tweets: Jennifer Kokell, Communications Specialist at Pfizer (see her LinkedIn profile).

Jennifer even has a photo of herself on the @pfizer_news Twitter page (see right). Several other pharmaceutical Twitter accounts also show who is the person who does the Tweeting.

Some pharmaceutical companies have hired "celebrities" as professional Tweeters. Racecar driver Charlie Kimball, for example, was hired by Novo Nordisk to Tweet via its @racewithinsulin Twitter account (listen to this podcast: "Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter"). I suspect that some of Charlie's Tweets are edited before being sent out (see "Novo Nordisk Selectively Copies & Edits Kimball's Tweets"). If so, is this editing done by an outside "professional Tweeter" (ie, agency) or is it someone inside Novo Nordisk?

There are many ways in which outside agencies and consultants can be hired by pharma companies to help manage their social media accounts. Pharma has always outsourced many marketing functions. Should social media be handled differently? After all, social media is supposed to be the "true voice" of the organization. It's more personal than other forms of corporate communications.

I would be very disappointed, for example, if @JNJBTW was written by anyone else than Marc Monseau. I have established a personal rapport with Marc via this account. I understand that Marc may not be employed at J&J in that capacity forever and that someone else will eventually take over the @JNJBTW Twitter account. When that happens, I hope it's another person inside the organization and not a hired gun.

BTW, I am not seriously considering become a clandestine "hired gun" Tweeter for a major pharmaceutical company. Of course, if I was, I wouldn't tell you!

Friday, July 23, 2010

On Being Voted Off the Social Media Island

Here's a bit of irony. Today, I was virtually "voted off" the social media (Twitter) island of #hcsmeu by @FarmerFunster for being too promotional. The irony is that many of the topics discussed via #hcsmeu concern how the pharmaceutical industry can get more involved in interacting with consumers via social media, as if that interaction is NOT promotional!

BTW, this is not the first time I've been "voted off" a social media site. See "Banned from CafePharma!" In that case, however, it was a badge of honor :-)

The issue prompting @FarmerFunster to vote to kick me off #hcsmeu was a question I submitted for discussion: "Pharmaguy Social Media Pioneer Award. Who should be nominated?" @FarmerFunster said "principle of it is OK but disagree with #hcsmeu being used as a promo channel within the hour tweet-up."

WARNING! PROMO AHEAD: Learn more about Pharmaguy's Social Media Pioneer Award here.

OK, so I wasn't really "voted off" the island. Only one disgruntled participant felt the topic was inappropriate. But one disgruntled social media participant can have a major impact -- go ask Sanofi-Aventis about that (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page") or read "Social Media: Ask Permission to Join the Conversation First or You Just Might Get Your Ass Kicked!"

What @FarmerFunster doesn't realize about me is that "I am all promo all the time. That's what a SM Pioneer shld do." My goal is to promote what I consider good pharma marketing practices. To do that, I need to promote myself and also promote colleagues and sometimes paid advertising clients.

I decided to get involved with awarding excellence in pharma social media leadership because I wanted to promote what OTHER people are doing, not me.

DISCLAIMER: I also am not making one red cent from this effort. There are no PAID sponsors. ExL's Digital Pharma East conference is a sponsor and has offered to provide a venue for the award winners ceremony during the conference. While ExL Pharma is an advertising client of mine, this sponsorship is an unpaid cooperative co-promotion.

Meanwhile, I did get some interesting insights and opinions from other #hcsmeu participants in this morning's discussion. I will review these in another post. Right now I have to avoid the sharks as I swim away from the island.

Thursday, July 22, 2010

Is This the Fate of Pharma Social Media Pioneers?

Recently, I announced the Pharmaguy Social Media Pioneer Award, which recognizes excellence in social media marketing leadership (see announcement here and latest list of nominees here). The Pharmaguy Social Media Pioneer Award is sponsored by ExL Pharma and the 4th Annual Digital Pharma East Conference. Winners will be announced at the conference in October, 2010.

While reading this week's issue of the New Yorker magazine, I came upon a cartoon that got me thinking about the fate of the people who may "win" this prestigious award.

Could it be that a similar fate awaits the ePharma Pioneers on my list?

Pharmaguy's Social Media Pioneer Award

Awarding Excellence in Social Media Marketing Leadership

Pharmaguy's Social Media Pioneer Award
Sponsored by ExL Pharma and the 4th Annual Digital Pharma East Conference

If you are a regular reader of Pharma Marketing Blog, you know that I generally do not like awards sponsored by pharma trade publications (see “Awards. What Are They Good For?”). Such awards are somewhat suspect because of the inherent conflicts of interests involved -- the winners tend to be the agencies that advertise the most in the sponsoring publication or that purchase big page ads announcing that they won the award.

Not all awards, of course, are self-aggrandizing “slaps on the back” among a close circle of colleagues. Dose of Digital’s "2010 Dose of Digital Dosie Award" for the best healthcare/pharmaceutical social media sites depended on a more open and transparent process. First, anybody could add sites to the list of contenders via a wiki site. Then Dose of Digital opened up the voting process to anyone who cared to vote. You can find the winners here.

Still, I find some problems with awards like the Dosie.

First of all, many of the contenders for the Dosie Award were not true social media sites in that they do not allow comments or “likes” (Facebook). This is true of the majority of finalists in the Best Brand Sponsored Patient Community (Communities created by a pharma or healthcare company for a brand or corporate effort). The finalists in this category were:
  • Accu-Check Diabetes Link (Roche)
  • Children with Diabetes (J&J Lifescan)
  • Crohn's and Me (UCB)
  • Diabetes Handprint (J&J Lifescan)
  • Voices of Diabetes (Novo Nordisk)
All of these "social network" Dosie finalists, with the exception of Children with Diabetes, which went on to win the Gold award, are "Faux Social Media" sites that don’t embrace what makes social media truly social. I, and others, have often criticized such forays into social media as being "inauthentic" because no real dialogue is allowed (see, for example, "Pharma "Social Networks": Close But No Cigar Award"). Without the dialogue, social media campaigns are not likely to reach full potential by "going viral," which is the point recently made by my Twitter friend Jonathan Richman during an #hcsmeu discussion last Friday. "Here's a hint for pharma," said Jon, "Nothing will go viral if you don't allow 'Likes' or comments. Guaranteed." Jonathan, by the way, was the creator of the Dosie Awards.

Another problem with these awards is that many of the sites that receive awards “go dark.” The Sanofi-Aventis GoInsulin YouTube Channel, for example, became unavailable soon after it won the Gold Dosie award.

The Pharmaguy Social Media Pioneer Award
Nevertheless, defenders of pharma “social media” site awards insist that we must reward even the most elementary attempts that pharma is making to have online conversations despite all the regulatory obstacles that they face. I agree. But instead of having awards for the work product, why not give awards to the pioneers who have lead the way to create these sites? We can learn more from how these pioneers overcame the obstacles to launch a social media project than from the end result – even if the end result is flawed or faux. People tend to live much longer than their creations and pharma social media pioneers are no exception. They may move on to new positions and spread their influence far and wide.

To better recognize the value of these pioneers, I propose the Pharmaguy Pharma Social Media Pioneer Award.

When discussing the Social Media Pioneer Award on Twitter, at least one person (@wiltonbound) suggested that the process should be “Open to all...no restrictions. Innovation knows no boundaries.” I responded that my goal is not to award innovation, but courage in the face of boundaries! I also do not wish to get into the business of giving awards to agencies and consultants because of the inherent conflict of interest I would have. Many agencies that would qualify for such an award are my paying clients (ie, Pharma Marketing News advertisers). I probably can make a lot more money giving my clients awards, but I don’t think it best serves the interests of my readers.


What's With the Hawaiian Shirt?
Let me explain the Hawaiian shirt motif of the award. Around the time that the FDA announced it would hold a public hearing regarding regulation of pharma’s use of the Internet and social media, I started appearing at conferences in a yellow Hawaiian shirt, which was left over from a Hunter S. Thompson Halloween costume (see “Pharma Social Media Crips vs. Legal/Regulatory Bloods: Call for a ‘Peace’ Conference” for a sighting of me in the shirt at the 3rd Annual Digital Pharma East Conference). I also considered wearing the shirt when I made my presentation to the FDA at the November, 2009 meeting (see “Fear and Loathing in Washington, DC”), but out of respect for the FDA and the audience, I opted for a traditional suit and tie.

Although I didn’t wear my Hawaiian shirt at the FDA hearing, it became an emblem for standing out from the crowd, which is a necessary trait for a social media marketing pioneer. I think a Hawaiian shirt motif befits, therefore, what the Pharmaguy Pharma Social Media Pioneer Award stands for.

The Nominees Are…
I have several people in mind as contenders for this award (see the end of this post), but first let me discuss what I consider to be the qualifications for nominees.

What are the qualifications to be nominated to receive this prestigious award?
First, a nominee must work or have worked within an FDA-regulated pharmaceutical, medical device, or biotech company when he or she pioneered in social media marketing or non-branded communications or was an advocate for such. Although there are many people in agencies that are true social media pioneers and who have been involved in many pharma social media projects, only the insider has the experience we are looking for. The insider has to contend with many stakeholders inside the organization and is ultimately responsible for the project. Consultants and agencies do not have nearly as much skin in the game as do insiders.

Although some pharma social media pioneers have subsequently moved on to other positions in non-pharma companies, they are still eligible for consideration as nominees for the Pharmaguy Pharma Social Media Pioneer Award.

Second, a nominee must have been a true social media pioneer. By that I mean someone who has been involved from the early days in marshaling the forces necessary to ultimately build a social media campaign. No matter if the campaign has been a failure. We often learn more from our failures than from our successes. Above all, we want nominees who have learned and who can share their learnings with us.

Third, although it is not necessary that a nominee to have experienced a “Mack Attack” such as that experienced by Novo Nordisk’s Ambre Morley (see “Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!”), it can’t hurt, especially if that person has survived and gone on to be interviewed by me (eg, “Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter”).

The type of social media that a nominee has been involved with is immaterial as long as it is one or more of the following: a blog, a Twitter account, a Facebook page, a network (community), a YouTube channel, etc.
That’s about it for qualifications.

Who Will Nominate Candidates and Determine Who Wins an Award?
Since this award has my Twitter name associated with it, I take ultimate responsibility for who to consider for this award and who wins an award. I already have several candidates in mind (see below).

Pharmaguy's Social Media Pioneer Award


However, I also depend upon my readers and colleagues to assist me. You can vote for my nominations and write-in other candidates using the online form here. Not only your vote, but the comments you add will go a long way awards influencing me, especially if you offer details that back up your choices. I especially need help identifying former pharma people who may be working at agencies, but who did a lot of their social media pioneering while employed at a pharmaceutical company.

Ultimately, I will use my best judgment and experience to decide who is qualified to enter the contest and who wins an award. My decision is final.

There will be three winners represented by different colors: YELLOW, ORANGE, and GREEN. The first place winner receives the YELLOW Hawaiian Shirt Award, of course. Second and third place winners receive ORANGE and GREEN shirts, respectively. Sorry, there is no “Mr. PINK” as in Tarantino’s Reservoir Dogs movie.

NOTE: It occurs to me that many pharma marketing initiatives – including social media initiatives – are the result of teamwork within the organization. For example, a SM Pioneer may operate behind the scenes to support a pioneering product manager who makes the decision. Both are pioneers and should be rewarded. It is possible, therefore, that several people may share the same award. I also recognize the fact that outside consultants and agencies may have played a critical role. When appropriate, these pioneers will also receive honorable mention when the awards are announced.

Let me start the process by nominating several people that I know and have interacted with listed in alphabetically by last name. You can click on each name to learn more about this person and add comments. More names will be added as the nominations continue. Please add your nominations and/or votes here.

Nominees
For the most up-to-date list, see Nominees for The Pharmaguy Social Media Award.

Tuesday, July 20, 2010

Will Janssen-Cilag's ADHD YouTube Video Go Viral and Win an Award?

I, and others, have often criticized pharms's forays into social media as being "inauthentic" because no real dialogue is allowed (see, for example, "Pharma "Social Networks": Close But No Cigar Award"). Without the dialogue, social media campaigns are not likely to reach full potential by "going viral," which is the point recently made by my Twitter friend @jonmrich during an #hcsmeu discussion last Friday. "Here's a hint for pharma," said Jon, "Nothing will go viral if you don't allow 'Likes' or comments. Guaranteed."

There are, however, a few pharma social media sites that DO allow comments and Johnson & Johnson (JNJ) leads the pack in that regard.

Today, I discovered (hat tip to @andrewspong) that Janssen-Cilag, Ltd, part of the Johnson & Johnson family of companies, is probably the first European pharmaceutical company to produce a non-branded disease awareness YouTube video that allows comments and "Likes." The video is entitled "ADHD: A day in the life by Janssen-Cilag Ltd." You can view the video here or see embedded version at end of this post. But just in case it is pulled in the future, here's a screen shot:


According to the channel notes "This new short film, produced by Janssen‐Cilag Ltd , tackles some of the issues surrounding Attention Deficit Hyperactivity Disorder (ADHD) from the perspective of a child with the condition. For more information visit www.livingwithadhd.co.uk.

"The film was made after talking to groups of doctors, patients, parents and teachers, who told us that too often people think 'ADHD' is just an excuse for 'badly behaved kids'. The film should help people understand what it's like to actually have ADHD.

"If you know anybody affected by ADHD, please do share this film with them. Together, let's make sure all families get the help and support they need."

The "Commenting Policy" states "All submissions will be reviewed and may not be posted if deemed inappropriate. Comments which are off-topic, offensive, or promotional, will not be posted. Please note that we will not post comments about any specific products or treatments, whether they are sold by Janssen-Cilag Ltd or not."

@garymonk, who apparently is the person responsible for this YouTube site, says that Janssen-Cilag has published the "vast majority" of comments. I believe it because there is "a couple of spats boiling away" according to @andrewspong, another Twitter friend of mine.

The site also allows visitors to vote whether or not they "Like" the video. As of today only 51 votes have be cast (43 like the video, 8 do not like it).

Will this video go viral? So far the video has been viewed 58, 624 times since it was uploaded on June 9, 2010.

It's interesting to note that the Johnson & Johnson (JNJ) YouTube video, "Brad's Story: A 12-year old with ADHD," is at the top of the list of related videos. It also allows comments and "Likes." The JNJ ADHD video was uploaded to YouTube back on June 22, 2009 and has been viewed 62,983 times (150 "Likes" vs 12 dislikes). So, by that measure, the Janssen-Cilag video is doing rather well. It should be pointed out that JNJ's YouTube Health Channel includes 302 videos. In all, the total upload views for JNJ's videos is 2,170,352.

JNJ Health Channel's Rob Halper, Director, Video Communication at Johnson & Johnson, is a "Friend" of Janssen-Cilag's Living with ADHD. "Great channel! Terrific contribution to You Tube," said Rob. BTW, Rob Halpert is one of the people nominated (by me) to receive the coveted Pharmaguy Social Media Pioneer Award (see the announcement below).


The Pharmaguy Social Media Pioneer Awards

We might be tempted to give Janssen-Cilag a reward for launching "ADHD: A day in the life" social networking campaign. But instead of having awards for specific pharma social media sites or campaigns, why not give awards to the pioneers who have lead the way? We can learn more from how these pioneers overcame the obstacles to launch social media projects or promote social media than from the end result – even if the end result is flawed. People tend to live much longer than their creations and pharma social media pioneers are no exception. They may move on to new positions and spread their influence far and wide.

Who is @garymonk, for example? I want to know more about this person. How did he get to be in charge of the Janssen-Cilag YouTube ADHD channel? What are the issues he had to deal with? Etc.

That is what the Pharmaguy Social Media Pioneer Award is all about. Let's discover the pioneers and hear their stories. Please use this online form to nominate candidates. The introduction explains the rules for nominating candidates and you can also vote on a dozen or so candidates that I have already chosen.

P.S. I found out who @garymonk is. He is Gary Monk, a Product Manager (Marketing) at Janssen Cilag and, according to his LinkedIn profile, he has already won a few awards such as: The "2009 PM Society Digital Awards - Triple Award Winner (1) Best overall promotional solution (2) Best Integrated Campaign (3) Best Edetail." Nevertheless, I added his name to the nominees for the Pharmaguy Social Media Pioneer Award.


Thursday, July 15, 2010

Actos Launches DTC Attack on Avandia

Ha! Takeda's sneak attack: Launches Actos DTC campaign today, a day that will live in infamy! 

GSK Kills the FDA Beast! Avandia Lives Another Day. Stay Tuned for DTC.

It seems that the 14 million pages of documents that GSK submitted to the FDA in defense of Avandia has had the intended effect: overwhelming FDA's advisory panel with "science," questionable as it may be.

I'm reminded of the scene in the original King Kong movie that fascinated me as a kid: the scene in which King Kong rips open the jaws of the T Rex and kills it. That's exactly what GSK has done to the FDA -- ripped open its regulatory jaws and rendered it powerless to take Avandia off the market even though it is known that the drug is responsible for the deaths of 400 times more people per year than is Toyota's cars (see "If Drugs Were Like Automobiles").

I have no doubt that the FDA will follow the recommendations of the advisory committee, the majority (17) of whose members voted to keep Avandia on the market albeit with stronger warnings or tighter restrictions on prescribing. Although 10 members voted to take the drug off the market, I don't see that view being taken seriously by the FDA. After all, Avandia's patent will expire within a year and it has received such bad press lately that it is hard to imagine physicians prescribing it. FDA's strategy may be to slap restrictions on Avandia and hope it dies a death of a thousand cuts. That way, the agency can appear to be responsible and science-driven rather than being gung ho anti-industry.

All this leads me to consider how GSK will address the problem of a likely drop off in prescribing by physicians. This is already happening. GSK hopes to solve that problem with a clinical trial that demonstrates that Avandia is as safe (or just as unsafe) as its competitors. It is reported, however, that GSK is having problems recruiting patients for this new study.

Just as BP is hedging its bets on stopping the Gulf oil leak by placing a new cap on the well rather than relying on the success of the relief well option, GSK will roll out a direct-to-consumer (DTC) ad campaign to hedge its bet on the comparison study.

A DTC campiagn can be launched almost immediately and may already be ready to roll. Such a campaign may resemble the Celebrex campaign that Pfizer launched after competitor drug Vioxx was removed from the market and put Celebrex's safety in doubt (see "Celebrex Ad: Let's Dive Deeper").

Keep in mind that DTC campaigns are aimed NOT just at consumers, but also at physicians who are even more likely to watch the evening news on TV than you or I. GSK may also simultaneously launch an equivalent direct-to-physician ad campaign.

The new Avandia advertising campaign will draw upon positive data that GSK cherry picks from its 14 million pages of documents just as the Senate Committee cherry picked negative data.

It was destined that the great Ape would die and so will Avandia. It won't be the FDA gunships that kill Avandia, however. It will be the "beauty" of the marketplace!

Police Lieutenant: Well, Denham, the airplanes got him.

Carl Denham: Oh no, it wasn't the airplanes. It was beauty killed the beast.

Tuesday, July 13, 2010

GSK's Coverup of Avandia's Heart Risk Data: Is This How the Entire Industry Views Its Responsibility to Patients?

The New York Times reports (see here) that as far back as March 29, 2001, a SmithKline (precursor to GSK) executive held back clinical trial data that suggested Avandia was "no better than Actos, but ... also provided clear signs that it was riskier to the heart." In an e-mail that the NYT recently received, this executive said "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." In another email message, this executive said "These [data] put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm. It is a difficult story to tell and we would hope that these do not see the light of day."

"Hiding the results of negative clinical trials was once widespread in the drug industry," says the Times. That was supposed to change when Congress mandated such disclosures. "But the postings are often little more than cryptic references, so the issue is far from resolved," says the Times.

As I write this, GSK is presenting its case before an FDA advisory committee. You can follow this meeting on Twitter -- but don't look at GSKUS, GSK's official Twitter account. That account, so far, is silent about this unfolding story.

Here is GSK's Advisory Committee Briefing Document (pdf). It's 166 pages long and full of meta and other data purporting to prove the conclusion that "observational, and large controlled clinical studies continue to support the overall positive benefit risk profile of RSG as an important medicine for type 2 diabetes mellitus (T2DM) patients. Better durability of glycemic control with RSG compared to both SU and MET has been demonstrated in two long-term studies. This durability benefit has the potential, in real life conditions, to reduce microvascular complications of type 2 diabetes and to avoid the need for additional therapy, including insulin. Treatment with RSG does not demonstrate an increased risk in macrovascular complications compared to MET and SU. Therefore, the overall benefit risk profile for RSG remains positive."

Whatever the new data show, it is clear that GSK in the past conspired to hold back negative data from the public. And not only negative data about Avandia. "GlaxoSmithKline was found in 2004 to have hidden data that showed that its antidepressant, Paxil, led children and teenagers to have more suicidal thoughts and behaviors," noted the Times article. GSK settled a lawsuit by agreeing to publicly post data from all of its trials.

Given this kind of attitude, it's no wonder the public has a low opinion of drug companies. I myself started writing this blog when Merck was found to be hiding negative data about Vioxx, a drug that was eventually withdrawn from the market -- a fate that I believe awaits Avandia.

UPDATE: @GSKUS posted this: GSK responds to July 12 Senate Finance Committee letter to FDA #FDA http://tinyurl.com/25t3fvd

The first sentence of GSK's response: "The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation."

14 million pages! Holy cow! I guess GSK learned from GM about how to swamp your opponents with tones of paper! I'm referring to the case that Nader brought against GM in "Unsafe at Any Speed." Remember the Gene Hackman movie "Class Action" that portrayed the story behind the case? When asked to supply relevant data, the auto company in the film sent a truckload of boxes of documents to bury the lawyers.

Thursday, July 08, 2010

Social Media Is Quicksand. Better Wear Your "Swimmies!"

My Twitter pal @PhilBaumann made a comparison between social media and quicksand in his blog. "What I’m saying is this," said Phil, "you can learn to swim in quick sand. But you’ll drown if you think you’re walking on solid ground. Sometimes assuming the worst can help you understand and see what’s best." See "What If Social Media Was Called Quick Sand" to get the point Phil was trying to make, which is be aware of what's below the surface.

Regardless of the point that Phil was trying to make, his statement immediately conjured up an image in my mind, which having nothing better to do, I created in Photoshop and posted here on the left.

In reply to Phil's comment, I tweeted  "You can't swim in quicksand, but you CAN dip your toe in. Exactly what pharma is doing in SM now."

What's MY point? You can dip your toe in social media and that's fine. You won't go under. But if you want to fully immerse yourself and start swimming in it, you better have "swimmies" such as guidelines from the FDA and some social media standard operating procedures and policies.

Wednesday, July 07, 2010

One Pharma Company's Social Media Policy: Threaten Physicians Who Complain About Your Drug Online

According to an article in today's Wall Street Journal (see here), URL Pharma's general counsel sent letters to several physicians who criticized the company's new treatment for gout in an online message board for rheumatologists sponsored by the American College of Rheumatology. The drug in question is Colcrys, which is equivalent to generic colchicine, a drug that cost pennies and has been around for so long that its use "predated the Food and Drug Administration and therefore didn't require the agency's vetting."

When Colcrys came on the market, a number of physicians voiced their displeasure online. Some doctors had advocated use of colchicine. "In response, URL Pharma's general counsel sent letters to several of the critics asking them to 'clarify the record' and saying there were 'potential risks and liability' associated with using unapproved versions."

"'These are shake-down letters to silence' critics, said John Goldman, an Atlanta rheumatologist. In his postings, he had criticized URL Pharma for conducting limited research and for its pricing of Colcrys. URL Pharma says it reached out to physicians to educate them about its clinical trials and help them prescribe the drug appropriately, not to quash criticism."

"We were trying to alert this small group of misinformed physicians to the fact that they were being led into medical malpractice liability," the company said in a statement.

URL's action may not be indicative of how the pharma industry as a whole "engages" with physicians who use social media, but it raises an important issue regarding pharma's participation in closed social networks such as the rheumatology discussion board in question. Obviously, URL physician employees or physicians hired by URL or an agency of URL were "lurking" on the board monitoring discussions. This is probably a common practice of many pharma companies. Should these agents identify themselves to the community?

In other cases, pharma companies have been transparent about their monitoring of physician communities. Pfizer, for example, has a deal with Sermo that allows their physicians to join the Sermo physician community. These physicians are clearly identified with a special logo, I believe. They obviously can "lurk" and not be seen unless they post a message, but Sermo and Pfizer were quite open about it to the Sermo community (see "Pfizer has a Gold Mine in Sermo!").



Pharma, Physicians, and Sermo: A Social Media Win-Win-Win!


BTW, URL Pharma should have read this post I made over a year ago: "Social Media: Ask Permission to Join the Conversation First or You Just Might Get Your Ass Kicked!"

Also see How Should Pharma Engage in Patient/Physician Social Networks? Survey Results.

Tuesday, July 06, 2010

Sex, Lies, and the Media: Did Businessweek Distort the Relation Between ED Drugs and STDs?

The headline in a recent story reported in Bloomberg Businessweek tells it all: "Men on Viagra, Cialis Show Triple Rate of Sex Diseases in Study." This was duly summarized in the Blogosphere on PharmaGossip:
"Men on Viagra, Cialis Show Triple Rate of Sex Diseases in Study - BusinessWeek

"Men taking drugs for sexual potency showed almost triple the rate of sexually transmitted diseases compared with those not taking the medications, a Harvard University study found.

"The results, from an analysis of the health insurance claims of men aged 40 and older, may have more to do with the nature of the men using the impotence drugs than with the medicines leading them to have riskier sex, the research report said. The study, looking at men taking Pfizer’s Inc. Viagra and Eli Lilly & Co.’s Cialis, was published today in the Annals of Internal Medicine."
Reading just the headlines and summaries such as the one above, you might be lead to believe that ED drugs CAUSE unsafe sex, which leads to more sexually-transmitted diseases (STDs). Right? WRONG!

You have to read down to the 11th paragraph of the 16 paragraph story to learn that the study does NOT prove that taking ED drugs leads to more unsafe sex. Quite the contrary: users of these drugs actually showed a DECREASE in STDs AFTER taking the drugs compared to BEFORE taking the drugs!

That paragraph states the study results: "The risk of getting HIV in the year before taking the pills was 3.32 times higher in drug-takers and 3.19 times greater in the year after, compared with those not taking the pills." [Find the article here.]

In other words, the groups of men who were prescribed ED drugs were in a high risk group BEFORE being prescribed ED drugs. In the abstract, the study authors were careful to point out "Significant changes in STD rates from the year before to the year after the first ED drug prescription was filled were not documented." [Find the abstract here.]

Pharma often complains that the media are "anti-pharma" and often emphasize the negative aspects of clinical trials, advertising, etc. (see, for example, "What's the Cause of the Drug Industry's Bad Reputation?"). The BusinessWeek article is just one case where I have to agree, although overall I sense that the industry gets a lot more positive traction from the media than negative (see, for example, "Academics Exaggerate, Journalists Regurgitate. What About Bloggers?").

What do YOU think?


Does the Media focus too much on bad news about the pharma industry?
Yes, definitely
Absolutely not
Maybe, sometimes
More often than not
It's pretty much balanced

  

Thursday, July 01, 2010

What's Top of List in Your Social Media Implementation Plan?

Sanofi-Aventis recently experienced a FaceBook fiasco and learned from the experience (listen to this podcast: "What Has Sanofi-Aventis Learned from Its Facebook Experience?"). In fact, it probably learned more from that experience than it learned from reaching out to people like me who were asked to provide some insights.

IMHO, every company should have a social media implementation plan in place. It may not prevent crises like the one S-A was faced with, but it will help your company deal with them.

To determine the relative importance of elements of a social media plan, I started a survey that asks respondents to indicate how important the following action items are in implementing a social media 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, regulatory people, corporate communications, C-level execs - on board
  • Develop guideposts, internal and external standard operating procedures
  • Train people who will be interacting directly with consumers
  • Develop a moderation strategy
  • Marshall necessary resources - use the best tools available
  • Create a social media Tsar position to oversee all the company's SM projects to assure compliance with guidelines
Respondents can answer
  • Should be TOP of list
  • Very important, near top of list
  • Somewhat important
  • Good idea
  • Ambivalent (not sure how important)
  • Near bottom of list
  • At very bottom of list
These items were suggested to me at an interactive session I moderated at a recent industry conference. The results to date from this survey are presented in the following chart:


Please take the survey and tell me what you think:

What's Your Social Media Implementation Plan?
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