Tuesday, December 30, 2008

2008 in Images from Pharma Marketing Blog

What better way to look back on the state of pharmaceutical marketing in 2008 than through the best cartoons, data charts, and other images from Pharma Marketing Blog?

I've put together about 40 of my favorite Pharma Marketing Blog images with some written commentary about each image and the date of publication in the following album, which can be viewed as a slide show. Enjoy!

Monday, December 29, 2008

APA Suffers from ESD: Excessive Secrecy Disorder

PROPOSED DSM V CRITERIA FOR EXCESSIVE SECRECY DISORDER (ESD)

A. A marked and persistent fear of “outsiders” gaining access to policies, processes, or procedures such as the American Psychiatric Association’s process of putting together the fifth edition of the Diagnostic and Statistical Manual (DSM) of Mental Disorders.

The individual with ESD fears that he or she will be “outed” in a way that will be humiliating or embarrassing, such as being accused of having Conflict of Interest Syndrome (COIS); eg, when psychiatrists working on DSM V receive “consultant” fees from pharmaceutical companies that market psychiatric drugs.

B. Exposure to the feared security breach situation almost invariably provokes anxiety, which may take the form of situationally bound or situationally predisposed panic attack.

C. The person recognizes that the fear is excessive or unreasonable, but the fear of losing income outweighs any other concern such as the fear of being labeled a “ secrecy nut” by peers.

D. The feared social or performance situations are endured with a pathological absence of anxiety or distress.

E. The anxious anticipation, or distress in the feared social or performance situation(s) interferes significantly with the person's normal routine, occupational (academic) functioning, or social activities or relationships with pharmaceutical companies ONLY if Sen. Grassley has a hearing and “outs” the person in a press release.

Backstory: "DSM psychiatry manual's secrecy criticized"

Thursday, December 18, 2008

Pharma Industry Out of Touch with Their Customers When It Comes to Who They Favor for FDA Commissioner

FDA critics like Steve Nissen and Peter Rost are the candidates of choice in the Pharma Marketing News survey that asked respondents to vote on who they think should be nominated as the next FDA Commissioner.

The survey included representatives from various stakeholders, including executives and staffers working within the pharmaceutical industry, agents and vendors to the industry, healthcare professionals, members of the general public, and staffers within government health agencies.

It is particularly interesting that former FDA Commissioner David Kessler is almost as popular as Janet Woodcock among pharmaceutical industry respondents.

Perhaps it is not surprising that the drug industry favors these “insiders” and not “change agent” outsiders like Nissen, Rost, or Susan Wood, who are favored by pharma's customers: the general public and healthcare professionals.

It’s just another indication that the industry may not be ready for changes that their customers want to see.

You can get the complete results of the survey here: http://tinyurl.com/43o6o2

Tuesday, December 16, 2008

Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss"

BETHESDA, Md -- Yesterday, as FDA Commissioner Andrew von Eschenbach was announcing that he plans to resign effective Jan. 20, 2009, a disgruntled FDA staffer rose abruptly from his seat about 12 feet away, reared his right arm and fired a shoe at the commissioner’s head while shouting: “This is a gift from the entire FDA staff; this is the farewell kiss, you dog!” The incident was captured by CNN cameras (see a frame from the video below).


Dr. von Eschenbach deftly ducked and the shoe narrowly missed him. A few seconds later, the un-named staffer tossed his other shoe, again with great force, this time shouting, “This is from the elderly, the poor and those who were harmed by dangerous drugs approved by the FDA!” Again, the shoe sailed over the commissioner’s head.

The shoe thrower was subdued by Janet Woodcock, Director of the FDA's Center for Drug Evaluation & Research and then beaten by members of her staff. The shoe thrower's cries could be heard from a nearby room as von Eschenbach quipped "You wont have Andy to kick around anymore, because ladies and gentlemen, this is my last press conference."

Immediately, a great cheer went up from the audience, which marched out the door with shoes in hand to form a spontaneous demonstration in front of FDA headquarters.

"This is like a holiday," said one unidentified demonstrator. "This is just what we needed for revenge."

Monday, December 15, 2008

Pharmaceutical Executive Magazine's Drug "Pipeline" Looks More Like a Money Drain!

Whenever I hear or read about pharmaceutical executives bragging about their product "pipelines" to Wall Street investors I think of the Alaska oil pipeline -- a huge and imposing structure, carefully engineered to bring me a product I need and desire.

I don't think about bathroom drain pipes discharging waste that I want to get rid of.

But that's apparently how the editors of Pharmaceutical Executive Magazine see drug pipelines if the cover image of the latest, December 2008, issue is any guide.

PE has chosen to represent a drug pipeline by the type of PVC drain pipes commonly seen under our bathroom sinks, complete with the U-shaped "sludge" trap and all.

PE shows money flowing into its "pipeline" at one end and pills coming out the other.

But we all know that with bathroom drains, it's always garbage in, garbage out!

Is there some kind of subliminal message that PE is sending here? "Money down the drain" comes to mind!

PE forgot to add one little important feature to its "drug R&D money drain" image: a handy-dandy clean-out plug for removing products stuck in the pipeline (see image below). For more on how useful that is, see "torcetrapib: '$800 Million' Failure but Kindler Safe."

Friday, December 12, 2008

Preview of December Issue of Pharma Marketing News

Planned Articles
  • The Changing Policy Landscape & What to Do About It
    Prepare Now for Coming FDA and Pharmaceutical Marketing Reforms

    “The two traditional means by which pharmaceutical marketers have relied on for many, many years to encourage the uptake of new pharmaceutical products – direct-to-consumer advertising and physician marketing – are about to change,” warned Mark S. Senak, J.D., SVP, Fleishman-Hillard Washington D.C. , in a presentation at the recent DTC in the Era of Consumer Choice conference.

    Senak summarized all the possibly policy changes coming down the pike that will specifically impart pharmaceutical marketing. He also suggests what the industry should be doing to meet these challenges.

    This article is summarizes Senak’s presentation, which he later expanded upon in a YouTube video.
  • Patient Assistance Program Rankings
    Going Beyond Sales Force Effectiveness to Customer Experience Satisfaction

    “While free samples clearly play a valuable role in helping millions of financially-struggling patients get access to the medicines they need to live healthier lives, patients should know there are other options,” said Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson.

    Among the "other options" patients have to get access to the medicines they need are the over 200 Patient Assistance Programs (PAPs) sponsored by pharmaceutical and biotech companies. Patient assistance programs are offered by pharmaceutical companies to help low-income, under-insured, or uninsured individuals and families afford necessary medications, with reduced-cost or free prescription drugs.

    In a syndicated study that identifies what primary care physicians perceive to be the top pharmaceutical PAPs in the industry, Market Strategies -- research and strategic consulting firm -- identified how PAP image influences overall corporate image among primary care physicians, what performance measures drive a pharmaceutical company's PAP image, and which companies are perceived as having the best PAP.

    This article reviews this research with comments from Peter Carlin, Senior Vice President of Market Strategies.

  • Reforming the FDA
    It All Starts with A New FDA Commissioner - Survey Results

    "[The Committee on Energy and Commerce in the US House and Representatives] has found that FDA not only failed in its basic mission, but refused to admit its failures and take steps to protect Americans from unsafe food and drugs," said Rep. John D. Dingell (D-MI), former chairman of that committee. "In the 111th Congress, the committee will swiftly move FDA reform legislation that is needed to ensure FDA does its job." Now that Henry Waxman is the new chairman, "swift" may be inadequate to describe the changes ahead for the FDA.

    The biggest and possibly most important change, however, is who President-elect Obama and his Secretary of HHS, Tom Daschle, decide to nominate for the new FDA Commissioner. "Now, in the Administration's final days, policymakers at FDA want to appear to be tough on industry," said Sen. Bart Stupak (D-MI). "This latest posturing is no reason for FDA political appointees to retain their positions. I encourage the incoming Obama Administration to clean house among FDA’s political appointees and bring change to an agency that badly needs it."

    It seems like everyone in the Pharma Blogosphere and the press is recommending or wondering who Dr. Andrew von Eschenbach's replacement will be.

    To help take the pulse of various stakeholders, Pharma Marketing News hosted the "Who Should Obama Nominate for FDA Commissioner?" survey starting in November, 2008. To date, over 400 consumers, healthcare professionals, government agency staffers, and drug industry executives have voted in this survey. This article summarizes the results of that survey.

  • Critical
    What Daschle Plans to Do About the Healthcare Crisis

    "The time has come, finally, to fix our broken health-care system," says Tom Daschle in the close of best-selling book, "Critical: What We Can to Do About the Healthcare." Daschle, of course, is Obama's choice for Secretary of Health and Human Services. Daschle will also lead a new White House office of health reform.

    To paraphrase General Patton, "Daschle, you magnificent bastard, we read your book!" Which is what all pharmaceutical executives and marketers should do. After all, Daschle warns that the "health-care industry would have to reconsider its business model" and he include pharmaceutical companies as part of the "health-care industry."

    For those among you who do not have time to read Daschle's book, Pharma Marketing News has done it for you. This article summarizes the main points Daschle makes and reveals his plan for "fixing" the problem.
Anticipated Publication Date
18-December-2008
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Thursday, December 11, 2008

Revised DTC Guidelines Do Little to Appease Legislators

According to a story in AdvertisingAge, PhRMA's revisions of its DTC Guidelines are getting "less-than-encouraging reviews from some key legislators" (see "PhRMA Guideline Revisions Don't Go Far Enough for Legislators").

"On the one hand, PhRMA has taken our committee's concerns seriously by revising parts of their DTC code," said Rep. Bart Stupak, chairman of the committee's oversight and investigations panel. "On the other hand, some of these changes are merely a rewording of prior policy that does nothing to increase consumer protection."

If the revisions were meant to APPEASE the legislators, then the endeavor failed and it appears that the pharmaceutical industry is in for some major policy changes in 2009. What's in store from Congress will be the focus of the article "The Changing Policy Landscape and What to Do About It" in the upcoming December 2008 issue of Pharma Marketing News. Subscribe now and get it free.

Wednesday, December 10, 2008

New PhRMA DTC Guidelines Ignore Elephant in Room: Moratorium

According to a press release issued today, the Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors has adopted measures to strengthen the PhRMA Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines.

What's missing is any mention of a moratorium on DTC advertising for new drugs.

At the recent "DTC in the Era of Consumer Choice" conference hosted by DTC Perspectives magazine, Hugh O'Neil, VP and Head of Market Access at Sanofi-Aventis, stated that PhRMA's members are likely to agree on a DTC advertising moratorium for newly approved drugs (see "An Experiment: Ban All DTC Broadcast Advertising for One Year"). O'Neil said there was a debate about the exact length of the moratorium -- whether it should be 6 months, one year, or longer. Most experts in attendance expected PhRMA to recommend a 1-year moratorium.

So much for insider expert opinion!

I guess PhRMA did not want to open a crack in which Henry Waxman could insert a crowbar. According to the WSJ Health Blog, Waxman "voiced support for legislation that would give FDA the power to ban direct-to-consumer advertising for some drugs during their first two years on the market."

The Problem with Social Networks: Where's the Wisdom in 1% of a Crowd?

In his book "The Wisdom of Crowds: Why the Many Are Smarter Than the Few and How Collective Wisdom Shapes Business, Economies, Societies and Nations," author James Surowiecki argued that aggregate information gleaned from groups results in decisions that are often better than could have been made by any single member of the group.

It all depends on how you define "GROUP"or "CROWD." What if it's only a few "knuckleheads?" That's what Dan McKillen asked in his recent MM&M "Web Watch" column:
"Online communities have a substantial amount of influence on almost all web users. Product reviews, visitor comments and recommendations posted online are second to word-of-mouth as a way to drive sales for all web users. The scary part is that so many of the comments, advice and postings come from only 1% of the community. Two or three knuckleheads with a laptop can have a profound influence by posting messages and responding to questions that all the lurkers absorb as factual user-generated content. And that's fine if this 1% is really knowledgeable and honest. But what if they are hired by the local plastic surgeon or a state tourism agency to say nice things about their client?"
That is SO true!

I have a confession to make: on my Pharma Marketing Network Forums online community, out of 1,000 registered users and about 3,000 daily visitors, one individual does most of the posting and that individual is me! Not only do I post a lot of stuff under my real name, but I have several user names (persona) that I also post under. Occasionally, I even post anonymously!

I don't expect a social networking site for pharmaceutical marketing professionals to be as interactive as a site for moms whose sons have ADHD. What my visitors are looking for is information they can trust and I provide that by posting RSS feeds from many different sources, including this blog.

Given that some experts like Dan believe the wisdom of social networks can be manipulated by special interests because so few members participate in the discussion, I find it curious that on the same page as Dan's column in the December, 2008, issue of MM&M there was a news item about Sermo teaming up with Bloomberg so that investors can tap into the "wisdom" of Sermo's physician crowd.
"Investors and analysts will be able to pose questions to physicians to gauge opinion and reactions to potentially market-changing information, such as company statements about the efficacy of therapies or media stories about adverse events" (see article).
This venture "gives users direct access to the observations and insights of Sermo's 90,000-strong physician community." According to McKillen, however, it may give investors access to only 900 physicians in the community, if that. Even if all these 900 were to respond to information requests, the 1% response rate is worse than response rates from direct mail campaigns or simple email!

And don't forget the "knucklehead" factor. It opens up a whole new world of physician influence by pharmaceutical companies -- especially since Sermo has opened its doors to the pharma industry (see "Sermo CEO Talks About Pfizer Collaboration" and "Pfizer has a Gold Mine in Sermo!").

Imagine Pfizer docs lurking on Sermo who see that investors are asking about the adverse effects of a drug that Pfizer is developing. Maybe these docs can't post comments anonymously, but they may get the word out to their Sermo "buddies" to post nice comments on their behalf. And then there's always those physicians with their own special interests.

How are investors going to distinguish between the "really knowledgeable and honest" user-generated content from the "knucklehead" content? Inquiring minds -- and us poser dogs -- want to know.

Tuesday, December 09, 2008

Death of the One-Click "Rule" or "Received Precedent" or Whatever!

It has long been FDA's position that no new guidance regarding pharmaceutical marketing via the Internet was necessary because the rules that apply to print and broadcast media also apply to the Internet.

Recently, however, the FDA issued a little-noticed warning letter (click on image at left to read the relevant section) that addresses a specific Internet marketing ploy: branded banner ads that mention a product's indication and benefit without including fair balance (ie, risk information).

Pharmaceutical marketers and online partners (eg Google) have often justified these types of ads by invoking the the so-called "one-click rule," which Jim Nail, CMO at TNS Media Intelligence/Cymfony, explains this way: "...there is no 'official' FDA one-click rule...there is a 'received precedent' that if you have one click from your brand site to the PI or labeling information, that is acceptable. Or call it 'best practice'. Or call it just 'common practice'." I took issue with this thinking way back in November, 2007 (see "The "One-Click Rule": Rant or No Rant?").

Well, now pharmaceutical marketers have received a NEW precedent that may put to rest the "one-click rule." I say "may" because Diovan is a special case: it's package insert carries a "black box" warning. This type of notice is required for Rx drugs with serious side effects such as death! "Diovan is associated with a number of serious risks," says the FDA. "The PI for Diovan includes a black box warning concerning the risk of injury or death to the developing fetus when used in pregnancy..."

I have always thought that pharmaceutical marketers avoided doing DTC broadcast and Internet display ads for drugs with black box warnings because they knew that the required fair balance statements would turn people off (to say the least). What Novartis did was use a the one-click "rule," "received precedent," or whatever to circumvent this. Just another Web trick for marketing dummies (see more tricks here).

It's interesting, however, that this precedent has gone virtually unnoticed in the Pharma Blogosphere and trade press -- the exceptions are a post on IgniteBlog by my friend Fabio Gratton in October ("FDA Warning to Diovan on Banner Ad ... will there be more?") and a two inch mention on page 28 of the December 2008 issue of MM&M.

Fabio had this to say: "Upon careful review of the words in the FDA's letter, it appears they are insisting on the inclusion of risk information, warnings, precautions, and the most frequently reported adverse events INSIDE the actual banner -- at least in this particular case (which will probably set a precedent)." It's possible, however, that pharma marketers will look at this letter as a "partial received precedent" applicable only to cases involving drugs with black box warnings.

Here's the relevant section of the warning letter:
"... The banners, however, entirely omit all risk information, including the warnings, precautions,and the most frequently reported adverse events from the PI. We note that a link to the PI and Patient Product Information (PPI) is included at the bottom of the banners. However, this does not mitigate the misleading omission of risk information from the banners. For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any effectiveness or safety claims made in that part. By omitting the most serious and frequently occurring risks associated with the drug, the banners misleadingly suggest that Diovan is safer than has been demonstrated."
Jim Nail's consulting company issued a Social Media Marketing Framework White Paper last year that reviewed the FDA's published guidelines and attempted to demonstrate how they apply to the Internet and to social media.
"Pharmaceutical companies are missing a tremendous learning and consumer engagement opportunity with social media because they are uncertain about the FDA's position on this type of marketing," said Nail. "Our framework gives their marketing, legal and regulatory groups a common ground to design a social media strategy."
BTW, Nail's white paper is no longer available. I guess some re-writing is going on!

Monday, December 08, 2008

Brain Drugs: This is Your Brain on Adderall

"We should welcome new methods of improving our brain function. In a world in which human workspans and lifespans are increasing, cognitive enhancement tools — including the pharmacological — will be increasingly useful for improved quality of life and extended work productivity, as well as to stave off normal and pathological age-related cognitive declines23. Safe and effective cognitive enhancers will benefit both the individual and society."

So say a bunch of brain-adderalled psychiatrists, an ethicist, a couple of neuroscientists, etc. -- at least two of whom consult for or receive grants from "a number of pharmaceutical companies" -- in a "provocative commentary" in Nature magazine (see "Scientists back brain drugs for healthy people").

Well, if that makes sense, then let's first legalize marijuana is all I got to say on that!

When I was a college student, I didn't have no stinkin' adderall to help me pass exams. It was old-fashioned "all nighters" and nodoze that pulled me through! Today it's just caffeine delivered via coffee.

But I would never take a PRESCRIPTION pill developed by our stellar drug industry to enhance my brain power! After all, caffeine and marijuana have been around for a long, long time and we know the risk profile pretty well. Adderall, not so much!

Ad Spending: "Worst is yet to come"

"For the advertising and media industries, the worst is yet to come, according to some of Madison Avenue's most closely watched forecasts," according to an article in today's Wall Street Journal (see "Ad-Spending Forecasts Are Glum").

What about pharma ad spending?

I've already predicted that DTC ad spending will decrease in 2009 (see "DTC Ad Spending Will Decrease 9% in 2008 and 11% in 2009!").

So far, about one-third of respondents to my Future of Rx DTC Advertising survey agree with me.

Please take a few minutes to tell me your opinion:
http://tinyurl.com/63o2kx

Sunday, December 07, 2008

A Virtual Brainstorming Session for You to Give Obama Health-care Reform Input

As reported in the Washington Post, President-elect Obama is asking the nation for input on health care reform (see "Obama Asks Nation for Input On Reforming Health System").

"As he gears up for major health reform legislation next year, Obama is encouraging average Americans to host informal gatherings to brainstorm about how to improve the U.S. system," reports the Washington Post.

Former senator Thomas A. Daschle, selected by President-elect Barack Obama to be health and human services secretary, will attend at least one "Health Care Community Discussion" and report back to his boss.

To make it easier for Daschle to "attend" at least one such session, and in keeping with Obama's masterful use of Internet grass root campaigning, I have started a "virtual brainstorming session" online at the NEW Health Care Community Discussion Forum.

Although the pharma industry may be one of those "powerful special interests that have quashed previous health-care reform efforts," I believe readers of this blog and Pharma Marketing News -- who overwhelming support the pharmaceutical industry, yet favored Obama over McCain 55% to 29% -- deserve to have their voices heard by Daschle and Obama even though the new administration may wish to circumvent special interest groups.

What I've learned over the years writing this blog is that we are not PhRMA and many of us wish to improve our country even if it means that the pharmaceutical industry will be faced with new challenges. In my view, BTW, having more people covered by health care insurance and focusing on outcomes will be a net benefit to the drug industry, which needs impetus to be more innovative and provide products that have clear benefits. Indeed, the drug industry needs to learn a lesson from Detroit: innovate, provide real value, or die! Or some day you'll see pharma CEOs visiting Congress with their hats in hand, begging -- just remember to leave the corporate jets and helicopters at home!

I've started the discussion going with the following post to the Health Care Community Discussion Forum:
Extend Health Care Insurance for Children Up to Age 25

The one most pressing issue for me -- and I am sure many other parents today -- is health care insurance coverage for their children over the age of 18 when most insurance policies of the parents no longer cover children (at least in my state, which is PA). The exception -- in our family policy -- is if the child is a full-time student; then the coverage is extended til the age of 23.

My oldest son will be graduating college in May, 2009. He will be 22 years old and, given the state of the economy, he will be facing the almost impossible task of landing a full-time job that will provide him with health insurance. It may take him several months or even years, during which time he will not have coverage!

President-elect Obama proposed to allow children to stay on parents' health insurance through age 25 (see "FACTBOX: Obama's ambitious healthcare plan").

I hope Obama can fulfill that promise. I'm not sure what will have to be done, but I guess it will require some act of Congress and we all know what that means -- special interest influence (especially from insurance companies). It may take years before the needle moves on this issue through that process -- too long to help my son and millions of other young Americans like him.

I believe that extraordinary times call for extraordinary measures.

Here's my "exact idea": Declare a national health emergency and by executive decree require health insurance companies to extend coverage to children up to the age of 25. Probably not going to happen.

But how are we going to make these kinds of changes if we are hobbled by special interests?

There has got to be a way to get Congress to pass an emergency health plan -- one small bill at a time -- just a expeditiously as it passed a $700 billion bailout for the financial industry -- a bailout that got us absolutely nowhere!

Friday, December 05, 2008

Despite FDA Warning Letter, YAZ Web Site Still Connects YAZ with Treatment of Acne!


YAZ birth control pill marketers seem to be thumbing their noses at the FDA, which recently sent Bayer a letter expressing concerns that two ads for the drug go too far in suggesting the drug was approved to treat acne (see "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"). FDA was concerned that the TV ads could be viewed as suggesting the drug also remedied PMS and broader conditions of acne.

The ads in question were halted -- actually, ran their course on TV -- and removed from the YAZ Web site, but now acne is mentioned front and center on the home page in a way that implies that YAZ is approved for the treatment of the broader conditions of acne. IMHO. Tell me what you think.

What immediately drew my attention was the poll that asked: "Would you consider taking birth control pills to help treat acne, if you were also seeking contraception?" Well, yeah! Duh! No surprise that over 90% of "respondents" said "Yes" and only 3% said "No." I suspect the minions at YAZ's ad agency click that "Yes" button several times a day in order to keep that percentage above 90!

Not only is there a suggestive poll linking YAZ to the treatment of acne, there is also a helpful quiz that asks the rhetorical question "Can birth control pills help clear up acne?" Hey, I don't need no stinkin' quiz! YAZ can clear up acne; I know that! Of course I know that!

In other words, I suspect that a lot of women would not bother to take the quiz and would just take away the implied message that YAZ will clear up broader conditions of acne. But I took the quiz anyway.

The quiz did not mention acne until the fifth question where it was finally revealed that YAZ treats "moderate acne in women who choose the Pill for contraception."

This just strikes me as obeying the letter of the law but not the spirit. YAZ marketers simply will NOT give up using acne to sell their product. It's not even a unique selling point as every Pill will have the same effect on "moderate acne in women who choose the Pill for contraception."

--------
P.S. The YAZ-acne poll is just another example of a Web 2.0 trick that can be performed right under the FDA's nose (see PMN Reprint 68-02 and this Blog post).

The poll implies that it is authentic feedback from readers when in fact it is very deceptive because (1) the results do no include how many votes were cast and (2) we do not know if a single person can cast multiple votes in a single sitting. In other words, it is not genuine "user-generated content" that users can trust.

------------
UPDATE: It appears that the YAZ marketers have heard about my criticism of its little poll and have disabled it. The poll is still there as of December 11, 2008, but if you click on "View Results" there are NO results shown (actually all answers are set to "0 %"). And if you try to vote, it crashes -- a blank page fills your browser. Maybe this is is just a temporary technical glitch or maybe it is a quick fix that has gone awry.

Thursday, December 04, 2008

Byrd Loves Rost and Scores!

Cary Byrd of eDrugSearch.com supports Peter Rost -- who has made a reputation as whistle blower, muckraker, and Pfizer nemesis -- for FDA Commissioner!

"It should come as no surprise to readers of this blog that we are delighted about the prospect of a new FDA commissioner in 2009 -- one who we hope will put the interests of the people above those of large pharmaceutical companies," says Byrd. "We have also been pleasantly surprised to see the groundswell of public support for Pfizer whistleblower Dr. Peter Rost for the FDA's top job."

By "groundswell of public support" Byrd is referring to my "Who Should Obama Nominate for FDA Commissioner?" survey, which has about 300 respondents so far. I've covered some highlights of the results of this survey a few days ago (see "Meet the Person Likely to be the Next FDA Commissioner").

In return for Byrd's support, Rost has answered a few questions about how he would handle the commissioner's job. See Byrd's interview of Rost here.

Just for the record, I personally endorse Susan Wood (see "Susan Wood: "The One to Take the Lead" of the FDA"). I have corresponded with Ms. Wood and asked her to respond to the following questions:
  • Should the FDA be given authority to control tobacco and nicotine as a drug?
  • Should the FDA have more resources and use them to bolster inspections of imported food and drug products and allow re-importation of cheaper Rx drugs?
  • Should the FDA be given authority to review and approve generic versions of biologic drugs?
  • Should the FDA preemption of consumer lawsuits against drug companies be eliminated?
  • (my favorite) Should the FDA issue specific guidance on the use of the Internet for the promotion of Rx drugs?
So far, I have not heard back from her on these specific issues, but regarding the possibility that she could be nominated, she did say "I apprecitate (sic) your support for such a hypothetical situation".

NOTE: Among respondents to my survey who say they are very or somewhat supportive of the pharmaceutical industry, Rost comes in 5th behind Nissen, Wood, Woodcock, and Califf.

Take the survey here and vote for your choice.

Marketing Causes Death: the Link Between Black Friday and Black Boxes

AdvertisingAge reports: "Security should have been better, but advertising also helped kill a temporary worker at Wal-Mart, according to a lawsuit filed by the estate and relatives of the 34-year-old man trampled by a pre-dawn Black Friday crowd at a Valley Stream, N.Y., store" (see "Lawsuit: Marketing Blamed in Wal-Mart Trampling Death").

Meanwhile, across the pond, a BMJ commentary written by David P Kao, fellow, cardiovascular medicine at the University of Colorado Health Sciences Center, concludes "New efficiencies in drug marketing exacerbate the problem [of reduced FDA focus on safety] because rapid adoption of new drugs can quickly expose large numbers of patients to unknown risks" (see "What can we learn from drug marketing efficiency?" and "Aggressive Drug Marketing May Endanger People").

It's a rare thing to see two independent, nearly simultaneous accusations that marketing can be dangerous to our health and well-being!

Experts in both these cases cite the need for better safety oversight.

In the Wal-Mart case, "Wal-Mart didn't appear to have enough security to handle the crowds and that police had told retailers in the county two weeks earlier that security and crowd control were their responsibility," reports AdvertisingAge.

In the drug case, David Kao suggests that drug companies' marketing techniques could be used to improve safety surveillance systems, which is largely the responsibility of Physicians. The FDA oversees the process, but really does not have enough "boots on the ground" to effectively enforce day-to-day drug safety issues. Similarly, police forces do not have enough personnel to provide security at every Wal-Mart.

With drug safety, it's largely up to physicians and patients to voluntarily report problems to the FDA and although drug companies have promised to do post-marketing safety surveillance, the majority of those promises go unfulfilled.

I suspect that Wal-Mart and other stores will also promise to implement better security, but that these promises will also go unfulfilled.

Oh, well. Such is the story in our "market-driven" economy!

Lilly's Cialis Campaign Wins "Marketing Overdose Award"

Eli Lilly takes this year's Marketing Overdose Award for the promotion of its erectile dysfunction (ED) drug, Cialis. The award was given by Consumers International (CI), a non-profit international consumer advocacy group with member organizations in 220 countries (ie, Consumers Union in the US).

"Eli Lilly has run foul of marketing regulations in the promotion of it's erectile dysfunction (ED) drug Cialis on a number of occasions around the world," states CI (see "Eli Lilly -- The Marketing Overdose Award for rampant promotion"). "In October 2008, the UK [Prescription Medicines Code of Practice Authority] reprimanded Lilly for not providing adequate information about the side effects of Cialis in its online and in-surgery promotions. The online information site was linked to the first ever television ‘infomercial’ by a drug company in the UK, and the need for its censure is a worrying indication of where drug promotion in the Britain may be heading," says CI.

The Web site and campaign CI is talking about is the “40 over 40” campaign, which claims that "40 per cent of men aged over 40 had problems with erectile dysfunction."

"Erectile dysfunction is a serious condition that affects millions of people worldwide," said Justin Macmullan, Consumers International Head of Campaigns. "But consumer-focused promotions for drugs like Cialis exaggerate the number of potential sufferers and encourage men and their partners to seek prescription drugs for conditions that could be alleviated by changes in lifestyle. This is irresponsible drug marketing at its worst."

I pointed out all of this in July, 2008, BEFORE Lilly was reprimanded. See 40over40: Lilly's DTC ED Awareness Campaign in the UK.

Neither CI nor the UK watchdog, however, mention a neat marketing trick Lilly employed on the Web site to get around the ban on promotion of brand name drugs in the UK.

In July, I noticed a section of the 40over40.com site is about "ED treatment options," which included a table listing oral treatments, penile injections, and vacuum pumps. But due to EU laws banning DTC advertising, the site did not list oral treatments by name and referred to them simply as "product 1," "product 2," and "product 3."

Visitors were urged to talk to their doctors about treatment options, which I imagine would go like this: "doc, I would like 'product 1' please." [Who would bother to ask about product 2 or 3, which clearly were not as good as product 1?] It would be pretty easy for Lilly sales reps to prep doctors so that they know that "product 1" is Cialis when UK guys come in and ask for it.

Today, when you visit the 40 over 40 site, you can still find the link to "10 treatments that can help you" on the home page, but the link leads to a note that says "This page is currently being updated. Sorry for any inconvenience." This "update" has been going on for quite a while.

I tried finding an archive of the page on the Way Back Machine Web Archive (www.webarchive.com), but there were no entries beyond 2005. I did discover, however, that the 40over40.com domain name was once used by Brenda Kinsel, the author of 40 Over 40: 40 Things Every Woman Over 40 Needs to Know About Getting Dressed.

Maybe Lilly will change its campaign to focus on "40 things every man over 40 needs to know about getting an erection." Now that would be ED marketing even I could appreciate!

Wednesday, December 03, 2008

New Rozerem Print Ad Takes Cue from Pepsi Marketers

Under the leadership and creative guidance of its advertising agency, the marketers of Rozerem sleep-aid medication launched a new print ad campaign that emulates the edgy, break-through-the clutter type of ads common in the packaged goods industry.

The new ad is shown on the left.

This is the first time that a pharmaceutical company (Takeda) has coordinated efforts with a packaged goods company -- ie, Pepsi -- to use similar themes and images to create consumer ads.

AdvertisingAge showcased the original Pepsi ads in a recent article (see "Pepsi Opens a Vein of Controversy With New Suicide-Themed Ads").

"There's but one calorie in PepsiMax and, as we know, one is the loneliest number," said AdvertisingAge. "So it only makes sense that a new flight of print ads from BBDO Dusseldorf show a cute but sad little personification of a calorie committing suicide in a few ultraviolent ways, including a gunshot, a hanging, self-immolation and even his slitting his little blue wrist with a razor blade."

It only makes sense as well to exploit the suicide theme in sleep-aid drug ads. Studies reported in the anti-drug industry press have shown a definite link between lack of restful, dreamy sleep and suicide in certain people.

The new Rozerem ad still features Abe Lincoln and the Beaver, although their roles seem to have diminished and they serve only as icons linking us back to the classic Rozerem ads of yesterday (see "Rozerem Ads Dis Lincoln, Show Beaver"). It also makes sense to exploit again the image of the 16th president in ads now that Barack Obama is president-elect. I say that because we are often reminded of the similarities between Obama's campaign and Lincoln's as well as the type of cabinet both presidents have assembled.

Cramer-Krasselt, the Rozerem ad agency of record, could not be reached for comment. Actually, I never even tried :-(

P.S. I just can't wait for April 1!

Monday, December 01, 2008

It's Official! US has been in Recession since 2007! Pharma since 2006!

How about this:
"The U.S. economy has been in recession for about a year, according to the research organization [NBER] that tracks economic cycles. The determination was made Friday and released to the public Monday." (WSJ)
[It sure took them a long time for these dodos to release this information!]

According to NBER: "A recession is a significant decline in economic activity spread across the economy, lasting more than a few months, normally visible in production, employment, real income, and other indicators. A recession begins when the economy reaches a peak of activity and ends when the economy reaches its trough. Between trough and peak, the economy is in an expansion."

I asked back in March 2008 if the pharma industry was in a recession (see here). From the start of that poll, the vast majority of respondents agreed that the industry was in a recession.

But using the NBER "peak and trough" definition of recession and looking at this chart (on left) of annual spending on direct-to-consumer (DTC) advertising, it appears that the pharma industry economy "peaked" in 2006, one full year prior to the US economy as a whole!

I am predicting that the "trough" in the pharma economy won't happen until 2009. If the US economy continues to lag the pharma economy by a full year, then I expect the US economy won't be in expansion until 2010-2011!

What do you think is The Future of Rx DTC Advertising? Take my survey and predict what the level of DTC spending will be in 2009.

P.S. AdvertisingAge confirms that the advertising industry began its recession before the general industry did: "Ad-industry employment has dropped by 52,000 since hitting its peak in November 2007" (see "No Surprise: We're in a Recession").

Microsoft Claims Web Searches Bad for Your Health?

People needlessly fear the worst diagnosis after surfing the net concludes a Microsoft study of health-related Web searches on popular search engines and a survey of 515 of its own employees about their health-related searching. This was reported by BBC news (see "Web searches feed health fears").

"The researchers found Web searches for common symptoms such as headache and chest pain were just as likely or more likely to lead people to pages describing serious conditions as benign ones, even though the serious illnesses are much more rare."

We've heard this kind of stuff about a new generation of "cyberchondriacs" before. Usually, reports of such research ends with the warning: "health information on the Web was no substitute for expert advice." This report follows that rule.

In response to this research, I would point out that "you can lead a horse to water, but you can't make him drink it," especially if it's poisoned! The horse instinctively knows. In the case of humans searching the Web for health information, Health 2.0 tools and sites (eg, discussion forums, etc.) can help distinguish poisoned from refreshing waters.

Meet the Person Likely to be the Next FDA Commissioner

To date, nearly 250 people have responded to my Who Should Obama Nominate for FDA Commissioner? survey. The results so far show Rost, Wood, Nissen, Woodcock, and Califf as the top 5 contenders.

Eighty-six percent (86%) of respondents are from the US and the charts below focus on choices made by these respondents. These are preliminary results -- I intend to keep the survey going until someone is nominated. If you haven't yet voted, I hope you will take a couple of minutes to do it now and include what you think should be at the TOP of the new commissioner's agenda.


Peter Rost -- who has made a reputation as whistle blower, muckraker, and Pfizer nemesis -- holds the lead among all US respondents, 31% and 28% of whom are very and somewhat supportive of the pharma industry, respectively. Most of Rost's US voters are among those who claim to be very or somewhat unsupportive of the industry (see chart below).
"[Peter Rost] knows how Big Pharma operates, isn't owned by them and probably wouldn't be bought, either. He is also two cents short of a dollar, which helps." -- Anonymous respondent
Among industry supportive US voters, Susan Wood is the person of choice, but Steve Nissen, M.D., who has often criticized clinical trial data, is the #2 choice among US voters who support the drug industry.


"[Susan Wood is] a true believer in the promise of change. Return the FDA to science based leadership." -- Anonymous

"[Steve Nissen] is a doctor, he's not scared to stand up to pharma, he's intelligent, and the new commish should clean house of the 'insiders' who have gotten too cozy to big pharma." -- Robert Lands, Engineer, Union Pacific Railroad. Robert says he "somewhat supportive" of the pharma industry.
The level of industry support of voters for the top 5 contenders is illustrated in the chart below. Industry support is rated on a scale of -2 (very unsupportive) to +2 (very supportive) with neutral=0.


Some comments about other contenders include:
"[Robert Califf has an] excellent background and credentials...does not come from pharma." -- Vince DeChellis, Principal, NHHS Healthcare Consulting

"I think [Dora Hughes] will offer a balance between business and science that will ring true." -- Norma-Jeanne Hennis, President, MedPharm Communications

"[David Kessler is] Someone who is familiar with industry and how it works but who will call the executives on the carpet when they knowingly are pushing medicines for dollars not patient quality of life." -- Juanita Hawkins, President, Juanita Hawkins Consulting LLC

"[FDA] needs [Janet Woodcock who has a] ... deep history and knowledge of FDA." -- Anonymous
Who's your choice? Vote here.