Sunday, January 23, 2011

GSK's U.S. Sales Reps "Europeanized": No Longer Rewarded for Ability to Push Prescriptions

According to the Financial Times, "GlaxoSmithKline will this month scrap payments to its US-based commercial staff based on individual sales targets, as it attempts to draw a line under past aggressive marketing practices that have incurred substantial fines" (see here).

GSK’s sales "reps" will no longer receive commissions "based on their ability to push prescriptions. They will instead be paid based on their scientific knowledge, feedback from customers and the performance of their business unit."

An anonymous poster to CafePharma described what the "new" sales model will look like:
You will be judged on 3 categories. Product Knowledge, Customer Value, and Business Acumen. Each one of these will be split into 2 parts. Preparation and implementation. Basically, 6 categories to be subjectively assigned expertise levels by your manager. Hope you have a good relationship... This is how you will get your "cut" of your region's take of bonus dollars.

Oh yeah... you are also no longer referred to as pharmaceutical sales reps... from now on you are called "Customer Facing Staff". No joke...

GSK recently revealed a $3.5bn charge to settle product liability lawsuits and regulatory fines linked to past sales practices (see story here), which may have prompted this change as well as changes in funding physician continuing medical education (CME): GSK will now restrict funding CME courses to a small number of non-profit institutions.

This seems to be a radical shift in the evolution of the pharma sales model that has been followed by companies like Kantar Health. I've written on this subject in several Pharma Marketing News articles over the past year or so. See this recent article: "The Changing Pharma Commercial Model in 2010 and Beyond" (use discount code '95MDK' to download it free).

I also note that in order for a pharma company to reward its sales reps based on prescription volume of physicians they have detailed (the "old" model), the company has to have access to the prescription writing data of individual physicians. It's not a coincidence perhaps that the Supreme Court will soon determine if states have the right to prevent access to that data by pharma companies (see "Supreme Court to Decide Fate of State Laws that Prohibit Use of Rx Records by Pharma"). GSK may be sensing that the decision will go against them and they can take the "high" voluntary road now instead of taking the "low" legally-forced road tomorrow.

Although this model may be new in the U.S., it's not so new in Europe where pharma companies never had access to individual physician prescribing behavior. In Europe -- as I understand it -- pharma companies can only see how prescriptions change among a block of physicians in a certain geographical area more or less equivalent to a zip code in the U.S. Thus, basing sales rep commissions upon "district" performance in the U.S. is similar to how it's done in the EU. From the anonymous post made to CafePharma cited above, it looks like U.S. reps are not going to be happy to be "Europeanized."

Friday, January 21, 2011

Are Doctors Avoiding Twitter Because of "Doctor Bashing"?

"Recently, I was told that some doctors avoid social media because of what they view as 'doctor bashing,'" said Kelly Young (@rawarrior), author of the Rheumatoid Arthritis Warrior site.

In a post to The Orthopedic Posterous blog (here), Young cited a Twitter exchange during a recent #rheum (rheumatology topics) chat. She quoted one doctor who observed this Twitter interaction: "[I'm] a bit uncomfortable with content of these tweets. Doc bashing online puts docs off communicating with patients via this medium."

I am not sure how many doctors use Twitter to communicate with patients. But if they are hesitant to do so, they have many other reasons than online "doctor bashing," which isn't really new. "Doctor bashing" was here already, long ago, on online patient bulletin boards and listservs that are "old school" types of social media.

So what are some of the concerns that doctors have about communicating with patients via today's (Web 2.0) social media tools such as Twitter? How are physicians and patients currently using Social Media? What are expectations and limits? What are Best Practices?

As it so happens, those questions will be addressed at the Doctors 2.0 & You conference in Paris this June (see the agenda here). Denise Silber (@Health20Paris) is the conference organizer. Denise and I have set up an "old school" discussion board on Pharma Marketing Network (here) where you can contribute to the discussion about doctor bashing and other issues that will be covered at the conference. Also, you can follow the #doctors20 hash tag via Twitter (especially if you are a doctor! Don't worry, there will be no "doctor bashing" by us!).

BTW, I am on the advisory board and will be a speaker at the Doctors 2.0 & You conference. My workshop is entitled: "Essential elements of an external corporate media policy." I hope to moderate an interactive discussion looking at "the good, the bad, and the ugly" sides of social media policies as exhibited in the real world and in the end come up with a list of items that must be included in a social media policy that takes into account the different cultural/regulatory environments of the global pharmaceutical market. End of pitch :-)





[Twitter Bird/Medical Caduseus illustration by Bryan Smith.]

P.S. Here's a doctor that should have been "bashed" online, but wasn't. Posted by @nalts on Twitter: "Who knew what the now-arraigned PA abortion doctor did? Umm. The internet? (vitals.com) http://bit.ly/FreezeYourBaby #fdasm"

Thursday, January 20, 2011

FDA Needs to Do a Better Job Regulating Food Labels, Says GAO

When it comes to false health claims made by food advertisers, the Federal Trade Commission (FTC) is the federal agency that is empowered to act (see, for example, "Kellogg Engages in Serial Advertising Misbehavior"). But the FDA has jurisdiction over the labelling, which is what is written on the box or container in which the food is delivered.

In a report, the Government Accounting Office (GAO) -- the investigative arm of Congress -- said "FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims." In fact, that is the name of the report, which you can find here.

Health claims made by food companies is a "a complex and challenging legal and regulatory" issue. There are several different kinds of health claims that FDA has defined, one of which is a "structure/function" claim. Here's how FDA defines a structure/function claim:
Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity," or they may describe general well-being from consumption of a nutrient or dietary ingredient. Structure/function claims may also describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading.
The problem, says GAO, "FDA - unlike the Federal Trade Commission (FTC), which can require companies to submit any relevant evidence as part of an investigation of whether claims are substantiated - does not have the ability to compel companies to turn over their substantiation documents....FDA does not have express legal authority to compel the company to provide such information."

Not only is FDA's legal authority a problem, FDA has not provided guidance to industry on the evidence it needs to support such claims, says the GAO.

It's no wonder that the FTC has had more success quashing these claims than the FDA. One notable example of that is the action taken against Dannon for allegedly overstating the digestive, immunity and other health benefits related to Activia yogurt and DanActive dairy drinks. Dannon had to pay a fine of $21 million and Jamie Lee Curtis can no longer make "deceptive hypes for health and digestive benefits of Activia and DanActive,” Attorney General Richard Blumenthal said. “Dannon outrageously overplayed the health power of yogurt — making unscientific claims about promoting good digestion, preventing flu and enhancing health," said Blumenthal.



Those Activia commercials seemed pretty over-the-top to me and many comedians developed skits around the claims (see this Saturday Night Live excerpt on Hulu). But the typical consumer is confused, says the GAO. "Consumers find it difficult to distinguish among the many different types of claims on food labels, including health claims, qualified health claims, and structure/function claims." I'm pretty confused myself.

Thursday, January 13, 2011

The 10 Most Important, Awesome Pharma Marketing Highlights of 2010

The 2010 edition of the Pharma Marketing Yearbook™ is a commemorative record of pharmaceutical marketing issues and highlights of the past year as seen through my eyes and the eyes of my "network" of readers, subscribers, colleagues and followers. It has all been documented here on this blog, which after all is meant to be a log of such things.

I've been told that people like lists, so here's my list of the 10 Most Important, Awesome Pharma Marketing Highlights of 2010. I invite you to suggest your own list in comments to this post. There's space reserved in the Yearbook -- which will be updated periodically -- for your list. I also invite you to "sign" the Yearbook and become part of record.

Awesome Highlight #1: I was quoted in TIME magazine!

Dude! That was awesome for me, but maybe not so much for you.

Awesome Highlight #2: FDA did NOT issue any social media guidance for the drug industry in 2010

Bummer! That's got to be an important event even though it was a NON-event! Some people are giving up on the whole thing and saying "damn the torpedoes, full steam ahead!" Well, maybe not using those words. My Twitter pal Jonathan Richman -- who also loves lists -- says he is "more than a bit tired of hearing about 'the guidelines'" and is "Ready, Willing, and Legal" to proceed with pharma social media "marketing" without guidelines. In fact, he says "not a single industry program on [his wiki] list has ever received a Warning Letter or Notice of Violation from the FDA. Someone is doing something and not getting into any trouble." Novartis's Tasigna branded "Facebook Share" social media widget may not be on Jon's list, BUT Novartis DID get a warning letter from the FDA regarding that piece of marketing (follow the links in this post: "Update on FDA Regulation of Pharma Metadata & Impact on Search"). Come to think of it, THAT letter should have been included as a standalone AWESOME highlight of 2010, but I'm content to leave it as part of #2.

Awesome Highlight #3: The Hawaiian Shirt Off Pharmaguy’s Back!

Congrats! Alex Butler gets the first-ever Pharmaguy Social Media Pioneering Award in recognition of his pioneering efforts. Truly a nice guy! And this proves that I am on the same page as Jon about the possibility of being "legal" without guidelines. However, it takes an extraordinary person like Butler and his team at Janssen to do it without guidelines. Guidelines are for those idiots out there who insist on pushing the envelope and altering the playing field to their advantage. Just imagine a football game without sidelines!

Here's just a bit of Alex's comment he made in the Yearbook:
"Thanks for your work in 2010 John. Obviously a very personal highlight for me was receiving the Pharmaguy pioneer award, especially considering the fantastic list of people I had the honour to rub shoulders with on the nomination list. ... For me though we are in danger of heading down the wrong road. Many companies are trying to do the right thing with the wrong people. ... This is about communication- a fundamental change to the way we communicate about our business and our products, not about platforms. We need people with expertise in communications and in the positive sense, new marketing, to lead the cultural shift necessary within our industry."
For more on that issue -- finding people with the right expertise in new media communications -- listen to this Pharma Marketing Talk podcast: The Coming Digital El NiƱo: Traditional Interactive Agencies are Facing Extinction.

Awesome Highlight #4: Sanofi-Aventis Meets the Disgruntled Patient

And it wasn't pretty! Yes, it's possible for the pharmaceutical industry to do social media without FDA guidelines, but that doesn't mean that they will do it right. A case in point is the experience that sanofi-aventis had with Shirley Ledlie, who I labeled a "disgruntled patient" because she overwhelmed S-A's Facebook page with images of her bald head. You can read all about this by following the links in the 2010 Pharma Marketing Yearbook, which Shirley signed:
"As I was the 'Disgruntled Patient' feel proud that I managed to closed down the FB page of Sanofi Aventis. Although it reopened it no longer accepts comments from the public. This only goes to prove a point- only SA cant see that! Thank you John for including this episode in your Year Book 2010."
Awesome Highlight #5: The Adventures of Social Media Intern

Speaking of Social Media Faux Pas! Social Media Intern made the scene in 2010. "I enjoy changing the course of social networks, fixing an errant Facebook page faster than a speeding bullet, and jumping over the highest hurdles of any pharma legal/regulatory department," says Social Media Intern. "As an intern I do not make much money. My job is to find pharma social media 'dummies' who launch social media campaigns without thinking!"

Awesome Highlight #6: Dark, Secret, and Fake Patients on the Internet

FDA Guidelines are irrelevant here! In 2010, we learned about "dark" networks that are not open to pharma marketers. You can read all about this by following the links in the 2010 Pharma Marketing Yearbook.

Awesome Highlight #7: I Learned How to “Pronounce Boehringer Ingelheim!

Say it! Funny story... I had to edit the podcast "Scientist Vs salesman: Which approach will enable your sales reps to raise their value to the industry?" to make sure we were saying it correctly! If only I had the rebus to help me -- for more on that, refer to the 2010 Pharma Marketing Yearbook.

Awesome Highlight #8: Digital Pharma Idiot Savants Discovered

Who knew?! A pharma company can be both a feeble-minded digital idiot and a digital genius at the same time!

Awesome Highlight #9: Pharma Payments to Physicians

Whoa boy! 2010 was the year the dirt came out about physicians, medical schools, and advocacy groups who received payments from pharmaceutical companies. So far, disclosures have not been entirely transparent -- more like translucent. Maybe the pharma industry will lobby Congress in 2011 to eliminate the part of the Health Reform law that requires ALL pharma companies to reveal such payments.

Awesome Highlight #10: Pharma Companies Behaving Badly

So what else is new?! 2010 was the year that Johnson & Johnson fell off its much ballyhooed pedestal. I was particularly dismayed that the CEO sent an unprepared underling to face the music before a Congressional Committee! Not a good precedent for women pharma executives when one of their own is hung out to dry like that.

For more details about these Most Important, Awesome Pharma Marketing Highlights of 2010 and more, follow the links in the 2010 Pharma Marketing Yearbook.

Monday, January 10, 2011

FDA Says There are "No simple solutions" to Speed Up Its Regulatory Guidance Process

In a report issued last week by FDA's Transparency Task Force (see "19 steps FDA is taking to improve its transparency to regulated industry") the FDA took note of several comments it received stating that the timeliness of its regulatory guidance process must be improved; comments such as: “the process moves too slowly to provide meaningful information to industry."

In response, the Task Force report says that "there are no simple solutions to such problems":

"In part because of competing, sometimes higher-priority [my emphasis], demands on agency staff, there are no simple solutions to such problems as lack of predictability about when a guidance document will issue. For example, if application review, regulation development and crisis management are all given a higher priority than guidance development, and the same staff are responsible for all of these activities, it may be impossible to predict when guidance documents will be completed. In addition, many of the problems, such as timeliness, cannot be addressed solely by greater transparency."

Timeliness of issuing FDA guidance was top of mind in 2010 for the many pharma marketers who waited for social media/internet draft guidance that the FDA hoped would be released before the end of 2010. That did not happen (see the 2010 Pharma Marketing Yearbook for a review) and many of us were left wondering why -- especially when it seemed likely that the FDA would take more manageable "baby steps" and issue multiple guidances on specific issues such as space limitations in social media and search engine advertising (see "FDA Social Media Guidelines Best Done in Baby Steps" and "I Predicted It: Social Media Guidance Likely To Be Split Into Multiple Documents").

In response to the criticism, the FDA's Task Force suggested the following ACTION STEP:
ACTION 11:
To examine suggestions for improving the guidance process, the Commissioner has formed a cross-agency working group under the leadership of the Office of Policy. This working group is examining the current process and will identify best practices for improving the agency’s work on guidance. Topics include streamlining guidance development, reducing the time between issuance of draft and final guidance, and making it easier to find guidance documents on the FDA Web site.
With regard to the implementation of this "ACTION STEP," the Task Force said: "The working group will summarize their review of the guidance development process and make recommendations, as appropriate, by the end of FY 2011."

These recommendations, however, will not likely have any impact on current guidances currently working their way through FDA's sausage making -- er, I mean guidance development -- process.

In order to provide "more predictability and clarity" with respect to the guidance development process, the FDA "will inform industry about the progress of certain high priority guidances [my emphasis] in development by disclosing a timeline from the start of the agency’s work on a draft guidance to publication of the final guidance."

What does FDA consider to be "high priority guidances?" In a footnote, the Task Force defines it this way: "A certain guidance document may be considered 'high priority' if the content in the planned guidance would benefit public health (e.g., responds to a public health risk or provides information about clinical study design), is required by statute, would improve agency operations, or is included as part of user fee negotiations."

Whether or not social media guidance is high priority is up for debate. Many pharmaceutical companies, however, suggested that lack of guidance for drug promotion via the Internet and social media adversely affects public health because of the mis-information about products proliferating throughout the Internet.

Whatever the merits of the public health argument, it appears that the drug industry can MAKE the issuance of social media guidelines a "high priority" by PAYING for it (ie, include it "as part of user fee negotiations"). Is it possible that the FDA is blackmailing the drug industry into paying more user fees before it issues social media guidance?

See "FDA, DOJ, & Google: Conspiracy Theory, Part 2" for more speculation as to why the FDA has delayed issuing SM guidance.

Friday, January 07, 2011

10 Reasons Why I Hate Lists

My Twitter pal Jonathan Richman (@jonmrich) has another list: "10 Things to Inspire Your Digital Marketing in 2011."

Jon likes lists. He's written a lot of them. You should read them.

Everyone seems to like lists, especially this time of year. There's lists for Santa before Christmas and there are lists of New Year's resolutions.

OK, I've done lists too; see, for example, "Pharma's 2010 Christmas Wish List for Santa".

But I HATE NUMBERED LISTS, for these reasons:
  1. A numbered list implies that the first item on the list is most important. Who are you to judge?
  2. A numbered list implies that the last item on the list was included just to have 10 items on the list.
  3. All the items between (2) and (10) are worthless. Who cares about #2 or #3, etc.?
  4. You've probably stopped reading this list already!
  5. By now the list is really getting boring.
  6. Ditto
  7. Ditto
  8. Ditto
  9. Ditto
  10. You should "sign" the 2010 Pharma Marketing Yearbook!

Elitist Pharmaceutical Marketing

After writing about golf pro Phil Mickelson being a "shill" for ENBREL (see "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign"), I got into a conversation with a Twitter friend who shall remain anonymous. This person suggested that it is possible that golf and golf pro sponsorships consume more than 15% of a pharma company's DTC marketing budget. "15% for Golf is huge!", I said. "Not necessarily," said my friend. "The dollars also include other expenses besides endorsement such as internal PR costs."

I'm not sure what this person meant by "internal PR" costs. Some money obviously was spent getting the "Phil Mickelson takes ENBREL and feels NO pain" stories published in the "free" press.

I made my final point: "I think the bigger issue is the focus on golf endorsements rather than on patient support. It's just too elitist!"

This got me thinking about "elitist marketing." What did I mean by that?

First of all, let me admit that I think golf is an elitist sport although I am aware than many working class people play the game. Golf is a game that has many elitist tendencies such as expensive golf resorts, memberships, etc. that are geared to executives and not to the "duffer" riff raff. Phil Mickelson is a "hero" of the elite golf world.

A pharma marketing executive can easily achieve fame amongst his peers -- as well as achieve one degree of separation from TRUE fame -- by obtaining a celebrity endorsement. I mentioned this before in a post about another celebrity endorsement deal: "Are You Serious?™ A Good Example of Why Pharma Brand Managers 'Love Its' TV". In that case, actor/comedian Jon Lovitz was hired by J&J's Centocor to raise awareness for -- SURPRISE -- psoriasis! The product manager got his dose of elitist fame not only by schmoozing with Lovitz behind the scenes, but by actually playing a bit part in the TV commercials!

I'm sure the AMGEN and PFIZER ENBREL product managers have also schmoozed with Mickelson and may have even played nine holes with him at the Doral Golf and Spa Resort!

One wonders if advertising budgets are to serve the people credible information or to serve the ambitions of product managers? And when elite sporting celebrities are involved, does the advertising serve an elitist audience rather than the general population?

OK, now for the hate mail from all you golfers out there!

P.S. I've been told that Pharma Marketing Blog is blocked by AMGEN, who does not want its employees reading this blog. How elitist is that?

UPDATE (8 Jan 2011): The ROI Question
@MarianCutler, a "Jersey girl" and pharmaceutical/healthcare PR professional, tweeted this response to the above: "Couldn't disagree more @pharmaguy; question to ask is the ROI on the sponsorship."

So, I did ask a question: "How do you measure ROI of celebrity golf sponsorships?"
Every pharma marketer talks about marketing ROI (return on investment), but practically none "walks the talk" and executes a credible ROI analysis.

One of the major problems in measuring the ROI of a specific campaign like this one is that it's impossible to isolate other variables.

Another Twitter pal of mind said this golf campaign may be aimed at doctors who are notorious duffers. Well, I'm sure there is a whole array of other ENBREL marketing campaigns aimed at doctors going on at the same time. How do ENBREL marketers know if the Mickelson sponsorship is effective and what the ROI is?

I suppose they can see if there's an uptick in ENBREL scripts written that corresponds with the "launch" of ENBREL Phil. I guess it's possible that docs will prescribe the drug just because Phil is using it -- and what a pitiful reason to do so! What's more likely to happen is that pharma sales reps will be getting more access to docs because they have some golf-enhanced promotional literature and deals that docs will be interested in seeing. They will then open the door to reps.
OK, maybe there's a positive ROI considering that a single new script for ENBREL is worth thousands and thousands of dollars! How many NEW scripts will it take to pay off the $ millions(?) that Phil is getting from PFIZER and AMGEN? You do the math.

Amgen Blows Its Marketing Budget on Phil Mickelson Campaign

Back in August 2010, I asked "Is Phil Mickelson Shilling for Enbrel?" (see this post). My question was prompted by a couple of "news" stories, one of which proclaimed "PGA Championship 2010, Whistling Straits: Phil Mickelson Has Psoriatic Arthritis - Uses Enbrel To Help Manage Condition."

The story also included this quote from Phil: "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been."

That's quite a claim! If Phil made such a claim while being a paid spokesperson for ENBREL, he would have probably violated FDA regulations regarding unsubstantiated claims. He also would have violated FTC regulations regarding celebrity endorsements and testimonials by not disclosing "material connections" (payments or free products) between advertisers and endorsers – connections that consumers would not expect.

Well, Phil IS a shill for ENBREL after all! I missed this November 2010 AMGEN/PFIZER press release that made the announcement. In case that press release is no longer available, here's what it said:
Amgen Inc. (Nasdaq: AMGN), Pfizer Inc. (NYSE: PFE) and world-class professional golfer Phil Mickelson, have entered into a partnership to share Phil's experience with his diagnosis of psoriatic arthritis and treatment with Enbrel(R) (etanercept), and to encourage patients with similar symptoms to visit their doctor for proper assessment and care.


"This partnership with Amgen and Pfizer is important because being a psoriatic arthritis patient has motivated me to share my story," said Phil Mickelson. "I hope to encourage other patients to work with their doctors, learn about their condition and take action so that they have an opportunity to get back to some of the things that matter most to them."


Psoriatic arthritis is a form of arthritis caused by an overactive immune system that can affect not only the body's joints but also the skin. Approximately 600,000 Americans may have psoriatic arthritis. The main joint symptoms of psoriatic arthritis are pain, stiffness and swelling. Rheumatoid arthritis patients experience similar symptoms, however there are important differences between the two conditions, making it important to see a doctor.


Amgen and Pfizer were inspired by Mickelson's approach to managing his condition and by his continued drive to maintain his health. Those same qualities have kept him on top of the competitive world of golf and this is why the companies are excited to be partnering with him. Amgen and Pfizer believe his perseverance in the face of adversity will encourage patients to also work with their doctors to manage their condition and help them get back on course.


Further details and timing of future partnership initiatives will be announced in 2011.
I can't wait for these "further details" to learn more.

One thing I did learn from an insider is this: Amgen cannot afford to sponsor "a cheap and effective Web and cell phone-based patient adherence solution" because it has blown its entire marketing budget on the Phil Mickelson campaign.

It's worth more to AMGEN -- maybe PFIZER too -- to get the ENBREL brand associated with a celebrity and a golf tournament than it is to support patients who are already taking the drug. Considering that the demographic that is attracted to Phil -- mostly older, more affluent men -- it's also a slap in the face to more typical psoriasis sufferers who probably can't afford ENBREL in the first place!