Wednesday, November 30, 2005

Jerry Hall, Women and Pharma Marketing

This week's post "Sexy Reps Sell Rx" generated an interesting thread on women, beauty vs brains and pharmaceutical marketing on the PHARMA-MKTING online discussion list (see below).

In the midst of that discussion, I was made aware of a press release announcing the retention of Jerry Hall -- the super model, actress, and former wife of Mick Jagger -- as the (get this) "Global Ambassador for [Bayer HealthCare's] Erectile Dysfunction Campaign."

Jerry Hall might be famous for this quote: ""My mother said it was simple to keep a man, you must be a maid in the living room, a cook in the kitchen and a whore in the bedroom. I said I'd hire the other two and take care of the bedroom bit."

So much for a wholesome image that should, in a more perfect world, be encouraged as spokespeople for pharmaceutical products (in this case, Levitra). I've come across some suggestive photos of Ms. Hall on the Internet, but I have chosen not to reproduce them here. Let's just say that the images are not meant to evoke wholesomeness.

Putting that whole issue aside, I find this tack by Bayer interesting because it confirms that women (especially sexy women) sell. In the past, Levitra used male images and spokepeople in its ads -- e.g., football coach Mike Ditka to launch the "Levitra® Challenge" during Super Bowl XXXVIII. He was dropped as was former senator Dole who spoke for Viagra.

It seems that ads with men telling men to see their docs to ask about ED were duds. I thought this might have to do with overstating the problem by ED drug marketers (see, for example, "
ED Drug Sales Limp"). However, it may have been the fault of marketing not obeying the "sex sells" maxim. Cialis may have gained market share in part due to its ads that portrayed couples on the verge of coupling as it were. And then Levitra started using a woman actress to talk about her man, Now they have upped the ante and will employ a celebrity sex symbol as spokesperson!

It appears that Jerry Hall will be used to raise physicians' "awareness" of levitra and to entice them to prescribe it. As stated in the press release:

Jerry Hall will make her first statement, public appearance and conduct interviews for the campaign on 4 December at Bayer HealthCare’s press conference “It Takes Two: Bayer’s Commitment to Couples” to be held at the 8th European Society of Sexual Medicine (ESSM) Congress taking place 4-7 December 2005, in Copenhagen, Denmark.
Discussion Thread
This leads right back to the use of sexy reps to sell drugs to physicians and the PHARMA-MKTING thread on that topic, which I now reproduce below:

From Brian Towell (across the pond, so mind the spelling):

I belong more to John's serious school of thought - the industry shooting itself once again in the foot while the foot is once again wedged firmly in its mouth.

The quality of a relationship between any stakeholder who has influence over whether or not this or that drug is selected for these or those patients is the primary objective of any skilled salesperson. It's all about trust, familiarity, honesty and a certain intellectual resonance. I despaired to see John's leaked 'sales training' manual earlier this year, and it still causes me some frustration that the industry can propose such a myopic view. If sex sells, then don't package it as sex.

If you want to focus on women as an asset to your business, then look at what women can actually do really well that male leaders struggle with.

  • Link [rather than rank] workers;
  • favour interactive-collaborative leadership style [empowerment beats top-down decision making];
  • sustain fruitful collaborations;
  • comfortable with sharing information;
  • see redistribution of power as victory, not surrender;
  • favour multi-dimensional feedback;
  • value technical & interpersonal skills, individual & group contributions equally;
  • readily accept ambiguity;
  • honour intuition as well as pure "rationality"; (this is one of my personal favourites, but as a male, most women already knew that)
  • inherently flexible;
  • appreciate cultural diversity.
Let's face it, Women really should rule!!

Who manages more things at once?
Who puts more effort into their appearance?
Who usually takes care of the details?
Who finds it easier to meet new people?
Who asks more questions in a conversation?
Who is a better listener?
Who has more interest in communication skills?
Who is more inclined to get involved?
Who encourages harmony and agreement?
Who has better intuition?
Who works with a longer 'to do' list?
Who enjoys a recap to the day's events?
Who is better at keeping in touch with others?"

Not sure if looking pretty in your Maybelline and Estee Lauder adds anything to that, but lets face it, if you can package all of those skill sets into a 5' 7" brunette size 8 with pom-poms and great 'assets', maybe the industry is right? (Tongue firmly [and already apologetically] in cheek there!)

Interesting thread this, John. I wonder how the other women on the group feel about this?
  A de-identified person readily took on Brian's challenge:

You asked for it, so here is one woman's perspective on this topic.

Not to be too uptight (I was a rep once myself in this industry), but I think that this highly cynical view of "selling" is exactly what has frustrated my own personal physician, who, upon finding out that I am now a biomedical marketer, took me into his back room and showed me an overflowing trash can of marketing literature, post-its, pens, etc. etc.

He says that he also declines all invitations to "events," regardless of whether they comply with AMA guildelines or not and refuses to see all reps. He says that he is fed up with the nonsense, and I totally understand.

Not to get on my high horse, but my physician clients became my personal friends for the most part, but that was because they could trust me (and my B.S. in Molecular Biology) to detail them properly and answer their questions honestly. I was always welcome in the offices, got appointments, catered lunches that the docs attended (and then gave me office time), and gained the coveted "come and sit with us while we discuss organizational politics" invitations. I really enjoyed all of it and loved my job, because it was genuine. I agree with a famous CEO who said (and I am paraphrasing) that in the end, what really sells is your authenticity.

By the way, my sales numbers were always top-notch.

We (the docs and I) would also sit around and laugh at the other girls in their short skirts and low cut blouses, hanging all over their married friends AS WELL AS at the look-alike coiffed male reps all scrambling to get them out to the local baseball game and strip clubs. News flash: the docs see right through it, and they know there is the attempt to manipulate them. Sales managers should take heed and build teams that truly understand the word "integrity."
Bill Comcowich questioned the assumed, implied or inferred inverse relationship between beauty and integrity while simultaneously dissing CNBC's Dylan Ratigan:

And you can't have "authenticity" or "integrity" if you're pretty or handsome??

I got a big charge out of the story being picked up by the Dylan Ratigan show on CNBC... He was critical of hiring pharmas hiring "pretty women". Of course, it never occurred to him that most TV news anchors (including the vacuous Radigan) are hired largely because of their looks.
Jane Chin responded thusly:

Bill - exactly my point for my reply to John's Blogpost, which he graciously included in the update (see "Merck to Shed Fat, But Not in Sales & Marketing" under Sexy Reps Sell Rx Redux).

All things being equal, I prefer looks that are easy on the eyes - men and women. (I'm a woman the last time I checked, which also confirms what another responder noted about marketing to women with pretty women (with the benefits of airbrushing in glossies).

[Jane's referring to my comments: I must say that this view of the sales rep is unfair to all the reps out there that are trying to do the job above board and with proper attention to science and communicating the benefits and risks of drugs. These reps must come forward and blast this practice (of hiring cheerleaders) if it is widespread. I saw at least on one occasion a cheerleader-type female rep in my doctor's office. My doctor happens to be a woman. But, women are also used to sell to women -- note all the models on the covers of woman's magazines.]

Of course, once you open your mouth, I'd eventually become interested in how much comes out of your knowledge than peeking through your {name preferred article of clothing}, unless I were someone who really don't care about the information and wanted something inappropriate. That would speak more to the integrity and behavior of the perpetrator than the person wearing tight clothes, would it?

Since all things aren't equal, the inequality may come from hiring practices, or the inequality may come from poor employee preparation ("training"), to start. Why not address these inequalities instead? Because we're just following a safe bet of a sensational story - scandals, corruption, now throw in the sex for a 6-month ride atop the headlines.
Shivam A. suggested that knowledge and good looks are essential rep qualities:

Imagine reps who are valuable information providers, intellectual knowledge about drugs and one who has the clearity about why prescribing is better for a part brand over another ( supported by results from clinical trials etc)as mentioned here...

+ sexy impressive looks.

I am sure the blend of all above could definitely make a difference and impress upon the Rxers.

But lemme repeat it may not work out with someone who has either quality alone.
Frank said:

In my opinion the discussion ignores the simple fact, that it is one thing to hire people (cheerleaders in this case) just for their looks, and another to hire people for their talent in telling stories, being convincing and closing deals.

The story as proposed in the article implies, that people are hired just for their looks, which - again in my opinion - were a stupid thing to do, but of course is good story to be told in a newspaper (prove: the group, and the thread goes crazy about the story). I doubt that cheerleaders without further talent (opposite to bedside) will be hired.

Yes, all people prefer to listen to a story told by someone pretty and handsome. That's a fact which can help to increase sales. But if the story coming out is crap, there will be no sales, as most doctors - in the mean time - did understand, that a pretty rep does not necessarily translate into a ex-affair.

Tuesday, November 29, 2005

Merck to Shed Fat, But Not in Sales & Marketing

As reported by Gary Haber in The News Journal, Merck plans to cut 7,000 jobs (11% of its global work force) and improve manufacturing efficiencies to maintain its profit margin despite loses from the Vioxx withdrawal, Vioxx lawsuits, and soon-to-be-off-patent Zocor.
"Whitehouse Station, N.J.-based Merck, the world's third-largest drug company, said it will close or sell five of its 31 manufacturing plants. The locations were not disclosed, but Merck, which employs 62,000 worldwide, said about half of the job cuts would be in the United States."
"I'm confident this first phase of the restructuring plan sets the course for us," Richard Clark, Merck's chief executive, said in a conference call Monday.

The guy on the left is Richard Clark, Merck's chief executive. (Hmmmm...he looks very familiar.) Back when Merck was looking for a new CEO, I turned down the job (see "
John Mack Rebuffs MerckÂ’s CEO Offer") citing other mountains to climb.( Come to think of it, Clark looks a lot like me with my beard and mustache shaved, as they are now! Who knew Merck would select a Mack look-alike for CEO when they couldn't get the real thing!) Anyway, Clark obviously is no mountain climber, and Wall Street has given his ideas a vote of no confidence.

The article goes on to quote me:

While the job cuts are due in part to the company's situation, they also reflect general industry conditions, said John Mack, publisher of Pharma Marketing News, an industry publication. Drug manufacturers are scrambling to find new markets as most of the chronic medical conditions affecting people already have multiple drug offerings, Mack said. Merck "is losing two major products, which is more than other companies are losing," Mack said. "If you're losing major products, you have to cut back on manufacturing. There is no sense in maintaining capacity if you don't have the products to sell."
I had a few other comments, which were not published, that I'll share with you now.

Why Isn't Merck Making Cuts in Sales and Marketing?

The pharma industry has been criticized for its humongous sales force and doctors are beginning to push back and restrict sales rep access. Some companies, such as Pfizer, have responded with cuts in its sales and marketing departments (see "
Pfizer to Slash 30% of its Sales & Marketing Staff"). Other pharma companies have also announced cuts in sales and marketing (note: Pfizer may not cut as many as 30% of its work force as was rumored).

Doesn't Merck -- like Pfizer and most major pharma companies -- have a lot of fat in sales and marketing that can be cut? Some experts think so: "When you start seeing these big, big products coming off patent, there's plenty for most of them to cut," said Les Funtleyder, a health care strategist at Miller Tabak & Co. in New York. "It is quite possible that all of them have plenty more to cut if they want to."

Many of Merck's leading drugs such as Zocor and Fosamax will be facing generic competition in the coming years. To reap the maximum revenue from these products in the allotted timeframe, now is not a good time for Merck to cut its sales and marketing staff.

So, despite Wall Street's concerns about Merck's strategy, it may be the only strategy open to Merck at this time. Or is it?

Apply Technology in Sales and Marketing as Well as in Manufacturing

If Merck wants to realize efficienciess to maintain its margins, why doesn't it do something to increase sales and marketing efficiencies? One way to do that is to use the Internet more effectively to market to physicians and consumers. eDetailing, for example, offers efficienciess, especially for late-cycle drugs like Zocor and Fosamax (see, for example, "
eDetailing ROI Better Than DTC?" and "eDetailing Supplement"). According to Manhattan Research, Merck does not rank very high among the top seven pharma companies using eDetailing (In rank order, the top seven pharma companies in reaching physicians with edetailing are Pfizer, AstraZeneca, Novartis, GSK, Aventis, Merck, and Lilly.) It could do better.

Sexy Reps Sell Rx Redux

I've gotten some feedback from
PHARMA-MKTING listserv members regardingmyu comments about the use of cheerleaders as pharmaceutical sales reps (see original post: Sexy Reps Sell Rx).

Jane Chin, Ph.D., President, Medical Science Liaison Institute, had this to say:

Reps who got the spotlight in Stephanie Saul's article may not have gotten the sneering tone, but the article focuses entirely on their appearances and the pros and cons that came with being too beautiful. Throw in a lawsuit and you've got another hot-selling item on the newspapers. Looks like sex sold this story for the NYT publication.

Here's my question: Would the media feel better if doctors are visited by UGLY reps?

Obviously the author wants us to be uncomfortable with PRETTY reps - especially PRETTY FEMALE reps. There were no mention of the beautiful MALE reps that populate pharma's sales forces, or any mention of the number of reps with backgrounds in other disciplines (for example, the military) that are just as athletic but less predisposed to emotional baggage of the pretty-cheerleader-type.

This is the case of the misplaced "b" - a focus on "beauty" in the problem rather than "brains" in the problem. After the first season of the television shows "Survivor" and "The Apprentice" the media highlighted the growing attractiveness of the following seasons candidates. A popular show gets increasing applications, just like a popular profession gets increasing applications. Companies that have the luxury to pick and choose candidates from a large pool of
applicants make their preferential choices when hiring. Why does the media act surprised when it had a helping hand in shaping these trends?

Ultimately, what the article does not focus on is what the pharma companies do once the candidates got hired. There was no mention of the rigors or relevance (or lack thereof) of the training program. No mention of the amount of time (or lack thereof) companies give reps to prepare before deploying them into the field. These issues are the REAL problems in the loss of credibility that industry and its employees experience today.
Jane, I agree with your points and wish I had made a stronger case for the brains (or training) vs. beauty angle!

Georgette, a female sales rep, had this to say:
I hope that this was statement was made "tongue in cheek." Being a sales person in the industry, I hate to think that the reason doctors saw me was because I was attractive ... although not a cheerleader, that is for sure.
Perhaps Georgette is referring to the "Sex sells and that is the name of the game" comment. I must admit that I was merely repeating what I believe is a marketing truism that "sex sells." And selling is the ultimate goal of marketing and sales.

I also hope that doctors want to see reps for other reasons than good looks. There's also the pizza, don't forget that! (a bit of "TIC" here).

Monday, November 28, 2005

Sexy Reps Sell Rx Drugs

"Known for their athleticism, postage-stamp skirts and persuasive enthusiasm, cheerleaders have many qualities the drug industry looks for in its sales force," according to an article in today's New York Times (see "Gimme an Rx! Cheerleaders Pep Up Drug Sales").

What next? Strippers? "I only strip to work my way through college," said Heather, a pharma sales rep recruit. "My real goal is to be a pharma sales representative where I can better put my talents to work."

What about woman physicians? Are pharmaceutical companies overlooking their sexual needs? Or are young male Chippendale performers also being sought after as sales reps? I guess so, if the following observation is true:

"There's a saying that you'll never meet an ugly drug rep," said Dr. Thomas Carli of the University of Michigan. He led efforts to limit access to the representatives who once trolled hospital hallways. But Dr. Carli, who notes that even male drug representatives are athletic and handsome, predicts that the drug industry, whose image has suffered from safety problems and aggressive marketing tactics, will soon come to realize that "the days of this sexual marketing are really quite limited." [NY Times]

OK, so drug companies like to hire good-looking, out-going, young people as sales reps. This is not news. However, some critics -- like Dr. Thomas Carli of the University of Michigan -- claim that seduction is a deliberate industry strategy. I doubt that this is true. More troubling, however, is the dumbing down trend among pharma sales reps. Could increased recruiting of cheerleaders be a factor?

Dumbing Down
In an article in this month's
Pharma Marketing News, a methodology for evaluating pharmaceutical sales rep effectiveness is reviewed ("Sales Rep Assessment: Shoot the Messenger, the Message, or Both?"). The methodology centers on using trained physicians to score sales reps on a number of parameters such as building rapport and product knowledge. According to Michael Kessler, MD, VP of Metamorph Doctors, LLC., a company doing sales rep assessments, "representatives, in general, are scoring lower in their ability to communicate clinical information in a way that is palatable and understandable to the doctor."
According to T. Lynn Williamson, a cheerleading adviser at the University of Kentucky, pharma sales rep recruiters "don't ask what the major is." Proven cheerleading skills suffice. "Exaggerated motions, exaggerated smiles, exaggerated enthusiasm - they learn those things, and they can get people to do what they want." [NY Times]

I will close with this: Pharma companies continue to shoot themselves in the foot and this is just another example of that syndrome. Perhaps they can't avoid it. Sex sells and that is the name of the game. But, when Michael Moore comes out with his new documentary exposing this and other sales rep practices, the shit will really hit the fan.

Tuesday, November 22, 2005

Pfizer Tries Unbranded ED DTC Ads

Despite what its own executives are saying to the FDA--i.e., unbranded DTC ads are not as effective as branded ads to drive consumers to doctors' offices (see "Why unbranded ads don't work")--yet fulfilling its pledge to spend more of its media budget on disease-awareness ads, Pfizer is said to "break a TV ad this week talking about erectile dysfunction [ED]" WITHOUT mentioning the Viagra brand in the ad.

According to Brandweek (see "
Pfizer Breaks New ED Advertising"):
The new ad is unbranded and takes the form of an educational campaign encouraging men to call a Pfizer helpline to talk about their condition and to receive advice on how to approach their doctors about it. The theme is, "Make the call."

The approach is consistent with Pfizer's vow earlier this year to make its advertising more informative and educational. However, the company's Viagra brand, which is not mentioned in the advertising, clearly stands to gain—when patients go to their doctors with specific ad-driven requests, the leading brand in the category tends to benefit most.
I have been calling for marketers of ED drugs (Pfizer, Lilly, GSK) to include more information about ED in their TV and print DTC ads (see, for example, "Pfizer DTC Pledge: ED is Litmus Test"). This hasn't escaped notice by the Wall Street Journal, which wrote about me recently:
"Among his pet peeves is erectile-dysfunction advertising, which he believes focuses too heavily on younger men and libido-enhancing promises while failing to educate consumers about the disease." (See WSJ Cites PM Blog as "Must Read".)
I'm not sure if the "pet peeve" comment is a put-down or not. Anyway, I am still on the case and look forward to seeing these ads. Until I do, I will reserve judgmentt on how "educational" they are. That will be the subject of a future post to this blog!

Thursday, November 17, 2005

AstraZeneca's Risky Proposition

AstraZeneca stunned attendees at the recent FDA hearings -- at least those "in the know" -- with an announcement that it submitted written testimony proposing "a mandatory requirement for pharmaceutical companies to submit all [emphasis added] direct-to-consumer (DTC) advertising to the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing and Communication (DDMAC) for review prior to its use. (See "AstraZeneca Proposes Mandatory FDA Review Of All Pharmaceutical Direct-To-Consumer Advertising.")
"The PhRMA guidelines are a solid first step, but the proposals we're making today make clear that AstraZeneca views the PhRMA principles as a floor, not a ceiling," said Tony Zook, Senior Vice President, Commercial Operations, and President and CEO designate, AstraZeneca Pharmaceuticals LP. "If our collective goal is to ensure that accurate and responsible information is communicated to patients and health care providers, then manufacturers, patients, physicians and policymakers ought to welcome such a review process."
AstraZeneca's proposal includes several tradeoffs and loopholes. For example, any pre-approved ad would be exempt from a subsequent finding by the FDA that the advertisement is misleading or inaccurate.

Also, AstraZeneca would support legislation that would require a mandatory review of DTC advertisements by the FDA, but
only [emphasis added] where DDMAC has the necessary resources to conduct its review within a specific timeframe. That's a Catch-22 noted by several Pharma Marketing Roundtable members who unanimously agreed that the announcement was a red herring -- AstraZeneca knows full-well that the FDA doesn't have the resources to pre-approve all DTC ads, including print as well as TV ads.

Smart Move or Dumbass?

James Gardner, a Pharma Marketing Roundtable member, had this to say in his recent post to
The Health Care Blog: "Knowing that the FDA is woefully understaffed for this type of effort, it's a "can't lose" offer on Astra Zeneca's part! However, it'’ll play well in the popular press so my sense is that it was a smart move on their part."

But, this "smart move" may backfire. "AstraZeneca put forth a pretty risky proposition," says Harry Sweeney, Pharma Marketing Roundtable member and CEO/Chief Creative Officer at Dorland Global Health Communications. "If the agency says it doesn't have the resources, then you'll have Congressman Henry Waxman jumping up and down on the Hill promising to get additional resources for the FDA. You just don't know what will happen."

What we're witnessing here is a classic blunder by the pharmaceutical industry. Each company is trying to outdo the other in going beyond the voluntary guidelines for DTC set forth by PhRMA. The 2006 and 2008 political candidates are watching closely the cards that the industry is revealing. They now know how far to go in crafting new legislation to reign in DTC and/or to give the FDA more power. In the end, the industry's voluntary guidelines, plus the extras being piled on by AstraZeneca and other pharma companies, may become mandatory through legislation.

I know there are some industry leaders out there who are saying to themselves about now: "This is the slippery slope down which PhRMA's voluntary guidelines have led us." If they are slipping, they have no one else to blame but themselves.

Wednesday, November 16, 2005

WSJ Cites PM Blog as "Must Read"

The Wall Street Journal, in the article "What the In-Crowd Knows", lists Pharma Marketing Blog as a blog insiders read to stay current. Here's what health reporter Laura Landro had to say:
The site focuses on how drug companies can get accurate and trustworthy information to doctors and consumers. John Mack, publisher of the monthly online newsletter Pharma Marketing News, started his blog in January 2005. He offers commentary on news events and is often critical of the industry's focus on blockbuster drugs and what Mr. Mack views as unethical or misguided marketing. Among his pet peeves is erectile-dysfunction advertising, which he believes focuses too heavily on younger men and libido-enhancing promises while failing to educate consumers about the disease. The site lambastes pharma companies for ads that foster a "magic pill solution preference among Americans," while rarely mentioning changes in lifestyle or diet that will help reduce risks such as cardiovascular disease. But he's quick to praise efforts that address the industry's credibility problem with consumers, such as Johnson & Johnson's new TV and print campaigns that he says put drug risks on more-equal footing with drug benefits.
I think this captures well the essence of the mission of Pharma Marketing Blog, which is to lambast unethical or misguided pharmaceutical marketing and to praise efforts that address (rather than criticize) the industry's credibility issues.

How have I become a source that pharmaceutical marketers "must read"? Simple. I rely on a
network of experts who have worked in the industry for many years. This network includes the interactive online PHARMA-MKTING discussion group and the Pharma Marketing Roundtable as well as subscribers to the monthly Pharma Marketing News e-newsletter. These experts often participate in online surveys, conference calls, and meetings hosted by Pharma Marketing Network.

Many professionals in pharmaceutical marketing want to do the right thing. Sometimes, however, they stray from what I and others would consider acceptable boundaries. When that happens, the entire industry can suffer. (And suffer in the pocketbook too. See "
Big Drug Makers See Sales Decline With Their Image.") These boundaries are always changing and it is imperative that we constantly evaluate pharmaceutical marketing to keep it within limits considered acceptable by consumers and physicians.

Hopefully, what I do helps in some small way.

Tuesday, November 15, 2005

Plan B FDAgate

FDA's decision to block approval of OTC status for the Plan B contraceptive is rapidly becoming the center of an FDA controversy that has all the earmarks of a Watergate conspiracy.

At the center of the controversy is a report by the non-partisan Government Accountability Office (GAO) released yesterday to Congress. The report claims that top officials at the Food and Drug Administration decided to block over-the-counter sales of the Plan B contraceptive months before completing their review of the application in 2004.

Two FDA commissioners appointed by president Bush -- Mark B. McClellan and Lester M. Crawford -- were allegedly involved in the decision to bar Barr's Plan B OTC conversion. Both commissioners resigned after very short terms. According to
a story in the NY Times, the FDA deleted or threw out all of McClellan's e-mail and written correspondence on the subject (reminds me of Nixon's lost section of tape) and Crawford has conveniently refused to cooperate with the GAO inquiry. And we all though Lester left town because of financial conflicts of interest! Sure.

According to the Times story, the GAO report called FDA's decision on Plan B unusual in several respects:

Top agency officials were deeply involved in the decision, which was "very, very rare," a top F.D.A. review official told investigators. The officials' decision to ignore the recommendation of an independent advisory committee as well as the agency's own scientific review staff was unprecedented, the report found. And a top official's "novel" rationale for rejecting the application contradicted past agency practices, it concluded.
In the 10 years prior to the rejection of Plan B OTC status, when the FDA reviewed 23 applications to switch drugs from Rx to OTC, the FDA never went against the advice of its own advisory committee as it did with Plan B.

The FDA's "novel" rationale for rejecting Plan B was explained by Dr. Steven Galston, the acting director of the FDA's Center for Drug Evaluation and Research:

Dr. Galston said younger teenagers might act differently than older ones and might engage in riskier sex if they knew an emergency contraceptive was easily available. The company needed more data to ensure that this was not true, he said.
In the rejection letter, Galston suggested Barr could get approval if it would sell the drug "behind-the-counter," making it easily available only to women 16 and older, with younger women still needing a prescription.

Barr chose that option in a new application filed in July 2004. FDA rules required it to issue a decision by January, 2005, but it has delayed doing so indefinitely. Soon after the FDA waffled and opened a 60-day comment period, Susan Wood resigned from her position as FDA assistant commissioner for women's health in protest of the Plan B decision.

"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," said Wood.

Matthew Holt over at
The Health Care Blog, claims that Plan B FDAgate "is only one small battle in the war to keep the creationists and fundamentalists loons outside of science. A battle that weÂ’ve lost."

Watch out Matt! Pat Robinson may curse you as he cursed a town in Pennsylvania for exercising their democratic right to vote out creationists on their school board. Or he may call for your assassination.

Regardless of your views on contraception, abortions, and evolution, it's a sad day when government officials subvert the checks and balances built into our system of government that prevent dictatorships. If FDA commissioners can overrule their staffs and later cover up and refuse to account for their actions, then the next step is a system based on Commissars.

Monday, November 14, 2005

Preview of Upcoming Articles

The following topics will be covered in depth in the upcoming November issue of Pharma Marketing News. Access the preview online at

DTC Pros and Cons Presented at FDA Hearing

ePeople are polite in Washington, DC. They don’t rush and knock you down in the Metro (subway) like people do in NYC. Similarly, FDA staffers and presenters at the recent public hearing on DTC were very polite too. The nice FDA people asked nice questions and the nice presenters, for the most part, didn’t blast the FDA for not doing anything to reign in DTC or for doing too much. Presenters were more or less evenly divided as to whether they supported DTC or were against it.

This article summarizes the main points, both pro and con, made by presenters at this meeting and includes commentary from expert members of the Pharms Marketing Roundtable, which met to discuss the issues raised at this hearing.

If you are interested in joining the EXCLUSIVE Pharma Marketing Roundtable, click here for an application form. M
embers include professionals working within pharmaceutical companies as well as in advertising agencies, medical communications companies, and other pharmaceutical vendor companies. The PMN Roundtable meets periodically via conference call.

For a review of a few of the summaries made at the FDA hearing, see
FDA DTC Hearings: Snippets from Day 1 and FDA DTC Hearings Day 2.

Predictive Physician Marketing
According to some experts, the pharmaceutical industry has only itself to blame for limited physician access and two minute sales calls (see "Marketing's Role in Limiting Physician Access and What to Do About It," Increase Physician Access and Detailing Effectiveness Special PMN Supplement).

Creating product detail pieces and training representatives on the use of new materials represents a considerable marketing investment. It would be extremely valuable, therefore, to be able to predict how well a campaign will be before it is launched.

Now there is a method proven to predict the success of a campaign prior to launch. The ProSigma™ Detail Model created by TargetRx, a marketing information services company located in Horsham, PA, helps pharmaceutical marketers develop the best detail and detail piece to drive prescribing behavior.

GSK Strikes Back with a Grassroots Campaign

Mike Pucci, Vice President of External Affairs at GlaxoSmithKline (GSK), is a man with a mission, which is to get the word out about the good that the pharmaceutical industry is doing (or, as Pucci expressed his goal: to "Restore the reputation of the industry by communicating the value of our products, our research and our hope for the future"). He spoke recently at an industry Forum on Customer Relationship Management (CRM) held in Princeton, New Jersey.

For more on this topic, see a previous post to Pharma Marketing Blog (The Empire Strikes Back).

Global Digital Asset Brand Management
As pharmaceutical marketers turn toward the Internet, the demand for digital "rich media"-streaming video and audio, Flash animation, Java applets, streaming video and interactivity-is growing rapidly. There is a need to leverage this rich media content across brands and marketing campaigns on a global scale, but analysts estimate as much as 30 percent of all content is lost or misplaced annually, resulting in huge cost burdens for companies to recreate lost assets.
This article is a review of ClearStory Systems' ActiveMedia, which is an example of a next-generation digital asset management (DAM) solution for managing rich media.

Sales Rep Assessment: Shoot the Messenger, the Message, or Both?

Getting sales representatives in front of doctors is still the most effective way to present the "story" of a drug, according to Hank McKinnell, CEO of Pfizer. The story is the marketing messages contained in the detail aid and talking points that sales reps use when calling upon physicians. Getting the story right and delivering it effectively is more important than ever and it is crucial that sales reps get proper training.
This article is a review of Metamorph, Inc.'s methodology of using specially trained physicians to assess and validate sales strategy, marketing messages and sales aids of pharmaceutical companies based on real-time calls with reps using a standardised set of data points.

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Friday, November 04, 2005

Why unbranded ads don't work

Patrick Kelly, President of Pfizer US Pharmaceuticals, who testified at the recent FDA public hearing on DTC, announced that Pfizer has allocated a portion of their media budget a financial amount "equivalent to one major medicine" to address general public health as a "stand-alone brand" without mentioning any drug brand. Part of this sum may be used to develop a special category of unbranded ads: Help-seeking ads or unbranded disease-awareness ads. (This is mentioned in Pfizer's DTC Pledge (see "Pfizer DTC Pledge: ED is Litmus Test").

Disease-awareness ads are not subject to the disclosure requirements of the Federal Food, Drug, and Cosmetics Act and FDA regulations. These ads are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device.

Even though Pfizer -- and other pharma companies -- may be spending more of their media budget in the future on disease-awareness ads, they don't believe these ads are as effective as branded DTC in driving consumers to seek help.

According to Kelly, "general disease-awareness and help-seeking ads do not drive patients to the doctor to anywhere near the degree that information about a solution or a potential solution will." This finding is "not well-understood," said Kelly.

"What we have found," Kelly said, "is that if your express just that you should be aware that there is a medical condition or a disease that you should worry about, it doesn't generate as much action as if you then say there might be potential solutions that you should consult with your provider about. So it is the other connection that is important for motivating action."

Why don't unbranded ads work?

First, Kelly did not identify any scientific analysis of this problem or any data to support his contention that branded ads are better motivators than unbranded ads. He may be referring to real world experience at Pfizer -- internal data that we don't have access to.

This issue was discussed recently on the
Pharma Marketing Online Discussion Forum and I quote the discussion thread here. David, who works at a marketing research firm, opened the discussion:
Having developed and tested many OTC and Rx DTC ads, I believe I can provide some insight as to why unbranded disease awareness ads do not generate response and how to improve these ads.

The reason that consumers respond to branded ads more than unbranded disease awareness ads is primarily not because of a branding effect, although branding is powerful in its own right. Consumers do not respond to a disease awareness ad because they are being made more aware and knowledgeable about a "problem" and less aware and knowledgeable about a "solution" to address that problem. Simply: Who in their right mind wants to know about having a problem for which there is no solution?

So disease awareness ads to get better response, they must discuss availability solutions in greater depth and tangibility without mentioning the brand as well as stay within FDA regulations. This same reasoning is also why health promotion is always more effective than health education. In a consumer driven market, consumers simply want solutions, not problems.
Sounds reasonable. Note that David leaves the door open to how disease awareness ads can be improved without mentioning specific products. James, who works at an interactive ad agency, had this to say:
I think your point is a good one: many historical condition ads have missed the mark for various strategic/tactical reasons. That said, I'm personally not yet willing to temper my current enthusiasm for *good* condition advertising just because many (most?) executions to-date have been ill-conceived or poorly executed.

Good condition advertising, like all effective advertising, doesn't stop with the highlighting of a problem or unmet need ... it has to point to a solution and have a call-to-action. It also has to be distinctive, engaging, and relevant to your target. Shame on clients and agencies who lose sight of these old advertising truths as they move out of their branded ad comfort zone!

As a possible best practice, consider GSK's television ads for their condition website, If you've seen them, it's a compelling (frightening?) narrative of a middle-aged man talking candidly about he failed to take his diabetes seriously. As the commercial unfolds, it's clear that something isn't "just right" with him and his face. My heart skipped a beat as he proceeded to end the commercial by picking up a white cane and shuffling from the room. Yikes.

Ending here would have been a mistake, so I was pleased to see the clear call-to-action: take suspected or diagnosed diabetes seriously, get informed about how to take care of yourself, and see a physician soon if you're at risk. There's hope but you need to take the first few steps.

I'm connected to another unbranded campaign currently in-market for the GSK/ALA "Asthma Control Test" and can't comment on its effectiveness, but perhaps some of you have seen the so-called "Stethoscope" ads and have a POV.
To which David replied:
I agree, there is no reason why condition advertising cannot be improved greatly. As I pointed out, there needs to be solutions conveyed in this advertising so that it is not problem-only advertising. However, here is where the missing branding effect needs to be addressed. Branding, or naming, has a very powerful effect on solutions. Naming gives identity and reality to products and services, and becomes an anchor for advertising communication to keep building meaning and equity around.

But as you point out below, in the GSK ad the call to action is to get diagnosed of the PROBLEM. Getting informed about how to take care of yourself is not necessarily perceived as a solution. Compared to an easy-to-swallow magic pill, taking care of yourself could instead be seen as a difficult on-going challenge of lifestyle change for the rest of one's life, requiring change, giving up some things you like to do, having to exercise and work out, going to a managed care doctor who is very short an unsympathetic and possibly even frightening that the doctor may discover even more serious problems.

I think pharma and managed care should try to see how consumers actually see and experience the healthcare world, not be so immersed in their own beliefs of doing good. I'm not surprised that pharma has an image problem. There is a huge scientific literacy problem in the US. Consumers see drugs as "chemicals" and if a patient has hypertension or Hyperlipidemia, they see the prospect of having to take drugs the rest of their lives as becoming dependent on drugs. On top of it, approved drugs are often latter discovered after widespread usage to have serious and even fatal side effects. No wonder there is a compliance problem!

Instead of 30 and 60 second blurbs, I have often thought that pharma should invest in 30 or 60 minute infomercials where they do real patient education and even an integrated disease management program that is supported by interactive call centers and websites. Unfortunately, morbidity and mortality of the top 6 leading US causes of death can improved significantly with lifestyle changes. But lifestyle change is not easy to accomplish.
I agree with many of the points made by David and James. I would add that pharmaceutical companies, mainly through relentless product-branded "solution" ads to consumers, is the major culprit in fostering the "magic-pill" solution preference among Americans.

Some DTC ads (branded or not) mention lifestyle changes as alternatives to drugs, but they do so only fleetingly. They don't say, for example, that if you are overweight and lose X number of pounds your cadiovascular risk will be lessened by Y%. This is the kind of "solution" message, if repeated often enough (as often as the "take a pill" message is repeated), people might find motivating.

Thursday, November 03, 2005

FDA DTC Hearings Day 2

The second day of the FDA hearings on DTC was essentially more of the same as the first day. There were, however, a few nuggets here and there that I feel are "blogworthy" enough to include here. I left early, so I can only cover the morning presentations.

Alex Sugarman-Brozan, representing a group called Prescription Access Litigation, looked like a radical on the program guide and he did not disappoint. His group claims to represent consumers in class action lawsuits against pharmaceutical companies and targets deceptive marketing. He was against any DTC advertising that did not include the complete product labeling. This includes TV ads, which the FDA says are OK without the full labelling as long as "adequate provision" was made for consumers to access the labeling in other media -- i.e., print and the Internet. In other words, Mr. Sugarman-Brozan (I hate people with 2 last names! Not really. I just hate wasting my time on unnecessary typing!) is against the adequate provision regulation that allows DTC on TV and radio.

Pre-Approval of DTCA by FDA

On the other hand, SB made several interesting observations that should be taken seriously, one of which involves pre-approval of DTC promotions by FDA. Pre-approval has been recommended by PhRMA in its voluntary guidelines and several pharma companies pledged to submit all their DTC ads to FDA before running them (Astrazeneca on Tuesday "proposed a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer advertising to the U.S. Food and Drug Administration for review prior to its use," according to a
Reuters news story).

SB's observation is that the FDA has 40 staff members to view all drug promotions, including DTC and promotions to health care professionals. SB claimed there were 53,000 such promotions in 2004. That means each FDA reviewer would need to review 5.5 promotions per day. This, of course, would be impossible. Although these numbers may be inflated (e.g., include all promotions, not just DTC), the FDA would be hard-pressed to review all DTC promotions before airing in a timely fashion. To do so would require additional staff and funding. Another presenter suggested that a new type of "users fee" be imposed on the industry to cover this extra expense. In other words, these critics would set up a DTC promotion approval regime similar to the drug approval process. Yeah, that'll happen! I expect the drug industry would like that as much as the drug approval process (think DELAY; this is a major sore point with the industry. According to FDLI SmartBrief,"Pharmaceutical firms now need an average 8.5 years to move a new product through clinical and approval phases, according to a study by the Tufts Center for the Study of Drug Development.")

Nevertheless, SB recommended that FDA review all DTCA, including broadcast, print
and online ads. He also recommended the following:

FDA should seek power to impose civil monetary penalties.
He criticized the current method of issuing warning letters and likened it to British Bobbies shouting out "Stop! Or I'll shout stop again" as they pursue bad guys with no threat of force. The audience had a good laugh at that one.

[AN ASIDE: Generally, I found DTC critics much more entertaining at the hearing than supporters. They were lively presenters and often had multimedia accompaniment. The supports were dry and boring for the most part. Jeez! Why do they leave all their marketing skills at the office! Maybe if they were more entertaining and even had a few sound bites like the above I would write about them in this blog more often. However, it is not my goal here to be balanced and present all views no matter how entertaining they may be.]

End FDA Chief Counsel review of all enforcement letters.
Although SB doesn't think FDA warning letters are effective, he nevertheless suggested that these letters not be impeded by FDA's chief counsel review. This issue was discussed in a previous post to this blog (see "WLF Watches FDA Watching Drug Ads").

Regulate Disease Awareness Ads.
There was much discussion of this type of promotion, which is non-branded. Most of the discussion was about how effective these ads are in driving people to seek medical help -- a key benefit of branded DTC cited by proponents (J. Patrick Kelly from Pfizer reported on a study that claimed to show that branded DTC ads were much more effective at getting people to see their doctors than non-branded disease awareness-type ads. FDA referred to this study over and over again when questioning critics, raising it's conclusion to the level of dogma or conventional wisdom. I have not yet examined the study but at least one critic testifying at the hearing dismissed it).

SB suggested, however, that the disease awareness ad may become the "new reminder ad" and serves merely to drive consumers to branded promotions in other media such as the Internet. He cited a Pfizer TV ad on depression, which did not mention any product name but urged viewers to visit the web site, which is clearly a site that promotes Zoloft, Pfizer's antidepressant drug. On the site, Lorraine Bracco, the actor who played a psychiatrist on the HBO show The Sopranos, says "[my doctor] put me on Zoloft (link to I was also on therapy... And let me tell you something...getting treatment was the best thing I've ever done for myself."

[I include her photo to add some visual interest. She looks great, huh? The photo must have been taken a long time ago, because I saw her on a recent Law and Order show and she looked
really fat and ugly! (I should talk!) Maybe she wore a fat suit on the show and it is a recent photo and she went on the South Beach diet and shot up a lot of Botox after the show. Nah! I think it's an old photo. I wish I had more photos of me when I was younger! If only I knew that I'd be a blog celebrity way back then!]

SB proposed that such disease awareness ads -- where there is a link to branded promotion on the Internet -- should be regulated by the FDA as if they were product ads, The two, in other words, should be regulated as one ad. This is a quite interesting idea and bears looking into some more.

But not now, not here. I have to get to work. More on the FDA DTC hearing later.

Tuesday, November 01, 2005

FDA DTC Hearings: Snippets from Day 1

I am in Washington, DC attending the FDA public hearing on DTC. I will try to summarize a few of the more interesting presentations here. Later, I will cover the proceedings in more detail in the Pharma Marketing News newsletter.

People are polite in Washington, DC. They don’t rush and knock you down in the Metro (subway) like people do in NYC. Similarly, FDA people and presenters at today’s public hearing on DTC were very polite too. The nice FDA people asked nice questions and the nice presenters, for the most part, didn’t blast the FDA for not doing anything to reign in DTC.

[There was one exception: Lisa Van Syckel from made an impassioned presentation that claimed drugs like Paxil and Prozac were responsible for the deaths of many adolescents. The video she presented was very disturbing and it suggested that the FDA rejected evidence and refused to do anything about these drugs.]

I rated each presenter as to whether they supported DTC or were against it. By my estimate, the presenters were evenly divided: 50% for and 50% against. Good balance FDA!

Anyway, the first panel, for the most part presented results from cognitive and linguistic studies. These studies measured readability, etc. and were designed to quantify “fair balance” in ads; i.e., presentation of risk and side effect information commensurate with benefit information. Most confirmed the obvious like: risk information in print DTC requires a reading level two grades higher than that required for the benefit information.

A study reported by Ruth Day of Duke University, discovered that the bee in the Nasonex TV commercial beat its wings furiously when risk information was being presented but was still when benefit information was presented. Day claimed that the beating wings divert viewers’ attention from the risk information. Pretty neat, eh?

How devious DTC advertisers are! I never thought they were clever enough to employ such nefarious devices to subvert the fair balance guidelines of the FDA, which never had a clue!

Notwithstanding the credibility of her studies, Day’s main point was this: In TV and print DTC ads “risk information is physically present but functionally absent.” There’s a sound bite for you!

Lewis Glinert of Dartmouth was a very witty and droll presenter on the linguistic merits of DTC advertising. He stated, for example, “consumers should not expect to find any logic in ads.” He also claimed that DTC ads have many touches of “postmodernist irony.” He didn’t explain what that meant nor did he offer any examples. Too bad.

Gilbert threw out some linguistic terms like “fragmatics” and cited the phrase “ask your doctor” as an example. It all depends on what you mean by the word “ask,” which according to Gilbert has a “web of meanings.” Who knew drug advertisers had such a depth of linguistic knowledge? Anyway, the FDA promised to look into this.

A few panelists presented convincing data that showed that DTC was effective in people to seek medical care. One study presented by Andrew Kleit of Penn State also claimed to show that DTC was “efficient,” meaning that it drove the right people – those who would benefit the most from the advertised treatment – to seek help better than those who were not the best candidates.

On the other hand, Micelle Spence of Kaiser Permanente cited her organization did that showed patients who saw a COX 2 ad and asked their docs about the drug were significantly more likely to be prescribed the drug even though clinical guidelines recommended other NSAIDs for these patients. Of course, the guidelines were based on cost-effectiveness rather than clinical data. Spence concluded that many new drugs promoted by DTC demonstrate a “small benefit for a large fee.”

A couple of other interesting tidbits before I call it quits for the night:
Celebrities in advertising: Abby Mehta of Gallup and Robinson did a study of Celebrities in DTC Advertising financed by Pfizer. She found that although ads featuring celebrities were more effective at “breaking through the clutter” and were more “likeable” by consumers, the ads generally were not more informative or believable and may or may not motivate consumers to seek treatment (it depends on the condition).

Power of images: Diana Zuckerman of the National Research Center for Women & Families suggested that the power of DTC is in the images, not the words. The positive benefit images are so powerful, she contended, that the images defeat any attempt at fair balance. This left the FDA wondering how it would regulate images to achieve fair balance – how could they measure the effect? Zuckerman suggested that the only way to guarantee fair balance is to do away with images in ads. Yeah, that could happen.

Don’t ask me what the likely outcome of this hearing will be viz-a-viz possible new regulations from the FDA. All I can point to is the tenor of the questions that the FDA asked as a hint to where they may be going.

Clearly fair balance and better presentation of risk information is of great interest to the FDA. With so many nuances like the use of certain words and phrases, images, font size, placement, etc. that affect fair balance, it would require a great deal of micromanaging the creative process to regulate DTC ads under a new regulatory regime focused on balancing benefits and risks. It may be easier to place a moratorium on DTC advertising of new drugs until doctors and the public become more familiar with side effects. After all, many presenters – especially representatives of drug companies – are careful to point out that DTC is only one source of information about drugs and not even the top source. A few months without DTC, therefore, would not limit consumers’ knowledge of available treatments nor adversely affect their motivation to seek treatment.
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