What was hot in 2006 for readers of Pharma Marketing Blog? To determine this, I looked at the posts that received the most page views or that generated the most comments from readers and came up with the following review of 2006 highlights.
Failure, Fops, and Pfizer
By far, readers seemed most interested in catastrophic failures of the high and mighty, whether it be the fall of high-profile CEOs (eg, "Another Pharma CEO Bites the Dust!") or highly-anticipated blockbusters (eg, "Pfizer's torcetrapib: Who Knew What, When?" and "torcetrapib: "$800 Million" Failure but Kindler Safe").
Speaking of the high and mighty, readers were VERY interested in "Marketing Executive Salaries."
Pfizer, being the highest of the high and the mightiest of the mighty, is always a good subject for blogging and polling. When I wrote about torcetrapib's failure, it generated quite a bit of discussion on the online Pharma Marketing Discussion Board, where at least one person characterized Pfizer as being arrogant. I wondered how many other people shared this view, so I ran a poll (see "Is Pfizer Arrogant and Superior?") and came up with this:
I suppose Pfizer can live with that.
The post about Dr. Robert Jarvik, inventor of the Jarvik artificial heart and Lipitor "celebrity" spokesperson ("Lipitor's Jarvik: Fop or Flop?"), was inspired by the purple tie he wore in some commercials. I learned that his claim as the inventor of the artificial heart is contested and some readers felt I was being too glib and even "snarky." To see if other readers agreed, I did a poll (see "Snark Meter") and asked readers their opinion. The results are shown below:
I can live with that!
"Disease Mongering" was a topic that frequently came up in 2006. The first time was the post "Disease Awareness or Disease Mongering?", which appeared in April. The post "Pharma Tail Wags Patient Dogs", which was the third most viewed page in June, discussed pharmaceutical company support of patient advocacy organizations that failed to disclose this support. The dog wags the tail, however, when these organizations are created de novo by pharmaceutical marketers, which certainly has to be the case with the Restless Leg Syndrome Foundation (for more on that, see "Restless Pharma Marketing"). It's all part and parcel of what critics call "disease mongering." You can hear a Pharma Marketing Talk podcast on this subject here.
Dis Lincoln, Show Beaver
Insomnia posts were only second to erectile dysfunction posts in the number of page views received. Certainly, this topic received the most comments from readers. Back in September, 2005, I predicted that insomnia would be a hot pharma marketing topic (see "Insomnia - the Next DTC Frontier") and I wasn't disappointed. The high point (or low point, depending on your point of view) came in July, 2006, when I posted a critique of the Rozerem ad campaign (see "Rozerem Ads Dis Lincoln, Show Beaver"), which has generated at least 52 comments -- the most for any subject. This post is now a classic and still top-rated in a Google search for "rozerem ad" or "rozerem commercial."
2006 was the year when pharmaceutical marketers were blitzed by agencies selling them on the merits of Web 2.0, social networking and engaging the consumer/patient. I've written quite a number of posts on topics related to this. In "Question Everything," I question the authenticity of the participants of an online bulletin board sponsored by a pharmaceutical company. This issue -- authentic response by consumers vs. "sock-puppet" marketing (or marketers disguised as consumers) -- comes up often in the comments made to this blog. For example, a comment to a Rozerem ad critique was supposedly written by a "typical woman" who viewed an Abe Lincloln/Beaver Rozerem TV ad and decided right then and there to switch to Rozerem from Ambien. Yeah, and I have a bridge in Brooklyn to sell you! Of course, no one was fooled as the results of a poll showed:
Web 2.0 and the advent of social network marketing is the new wild, wild west of Internet advertising. Isn't it time for the FDA to get its head out of whatever hole it is in and issue some guidance on acceptable pharmaceutical Internet marketing practices? Better yet, the industry should take some steps to define its own guidelines to stave off overly-restrictive FDA guidance based on insufficient knowledge of the technology (for more on this, see "Where's DDMAC's Head At?").
BTW, I had some first-hand dealing with pharmaceutical consumer relations that received a few comments from readers who were not all surprised (see "The Call Center from Hell").
The Adventures of PhRMA Intern
The antics of the Pharmaceutical Research and Manufacturers Association (PhRMA) often came under scrutiny on this blog. This year, the Adventures of PhRMA Intern debuted and delighted many readers. PhRMA Intern has been characterized as a "Strange visitor from an Ivy League school who came to PhRMA with powers and ability far beyond those of Ken Johnson. PhRMA Intern! Who can change the course of mighty news stories, bend the truth at will, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great pharmaceutical trade association, fights a never ending battle for believability, justice for pharmaceutical companies, and the PhRMA way!"
PhRMA Intern's first assignment was to respond to complaints PhRMA received regarding violations of its voluntary guidelines on DTC advertising (see "Adventures of PhRMA Intern!"). From there, she moved on to tackling terrorists on the issue of drug reimportation ("PhRMA Intern Tackles Terrorists") and then to PR agencies ("PhRMA Intern vs. the Pharma PR Agency") on the issue of whether or not "PR marketing" should follow PhRMA's DTC guidelines. She met her match, however, fighting Allergan -- the "we don't need no stinking guidelines" company (see "PhRMA Intern vs. BOTOX!").
I have no doubt that PhRMA Intern may be reincarnated in a new internship -- perhaps at a pharmaceutical company or even at the FDA. Stay tuned!
Breaking the Rules
Speaking of not needing stinking guidelines, there was plenty of opportunity this year to criticize companies that violated their own pledges to abide by PhRMA's DTC Guidelines (see, for example, "Sepracor Sneaks In Lunesta Reminder Ad") or even run Internet ads that violate FDA regulations. For an example of the latter, see "Lunesta, Google, and bAdWords", which broached the topic of violative Google Adwords, which mention the brand name and indication but do not include side effect information or brief summary or any direct link to this information. It turns out that Google may be encouraging pharmaceutical marketers to use these types of ads. I pointed this out in a provocative -- some might even say "snarky" -- post entitled "The Girl from Google." I received a lot of flack in comments to that post, but at least 79% of readers agreed with me that these ads violate FDA regulations (see chart below):
These results are pretty one-sided! It prompted me to submit an official complaint to the FDA. I haven't heard back from that agency yet. Perhaps they are waiting for a summer intern to respond. While we're waiting, enjoy the following video:
Requiem for Pharmaceutical Sales Reps
"Industry PR & Rep Morale" reviewed a survey that showed that the vast majority (85%) of pharmaceutical sales reps believed that public opinion of the industry has decreased. At the time, I thought that getting reps involved in improving public opinion by engaging in public appearances and whatnot was a good move by the industry. I didn't think it would improve the public image of the industry (see "Sales Reps Make Poor Spokespeople"), but I thought the activity would boost rep morale and improve sales force efficiency. The industry, however, has a better, quicker way to improve efficiency -- less reps!
I could go on, but I think this is a pretty good sampling of what was of interest to readers of this blog in 2006. I have every reason to believe that 2007 will be as interesting with lots of issues to discuss.
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Happy New Year!
I wish everyone a happy, prosperous, and productive New Year. Let's just try to keep the bullshit to a minimum, OK?
Thursday, December 28, 2006
What was hot in 2006 for readers of Pharma Marketing Blog? To determine this, I looked at the posts that received the most page views or that generated the most comments from readers and came up with the following review of 2006 highlights.
Wednesday, December 27, 2006
Regular readers of this blog know how often I have berated Sepracor about its Lunesta ad campaign tactics. Over the months I have made many criticisms of Sepracor's marketing efforts:
- Sepracor's reminder Lunesta ads violate PhRMA DTC Guidelines, to which Sepracor is a signatory (see "Sepracor Sneaks In Lunesta Reminder Ad")
- Worse, Lunesta online advertising violates FDA regulations (see "Lunesta, Google, and bAdWords")
- Despite $200 million or more per year spent on the ad campaign, Lunetsa sales were sleepy (see "Lunesta, a Sleeping Dog")
The article continues: "In a note to investors just before Christmas, Merrill Lynch's Gregg Gilbert wrote that Lunesta's marketing, advertising and promotional materials will be changed early in the new year to reflect positive results from studies of the drug in people with depression, anxiety and menopause. No further details on the campaign were given."
Not only will the ads change, but the Speracor marketing department is also in flux, according to BrandWeek: "...there has been a change in leadership in Sepracor's marketing department. Marketing chief Timothy Healey left the Marlborough, Mass., company recently to take a post at Advanced Magnetics in Cambridge, Mass."
I don't know if that's a step up or down, but Mr. Healey may miss out on a great opportunity; namely, a buyout of Speracor by Pfizer. At least that's the rumor. No replacement for Healey has been named, according to BrandWeek.
The anticipated changes of the Lunesta ad message, in which insomnia is related to serious and prevasive medical conditions like depression and menopause, parallels a similar shift in ads for erectile dysfuntion, which link that condition to the more serious medical problems of diabetes and high blood pressure.
I haven't looked at the data supporting the incidence of insomnia among depressed people and women in menopause, but I suspect the shift is being made primarily because the old message -- you're too worried about your work -- has not worked. At least not well enough to distinguish Lunesta from the market leader Ambien and AmbienCR, which together still command 53% of the insomnia market vs. Lunesta's 13%.
The Numbers Don't Add UpIf Lunesta is changing its advertising to help it surpass the 13% market share number, then Rozerem surely should follow suit to break through its pitiful 2-3% market share barrier. I am waiting for that other shoe to drop.
BTW, I got these market share numbers from BrandWeek, which appears to have gotten them from Merrill Lynch who got them form... I dunno! If we add up the Ambien and Lunesta market share numbers, we get 66%, which leaves 34% to Rozerem and Sonata, the other drugs in the insomnia category. Sonata must be a minor player, so the bulk of that 34% must represent Rozerem's market share according to these numbers.
But there's something clearly wrong here. As I reported in a previous post to this blog, according to Wolters Kluwer, "from March through August 2006, Rozerem sales grew to $38 million, capturing a 1.9 percent market share" (see "Rozerem Ads Innovatively Ineffectual"). I cannot reconcile 1.9% with 34%. Perhaps readers have better numbers for us.
Update on Insomnia Market Share Data
P.S. Jim Edwards, Senior Editor at BrandWeek was kind enough to send me the following information regarding the market share data for various drugs used to treat insomnia. Jim said:
Here's the text of ML's take on insomnia market share:I used some of this data to create this chart of Market Share based on New Prescriptions (NRx):
Lunesta TRx's were 136,173 for an 11.6% share of the sleep agent market (up
10 b.p. wk/wk). Refills accounted for 43% of TRx. Based on $82 per TRx,
Lunesta end-user sales are annualizing at roughly $580.6 million. Rolling
4-week TRx growth for the market was down 70 b.p. to 10.2%.
Lunesta NRx's were 78,011 for a 12.5% share of the sleep agent market (up 10
b.p. wk/wk). Sanofi's Ambien CR NRx share was up 40 b.p. to 17.3%, Ambien
NRx share was down 10 b.p. to 35.9%, King's Sonata NRx share was up 4 b.p.
to 1.92%, Takeda's Rozerem NRx share was up 1 b.p. to 2.57%, temazepam NRx
share was up 10 b.p. to 10.7%, and trazodone NRx share was down 50 b.p. to
15.3%. Rolling 4-week NRx growth for the market was down 50 b.p. to 5.0%
yr/yr (vs. roughly 7.2%-8.0% prior to Lunesta launch)
Friday, December 22, 2006
CNN Money reports that "After a rough couple of years dealing with patent expirations and the often frustrating hunt for new products, drug industry executives would love nothing better than an oracle to predict what products in their labs will become the big blockbuster drugs over the next few years." (See "Big Pharma's drug wish list for 2007").
I'd like to try a "wisdom of the crowd" experiment and see if readers of this blog may be the oracle sought by the industry. So, here are the contenders for blockbusters and a bit of information about them. You add your own information and then vote on which ones you think will achieve blockbuster ($1 billion or more in yearly sales) status over the next few years.
- Januvia (Merck) - a recently approved "first-in-class" diabetes drug (enhances the body's ability to produce its own insulin).
- Galvus (Novartis) - an experimental diabetes drug, will compete with Januvia
- MK-0524A (Merck) - experimental drug being tested for its ability to increase HDL (similar to Pfizer's ill-fated torcetrapib)
- Arcoxia (Merck) - experimental anti-inflammatory pain killer drug for arthritis. Available outside US, may be approved next year by FDA.
- Acomplia (Sanofi-Aventis) - generally considered an anti-obesity drug. Available overseas, trying to get approved by the FDA in the US.
Tuesday, December 19, 2006
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Never heard of Disease Mongering? Read "Disease Awareness or Disease Mongering?".
Go to the Pharma Marketing Talk Channel Page to listen in.
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. Today's definition includes the accusation that, for example, cardio metabolic syndrome is really a cluster of risk factors for patients with diabetes, hypertension and heart disease. This podcast provides a highly interactive debate incorporating the view points of people from both ends of the spectrum. It also explores the concern that pharma may be loosing credibility with physicians and the general public by "creating" these syndromes.
Some examples of "diseases" that the authors of a PLoS report consider "mongered" include:
Some questions addressed in this podcast include:
The November GAO report on FDA's Oversight of Direct-to-Consumer (DTC) advertising, which I mentioned in yesterday's post (see "Where's DDMAC's Head At?"), includes data from IMS on Rx promotion and R&D spending going back to 1995 (see table; click on it to see the larger, more readable version).
The GAO report states:
The amount that drug companies spend on DTC advertising increased twice as fast as spending on promotion to physicians or on research and development. IMS Health estimated that, from 1997 through 2005, spending on DTC advertising in the United States increased from $1.1 billion to $4.2 billion -- an average annual increase of almost 20 percent. [See "Total U.S. Promotional Spend by Type, 2005."] In contrast, over the same time period, IMS Health estimated that spending on drug promotion to physicians increased by 9 percent annually. Further, PhRMA reported that spending on the research and development of new drugs increased by about 9 percent annually during the same period. While spending on DTC advertising has grown rapidly, companies continue to spend more on promotion to physicians and on research and development.The DTC estimate includes TV, magazines, newspapers, radio, and outdoor advertising, but not Internet based advertising (for more on that, see "Pharma eMarketing in a Slump"). Physician promotion includes estimated spending on office - and hospital-based promotion to physicians and journal advertising. These estimates do not include other spending, such as drug company spending on meetings and events (eg, CME and advertising at CME events, which could be as much as $1.5 billion), or spending on promotion that targets medical professionals other than physicians, such as nurse practitioners and physicians assistants.
The GAO was careful to point out that more is spent on promotion to physicians than to consumers -- a lot more; 71% more, to be precise ($7.2 vs. 4.2 billion). It emphasized, however, the rate of growth difference; namely, 20 percent average annual growth for DTC spending vs. 9% for DTP (ie, direct-to-physician) spending.
At what point, I thought, would DTC spending surpass DTP spending if those rates of growth continued? I did the calculations and plotted the results and found that, under these assumptions, DTC spending would surpass DTP spending in 20011!
This was interesting, so I looked at the raw data again to see if the 20% vs. 9% numbers were valid assumptions. What I was thinking was that there was practically NO DTC prior to 1997, so any spending would represent a huge percentage increase for years afterward. Maybe it wasn't fair to use the 8-year average of 20% growth. It might be better to look at the last 5 years only, for both DTC and DTP, and redo the calculation.
Today's show airs live! at 1 PM Eastern US time. The topic is Disease Mongering. Click here for details about the show and instructions for tuning in via your computer or downloading the audio archive afterward.
Before I get to that, I'd should mention that I could not verify GAO's numbers exactly. I calculated an average of 19.13% rate of increase in DTC spending from 1997 through 2005 (GAO said it was 20% -- actually, 19.6% rounded up) and an 8.25% average increase for DTP (GAO said 9.0%). Rounded down, my numbers were 19% vs. 8%. Using those numbers adds 1 more year to the estimate of when DTC will surpass DTP. I also do not understand how GAO got a total percentage increase in DTC spending from 1997 through 2005 of 296.4%. When I do the math, it comes out to 281.8%. It makes me nervous -- GAO is supposed to be accountants!
Any hoo, if you look at the percent change in DTC and DTP spending year-vs-year, you find there are wide fluctuations, as shown in the following chart:
For example, DTP spending dropped precipitously in 2005 vs. 2004. Wha happened? I leave that up to you as an exercise.
DTC spending seems to be cyclical - rising and falling with the political tide!
So, who knows what the future holds for DTC and DTP spending? Things are in flux with the new Congress (see "Congress vs. Pharma: Trouble Ahead?"). However, let's use recent rates of increase (2000 through 2005; 11.5% for DTC and 5.4% for DTP) as a basis for predicting when DTC spending might overtake DTP spending and see what we get.
What we get is 2015. That is the year that I predict DTC spending will surpass DTP spending ($12.4 billion vs. $12.2 billion, respectively):
So, what's the point of this exercise? Nothing really, except perhaps that the GAO could have included a chart like the above to emphasize further where DTC may be headed in the not too distant future and what the FDA may be up against trying to keep up with it all.
BTW, using my 11.5% growth rate number for DTC and the 6.0% growth rate that GAO reports for R&D spending, I predict DTC spending will outstrip R&D expenditures in 2045, well after many of us are gone and the whole issue is moot to us!
Monday, December 18, 2006
At the recent Healthcare Blogging Summit (see "Physician Blogging - Survey Results"), an audience member asked the following question:
How is DDMAC likely to regulate pharmaceutical promotion via blogs?
Or, something to that effect.
In the new world of "Web 2.0," pharma marketers need to know where the lines are drawn by FDA. [DDMAC, the Division of Drug Marketing, Advertising, and Communications, is the FDA entity in charge of regulating all promotion and advertising of prescription drugs, including direct-to-patient (DTC) and advertising and physician promotion.]
Since I was on the panel to which this question was directed, I took a stab at answering it.
"The image that comes to my mind," I said, "is an ostrich with its head in a hole in the ground." Actually, I said "big bird," but everyone knew what I meant.
Another audience member agreed, but said he had different hole in mind.
It was an interesting image to end the session with.
The saga of the FDA vs. the Internet goes back at least ten years -- to October 16 & 17, 1996 -- when the FDA hosted its first ever (and maybe last ever) public hearing on the Internet. The purpose of this 2-day gathering was to help FDA evaluate how "the statutory provisions, regulations, and policies concerning advertising and labeling should be applied to product-related information on the Internet and whether any additional regulations, policies, or guidances are needed."
I guess the FDA decided there were no additional "regulations, policies, or guidances" needed because it has been mostly silent on the issue all these many years.
In attendance at that seminal FDA meeting were many of the people directly responsible for creating the "Medical Internet." I participated on the Web Links Panel, which included representatives from the pharmaceutical industry, advertising and marketing industry, medical associations and publishers, patient advocacy groups, other government agencies like the Federal Trade Association (FTC), physicians, web site developers, etc.
All you "newbies," which I define as anyone who began using the Internet for marketing AFTER 2000, should read the minutes of that meeting. You might just learn something!
The FDA, like the industry it regulates, focuses 94% of its attention to broadcast (mostly TV) and print communications, even while these media channels are losing ground to the Internet in terms of reach.
This was made evident to me from data reported in a recent Government Accounting Office (GAO) report to Congress: "Prescription Drugs - Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising." You can access the report here.
In the report, the GAO claims the FDA "lacks an effective way to screen, review and track the more than 10,000 ads and Web sites brought to the agency's attention each year" (see "Group Wants FDA to Review More Drug Ads," NYT, 12/14/2006).
There is some revealing data in the GAO report that illustrates where DDMAC's head is at.
First, the FDA reviews every DTC TV ad it receives, regardless of the merit of the claim against it. The GAO states: "FDA officials told us that they review all final and draft DTC television advertisements that FDA receives because these materials are likely to be widely disseminated to consumers."
While TV does have incredible reach among consumers, so does the Internet. Forgive me for not getting into all the numbers in defense of that statement. Go ask Jack Barrette at Yahoo! for his slide deck. NOTE: Also take a look at today's post to Eye On FDA where you can find links to numbers (see "New Media and YOU").
The FDA should be taking a closer look at drug promotion via the Internet because there seems to be a wild-wild West scenario playing out right now with many companies pushing the envelope and using ad techniques that a majority of experts consider violative of FDA regulations (see, for example, "The Girl From Google" and "Celebrex Joins the bAdWord Bandwagon!").
Take a look at the following chart, which shows the number of final DTC and "consumer-directed" (eg, patient brochures distributed by physicians) materials submitted to the FDA from 1999 through 2005. The data is from the GAO report. I replotted it to better demonstrate the trends.
The red "DTC" line excludes the Internet, which is shown by the blue line. The main trend I think this chart shows is that while there has been an across-the-board increase in all types of materials submitted to the FDA for review, the number of Internet materials is increasing fastest, at least up until 2004.
Obviously, there is a lot of Rx promotion via the Internet and DDMAC should not keep its head in the broadcast/print sand and continue to ignore what's happening in the real world.
In the future, the drug industry will bombard the FDA with lots more TV-based materials for review prior to airing (see "Pay Per DTC Ad View Update"). If the FDA continues to give these priority -- and it will because the industry will pay the FDA to do it! -- then advertising on the Internet will continue to fly under its radar for a long time to come (unless Congress prohibits DTC altogether -- not likely, in my book).
The Case for Self-Regulation
The GAO report also documents that prior to 2002 it took the FDA just 2 weeks on average to issue warning letters about violative Rx promotions, whereas today it takes 4 months. This is due, claims GAO, to the additional resources needed for these letters to pass legal review within FDA. HHS defended the review process because it increases compliance by the drug industry.
"The FDA cannot review every piece of direct-to-consumer advertising. As a result, we must rely in great part on voluntary compliance. [my emphasis] The OCC [Office of Chief Counsel] review has strengthened the quality and legal sustainability of the letters actually issued by the FDA and, by doing so, has paved the way for for enforcement actions with real teeth. That, more than anything else, has encouraged voluntary compliance with our regulations." -- HHS as quoted in GAO reportIf the FDA depends upon voluntary compliance, then it makes sense for the industry to develop its own voluntary guideline for Internet advertising just as it did for broadcast and print. This way, if and when DDMAC gets its head out the ground or wherever else it may be, the industry won't be hit with the "teeth" of enforcement.
[BTW, four months real world time is about 1 year Internet time! That pace of regulation just wouldn't cut it with the Internet.]
That's my opinion and I'm sticking to it!
Thursday, December 14, 2006
Merck is on a roll these days.
For one thing, it's stock price has almost recovered from its low point after Vioxx was withdrawn from the market:
Who among us -- who did NOT cast the first stone -- bought stock in Merck around December, 2004?
What has contributed to this reversal of fortunes?
Was It Victory in Vioxx Litigation?
The Wall Street Journal reports today that Merck "prevailed in the 12th Vioxx trial since the painkiller [Vioxx] was pulled from the market, convincing a New Orleans jury that it shouldn't be held responsible for a heart attack suffered by a man who took the drug." You can download the WSJ Vioxx Trail ScoreCard here, which gives some details of this and other Vioxx cases that have been decided in court.
The WSJ article also mentions that there are some 27,200 trials that Merck vows to fight one by one. At the current rate of 6 trials per year, that could take quite a while (4,533 years to be mathematically precise).
But if you look at it another way -- ie, percent of past trials won (blue), lost (red), or tied (gray) -- and if you believe that future expectation is based on past experience (as many investors seem to do), then it looks rosy for Merck.
Was It the PR?
Soon after the Vioxx debacle, Merck initiated its "Patients Come First" campaign, which I am sure the PR agency will cite as a major contributor to the upswing in Merck's stock. I criticised that campaign back in June, 2005 and questioned its veracity (see "Patients Come First?").
I doubt that positive spin alone would have helped. I was skeptical and I am sure the majority of TV viewers of the ads also were skeptical.
It Was Gardasil, Stupid!
It wasn't the Vioxx Victories or the PR that killed the Merck beast (aka, negative public image), it was Gardasil, Merck's new cervical cancer vaccine.
Although the Gardasil DTC campaign may need improving (see Rich Meyer's criticisms at The World of DTC Marketing blog: "Gardasil launches DTC with little fanfare"), it was effective for me. And I am sure that word of mouth will spread quickly.
For me, the launch of Gardasil sent the message that Merck is a leader in the area of disease prevention, which puts people first. That should have been the PR message -- "people come first" -- not "patients come first." We all want to avoid becoming patients. In any case, Gardasil gave the PR campaign veracity.
In the background for me is the fact that Merck is not shying away from taking on the religious right that above all wants to deny that teenagers have sex. In every Gardasil ad I've seen, there's a young girl and the message is clear: protect her!
It is said that vaccines are not a profitable business for pharmaceutical companies and few are pursuing that area of development (unless they gets oodles of bucks from the Bioshield Boondoggle). Gardasil says that Merck remains a leader in vaccine development, which is another plus in my book.
Redemption or Bumps Ahead?
So, it is possible for a drug company to redeem itself -- even in my eyes. I sincerely hope that years from now we don't discover some problem with Gardasil and that it is shown to be truly effective. There's always a risk, but I am glad Merck took it.
Still, all may not be rosy for Merck ahead. Merck confirmed for the first time yesterday that it is developing a cholesterol drug in the same class as torcetrapib, "the once-promising compound for which Pfizer Inc. halted development earlier this month due to a higher-than-expected death rate in a patient trial. The study's halt raised concerns that other so-called CETP inhibitors in development would have safety problems." (WSJ)
"But the Merck compound, MK-0859, showed no serious cardiovascular problems in an eight-week mid-stage trial, Peter Kim, president of Merck's research arm, told analysts and investors..." (see "Merck Gives Glimpse Of Its Drug Pipeline").I hope that isn't just another spin of the facts designed to pump up investor confidence.
For more on Pfizer's torcetrapib failure, see "Pfizer's torcetrapib: Who Knew What, When?"
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Wednesday, December 13, 2006
Just when I thought it was safe to stop raking Pfizer over the coals about torcetrapib, they go and do something stupid! I'm talking about running a Google Adword program that at least 85% respondents to my poll on the topic (see below) consider in violation of FDA regulations.
In case you haven't seen the previous posts on the topic of Google pharmaceutical "bAdWords," start by looking at "The Girl from Google," which describes the issue when it first arose with Lunesta.
BTW, these are not reproduced actual size here. The real ads have "Leaderboard" dimensions of 728 x 90 pixels, much larger than the typical 468 x 60 "banner" ad. (You can click on the images to see the full-size versions.)
Once again, like the Lunesta bAdword, these ads appear to violate FDA regulations regarding DTC advertising; namely, that whenever an Rx brand name and its indication are mentioned in the same ad, fair balance or the brief summary of the package insert must also be included. Generally, on the Internet, that means a direct link to the package insert. There is no such link in the above ad.
Google AdWords Not Advanced Enough for Online Pharmaceutical AdvertisingWhat do you think? (Ignore this poll if you've taken it before for the Lunesta ad.)
If Pfizer ran a more technically advanced type of ad, such as a "Rich Media" ad, it could include a mouse rollover, for example, that pops open a window containing fair balance information. Unfortunately, this kind of thing isn't possible using inexpensive (but pervasive) Google Adwords, which can contain only one active link. Another limitation of Google AdWords is the inability -- no matter how large the box -- to include more than about 50 characters in the descriptive text block. This is not enough to do a compliant brand ad (unless it were a "reminder ad").
It could be that the Celebrex brand team hired the same online ad agency that was responsible for the Lunesta Adword account. The Pfizer people simply may not know what's going on -- not the best defense, but, if true, there's hope that someone in authority at Pfizer will see this post and put an end to this Google campaign. I note that the Lunesta bAdWords disappeared soon after I outed them in this blog. Hopefully, Pfizer will do the same.
Pulling the Celebrex bAdWord may send a message to Google, which must share some of the blame. After all, the "Girl form Google" gave a presentation at a major industry conference and used this type of AdWord as an example of how pharmaceutical companies should advertise with Google.
Google Says: "We're Not in That Business"
My good personal friend, Harry Sweeney, who is also a friend of the pharmaceutical industry and often disagrees with my position on many pharmaceutical issues, agrees with me on this. Here's what he said about Google's promulgation of bAdWords in a recent article he wrote for Pharma Marketing News:
I felt sorry for one presenter from a major search engine company who brightly demonstrated how all of the online services might be supported by pharmaceutical advertising, using a patently violative, illegal, online ad to do it. When she was questioned about the legality and potential risks for advertisers from the audience, her naivete spilled over when she replied "That's for individual companies to figure out. We're not in that business." Or words to that effect. -- see "Pharma's Plodding Approach to eMarketing."Harry was referring to the Google presentation I mentioned above and in my GfG post. Clearly, Google is aiding and abetting as the actors in Law & Order might say.
What Could Pfizer Do?
Here's what I think Pfizer could do:
- find out who's responsible for this ad campaign and put a stop to it;
- lead the way in developing guidelines for online DTC advertising that not only are consistent with FDA laws, regulations and guidelines, but that allows for effective use of the Internet's unique features. One such guideline could be: In all ads that mention a brand name and its approved indication, provide at least a one-click method by which the viewer can access side effect information and/or brief summary; and
- communicate these guidelines to the agencies that handle Pfizer's online ad accounts.
Tuesday, December 12, 2006
Yesterday, I participated in a panel discussion at the first Healthcare Blogging Summit, which was co-located with the larger Consumer Health World conference in Washington, DC. The summit was organized by Dmitriy Kruglyak, CEO of Trusted.MD, a social network formerly known as The Medical Blog Network (TMBN).
The main focus of the larger Consumer Health World conference was "consumer-directed healthcare" (CDH) and fellow-traveling disciplines such as wellness, spas, alternative medicine, etc. Many attendees were from the managed care industry and despite the hype of CDH as the "next new thing," much of the movement towards CDH is happening within managed care organizations.Anyway, back to the Healthcare Blogging Summit. I hope Dmitriy invites me to the next summit, which is scheduled for April, 2007 at the Las Vegas Venetian Hotel! I think I can make a good case for getting an invite, especially after Fard Johnmar -- another panel member and blogger over at Envisioning 2.0 --– voted me one of the three best healthcare bloggeres! (It's good to be #3!)
There is intense interest in CDH on the pharma side, and rightly so. Some of the seamy side of CDH involves alternative, holistic medicine, which means it's anti-pharmaceutical. Yet, major CDH proponents are huge payers -- health plans and employers -- that pharma needs to court.
I have a feeling that as CDH programs are rolled out, more and more charlatans will come out of the woodwork to vie for consumers' HSA funds and the money that plans will give them for "wellness" and other prevention programs as enticements.
at the start of the panel. Physicians comprised the largest segment of responders to the survey. “This is not surprising,” says With regard to healthcare blogging, Fard should know what he's talking about. He and Dmitriy conducted a survey of over 200 healthcare bloggers, the results of which were summarized by FardFard, “physicians really started the healthcare blogosphere.”
Some other top-level results of the survey, which you can access here, are the following:
- 47% of respondents spend between one and two hours a day maintaining their blogs.
For physicians to spend that amount of time each day writing blogs is truly amazing.
Another key finding:
- Respondents are split on whether running advertising negatively impacts a blogger’s credibility. However, 54% say they are willing to continue or begin featuring advertising on their blogs.
But another healthcare blogging statistic may put a damper on pharmaceutical interest:
- About 40% of those surveyed hide their identity while blogging in order to protect themselves from recriminations
To download a free copy of the survey report, please go to: www.envisionsolutionsnow.com/survey.html
Sunday, December 10, 2006
Last week I questioned the $800 million quoted in the press and other blogs as the cost of Pfizer's torcetrapib failure (see torcetrapib: "$800 Million" Failure but Kindler Safe). I doubted this was the real cost and suggested that Pfizer was just quoting the results of a 2001 study by the Tufts Center for the Study of Drug Development.
Mostly, I was upset that journalists would just accept this number at face value as the actual loss due to torcetrapib's failure. I suggested that this was an "estimate" that the industry trots out whenever it wants to argue how expensive it is to develop new drugs.
In my post, I mentioned that the Tufts' estimate was disputed because of the inclusion of "opportunity cost of capital" in the calculation. Apparently, I misunderstood the economics, because the lead author of the study, Joseph A. DiMasi, PhD, Tufts CSDD Director of Economic Analysis, submitted the following tough, no holds barred, comment to this blog in defense of the estimate:
I don't read your blog, so I don't know all that you may have written about R&D costs, but someone forwarded this particular blog entry to me. I won't comment about torcetrapib because I don't know (nor do you) what their actual or projected costs were or what they included (i.e., discovery costs, preclinical development, chemistry, manufacturing and controls R&D throughout the process, all clinical trials for all indications, infrastructure costs for an ongoing concern, interaction with regulatory authorities and preparation of regulatory submissions, etc.). I doubt, given in particular statements that I recall from Pfizer people about what they think average costs are for a more recent period than we analyzed, that they simply took $800 million from our (Tufts) study (which included the costs of failures and what may be called time or financing costs).My main takeaway from Dr. DiMasi's comment is that he's trying to scam me out of $50,000! Of course, I refused his offer ("Too bad," he said, "I was hoping you would take me up on my offer.") .
I will, however, correct you on what you have written in this blog entry about our study and its methodology. For your information, PhRMA did not, as you wrote, sponsor the study (nor, for that matter, did pharma). You write that the study is disputed. That's true, but, as far as I can see, the ultimate sources of that criticism are those with obvious political agendas and who lack appropriate expertise. I have never seen a criticism of the methodology from a bona fide economist. The paper and its predecessor were published in the most methodologically rigorous journal in the field of health economics. Anonymous referees and the editors of the journal, who are among world's leading health economists, reviewed the methodology.
What you call financing costs were clearly quantified in these papers and distinguished from actual cash outlays. [my emphasis] Economists do not dispute the relevance of the time, or financing, costs. You wrote: "It's like me saying that the cost of my BMW equals the actual $50,000 I spent on it plus the money I didn't earn by failing to invest the $50,000 elsewhere. Well, actually no. It's nothing at all like that. You have confused a consumption good with an investment good. That makes it impossible to present a realistic analogy, but keeping to your context an appropriate analogy would go as follows. It's rather like you paying $50,000 for your BMW in cash today, but dealer won't deliver the car to you for ten years.
If you still doubt this logic, then I have a proposition for you. The next time that you want to buy a BMW send me a $50,000 check instead. I promise to pay you back exactly $50,000 ten years from now. By your logic you should be OK with that. Both possibilities should be equally valuable to you. In fact, I would sweeten the pot and pay you an extra dollar ten years from now so that, by your logic, you would actually be better off by sending me the $50,000 check.
If Dr. DiMasi didn't like my analogy (confusing a "consumption good" with an "investment good"), then he surely won't like this analogy presented by my friend Matthew Holt resident maven on The Health Care Blog:
To illustrate, Lets say me and a friend have drunk 3 beers a day for two years at $10 a day. Let's say instead of drinking for the first three months, I'd invested that money in Google stock instead. Now I spent $6,000 on beer and $1,000 on Google stock. My friend spent $7,000 on beer. But at the end of the 2 years my Google stock made me a profit of roughly $6000. By Tufts' accounting logic my friend spent $13,000 on beer--the $7,0000 he spent and the $6,000 he didn’t make on the Google stock because he spent the first $1000 on beer.Matthew uses both a consumption good (beer) and Google stock (an investment good) in his analogy! I love his creativity, however, and urge readers to submit other examples illustrating the concept of opportunity cost to help us non-bona fide economists understand.
The problem with their logic is that it ignores the expected returns -- his hangover and my expected financial reward. My financial reward is of course analogous to the money pharma makes when its products are successful (which is a hell of a lot more than 1.2bn over 10 years!)
To get you started, here are some more examples I found:
"An example of opportunity cost would be going to the movies. The cost of going to the movie is $9.00 or whatever ridiculous amount of money your movie theater charges. The opportunity cost would be something else you could have done with that time, such as studying." [This from the Teenanalyst.com, a site advising teenagers about investments. I'm sure studying is an opportunity cost uppermost in the minds of teenagers!]Here's one I just thought of:
"If a shipwrecked sailor on a desert island is capable of catching 10 fish or harvesting 5 coconuts in one day, then the opportunity cost of producing one coconut is two fish (10 fish / 5 coconuts)." [That's just weird!]
"The opportunity cost of buying a box of Cracklin Oat Bran is one-and-a half boxes of Wheat Chex, if that's your second favorite cereal."
Assuming it takes my son only 4 years to complete his undergraduate study at Penn State, I will have spent over $100,000 on tuition, room, board, books, wine-in-a-box, transportation, etc. A college education is clearly an investment good -- there's no payback until 2009 at least, when my son is scheduled to get his degree (a college education isn't worth anything without the degree!). Sure, some of you might say wine-in-a-box shouldn't be considered in the calculation, but then I'd say you are not a bona fide expert (ie, a parent of a college student)!However, as Dr. DiMasi says, we don't know what Pfizer actually spent, so it's a moot point.
But wait! I forgot my lost opportunity to invest that $100,000 in the next best thing (whatever that is). I could have made another $100,000 with a better investment. So, I will really be spending $200,000 on my investment in my son's degree. I'll have to factor that in on my next IRS return!
But wait! Suppose my son, God forbid!, quit college in his junior year and never earned his BS degree? Did I actually spend $200,000 on his failed attempt? I mean, could I go around to my friends and relatives and say, it was a $200,000 failure? I don't think so. But, IMHO, that's what Pfizer did with torcetrapib -- it spent something, probably a great deal, but the development of torcetrapib was cut short before approval. The $800 million Tufts estimate doesn't apply to that situation.
Anyway, I thought readers (and Dr. DiMasi, if "someone" should happen to forward this blog entry to him) might be interested in what a few other people had to say on this topic. The following is a recent thread from the Pharma Marketing Online Discussion Forum (not all members of this forum have "obvious political agendas" and I doubt there's a bona fide economist among them):
Tufts pegs the cost of developing a biotechnology drug at an even higher $1.2 B in the following release: http://csdd.tufts.edu/NewsEvents/NewsArticle.asp?newsid=69That's enough on this subject from me -- discuss!
Do these claims of extremely high drug development costs help pharmas justify the high price tags for their products?
People are considering torcetrapib a major loss. And while it's true that the $1 billion loss is a large onetime loss. You must consider the amount of derivative research data that is now available to Pfizer. I believe Pfizer has a secondary HDL drug in the pipe. How much cross pollination do you think there will be from the data collected from the torcetrapib trial?
While Tufts includes the projected cost of projects that never make it to market (perhaps those that never get past Phase 1), let's not forget that 55% of their funding comes from "unrestricted" grants and commissioned projects from the pharmaceutical industry.
I personally do not doubt that when you figure in the cost of salaries, benefits, overhead, legal services, attending conferences, publishing study reports, etc., these costs are realistic.
From a clinical point of view, it is interesting that I can accomplish the same objective with soy, exercise and niacin. Didn't cost $1.2 billion to figure it out, and I don't have the problem of killing off my patients.
--Avery L. Jenkins
The Tufts studies are certainly very high estimates of drug development costs.
I'd suggest that interested readers check out Public Citizen's critique of the Tufts studies prior to accepting their results. Link here: http://www.citizen.org/pressroom/release.cfm?ID=954
So, yes, the Tufts studies help the drug industry make claims as to why it needs to keep prices high, but the costs of drug development in the Tufts studies are not accurate, thus making the argument for high prices less compelling. And when making a me-too drug or altering the molecule of one's own existing product just enough to market it as new, that certainly costs much less than a billion bucks. Switching a drug to extended release format is also not likely to run anywhere near a billion dollars.
--CP, Clinical Psych Blog
Does it cost that much to discover and develop innovative products? Yes, if you consider the costs ploughed into all the investigational drugs that fail in each Phase of testing, not to mention those such as torcetrapib that have cost a boatload of money that will never be recouped. BUT, that still doesn't justify the fact that clear profits for Pharma average about 17%-20% when the clear profit margin for most other innovation-based industries is about 12%. The first company to swallow the short-term losses, tell Wall Street to piss-off with the quarterly pressure, and lower their prices just a little will be the winner.
--Siobhán NíBhuachalla, M.P.H.
The major problem with the Tufts studies (other than their propaganda use) is that the "opportunity cost of capital" is a huge part of the number. I cant think of any reason to count that, as it has a return at the end.
But no problem--the $800m/$1.2 bn number makes the industry feel good. Who cares how it came about?
I'm off to Washington, DC, where I am participating in the Healthcare Blogging Summit. Hopefully, I'll have a report on that for Tuesday's posting.
Thursday, December 07, 2006
The members of the online Pharma Marketing Discussion Board, which I moderate, had a lively exchange on the subject of Pfizer, torcetrapib, and drug costs over the past several days. I'd like to summarize that discussion here. Keep in mind that all these people are professionals working within the pharmaceutical industry either employed at major pharmaceutical companies or with outside agencies or vendors providing services to the industry. I include only their first name and initials here to protect their identity, although they had no qualms about that amongst their colleagues on the discussion board.
Pfizer: "Arrogant and Superior"?
One repercussion of the torcetrapib failure is the negative publicity Pfizer is receiving and criticisms from Wall Street analysts (see for example "torcetrapib: $800 Million Failure but Kindler Safe"). Some of the latter may be driven by short-sellers, but some people in the industry seem to have pent-up feelings, such as the following:
While I agree that jumping all over Pfizer is not in the best interest of learning from this situation, I can tell you that as a former vendor, they do hold a reputation as arrogant and superior to everyone else, and this may be a way for many to retaliate.John M. (another John M., not me!) disagreed with Mike's suggestion that Pfizer has an "arrogant and superior" reputation and offered offered his personal experience as an example:
Concerning the mea culpa within 5 hours - that will be a question many will ask: "What did they know and when did they know it?"
Could things have been done better? Perhaps. A more extensive safety trial prior to phase-3? Less of a focus on developing drugs to protect a market niche held by a product with only a few years left on its patent?
The pharmaceutical industry is fully aware and accepts the fact that many of the drug compounds in development will not reach it to market. It becomes major news when so much money is invested and people die. Just the realities of life.
Probably different groups, but my Pfizer clients have always been among the best.to which Mike responded:
Not my personal experience either, but this is what I have heard from many companies who have dealt with them. The most common comment, paraphrased, is "We just want you to execute our strategies and tactics - don't think. We wouldn't be as big as we are if we didn't know what we were doing."You can't argue with success (to date)! Luis Q. put it this way:
a lots of times, if a person show skills for think in a laboral interview, he/she is "overqualify".We've all been there!
My own viewpoint is this: Most of the people I have dealt with at pharmaceutical companies -- including people at Pfizer -- have been very competent, knowledgeable and great to work for. For the record, I am currently doing some consulting work for Pfizer, so I may be biased.
So many times I have heard from pharmaceutical people at conferences how much they enjoy my blog or participating in the online discussion board -- at least listening in. The most common remark is something like this: "What you said about X was right on. I wish I could say that!" There are some things that pharmaceutical companies do based on strategies developed at the highest levels that do not sit well with the rank and file. Same as with other industries. But if we all just say "Yes sir, great strategy" are we doing the industry a favor?
Anyway, I digress. Adam B. adamantly defended Pfizer's handling of the torcetrapib debacle:
Woo-hoo! A lot of people are really stepping out on the ledge this week and criticizing Pfizer. Do you also like cute puppies and dislike Osama bin Laden?I wish Adam hadn't mentioned the "O" word and brought politics into the picture! I don't want the Negroponte and other folks at NSA snooping through my email and the email of the other members of the discussion board who received Adam's message.
* How about some solutions for how Pfizer can best respond now?
* How can other companies avoid this sort of crisis?
* Is M&A to create mega-pharmas a failed strategy?
* Why hasn't Pfizer gotten any positive coverage for so quickly yanking the clinical trial? (The last time you made a major mistake, did you publish a mea culpa within five hours?)
Mike A.'s comment, which I quoted at the beginning of this post, was actually a response to Adam. For the record, I gave Pfizer a "B" for pulling the plug on torcetrapib (see "Pfizer's torcetrapib: Who Knew What, When?"). That's pretty good coming from me, but remember, I may be biased!
As always, the discussion veered at this point to other matters, which I may cover in a future post.
I'd like to end this with a poll of readers asking you whether or not you agree that Pfizer is "arrogant and superior." You can vote below and add comments to this post by clicking on "Comments" at the end. It's all anonymous, so don't worry about losing your job.
Wednesday, December 06, 2006
Pfizer's failure to launch torcetrapib will have repercussions throughout the industry on many different levels. As a seminal event, it will rival the withdrawal of Vioxx from the market.
First, it is "devastating to Pfizer" whose executives bet big on torcetrapib as a replacement for Lipitor, which will go off patent in 2010.
Pfizer Chief Executive Jeffrey Kindler believed that torcetrapib was "one of the most important developments in our generation" and Pfizer research president John LaMattina said, "We believe this is the most important new development in cardiovascular medicine in years." (See, for example, "Demise of a Blockbuster Drug Complicates Pfizer's Revamp".)
Pfizer Psyche Shaken
These executives as well as every Pfizer employee must be in shock and awe. Shocked that their company could fail so publicly and awed by the power of the butterfly effect that a rise in a few millimeters of mercury of blood pressure can have.
The failure of torcetrapib not only affects the psyche of Pfizer, but also its people, more of whom are now likely to be out of work on top of the previously announced 20% cut.
While Mr. Kindler says he is "relentlessly focused on shareholder value," some $20 billion of it evaporated on Monday, according to the Wall Street Journal. That makes the $800 million Pfizer claims to have spent on development costs look like a rounding error, as one member of the online Pharma Marketing Discussion Board quipped.
Another repercussion concerns mergers and acquisitions. Some analysts are predicting that Pfizer will have to buy new drugs for its pipeline through mergers and acquisitions and this will speed up M&A activity throughout the industry.
Door Opens for Real Snakes
The visible failure of Pfizer’s prize replacement for Lipitor may also be sending a chill through the public, which could be losing confidence in Lipitor and other lipid-fighting drugs despite the lack of any supporting scientific evidence.
For proof of this, I cite the new anti-cholesterol spam emails I have been receiving lately touting cholesterol "breakthroughs", such as the following:
Receiving this email at this time may have been a coincidence, but as a believer in the opportunistic nature of marketers, I think not.
"Drugs like Lipitor®, Zocor®, Crestor® and the other statins can cause a whole new set of problems," claims this ad. "So, ask your doctor if you can try the safe, natural alternative. It really works" (read between the lines: "It really works, unlike torcetrapib, the replacement drug for Lipitor, which has its own set of problems.")
At least this ad urges readers to "follow your doctor's advice, and don't stop taking any prescription until you get your physician's okay." Others may not be so finicky.
Drug Development Without Medical Science Foundation
Torcetrapib problems may have resulted from raising the level of “bad” HDL. If so, that would signal trouble for the entire class of CETP inhibitors. "The whole class goes down at that point," said Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic.
Finally, the torcetrapib failure puts a monkey wrench into the ascendancy of commercialization over science. Some experts claim that, like it or not, “we are in an era where development of "successful" drugs is going to be shaped by potential marketplace success” rather than clinical efficacy (according to an expert quoted in the upcoming December issue of Pharma Marketing News).
Torcetrapib may have been one of these drugs shaped more by commercial potential--ie, blockbuster potential--than by any viable science to back it up.
A recent article by an assistant managing editor at The Wall Street Journal ("Drug's Demise Demonstrates Why CEO Is Pushing to 'Transform' Pfizer") questions this strategy and suggests that Pfizer and the rest of the pharmaceutical industry needs to change its "creaky traditions," including how it develops drugs, sells drugs, and manages public opinion. Here's his words on that:
"That leads to the first transformation Mr. Kindler needs to make: a transformation in the way Pfizer develops drugs. Instead of one big blockbuster, it's probably going to have to figure out a way to nurture a large number of smaller hits to keep growing.Amen to that!
"And then there's the transformation needed in the way Pfizer sells drugs. The sales effort relies heavily on a huge and costly sales force that has often consisted of attractive females whose first job is to get in the doctor's door so they can make their pitch. Mr. Kindler has already announced plans to shed 2,200 members of that sales force, and more cuts are likely.
"Finally there's the transformation in the way Pfizer deals with politicians and a public upset about the high cost of drugs. In the past, the company's approach has been to buy the former and ignore the latter. But that strategy is clearly fraying, and the threat of price controls, in one form or another, hovers on the horizon."
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