Wednesday, January 31, 2007

Tilting Again at the PhRMA Windmill

It's deja vu all over again! I am once again sending a complaint off to PhRMA (see my previous tilt at this windmill: "PhRMA's Response - PRwise, it Stinks!").

I've just sent a letter to PhRMA officially submitting a comment on Takeda's violation of PhRMA DTC Advertising Guideline #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.

I also sent a copy to Mark Booth, the president of Takeda Pharmaceutical North America and Matt Kuhn, the Takeda spokesperson cited below. I also faxed the letter and submission form to PhRMA.

For the Record
The letters went out today by certified mail. You can see when they were delivered and who signed for them at the site by entering the the following tracking numbers:
  • PhRMA: 7006 2150 0003 4883 1169
  • Booth: 7006 2150 0003 4883 1183
  • Kuhn: 7006 2150 0003 4883 1190
Here's some background information:

"Rozerem Reverts to Reminder TV Ads"
"Takeda: It Isn't a Reminder Ad --- Wha!!!" -- you can find information here for sending your own comment form to PhRMA

Amusing Defense but a Dangerous Precedent
I thought Takeda's defense was amusing and sets a precedent I hope other pharma companies don't follow: "We don’t believe that they are reminder ads," said Matt Kuhn, spokesman for Takeda Pharmaceuticals North America. "Rather, they are bookends to the full ad which…opens the commercial break."

I do not believe this argument has merit. In fact, it makes a mockery of the PhRMA guidelines and worsens the industry's reputation as evidenced by several news stories and blog posts devoted to this incident.

Takeda says it adheres to those guidelines but doesn't see its use of the so-called trailer ads as a contradiction.

"If you think about the whole approach to how the brand has been marketed, we think it has been unique," Kuhn said. "And we think this a continuation of that, a somewhat unique approach."

This defense is not endearing the industry to the public and Takeda's defense must be shot down. I just hope I am not the only one speaking out against it.

Pfizer PhD Phobia

The Annals of Family Medicine study of DTC advertising (see "TV DTC Educate Little, Increase Sales Less") may or may not be Pharma Marketing Blogworthy (ie, worth my time analyzing here), but a statement from a Pfizer spokesperson meant to counteract the conclusions of the study is blogworthy.

Jack Cox, a spokesman for New York-based Pfizer, the world's largest drug company, said in a phone interview: "It was a bunch of Ph.D.'s sitting around, looking at ads."

As far as comebacks go, this ranks up there with Pee-Wee Herman's famous line: "I know you are, but what am I?"

If this expression of disdain for PhDs is representative of Pfizer's attitude, it may explain its recent problems bringing drugs to market (see "Pfizer's torcetrapib: Who Knew What, When?" for example).

Or maybe Pfizer is not with the mainstream thinking of pharma-friendly organizations like the Coalition of Healthcare Communication, which urges that FDA fund more studies by PhDs and other experts on how to communicate risk in DTC ads.

Tuesday, January 30, 2007

Barbie Drug Reps I'd Like to See

In case you haven't noticed, sometimes I work in sync with Insider over at PharmaGossip. We seem to be on a hot streak right now.

You can dress Barbie dolls for any occasion -- even for detailing physicians as pharmaceutical reps. The site Denise Designs for Dolls suggests the following outfit for the successful female rep:

May I suggest that the following ensemble is more representative of today's pharma representative?

Takeda: It Isn't a Reminder Ad --- Wha!!!

You heard about the Rozerem reminder ad first on Pharma Marketing Blog (see "Rozerem Reverts to Reminder TV Ads"). Now get a load of Takeda's lame defense:
"We don’t believe that they are reminder ads," said Matt Kuhn, spokesman for Takeda Pharmaceuticals North America. "Rather, they are bookends to the full ad which…opens the commercial break."
We have a saying in New York where I come from: "If you buy that, then I have a bridge to sell you."

You can read more about this here..."Reminder ads draw fire as they gain adherents"

This MM&M piece goes on to say:
As for the reminder ads, Takeda started running them about two weeks ago as part of a DTC campaign that has been on air since last July. Its latest ad was first reported on [my emphasis]

Among its voluntary guidelines on DTC ads for members, the trade group PhRMA calls for a ban on reminder ads. Takeda says it adheres to those guidelines but doesn’t see its use of the so-called trailer ads as a contradiction.

"If you think about the whole approach to how the brand has been marketed, we think it has been unique," Kuhn said. "And we think this a continuation of that, a somewhat unique approach."
Matt, Matt, Matt, Matt, Matt... wake up and smell the roses. You are piling the BS on us so high and so deep, I can't smell anything but you-know-what!

PhRMA Intern LogoIt seems that Takeda, after all, did agree to abide by the PhRMA DTC Guidelines. Matt chooses to redefine what a reminder ad is rather than admit that Takeda is in violation of it's agreement. Looks like I'll have to get PhRMA Intern on the case!

If you have seen the ad in question, how about joining me in reporting it to PhRMA? We'll compare notes on how long, if at all, PhRMA takes to respond. Who knows, we may get another letter from Emily!

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 (click to view form) and mailed to the PhRMA Office of Accountability, 950 F Street, NW, Washington, DC 20004 or faxed to 202-775-0258. [Get with the times, PhRMA! How about an online form? Afraid of getting too many comments?]

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. [Don't hold your breath!]

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

Download the form
and fill it out.

Prilosec OTC Bunco Artists

P&G's OTC Prilosec marketers are doing something you'll never see an Rx product marketer do: sponsor a Bunco tournament. Bunco, for those of you who do not know, is a dice game that "likely began in the U.S. during the Gold Rush, when swindlers came to San Francisco with the fast-paced game, then played with dice or cards, to con laborers out of their money. Bunco parlors eventually formed, leading to the use of the word "bunco" as a synonym for financial scams" (see "An Old Dice Game Catches On Again, Pushed by P&G").
Here are some synonyms from for bunco as in "bunco artist": bilker, cheater, clip artist, con man, crook, deceiver, fleecer, flimflammer, fraud, hoser, hustler, mountebank, scam artist, scammer, shark, sharpie, smoothie, swindler. I've already explored the link between marketers and bullshit artists (see "Is Pharmaceutical Marketing BS?"). Now I can add bunco artist to the list. That label is a bit more sinister than BS artist. BS, after all, is not against the law, whereas bunco schemes are (hence, the police "bunco squads" of yore).
These days, bunco is played mostly by middle-aged suburban women who like Nascar, camping in RVs, traveling by Greyhound, and listening to country music. They also like tailgate parties at NFL games -- so look for Prilosec ads during the Superbowl game. I know this because P&G has done it's research, according to the WSJ article cited above:
"It's a natural fit for Prilosec OTC, whose ads have long focused on a certain core consumer: the middle-aged woman who loves to socialize.

[Sorry, I couldn't find a more representative image of a "bunco babe" to show you. You'll just have to settle for this "babe." I note that marketers often focus their ads on a younger demographic.]

"That's where her passion -- and her heartburn -- lie," says Mauricio Troncoso, Prilosec OTC's marketing director. P&G figures that 70% of frequent-heartburn sufferers are women.

"P&G studies this consumer so closely that it has a name for her: Joanne. And in order to observe her in her natural habitat, P&G urges everyone who works with the brand to participate in activities Joanne enjoys.

"Studying Joanne has led Prilosec OTC marketers to attend Nascar races, camp in RVs, travel by Greyhound, listen to country music and tailgate at NFL games."
Now that's a passion for the consumer of your product you'd NEVER see a brand Rx marketer have. Imagine, if you will, Pfizer marketers living in the shoes of a middle-aged man suffering from erectile dysfunction! Won't happen. First of all, Pfizer thinks these men are devilish scamps that accompany their women into lingerie shops.

I can think of a couple of other reasons why you wouldn't see this sort of marketing from Rx folks.

P&G is sponsoring bunco tournaments around the nation, including a "Bunco World Tour" with a tournament in Kansas City, Mo., "attended by 135 players. P&G had a pharmacist on hand to answer questions about heartburn and pass out samples of Prilosec OTC."

I don't suppose you can hand out free samples of Rx products like you can with OTC products like Prilosec (they used a pharmacist just for show, I imagine).

P&G is branding everything in its tour with the Prilosec logo and benefit statements as exemplified in its "Bunco Central Scoresheet," the bottom portion of which is shown below:

What's missing is any information about side effects. Inclusion of this information, of course, would be necessary if Prilosec were still an Rx product regulated by the FDA. But it's not and FDA cannot insist that the side effect information be clearly visible on the scorecard, which would defeat the whole idea, wouldn't it? And you can't put this stuff on the back of the card either as Daiichi has learned with its Evoxac calendars (see "Nice try, Daiichi!").

Too bad Rx marketers can not be as clever and gimmicky as the P&G Prilosec OTC drug marketers. But then they'd be bunco artists rather than just bullshit artists.

Monday, January 29, 2007

Rozerem Reverts to Reminder TV Ads

More than one and a half years since the Pharmaceutical Research and Manufacturers of America (PhRMA) released its Guiding Principles for Direct-to-Consumer Advertising, I still cannot name all the 23 pharmaceutical companies that have signed on to abide by the principles.

I know there are 23 because I've read the articles that appeared in the press that mentioned this factoid. You won't find the list on
PhRMA's Web site.

Rozerem Reminder Ad
Takeda Pharmaceuticals -- the company that brought us Rozerem -- sign on to the principles or not? Because if they did, they violated that commitment last night during the show 60 Minutes when they ran a Rozerem "reminder ad" (violation of principle #10: Information about the Medicine’s Approved Purpose and Major Risks). This ad featured an Abe Lincoln ("Hello. Honest Abe!") and a beaver in a room without windows. Abe was amusing himself by flipping paper balls at the beaver. The name of the drug was mentioned, but nothing else. Aside from reminding me about Rozerem, it also reminded me how dumb this ad campaign really is!
BTW, although the Abe & beaver Rozerem ads have generated a lot of buzz in the press and in blogs like this one and have even won awards, they are ineffectual in actually increasing sales beyond the investment in the ads themselves (see "Rozerem Ads Innovatively Ineffectual" and "Lincoln Shot Dead! Beaver Sought for Questioning").
Takeda may not have actually agreed to abide by ALL of PhRMA's DTC principles, just one or two. For example, according to the article "23 Drug Companies Agree to New Guidelines on Advertising", Takeda agreed to abide by Principle #6 (Education of Health Care Providers Prior to Launch of Advertising Campaign):
Takeda Pharmaceuticals North America officials said that the company will delay TV ads for the new insomnia treatment Rozerem and take time to educate physicians about the medication. "The last thing we want to do is drive patients into physicians' offices asking them about a new product that physicians aren't necessarily going to have all of the recent information on," Takeda spokesperson Matt Kuhn said (Chicago Tribune, 8/3).
The funny thing is, some people have blamed the lagging sales of Rozerem on Takeda's observance of Principle #6 (see "Lincoln Shot Dead! Beaver Sought for Questioning").

My advice to
Takeda: If you're going to abide by the DTC Guidelines on a piecemeal basis, you might as well pick the ones without an impact on sales! Duh!

Friday, January 26, 2007

If Bill Gates Ran Pharma

In the January 2007 issue of Pharmaceutical Executive Magazine, columnist Sander Flaum contributed a piece entitled "If Bill Gates Ran PhRMA." Flaum believes pharma's (as opposed to PhRMA's) problems are mostly a matter of image and all that's needed is a better spokesperson:
"Pharma has a classic image problem. Sometimes the products don't do what they're supposed to. Innovation is key, but too slow. Business practices can look sleazy. What if our spokesman was a guy who'd beaten those problems?"
As it happens, Gates has taken this seriously and was heard to proclaim: "If the pharmaceutical industry developed and promoted drugs like Microsoft develops and promotes software, we would all be paying only $25 a year for all the drugs we need."

A pharmaceutical executive standing nearby whispered to his companion lest Gates overhear what he said, "Yeah, and if drugs were like software that Microsoft develops and promotes, they would stop working for no reason, and when you tried to get a different brand, there wouldn't be any."

Even Bill Gates Can't Fix Pharma's Image with the Same Old Tactics
All seriousness aside, not even Bill Gates can save the pharmaceutical industry, especially using the tactics that Flaum suggests in his article. Most of these are the same tactics the industry already employs today.

To counteract the "free gifts to physicians" brouhaha, for example, Flaum would have Gates respond with this red herring often used currently by the industry without help from Gates: "Is there anyone who seriously thinks a doctor will write one brand over another because of a ballpoint pen or a pad of paper?" Of course not! But in the eyes of many physicians, patients and consumers, excessive branded gift items littering a doctor's office may be an important issue (see "Drug Rep Toys" for an amusing accounting of gifts physicians receive from pharma companies; some pens do not even work!). Gates, according to Flaum should also berate the AMA, thus further alienating its customers.

Gates is successful because Microsoft is a virtual monopoly (success breeds more success). Go ahead and try to run your business without Windows machines and see how far you get. The pharma industry does not have that advantage.

Besides, even Gates is perhaps not the best role model for PhRMA to follow. I read a commentary by an adjunct fellow at the American Enterprise Institute in today's Wall Street Journal that said the Gates Foundation was blasted three weeks ago in the Los Angeles Times, which ran a series accusing the foundation of reaping "vast financial gains" from corporations with "environmental lapses, employment discrimination, disregard for worker rights, or unethical practices" that "contravene its good works."

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Thursday, January 25, 2007

Disease Mongering and Pharma Credibility

"Disease mongering" is a term that was coined by the late journalist Lynn Payer to describe what she saw as the confluence of interests by some doctors, drug companies, patient advocacy groups and media in exaggerating the severity of illness and the ability of drugs to "cure" them.

Disease Mongering -- Is it real or not?

The following examples of disease mongering were cited in the April, 2006 issue of PLoS:
  • 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
The organization that hosted the Inaugural Conference on Disease Mongering, produced the following video and distributed it via YouTube. It's quite well-done.

Sometimes, there is thin line between "disease mongering" and disease awareness advertising and PR (see, for example, "Disease Awareness or 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." - PLoS
This past Tuesday, Neil H. Gray, Managing Partner, Healthcare Trends & Strategies, LLC, and I put together a "Point-Counterpoint" debate on the issues related to disease mongering and pharma credibility at the Patient Education and Disease Awareness Summit in Philadelphia. Neil and I have discussed this topic before in a Pharma Marketing Talk podcast, which you can listen to here.

For the Summit audience, we decided to take opposite sides to debate several questions, including:
  • Is it a real issue?
  • Lack of blockbuster drugs in pipeline a factor?
  • Influence of DTC advertising
  • Impact on pharma credibility
You can find more details in the PPT presentation here.

One of the main tenets of disease mongering is that pharmaceutical companies are putting sales potential & profit before patient health when deciding what drugs to develop. A recent survey by PricewaterhouseCoopers ("Recapturing the Vision: Restoring Trust in the Pharmaceutical Industry by Translating Expectations into Actions") showed that consumers and pharmaceutical executives are far apart on what really motivates the drug industry. Take a look at the following chart prepared from survey data:

"Pharmaceutical companies need to demonstrate a better balance of their primary healthcare mission with their fiduciary obligation to shareholders through patient-focused behavior. Research has shown that a 5 percent positive change in corporate reputation translates into a 3 percent to 5 percent positive change in market capitalization." -- Peter Claude, a partner in PricewaterhouseCoopers Pharmaceutical and Life Sciences Advisory Services Group
Disease mongering may be just one more nail in the coffin of pharma credibility, but it will become a more important factor as the industry adapts to weak pipelines for new innovative drugs and must find new indications for old drugs.

I am interested in your opinion. Please take my survey. After completing the survey you will be able to see a summary of results (de-identified, excludes open-ended responses and comments that may identify the respondent). You can also use filters to examine results from different subsets of respondents (e.g., pharma company employees vs. non-pharma people, etc.).

Disease Mongering -- Is it real or not?

Wednesday, January 24, 2007

Revolution Health and the Wisdom of Crowds

A couple of weeks ago I was invited to preview the new health portal site prior to its official launch on 22 January 2007 (see the press release).

Revolution Health was founded in March 2005 by Steve Case, best known as the co-founder and former chief executive officer and chairman of America Online (AOL). According to the press release, Revolution Health's goal is "to create products and services that empower people by putting them at the center of the health system." A year and a half ago, when Revolution Health was pitching its services to pharma companies, some executives thought it would have a huge impact on healthcare, but others pooh-poohed the idea.

Now comes the portal site. I am particularly interested in the "social networking" aspect of the site where users can rate products and post comments, specifically in the Conditions & Treatments (shown below).

In this area of the site, visitors can rate Rx drugs and other treatments. According to the site, "Revolution Health users have rated more than 4,000 remedies. Check out the most preferred treatments—or add your own rating to help everyone else." I decided to explore more about ED and insomnia treatments.

Add Your Own Rating
In the Erectile Dysfunction area several treatments were listed including the well-advertised Rx drugs (Viagra, Cialis, and Levitra) as well as some lesser advertised ones (Caverject) and some more exotic treatments and devices (vacuum pumps, MACA, and Horny Goat Weed). Visitors can rate these in terms of effectiveness, side effects, ease of use, and cost effectiveness. The rating for Viagra is shown on the left. It was rated better than Horny Goat Weed, which received only one rating (overall: 3.0). The guy who rated it gave it a zero for effectiveness (duh!). However, he did give it a 5.0 for cost effectiveness, which beat out Viagra. Levitra, with the lowest US market share among the top 3 Rx's, beat all with an overall rating of 8.3 (based on only 9 votes). Does this mean that Levitra has potential if only it were marketed better? I don't think we have enough data here to make that conclusion.

Where's the Crowd?
Revolution Health's treatment rating system is intriguing although flawed. I could find no guidelines for what to consider when voting. What does cost effectiveness or ease of use mean, for example? These can mean different things to different people. There is the problem of statistical significance as well. Twenty or 36 votes is hardly a large enough sample to achieve any "wisdom of crowds" effect.

Revolution Health acknowledges this problem:
IMPORTANT MESSAGE: This service is in its infancy, but our philosophy is that if millions of people participate, it will emerge as a very useful tool for people as they consider their treatment options. also allows visitors to post comments about treatments. One comment I saw right off the bat was negative about Viagra:
TOPIC: Too awkward
"Yes, it gave me an erection but only if I didn't have ANY fat or oil in my meals that day - it apparently is negated by fat and this can be a strong effect in some individuals. It also gave me a constant runny nose, flushing, and an anxious feeling. I was disappointed with the shortness of its effectiveness - the window period for me was one or two hours - after that, it didn't help. I consider Viagra a good beginning to solving this problem. Cialis was a big improvement."
Good for Cialis but not for Viagra. Who knows? Maybe this was a post made by a Cilais brand team member or an ad agency working for Lilly?

I am a great proponent for the use and support of social networking tools by pharmaceutical marketers. But this kind of thing might scare them off as advertisers. Or maybe not.

Also, as a user, I would be wary of the possibility that the system can be "gamed" by people with an agenda. I've seen this happen in my own surveys, for example. Maybe it happens also on non-health Web sites that sell products like flat screen TVs. But there, the buying decision is different (you don't need a prescription -- another person's permission -- to buy one) and the consequences of a bad decision is much less critical to your health.

Podcast Interview
Anyway, I haven't learned enough about to really be too critical. That's why I plan to interview Jay Silverstein, the COO of Revolution Health, in my next Pharma Marketing Talk live! podcast (more info about that here).

Tuesday, January 23, 2007

Nice Try, Daiichi!

FDA. officials say they "deal" with 54,000 drug promotions each year, aimed at both doctors and consumers (see NY Times article: "Showdown Looms in Congress Over Drug Advertising on TV"). A couple of these promotions stood out from the rest -- a wall calendar and a dry erase board for Evoxac Capsules submitted by Daiichi Sankyo, Inc. (Daiichi) under cover of Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use).

Form 2253 is used by drug companies when submitting promotional materials to the FDA for review, usually after the promotions are distributed.

In this case, the FDA found a problem with the Evoxac materials and issued a warning letter to Daiichi saying, in part, "These promotional materials are false or misleading because they present efficacy claims for Evoxac but fail to communicate information about the risks associated with its use. Thus, your wall calendar and dry erase board misbrand Evoxac in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 352(a) and 321(n)."

The FDA letter points out a major problem: "the pieces are not designed to allow the risk information to be visible or even accessible." Note that risk information doesn't appear on the front of the calendar. That's because Daiichi put that information on the back of the calendar! Pretty slick.

The letter says:
"The wall calendar and dry erase board present effectiveness claims for Evoxac but fail to communicate risk information associated with its use. Risk information for Evoxac is printed on the back of the wall calendar and dry erase board; however, as a practical matter, this information is not visible or even accessible to the viewer. The backs of the calendar and dry erase board are covered with an adhesive and completely obscured by an opaque paper backing to prevent sticking. This backing completely covers all the risk information presented. Furthermore, the wall calendar and dry erase board are designed to be adhered to walls or similar surfaces, so even once the opaque paper backing is removed, the pieces are not designed to allow the risk information to be visible or even accessible. Presenting risk information in this manner is not sufficient to ensure that the claims in each part of the wall calendar and dry erase board are truthful and non-misleading. As a result, the pieces misleadingly suggest that Evoxac is safer than has been demonstrated by substantial evidence or substantial clinical evidence. We note that, even if the information on the back of the calendar or dry erase board could be accessed (i.e., the materials did not adhere to the wall and could be flipped), the misbranding would not be cured. Your failure to include any risk information on the front of these materials cannot be corrected merely by including that information in another part of the materials. Rather, there must be some disclosure beyond a disclaimer in the same place in which the effectiveness claims appear."
What was Daiichi thinking?

Maybe Daiichi figured its Form 2253 submission would get lost in the shuffle of 54,000 other submissions. Or maybe Daiichi knew it could distribute the calendars and the FDA would not require recalling them. FDA merely "requested" that Daiichi "immediately cease the dissemination of violative promotional materials for Evoxac such as those described above."

FDA warnings letters are often characterized as "closing the barn doors after the cows have left." This is just another example.

Thursday, January 18, 2007

Banned from CafePharma!

I'm not banned yet, but I soon expect to be banned from CafePharma. At the moment, all my posts have been deleted. Here's the story, which is an object lesson in non-social online networking!

Recently, I have been visiting CafePharma and posting a few messages there to learn what the "other half" -- sales -- thinks of pharmaceutical issues. One of the more popular questions I asked was "Are Sales Reps Necessary?" This was part of research I was doing for this blog and an article that was recently published in Pharma Marketing News (see "Are Sales Reps Necessary?").

For those of you who have never heard of CafePharma, it is an online site for pharmaceutical sales representatives and features bulletin boards where visitors have anonymous "discussions" on a range of topics. I would characterize the majority of these discussions as "Potty-Mouth Gossip Fests." Nevertheless, there can be some nuggets among the nuts.

All my CafePharma posts were deleted, including the entire thread "Are Sales Reps Necessary?". Here's what the CafePharma Administrator said:
"I'm sorry, but your posts are going to be deleted because they violate our board advertising and solicitation policy. Please do not continue to use this board to advertise your blog, or we will delete your account."
A bit Stalinesque, wouldn't you say? I was hardly advertising my blog, but doing some research for an article I was writing. I did link to a blog post I made as background, just as many other people do on CafePharma. The only thing is, I did it under my own name and not anonymously.

I expect now to be totally banned from CafePharma after they see this post and a similar one I made over there in response to a thread entitled "Why are threads being deleted???".

It seems that some CafePharma users don't like the delete first, ask questions later policy at CafePharma.

Non-social Online Networking
I am new to Web-based social networking and have just started my own site for pharmaceutical marketers to chat and network. The site is Pharma Markleting Network Forums (PMN Forums) and you can read about in this article (totally free): "An Online Community to Call Our Own"

Another reason why I was interested in CafePharma was to learn more about online social networking best policies. It turns out that CafePharma offers me a good model NOT to follow.

First, of course, is how they treated me and arbitrarily deleted a whole thread I started, whereas they could have just edited out the link to my blog in my original post. Or asked me to do it. I know this is possible with the software, which I also use to run the PMN Forums. That way, the discussion could continue and nothing in it would violate their policies.

Another thing I learned from CafePharma by negative example, is to provide members with a forum that they can use to promote themselves within reason. You need to know something about the people you are talking to online. When I ran the e-mail based PHARMA-MKTINGlistserv, people could include links and other information about themselves in their posts and signature lines. They can now do the same thing on PMN Forums. They can also have a complete public profile that includes a biography, photo, e-mail address, and links to their web sites.

In fact, I encourage PMN Forums users to include links in their posts to blog posts, articles, white papers, etc., as long as it helps in the discussion of the issue at hand and is informative rather than just promotional.

Another point about online social networking is that many people who get to know one another online would also like to meet in person. That is why I host a live networking dinner event every year and it's been very successful. There's no replacing personal, face-to-face contact as any sales rep will tell you (yes, sales reps ARE necessary!).

There's a lot I have to learn about social networking, but unfortunately CafePharma doesn't have much more it can teach me in that regard. I guess I will just be another one of its horde of anonymous visitors and posters who have as much community awareness as [insert your own species of non-social animal here; I am too stressed to Google one myself].

Wednesday, January 17, 2007

PDUFA Payola!

The FDA says it needs 27 additional staff to review DTC TV ads and projects related user fees of $6.2 million in 2008, reports MM&M Newsbrief.

"The agency called for a separate new user fee program to cover DTC TV ad reviews in its proposed outline for reauthorization of the Prescription Drug User Fee Act [PDUFA, sounds like "P'doofah"]. The agency’s plan would raise user fees under the existing program by $87.4 million to $392.8 million annually in order to fund an expanded drug safety programming, increased screening of DTC ads and the agency’s Critical Path initiative."

You can read FDA's announcement in the Federal Register, but I have extracted the relevant paragraphs here (emphasis added):

What We Are Proposing to Recommend for Review of Direct-To-Consumer Advertising

In addition to our proposed recommendations for enhancements to the current human drug review program, we are proposing to recommend a program separate from, but related to, PFUFA assessing fees for advisory reviews of DTC television advertisements. ...
Companies recognize the benefits this advisory review mechanism offers. In fact, PhRMA recently stated in its voluntary guidance principles on DTC advertising that companies should submit all new DTC television advertisements to FDA before broadcasting them... However, although FDA's DTC advisory review workload has been steadily increasing, staffing for this activity has remained level. As a result, it is impossible for FDA to review all of the DTC television advertisement advisory submissions it receives in a timely manner. The lack of timely, predictable FDA review times for DTC television advertisements is detrimental to companies' ability to accurately set timeframes for their marketing campaigns and discourages companies from submitting these materials for advisory review.

We propose creating a separate program, not directly included under PDUFA IV, to assess, collect, and use fees for the advisory review of prescription drug television advertisements. These user fees would not be funded by application, product, or establishment fees assessed under PDUFA.
Instead, these new fees would be assessed separately and collected only from those companies that intend to seek FDA advisory reviews of DTC television advertisements. The proposed recommendation for fee funding and the estimated number of supported staff are summarized in table 2 of this document.

This program would provide for increased FDA resources to allow for the timely review of DTC television advertisement advisory submissions. To ensure stable funding for the program in case the number of advisory submissions fluctuates widely from year to year, the program would assess a onetime participation fee. The program would then charge fees each year for each advisory review requested. These new fees would provide sufficient resources for FDA to hire additional staff to review DTC television advisory submissions in a predictable, timely manner.
FDA anticipates collecting $6.25 million in annual fees during the first year of the program (and a similar amount to go into the reserve fund) to support 27 additional staff to review DTC television advertising. Advisory review fee amounts would be adjusted annually for inflation and to take into account increases in workload. As part of this program, FDA is proposing to commit to certain performance goals including review of a certain number of original advisory review submissions in 45 days and resubmissions in 30 days. The goals would be phased in over the 5 years of the program to allow for recruitment and training of staff.
In the overall scheme, $6.25 million is a crumb. But, since we are concerned only with that crumb here, let's do some math with these numbers. The analysis might be applicable to the entire PDUFA budget.

First, $6.25 million for salaries and benefits of 27 staffers (FTEs) works out to be $231,481.48 per person per year. Where's the job application? I'll sign up today.
FTE or Payola?
I doubt FDA will actually pay staffers anywhere near that amount. A substantial portion of the $6.25 million, therefore, must be pure payola -- and I mean that literally! Want your ad to play on TV? Then you got to pay, baby. Of course, "these new fees," says FDA, "would be ... collected only from those companies that intend to seek FDA advisory reviews of DTC television advertisements." Pity the fool that isn't with the program!

What about cost per TV DTC piece or campaign reviewed?

In a previous post ("Where's DDMAC's Head At?") I showed a chart of the number of DTC materials submitted to the FDA each year. In 2005 about 4,600 print and TV DTC pieces were submitted for review. Maybe 2,000 were TV-related. If FDA gets more money to review TV ads, this could increase to 3,000. The fee per piece (eg., storyboard for one ad) works out to about $2,000. Again, this seems like a lot of money to review a single piece. I could do it for $1,000!

Which leads me to make this suggestion: FDA should farm these reviews out to us bloggers or consultants. Better yet, drug companies could improve their own internal review and obey the law!
This could save the drug industry a bit of cash!

But that would eliminate the payola component.

Monday, January 15, 2007

Introducing...the All-Pharma Lobbying Lineup!

Last week, the House voted to require the government to negotiate lower prescription drug prices for Medicare beneficiaries. Although the vote was 255 to 170, with 24 Republicans joining 231 Democrats in approving the legislation, it could have been a much worse scenario if it were not for pharmaceutical lobbyists.

As reported in the Washington Post ("Drug Bill Demonstrates Lobby's Pull"):
"Before taking control of the House last week, Democratic leaders briefly considered proposing a new government-run prescription drug program as a way to reduce seniors' drug costs, according to Democratic aides and lawmakers involved in the deliberations.

"But House Speaker Nancy Pelosi (D-Calif.) and her allies chose a far less ambitious plan -- to require the government to negotiate for lower Medicare drug prices -- that will come to a vote today. They stepped back largely out of concern that the pharmaceutical industry would stall a complex change, denying them a quick victory on a top consumer-oriented priority, aides say.

"They had reason to be wary: Despite years of lopsidedly favoring GOP lawmakers with campaign cash and other benefits, the drug lobby continues to wield tremendous power in the Democratic-controlled Congress."

"To strengthen their position, drug firms and their trade groups have been transforming their Washington operations by hiring top Democratic lobbyists to gain access to new committee chairmen, bolstering Democratic political donations and spending millions on public relations campaigns to overcome an image, indicated in recent surveys, that the industry puts profits ahead of patients."

"Even longtime industry nemeses like Rep. Fortney 'Pete' Stark (D-Calif.), chairman of a House health panel, are impressed. '
They're pretty potent,' he said this week."
Potent indeed. I have done some research to determine who these pharmaceutical lobbyists are and have found that several of the male lobbyists may be moonlighting as Chippendales dancers!

Pharmaceutical companies have long had a penchant for hiring female cheerleaders as sales representatives (see "Sexy Reps Sell Rx" and "Introducing...the All-Pharma Cheerleading Squad!"). For lobbying efforts it seems male strippers are more favored by politicians these days.

The All-Pharma Lobbying Lineup!
With a tip of the hat to eDrugSearch Blog, I decided to do a quick scan of the Chippendales Web site to see who might be listed as pharmaceutical lobbyists. The following is my
All-Pharma Lobbying Lineup -- current Chippendales male dancers who I imagine double (and undoubtedly receive double takes) as pharmaceutical lobbyists:

Jordan D., a "Pfizer" lobbyist (shown on the left in the image above), really likes Dems, but his idol is Jack Abramoff (shown on the right), the former Republican lobbyist and convicted felon. Obviously, the Abramoff legacy lives on!

NOTE: In keeping with the pharmaceutical industry's interest in improving its public image and wooing Democrats, pharma lobbyists only wear democratic WHITE hats, which convey a more positive message about their motives than do republican black hats.

Alan R., a "Lilly" Lobbyist, also likes hats, but of a different sort (above). Favorite movie: Brokeback Mountain.

Chaun W. (above) I imagine works for Allergan and Sepracor--two companies that really don't give a crap when it comes to good marketing practices (see "Allergan Ignores Guidelines, Wins Award Anyway" and "Sepracor Sneaks In Lunesta Reminder Ad," for example). Chaun's pose in this photo appropriately telegraphs his employers' message.

Finally, there's Charles H. Don't mess with him -- or any pharma lobbyist for that matter. He'd just as soon burn your next campaign in Hell as give you $50,000!

Closing Factoid
Drug companies spent more on lobbying than any other industry between 1998 and 2005 -- $900 million, according to the nonpartisan Center for Responsive Politics.

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Friday, January 12, 2007

A New Forum for Marketers!

Pharma Marketing Network Forums

Many readers of this blog may not know some of the other online venues I am responsible for that help pharmaceutical marketers stay in touch with the issues and with each other.

The newest example is Pharma Marketing Forums, which is a web-based community that features discussion boards. The Forums are a re-incarnation of the PHARMA-MKTING listserv that I have been hosting and moderating for 10 years! For those youngsters out there who may not know what a listserv is, let me enlighten you.

A listserv is an e-mail list software application by a company called L-SOFT. It allows members to send e-mail messages to the entire list. The PHARMA-MKTING list now has about 2400 members worldwide!

A listserv is a great collaboration and communications tool. However, it has limits. The main problem is that it generates a lot of e-mail and these days people get too much e-mail. I am especially guilty of sending out a lot of e-mail already in support of my free newsletter, Pharma Marketing News.

The Web-based Pharma Marketing Network Forums allow discussions like a listserv, but also includes many other neat social networking tools like buddy lists, member profiles, calendars, private messaging between members, user-generated content, polling, content rating, calendar submissions, etc., etc. Members can also decide which discussions they wish to keep track of by e-mail notification. Members can register under a pseudonym and remain anonymous. In other words, members have much more control over what information about them others see and how they interact with discussions.

So, I am disbanding the PHARMA-MKTING listserv effective February 1, 2007, and encouraging everyone to join the Pharma Marketing Forums. Note: members get some special privileges, but even guests can post threads and participate in discussions. So, check it out.

The following is an outline of the discussion boards available. This structure is subject to change.

These are forums related to discussion of rules of usage, who we are, how to use the features of forums, etc.
  • Rules and Regulations
  • Who We Are -- Tell us who you are and what you do.
  • How Do I...? Ask questions and get answers about using the forums.
  • Suggestions -- Give the Webmaster suggestions for improvement.
News & Views
Abstracts of pharmaceutical marketing news sources, blogs, conferences, etc.
  • Industry News -- User contributed or generated sources of pharmaceutical news from newsfeeds, press releases, news stories, etc.
  • Pharma Marketing Blog Forum -- Notices of posts made to Pharma Marketing Blog and discussions related to those posts.
  • Pharma Marketing News -- Executives summaries of the monthly Pharma Marketing News e-newsletter.
  • Join Today!
Open Discussion Forums
Open to all registered members and guests, these forums are for the discussion of a range of pharmaceutical marketing topics.
  • Free for All -- Any topic at all! Useful for topics that don't fit other categories.
  • eMarketing -- Internet-based pharmaceutical marketing topics.
  • Physician Marketing -- Discussions related to physician marketing and advertising.
  • Physician Education -- Discussions relating to CME and non-CME physician education issues as distinct from physician marketing. Includes discussions about MSLs, KOLS, etc.
  • DTC Marketing -- Discussions related to direct-to-consumer marketing and advertising.
  • Disease Awareness Marketing -- Discussions related to disease awareness or unbrnded marketing and advertising.
  • Product Manager Corner -- A place for pharmaceutical product managers, brand team leaders, etc.
  • Market Research -- Discussions related to pharmaceutical market research.
  • Pharmaceutical Sales -- This forum is for the discussion of pharmaceutical sales issues and practices, including sales force effectiveness, training, etc.
  • Regulatory Issues -- This forum is for discussions related to marketing laws, regulations and guidelines.
  • Join Today!
International Forums
These are forums for non-US pharmaceutical marketing discussions
  • Indian Market Forum -- This forum is for the discussion of issues specific to the Indian pharmaceutical market.
  • European Market Forum -- This forum is for the discussion of issues specific to the European pharmaceutical market.
  • Join Today!

Thursday, January 11, 2007

Viagra Spray Not Far Away?

I read with interest over at PharmaGossip that Pfizer may be planning an OTC Viagra spray. My vision of the product can be seen on the left.

Actually, the story "Pfizer Viagra spray set to revolutionize drugs market" appears in The Business, a UK publication. See the Pharma Marketing Network Forum for the full story.

It's interesting to note this might be in reaction to Viagra's loss of market share outside the US and its struggle against counterfeit product in countries like China.

"Last year, Viagra earned Pfizer $1.6bn (£800m, E1.2bn) worldwide. But its money-spinning status has been hit by counterfeit versions widely available on the internet, and patent challenges to its active ingredient sildenafil citrate, in developing countries such as China and Columbia."

China and Columbia are notorious illegal drug snorting nations! Therefore, a Viagra spray may fit well in those markets.

Speaking of market share, MM&M reports that Lilly claims Cialis holds 35.5% of the non-US market share and is set to become the No. 1 global ED drug in 2007. In the US market, Viagra sales were down 6% for the first nine months of 2006, whereas Cialis was up 26% and Levitra up 30%. Viagra held on to 56.6% of the US market, while Cialis has 27% -- Levitra comes in at 13.3%.

A new formulation or delivery system is a tried-and-true way of extending the patent life of a drug. So, I am curious why Pfizer is thinking of going over-the-counter with a spray version, unless I am mistaken that it can qualify as a new drug by the FDA and thereby enjoy extended patent life.

In any case, an OTC form of Viagra may be problematic given the fact that some deaths have been reported in men who use Viagra in combination with nitrates for angina.

Another way that Pfizer likes to extend patent life of its drugs is by combination as it did when it created Caduet by combining Norvasc (for hypertension) and Lipitor (cholesterol) (see "Caduet, Smaduet! Add some wood to the fire!").

I don't know about you, but I'd like to see a combination product that included Viagra and Listerine (a Pfizer OTC product) -- good wood and clean breath in one spray! I call it
Viagrine(tm)! (Tip of the hat to PhamaGossip for suggesting a similar combination product.)

BTW, go to the Listerine product site and check out the "Mouth-Body Connection" -- a "fun interactive tool." I kid you not! A healthy mouth can improve your overall health -- it may have something to do with plaque bacteria infecting your arteries in your heart AND in your penis (where it can lead to ED).

This is my half-baked idea, not Pfizer's. Pfizer merely claims "Even if this connection is never fully explained by science, one thing is clear: a healthy mouth and a good oral care routine can only lead to good things." Imagine the good things Viagrine(tm) can lead to!

Wednesday, January 10, 2007

Web 2.0 for Pharma Marketing Podcast

Some readers of this blog may know that I also host a podcast called Pharma Marketing Talk, which is a biweekly online and archived streaming audio "talk radio show" that you can listen to live or download to your iPod (or other portable MP3 player).

Yesterday, the topic was Web 2.0 for Pharma Marketing and my guests were:
  • Dmitriy Kruglyak, Trusted.MD and Publisher of the Medical Blog Network
  • Mark Gleason, HyGro Consulting Group
  • Unity Stoakes, President, OrganizedWisdom
The return on investments for traditional pharma marketing channels -- TV, drug reps, print -- is declining. A new approach to the way forward in pharma marketing is needed. Is it time for the pharmaceutical industry to take the advice of some of its critics and use the new Web 2.0 tools available to it and extricate itself from its moribund situation of declining ROI? This program will feature a discussion with experts in physician and consumer marketing using "social networking' and other Web 2.0 technologies. Also, see "YouPharma(tm): A Brave New World of Marketing?"

You can listen to the archive here:

Tuesday, January 09, 2007

Lincoln Shot Dead! Beaver Sought for Questioning!

It is with great sadness that I reprint the following story from DTC Perplexities Magazine:
Yesterday at about 9:30 A.M., while recording a Rozerem TV drug ad, former president Lincoln was shot by John Wilkes Beaver, the ad's co-star, who suddenly dropped the jump rope used in the filming of the commercial and approached the President from behind.

Lincoln and Beaver on the Rozerem set of the commercial just prior to the shooting.

Siempre, Takeda," shouted Beaver as he leaped off the set, bolted out of the building and onto the streets surrounding Rockefeller Plaza in New York.

Many witnesses came forth who claimed to have seen a rodent scurry down a subway entrance, but these reports could not be confirmed as there are many such rodents in New York.

The motive for the assassination is not established. Friends of JW Beaver, however, told this reporter that Lincoln recently made some comments that did not sit well with his rodent partner (see "Imprecise DTC Benefit Messages").

Friends and relatives of Beaver expressed shock. "He was always the quiet type," remarked W. Woodchuck, a long-time woodland pal of Beaver. "He and Lincoln would sit for hours playing chess. I'd fall asleep just watching them. I guess maybe that's why Rozerem is such a flop."

N. Squirrel, also a long-time friend, suggested that Deep-sea Diver may have been involved. Diver sometimes appeared in the Rozerem commercials along with Lincoln and Beaver, but always mysteriously lurking in the background. "That guy creeped me out," commented Squirrel. "You never saw his face. I think there was kind of triangle thing going on there.Know what I mean?"

Diver could not be reached for comment.

"Despite this great loss," said said Paul Boidy, Takeda's director of neuroscience marketing, "our ad campaign will continue. Obviously, we will employ computer graphics to render Abe and Beaver. We think this will create even more buzz about the commercials."
This story is a fictional account of future events. Only the names are real. The story is inspired by recent Rozerem marketing revelations reported in Brandweek (see "Ads Were a Dream, Sales a Nightmare").

The numbers tell the real story.
Brandweek reports:

" months into the
Rozerem campaign the results are mixed, to put it mildly. The brand is a distant sixth in its category, with a 2.4% share behind two unadvertised generics and the category's titans: Ambien (36.8% for Ambien, 17.5% for Ambien CR) and Lunesta (12.3%), per IMS Health.

Takeda may have spent more on ads than the drug made back in sales: between January and September 2006, Rozerem earned $48.7 million in estimated wholesale revenue, according to IMS Health (that number does not include prescriptions handled by mail). But the company has spent nearly $100 million on ads, per Nielsen Monitor-Plus."

I hate to say "I told you so!", but I did.

Back in October, I predicted that the
Rozerem DTC campaign was in negative ROI territory (see "Rozerem Ads Innovatively Ineffectual").

I estimated that
Takeda spent $50 million to make an additional $19 million in sales for the period from March through August 2006. This is a loss of $31 million over 6 months or about negative $5.2 million per month.

Compare that with the figures in the
Brandweek article: for the period Jan-Sep 2006 sales were $48.7 and ad spending was $100 million for a loss of $51.3 million over 9 months or negative $5.7 million per month!

Am I good or what? I was incredibly close. Even closer if you deduct baseline sales before the campaign started.

Those numbers are so bad that any sane person would expect
Takeda to fire their ad agency -- is it Cramer-Krasselt of Chicago or Abelson? But, noooo... Takeda is said to be happy with the results. "Boidy," claims Brandweek, "said he has also ordered up new ads using the same surreal theme as the first round."

This deserves a Lewis Black comedy break:

But here is the
aneurysm-causing thing that really is rattling around in my brain. There is some talk that the culprit was the 1-year self-imposed moratorium on DTC advertising. "Derek Lowe," reports Brandweek, "a drug research scientist who asked that his employer, a major drug company, not be identified, said other drug companies may see Rozerem's example and decide not to accede to the drug industry's voluntary code to wait to run ads until doctors are fully educated about the drug."

I bet this guy Lowe works at
Sepracor, which markets the competing product Lunesta. Speracor is known not to be a big advocate of PhRMA's Guiding Principles for DTC advertising (see "Sepracor Sneaks In Lunesta Reminder Ad").

Takeda's embrace of creativity was not enough to overcome Ambien and Lunesta's leads," reports Brandweek. "Last fall, a rival exec, Jean-Luc Pilon, director of consumer marketing for Ambien at Sanofi-Aventis, reportedly made a presentation at a drug conference that showed Takeda's ads had made virtually no difference in Rozerem's sales."

A little side note for Jim Edwards, Senior Editor of
Brandweek. When you say "reportedly," do you mean reported by me in the previously mention post to this Blog (ie, "Rozerem Ads Innovatively Ineffectual")? Because if that is what you meant, I would appreciate a plug every once in a while. Know what I mean?
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