Lunesta: Golden or Bitter Pill?

The results are in! Lunesta wins both the DTC National Gold Award as well as Prescription Access Litigation (PAL) Project's "While You were Sleeping" Bitter Pill Award! (For more on these awards, see "DTC National Advertising Awards Winners" and "The While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who's ever had a Bad Night's Sleep").

Guess which one Lunesta marketing director Jay Popli and McCann-Erickson (the Lunesta ad agency) general manager Andrew Schirmer will hang on their walls?

I wasn't at the DTC National Award Dinner -- me getting a press pass for that event is about as easy as a camel passing through the eye of a needle -- but I was invited to PAL's online Bitter Pill awards press conference.

These two organizations square off against each other viz-a-viz competing drug ad awards every year.

PAL claims to represent consumers in class action lawsuits against pharmaceutical companies and targets deceptive marketing. It is against any DTC advertising -- including 60-second TV ads -- that do not include the full product labeling (see "FDA DTC Hearings Day 2").

DTC Prespectives Magazine, which hosts the DTC National Awards, is an industry publication whose very existence obviously completely depends on DTC advertising.

These two organizations could not be further apart on the DTC advocacy spectrum. Both agree, however, that Lunesta deserves an award -- isn't that nice?

According to PAL, Lunesta had more than $321 million in sales in 2005 and Sepracor spent more than $215 million advertising it that year, making it #2 in direct to consumer advertising for all prescription drugs (PAL cites credible sources for these data).

I guess you could call that a positive return on investment: for every dollar spent on advertising, Lunesta made $1.49. It's a bit less, however, than the $1.68, estimated for DTC in general (see "eDetailing ROI Better than DTC?"). Keep in mind that it's only the first year the product is on the market and the competition for market share is fierce. "Its sales in 2006," notes PAL, "are expected to increase significantly as the aggressive marketing begins to really pay off."

PAL levels several criticisms of the Lunesta ad campaign including the allegation that Sepracor is violating the PhRMA DTC Guiding Principles by running reminder ads. I have also pointed this out recently (see "Sepracor Sneaks In Lunesta Reminder Ad"). Either PAL is confirming my observation or else they are just picking up what I posted without attribution to me. I didn't bother to ask them what evidence they had to back up their claim.

What Chutzpah!
Given that some Lunesta ads are in violation of at least one of PhRMA's DTC guidelines, I find it strange that attendees of the DTC National conference would have the chutzpah to give Lunesta marketers a Gold Award at a conference in which "Critical Issue #1" was "What is the future of DTC marketing? Are you ready for the new rules -- from FDA -- from Congress? The PhRMA guiding principles?" Not only that, but representatives from the FDA, PhRMA, and Public Citizen -- Ralph Nader was an invited speaker/panel member -- were also in attendance!

Tell me, Ralph, did you find any irony in this?

How Not to Influence Physician Bloggers

Nicholas Genes, a physician who publishes Blogborygmi, a blog he characterizes as a "digest of developments in the life of an emergency medicine resident" posted an April Fool's joke on his blog, which depicted an all-too believable scenario of GSK influence over physician bloggers:

"Over the past few weeks I've been negotiating with a team at GlaxoSmithKline. They want to 'get into this blog business,' and we're looking for ways expand the readership of mdical [sic] blogs. I saw an opportunity." [See "Grand Rounds, brought to you by GlaxoSmithKline."]

I must admit I fell for it!

I believed the premise that GSK was interested in blogging because a GSK executive responsible for grassroots campaigns expressed an interest in blogs. However, I didn't envision that the best way for GSK or any pharma company to get involved with blogs was by promoting physician bloggers and influencing what they say. I suggested instead that GSK start its own corporate blog to improve the company's public image (see, for example, "Sales Reps Make Poor Spokespeople" and "GSK Strikes Back with a Grassroots Campaign").

Still, pharma companies are being pushed to get into blogging not for PR purposes but to achieve marketing goals (see "Buzz 'n Blogs -- Stealth Marketing"). Dr. Genes' farce is a strategy that could easily be adopted by a pharmaceutical company.

Genes farce depicted GSK as a sponsor of "Grand Rounds," a weekly compendium of the "best in medical blogging" hosted by different physicians on their blogs. According to Genes' farcical description of how this might work is as follows:

"[Grand Rounds] has exemplified two principles: 1) there's no better way to learn about healthcare than from those in the field and 2) self-promotion is a powerful motivator.

"Glaxo recognizes this, and they want to capitalize. It's the high quality of written submissions, the creative hosting efforts, and brazen opportunism that have make Grand Rounds great -- and led us to this unique new collaboration.

"So, starting this week [April 1, 2006] , the GlaxoSmithKline homepage will run a link to Grand Rounds every Tuesday morning! Also, Glaxo drug reps will start handing out cards with the URL of the Grand Rounds archive to doctors and students they identify as "computer-oriented" or "loners."

"Now, in return for this torrent of traffic, Glaxo has asked for something in return. They would like each host to run a link to GSK.com and, as appropriate, to individual product sites. The hosts can choose to whether to place this link in the body of the Grand Rounds post, or high up in their blog's sidebar. Hosts can also choose the color of the text.

"This ties in closely with something else: Glaxo will be encouraging more "theme" editions. Now, some of the best Grand Rounds have featured themes. These new themes will revolve around some of the drugs Glaxo makes.

"For instance, the upcoming April Fourth edition will be hosted by a urologist, and so will naturally feature submissions on erectile dysfunction. Specifically, posts about Levitra will be prominently displayed up at the top of Grand Rounds. "

I re-iterate that this is a fantasy -- as of now. I haven't seen any links on GSK's home page and I haven't seen Levitra ads in the urology Grand Rounds posting. But I have seen some blog "theme" articles published by Grand Rounds participants.

On April 21, for example, the (non-farcical) post "An interesting DTC approach" was made to Health Business Blog (a Grand Rounds participant) by David Williams who happens to be a "co-founder of MedPharma Partners LLC, strategy consultant to pharma, biotech, device, and technology enabled healthcare services industries."

The approach that Williams found "interesting" was a GSK marketing program for the new Fruit Chill flavor of its OTC Nicorette gum.

The "interesting approach" is based on the use of coupons and a chance to win prizes as a ploy to get consumers to buy Nicorette. While Nicorette is not an Rx product, the use of coupons in Rx marketing has drawn some attention lately by the FDA (see, for example, "FDA, Coupons, and Sleep Aid DTC Ads"). FDA intended to look at whether coupons and rebates that are part of some prescription-drug advertisements might cause consumers to think a drug is safer or more effective than it really is. A few days later, however, the FDA mysteriously "yanked" its notice in the Federal Register (see "FDA Backs Down on Coupon Study").

Genes ends his farce thusly:

"While I suspect this may ruffle some feathers, I want to stress that bloggers can write whatever they want about Levitra -- Grand Rounds is still very much an open forum (though representatives from Glaxo have asked to evaluate each submission before its inclusion in Grand Rounds; the hosts will comply). If you're worried about participating in some kind of viral marketing campaign, remember: Glaxo makes antivirals."

I should have been tipped off by the humorous bit at the end. However, Genes does provide a link to the Relenza product Web site. Relenza is GSK's product for the treatment of influenza. I didn't think that was a joke. It is thoroughly conceivable that pharma marketers could negotiate product placement ads on physician blogs. I notice Viagra ads placed in plenty of movies and HBO programs.

The main lesson I learned from all this is -- don't believe everything you read! I should have noted the date of Dr. Genes' post and put two and two together. But I was primed to believe the story. For that, I apologize to GSK, the Grand Rounds physician bloggers, and to the readers of this blog.

Spinning Bad News about FDA & Drug Safety

Peter Pitts, former spinmeister -- er... I mean Associate Commissioner for External Relations -- for the FDA and currently spinning for the pharmaceutical industry at Manning, Selvage & Lee, is also a "pundit" at DrugWonks, which cranks out tons of pro-pharma BS under the guise of "debate."

A recent post by Pitts entitled "General GAO's Chicken" is a good example of the Pitts style. Aside from dissing my favorite Chinese takeout dish, this post is critical of the just released Government Accountability Office (GAO) report that found that "the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings." [see the report "Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process"; read the Washington Post story: "FDA Is Criticized Over Drugs' Safety Problems".]

Pitts simply dismisses the entire report by suggesting it's old news and that the real issue is money ("Senator [Grassley, whose Senate committee ordered the GAO report after the Vioxx debacle], for the umteenth time — SHOW FDA THE MONEY!").

Actually money is not the real issue, as anyone who takes the time to read the recommendations of the GAO report would quickly see. [Pitts, of course, does not bother to provide any links to primary or even secondary sources so readers can check his facts or make up their own minds. Typical of a spinmeister who needs to control access to information, not share it. Some blogger!]

The GAO recommendations are as follows (and I quote, see page 2 of the report):

1. To improve the decision-making process for postmarket drug safety, GAO suggests that the Congress consider expanding FDA'’s authority to require drug sponsors to conduct postmarket studies when needed.
2. GAO also recommends that FDA systematically track postmarket drug safety issues,
3. revise and implement its draft policy on major postmarket safety decisions,
4. improve the dispute resolution process, and
5. clarify ODS's [Office of Drug Safety] role in scientific advisory committees.

None of these recommendations seems to require a bigger FDA budget, although I concede that recommendation #1 may require pharmaceutical companies to spend more dough, which is probably Peter's real gripe.

Speaking of postmarketing studies by the drug industry, it is a well-known fact that the industry is renegging on its pledge to do the necessary research on drug safety. The FDA recently reported on the status of postmarketing study commitments made by the industry (see the March 3, 2006 Federal Register entry). The data are plotted in the following chart (which I find much more enlightening than looking at numbers in a table):

• Pending: The study has not been initiated, but does not meet the criterion for delayed;
• Ongoing: The study is proceeding according to or ahead of the original schedule;
• Delayed: The study is behind the original schedule;
• Terminated: The study was ended before completion, but a final study report has not been submitted to FDA; or
• Submitted: The study has been completed or terminated, and a final study report has been submitted to FDA.

Clearly, if 65% of these studies haven't even started and only 14% have been completed and submitted, the FDA does need more authority to enforce these commitments by the industry.

FDA Coming to a Mall Near You?

The FDA plans to interrupt about 1,800 "self-identified, moderately overweight" shoppers at malls to survey them on the content and format of the brief summary in direct-to-consumer (DTC) print ads, according to a notice published today in the Federal Register ["Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs"; DOCID:fr25ap06-80]

This is what a "brief summary" statement looks like in a typical print ad:




A mall is probably an ideal place to find moderately overweight consumers. But you gotta wonder what incentives FDA plans to offer people to spend 20 minutes reading this stuff? Perhaps a coupon for a free Big Mac!

Current FDA regulations require every risk in an advertised drug's approved labeling to be included in the brief summary, which my friend Harry Sweeney rightly pints out is "neither brief, nor a summary" (see "Communicating Risk: Let the Dialog Begin" in the April 2006 Issue of Pharma Marketing News).

One thing the FDA intends to study is its "less is more" idea: ie, is a "short list" of side effects better than a "long list"?

The number of side effects will be varied to create "short" and "long" levels as follows:

Short: "Side effects include a, b, and c. This is not a complete
list. Talk to your doctor for more information."
Long: "Side effects include a, b, c, d, e, f, g, and h. Talk to
your doctor for more information."

The Coalition for Healthcare Communication (CHC), which recently submitted a petition to the FDA seeking to simply the communication of risk information in broadcast, print, and Internet DTC ads (see "DTC without the Risk"), should be interested in the proposed FDA survey of consumers. In its petition, the CHC suggested that a short list is best.

The CHC has been doing its own survey about drug safety and DTC. Unfortunately, the results of their survey do not support the "learned intermediary" premise of their petition to the FDA. Here are some results of that survey:

1. Drug prescribers are keenly aware of the safety issues surrounding every drug they prescribe. 68% of respondents disagreed with this statement, 18% agreed, and 20% were unsure.

The CHC believes that patients should rely on their physicians as "learned intermediaries" and not on DTC advertising for communicating drug risk details. If this survey is any indication of how "learned" physicians are, then we are in big trouble.

2. Most patients think drugs are safe if prescribed by their doctors. 89% agreed and 9% disagreed.

3. Most patients read, understand and pay strict attention to the warnings that are given by their doctors and/or that are contained in product inserts and pharmacy literature. 91% disagreed and 7% agreed.

This result suggests that patients need to be exposed to warnings about drug side effects in multiple ways, not just through their physicians.

4. Most doctors are careful to be sure that patients understand the possible side effects of drugs being prescribed. 84% disagreed, 7% agreed.

It seems that despite these indications that physicians are not prepared to take up the slack, the FDA intends to have less risk information in DTC print ads and force consumers to rely more on physicians to communicate the details. The FDA survey will no doubt support that effort.

Sepracor Sneaks In Lunesta Reminder Ad

Has Sepracor decided to sneak in one or two more Lunesta "reminder" ads on TV despite its announcement last year that it has "adopted' PhRMA's Guiding Principles for DTC advertising, which put a kibosh on such advertising?

Principle #10: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." [See "Reminder Ads - Pharma's Dodo?"]

NOTE: In the blog post mentioned above I had links to the PhRMA DTC Guiding Principles, but these links no longer work. You can find the principles by clicking here.

The FDA supported PhRMA's stance against reminder ads:

"Reminder ads" may disclose the name of the product and certain specific descriptive information such as dosage form (i.e., tablet, capsule, or syrup) or price information, but they are not allowed to give the product’s indication (use) or to make any claims or representations about the product. Reminder ads specifically are not allowed for products with serious warnings (called "black box" warnings) in their approved labeling. The regulations specifically exempt "reminder" ads from the risk disclosure requirements because historically they were designed generally to remind health care professionals of a product's availability. These ads can be confusing and frustrating to consumers – and potentially misleading – but, increasingly, we find them to be testing the limits of what might be considered a product claim. Because we believe they serve no useful purpose in the DTC arena, and have the potential to cause harm, we welcome the recent announcement from the Pharmaceutical Research and Manufacturers Association (PhRMA) that essentially supports the elimination of this type of advertisement directed at a consumer audience. [See "Statemnet Before Senate Special Committee on Aging".]

According to an August 2, 2005, Sepracor press release:

"Sepracor is committed to responsibly communicating with patients and consumers through patient awareness programs, such as that for our insomnia drug, LUNESTA(TM) brand eszopiclone. Our philosophy of increasing disease awareness, improving patient education, and encouraging candid dialogue with physicians, is mirrored in the new Guiding Principles," said Timothy J. Barberich, Chairman and Chief Executive Officer of Sepracor. "We believe that this approach to patient awareness is crucial in establishing trust with patients and physicians alike and serves as an important mechanism to help patients make more informed decisions about their health." [see "Sepracor Adopts 'Guiding Principles' for Consumer Advertising".]

The press release doesn't say Sepracor will adopt only some of the principles, so I assume it promised to adopt principle #10 as well. I was surpised, therefore, to see a Lunesta reminder ad last Friday evening on TV -- I believe it was on the History channel.

I looked into reporting this to PhRMA's "Office of Accountability," which accepts comments form the public. Unfortunately, PhRMA doesn't accept e-mail comments from the public, only written letters:

"If you would like to submit a comment to the PhRMA Office of Accountability about a particular DTC advertisement, please follow these steps:

1. The Office can only accept comments made in writing and mailed to the PhRMA Office of Accountability, 950 F Street, NW, Washington, DC 20004 or faxed to 202-775-0258.
2. The comment should provide information sufficient to identify the company and/or DTC advertisement at issue.
3. The comment should relate in some way to an aspect of DTC advertising covered by the Principles.
4. Please be sure to include a return address so the Office of Accountability can acknowledge receipt of your comment.

"If your comment relates to an aspect of a signatory companyÂ’s advertising that is covered by the Principles, the Office of Accountability will forward your comment to the relevant company for consideration. "

I don't know about you, but the last time I wrote a letter was... I can't remember! PhRMA certainly isn't making it easy to report these violations. Besides, I could just as easily do what PhRMA promises to do -- send my complaint to Sepracor directly. The person to contact is probably the person listed at the bottom of the press release: Jonae R. Barnes, Vice President, Investor Relations, 508-481-6700. I hope he doesn't answer calls from investors only.

It's interesting that just the other day -- before I saw the Lunesta reminder ad -- a BusinessWeek reporter called me to discuss the topic of "Disease Mongering". She read my recent blog on the subject (see "Disease Awareness or Disease Mongering?").

One question she asked was: "Did you think pharmaceutical companies were only playing lip service to PhRMA's guidelines and sneaking in ads that violated them?"

Being, as always, fair to the industry, I responded that it seemed that the industry was actually abiding by the principles. I did mention that Sepracor had been running Lunesta reminder ads on TV right up to the January 1, 2006 effective date of the guidelines, which I thought was a calculated compliance with the letter of the guidelines but a violation of the spirit (see "Insomnia - the Next DTC Frontier").

Besides, I honestly bought the argument that the air time for these ads were purchased well before the guidelines were announced and one might forgive a few that were aired after the announcement on that basis. However, it is now several months into 2006 and that argument no longer has merit.

So, why is Sepracor running these reminder ads? Well, for one thing, there is a lot of competition in the "sleep aid" market and pharma marketers may be pressured to push the envelope (see "Insomnia - the Next DTC Frontier"). It's especially easy to run reminder ads under the radar as it were on cable TV. Sepracor could plausibly deny any knowledge of such ads being run -- end of story.

Restless Pharma Marketing

Yesterday I posted a commentary on "disease mongering" (see "Disease Awareness or Disease Mongering?") in which I mentioned Restless Leg Syndrome as an example. Jane Chin, a member of the PHARMA-MKTING Online Discussion Group, made these comments:

Whenever I see the ad for "restless leg syndrome" on TV, I really get miffed. One may argue that it's such a rare condition that if it weren't televised, those who suffer from it may not catch on. Same principle as putting "America's Most Wanted" on TV.

On the other hand, come on! Restless leg syndrome on TV, marketed to consumers on primetime?

I have the same reaction for ED ads. An ad I particularly can't stand is one where a woman is on the porch outside her house, and she's talking about her husband's ED, and how after taking the branded drug, their relationships have become so much better, therefore "ask your doctor about ..." Now drug ads are trying to get other people in our lives to make us "ask our doctor about" a drug?

Drug companies are going to unbranded ED "education" because there are just too many brands now. Whatever clever brand ads you come up with won't matter unless you "expand the total market" and everyone gets a slice of a bigger pie, instead of fighting over a bigger slice of the same pie. (See her post in the Medical Science Liaison Blog).

Another member of the PHARMA-MKTING Online Discussion Group retorted:

According to the National Sleep Foundation, RLS may afflict up to 10% of the population. Not quite a "rare condition".

It seems to me that many of these syndromes affect similar numbers of people. 10% here, 10% there; pretty soon you have everyone suffering from one or two of these things. That's the point of critics who claim that the pharmaceutical industry is turning everyday, minor problems into medical conditions that must be treated. Restless Leg Syndrome may be one of these.

You have to take a critical look at any statistic promulgated by the Restless Leg Syndrome Foundation.

If you visit the RLS Foundation's Web site, it's a bit difficult to find out where it gets its money from. You have to dig down a few pages to learn that GSK and Boehringer Ingelheim are "Gold Level Sponsors." Both of these pharmaceutical companies market treatments for RLS.

Not that's anything wrong with that.

But an RLS Foundation November 15, 2005 Press Release announced the first RLS Foundation Science Award went to Ronald L. Krall, MD, Senior VP of Worldwide Development at GSK! That's a first! Pipe money into a foundation and viola! you (or a VP in your company) gets an award!

Not only that, Dr. Richard Allen, a member of the RLS Foundation's Medical Advisory Board, proudly reveals in the press release that he had the "pleasure" of "collaborating" with the research team selected by Dr. Krall to do studies supposedly supporting the data on the prevalence of RLS in the US and in Europe.

[Allen also hinted that RLS may have something to do with attention deficit disorder in children, another condition often criticised as over treated. Will we soon see kids on Requip, GSK's drug for RLS?]

A couple of other suspicious findings: Although the RLS Foundation Web site claims the organization was incorporated in 1992, the earliest press release available on the site is dated November 14, 2005, just one day before the press announcement of FDA approval of Requip in the US. Even the color scheme of the Requip.com and RLS Foundation Web sites match (blue and orange). Coincidence? Probably; there are so many sites with those colors!

So, to sum up.

• GSK is a Gold Corporate Sponsor of the RLS Foundation, which means it has given the foundation a good chunk of change (the amount is not revealed; I'm going to ask for their financials and see where it gets me);
• at least one member of the Foundation's Medical Advisory Board has financial ties to a pharmaceutical company (GSK) with a treatment for RLS;
• the PR activity of the organization seems to have picked up right when that company's drug hit (ReQuip) the market;
• (I'm letting the award to a GSK VP slide.)

I am sure that a little more investigation would reveal many more ties between GSK and/or Boehringer Ingelheim and the RSL Foundation. Investigation, however, is not the forte of the many journalists who have written stories about RLS and its prevalence (see, for example, "Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick" which presents results of an analysis of RLS news stories).

Some Additional Comments
I received some comments on this topic from colleagues via email that you might find interesting:

Sameer Nanda wrote:

Thanks John for choosing another interesting/debatable topic as always. I will
prefer to be neutral in this regard. On one hand, there is a real need for
education of certain life threatening diseases/vaccination program especially in
developing countries (AIDS, Breast Cancer, Polio, Tetanus, Rabies etc), on the
other hand, pharma companies generate sales based on earlier created
"patho-phobic" brain space. It is probably another classic example of imbalance
of "done and overdone".

Several years back, I remember the presentation on Hepatitis B by a very
reputed global pharma company. The speaker explained why one should get
vaccinated for Hep-B (in India it's not covered by government vaccination
program) with the help of many colorful and complicated charts, graphs, figures
and tables. Somehow at one point the speaker (a top ranked marketing
professional from the company) tried to instill the idea that one can transmit
Hep-B by sharing the same swimming pool with a Hep-B patient. When I asked for
data supporting his vies, he promised to revert back, which he never did.

ED in 80% of cases psychogenic. With proper psychological counseling and
therapy (e.g. behavioral therapy), ED can be successfully treated. However it
seems people taking medications more and more before trying to resolve the real
problem (potentially solvable problems of psychogenic nature).

Everything said and done, probably it is difficult to draw a thin line between
"educational campaign" and "unethical camouflaged sales campaign".

The Hep-B story reminds me of the "Thanks for Smoking" movie trailer (I haven't seen the movie itself) where the Tobacco Industry PR guy is testing before a Senate committe that "just the other day he saw a report that smoking can help cure Parkinson's Disease." I'm paraphrasing. Not that there's any relation between the pharma and tobacco industries (other than their low level of trust among consumers).

The following was submitted by Mario Cavallini:

I enjoy April Fools Day news pranks, and BMJ pulled a great one this year with "Scientists find new disease: motivational deficiency disorder", describing a fictitious syndrome and its treatment, a cannabinoid receptor antagonist called "indolebant."

But BMJ didn't stop there. As part of the joke report, the writer associated the story with an Inaugural Conference on Disease-Mongering and a themed-issue of PLoS Medicine devoted to the subject. It takes some persistent investigation, such as finding an earlier article by the prank author and conference organizer to be sure, but the conference and the PLoS articles are legitimate.

Perhaps these legitimate trappings, as well as some straight-out joke-mongering by the prank author, caused the Australian Broadcast Corporation and others to treat the prank as legitimate news. At any rate, BMJ followed up by castigating news services for being so foolish as to believe them.

I would say that BMJ went too far in confusing a practical joke with a teachable moment. The authors put a lot of effort into misleading the ABC and the general public, with the intention of spurring people to greater skepticism of drug marketing and general news reports. What they have merited, however, is greater skepticism toward the medical equivalent of the military-industrial complex -- the university-journal complex, which has just as much vested interest in monopolizing share of voice as the pharmaceutical industry does.

Disease Awareness or "Disease Mongering?"

[Also see results of this survey: "Disease Mongering: Real or Fantasy?"]


Recently, some pharmaceutical companies have stepped up their use of unbranded DTC ads whose messages focus only on the medical condition -- e,g., erectile dysfunction (ED) -- that the branded product treats with no mention of the brand. The industry calls these "disease awareness" ads. Some industry critics, however, call it "disease mongering."

"[Disease Mongering"] is exemplified mostly explicitly by many pharmaceutical industry-funded disease awareness campaigns - more often designed to sell drugs than to illuminate or to inform or educate about the prevention of illness or the maintenance of health." [Public Library of Science Medicine report]

I first heard the term "disease mongering" mentioned in a post by Peter Rost ("Pharma's Black Knight") in his blog over at the Huffington Post conglomerate (the Wall Mart of Blogs) -- see "Convincing Men That They Can't Perform."

[I'm jealous! According to Peter, "Several of the Huffington Post readers have asked me to take my clothes off and show some naughty pictures..." Finally, a blogger has achieved the real goal of all us nerdy bloggers -- sex appeal! He offers up some beefcake press conference photo opps. I am sure Peter will appear in movies (eg, Michael Moore's "Sicko" -- see "Michael Moore Seeks Sickos") and perhaps even star in the first ever Pharma Reality Show -- where contestants compete to overcome their lifestyle inadequacies like ED within the budgets of their consumer-directed, high deductible insurance plans. But I digress...]

What is "Disease Mongering"? "Disease mongering" -- according to a paper written on the subject in the PLoS Report mentioned above -- is "the effort by pharmaceutical companies (or others with similar financial interests) to enlarge the market for a treatment by convincing people that they are sick and need medical intervention."

Some "diseases" that the authors of the report consider "mongered" include:

• Restless leg syndrome - Prevalence of rare condition exaggerated
• Irritable bowel syndrome - Promoted as a serious illness needing therapy, when usually a mild problem
• Menopause - Too often medicalised as a disorder when really a normal part of life

One of the authors -- Ray Moyniham, visiting editor and contributor to the British Medical Journal -- is also co-author of the book "Selling Sickness: How the World's Biggest Pharmaceutical Companies are Turning Us All into Patients."

Legitimate Awareness vs. Mongering
Although I hadn't heard the term "Disease Mongering" before, I have written on the subject in the past, most frequently in the area of ED. See, for example, "Indication Bloat - The Next DTC Issue" and "ED Drug Sales Limp", in which I suggest that sales goals for Viagra et al are not being met because pharma marketers were drinking their own Kool Aid regarding the high estimated prevalence of the condition.

ED: It's A Little Problem After All!
Pfizer, for example, says that "over half of all men over 40 have ED to some degree" (see "What you should know about erectile dysfunction (ED)"). A long time ago, I pointed out how ridiculous and misleading this statement is (see "Why are ED drug sales falling?"). According to an article in the New York Times, "What is not generally spelled out is that about 80 percent of those classified as having erectile dysfunction in the study were categorized as having only a moderate or minimal problem."

Recently, there have been a spate of ED disease awareness ads that talk about the potential causes of ED: high blood pressure, diabetes, and high cholesterol. On the one hand, I applaud this as truly educational (see "Pfizer Tries Unbranded ED DTC Ads"). For many years the branded ads said zip about the causes of ED. On the other hand, these ads may be an attempt to widen the potential market for ED drugs -- to all men with high blood pressure, high cholesterol, and/or diabetes; not just men who want to please their wives (like that poor guy in HBO's "Big Love"!).

The marketers of ED drugs -- especially the laggards in the market -- must be pretty desperate to engage in unbranded disease awareness advertising since it is a well-known axiom that disease awareness ads benefit the market leader (ie, Viagra in the ED market) most. In this case, however, "disease mongering" -- or, if you prefer, "disease awareness" -- efforts are a rising tide that will float all ED drug ships.

DTC without Risk Revisited

On March 31, I posted a critique of the Coalition for Health Communication's (CHC's) petition to the FDA, the aim of which I said was "the elimination of specific risk information in print and broadcast DTC" (see "DTC without the Risk"). I was not alone in this interpretation. The Associated Press picked up on this story and the following day reported that the CHC "wants to strip most of the warnings from prescription drug ads aimed at consumers" (see "Coalition wants most warnings banished from consumer drug ads").

So, we have a mainstream news source and a blogger reaching essentially the same conclusion independently (I am assuming, however, that the AP reporter didn't just read my blog without doing his own investigation). Harry Sweeney, CHC's executive committee chair and outspoken proponent of the pharmaceutical industry (see, for example, "Clash!"), said my conclusion -- and by extension, AP's conclusion as well -- was "simply wrong."

Harry was speaking at a recent Pharma Marketing Roundtable conference call that I organized. This Roundtable discussion will be published in the April 2006 issue of Pharma Marketing News due to be published next week. Subscribe Now and get it free!

After doing a search on Google for other stories and blogs related to the CHC petition, and after surveying readers of Pharma Marketing News, I found that the general reaction has not been very positive.

For example, the survey (which you can take by clicking here) results suggested that the petition's proposal may have merit, but the FDA is not likely to adopt the regulatory amendments proposed.

When asked "In your opinion, does this proposal have merit?," 50% of respondents said "Yes" and 50% said "No." However, when asked "How likely or unlikely, in your opinion, is it that the FDA will adopt such an amendment to its regulation of DTC advertising?", none said it was "very likely," only 7% said it was "somewhat likely," whereas 14% said it was "somewhat unlikely" and 71% said it was "very unlikely." (See Survey).

Some comments from survey respondents:

"Eliminating risk information from advertising will make the public trust pharma less, not more. While there are certainly problems with current risk provision, audiences feel that advertising without risk information is unbalanced. This proposal runs counter to the current trend in DTC advertising with pharmaceutical companies providing more informative advertising."

"It is absurd to require specific DTC disclosure for products that are available only through an informed intermediary. To insist that risks be disclosed directly to potential patients, is an abject lack of respect for prescribing professionals and the healthcare system."

"I hope the FDA does not yield to industry pressure to remove these warnings. Doctors do not have the time nor inclination to warn patients. Patients are being led by the nose into believing that drugs are completely safe. This proposal would make it even easier to have patients continue in their delusion. It's dishonest, unethical, and meant only to manipulate patients into demanding specific drugs from their doctors."

"Irrational thinking in today's world of moving toward patient/consumer-directed health care; if anything, health information needs are heightened to weigh risk/benefit in making informed decisions on health care matters. Balanced information applies to not only decisions about drugs -- it extends to devices, procedures, plan benefits, etc."

"One advertising network chairman said this was done to because 'great advertising' required clear messages...well, the message here is loud and clear: ad agencies involved in this are trying to re-shape the PhRMA DTC guidelines to their benefit, where the real point is to shape them to the benefit of the patient and consumer. It also is absurd to think a doctor has time to go over all the information a patient needs in their time-squeezed environment."

"Thin-slicing the petition leads me to the (albeit cynical) view that this is a transparently veiled tactic to protect the massive earnings that could potentially be lost if FDA regulation on DTC is tightened/becomes more restrictive. Why not simplify the entire proposal to an old bit of latin: caveat emptor."

I hope these opinions were based on actual reading of the CHC petition and not just my interpretation. You can find a copy of the petition here. I urge you to read it yourself and then take the survey and let me know what you think. The Coalition wants a dialog. Bring it on!

Merck Misled FDA According to NJ Jury

According to the Wall Street Journal, "Merck was ordered to pay $9 million in punitive damages to a man who had a heart attack while taking Vioxx. The verdict came after a jury in New Jersey concluded that the drug maker willfully and wantonly misled regulators about its troubled painkiller." (See "Vioxx Jury Adds $9 Million To Damages Merck Must Pay." Subscription required.)

"Under a 1995 New Jersey state law aimed at tort reform, plaintiffs generally can't get punitive damages for harm caused by an approved drug unless they can prove the drug maker knowingly withheld material information from the Food and Drug Administration."

Merck has always claimed that it was completely honest with the FDA and released all relevant risks regarding Vioxx to the FDA. The jury's decision obviously disputes that claim.

In a previous trial, according to the WSJ, "the jury voted unanimously at the time that Merck failed to warn doctors about the drug's cardiovascular risks, and that the company committed consumer fraud."

Merck has previously been accused of manipulating data released to physicians. See, for example, "Merck's Hand in the Cookie Jar", regarding excising data from a peer-reviewed journal article. Also, it was accused of advising sales reps to "dodge" the issue of Vioxx cardiovascular risks when raised by physicians (see "Get a Load of Those Gams!").

Merck, juries and others have claimed, misled consumers, physicians, and the FDA. A perfect trifecta!

Rather than focusing on how many of these trials it is winning or losing, Merck should be more concerned about the damaging evidence or public opinion being raised by these trials. Each trial and jury decision drives another nail into Merck's reputation. The latest jury, for example, puts into question Merck's interaction with the FDA.

Rost to Roost in Blogosphere

For months I have been receiving "personal emails" from Peter Rost -- Pharma's Black Knight -- informing me of his latest trials and tribulations regarding his whistle-blower case against Pfizer.

Rost has just announced he will write his own blog: "Lot's of people have been writing about me, so I think it's about time for me to start writing on my own."

After receiving all the email from Rost, I am not surprised that he has received comments from people suggesting he begin a blog. "Get a Blog already," I imagine his racketball buddy saying, "and stop sending me tirades by email!" [There are several other people I know who should get a blog already. But that's another story.]

Rost's first foray into blogging is his piece appearing in The Huffington Post ("The New Robber Barons"). By the look of the number and caliber of comments, he's going to do very well as a blogger (and it doesn't hurt to get previewed in The Huffington Post!).

The first thing that caught my attention -- and which a lot of commenters latched on to -- was how much money Rost claims he made as a VP at Pfizer: "my salary was over half a million"!

Rost compares that with his "severance package", which, he says, is nothing more than unemployment compensation of $13,078 annually. He says, contrary to press reports, he received no golden parachute from Pfizer (the bastards!).

"well well well, how the mighty have fallen...hope they gave you a golden parachute or at least let you keep the Lexus or something LOL..." -- Commenter to Rost's Post

Rost's post to The HP focuses on the excessive compensation of Pharma and other big corporate CEOs. He especially focuses on the "greed" of Fred Hassan, former CEO of Pharmacia, which was acquired by Pfizer:

"Greed is to become CEO for a drug company such as Pfizer, be responsible for a stock price drop of 40% over his five year tenure, twice as much as the AMEX Pharmaceutical Index, secure a $80 million retirement package while firing 16,385 Pharmacia and Pfizer employees, and get a 72% pay increase to $16.6 million as his reward."

Rost's main point? "The American democracy has been stolen by our new class of Robber Barons--the CEO's of our big corporations."

It seems to me that Rost has a personal axe to grind: first, he gets no severance package, second his qui tam case against Pharmacia/Pfizer isn't panning out as he hoped. So, I am not sure how much he really believes what he says or whether it's all a calculated ploy for publicity and grist for his case's mill (ie, stuff he can present as evidence).

"Wow, Peter, I would have been SO impressed if you'd written this piece BEFORE you got fired. Anyway, welcome to the real world." -- Commenter to Rost's Post

That comment is not fair -- Rost was quite outspoken about Pharma's stand on issues like the re-importation of drugs before was fired. At least one commenter pointed this out:

"The comments above are stupid remarks from angry puny morons. So sadly typical of the sleazy Huffington Post slime machine. I am familiar with your efforts and background Dr. Rost, and I thank you for blogging on this site. FYI - "Dr. Rost became well known in 2004 when he became the first drug company executive to speak out in favor of reimportation of drugs."

However, Pfizer firing Rost could help his qui tam case and may have been part of his plan from the start.

Maybe after seeing this post, Rost will stop sending me email. Oh well, my loss. But at least there will be his Blog to fall back on in case I need to know what's going on in his world!

Clash!

Medical Marketing & Media (MM&M), one of the more interesting industry magazines, just printed a piece by my friend and colleague, Harry Sweeney, called "Clash of Civilizations"(see figure below).





The juxtaposition of the editorial copy and the ad must surely have been deliberate -- the colors even match. Talk about separation of church and state! A reader might even be misled to believe that the ad is really an illustration accompanying the article, which begins with the phrase "wooly-headed." The "Hippie" image in the ad is certainly an icon of "wooly-headedness" if ever I saw one.

In the article, Harry describes the position taken by the authors of a recent Journal of the American Medical Association (JAMA) article, which urged physicians to reject gifts and payments from the pharmaceutical industry (for more on this, see "Gifts That Keep on Giving" and "Free Gifts to Physicians: What's the Big Deal?").

A quick search of Google suggests that "wooly-headed," "liberal," and "ivory tower" are often used in conjunction with one another, as in "wooly-headed liberal thinking." Harry, for example, goes on to accuse the authors of the JAMA article of "Ivory Tower extortion" because they dared to suggest that CME grants from pharma companies be managed by accredited institutions rather than by individual physicians. He also hints that these "wooly-headed," "Ivory Tower" ideas are unAmerican (he says the authors' statements don't fit with his idea of collegiality or with "modern American capitalism").

What better image of "wooly-headedness" could you pick than the Hippie in the ad? [How about Frederick Douglass? Just before the civil War, when Frederick Douglass was managing the underground railroad helping slaves flee the South, he was often described as a "wooly headed son of Africa."]

I also like the title of Harry's piece -- "Clash of Civilizations" -- in conjunction with the Hippie image. It reminds me of the clashes between New York construction workers and anti-Vietnam War, hippie demonstrators. Harry, you surely do not want to elevate the conflict between academia and the pharma industry to that level do you?

Harry also wonders if the academics are "living on another planet."

If you read the ad copy and you make the connection between Harry and the Coalition for Healthcare coalition (CHC) and if you have read about the CHC's petition to the FDA (see "DTC without the Risk"), you might just conclude that Harry is on another planet.

The ad talks about marketing communications focused on the over fifty baby boomer and former hippie: "He didn't settle for easy answers then, and he won't now. He's demanding to know more about his medical choices..."

The CHC, of which Harry is the executive committee chair, recently suggested that the FDA approve direct-to-consumer ads without specific risk information (an easy answer to the problem of communicating risk to demanding consumers). The CHC also said that "the patient is the decision-maker only with respect to whether a practitioner should be approached."

Sounds like "wooly-headed" thinking to me.

BTW, here's what I looked like back in the day when I was just 25: