Thursday, December 29, 2005

The BEST of Pharma Marketing Blog in 2005

I can't resist the urge to do a TOP TEN list! Of the more than 120 posts made to this blog in 2005, the following are my picks for the TOP TEN, based on my own criteria and feedback from readers. Most of the these address in one way or another the TOP concern I have about the pharmaceutical industry and pharmaceutical marketing: a lack of transparency... a lack of transparency about drug risks, a lack of transparency in DTC advertising, and a lack of transparency about issues like drug reimportation. You'll have to read some of these TOP TEN posts to see what I mean. Or read this article: "Blogs and the Pharmaceutical Industry."

An now [drum roll, please] the TOP TEN, counting down from 10...


NUMBER 10:
Proposal for a Drug Risk Advisory System -- Taking a page from the Homeland Security Advisory system, in May I proposed a similar color-coded system for notifying the public about drug risks. I thought it was a good idea as did quite a few respondents to my survey on the topic (see "Notifying Consumers of Drug Risks"). I even suggested it the FDA, but they haven't gotten back to me yet. In fact, the agency may dump the whole idea for a "Drug Watch" Web site (see "FDA Drug Watch: Too Hot to Handle"). The drug industry really opposed this initiative, so it's not surprising that the FDA has quietly put the idea to bed -- it could never work without the cooperation of the industry.

NUMBER 9:
Is Pharmaceutical Marketing BS? -- After watching a 60 Minutes show that featured a story on a book titled "On Bullshit," I just had to go out and get the last copy in my local bookstore, especially since the commentary also noted that marketing is one of the most notorious sources of bullshit. Of course, pharmaceutical marketing is often "top-of-the-line" as far as bullshit goes. Learn about my pharma marketing "bullshit meter" from this post. Also, try this article (reprint available): "Is Pharma Marketing a Lot of BS?" (fun reading for the New year!).

NUMBER 8:
Merck's Hand in the Cookie Jar -- There's so much [bad] news about Merck and Vioxx that I just cannot not help but write about the company's trials and tribulations. At least 13 posts were devoted to Merck. I picked this one because it was the last straw and so obvious that Merck was "cooking the books" so to speak. I anticipate more disturbing revelations in 2006.

NUMBER 7:
The Two Bobs: Enzyte vs. Viagra -- One editor calls for Enzyte (the "natural male enhancement pill") ads to be pulled, the other wonders why Viagra ("the blue pill") asd aren't vilified as well. Which Bob do you like? Or which Bob is more like you (or a male acquaintance of yours)? The parallels between these products, how they are marketed, and how they have been or not been regulated is very interesting. In August, I suggested that the promotion of Viagra would be a test of Pfizer's new DTC pledge (see "Pfizer DTC Pledge: ED is Litmus Test"). These days, Viagra has virtually disappeared from TV -- at least prime-time TV -- whereas Enzyte ads dominate the afternoon ESPN ad space.

NUMBER 6:
It's the land of success! -- Oops! This is another Merck/Vioxx related post, but written in the style of the old rhyming Crestor ad. It's about "fixing" data in a Vioxx trial to make the results more favorable. See also Merck's Hand in the Cookie Jar where you will find the smoking gun.

NUMBER 5:
Peter Rost: Pharma's Black Knight -- When Pfizer cut off whistle blower Peter Rost's cell phone and email service after he was interviewed on 60 minutes, I couldn't help compare Rost with the Black Knight in the movie "Monty Python and the Holy Grail."

NUMBER 4:
WSJ Cites PM Blog as "Must Read" -- When the Wall Street Journal cited Pharma Marketing Blog as a blog insiders should read to stay current, you could have bowled me over. That day, the number of visitors increased tenfold! Just shows the power of the press.

NUMBER 3:
Pharma Marketing Mensa Invitational -- Take any pharmaceutical marketing term, alter it by adding, subtracting, or changing one letter, and supply a new definition. The results are pretty hilarious!

NUMBER 2:
Sexy Reps Sell Rx -- This post about the propensity of pharma companies to hire cheerleaders as sales reps resulted in a lively discussion among members of the PHARMA-MKTING listserv concerning the role of women in the industry. Smack in the middle of that discussion, we learned that Jerry Hall, super model, was named the (get this) "Global Ambassador for [Bayer HealthCare's] Erectile Dysfunction Campaign." Could it get any better for a blogger? You just can't make this stuff up!

NUMBER 1:
John Mack Rebuffs Merck's CEO Offer -- When Merck was looking for a new CEO, I couldn't believe that the leading prospect would reject the overture because he was scheduled to climb a mountain! Who could have scripted such a comment? This post was based on a more or less serious article in the Wall Street Journal, which I am sure had a bit of tongue in cheek. I couldn't resist taking the analogy to the extreme and come up with this comic spoof that won a few accolades from friends and colleagues. I should have waited a couple of days, however, for April Fool's day. Timing is everything in the blogosphere!

Tuesday, December 27, 2005

Lilly's Off-Label Promo Shenanigans

Recently, Eli Lilly agreed to plead guilty and to pay $36 million in connection with its "illegal promotion" of the drug Evista, which is approved by the FDA for the prevention and treatment of osteoporosis in post-menopausal women (see DOJ December 12, 2005 press release).

The case, brought by the Department of Justice (DOJ), reveals a few tactics that Lilly employed to skirt the prohibition by the FDA of "off-label promotion" of prescription drugs (see
PMN Glossary Definition). What Lilly did, according to documents from the DOJ, was to promote the use of Evista for the treatment of heart disease and breast cancer in women.

Off-label promotion is seen by some -- including the Washington Legal Foundation (WLF), an organization that continually confronts the FDA concerning commercial free speech issues -- as a First Amendment issue:


According to the WLF: "The core question is whether a manufacturer can be prohibited from discussing or promoting drugs that are being legally prescribed in an 'off-label' manner by physicians." (See "
OFF-LABEL" SPEECH: UNCERTAINTY REIGNS FOR DEVICE AND DRUG MAKERS".)

Reviewing the evidence in the Lilly case, it is obvious that the core question is really the role that pharmaceutical companies play in urging physicians to prescribe off-label in the first place. BTW, in case you did not know it already, off-label use of drugs by physicians is perfectly legal. A physician can prescribe any drug for any purpose, except where fear of malpractice suits may restrain the practice.


According to the information provided by DOJ, unrealized Evista sales forecasts spurred Lilly's new off-label promotion business plan.


"...the first year's sales of Evista in the U.S. were disappointing compared to Lilly's original forecast. According to the information, in October of 1998, the company reduced the forecast of Evista's first year's sales in the U.S. from $401 million to $120 million." [
DOJ press release]

So, it appears that prior to October, 1998, physicians may not have been doing much prescribing of Evista at all, let alone off-label prescribing.


According to DOJ information, which includes a lot of quotes from Lilly brand team e-mail messages, Lilly -- with some input from an "independent communications consultant" -- realized that to solve the problem it was essential to "elevate the efficacy image of Evista" and talk to physicians about not just the prevention osteoporosis, but also prevention of "cardiovascular complications, prevention of breast cancer." (See
DOJ Information submitted to US District Court in Indianapolis.)

Thus begins the slippery slope of illegal off-label promotion of Evista by Lilly, which used the following tactics (according to the DOJ):


Prompting Doctors to Ask for Off-label Information

One-on-one sales pitches by sales representatives promoting Evista to physicians about off-label uses of Evista. Sales representatives were trained to prompt or bait questions by doctors in order to promote Evista for unapproved uses.
[DOJ press release]

The FDA allows companies to distribute off-label information such as might appear in peer-reviewed medical journal articles to a doctor only if specifically solicited by the doctor. This is where the WLF has a problem with the law as a First Amendment issue. I also have some qualms about not allowing pharma companies to freely distribute some off-label information, especially information published in peer-reviewed literature.


Be that as it may, it is very hard to prove that sales reps engage in this kind of activity unless documentation is found. The DOJ information refers to "medical letters" that sales reps were encouraged to send unsolicited to doctors. The letters "go beyond what we are able to discuss with our customers," according to an e-mail sent by a Lilly District Manager to his sales reps.

Just a little side note regarding eDetailing. The ability of live sales reps to "wink and nod" while conversing with docs and thereby skirt some regulations to promote off-label use of drugs is something that could never be accomplished through eDetailing. As long as off-label use is critical for a brand, eDetailing will never be a good technique for that brand to employ. eDetailing is a tool for a more perfect world (i.e., a world where drug sales are based solely on FDA-approved use).
Lack of Transparency
Training sales representatives to promote Evista for the prevention and reduction in the risk of breast cancer by use of a medical reprint in a way that highlighted key results of Evista and thereby promoted Evista to doctors for an unapproved use. Some sales representatives were instructed to hide the disclosure page of the reprint which noted, among other things, that "All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written," and "The prescribing information provides that 'The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.' "
[DOJ press release]

It is one thing to say that pharma companies have a First Amendment right to distribute off-label information, but pharma reps should not have the right to edit and manipulate that information in order to deceive the physician. I should think this goes without saying. It seems to me, based upon this kind of evidence, that if WLF wins its case against the FDA, and pharma companies gain the right to distribute off-label materials, they are likely to abuse the right and engage in the sort of practice that Lilly has been accused of.


The ROI Dilemma

Calculating the incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998. The advisory board meetings included discussion of unapproved uses for Evista. By measuring and analyzing incremental new prescriptions for doctors who attended the advisory board meetings, Lilly was using this intervention as a tool to promote and sell Evista.
[DOJ press release]

Measuring physician prescribing patterns and new prescriptions is a tried and true way of determining the effectiveness -- i.e. return on investment (ROI) -- of pharmaceutical marketing (see, for example, "
The New Written Prescription: Leveraging Technology to Measure Change in Physician Behavior as it Occurs", a Pharma Marketing News reprint).

Measuring the success of pharma-sponsored medical education, on the other hand, is more problematic because US regulatory authorities take a dim view of using prescribing behavior as a measure of ROI (see, for example,"
Provider/Pharmaceutical Partnerships - Are They Possible Without Conflict of Interest?", a Pharma Marketing News reprint). The use of "advisory board" meetings by Lilly is a case in point.

Other market research cited by the DOJ indicated that Lilly's tactics -- only a few of which are described above -- were successful. Twenty-four percent (24%) of doctors surveyed recalled receiving the message from Lilly sales reps that Evista may reduce the risk of breast cancer. Six months earlier, before Lilly's new off-label campaign, there had been no indication that doctors recalled that Evista may reduce the risk of breast cancer.


There's no disputing that off-label promotion works. But can it be done legally and with transparency?

Wednesday, December 14, 2005

Pharmaceutical "Tribal Marketing"

Tribal marketing n. A marketing strategy that attempts to create social groups or communities that are centered around a product or service. The credo of tribal marketing is that postmodern people are looking for products and services that not only enable them to be freer, but can also link them to others, to a community, to a tribe.

An example of a tribal marketing tactic is reported on in today's Wall Street Journal in an article entitled "
Marketers' New Idea: Get the Consumer To Design the Ads" (subscription required):
"Drawing consumers into marketing campaigns is a time-honored tactic, whether companies are searching for the new Oscar Mayer kid, Brawny man, or Crayola Crayon colors. But in recent years, the Internet has furthered the conversation between corporations and consumers, tapping into the public's views and talents on a grander scale. Meanwhile, new technologies enable even amateurs to create sophisticated images.' [WSJ]
I've often said that ideas from general packaged goods consumer advertising eventually make their way into Rx direct-to-consumer (DTC) advertising. Divisions of the same ad agencies create pharma ads and the pharma industry has been open to learning techniques from the packaged goods industry.

Imagine, if you will, creating your own Viagra ad!


Recent criticisms of DTC may put a damper on such cross-industry creative pollination. The pharma industry has to be very careful how it advertises drugs, especially those with serious potential side effects. Case in point: Vioxx. Merck's advertising and marketing were cited as the main reason why the lone juror in the recent federal Vioxx case held out and caused a mistrial. I haven't seen that lone juror's comments, only comments from other jurors like this one:

According to one juror, the holdout wasn't swayed by the majority's argument. "Basically the sticking point was the marketing" of Vioxx, this juror said. "There was just folding of the arms and rolling of the eyes and not listening," and saying that "the marketing was inappropriate and that kind of thing," the juror added. [Reported in yesterday's WSJ: "Lone Holdout Forces Mistrial in Third Vioxx Case"]
Generation Rx Tribal Marketing
Tribal marketing is exactly what the pharmaceutical industry has already perfected according to Greg Crister, in his new book,
Generation Rx: How Prescription Drugs Are Altering American Lives, Minds, and Bodies.

Crister puts forth the notion that "big pharma" has created a nation of pharmaceutical tribes, each with its own unique beliefs, taboos, and brand loyalties. According to Crister, there are 3 such tribes:


Tribe of High-Performance Youth
: children and adolescents who are medicated for depression, attention deficit disorder, and a range of other psychological and behavioral problems mostly because of "“their parents' completely understandable wish that they perform well in a society of ever increasing demands to perform well, nay, superbly."

Tribe of Productivity and Comfort
(Middle Years): those of us at the middle-to-late points in our careers as parents and/or earners who are preprogrammed to consume drugs like Lipitor, Viagra, Prozac, and Prilosec, to "“shore up our ability to produce more and better and to relieve discomfit, including the discomfit of having to watch what and how much we eat and drink and of sitting on our duff."

Tribe of High-Performance Aging
: seniors who take drugs "“not only to alleviate the discomfit of aging, but also to extend their lives."

You can read more about Crister's thesis and an interesting first-person history of pharmaceutical marketing by reading the
upcoming issue of Pharma Marketing News (subscription required).

Tuesday, December 13, 2005

Marketing "Acceptable Risk"

A few days ago I posted comments regarding Merck's hand in the last minute editing of an important Vioxx clinical trail article published in the New England Journal of Medicine (see "Merck's Hand in the Cookie Jar"). Several members of the PHARMA-MKTING online discussion forum commented on this issue and focused on risk, arguing that there is always some risk associated with Rx medications and the important question is who should determine what level of risk is "acceptable."

My friend and Pharma Marketing Roundtable member Harry Sweeney started off the conversation:

"Having just returned from the two-day, FDA hearings on risk communications (see "FDA Seeks Input on Communication of Drug Safety Information"), I may be more sensitive than usual to the NEJM revelations. It appears that someone decided to follow the letter of the study protocols in writing or editing the NEJM article but overlooked their spirit, and woefully underestimated how that decision might appear with 20:20 hindsight, particularly in a deteriorating public confidence environment."

"The news article did provide an interesting couple of numbers that I have been asking about since the story broke some months ago. The seventeen reported deaths were characterized as "four times greater" for Vioxx than for naproxen, and with the three additional deaths as "five times greater" than for naproxen. The article also said that there were "more than 8,000" cases in the study."

"Using those numbers, 20/8,000 means that the mortality risk for Vioxx is one-quarter of one percent, or that the odds are 1 in 400. Those numbers also mean that naproxen's mortality risk would be 4/8,000 or one-twentieth of one percent, and that the odds are 1 in 2,000."

"Since most people are not interested in epidemiologic statistics, generally, but rather in a "statistic" of one -- themselves, or a loved one -- wouldn't it make more sense to report risks in those terms as well as the ways favored by economists and epidemiologists?" [My Emphasis.]
Harry, you pharmaceutical marketer you, I see where you might be going. What you suggest is a way for marketers to make risk sound more acceptable in future drug ads in which the FDA will require more discussion of risk. I wouldn't call it "spinning" or bullshit, but just what marketers do.

In my opinion, the terms by which risk is communicated (i.e., relative vs. absolute) is the critical issue that the FDA should regulate, not how big the type is or whether the risk information comes earlier or later in the ad.


Harry goes on:

"All of this raises, for me at least, a much more fundamental question: Who should decide how much risk I am willing to accept? Is there some baseline, consensus level of risk for prescription drugs generally? By class? For each drug? We know "zero-defects" is not attainable; so where should the line be drawn?"

"I don't think that we have begun to have enough of a public discussion about the complexity of these decisions. What do you think?"
I, of course, agree that the more public discourse, the better. Regarding who should decide what is "acceptable risk," pharmaceutical companies and pharma marketers certainly should not be the ones to decide. No matter how you look at it, they are necessarily biased.

That is why Merck's secretive, last-minute manipulation of the numbers to be published in a peer-reviewed article is heinous in my opinion (regardless of how the statistics are presented). It was an attempt to circumvent an important avenue by which patients -- through their physicians who read these journals -- can evaluate their risk and determine for themselves what is and what is not "acceptable."


On the issue of statistics, I bow to a higher authority, Mark Twain, who said: "Figures often beguile me, particularly when I have the arranging of them myself; 'There are three kinds of lies: lies, damned lies and statistics.' " Pharmaceutical marketers often use statistics in a way that increases the bullshit level in their communications (for more on this topic, see "
Is Pharmaceutical Marketing BS?"). Although the communication of risk information in today's DTC advertising is less than perfect, I predict that in the future the problem will be perfected communication of faulty (or BS) statistics.

Terry Nugent, another member of the PHARMA-MKTING online discussion group, also looked into his crystal ball to see what effect risk would have on DTC advertising:

"I think the industry and the health professions have to come to grips with a certain inappropriate nonchalance regarding fatal side effects involving medications with an unjustifiable risk-reward ratio. "

"For example, an FDA advisory just came out regarding Advair, recommending against it as a first line therapy for asthma due to potentially fatal adverse reactions not associated with alternatives. Yet, my personal interactions with a pharmacist and pulmonologist found them unaware of the announcement and not particularly alarmed."

"In the case of Vioxx, the risk-reward ratio can be huge if the product is overprescribed. Tennis elbow can be endured if treatment carries the risk of death, no matter how small. The tradeoff of course was GI bleed caused by therapeutic alternatives. Now we see studies that argue the GI bleed risk is no lower with COX-2s than aspirin et. al., but in fairness that was not known at the time Vioxx was being prescribed."

"
My point is that going forward the industry is going to have to be much more conservative in marketing products with potentially fatal side effects, no matter how rare, for non-life threatening conditions. [My emphasis.] The litigation cost of Vioxx and the even more devastating cost to Merck's reputation will probably be enough to compel the change in mindset, which will then need to be communicated to a skeptical professional and public audience. "

[Journal Process Graphic]
Ghostwriting and Risk Communication

Regarding changes in industry's mindset about communicating risk to professionals, a story in today's Wall Street Journal about medical ghostwriting in scientific journals may be relevant (see "
At Medical Journals, Writers Paid by Industry Play Big Role"; subscription required).

The most important mindset to be changed, in my opinion, is the industry's apparent lack of transparency. Medical ghostwriting is another case where the industry's lack of transparency is causing them problems in the press.


"Medical writers and communications firms," according to the WSJ article, "often help prepare articles for scientific journals, but their work isn't always disclosed."


This is not such a big secret amongst pharma marketing professionals and it is something I have known about for many years. Disclosure: My career working in companies that service the pharmaceutical industry included a stint with a small mom-and-pop (literally) operation that specialized in ghostwriting clinical trial studies for publication in medical journals. I also worked for a division of Excerpta Medica, which is mentioned in the WSJ article.


A patient's best partner in determining what level of risk is acceptable is his or her physician. It is inappropriate, therefore, for pharma companies to manipulate this partnership by unduly influencing how data from their clinical studies are presented in the medical literature. As the WSJ article mentions, "These seemingly objective articles, which doctors around the world use to guide their care of patients, are often part of a marketing campaign by companies to promote a product or play up the condition it treats."


To offset any question of influence, pharmaceutical companies should be more transparent with medical journals about their role in assisting researchers to write articles about their studies.


Getting back to marketing acceptable risk and the Vioxx case, Katherine A. O'Neill, another member of the PHARMA-MKTING online discussion group had this to say:

"The Vioxx situation is much more complex than simply an issue of marketing a drug with potentially fatal side effects. The fact is that if it is used in the right patient group, it is safe. Pencillin can be fatal to those with penicillin allergy - but it's still on the market. Potential wrongdoing by Merck is just obscuring the facts about the pharmacology of the drug."

"Regardless of how the product was positioned - better tolerated in terms of GI SEs, or whatever -- the NSAID market - consisting of bruise and injury but also an enormous group of arthritis patients is a very unsatisfied market. There are many patients who do not obtain satisfactory results from the available meds. That's why every time a new NSAID is introduced, you can be sure that docs will be pretty eager to write it for those patients that have been on 5 or 6 different NSAIDs and are still in pain and have limited mobility."

"Who should decide the risk/benefit ratio? To some degree, the FDA. But patients/consumers need to take more responsibility, too. There is risk involved in every activity we undertake, including taking medication. How many people took Vioxx? How many deaths occurred? Over a million patients? 100 deaths? I think that's safer than driving a car."
Yeah, but WHAT car? If you think you are getting a safe, practical car because it was written up in a car mag with good safety numbers, but it was actually a bit less safe than the article suggested (the article was ghostwritten by writers hired by the manufacturer and the safety numbers massaged), maybe you'd want to know that.

The use of risk analogies by pharma marketers is another type of marketing communications trick of the trade that will confuse patients in the future. It is good, therefore, that patients continue to view pharma marketing with a skeptical eye. The more they do that, the more pharma marketers will have to jettison its tricks and bullshit and just find more open and transparent ways to get the right message across to the right audience at the right time.

Friday, December 09, 2005

Merck's Hand in the Cookie Jar

It seems that Merck has been caught with its hand in the cookie jar. The New England Journal of Medicine (NEJM), that bastion of medical journalism and former bully pulpit of Marcia Angell -- author of "The Truth About the Drug Companies", which tore a new one for the industry -- has issued a highly unusual "Expression of Concern," according to an article in today's Wall Street Journal ("Medical Journal Says Merck Study Omitted Key Data").

The data -- about three Vioxx patients who suffered heart attacks -- were "excised" from the crucial and mull-maligned Vigor clinical trial. According to WSJ: "The medical journal said it had discovered from a computer diskette submitted along with the article that some data were deleted from the manuscript just two days before it was initially submitted for publication in May 2000."


The NEJM editorial states:

Until the end of November 2005, we believed that these were late events that were not known to the authors in time to be included in the article published in the Journal on November 23, 2000. It now appears, however, from a memorandum dated July 5, 2000, that was obtained by subpoena in the Vioxx litigation and made available to the Journal, that at least two of the authors knew about the three additional myocardial infarctions at least two weeks before the authors submitted the first of two revisions and 41∕2 months before publication of the article. Given this memorandum, it appears that there was ample time to include the data on these three additional infarctions in the article. (See "Expression of Concern".)
Merck says:
The additional events referred to in the editorial were events that were reported after the pre-specified cut-off date and therefore were not included in the primary analysis reported in the New England Journal article. Nevertheless, these additional events were disclosed to the FDA in 2000, presented publicly at the FDA's Advisory Committee in February 2001, and included in numerous press releases subsequently issued by Merck. (See "Merck's Statement on NEJM Editorial".)
Yes, we've seen how Merck trained its sales reps to inform doctors about the Vigor trial. The training program was called "Dodge Ball" as I recall. Whenever a doc raised issues regarding Vigor, the reps were trained to dodge the question with facts from a Merck playlist.

Reporting side effects and adverse events to the FDA is like me confessing to a priest -- the data go in but they don't get out. You'll note that recently the FDA has quietly dropped its plan to do a Drug Watch Web site so that these "emerging" side effect issues would be made more widely available to docs and patients who may not have read Merck's press releases (see "
FDA Drug Watch: Too Hot to Handle").

One additional small point was made in the article: "Using word-processing software to track down when changes had been made and by whom, the editors found out the data had been taken out two days before the article was submitted to the journal... [the editors] determined the deletions were made by someone working from a Merck computer."


WORKING FROM A MERCK COMPUTER!!!


This is evidence of the hand in the cookie jar! Can you imagine the scenario? Do I have to spell it out for you?


Advice to Merck

So your excuse is you had a press release and told the FDA. That's supposed to let you off the hook? Whatever happened to "Patients Come First"? Is that campaign just a lot of bullshit like I said it was (see "
Patients Come First?").

I also like (meaning I don't like) your argument that the events "were reported after the pre-specified cut-off date" for the trail. I can tell you that this argument won't work in front of a jury. It just sounds like you were cooking the books -- it's an accounting trick and people don't like accountants, especially after Enron. You don't want that word brought up in trial, do you?


Take a lesson from Japan. According to a BusinessWeek Online article ("
Big Pharma Seeks an Image Cure"):
"U.S. drugmakers are scrambling to resuscitate their collective reputation -- and they've got a lot of room for improvement. Just look at Japan. There, more than 70% of the public believes its pharma industry is trustworthy.

It's not hard to see why there's a perception gap, says Hatsuo Aoki, chairman of Tokyo-based Astellas Pharma. Patients in Japan don't have to deal with sky-high drug prices because the costs are covered by universal health care. What's more, Japanese drug companies don't produce the high profits that their U.S. counterparts are known for, and their top executives aren't similarly compensated.

"The idea of the corporation in Japan is different than in the West," Aoki says. "We don't only serve investors. The public and our employees are considered just as important."
Merck, reaffirm your commitment to patients over profits (CEO George W. Merck once said: "We try never to forget that medicine is for the people. Not for the profits. The profits follow, and if we have remembered that, they have never failed to appear.") But, I am not talking about more PR and TV commercials!

I suggest Merck initiate a public cleansing like Japanese corporations sometimes have to do. Merck, why don't you just say you are sorry, you strayed from your core mission, you will pay reasonable damages and you will move on with a new management team that is
actually committed to the "Patients Come First" tag line.

A quick death (and, hopefully, a triumphant rebirth) is better than this long, drawn out slow death, one dollar in per share value at a time! This will not only help your investors but will also help you maintain employee morale. Speaking of employee morale, I was quoted in the above-mentioned BusinessWeek article on this very subject: "[pharma companies] need employees who are highly motivated, and morale is pretty bad in the industry right now."

Wednesday, December 07, 2005

Less DTC, Better Public Image?

A lot of attention is being paid these days to pharma's tarnished public image. The prominence of direct-to-consumer (DTC) advertising has been linked to the deterioration of this image and some pharma companies have responded by cutting back on branded DTC. But none have advocated an immediate and complete withdrawal.

The discussion regarding J&J by several members of the online
PHARMA-MKTING discussion group shed further light on the relationship between DTC and pharma's image crisis. Members responded to yesterday's post to this blog ("J&J Scores High in Reputation Quotient Study") and helped me answer the question I posed: Why Did J&J Score High in Reputation Quotient Study?

David Hoo, a former employee of J&J and a current member of the
Pharma Marketing Roundtable, listed a few credible reasons:
Having worked for J&J over 10 years and through the Tylenol cyanide crises, much of J&J's goodwill comes from how that very crisis and other public issues have been handled and have become peerless text book case studies of responsible corporate behavior.

For anyone too young to be familiar, for public safety J&J recalled and destroy every package of Tylenol after the Chicago tampering and then relaunched Tylenol in completely new tamper evident packaging, all at J&J's expense at 100's of millions with absolutely no hesitation whatsoever. I don't believe any company in any industry any where in the world has exemplified any thing close to this ever.

There are a number of other reasons why J&J has such a good public image, all of which I believe are by intentional design.

First, it is best known by consumers for its baby business and bandage business. Its
hard not to love and be fond of babies and first aid.

Second, J&J is both a highly diversified and highly decentralized business.

Pharmaceuticals do not represent the majority of its business. Also pharmaceuticals are marketed not only under specific brand names, but also from different operating companies which do not have the J&J name prominently promoted.

Pharmaceuticals are primarily promoted to professionals. J&J has not been that heavy of a DTC advertiser compared to other pharma companies. So if there are consumer issues/controversy, the J&J name is not directly associated.

J&J has very high standards of how it promotes its products. For example, it never capitalizes on another company's/product's misfortunes.

But in the end, how J&J handled the Tylenol crisis and its Credo of operating principles

NOTE: C Nguyen, another PHARMA-MKTING discussion participant, said: "J&J stayed with their credo and how many pharmaceutical [companies out there] follow [a similar] credo?"

However, consistency in handling other issues plus high standards for quality products, marketing and promotion and endless steady growth may also contribute as much to such a burnished and untarnished image. that easily guided through this crisis is the major reason I believe for its tremendous public image.
J&J's handling of the Tylenol tampering incident is the "gold standard" of crisis management, the main ingredient of which was transparency. J&J's CEO was the main spokeperson, made all the facts known and was available to the press throughout the crisis. Pharma companies should use the same crisis management tactic -- i.e., transparency -- to handle its current image crisis.

Unfortunately, the gold standard today is to circle the wagons and hide behind corporate communications departments and lawyers. Even J&J -- the original standard bearer -- may not have been so transparent in managing its recent crises.

Back in June, 2005, J&J faced some criticism over its continued promotion of Propulsid for use in children after serious safety issues were raised by the FDA (see "
Say it isn't so, J&J!"). It only pulled Propulsid from the market two years after the fact. According to a New York Times story:
"Two years later, as reports of heart injuries and deaths mounted, Johnson & Johnson continued defending the safety of Propulsid, but then pulled it from the market before a government hearing threatened to draw attention to the drug's long, largely hidden, record of trouble."
Even more troubling was that J&J "declined repeated requests to make executives available to be interviewed" for the article. Unfortunately, these days, such reluctance of corporate executives to be forthright and open with the public is a typical pharmaceutical company response to handling crises. CEO's are too busy preparing for the next investor conference call.

This, I believe, is contrary to the J&J credo, mentioned above, which pledges to put "customers first, stockholders last" (see "
Our Credo Explained"). But, I digress.


J&J's Marketing Savvy

More than its handling of the Tylenol incident, J&J's good reputation may be tied to its unique product portfolio, marketing savvy, and corporate structure. As Hoo suggested, J&J may do very little DTC advertising for its pharmaceuticals and devices compared to other pharma companies, but a whole lot of baby product advertising. The result is that J&J has tied its corporate image to the baby image.


Tom Baker, a member of PHARMA-MKTING, had this to say about that:

My company consults to several of the JNJ operating companies on pharma/biotech strategy issues. When my wife and I had our first baby, they sent us a baby kit -- shampoo, wipes, etc. -- full of JNJ products. That is why they rank so high: I know they make drugs, I work on those drugs, yet I will always think of the baby kit first. That's genius marketing.
Less DTC = Better Public Image?
Hoo also mentioned that J&J focuses less on DTC advertising than do most pharma companies and when it does, it is under different operating company names and the J&J name does not figure prominently in the commercials. If this has helped J&J maintain its reputation, then it should indeed continue to "keep quiet about pharmaceuticals" at least in front of consumers.


It's a good argument for getting rid of DTC. Imagine that, if you can!


Imagine there's no DTC

It's easy if you try

No hell to catch from FDA and Congress

Only uninterrupted CSI

Imagine all the TV viewers

Not turning their eyes away


Imagine there's no me-too drugs

It isn't hard to do

Nothing to compete for

And no off-label usage too

Imagine all the people

Living life in safety


You may say that I'm a dreamer

But I'm not the only one

I hope someday we'’ll all join Frist, Grassley, Kennedy, and Waxman

And the world will be as one

Tuesday, December 06, 2005

J&J Scores High in Reputation Quotient Study

Results of the recent Harris Interactive corporate reputation study, reported in today's Wall Street Journal (see "Ranking Corporate Reputations"), place pharmaceutical companies low on the overall reputation totem pole (only tobacco companies ranked lower).

That's not news.


What *is* interesting is the consistent high ranking of Johnson & Johnson in this survey over the years. It stands out among pharmaceutical companies. According to the WSJ article:

One company has shown particular consistency. Johnson & Johnson has had a lock on first place since the survey began in 1999, successfully dodging the bullets fired at other pharmaceutical companies. It scored well for the quality of its products and for emotional appeal because of people's warm feelings about its baby-products business. It also received the highest scores for being ethical and trustworthy. J&J "is as American as Mom and apple pie," one respondent commented.
Merck, on the other hand, slipped to 45th place (out of 60), which is down from 32nd place in 2003.

So why did J&J do so well?

Primarily by staying out of the public eye.
If you look at some other results of the survey, you find that J&J ranks very low (56th place) on "media coverage recall." Only 21% of respondents say they recall mention of the company in the media in the past 12 months.

Merck Could learn a Lesson or Two
Another piece of advice was offered by one survey respondent who suggested that J&J "should just keep quiet about pharmaceuticals." Perhaps Merck should consider that advice as well and stop running its "Patients Come First" ads.

Here's another way Merck could redeem itself. The aforementioned ads portray Merck as the company that defeated childhood diseases with vaccines. Another article in today's WSJ talks about NIH investing in start-up (i.e., risky) biotech companies to help them develop a new anthrax vaccine, which would help us in case terrorists try to use anthrax as a WMD against US citizens.

NIH gave away $877 million dollars to a company that failed to produce the vaccine on schedule.

Why doesn't Merck -- by its own account a proven vaccine development leader -- come forward and develop and manufacture anthrax or other needed vaccines? Yes, it will lose money, but not as much as it will lose in VIOXX cases because it cannot find sympathetic juries!

Monday, December 05, 2005

Why are ED drug sales falling?

As reported in Sunday's New York Times, sales of erectile dysfunction drugs (Viagra, Cialis, Levitra) are falling (see figure at left). "...the market for impotence medicines appears to have fallen well short of what was once predicted," according to the story.

"Heavy advertising to consumers, totaling more than $400 million in 2004, has made Viagra and its newer competitors, Cialis and Levitra, among the best-known drug brands in the United States, and their combined global sales reached about $2.5 billion last year. But the number of new prescriptions for the drugs has fallen steadily this year. Doctors wrote about 10 percent fewer new prescriptions in October than they did in October of 2004." [NYT]


The article suggests that the drop in prescriptions for these drugs is "another sign of the limits of consumer advertising to drive demand for drugs." The article claims that the "effectiveness of television advertising for prescription drugs may be wearing off" and an analyst claimed: "Pharma ads have less impact than they used to, because we're accustomed to it."


Another explanation was offered by Matt Beebe, United States brand team leader for Cialis, who said: "Both the media and analysts have overstated the size of the market for impotence drugs."


Say what?


Did Matt happen to read by blog back in January when I said virtually the same thing? What I said was: "I think the marketers are drinking their own Kool Aid. They have overestimated the market and tried to put too many men in the ED category." (See "
ED Drug Sales Limp")

[Beebe criticized the media and Wall Street analysts for overstating the market, not his company's executives who fed market expectation numbers to the media and analysts. He remains positive with regard to the growth of the ED marketplace.]


Since January, the ED marketers -- at least the Viagra and Levitra marketers -- have made some changes to their campaigns. These tactics involve convincing more men to talk about the "problem" with their docs. Pfizer (maker and marketer of Viagra) will run unbranded ads -- ads that do not mention Viagra -- to motivate men "to make the call" (see "
Pfizer Tries Unbranded ED DTC Ads"). Bayer (marketer of Levitra) will employ Jerry Hall to be "Global Ambassador for [Bayer HealthCare's] Erectile Dysfunction Campaign" (see "Jerry Hall, Women and Pharma Marketing").

It seems that the Viagra and Levitra marketing teams do not think that the market for ED drugs have been overestimated. They just think that men need more motivation.


"We think there's an opportunity to expand awareness and usage," said Greg Duncan, a senior vice president of United States marketing for Pfizer. Many men are still reluctant to ask their doctors about Viagra, and Pfizer wants to remove any stigma still associated with erectile dysfunction, he said. Pfizer also plans to encourage younger men to take Viagra, Mr. Duncan said. [NYT]


ED Becomes EQ

Meanwhile, marketers of Levitra -- the market laggard -- apparently have solved the ED stigma problem. They merely have ditched "dysfunction" and added "quality" and, voila, have come up with "Erection Quality" or EQ! The Levitra product web site features "erection quality" on every page and includes a campaign to "talk to your doctor about improving erectile quality (EQ)."


This is a testament to the staying power of pharmaceutical marketers! They just won't admit that the product may not be working as advertised or that not everyone who suffers from ED want to be helped. In fact, they may not be a position to be helped even if they wanted it.


According to the NYT story: "In some cases, older men do not use the drugs because they have grown used to sexless relationships, because their spouses are physically unable to have sex, or because they are no longer interested in intercourse."


"With older men, some of them lose their partners, because their partners die or get sick, or they may develop an illness that reduces their sexual interest," said Dr. Ira Sharlip, clinical professor of urology at University of California at San Francisco.


Perhaps Bayer is right, “It Takes Two"...

Thursday, December 01, 2005

Coming Soon: Sexy eDetailing?

There's a lot of interest these days among pharmaceutical marketing and sales executives in sales force effectiveness (SFE). The brisk sales of a compilation of reprints I have put together on this topic (see "Increase Physician Access and Detailing Effectiveness"; a Special Supplement to Pharma Marketing News) is part of the reason why I make this claim, but it is a well-recognized trend supported by a large number of industry conferences devoted to the topic.

It used to be that SFE implied technology -- call tracking databases, tablet PCs, etc. -- but lately it's about actually getting in to see the physician and making the most of the 2 minutes allotted. Many physicians feel overwhelmed by reps seeking face time. They are pushing back.

The eDetailing Solution
There have been a number of solutions suggested for this problem. eDetailing is one solution that is gaining momentum, especially among the pharma marketing "e-literati." Again, I base this on how well another Special Supplement is selling (see "
eDetailing").

On the one hand, I think proponents of eDetailing are drinking their own Kool-aid (see, for example, "
eDetailing: Surveys Say..."). On the other hand, I think it is a viable solution (see, for example, "eDetailing ROI Better Than DTC?").

Needs Some Spice
eDetailing, however, lacks at least one essential element:
human interaction. Believe it or not, some doctors like to see at least some of the reps that call on them. Considering that pharma companies may be placing more emphasis on sales rep beauty and personality than on knowledge (see "Sexy Reps Sell Rx"), this is not surprising.

Sex and money have been proven human motivators for centuries (eons even!). And pharmaceutical marketers have used both. For example, pharma companies have been caught many times enticing doctors to prescribe their products in exchange for lucre. This practice ranges from the illegal (as in kickbacks) to the unethical (as in paying docs to see reps or view eDetails). The OIG (Office of the Inspector General at HHS) and the Department of Justice are taking care of the former, while AMA and PhRMA guidelines have taken care of the latter.


How About Adding Some Sex Appeal?
Consequently, there is today an
eDetailing incentive vacuum. Doctors cannot be offered cash anymore to sit through eDetails. The only option left, therefore, is sex appeal. I don't think there are any guidelines that address that. So, why not try it? Yes, add sex to eDetails! Before you pooh-pooh this idea, consider how sex is now being added to ED drug marketing and consumer education (see "Jerry Hall, Women and Pharma Marketing").

You might say, "There are other ways to jazz up eDetails, aside from sex and money, to motivate docs. Make it fun, for example." Good point. Most eDetails are pretty boring. Many eDetailing designers jazz up their programs to look like video games and I am sure you will see more of that in the future. But even video games these days are not enticing enough just relying on the fun factor (like killing people or stealing cars). They also include sex -- as in sexy celebrity avatars within the games themselves (and my son thinks I don't see this?).


Now that Bayer has Jerry Hall on the pay role and is unfurling her at medical meetings to entice docs to visit the Levitra booth, why not use her sexy image and voice in eDetails? Or you could use cheerleader-type sales rep images as "guides." Doctors could choose their own guide according to their preferences regarding sex (male of female), celebrity, race, etc. This would add a bit more human-like interaction -- like a warm and fuzzy HAL a la the movie 2001.
Hey, it could work!

But I can think of one problem: Michael Moore! Imagine if he got hold of images and video from such an eDetailing program! OMG!


It's just so darn unfair that technology cannot use all the tools -- like Jerry Hall and sexy cheerleaders -- that are used for live details, special events and even on TV!
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