Thursday, September 28, 2006

Odds & Ends & interpretations

I didn't have a topic worthy to explore in detail today, but there were a few bits and pieces in the news and readers' comments that are worthy of encapsulation.

1. Vioxx Scorecard Update
I originally published my Vioxx Scorecard in this blog back on August 6, 2006 (see "Vioxx Scorecard: 5-3-14192"). I am not sure if this was the first time a "scorecard" analogy was used, but it certainly has caught on. The
Wall Street Journal, for example, now has its own "Trial Scorecard."

The current scorecard tally is 5-4-14190 (1 undecided). Let me plot that out for you (in logarithmic scale, otherwise the wins and losses would be invisible):

Merck's record, in other words, has gotten worse since August despite a recent win in New Orleans (see WSJ: "Merck Is Victorious In New Orleans Vioxx Trial"). You might like to take my little quiz or see how long the Vioxx trial season will be according to our readers:

In what year will the last Vioxx trial be settled at the current rate?
StarDate 44012.3

2. Rozerem Ad Team Fesses Up
Ever since I posted the "Rozerem Ads Dis Lincoln, Show Beaver" it's been the number 1 page visited and has generated the most comments. Like the Vioxx trial topic, the Rozerem DTC campaign will likely be grist for my blog mill for eons to come.

Recently, two anonymous commenters interpreted the ad. They claim to "work for Takeda Pharmaceeticals [sic] (Rozerem)", which I interpret to mean that they work for one of the ad agencies employed by Takeda to produce these ads. Who else would (1) misspell the name of the company they work for, (2) append "(Rozerem)' at the end of the name, and (3) give a shit about getting the record straight?

Anyway here's what they have to say about the use of Abe Lincoln, beaver, et al (I added the bold typeface[e and italics for emphasis):
"I work for Takeda Pharmaceeticals (Rozerem) and let me explain what the figures in the ad mean. Honest Abe signifies honesty and the beaver signifies hard work and industriousness. The clock shows that if you suffer from insomnia, it doesn't matter what time it is, because you're still awake regardless, and your Sleep-Wake cycle is off-balance. Rozerem is the only prescription based sleep drug that works on different receptors in your brain that allows you to sleep to REM state(dream state) and this is where you want to be for restful sleep. Other drugs like Ambien and Lunesta work different so that your brain often does not get to the dream state."

"Just as the above writer, I too work for Takeda Pharmaceuticals (Rozerem). The title of the ad campaign is "your dreams miss you". The reason for that is b/c just as mentioned above,
Rozerem is the only sleep aid that DOES NOT have a risk of suppressing stages 3,4 and REM (dream) sleep. These stages are imparative to mental restoration. If you suppress these stages, patients are not getting a completely restful night of sleep. They are getting to those stages and restoring their bodies. Also, Rozerem has ZERO risk for abuse or dependency, not just a low risk, NO risk. Everyone has dreams that are strange and the point of the commerical is that Rozerem can take you back to those dreams which so many insomnia patients would love to have. Takeda made this commercial a little bizzare so it would catch a patients attention and they would talk to their doctors about the "new sleep drug commercial". Doctors can then explain how Rozerem is very different from any other sleep aid and explain Rozerem's benefits and how it should be taken. Since everyone is talking about it and analyzing it, obviously they've done their job!"
Note the claims made here: Rozerem is the only prescription based sleep drug that works on different receptors in your brain that allows you to sleep to REM state(dream state) and this is where you want to be for restful sleep...

It's too bad that these claims and benefits can't be made more directly in the ads. Certainly, I would have liked to been educated a bit more about sleep and the benefits of Rozerem. Education, after all, is what DTC is all about, isn't it?

Instead, us poor consumers have to rely on professionals to get this education: first, advertising professionals to interpret the ads and second, health care professionals who can "tell me how Rozerem is different."

Of course, I am quite suspicious about these claims. Could it be that Takeda does not have the EVIDENCE to back them up? But they must be telling the docs something they are not telling us. How else would the docs be able to tell us how Rozerem is different whereas the ads can't?

I assume the Takeda sales reps are presenting some choice data -- what I really mean is bullshit data -- on this REM gobbly gook. Perhaps the ACCME and the OIG might look into the CME programs that Takeda is supporting to see what doctors are being told about this drug by other doctors paid by Takeda.

Or maybe we need to stay tuned. Perhaps the second leg of the Rozerem DTC campaign will finally unveil the REM benefit in a more forthright fashion. Now that the DDMAC division of the FDA has added staff to review DTC ads (see "Apres IOM, le Deluge!"), I am sure the new Rozerem ads will get a close look and pass muster.

Wednesday, September 27, 2006

Apres IOM, le Deluge!

I came across the following in an MM&M NewsBrief yesterday:
[FDA's] Division of Drug Marketing, Advertising & Communication (DDMAC) has added a second DTC review group to meet soaring demand for advertising approvals, said DTC group leader Melissa Moncavage.

DDMAC fielded 9,285 consumer promotions in 2005 --– up from 8,417 in 2004 and 6,099 in 2003. The number of DTC ads submitted is expected to climb again for 2006.
"The number of DTC ads submitted is expected to climb again for 2006," reports MM&M. You think?

I plotted these numbers in the chart below and added an estimate for 2006, noting that PhRMA's Guiding Principles for DTC, which call for submission of all DTC ads to the FDA for approval before release, became effective January 1, 2006.

PhRMA's principles are voluntary, but in 2005, Astrazeneca 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 (see "FDA DTC Hearings Day 2"). AstraZeneca's original proposal suggests several tradeoffs desired by the industry. For example, AZ proposed that any pre-approved ad should be exempt from a subsequent finding by the FDA that the advertisement is misleading or inaccurate.

I estimated 15,000 DTC ads based on the fact that "the agency received 39,153 pieces of professional promotion for review in 2005," according to MM&M. At least half as many DTC pieces as professional pieces must be produced by the drug industry.
[BTW, 39,153 different and unique professional promotional pieces is a remarkable achievement if you consider the 80/20 rule of promotion, which states that 80% of your effort should be focused on the top 20% of prescribers. The AMA doctor finder has 690,000 physicians in its database. 20% of that number is about 140,000, which means that practically every 3-4 doctors may get their own unique promotional piece designed especially for them! The drug industry in other words is achieving near one-to-one marketing as far as physicians are concerned!]
The MM&M NewsBrief ends with this:
The addition of the second DTC review team, first reported in The Pink Sheet, has fueled discussion between the agency and industry of a possible increase in PDUFA user fees. DDMAC also maintains four review groups dedicated to professional advertising.
While a recent Institute of Medicine (IOM) report was critical of the FDA and called for changes in DTC advertising (see "IOM Report Calls for DTC Moratorium"), it does not support increasing User Fees to cover FDA costs. In fact, the IOM suggests that User Fees be scaled back and that the agency get more direct funding form the government.

What's next? Mandatory Review of Professional Advertising?
"DDMAC also maintains four review groups dedicated to professional advertising," reports MM&M. "The agency received 39,153 pieces of professional promotion for review in 2005."
That's about 10,000 pieces per review group or 3,000 pieces per reviewer (about the same number as the DTC reviewers would have to process). To review all these pieces, a reviewer would have to process about 15 pieces per work day.

I don't know how realistic this is. It sounds like too heavy a workload to me. There are sure to be mistakes made. IMHO, therefore, the FDA should not cave in to industry demands that a pre-approved ad be exempt from a subsequent finding by the FDA that the advertisement is misleading or inaccurate.

Tuesday, September 26, 2006

What's New from Pharma Marketing News

I invite you to download the September 2006 issue of Pharma Marketing News, which includes the following articles:


Rx drug company salaries are decreasing while biotechnology company salaries are increasing. The numbers don't lie: expect much more biotech marketing in the years ahead. If nothing else, these VPs have to justify their salaries!
Read the full text of this OpEd piece...

Print DTC: How Does It Measure Up?

Over 60 drug ads that appeared in several major consumer magazines were analyzed. In each, the space allocated to images, benefit statements, risk information, and the brief summary was measured. This article summarizes the findings.

Fast Start to Customized ePromotion and eLearning Physician Programs

There is a broad spectrum of online promotional and educational opportunities that pharmaceutical companies have at their disposal to interact with, inform, and influence physicians. Lathian Systems, a provider of online marketing and sales solutions, offers these and more in its Spectrum of Solutions for life science companies.

eDetailingeDetailing Supplement
This Special Supplement to Pharma Marketing News brings together in one convenient document several topics and case studies on eDetailing and ePromotion to physicians. The resultant collective wisdom of many experts both inside pharmaceutical companies and outside provide a frank assessment of the role and impact of eDetailing on physician marketing as well as the challenges that lie ahead.

Order online here.

Pharma's Black Knight Confesses All!
A contrarian review of the book THE WHISTLEBLOWER: Confessions of a Healthcare Hitman.

Pharmacy TeleStocking

Astute Development Group (ADG), a global provider of technology telemarketing and IT sales lead generation programs, manages pharmacy stocking from afar.

Monday, September 25, 2006

IOM Report Calls for DTC Moratorium

According to the report "The Future of Drug Safety: Promoting and Protecting the Health of the Public" issued by the Institute of Medicine (IOM), which is chartered by Congress to advise the government on scientific and health policy issues, "Lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the U.S. Food and Drug Administration's ability to evaluate and address the safety of prescription drugs after they have reached the market."

"FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry," according to the
Report Brief.

The report had been requested by the FDA itself. Perhaps they got more then they asked for.

The IOM's recommendations include:

  • Labeling requirements and advertising limits for new medications (ie, specifically a 2-year moratorium on DTC for new drugs -- see below)
  • Clarified authority and additional enforcement tools for the agency
  • Clarification of FDA's role in gathering and communicating additional information on marketed products' risks and benefits
  • Mandatory registration of clinical trial results to facilitate public access to drug safety information
  • An increased role for FDA's drug safety staff
  • A large boost in funding and staffing for the agency
See excerpts at the end of this post.

Spin Control from PhRMA

The response from PhRMA was lukewarm at best and aimed at spin control rather than at reassuring the public of the industry's commitment to improving quality:

"We will review the 25 IOM drug safety recommendations to Congress in the context of knowing that what needs to be done is to make a good system better," said PhRMA Vice President Caroline Loew. "Though there is always room for improvements, it would be a mistake to accept the notion that the FDA drug safety system is seriously flawed. After all, fewer than three percent of approved prescription drugs have been withdrawn from the American market for safety reasons over the last 20 years."
Is a 3% Recall Rate Really "Good"?
The drug industry, through its trade association PhRMA, considers a 3% drug failure rate "good." Obviously, the IOM doesn't think a 3% failure rate represents a "good" system. In any other industry a 3% recall rate due to safety issues would be "bad."

In the airline industry, for example, if 3% of airline flights ended in fatal crashes, there would be no airline industry. The actual rate of "fatal events" in the airline industry ranges from 0.00 to 1.92 per
million flights. That's less than than 0.0002%! Which is well within "Six Sigma" quality standards.

To achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities.

The pharmaceutical industry usually prides itself on striving for quality and many pharmaceutical companies -- especially Johnson & Johnson -- embrace Six Sigma methodology to achieve quality goals in manufacturing, marketing and sales (see, for example, "
Growing Pharmaceutical Sales Utilizing Six Sigma and Lean").

So why would the industry settle for a 3% failure rate for new drugs -- about 10,000 times the defect rate allowed by Six Sigma? By Six Sigma standards, a 3% drug recall rate is not "good". It's not even "acceptable" or "poor." It's atrocious.

I am not suggesting that the pharmaceutical industry adopt Six Sigma as an achievable goal for reducing drug recalls. After all, that would amount to practically zero drugs recalled for safety reasons for the foreseeable future -- obviously too much to expect in any research-based endeavor.

But, still, is a 3% recall rate all that "good?" To to adopt the "3% is good" defense in a public statement demonstrates PhRMA's lack of public relations acumen.

Case for DTC Moratorium

If pharmaceutical companies want to be consumer-friendly and enjoy the right to market their products directly to consumers, then they must not settle for a 3% drug recall rate, IMHO. They may not have to go as far as Six Sigma, but how about at least Six Thousand Sigma (ie, a 0.34% drug recall rate)?

Excerpts from the Report Brief
Labeling Requirements: "Marking the label and all promotional material for newly approved drugs or indications with a special symbol [such as the black triangle used in the UK] will help increase awareness of the nature of newly approved therapies."

"FDA should restrict direct-to-consumer advertising during the period of time the special symbol is in effect. The symbol should remain on the drug label and related materials for 2 years unless FDA chooses to shorten or extend the period on a case by case basis."

Performance Goals for Safety: "The Prescription Drug User Fee Act mechanism that accounts for over half of the Center for Drug Evaluation and Research's funding and the reporting requirements associated with the user-fee program are excessively oriented toward supporting speed of approval and insufficiently attentive to safety."

Adequate Resources: "The effect on CDER'’s work of CDER'’s overdependence on PDUFA funding with restrictions on how FDA can use the money from user fees hurts FDA's credibility and may affect the agency's effectiveness. The committee favors appropriations from general revenues, rather than user fees, to support the full spectrum of new drug safety responsibilities proposed in this report." See "Pay-(FDA)-Per-(Pre)View of DTC".

Communication to the Public: "Patients also need timely information about emerging safety concerns or about a drug's effectiveness in order to make better decisions in collaboration with their health care providers." FDA started to do this, but abandoned the project. See "FDA Drug Watch Site Guidelines."

For more on the topic of DTC advertisinig and risk communication, Fard Johnmar over at Envisioning 2.0 recommends the current edition of Pharma Marketing News which features a very interesting analysis of risk vs. benefit information in print DTC ads. Its worth a read. Click here to access the article.

Also see other related blog posts:

Friday, September 22, 2006

PhRMA's OOA Issues First Report

Back in May, 2006, I wrote to PhRMA's Office of Accountability (OOA) complaining that Sepracor was "sneaking" in Lunesta "reminder ads" despite being a signatory to PhRMA's Guiding Principles for DTC Advertising (see "Wake Up PhRMA! or Tilting at Windmills"). Read my letter here.

It took more than 2 months for the OOA to respond and when it did the response was both a joke and an insult, which I prompted protested. You'll recall at that time someone named Emily Johnson (no title) responded in one or two sentences on handwritten letterhead. Emily, I guessed, was a hapless, unsupervised intern tasked beyond her capabilities (see "Adventures of PhRMA Intern!").

OOA Grows Up!
Since then the OOA has evolved and gotten some grown-up leadership. PhRMA's Chief Medical Officer, Dr. Paul Antony, was named as Director of the Office and will "supervise the Office's work." Emily should be happy about that. Maybe Antony will order some stationery as well.

The OOA also has improved its Web page making it easier to report violations ("submit comments") of the Guiding Principles by signatory drug companies.

You can now also identify members of the Review Panel whose purpose "is to provide transparent, unbiased analysis of the industry-wide progress made in improving direct to consumer advertising consistent with the new guidelines." The panel's main task is to "review reports from the Office of Accountability and evaluate overall DTC trends in the industry." The panel's observations and recommendations will be published in early 2007, and a copy of the panel'’s report will be provided to the FDA.

Up until now the panel had nothing to review -- no report from PhRMA had been issued. I just discovered, however, that a report was recently issued! If you go to the OOA' Web page -- as I am sure you do at least every Monday like clockwork -- you will see "New! Read the Office of Accountability report just issued". [You won't see, however, any press release from PhRMA about this.]

["New" is that tiny little starburst icon that was popular among amateur webmasters in the 90s.]

My Comment Has Been Counted! I Think.
The report analyzes comments received between January 6, 2006 and June 30, 2006. Here's the methodology:
PhRMA's Office of Accountability conducted a survey of all signatory companies in July 2006 asking them for the number and nature of comments they received (both through the Office as well as independently) between January 6, 2006, when the Principles took effect, and June 30, 2006. Unless otherwise indicated, all information provided in this report is based solely on signatory companies' survey responses.

The letter I got from Emily in July, 2006 was dated June 29, 2006. Here's Emily's letter
in toto:

June 29, 2006

Dear Mr. Mack:

Thank you for your comment regarding PhRMA's Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines. We appreciate your feedback on compliance with the Guiding Principles.

Your comment has been forwarded to Sepracor for consideration.

Emily M. Johnson
Office of Accountability
So, my comment made it under the wire! I assume it was counted, therefore, in the OOA's first report!
[My only concern is that Sepracor may NOT have responded to the OOA's survey. After all, it did not respond to my repeated direct requests for a response, so why would it respond to OOA? There's no way to know based on information in the OOA report, which does not list pharma companies that responded to the survey.]
The report characterized each or the 284 comments according to which Guiding Principle it was related to. It also noted whether the comment was about a TV or print ad and classified commenters as Patients/Consumers, Healthcare Providers, Consumer Advocacy Groups, or Other.

Guess which group submitted the most comments. Wrong! 88% of the comments came from Patients/Consumers. [You thought it was Advocacy Groups, right? C'mon, admit it.]

I'm not sure what group PhRMA put me in. Since I said I was the publisher of Pharma Marketing News, I would have guessed I'd be in the "Other" group. But no! Only 3 comments were submitted by this group and all of those were about print ads. My comment was about TV ads. Maybe PhRMA put me in the Consumer Advocacy Group, which submitted only 1 comment -- about a TV ad. Voila! There I am! Brilliant!

One Person can be as Effective as FDA
There was only one comment reported by OOA that concerned Principle 10, which calls for television advertisements to "clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." That has to be my comment!

The OOA report goes on to state:

"The commenter [that's me!] stated that the advertisement at issue did not meet this standard. The signatory company [that would be Sepracor] reported 'conducting an internal review, withdrawing the advertisement at issue, and modifying other messages to make it clear that they are sponsorships that do not fall within the Principles' definition of a DTC television advertisement.' "

My interpretation of Sepracor's response is (1) we stopped running the reminder ad for Lunesta on TV, and (2) we are still running reminder ads, but not on TV. Call it obeying the letter, not the spirit of the Guiding Principles.

I note that I have been at least as effective as the FDA in getting a drug company to close the barn door (pull the ad) after the cows have left (after the ads have run).

Of course, I am assuming that this response was from Sepracor based on the logic of Occam's razor or is it Sherlock Holmes' maxim: "Eliminate all other factors, and the one which remains must be the truth." Whatever!

Sepracor, however, remains silent and still has not returned my calls or responded to my letters to the CEO and corporate communications director.

Wednesday, September 20, 2006

(¼±»ý´Ô) Á¤Ç°100%!! ºÒ [Spam DTC Ad]

I received an interesting bit of spam email yesterday with the above subject line (not including "Spam DTC Ad", which I threw in there just for the benefit of search engines).

Maybe you've gotten this message too.

I must say that I get a lot of spam, but the subject line intrigued me (it probably caught your attention too!).

No, it's not Wile E. Coyote cursing that darn Road Runner. I think it's Korean, or my computer's translation of Korean characters into ASCII.

Elmer sent me this message. No, not Elmer Fudd; Elmer Sinclair. I don't know who Elmer Sinclair is, but he doesn't sound Korean to me. So why Elmer Sinclair is sending me a Korean language email is beyond me.

[A little sleuth work revealed that the message originated with Daum Communications, which, according to Yahoo! Finance, "owns and operates South Korea's second-largest Internet portal at The company provides e-mail, online shopping, entertainment offerings, and financial services."]

Something is lost in translation of the text part of the message. But the graphical part of the message, which depicts men, women, pills, thumbs, and conical mountain tops, is clear.

Here, take a look for yourself.

Obviously, we're looking at a Spam DTC ad here. The products are Cialis and Viagra (or counterfeit versions). BTW, I've never seen spam email offers for Levitra. Why is that?

Anyway, I cannot read the text, what little of it there is in this ad. But, like the Lincoln and beaver graphic in the Rozerem ads (see "Rozerem Ads Dis Lincoln, Show Beaver"), which also dominates that ad's space, I am able to easily decipher the above ad.

I am a bit confused, however, by a few panels.

Panel "1", for example, has got to be the setup. As such, it should show a guy with a performance problem. Every ad begins that way, doesn't it? The guy is obviously doing a strip tease in front of his mate. The prominent bulge in his briefs (look closely) tells us that he is ready to rock and roll. Why then does he need Cialis or Viagra? This is not a setup after all!

What about the off-camera seated woman -- who is still dressed -- holding what looks like a used condom? This, and her raised palm, is a complete turn-off! The women in ED DTC ads are supposed to want "it", not reject the guy! So, panel "1" misses the mark.

Panel "2" is cute. I especially like the Cialis dialog balloon! And I recognize the universal "OK", which leads me to think the guy in this panel is saying "Let's wait. I got 36 hours. OK?" Some guys also need to talk first, you know. I give panel "2" points for staying on message for that product.

Panel "3" is obvious. There's perhaps some unconventional sex going on, but each according to his and her tastes.

Panel "4" is also obvious. That thumb looks pretty erect to me! No ED there! I wonder what the characters below are saying? Whatever they say, it's superfluous.

Panel "5", on the other hand, requires deeper analysis. Here, we are looking at a triumphant man atop Mount Fuji holding up a Viagra pill, while down below is an exhausted loser, unable to mount Fuji.

The sexual symbolism of Mount Fuji has to be the reason why it is included in this ad. Why else would a Japanese icon be included in a Korean ad?

According to an entry in Wikipedia on the etymology of the name of this mountain, "The current kanji for Mt. Fuji .. mean wealth or abundan[ce] and a man with a certain status..." and "An early folk etymology claims that Fuji came from [kanji] meaning without equal or nonpareil. Another claims that it came from ... (not + exhaust), meaning neverending." and, finally, ""long well-shaped slope".

Panel "5", therefore, is a Viagra benefit statement, nonpareil!

This Korean spam DTC add, therefore, has all the major characteristics of an "effective" American-style print DTC ad -- such as the Rozerem ad. It depends a lot on imagery rather than words, it's a bit edgy and even obtuse, and it isn't afraid to use sexual symbolism. I would say it's very "creative" and definitely "cuts through the clutter." By these DTC standards, therefore, it has done its job!

Too bad it was sent to someone who could not translate the call to action, which appeared below the graphic: "
kgdbjg d i anyym pb nj nd dg tytw vhg w l"

Marketing Executive Salaries

"Everything is numbers" is the tagline of the hit TV show "Numb3rs". "People lie, number don't," says Charlie, the main character of the show.

I often use numbers to gain insight into pharmaceutical marketing issues. For example, all the hew and cry about too much risk in DTC ads (included print ads) -- see, for example, "
WLF: A No-Risk Ad is a Good Ad," "DTC without the Risk," and "Marketing 'Acceptable Risk'" -- shouts out for a quantitative analysis of how much space is allocated to risk vs. benefit information in print DTC ads. What are the numbers saying?

Well, you'll have to read the article "
Print DTC: How Does It Measure Up?" to find out. [Reprint fee or Free Subscription required.]

MM&M's Career and Salary Survey

This month, the venerable publication Medical Marketing & Media -- affectionately called MM&M -- published its annual salary survey, which you find
here. Lot's of nice numbers!

But what can we learn from these numbers other than the fact that most of us are not sharing in the wealth?

For one thing,
salaries are increasing for all employers (from an average of $122,300 last year to $127,100 in 2006) except for publications. Salaries in that sector decreased about 15% to $99,760 -- the only salary average under $100,000. Bummer!

That's surprising because publications are reaping DTC advertising rewards from the pharmaceutical industry this year (see "
Pharma eMarketing in a Slump"). Maybe the ads just sell themselves and talented marketing execs are not needed. Success breeds contempt!

MM&M's survey claims that the average salary for VPs of Marketing is $179,000. This is based on only 29 survey responders, 23 of whom are employed by manufacturers (Rx, OTC, Biotech, devices, etc.). The high was $310,000. All VPs also received an average bonus of $48,600.

In contrast, Peter Rost, whose new book "WHISTLEBLOWER: Confessions of a Healthcare Hitman" is reviewed in the September issue of Pharma Marketing News (click
here), claims his Pfizer salary was $600,000 when he was VP of Marketing at Pfizer.Salary Chart

Biotech on the Rise?
According to the MM&M survey, salaries in the biotechnology sector (chart on left; third pair of bars from top) are now higher than those in the Rx sector (chart; top). In fact, it's the only sector in which salaries have increased over the past year.

Rx drug company salaries are decreasing while biotechnology company salaries are increasing.

What are these numbers saying?

I think that biotech is really gearing up to market their products heavy duty style and they may be draining the marketing brains from the Rx sector, which is currently demoralized by mergers and management changes.

This trend is evident at PhRMA, the industry's trade association, which
just announced that Kevin Sharer, president, CEO and chairman of Amgen, the world's largest biotechnology company, became chairman of the board upon the resignation of Peter R. Dolan of Bristol-Myers Squibb. Peter, you recall, was ousted from BMS recently (see "Another Pharma CEO Bites the Dust!").

The numbers don't lie: expect much more biotech marketing in the years ahead. If nothing else, these VPs have to justify their salaries!

Tuesday, September 19, 2006

Pharma eMarketing in a Slump

eMarketing is a challenge for the pharmaceutical industry. It is estimated that the percent of the pharmaceutical marketing budget spent in the "e" space has remained at or below 5% since the dawn of the commercial Internet! (See "The Marketing Mix Maze" for numbers and estimates; compare to numbers below.)

According to an August, 2006 report by eMarketer ("Pharmaceuticals Online: Direct-to-Patient Becomes a Reality"):

The 13 major pharmaceutical companies spent $170.1 million in
measured online advertising in 2005, or 2.6% of their measured
media spending, according to Advertising Age/TNS data. Taking
"unmeasured" media into account, that share falls to just 1.23% of
the total advertising budget estimated by Advertising Age. Online
advertising by these companies dropped 15.1% in 2005, a much
steeper decline than the slight drop in overall ad spending that
year. Still, TNS does not include search advertising in its online
measurement, which is a tactic of major importance to
pharmaceutical companies, and could easily account for an
additional 40% of prescription drug online advertising.
Yet, while total DTC spending is up about 6.6% this year compared to last year (according to TNS Media Intelligence), online spending by pharma marketers dropped almost 3%.

Not only is this contrary to what pharmaceutical marketing experts expected (see, for example, "
Pharma eMarketing at Tipping Point?"), it bucks the general trend across all industries, which increased their online ad spending by about 18% (see "TNS MEDIA INTELLIGENCE REPORTS U.S. ADVERTISING MARKET GREW 4.1 PERCENT IN FIRST HALF OF 2006"). That is, the pharma industry has increased its overall marketing to consumers more than the industry average (6.6% vs. 4.1%) while decreasing its online marketing spend.

Since TNS numbers do not include search marketing, we cannot be sure what the trend in overall online pharma marketing has been. My guess is that search spending by pharma may have remained constant. In that case, total online spending by pharma (display ads, search, et al) still decreased by almost 3%.

While search is important, it's the final destination that counts for traditional advertisers. If less money is being spent delevoping those final destinations with their calls to action, then that indicates a rejection by pharma of online marketing's potential.

eMarketer had predicted that US pharmaceutical online spending would increase 25% in 2006 to reach $780 million. That doesn't look likely now.

Less TV, More Print
Back in 2005, many experts predicted that the pharmaceutical industry would spend less on TV advertising and divert some of that money to online (see, for example, "
Pull Back from DTC on TV?"). While pharma did indeed decrease TV ad spend by 2.5%, all of that money -- AND MUCH MORE -- went to print advertising (magazines and newspapers; see chart above).

These numbers focus on advertising and marketing to consumers. I suspect the same trends apply to physician marketing -- ie, big increase in journal advertising, decrease in online promotion.

Taking Lunesta and Ambien Out of the Equation
If you eliminate the $122,801,000 that Sepracor spent on Lunesta DTC in 2006 (it spend $0 in the same period in 2005) and the additional $46,206,000 that Sanofi-Aventis spent on Ambien DTC to catch up, overal DTC spending would have decreased by 6% instead of increased!

eDetailing in a Rut Too?
Regarding eDetailing, which has been touted as the 800-lb online physician promotion gorilla, I've heard the following from a knowledgeable source:

"It seems edetailing is in a 'rut' lately. Lack of enthusiasm, a number of clients with mixed or lackluster results..."
I'd say online pharmaceutical marketing is in a rut across the board these days!

Monday, September 18, 2006

Advertisers Don't Know How DTC Works. Say wha?

Practically every direct-to-consumer (DTC) ad on TV and in print prominently includes a statement such as "Ask Your Doctor if [BRAND X] is Right for You!" Advertisers call this the "Call to Action," which is the linchpin of all advertising; ie, get your target audience off its butt to take the next step toward the purchase of your brand!

Several studies have shown that this call to action of DTC works. In 2003, for example, the FDA released preliminary results from a physician survey it conducted (see "
Results from FDA Physician Survey on DTC Advertising"). The survey profiled 250 GP's and 250 specialists (dermatology, allergy/pulmonology, endocrinology, and psychiatry) from a random sample of the AMA Physician Masterfile, which includes a list of all U.S. medical school graduates.

One question the FDA survey asked was:

"Think about the most recent interaction you've had with a patient ... Can you think of a patient who initiated a discussion about a prescription drug they saw advertised?"
Ninety-two percent (92%) of the physicians surveyed said "Yes". (You can find this study here.)

Surveys of consumers seem to confirm the FDA's study results. According to eMarketer:

Much of the growth in DTC advertising is driven by one thing: consumer behavior. Of the 546 US adults surveyed online by MRxHealth and Medical Marketing & Media in March, 87% said they had requested and received a specific prescription drug from their doctor. -- "Pharmaceuticals Online: Direct-to-Patient Becomes a Reality", August, 2006. eMarketer
Contrarian View
CommonHealth, arguably part of the world's leading healthcare-communications network (ie, pharmaceutical advertising agency), filed research with the FDA this past July on direct-to-consumer (DTC) advertising that challenges the effectiveness of DTC's Call to Action.

In a nutshell, CommonHealth claims that DTC advertising is rarely referenced by patients when visiting physicians.
Their study says this happens only in 0.6% of visits! (See "CommonHealth Releases Compelling Results of Independent Large-Scale Study on DTC Advertising".)

How can the FDA and CommonHealth be so far apart on this issue (92% vs. 0.6%)? It's like they are on different planets!

Well, the methodologies they used are different: FDA asked physicians what they thought they heard, CommonHealth recorded actual patient-physician conversations and did a linguistic analysis looking to see if the patient said something like "I saw/heard this ad and want this prescription drug".

According to CommonHealth:

"What has not been available are data derived from direct recording and analysis of actual physician-patient visits --– and so, in a real sense, both supporters and critics of DTC advertising have been 'flying blind'."
I haven't been able to get hold of the report that CommonHealth submitted to the FDA, so I cannot critically analyze their methodology. The report hasn't been posted to the FDA Web site and CommonHealth refused to give me a copy. The FDA official who received the report from CommonHealth also could not give a copy when I asked her. The only way to get it is to visit the FDA Dockets Management branch in Bethesda, MD and ask to see Docket No. 2005N-0354; Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing; EMC 590 CommonHealth Vol #: 12. Maybe I'll submit an FOIA request. Good luck on that!

I was able to speak to Brad Davidson, Ph.D., a vice president at MBS/Vox and lead researcher for the study (I may report on this in an upcoming issue of
Pharma Marketing News).

It's apparent from my conversations with Dr. Davidson and from press releases, that the purpose of the study was to refute "many of the assumptions of both academic and public policy critics of DTC" and support the positive impact of DTC.

"We know that DTC has an effect on physician-patient interactions because other studies have shown that DTC drives patients into the office and raises awareness of both conditions and medications," said Davidson. "What our study uncovered is that DTC does not have the negative impact on the actual dialogue that many people allege."
FDA was definitely not one of these people. It concluded from its study -- despite the 92% number contradicting CommonHealth -- that DTC has had a positive impact!

Anyway, CommonHealth -- among the best advertising minds in the world -- leaves us with this insight from its study:

"We know DTC advertising works ... we may not know how."
This is an incredible admission! It's as if they are saying that advertising exists on a higher plane where it is impossible to analyze what works and what doesn't a priori. You might as well trash focus groups that ask consumers if, after seeing a drug ad, they would ask for the drug when they next visit their doctors. Yeah, I'm sure that would happen!

Thursday, September 14, 2006

Rozerem Beaver Buzz

I am having some fun looking over the visitor stats for this blog, finding out how people are ending up here, what the most popular pages/posts are, etc.

It's incredible, but true! The most visited page on this blog is the post about the Rozerem ad:
Rozerem Ads Dis Lincoln, Show Beaver. It could be the sexual symbolism of the beaver and/or the deep sea diver (see comments below) or it could be something else.

Many people, for example, are finding that particular page through search engines and they aren't looking for sex -- they appear to be looking specifically for information about the Rozerem ad.

If you search Google for any of the following terms (listed in rank order of page views that resulted from the search referral), the "Dis Lincoln, Show Beaver" page is listed as number 1 or number 2 in the natural search results:

  • rozerem commercial
  • rozerem ad
  • rozerem beaver
  • rozerem web
  • lincoln beaver
If you use "rozerem" or "rozerem web" in a Google search, you will a link to the official Rozerem Web site within the first or second entry on the page. So the search engine optimizers did a good job as far as that goes.

The search terms listed above, however, are not leading people to the Rozerem Web site. Most of the time the Rozerem Web site is NOT even on the first page of results! That's a shame, because the ad is obviously creating a lot of "buzz" and several commenters to this blog suggested that because of this buzz the ad "did its job."

"I believe the ad is doing exactly what it was set out to do. Create awareness and have people remember. You guys sure are talking a lot about it. I say job accomplished." -- Anonymous commenter.
I imagine many ordinary citizens -- as opposed to bloggers like me -- were confused about the ad or were interested in what the ad meant and may have searched for information about the ad itself or about Lincoln and the beaver. Unfortunately, that search activity only got them as far as me and my "snarky" critical post!

If the Rozerem advertisers' goal was to create buzz, they should have thought about how to close the loop and make sure that when consumers searched for more information about the ad (rather than the drug), they would be more likely to find the Rozerem Web site, not my blog! That would have completed the "buzz circle" and helped drive traffic to the Rozerem site.

That's my advice for today. Now, back to the beaver.

What Does the Beaver Mean?
A few people agreed with me that the beaver had a sexual connotation:

I don't like the talking beaver either, but its use seems obvious to me (as a male) -- the guy dreams about "beaver," aka sex. It's exactly the politically incorrect interpretation John alludes to. And yeah, it's pretty hokey when you think about it. Too clever by half. What's next, a train?
Speaking of beaver as sexual symbolism, have a look at this:

Other people eschewed the sexual interpretation in favor of a good old Puritan work ethic spin:
The only reason I can see for the Beaver is that if you're "busy as a beaver" you may be sleep deprived and/or have insomnia. I know that when I'm working my tail off (no pun intended), my brain is constantly working and I have trouble sleeping. Regardless, after looking at the website....I am unimpressed. I am not sure whether or not it is informative, because it could not keep my attention long enough for me find out.
Of course, we may all be analyzing this too much and finding deep meaning where there is none according to the following comment:
'I dreamt I was jumping rope with Abe Lincoln and a beaver' - no deeper meaning than a highly compelling evocation of how utterly ridiculous most of our dreams are.
One wonders what future Rozerem ads might be like.
I would hazard a guess that a few months after the Abe/beaver/diver commercials and ads are in the public's awareness, the commercials will start making more "sense."

Wednesday, September 13, 2006

The Call Center from Hell

If my personal experiences with Glaxo's customer response center and consumer-focused Web sites are typical, then all the comments I have been hearing about the drug industry's poor consumer focus are true.

The story begins with "
My Sojourn as Market Research Subject for Levitra."

Back in January, in response to a TV ad, I registered on to receive a Men's Facts Kit and free sample offer for Levitra, a treatment for erectile dysfunction (ED) manufactured by Bayer and marketed by GSK and Schering-Plough. In August, I was called by a market research firm and invited to come to their Philadelphia office for an interview, which I did.

However, afterward I felt that my privacy concerns were not adequately addressed before and during the interview. I also wondered how it came to be that I was called by phone when I did not give permission to anyone to call me. In fact, the web form I filled out did not even ask for my phone number. The privacy issues were covered previously (see "
Market Research: Privacy Matters").

I decided to followup with GSK (the company I reached by calling the 1-888 number on the privacy policy) and try to find out how they or their agents -- ie, the market research firm -- got my phone number and, more importantly, how it could be that I was called when I did not give permission (a clear violation of the privacy policy available on

So began my experience with the "Call Center from Hell." OK, maybe I exaggerate at bit. It may have been Purgatory rather than Hell. The point is, it took me three and a half weeks and three phone calls to get to someone that could actually tell me something about the information they had about me on file and who was able to do something to satisfy my concerns.

We've all had similar experiences calling company "hot" and "help" lines:

The First Call
I first called 1-888-825-5249 on August 21, 2006. "Nikki" answered. I told her my story and expressed my concern about being contacted by phone for market research although I never gave my phone number or permission to be contacted that way. I said my understanding of the policy was that I would only be contacted using the information I provided.

The policy states: "BAYER, GSK, and Schering-Plough will only collect personally identifiable information, such as your name, address, telephone number, or e-mail address, that you provide or that is provided to us with your permission." [I DID NOT GIVE MY PHONE NUMBER OR PERMISSION TO USE MY PHONE NUMBER TO CONTACT ME.]
Nikki said: "Let me see if I can get some information about that." She asked for my name, zip code, and phone number, which I gave her. I was put on hold for two and one half minutes.

Please Hold While We Deliver Some Drug Industry Propaganda

While on hold I was treated to several propaganda messages, which were recordings of people claiming to be Glaxo scientists and other employees. One "scientist" said "I want to cure cancer. Is that ambitious? Yes. Would you want it any other way?" Then the voiceover says "Glaxo SmithKline. Today's medicines, tomorrow's miracles." The underlying message is "we are working to cure cancer and the high prices of today's medicines finance this research."

The last message I heard while on hold featured how swell operators were at GSK in doing their jobs helping people who call GSK with questions. The take away was "We don't hang up until you have answers." There was hope for my case!

Anyway, when Nikki came back it was apparent that I wasn't going to get the answers to my questions.

At first, Nikki directed me to the privacy policy on, which I interpreted as the ultimate brush off.

But then she said "it is certainly surprising to us that you were called. Because that definitely shouldn'’t have happened. We apologize." That was a start and again I was hopeful.

Hope was dashed, however, when Nikki said she wanted to do more "research" about "our policy and how this program works regarding your information." She asked if she could call me back at the number I supplied after she gathered more information. I said yes.

The Second Call

I called again on August 24, 2006 and asked if they had any other information about my complaint. I also inquired about getting access to the personally identifiable information that GSK had on file about me.

The operator -- Paulette -- said Nikki sent the information to "the people who would research this." I was told that the "research" usually takes several days and not to expect an answer until next week.

I asked if she could help me find out what information GSK has on file about me for verification that this is the information I provided and that it included adequate permissions. Paulette said that I have wait for the research group and "all that information will be supplied to you. It could take a few more days."

The Third Call

On September 6, 2006, I called GSK again and this time Anita answered. Here's what I learned from Anita.

GSK had information about two "John Macks" in Newtown, PA at different addresses. It turns out that both were me -- one file had my business address, the other had my home address. Both files contained information I provided via Web sites.

The "business" data was from a Paxil support site -- HOPE for You ( That data set included permission to contact me by e-mail or regular mail, NOT by phone.

The "home" data was collected by and, according to Paulette, included permission to call me by phone. That's surprising because (1) the form doesn't have a box to enter a phone number, and (2) it does NOT ask for permission to call -- it only asks if I want to receive the kit by U.S. Mail, Online or Both.

Could it be that GSK combined data from the dataset with data from the dataset and gave this to the market research firm that called me for the Levitra interview? That certainly would not be kosher. Or could it be that GSK was lying about the permissions? That also would not be kosher.

In any case, tracking this down via GSK's call center is now dead end. I still don't know why I was called by the market research firm. My next step is to call the MR firm and get their side of the story. I may also contact GSK's privacy officer.

The lessons I learned are:

(1) don't expect much consumer-friendly help from drug company call centers when you have a problem with the sensitive information they have on file about you. They won't call you back and repeated calls to them are required to get any satisfactory answers; and

(2) the same is true dealing with drug companies through their Web sites. I tried to log in to but did not remember my password. I filled out the form to have my password sent to my e-mail address. That was 2 days ago. So far, nothing!

GSK, you have a long way to go before you earn my trust again!

Tuesday, September 12, 2006

Another Pharma CEO Bites the Dust!

Bristol-Myers Squibb Chief Executive Peter Dolan will leave the company effective immediately, according to a Wall Street Journal report just published (see "Bristol-Myers Ousts CEO Dolan, Names Cornelius Interim Successor"; subscription required, excerpts below).
"The board had faced pressure to fire Messrs Dolan and Willard after a federal monitor overseeing the New York company urged their dismissal last night," according to the WSJ..

"The board had little choice but to accept a monitor's recommendation when directors met today to determine the fate of Messrs. Dolan and Willard. The company is operating under the terms of a deferred-prosecution agreement reached with the U.S. Attorney in New Jersey last year following a three-year investigation into a $2.5 billion scandal at the company involving 'channel stuffing,' or overloading wholesalers with inventory to meet quarterly sales targets. If the board refuses to fire Mr. Dolan, the company could face charges in connection with the probe."
But the board had a couple of other good reasons to shove Dolan out:
  • Mr. Dolan's handling of Plavix
  • Bristol-Myers shares have fallen nearly 60% since Mr. Dolan became CEO in May 2001
If only BMS wasn't under that deferred-prosecution agreement through which it avoided charges of conspiracy to commit securities fraud as long as it stayed out of trouble for two years. That's a long time for a drug company to stay squeaky clean.

In this case, greed trumped caution. BMS got into "trouble" by attempting to extend its market exclusivity for Plavix and keep a lower-cost generic version out of the hands of consumers in the US.

As reported by the WSJ:

"Mr. Dolan's handling of Plavix already had put him on shaky ground with the board. After learning that the company's Plavix cash-cow was under threat from generic competition, he negotiated a deal that would have paid Canada's Apotex Inc. tens of millions of dollars to delay its introduction of a copycat drug. That pact, aimed at settling Apotex's legal challenge of the Plavix patent, unraveled in late July when the Department of Justice's antitrust division opened an investigation into it and state attorneys general rejected it.

"In filings to the federal court in New York overseeing the patent litigation, Apotex has alleged that Bristol-Myers struck a verbal side agreement with it during the settlement negotiations that it then hid from regulators. A lawyer for Bristol-Myers has denied this to the court and has suggested that Apotex fabricated the allegation to torpedo the settlement.

"In the meantime, Apotex used binding concessions it obtained during the negotiations to launch a knockoff version on Aug. 8, after the deal was rejected by regulators. The generic version quickly conquered 75% of the market, costing Bristol-Myers as much as $600 million in lost sales. The court overseeing the patent case ordered Apotex to stop selling the generic version on Aug. 31, but didn't force it to recall the product already in the distribution channel.

"Bristol-Myers pursued the deal with Apotex even though U.S. regulators have been hostile to such agreements on the grounds that they hurt consumers by keeping lower cost versions of life-saving drugs off the market. The Federal Trade Commission has criticized similar deals and has fought one of them all the way to the U.S. Supreme Court."
Boy, did that whole Plavix debacle make BMS look ridiculous! Losing 60% of its stock value only added injury to insult!

Mr. Dolan's removal marks the third ouster of a chief executive of a big U.S. drug company in the past 16 months. He joins Raymond Gilmartin (former CEO of Merck) and Henry McKinnell (former CEO of Pfizer) in the ranks of unemployed pharma CEOs.

What Do You Think?
Although the board may not have had a choice, of the two issues mentioned above, which do you think bothered the board the most and was the real reason for their ouster of Dolan (assuming the recommendation of the federal monitor was only a red herring)?

Which issue rankled the BMS board most?
Dolan's handling of Apotex
Loss of 60% of BMS's stock value
Neither of these issues bothered the board
Both were equally important

Sunday, September 10, 2006

Pharma's Black Knight Parties On!

Welcome to Peter Rost's World!

I first learned of Dr. Peter Rost, as most of us did, back in June, 2005 when he appeared on the
60 Minutes news show where he laid into the drug industry about drug re-importation, which is an issue often discussed on this blog.

One statement he made on that show was "You have certain drugs that cost 10 times more in the U.S. We're talking about exactly the same drug, made in the same plant, by the same manufacturer."

It was incredible! A VP at Pfizer, the world's largest and most powerful drug company, was attacking the industry's long-standing practice of charging US citizens the highest prices in the world for vital medicines.

Of course, both Rost and CBS included the disclaimer: "Rost is an executive for Pfizer, but he'’s not speaking for the drug company." Little did I realize, however, that this might have been merely the opening salvo AGAINST Pfizer!

It's not that I don't think Peter is sincere. But he has embarked on a mission few of us would care to be on -- that of a whistleblower in the pharmaceutical industry! I spoke of this mission in an article published in Pharma Marketing News in May, 2006, soon after Peter started his blog on Huffington Post (see "
Peter Rost: Whistle Blower, Pharma Blogger, ???").

I used triple question marks for a good reason -- I suspected other shoes were going to be dropped, but I didn't know what they were going to be or when they would drop.

I stayed tuned to Peter's trials and tribulations through his personal e-mail contact list, through his blog, and by recruiting him to participate in a panel I am moderating on "Disease Mongering" at an upcoming industry conference. So, Peter will be part of my life at least until then, or until he reads the rest of this blog.

"King Arthur" Strikes the First Blow!

Soon after Peter's expose appeared on
60 Minutes, Pfizer turned off his cell phone and he was denied access to his corporate email account. Yet, he was not ready to admit any wounds nor defeat. "Tis but a scratch!" as the Black Knight in Monty Python's Holy Grail says after his left arm is chopped off by King Arthur in a duel; Peter said, "I'm not that worried."

Recently, BrandWeek ran a story entitled "Pfizer Victorious in Whistle-Blowing Case," which reported on the dismissal of Rost's whistleblower case against Pfizer. As ever, Rost was the optimistic Black Knight, even after his second arm had been chopped off. "Just a flesh wound," said the Black Knight; "For me personally," says Rost, "it is a complete vindication of the false accusations Pfizer repeatedly made against me in the press."

Today, Peter has dropped another shoe -- his announcement of his new book, "THE WHISTLEBLOWER: Confessions of a Healthcare Hit Man."

It's Good to be the King!

CONFESSIONS is essentially a blow-by-blow chronicle of Peter's joust with Pfizer, which plays the role of King Arthur to Rost's Black Knight.

The book may or may not have been Peter's "last resort" as he claims in the Prologue. Certainly, I and others suggested early on that he write a book.

Unfortunately, this book is not the one I would have advised Peter to write. He should have written a "fictionalized" version as he says he originally wanted to do. He claims the publishers demanded a "tell all" type of book. The result is a book too much focused on Peter's travails and legal maneuvers than on the issues.

In 234 pages, I counted about 1500 I's or about 6 per page, or 2-3% of the total words. I don't have any statistics to compare with this number, but that seems like overusage of the first person singular.

I think it is appropriate for a blog to use "I" a lot, but not for a book (I've used the first person singular "I" about ten times so far in this post -- that's about 1.5% of the words).

That's the other problem I find with Peter's book -- it's really a blog put into a book format. Peter's blog makes great reading in small, daily doses, but when blog posts are collected into a book it can be -- how shall I say -- boring?

There is some dirt -- such as hints about who's sleeping with whom at Pfizer. How much more interesting this would have been in a fictionalized format with characters and details of trysts in corner offices! It definitely would have offered some relief and human interest interspersed between the legal documents, maneuvers and counter-ploys that fill the pages of the book.

Here's an example of what I mean. In the following passage, Peter is describing a meeting with Pfizer people at Pharmacia in preparation for Pfizer's takeover of that company.

"A third meeting took place when one of Pfizer's HR people, dressed in a red leather skirt, visited Pharmacia. Apparently, she had worked as a lawyer in a prior life, and she came off as fairly arrogant to the assembled Pharmacia crowd. When pressed with more and more pointed questions, she yelled to the packed room, 'You should realize that it is Pfizer taking over you and not the other way around.' The wolf had just dropped her sheep's clothing."
How much better this would have been rewritten in fictionalized format giving us deeper insight into the Pfizer HR woman in red as she prepared for her day trip to Pharmacia:
"Bernadette felt a tinge of pleasure as she tried on the red leather skirt, smoothing it out with her hand along her hips and thighs. It was the same skirt she wore making love to Brad, Pfizer's US marketing chief, late that night last week in his corner office on the 23rd floor. The lights were out and the blinds completely open as they made love against the cold floor-to-ceiling window facing 42nd Street. Who could see them way up here, she thought. Only the birds atop the distant Williamsburg bridge, if they cared about such things!"
Instead, we get:
"He [an HR manager, not given a name] had spent many years working at Pfizer and believed the rumors were true -- a group within Pfizer's management had been in and out of bed with each other for a number of years. In one instance a senior person allegedly dated a direct report while he was married. Soon after, that direct report turned and dated a guy reporting to her. And then this guy dated several women in his department."
I know Peter would have loved to take the fictionalized approach and liven up his book with steamy scenes of sex. He's often touched upon sex in his blogs and often displays revealing images! That's part of what makes reading his blog so much fun. The book could use some fun stuff as well.

But, Peter has another agenda: it's to win.

"...a single individual can win if he allies himself with the press or with law enforcement. Obviously, 'winning' is a matter of definition. That individual may never work in the same industry again, nor may he ever get same kind of income, but he may win in the eyes of the public opinion."
Like the Black Knight, Peter may not win, but he will never admit defeat. "All right," says the Black Knight's armless and legless torso to King Arthur, "we'll call it a draw."

Saturday, September 09, 2006

Have a Party!

Pharma's Black Knight Parties On!

Dr. Peter Rost, Pharma's Black Knight, is having a blog party all day Sunday, September 10 over at his blog.

See you there!

Meanwhile, some music and other videos I picked to entertain you...

Los 3 Doctores: Dr. Rost Makes 4!

How To Fold a Shirt: You'll Be Mesmerized -- Try It!

Anybody Else Like Rammstein?

I Saved the World Today

Friday, September 08, 2006

Health Literacy - Words Fail to Tell the Story

As reported in the Washington Post: "A new report by the National Center for Education Statistics found that most adults have intermediate health literacy. But intermediate is far from good, because so many health instructions are written in a way that is foreign to how people talk and think, said Rima Rudd of the Harvard School of Public Health." [See "U.S. Adults Deficient In Health Literacy"]

Find the report here: "
The Health Literacy of America's Adults"

The summary of the report states: "Health literacy was reported using four performance levels: Below Basic, Basic, Intermediate, and Proficient. The majority of adults (53 percent) had Intermediate health literacy. About 22 percent had Basic and 14 percent had Below Basic health literacy." The average health literacy score was 242 for men and 248 for women (highest score = 500). If these were SAT scores, they would be about 400 (the actual average SAT score this year, BTW, was 502-505).

What does it take to attain the "proficient" level in health literacy? Two key proficient-level abilities measured were:

  • reading lengthy, complex, abstract prose texts as well as synthesizing information and making complex inferences
  • integrating, synthesizing, and analyzing multiple pieces of information located in complex documents
"Lengthy, complex, abstract prose" is a perfect description of the "brief summary" -- the part of direct-to-consumer (DTC) print ads that conveys detailed risk information.

While FDA and the drug industry are looking for ways to strike the right balance between benefit and risk information in print DTC ads, some organizations, including the conservative Washington Legal Foundation (WLF), want to allocate the task of communicating risk in DTC ads completely to the brief summary (see "
WLF: A No-Risk Ad is a Good Ad").

According to the health literacy report, only 12% of US adults are at the proficient health literacy level; that is, only 12% of us have any hope of understanding the typical brief summary statement. (Keep reading for more on communicating risk in DTC ads.)

TV "Literacy" vs. Internet Literacy
There are a couple of interesting charts in the report, which I reproduce here.

Focus on the 3rd bar from the left in each of these charts. This bar represents where the majority of us (53%) stand with regard to health literacy -- at the intermediate level. Ninety-three percent (93%) of these people get health information from TV and radio (chart on left), whereas only 67% get health information from the Internet (chart on right). [BTW, if you can read these charts and use the quantitative information in them to solve a complex problem, which I am asking you to do, then you are at the "proficient" literacy level.]

A higher percentage of adults with Proficient health literacy than adults with lower levels of health literacy got a lot of information about health issues from the Internet. Higher percentages of adults with Below Basic or Basic health literacy than adults with Intermediate health literacy received a lot of information about health issues from radio and television. Adults with Proficient health literacy were least likely to receive a lot of information about health issues from those same nonprint media sources.

What I am getting from this is that TV is a good channel through which to reach people with low health literacy, whereas the Internet is a good channel to reach those with high health literacy. You have a two-tier, red state vs. blue state, system here! I don't think many pharmaceutical eMarketers realize who they are talking to on the Internet. The tendency is to use the Internet like another TV channel (for more on this see "
Web DTC Video: Boon or Bane?").

But TV is not a literary medium -- it is visual. Practically all of the information it conveys is through visual means, which is just fine for the health "illiterates" that tend to get their information from TV. However, the visuals exclusively convey
benefit statements, not risk statements.

Print DTC ads also depend heavily on visuals. In a study of over 60 print DTC ads I am doing for the article "Drug Print Ad Analysis: A Quantitative Approach" in the upcoming September issue of
Pharma Marketing News (Subscription Required), I found that 46% of the ad space is devoted to images (a recent Rozerem ad devotes 81% of its creative space to a visual; see "Rozerem Ads Dis Lincoln, Show Beaver").

My point is that drug marketers understand well how to communicate the benefits of drugs in TV and print DTC ads -- ie, by using visuals to compensate for the low intermediate level of health literacy of the average US adult.

According to the health literacy report, someone at the intermediate health literacy level is capable of "reading and understanding moderately dense, less commonplace prose texts as well as summarizing,making simple inferences,
determining cause and effect, and recognizing the author's purpose."

That's all that any DTC marketer could wish for; namely, the ad viewer should understand the ad's purpose: go see your physician, ask for the advertised drug, and you will enjoy the benefits shown. This purpose of DTC was stated succinctly not long ago by the Coalition for Healthcare Communication in its petition to the FDA: "the patient is the decision-maker only with respect to whether a practitioner should be approached" (see "
DTC without the Risk").

Speaking of Risk

If DTC advertising is to live up to the drug industry's claim that it is educational, marketers need to get serious about communicating risk information as well as benefit information. There has been some progress toward that goal. About 57% of the DTC print ads that I have studied attempt to present the brief summary (detailed risk information) in a consumer-friendly, easy-to-read (and understand) question-and-answer format. Not all succeed, however.

I agree wholeheartedly with Mark Senak, author of the blog
eyeonFDA, who said:
"Product marketing is more these days, than just being experienced at launching a drug -- it is about crisis, it is about regulatory preparation and it is about a track record in providing support services related to the proper use of medication and the management of risk in order to maximize benefit."
You can learn more about risk communication in DTC ads by listening in to the following LIVE AUDIOCONFERENCE:

Risk Communications: Balancing FDA Expectations, Physician Needs and Patient Health

WEDNESDAY, OCTOBER 25, 2006, 1:00-2:30 P.M. (Eastern)

Please visit the conference website.
When you register and use the code "RVIR", I get a few bucks! Thanks.


Is your product marketing adequately conveying risk and safety information to your customers? Are you fully aware of the common and emerging pitfalls in communicating risk information to consumers and healthcare providers? Hear from a former FDA insider Peter Pitts, risk communication expert Jeff Stier and consultant Jeffrey J. Stoddard to get a lessons learned perspective and a case study analysis on how FDA and EMEA guidance on risk management can be effectively implemented as the emerging regulatory and legal hurdles continue to intensify.

I will be listening in myself and hope to have a few questions for these experts. I'll report on anything I learn here.

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