Monday, June 30, 2008

I Opt-Out of My alli Challenge!

Sorry, but I just cannot bring myself to try alli as I challenged myself to do a few days ago (see "Take alli - I dare you!").

I went to my local CVS and spotted the diet section and alli was there in a very prominent, top-shelf location with lots of pamphlets, neat flip open panels that displayed information about alli ("what is alli?", "how does it work?", "what's the plan?" -- just flip up the panel and find out!) and even a window-shade gizmo that could be pulled down to reveal 6 questions or conditions I should agree to before trying alli.

Plan? Commitment?

What? Am I getting married to this product?

Somehow it made me feel right off the bat that if the pill didn't work, it was my fault for not being committed enough and not following the plan! Sounds like marriage to me!

[Maybe the commitment and plan stuff appeals more to women than to men?]

Then there was the cost of $49.95 for the "starter kit" which was a bulky white box that contained booklets, a portable pill case, and a bottle of 60 pills -- enough for 20 days. I did a quick calculation and learned that I would have to take three pills each day! Like Sally Field, I have enough things to do and don't want to worry about taking all those pills! Just give me one pill I can take every month and let me sit or stand for 30 minutes -- done!

So I realized that the price would be an issue -- nearly $75 per month! -- and compliance also -- remembering to take a pill with each meal (or before or after -- I didn't stick around to find out which) and I also had to remember to bring along the pill case when I eat out.

Of course, I already knew about the oily discharge "treatment effect" and I was willing to accept that challenge. The box suggested, however, that I start a low fat diet BEFORE I started taking alli. Jeez! If I was that committed, I wouldn't need the damn pill!

Then I read the back of the starter kit where it said that alli may interfere with the absorption of vitamins and I should take my multi-vitamin at bedtime. OK, that would require another change in my daily regimen!

Add to all that the comments I received by e-mail from fans who were wishing me luck but expressed concern that I would fail.

What I learned is that alli has a few problems other than its famous "treatment effect" that may be holding back sales.

Marketing Mix of Leading Pharma Advertisers

Thirteen (13) pharmaceutical companies made it into AdAge's 2008 list of 100 National Advertisers. They are:
  1. GlaxoSmithKline
  2. Johnson & Johnson
  3. Pfizer
  4. Schering-Plough Corp.
  5. Wyeth
  6. Bayer
  7. Bristol-Myers Squibb Co.
  8. Eli Lilly & Co.
  9. Merck & Co.
  10. AstraZeneca
  11. Novartis
  12. Boehringer Ingelheim
  13. Sanofi-Aventis
The list is based on "measured media" spending across 19 media and includes estimates of "unmeasured media," which includes direct marketing, product placement, and most notably, paid Internet search, which some analysts estimate is about 40% of the ***total ad spend** [CORRECTION: **total Internet ad spend**] of companies in general.

New to the list this year is Boehringer Ingelheim, which markets Mirapex for Restless Leg Syndrome in competition with GSK's Requip.

The total spend for these 13 pharma companies in 2007 was $6,998,700,000 measured vs. and estimated $6,834,600,000 unmeasured. That represents 13.1% of the total spending in 2007 of the entire group. NOTE: Not all of this represents direct-to-consumer (DTC) advertising. Magazines, for example, include B-2-B publications (ie, medical journals focused on physicians).

I plotted the media mix for pharma advertisers vs. non-pharma companies in the list and came up with this (click on the image for a larger view):

Based on these data, the top spending pharma companies have a media mix distinctly different from the top non-pharma companies. Pharma devotes a greater slice of its advertising pie to TV and magazines than do non-pharma companies. In fact, 92% of pharma's budget is devoted to these two categories of media! That leaves scant dollars for other media.

It makes sense that pharma would not spend as large a portion of its ad budget on newspapers, radio, and outdoor venues. These media focus on local markets rather than mass markets and pharma has little need to tailor their messages to local markets (although some drug categories may benefit from more exposure in communities with disproportionate medical problems, such as diabetes in African-American neighborhoods).

Why Pharma Lags in Internet Advertising
But it is surprising that pharmaceutical companies -- at least the 13 in this group of top spenders -- devotes only 3.1% of their ad budgets on the Internet whereas non-pharmaceutical companies devote 7.3% of their budgets to the Internet.

Why is this?

I believe that most pharmaceutical marketers have a mass-market mentality and do not view the Internet as a mass market medium. Every defense I've heard from these marketers for why they are not spending much on the Internet includes the phrase "lack of reach" in comparison to TV and magazines. True enough.

Also, the Internet is not nearly as motivating as TV in getting consumers to visit their doctors and ask for a specific brand of drug, which is the goal of all direct-to-consumer pharmaceutical advertising.

Not until the Internet, in the minds of pharmaceutical marketers, becomes more like TV, will the needle move on pharma Internet-based DTC advertising.

Rich Media Can Change Pharma's Mind About the Internet
But guess what! The Internet is becoming much more like TV because of Rich Media, which includes streaming audio video (eg, podcasts), animations and other programs that engage viewers like TV does, but also allows them to interact with the advertisement in ways that are not possible with TV.

More and more, I have seen pharmaceutical Web sites that embed videos of their latest TV ads. Some have even solicited consumer-generated videos for submission to YouTube.

I've been experimenting myself with rich media -- see "Blogs are Done! What’s Next for Pharma Marketing?". My most recent endeavor in this area is what I call a Vendor Video Showcase that I introduced at my June 4, 2008 Networking Dinner Reception.

For some time I have maintained an online directory of pharmaceutical vendors, solution providers, and consultants over at the Pharma Marketing Network portal (see www.vendors.pharma-mkting.com).

Up until now it was your typical static, Yellow pages type listing with text, maybe a graphical logo and links to the advertiser's Web site. The text included a short 150-250 word "pitch" for why pharmaceutical companies should hire the company in the listing.

Very standard stuff. Not terribly engaging and it doesn't give you a feel for the people who run the company. The Vendor Video Showcase is a new and exciting promotional option for the directory that helps overcome this limitation. It features an embedded video "sales pitch" included in the listing in which a company representative -- the CEO is best -- makes a 1-minute presentation about the company and what it has to offer. To see this in action, please visit the Consultants, Management/Strategy page of the directory and listen to Jan Heybroek, President of The Arcas Group. Jan's video pitch was recorded live at the networking dinner.

Aside from the video embedded in the listing, what's neat about this is that the video is also posted to my YouTube Channel where people -- eg, current and former clients of The Arcas Group -- can post comments (eg, testimonials) and rate the video. Just like pharma companies, however, advertisers may consider these "social media" aspects a double-edged sword. There is always the option to turn these functions off or to moderate comments before publishing them. The other advantage of housing the videos on YouTube is that they can be found by a Google search, which adds to the utility.

Pharma Marketing Network’s Vendor Video Showcase is the first online pharmaceutical marketing directory to offer rich media options. To learn more about this service, download the Vendor Video Showcase Fact Sheet (pdf file).

Friday, June 27, 2008

Battered Woman Imagery in Pfizer's New Fibromyalgia Ad

Pfizer has recently upped the stakes in its campaign to depict fibromyalgia as a "real" medical condition.

In an non-branded "disease awareness" TV ad that I saw last night, this point was hammered home by images of a woman showing black and blue bruises over her body. She says something like "Maybe if people saw me this way, they will believe that fibromyalgia is a real medical condition."

What I saw were disturbing images reminiscent of battered woman syndrome. The whole thing smacked of desperation on Pfizer's part to sell more drugs and represents DTC advertising sinking to a new low in exploiting women's fears!

I was not able to capture an image of the woman from my TV, so I am using the image above left that I found at the Medical Advocates/Battered Women web site. It accurately conveys the message that Pfizer put on the screen. (If you can get an actual screen shot of the ad, please send it to me at johnmack@virsci.com).

The ad urges viewers to visit the FibroCenter Web site where they can find information about a treatment option; ie, Lyrica, Pfizer's drug approved for the treatment of fibromyalgia.

Perhaps Pfizer is getting desperate to sell more Lyrica in the face of criticisms that fibromyalgia is not a real medical condition. The cartoon on the right from the Dry Bones Blog is a case in point.

Adverse Event Reporting Be Damned! Tell Us Your Story!

Meanwhile, if you visit the FibroCenter Web site you may be surprised to find that Pfizer is soliciting stories from patients (note: the same form can be accessed from the Lyrica.com site):

"Are you living with fibromyalgia? Would you be willing to share your story with others, so that they may learn from your experience? If so, please answer a few short questions to get started ..." (see here).

There are several multiple choice questions, but what shocks me is the box for an open-ended response with the instruction: "Please use this space to share your story about living with fibromyalgia. Please limit your story to 3000 characters or less. (Approximately 500 words.)"

WOW!

What an opportunity to collect ADVERSE EVENTS, which Pfizer must then submit to the FDA. I always thought -- and pharma people have always said -- that one of the reasons the industry is shunning Web 2.0 social network sites is the possibility that they would then have to report a slew of adverse events to the FDA. And who wants that? But here is Pfizer doing just that! If nothing else, this can be used as a case study to counteract the main argument pharma has used against social media engagement.

Pfizer also collects personal information that will uniquely identify people who "tell their stories": "In case it is selected for publishing on the site, we will need to collect your name, city, state, phone number, as well as your e-mail address so that we may notify you. By submitting your information, you agree that it will be governed by the Consent and Release statement below."

The consent form also admits that Pfizer is collecting personal medical information: "I grant my consent to use my name, biographical data and relevant medical history by Pfizer Inc in any Permitted Use identified below."

Pfizer, of course, hopes to collect contact information about patients so they can send them information about LYRICA (it says it will do that in the consent form). But it may be collecting more than it bargained for.

For example, Pfizer may collect stories such as the following, which I found in one of the first comments to the Dry Bones blog post I cited above:
"Having put up with Fibro since I was 25 (18 years ago)- I can tell you it exists. I loved the toon! I won't be taking Lyrica though, I keep it under control through weight control, light exercise and relying on G-d, "for man shall not live by bread alone, but by every word that proceeds from His mouth."
OK, "G_d" may not be Lyrica's #1 competitor, but life style changes may be. However, you won't find THAT option in the main menu at the FibroCenter Web site -- "A Community of Education, Support and Understanding for People With Fibromyalgia." You'll have to dig deeper.

Friday, June 20, 2008

Take alli - I dare you!

Much has been said about alli's "treatment effect" -- ie, anal leakage and brown pants. Although Wall Street analysts don't attribute alli's lackluster sales to this problem, many bloggers and other critics do.

Insider -- the blogger over at PharmaGossip -- had this to say in a comment to yesterday's post:

"It's hard to gild a turd!"

[Perhaps "Gee Dubya's TURD POLISH" shown on left may help? Kudos to theBlatantTruth for this image.]

"No big deal" is what I hear from the folks at alliConnect Blog. Just bring brown pants with you if you go out. That statement from the FORMER Vice President of Weight Control for GlaxoSmithKline Consumer Healthcare, although Web 2.0 compliant, may have cost him his job.

The alli Dare!
I am a believer in first-hand experience -- especially if I am to criticize something. Therefore, I am taking the "alli Dare"SM. I will go out and spend good money on an alli starter kit and see if I need those brown pants. I dare any other alli critic to do the same!

However, I will wait until I return from my 4-day trip to London -- better to be safe than sorry!

Thursday, June 19, 2008

The alli lesson: Pharma marketing is not ready for transparency

According to the alliConnect Blog:
"In the marketing profession, change is a constant. At alliconnect, we've recently had a change in leadership.

"Founding alliconnect blogger, Steve Burton, recently resigned from his position as Vice President of Weight Control for GlaxoSmithKline Consumer Healthcare. Steve was instrumental to the creation of alliconnect blog and his blog entry on his oops experience is still one of the most visited posts to date."
IMHO, the resignation of Mr. Burton specifically signals the end of the alliConnect Blog -- or at least the transparency it has championed -- and may portend the retreat of pharma marketing away from Web 2.0 principles in general.

The sales of alli have not lived up to expectations and analysts suggest that all this "transparency" about diet and exercise as part of the treatment mix is just too hard for advertising to tackle.
"As a drug that should theoretically trigger huge sales, the preliminary figures are 'pretty underwhelming,' said Steve Brozak, an analyst with WBB Securities. The problem may be that the drug's marketing campaign stresses the need to transform eating and exercise habits for it to be effective, Brozak said. That's not easy to accomplish through advertising, he said." (see "Glaxo: 4M people tried diet drug since launch").
If DTC advertising is going to survive Congressional scrutiny, tackling life style issues has to be part of the message in all DTC ads -- which is one principle espoused by the DTC Guidelines that PhRMA promised some senators it would revise.

Just like America is getting ready to jettison its environmental principles in order to produce more oil, Glaxo is replacing an advocate of Web 2.0 and transparency in advertising in order to increase sales. Ie, good bye to alliConnect!

Speaking of sales, I cannot make the numbers work that were reported in the AP analyst story cited above. Maybe you can help me do the math.

The story says: "At the time of the drug's launch, the company estimated it would eventually sell between 5 million and 6 million kits annually, translating to at least $1.5 billion in annual retail sales."

To generate $1.5 billion in sales from 6 million kits means that each kit must cost $250. Yet the article also says "A 60-capsule kit costs about $50 while a 90-capsule pack costs about $60."

DOES NOT COMPUTE!

What About Marketing ROI?
If 4 million people bought the kit (as the article says) and paid $50 per kit, that adds up to $200 million in sales. GSK may have spent $150 million in advertising alli to achieve these sales. ROI? $1.33. Which is about average for DTC advertising.

Tuesday, June 17, 2008

Life Science Profiles of Color: A Response to Racism in the Life Sciences

Back in October, 2007, Fard Johnmar over at HealthcareVOX blog, went "off topic" to comment on racist "gestures" like nooses hung on trees and doors and the brouhaha over a statement attributed to James Watson, winner of the Nobel Prize as co-discoverer of DNA's molecular structure. See Fard's comments here.

According to Bloomberg.com, Watson was quoted Oct. 14 in the Times of London saying he was "inherently gloomy about the prospect of Africa" because "all our social policies are based on the fact that their intelligence is the same as ours -- whereas all the testing says not really."

Ever since I read Watson's book, The Double Helix, I realized he was a pr*ck! His comment about Africans just confirms it. Let's put racism aside for a moment. May I ask, what do social policies have do with intelligence? I mean, should charity and financial aid go to only intelligent people rather than to anyone in need regardless of their intelligence?

Fard suggests that we should not waste our time condemning these idiots but rather counteract racist beliefs with communication:
"So, I have a simple suggestion for communicators of all colors and creeds. People are quoting the 'science,' IQ tests and SAT scores to suggest that Blacks and Whites are not of equal intelligence. They also rely on anecdotal evidence, saying "look around, you can't help but notice that most Blacks don't take advantage of the opportunities they have in this country." If we want to change these beliefs, we have to replace assumptions with the facts. Show people why they are wrong by citing examples of the quiet, unheralded contributions Blacks are making in business, science, education, law and other areas. Condemnation is good, but saying 'this is wrong' and going back to business as usual two weeks later is criminal."
Fard cites a few names of Blacks that have made unheralded contributions to our society. What I wanted to know was, where are they in the pharmaceutical industry? I know they are there! I've met a few at industry meetings like Digital Pharma and have written at least one story in my newsletter about the work of a Black pharma product manager.

I suggested to Fard that it would be a great idea to seek out Black professionals in the life sciences industry and begin telling their stories. Thus was born the idea for "Life Sciences Profiles of Color" blog.

Fard and I solicited the assistance of Craig DeLarge, Associate Director, eMarketing & Relationship Marketing at Novo Nordisk Inc. Craig is very well connected and volunteers as a mentor to young people interested in a career in the life sciences.

How people of color achieve success in the life sciences and what prepared them to assume positions of power and responsibility in the industry is often an untold story. The "Life Sciences Profiles of Color" (LSPOC) blog aims partially to fill this gap by:
  • Highlighting the achievements and contributions of people of color in the Life Sciences industry, and
  • Encouraging and inspiring young professionals and students who are considering a career in the Life Sciences industry.
Pharma Marketing Talk Live Podcast Today!
Racism in the Life Sciences: What Should be the Response?

Join me today at 2 PM Eastern time for a live, online conversation with Craig and Fard about The Life Science Profiles of Color project and blog. You'll be able to join a live chat session or call in with questions. For more information, see this Pharma Marketing Talk promo page.

If you can't join in live, you can always listen to the audio podcast archive later.

Friday, June 13, 2008

Social Media Marketing Not All It's Cracked Up to Be

This is very difficult for me to admit, but the social media emperor has no clothes and the hope that pharmaceutical companies will ever embrace this new technology to reach out and communicate with consumers and physicians is a pipe dream imagined by over-zealous entrepreneurs.

I have some personal experience and recent news items that back up what I say.

First, this bit of news reported in MM&M: "Revolution Health reduces staff by 50 to 'consolidate synergies'"

As you may know from at least one post to Pharma Marketing Blog, an interview on Pharma Marketing Talk, and an article in Pharma Marketing News, Revolution Health was founded in March 2005 by Steve Case and is a social networking site for consumers and patients.

Case blames pharma's notoriously puny e-Marketing budget for the need to downsize:
"...Case has publicly lamented the pharmaceutical industry's hesitation to embrace interactive marketing and inject a greater share of promotional budget into online initiatives.

'It is astonishing to me how under-invested this industry is in digital media,' Case told delegates at the seventh annual ePharma Summit in Philadelphia in January. 'This is crazy.'"
What's crazy is the idea that social networking sites can make money serving pharmaceutical ads, especially a site like Revolution Health that includes many comments from patients dissing brand name drugs!

But the causes for the failure of social networking sites goes much further than the lack of pharma buy-in.

I've been experimenting with social networking applications for some time. One site is the Pharma Marketing Network Forums to which marketing professionals can post content, engage in discussions, build "buddy lists," rate other posters, create polls, etc. The benefits of submitting content to the site are staggering -- eg, extremely HIGH search engine visibility -- but very few people are participating, even when I register them and set up their basic profiles!

You might say that I have not explained the benefits well enough to my audience. But that's not what I hear when I talk to colleagues. The main issue they cite: NOT ENOUGH TIME.

Given all the things we need to do in a day, WHO HAS THE TIME to post content on a regular basis to social network sites? Not me! I have engaged RSS technology to AUTOMATICALLY post content from other sources. From surveys I am finding that THAT is the most useful feature of my social networking site.

Only losers, malcontents, and bargain hunters have the time to engage in social networking. Is this the audience you want to reach with your ads? I think not!

OK, tell me how WRONG I am! Inquiring minds want to know!

Wednesday, June 11, 2008

Consumers Jazzed by Adverse Events!

As reported by FDA News and Pharmalot, consumers are outpacing physicians in the number of drug adverse events reported to the FDA.

According to the FDA's numbers (here), in 2007, consumers contributed about 174,000 AERs (adverse event reports) to the FDA, whereas physicians submitted exactly 121,000. Consumers have been outpacing physicians in reports submitted since 2004-2005 when the Vioxx withdrawal was big news.

But healthcare providers -- which include pharmacists and "other" healthcare professionals -- continue to submit many more reports than do consumers as the FDA chart below shows:


It's interesting to note that the RATE OF INCREASE in the number of reports submitted by consumers in the years 2004 through 2007 is much higher than that for physicians and other healthcare providers, which is something that Ed Silverman at Pharmalot also points out. See chart below.

If this trend continues, consumers will submit about 241,000 AERs in 2008, whereas all healthcare providers as a group will submit 223,000.

"Why the shift?," asks Silverman. "FDA News speculates that consumers may have greater awareness of safety issues. That seems to be a reasonable assumption, given the headlines over antidepressants and Vioxx in 2004, a trend that continued last year with Avandia and Chantix. However, we would point out that safety issues made headlines, albeit sporadically, in previous years in connection with other drugs."

I would point out that after the 2004 Vioxx withdrawal, FDA made it MUCH easier for consumers to submit AERs on its Medwatch web site. That, no doubt, contributed to the rate of increase in consumer-submitted AERs.

It would be interesting to know how many AERs were submitted by pharmaceutical companies themselves. I assume that number is part of the 60,000 submitted by "other healhcare professionals." If half of those come from pharma, then only 8% of AERs originate with pharmaceutical companies.

I could be wrong about that %, but I am sure it is somewhere in that area -- about 10%. If so, pharma's fear that Web 2.0 marketing would require them to submit more AERs may be unfounded. In a sea of nearly 500,000 total AERs, what's the harm in another 30,000 or so AERs?

Not All AERs are Created Equal
Of course, not all AERs are created equal -- I'm pretty sure consumer-initiated AERs are not nearly as important to the FDA's analysis as are physician-initiated AERs. I'd bet, in fact, that 1 physician AER is worth about 3 consumer AERs. I have no idea how much value FDA places on AERs submitted by pharmaceutical companies. Do you know?

P.S. Consumers really began being jazzed by AE's starting as early as 2003 when the number of AERs submitted by consumers increase by about 60% over the previous year. Since then, the rate of increase has cooled down somewhat (except for 2007 when it shot back up a bit):

2003 vs. 2002: 59.6% increase
2004 vs. 2003: 54.4% increase
2005 vs. 2004: 41.1% increase
2006 vs. 2005: 21.0% increase
2007 vs. 2006: 36.7% increase

Viagra Induces Major-League Wood!

Sorry, I had to create this cartoon image after reading the story over at the Daily Diagnosis Blog (NY Daily News) about athletes using Viagra as a performance enhancer (see "Viagra, the new vitamin").

"Any sport that's primarily an aerobic sport would benefit -- cross-country skiing, cyclists, marathoners, 10K runners, 5K runners," said John Romano, a senior editor of the bodybuilding magazine Muscular Development.

I invite my more creative Pharma BlogosphereTM buddies to come up with Viagra-enhanced athlete images for these other sports.

If only Pfizer could sponsor such a contest on Flickr or on its own Viva Viagra web site! Alas, it is forbidden to do so because that would be promoting an off-label use of Viagra and the FDA would send them a nasty letter -- about 2 months after the contest was over!

But wait! This story in the New York Daily News ("Why Vitamin V is a great workout partner") is the next best thing! What product manager could ask for more?

You'll note that the story does not mention any other erectile dysfunction (ED) drug -- eg, Levitra or Cialis -- by name, even though I would have thought Cialis would be the ED drug of choice for most athletes. You know, for when the "moment is right."

Here's my Cialis scenario for Major-League wood enhancement.
It's the bottom of the ninth and the Yanks are behind 5 to 3. There are 2 outs and 2 men on base. Derek Jetter is up at bat with 2 strikes. If the time was ever right, it's now! Derek glances over at the Yankee wives box. Bingo! Homer!
Why is it that Viagra is always mentioned by name in these kind of stories when we all know that its competitors may be just as effective in such off-label uses? Could it be that Pfizer wines and dines reporters more than its competitors do? I know Pfizer invites reporters to "roundtables." Did Pfizer invite the NY Daily News reporter and/or blogger who wrote the above stories to a nice dinner with Derek or Roger? Inquiring minds want to know!

Friday, June 06, 2008

Chantix "Roundtable" Apparently Not Round and Not a Table

Apparently, Pfizer's much-touted "roundtable" discussion with the media, which was held yesterday at its NYC headquarters, was not really round at all! I say "apparently" because although I was invited, I chose not to attend (more about that below). I say "not really round at all" because of comments like this from the journalists that did attend:

"The meeting, which lasted about 90 minutes, was largely uneventful, in so far as three Pfizer execs sat at a table in front of approximately 30 journalists and analysts," said Ed Silverman of the NJ Star Ledger's Pharmalot (see "The Pfizer Media 'Roundtable' For Chantix").

Ed puts Roundtable in quotes in the title of his post and accurately describes the layout, but does not belabor the point that there was actually no roundtable at all.

The main selling point of Pfizer's "initiative" was the roundtable format. It appears that Pfizer knows how to take reservations for a roundtable, but does not know how to deliver a roundtable. And the delivery of the roundtable is really the most important part of calling for a "roundtable discussion."

If I wanted to sit in an audience in front of a dais of experts and not at a roundtable AMONG them, I could have attended what was once called simply a "press conference!" Not that there's anything wrong about being invited to attend a press conference. But if I had traveled for 2 hours each way from from my home office to and from this event in NYC only to be part of a press conference rather than a roundtable discussion, I would have been mightily pissed off!

Apparently, neither Ed Silverman nor Avery Johnson at the WSJ Health Blog were pissed off -- but they had a much shorter commute. Avery, I am sure, was just a short cab ride away that the WSJ paid for anyway! Maybe that's why his post was titled "Pfizer Clears Air at Chantix Roundtable" -- and he didn't even put Roundtable in quotes!

I guess the closer you are geographically to your news source, the more sympathetic you are to their side of the story! After all, Jeff Kindler is only a short cab ride away from the Wall Street Journal offices (or did those offices also move to Hoboken with the rest of Wall Street?).

Apparently I was missed!
I do want to thank Pfizer, however, for inviting me inside their tent, roundtable or not. I did email Pfizer to say that I regretted not being able to attend. I didn't get a reply to that e-mail, but Ray Kerins, Vice President, Global Media Relations at Pfizer, submitted this comment to my blog post entitled "Pfizer Invites This Blogger to Chantix Media Roundtable Discussion":
"Based on the poem that you posted last week [here], we know that you were anxious to attend our media roundtable today. We’re sorry that you couldn't make it. Would be happy to set up some time with you to speak with some of our medical and safety folks to address your questions."
Thanks, Ray. I'm sorry I couldn't make it also, but not so sorry if you really had a roundtable discussion (did I mention that I expected a roundtable?). [I was completely wiped out after my Wednesday night Networking Dinner Meeting in Princeton, NJ. Which was a great success by the way!]

But let's put the roundness of the table aside. The important point is to have a "discussion" and your comment is a start. And I WOULD like to speak with some of your medical and safety folks. Here are the points I wish to discuss:
  1. Will the current perceived safety problems of Chantix require some kind of innovative DTC advertising like that for Celebrex? [Sorry I missed that part of your presentation in front of reporters yesterday.]

  2. What about some form of new media interaction with patients such as a Chantix Blog similar to the alli blog? Is it time for Pfizer to engage patients in that kind of transparent discussion of the risks vs. benefits? I have said before (see "Chantix: Opportunity for Social Marketing Lost?") that smoking cessation support is a perfect application for Web 2.0 (aka, social networking) technology like blogs. Who knows? If Pfizer had such a blog from the start it may have been able to more quickly and effectively address this issue with patients and physicians and head off the bad press -- not the good WSJ press -- at the pass!

  3. Is Pfizer planning any post-marketing surveillance studies to investigate the Chantix/suicide link?

  4. When does Pfizer expect the FDA to finish their review of AERs?

  5. Is Pfizer planning to look at databases (such as GPRD in the UK) to further investigate these side effects?
It appears from the reports on WSJ Blog and Pharmalot that the answer to questions #3 and #5 are "No": "Pfizer cautions that real-world, post-market reports aren’t the gold standard of clinical research and shouldn’t be interpreted as such." (WSJ Health Blog). Why then, does the FDA encourage and often require these studies, especially in return for quick approval of new drugs or indications?

I look forward to a personal "discussion" of these issues with the Pfizer "folks." Thanks in advance.

P.S. I will be taking a few days off "down the shore" and won't have much Internet/email access until Tuesday or Wednesday next week.

Wednesday, June 04, 2008

Bad News About "Good" Cholesterol Adds to Need for DTC Education

"'Good' cholesterol that scientists have thought helped unclog arteries had no effect on heart disease in a study, casting doubt on a theory drugmakers have spent more than $1 billion pursuing," says an article on Bloomberg.com (see "Why Pfizer Flopped: Good Cholesterol, not so good, says study").

Add this to results from the Vytorin/Zetia study that failed to prove that lowering 'bad' cholesterol does not seem to lessen buildup of plaque on arteries and you seem to have a "perfect storm" that may eventually sink the whole anti-cholesterol drug market!

Maybe I am not a good focus group of one, but in response to all this bad news about the failings of statins and other cholesterol-lowering drugs, I have done the following:
  1. Stopped taking my cholesterol drugs (Pravachol and Zetia) and focused instead on OTC products like Omega-III fish oil, niacin, and red yeast rice (which I also recently stopped because I suspect it gave me "geographic tongue!"), and

  2. I've had discussions with friends and relatives who are obsessed with their cholesterol numbers -- are they focusing on numbers rather than true cardiovascular health?
If millions of other people like me out there are undergoing the same kind of soul searching questioning of conventional pharma wisdom -- yes, I know, an obvious oxymoron -- then there is trouble ahead for many pharmaceutical companies like Pfizer who are investing a lot into getting those cholesterol numbers down, but no so much on improving real outcomes.

At the least, it seems obvious to me that anti-cholesterol drug marketers can no longer focus exclusively on cholesterol numbers as Pfizer once did in those classic Lipitor commercials showing a skier with LDL ("bad cholesterol") numbers on his back!

Crestor marketers have already taken a different approach (see, for example, "Crestor Print Ad Touts Plaque Buildup Advantage"), which they may have been more motivated to do in order to capitalize on Vytorin's misfortunes than to actually educate consumers (see "Exciting News: FDA approves new use for CRESTOR"). I'm still waiting, however, for that 150-second Vytorin commercial (see "Make Way for the 150-Second Vytorin TV Ad").

BTW, when I stopped taking my Rx medications, my cholesterol level has shot up, which prompted me to go back on pravastatin, the generic form of Pravachol. It seems that even I cannot ignore the power of numbers, albeit numbers that may have no relationship to outcomes!

P.S. Something else that my experience may presage: a trend to a more rapid switch to generics, which was already happening as a result of the Vytorin flap. It's a good compromise: If I am uncertain about the benefit of a drug, but I can't ignore numbers, then why pay more than I should to lower those numbers? I'll take the generic, thank you!

Monday, June 02, 2008

Evista: "Nobody is pointing a gun at us" says breast cancer advocate with ties to Lilly

According to an IndyStar.com article, the new Evista ads "are raising a new round of criticism from some women's health groups" (see "A new pitch for an old pill"). Lilly markets Evista.

The issue is whether or not Evista's breast cancer prevention benefit is worth the risk.

"Evista," says the article, "has been shown to raise the risk of blood clots and fatal strokes. In one clinical trial of 10,000 patients with coronary problems and other health issues, women who took Evista had a 49 percent higher risk of dying if they suffered a stroke than those who took a placebo.

"The drug's packaging insert even carries a black-box warning about those risks -- the strongest warning required by the Food and Drug Administration."

The article seems to be a "fair and balanced" critique and quotes a few different breast-cancer advocacy groups, some critical (eg, "This is not the approach we should be taking," said Brenda Salgado, program manager of Breast Cancer Awareness in San Francisco. "We believe that any pill powerful enough to lower the incidence of breast cancer will most certainly cause other health problems and diseases. Why should we substitute one problem for another?") and some supportive of Evista (eg, "Our hopes are really high for finding a way to prevent breast cancer long before the cancer forms," said Connie Rufenbarger, a breast-cancer survivor from Warsaw, Ind., who runs the Catherine Peachey Fund, a nonprofit aimed at supporting cancer research and prevention.)

In fact, Rufenbarger goes so far as to say: "As far as risks, all drugs have risks," Rufenbarger said. "Nobody is pointing a gun at us and saying we have to take these drugs."

To me, this sounded suspiciously like a statement PhRMA might make and I decided to learn more about the Catherine Peachey Fund. What I learned was that the fund received funding from Lilly!

It wasn't hard to find that little piece of information that was NOT mentioned in the IndyStar article. A link to a relevant press release was the #1 search result on Google! Talk about media standards, ethics, fact-checking and all that other high-brow stuff that distinguishes a true media reporter from a lowly blogger!

Here's the relevant bit from the press release:
"The Catherine Peachey Fund primarily has been a grassroots effort by women and men touched by breast cancer," said Mrs. Rufenbarger. "The establishment of the Catherine Peachey Breast Cancer Prevention Program moves that effort to a new level, which would not have happened nearly as quickly without a generous donation of matching funds from Eli Lilly and Company."

"Maintaining breast health is of utmost importance," said Cathy Sampier, manager of patient advocacy for Lilly Oncology’s U.S. affiliate. "We are pleased that our contribution to the Catherine Peachey Fund will ensure that Cathy’s efforts on behalf of breast cancer will continue to be honored and make a difference in people’s lives."
That press release was dated January 8, 2002, about 2 years BEFORE Lilly "paid a $36 million fine to the government for claiming to doctors and consumers that Evista treats breast cancer before it got FDA approval to do so."

Seems that the patient advocacy group at Lilly forgot to educate the sales people that while it is OK for Lilly to pay advocacy groups to tout the breast cancer benefits of Evista prior to FDA approval, it is NOT OK for sales and marketing to promote that use until AFTER the FDA approves it! Duh!

Another little quirk to this Evista story: Usually, when a drug has a black box warning it is the kiss of death for DTC (direct to consumer) advertising of that drug. But since the new Evista ads talk about breast cancer and NOT osteoporosis, I guess it's OK to run DTC ads -- no need to mention the black box stuff!
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