Monday, January 31, 2005
It seems that Cialis will be back at the Super Bowl with a 60-second commercial that may cost as much as $4.8 million (see "Impotence drug returns to Super Bowl A 60-second spot for Cialis to appear during this year's most-watched TV event").
While many may lament the "bursting of the 'G-rated' Super Bowl myth" because the ads must mention the four hour erection side effect, what about the amount of money being spent for these Super Bowl DTC ads? While $4-5 million is a drop in the bucket for an annual ad budget of over $137 million (see "ED Drug Sales Limp"), is it a waste of money?
I think not.
Buzz is Not Regulated by FDA
Super Bowl ads always create "buzz." Already there are several articles in the press about the Cialis ad and all this is FREE publicity and advertising. Even the four-hour erection side effect message is being touted as "the best marketing slogan of 2004" by a principal at a Los Angeles sports marketing consulting group (see "Provocative ads burst 'G-rated' Super Bowl myth").
Given this kind of exposure and the casting of a side effect as an innovative marketing slogan (a great example of Orwellian Newspeak), I think the buzz is the PRIMARY reason for these ads to appear on the Super Bowl.
And reporters eat right out of the marketers' hands, rarely questioning the statistics bandied about and quoting biased sources. And they can quote outlandish comments by so-called experts -- such as that LA sports marketing guy -- without any balance required whatsoever! Buzz is not a regulated activity -- not by the FDA nor by the FTC. It's all freedom of the press, you know.
For example, in each ED drug "buzz" article, the reporter dutifully repeats the nearly baseless statistic that 30 million men in the U.S. suffer from ED (erectile dysfunction). In a previous post (see "ED Drug Sales Limp"), I point out that medical experts hired by the pharmaceutical industry often quote this number whereas according to the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, the "Incidence [of ED] increases with age: About 5 percent of 40-year-old men and between 15 and 25 percent of 65-year-old men experience ED."
So, only about 5% of the male Super Bowl audience actually may need Cialis. But the news-reading public is a much older demographic and perhaps the TRUE target of the Super Bowl DTC ad -- through the inevitable "buzz" articles it creates.
Friday, January 28, 2005
Bob Erlich of DTC Perspectives magazine said in a recent newsletter:
"Drug makers ... need to be totally upfront about risk, educating consumers in understandable language on the odds of a serious side effect. Most consumers understand drugs have side effects, but need to know that serious side effects can occur and at what frequency." (DTC in Perspective, January 28, 2005).Presumably this would be done through Direct-to-Consumer Advertising (DTCA) on TV and in magazines.
In a recent New England Journal article entitled "To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs" (N ENGL J MED 352:4, January 27, 2005) the author -- Ernst B. Berndt, Ph.D. -- said "As an instrument promoting public health, direct-to-consumer advertising has considerable potential. But industry needs to respond to consumers and physicians, who seek more balanced communication of risks and benefits.
Less is More?
Indeed, on February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. The draft guidance "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements" encourages manufacturers to use clearer, less cluttered formats for presenting risk information and encourages them to focus their risk disclosures on the most important and the most common risks and to do so in language easily understood by the average consumer. (See "FDA Draft Guidance for Print DTCA: Less than Feared", Pharma Marketing News, Vol 3, #2).
Ads Can't Educate About Statistics
Is it really possible to convey adequate risk information in a 30- or 60-second DTC ad on TV?
I think not.
Take the COX-2 drug situation, for example. I find the risk information to be (1) confusing and (2) inconclusive. And that's after reading lengthy analyses such as in Public Citizen's "Petition to remove the Cox-2 Inhibitors Celecoxib (CELEBREX) and Valdecoxib (BEXTRA) From the Market."
Let's see. One study showed a statistically significant "four-fold increase" in the risk of having a myocardial infarction in patients taking rofecoxib compared with those taking naproxen. Another study showed a "two-fold" increase (3.5% vs. 1.9%).
"Four-fold" and "two-fold" sound like huge differences, but the actual numbers for both cases are VERY SMALL (e.g., 0.4% vs. 0.1%). This is a big difference for society as a whole, but it's an insignificant risk for me whether it be 0.1% or 0.4%.
Look at it this way. Suppose I wanted to get to grandma's house quickly and I had two different routes. One route was very long and difficult, but there was only a 1 in a thousand chance of me getting eaten by the wolf. The other route was short and easy but there is a 4 in thousand chance of getting eaten by the wolf. I'm only going to grandma's this one time to satisfy my mom. So, what the hell, I'll take the easy route and take the higher risk. It's not likely that I'll be eaten in any event.
I don't know if this is a good analogy, but my point is that any discussion of risk needs to be weighed against benefits and that kind of discussion cannot be accomplished via DTC advertising.
Even if DTC could adequately communicate risks and benefits, not all the risks associated with a drug are apparent or revealed when the drug is launched as the Vioxx example shows. Perhaps, as in the case of Vioxx, only when long-term use data are available will risks become apparent. By then it is too late -- the cow has already left the barn! Also, risks may be revealed only when millions of people have taken the drug in real-life situations as opposed to the artificial parameters of a clinical trial.
Keep in mind that DTC advertising is most intense when a new drug is launched and less so as the drug nears patent expiration. If you don't know the risk, how can you communicate it?
Don't Fix DTC, Solve the Problem
All this brings me back to how this problem should be solved rather than how DTC should be "fixed." In the recent post How the FDA Can Fix DTC, I suggest that DTC advertising -- at least the type of ad that mentions the drug by name -- be banned during and immediately after the launch phase of a drug and until the drug company can come up with post-marketing surveillance data. This data should reveal any risks. At that point, DTC ads could convey accurate risk information.
Even so, the ads won't be able to educate consumers about risks vs. benefits as some people would like them to do. Again, I am talking about those ads you see on TV.
So, what's a better idea?
Not enough effort or money, in my opinion, is spent to foster the synergy between DTC broadcast and print ads and the Internet. DTC ads focus on what may be a giant step for many people - go see your doctor. They don't emphasize enough an intermediate step - i.e., go to a website to learn more about the condition, the treatment options and the risks.
The FDA has urged that DTC broadcast ads refer viewers to an 800 number, website, or print ad to find more information. Print ads can include the full prescribing information and you can get brochures by calling the 800 number (although you might have to wait a long time; see article "Beyond DTC: Consumer Relationship Satisfaction"), but only the Web can offer in-depth education, interactivity, and personalization. This, not repetition of 30-second TV ads, is what's needed to truly educate consumers.
Wednesday, January 26, 2005
This survey was conducted around the time that Vioxx was withdrawn from the market and at the height of election season (October 2004). At the time, Merck's and FDA's alleged collusion to keep facts from the public while Vioxx was still marketing via DTC (see "Who Should Pay for Merck's Obstructionism?") was not revealed and passions about then Sen. Edwards anti-DTC legislation were at fever pitch. I think if the survey were done today, there would be less optimism about spending.
Can You Teach Old Dogs New Tricks?
The surveyers contend that the results indicate a trend away from spending on mass media (e.g., TV) if you listen to senior marketer respondents with more than 6 years of DTC experience. Overall, 65% of responders believe that less money should be spent on television advertising with Spot TV and Radio ranking next in line for spend reduction.
"This year, opinions run strong, particularly in media channel assessment. Marketers who have tenure in DTC are bringing an increasing sophistication of ideas to the market place. The majority will dramatically decrease spend on mass media in 2005, turning instead to e-marketing and other patient relationship media. This contrasts to more junior members of DTC marketing teams who will continue spending on traditional DTC media such as broadcast."I have heard this before. One of my pet peeves has always been that the pharma DTC promotional budget devoted to the Internet is a miniscule 1-3% of the total DTC spend and that this percentage has NOT changed since 1998 despite all the hoopla about how cost-effective it is and how it is best suited for enhancing patient relationships (see "What Stands in the Way of the Mainstream Use of the Internet by Pharmaceutical Companies?").
Of course, there is that "other patient relationship media" category. This includes physician office programs (the posters and pamphlets you see in your doc's office), pharmacy support programs, and direct mail. I suspect that this is where most of the increased budget will be spent rather than through e-channels -- although the e-mail channel was most often cited as primed for an increase in DTC spending in 2005.
Compliance, Compliance, Compliance - How Many Times Have We Heard That Tiresome Phrase?
Pharma marketers have long focused on acquiring new customers rather than keeping the ones they have. Compliance and persistency has always been a big problem in the pharma industry -- somewhat due to the lack of attention by marketers and/or their lack of experience with relationship marketing, which is a core expertise needed to drive compliance (see, for example, "Effective Pharma Adherence Programs Start With The Patient").
The 2004 DTC Checkup survey predicts that more attention will be paid to compliance in 2005, but maybe not if the agencies have their way. According to the survey, manufacturers differ from their suppliers in where DTC dollars should be spent. Over 77% of manufacturers feel greater investment should be made in direct-to-patient media, whereas only bout 50% of their suppliers agree.
The survey points out the obvious in that pharma marketers are well skilled in DTC marketing, but the new focus in marketing spend requires improved ability in multi-channel utilization, media optimization, and measurement. 65% of respondents indicated a need to improve their department's skills in measurement, a vital skill for relationship marketing.
As Dominique Hurley, VP Marketing at Optas and co-author of the survey white paper, says, "You can't do compliance without relationship marketing and you need specific expertise in this area to hit the ground running. It's impossible to retrofit mass market DTC techniques to relationship marketing." See the article "Out-of-the-Box Marketing: Will It Work for Pharma?" for more on this topic.
Tuesday, January 25, 2005
For example, prices for VIOXX alternatives -- such as Mobic -- have risen between 7% and 11% just this month alone! Obviously, Boehringer Ingelheim Corp. and Abbott Laboratories, co-marketers of Mobic, are taking advantage of the increased demand. No sympathy for any of the 40 million or so consumers without health insurance who must pay for these drugs out of their own pockets! Speaking of pain!
"Pfizer Inc. kicked off 2005 by raising the price this month on most of its U.S. medicines by nearly 5%, including an increase of about 5% on its hugely popular cholesterol-fighter Lipitor." I guess Pfizer is anticipating a huge loss when Celebrex crashes and burns as I predict it will! (see "Cox-2's Die Hard: With a Vengeance").
Many experts have warned that drug prices will continue to rise ahead of the effective date of the Medicare drug benefit (January 2006) and, as the WSJ article states, "This is a crucial year for drug makers, and the current round of increases could set the tone for 2005."
Eroding Industry Image
Even with recent profit gains by most of the big pharma companies, profits going forward are not guaranteed (see "Pharma Profits on Slippery Slope?") and the industry is very concerned about future profits (see "Drug Prices/Declining Profits Top Issues for 2005").
While it may be argued that the industry needs to maintain profits in anticipation of problems ahead, the TIMING of these price increases speaks volumes. It just negates all the recent PR efforts about drug discount cards and will only further erode the industry's negative image.
Fool Me Once, Fool Me Twice
It will now be just that much harder to defend drug price increases using the standard arguments -- needed to finance R&D, for example.
As Barnum said, you can't fool all of the people ALL of the time. You can, however, fool all the people SOME of the time - especially during a presidential election season!
Monday, January 24, 2005
At the last Super Bowl a brouhaha arose over the half-time show. It also brought some unwelcome attention to direct-to-consumer (DTC) advertising. A Comedy Central skit after the game, for instance, included blurred video of Janet Jackson's breast, an ad featuring a flatulent horse, and the Cialis logo. Not an auspicious Super Bowl debut for DTC advertising! See the article "Super Bowl DTC: Was It Good for You?" (Pharma Marketing News, Feb. 2004).
What's in store for this year's Super Bowl? Will there be more DTC ads for Cialis, Levitra, and Viagra too? Will other envelopes be pushed?
Event Marketing for Rx Drugs - What If?
What If Pharma Marketers took a page out of the Packaged Goods Marketers' handbook? Here's a possible scenario: Event Marketing.
A story in Today's WSJ ("Super Bowl XXXIX: Obstacle Course vs. 'Potty Palooza' ") gives us a glimpse into event marketing a la packaged goods like toilet tissue and beer. The idea is to give away samples on site and organize attention-grabbing shows to attract people to a booth or other location where the product is featured and given away.
According to the WSJ article, event marketing is one of the fastest growing tactics in marketers' repertoires. As a Cadillac marketer stated, "There is less and less [TV] network viewing by our target, and event marketing is one way to give customers first-hand experience with our products." ED drugs are targeted to exactly the same market as Cadillacs -- slightly older males. Well, older than the prime 18-35 year-old viewing public anyway. It would seem, therefore, that event marketing would also be of interest to ED marketers.
What if Viagra marketers decided to follow this advice and go one up on Cialis and Levitra marketers --- who broke ground by airing DTC ads at last year's Super Bowl -- by hosting an event at the Super Bowl? Could they give away free samples of Viagra? How would that work? Could it work?
The Viagra "Get It Up" Pavilion - Get It While You're Hot!
Not far from the Budweiser booth, which is giving away those crazy, Eagles' and Patriots' logoed helmets with two beer cans that feed you through tubes, is Viagra's "Get It Up" Pavilion. It is situated, as a matter of fact, between the Bud booth and the huge 56,000 square-foot Daimler-Chrysler exhibit that includes a simulated off-road racetrack. Talk about location, location, location.
In the (fictional) Viagra Pavilion, visitors can walk through a simulated penile environment aglow with pulsating blood vessels while sipping their Buds through tubes. (Not that it looks anything like a penis - no red-blooded American male would ever knowingly enter such a thing. It's just a walkway in a tube festooned with pulsating red racing lights).
At the end, the visitors are ejaculated as it were -- there's steep ramp at the end, which causes the visitors to speed up as they egress -- into an area populated with beautiful female models in cheerleader costumes. The "cheerleaders" escort them to physicians who, after a brief "examination" (just a few questions really - why should they do more? They get free Super Bowl tickets for their service!), hand them free trial packets of Viagra. (Perhaps this is a bit far fetched. It could be that the girls or fake doctors just give them coupons for free trails after they get a prescription from a real doctor somewhere else.)
Blue bus tours of Jacksonville's "red light" district are also offered.
Could This Happen?
I hope not! I've heard of blue pills being offered at events like concerts and at night clubs. Perhaps these are Viagra or merely sugar pills. As a result, there has been a lot of buzz about Viagra and urban legends generated. Can anyone say if this is the result of "event marketing?"
Pharma marketers are often advised to take a lesson from packaged goods marketers -- most often by packaged goods marketers recently transplanted to the pharma industry. Pharma marketers are new to dealing directly with consumers. This is why many packaged goods marketers have been recruited by pharma companies - - to give pharma more experience with consumer marketing techniques.
These PG transplants will drive DTC to new lows, which can be seen in recent erectile dysfunction (ED) drug ads -- Levitra is a good example -- that appeal to the emotions rather than to the intellect. That is, they make you WANT the product because it promises to make you FEEL GOOD! Hey, every guy wants a better sexual "experience!"
What's Good for the Gander Is Not Good for the Goose!
It's funny that the product that has brought the most attention to the problem with DTC ads is not in the ED category, but in the pain category - Vioxx. I venture to suppose that the vast majority of Vioxx users were women - I bet about 70%. Anyway, pain is not a male emotion that consumer ads can play off of and most pain remedy ads I have seen feature women sufferers. Not coincidentally, most Senators who criticize DTC, being men, have found Vioxx rather than Levitra to be a convenient target. Wink, wink, nod, nod, 'nuf said, eh what?
Anyway, now that DTC advertising is coming under increasing attack (see, for example, "How the FDA Can Fix DTC"), it is time for the pharma industry to reject the packaged goods marketer's repertoire. While I don't really believe that Pfizer would ever host anything like the fictional "Get It Up" pavilion mentioned here, they do give away samples of their products just like every other pharmaceutical company. This has been a staple of pharma marketing for years. Luckily, this is only done -- as far as I know -- within the legitimate confines of the doctor-patient relationship. I hope it stays that way.
Friday, January 21, 2005
Some fourth quarter data are in from the pharmaceutical industry and, on the surface, it looks good for profits:
Pfizer said it earned $4.39 billion, or 58 cents a share, in the fourth quarter, excluding one-time charges, compared with $3.78 billion, or 50 cents a share, a year earlier. (WSJ, "Pfizer's Net Income Quadruples On Lipitor Sales, Fewer Charges," 1/20/2005). Sales of Pfizer's Lipitor, the world's best-selling drug, jumped 23% from last year. Celebrex sales rose 24% to $1 billion, while Bextra climbed 57% to $417 million in the quarter.
The company said net profit in the fourth quarter was $1.38 billion, up 1% from $1.36 billion in the year-earlier period. Novartis said it expects a slight slowdown of its sales growth in branded drugs this year as pricing pressure and tougher industry conditions take their toll. Novartis Posted Profit Gain of 1% For Fourth Period (WSJ, 1/21/2005)
Celebrex Slippery Slope a Cautionary Tale
However, behind these numbers lie problems. Take Pfizer, for example. As mentioned in previous posts, Celebrex may be a problem in 2005. Recall that I predict Celebrex will crash and burn this year just like Vioxx (see "COX-2's Die Hard: With a Vengeance"). Pfizer itself has warned investors in its latest financial statements:
"Within [the] accumulated body of data," the company wrote in its earnings release, "there were certain studies in which there was an increased percentage of specific cardiovascular events for patients taking Celebrex versus patients taking placebo or other drugs; in other studies, there was a decreased percentage of specific cardiovascular events. The investigators of those studies determined at the time that the differences were not meaningful and did not establish an increased or decrease cardiovascular risk for Celebrex." (Forbes, "Pfizer's Celebrex Risk Gets Worse", 1/19/2005).Could the "accumulated body of data" include the following? (reported in FierceBiotech):
"One study concluded that heart bypass patients taking Pfizer's Bextra and an experimental Cox-2 inhibitor were three times more likely to have a heart attack or stroke than someone taking a placebo. The new study, which appeared in Circulation, used meta-analysis procedures to re-examine data for 2,000 patients in earlier trials. In another study, researchers concluded that mice prone to hardening of the arteries experienced a worsening of their symptoms after being treated with Cox-2 inhibitors and an aspirin substitute.Other sources also warn of problems ahead for Pfizer:
"Garret FitzGerald of the University of Pennsylvania concluded that the new research is substantial enough to warrant Pfizer to call off a planned study of Celebrex in patients with heart disease. "The clear emergence of a cardiovascular hazard from Cox-2 inhibitors in patients, the weak rationale for a study of their protective properties in the first instance, and now this evidence from mice would indicate to me that a trial in high-risk patients, such as that proposed for Celebrex is, at best, ill advised," FitzGerald told The Washington Post.
The US Food and Drug Administration (FDA) warned Pfizer about failing to disclose appropriate risk information in its Celebrex and Bextra advertising campaigns. It also claimed that Pfizer made "unsubstantiated effectiveness claims" in its ads. (See "Drug advertising: FDA warning may return to haunt Pfizer") To view a copy of the FDA warning letter to Pfizer, go to http://www.fda.gov/cder/warn/2005/12560-letter.pdfGiven all this, its no wonder that the industry puts profits as a top concern for 2005 (see "Drug Prices, Declining Profits Top Issues for 2005," Pharma Marketing News).
"Pfizer has withdrawn advertising of its COX-2 products in view of the FDA's concerns and the wider controversy surrounding the safety of COX-2s. Whether intentional or not, the 'misleading' advertisements will have benefited sales as the general public will mostly be unaware of the violations against the FDA's rulings. The immediate future does not look good for either the COX-2 class or Pfizer."
Tuesday, January 18, 2005
Obviously, the marketplace has changed in the past year. Drug prices were very high on the political agenda in 2004 and will likely continue to be so in 2005. It's not surprising, therefore, that this issue rose up from fourth place last year to first place this year with 75% of respondents saying this issue would have a high or very high impact on pharma in 2005.
Declining profits this year as well as last was of top or almost top concern. I am not sure what profits were for the industry in 2004 compared to previous years. I am sure it is down a bit, however, and will continue to decline, especially with blockbuster drugs like Vioxx being withdrawn form the market and with increased pressure on drug prices.
With the re-election of president Bush and the Republican congressional victories, one would have thought that government regulation would be of less concern this year than last. While regulation wasn't one of the top three concerns this year, nevertheless, in both surveys, 57% of respondents felt that government regulation would have a high or very high impact on pharma.
Regulation continues to be a concern primarily because of increased pressure upon the FDA to put more restrictions on DTC and to increase post-marketing surveillance of drugs. This may or may not lead to new legislation.
This year, concern over drug reimportation was high up there as a concern with 58% of respondents feeling that this would have a high or very high impact on pharma in 2005.
[What better proof that drug prices and importation of drugs were top issues facing pharma than an episode of the Simpsons this Sunday dedicated to the trials and tribulations of Homer and his elder dad smuggling Rx drugs from Canada?
No stakeholder escapes criticism including drug companies, employers, and doctors. Dr. Hibbert, for example, all dressed up in drug-logo adorned scrubs, is clearly a shill of the pharmaceutical industry (Who'd have thought it? Surely, Dr. Nick Riviera would have been suspect, but Dr. Hibbert?).
Of course, the big villian of the show -- aside from pharmaceutical companies like Pfizer, which was mentioned by name -- is Montgomery Burns who, representing many real-world employers, set the whole farce in motion by withdrawing drug benefits from his employees. Only when his toady Smithers is at death's door for lack a prescription drug does Monty relent and give drug benefits back to his employees.}
Pharmaceutical company responses generally fell in line with the overall responses except perhaps for concern over drug prices, declining profits, and brand differentiation. Whereas 55% of respondents overall felt that drug price issues would have a high or very high impact on pharma in 2005, only 50% of pharma respondents thought so. Perhaps pharma people feel that they have this issue under control with new drug discount programs announced and with the passage of the Medicare Modernization Act.
Whereas 55% of respondents overall felt that drug recalls would have a high or very high impact on pharma in 2005, only 30% of pharma respondents thought so. This might reflect a "can't happen here" syndrome.
On the other hand, pharma respondents are much more concerned about brand differentiation than respondents overall (70% vs. 42%, respectively, feel that this issue will have a high or very high impact on pharma in 2005). Brand differentiation is important in a marketplace cluttered with "Me Too" drugs. Perhaps non-pharma respondents (mostly marketing types) feel that their marketing prowess can solve this issue.
Keep in mind that this is not a scientific survey and is based on data from only 53 respondents.
Friday, January 14, 2005
This is quote surprising, coming as it does from two companies that top the list of DTC advertisers in the US. DTC spending for Nexium and Crestor -- AstraZeneca drugs -- totaled $228 million in the first 2 quarters of 2004. They were #1 and #3 on the list. Flonase and Wellbutrin -- GlaxoSimithKline drugs -- were #7 and #9!
To put this into context: It is estimated that a total of $5 billion dollars will be spent in 2004 on DTC advertising in the US. (Some DTC proponents, such as the editors at DTC Perspectives magazine, are very defensive about this number as more and more people criticize DTC. They claim it is based on an advertising "list price" which pharma companies rarely pay and that the real figure is more like $2.5 billion. As one US Senator once said, "A $billion here and a $billion there, pretty soon we are talking about real money.")The remarks by Glaxo and AstraZeneca are also surprising because DTC is vigorously defended by drug companies here in the US. Just a few days ago I reported that a Glaxo spokesperson in London claimed that it was tough to sell ED drugs without the help of consumer advertising (see "ED Drug Sales Limp").
DTC is a double-edged sword. It is effective in getting market share for new drugs quickly after launch, but its mere presence shines a light on drug issues like high prices and misleading ads hurt pharma's image. Just a few days ago the FDA issued the first warning letter of 2005 to Pfizer for misleading DTC ads for Bextra and Celebrex (see the letter at: http://www.fda.gov/cder/warn/2005/12560-letter.pdf).
It may be that drug companies are looking for a way to end DTC thereby saving them a few billion dollars and a lot of grief.
So why don't they stop doing DTC? Simple, no one company can afford to be the first and only company to stop DTC advertising. They would be at a competitive disadvantage. Also, there is a HUGE ad and marketing industry financed by DTC. Media -- especially print and TV media -- would suffer. DTC advertising feeds a lot of mouths.
Interestingly, however, there is a savior out there -- the FDA! Yes, that much maligned agency can help the industry. It thinks it helps the industry by not being too tough on DTC (see "FDA Draft Guidance for Print DTCA: Less than Feared"), but a little "tough love" is really needed by imposing stricter guidelines on DTC advertising in the US.
I predict that this is precisely what the FDA will do within the next few months.
Here's My Suggestion for the FDA
I am not sure how strict the guidelines will be, but I have a suggestion. Restricting DTC should be tied into (1) a requirement that drug companies perform more post launch surveillance studies to prove the safety of their drugs in the marketplace -- the restriction on DTC can be provisional upon completion of those studies; (2) increase the patent life of drugs so that drug manufacturers can make up for lost income due to lack of DTC after launch; and (3) make it much harder for "Me Too" drugs to be launched, especially during and immediately after the provisional period of the first-to-market drug where DTC is restricted -- this would prevent the copy cat from taking advantage of the groundwork established by the first-to-market drug, especially with regard to the safety studies.
Thursday, January 13, 2005
The Vioxx withdrawal put the Food and Drug Administration (FDA) under the spotlight. There were allegations that the FDA was in cahoots with Merck in keeping Vioxx problems under wraps (see, for example, Will COX-2 Inhibitors Crash and Burn?). A New York Times story reported "Members of Congress, an internal F.D.A. whistleblower and prominent medical journals have said the agency is incapable of uncovering the perils of drugs that have been approved and are in wide distribution."
Other critics, such as Dr. Angell (see "The Truth About the Drug Companies: What To Do About It"), have broader issues with the FDA. Among the suggestions for revamping the FDA are the following:
- Repeal the Prescription Drug User Fee Act, which authorizes drug companies to pay fees to FDA for each drug reviewed.
- FDA advisory committees should not include experts with financial ties to the drug industry.
- Restructure the FDA to separate the job of monitoring safety of approved drugs from the job of approving drugs in the first place.
- FDA should seek additional authority to suspend the sale of drugs already on the market.
- Improve safety surveillance of approved drugs (e.g., establish patient registries and/or require drug companies to undertake new safety tests once a drug is approved).
You are invited to Click Here to Take the FDA Reform Survey.
Wednesday, January 12, 2005
The Pharma Marketing News 2005 HOT ISSUE Survey reveals some insight into the issues of most concern to pharmaceutical marketers in 2005. At the top of the list are drug prices and brand differentiation. (You can take the survey and see more detailed results by clicking here.)
The pharma industry is facing mounting criticism over drug prices. There's interest in Congress in passing drug importation laws allowing US citizens to import presumably cheaper Rx drugs from Canada (see, however, "Canada: Mad Cows Yes, Drugs No"). In 2006 the Medicare Moderization Act kicks in with government paying for elder drug benefits and this is sure to put pressure on pharma companies to lower prices.
So it's not surprising that 78% of respondents to our survey believe that drug prices will have a high or very high impact on the course of the pharmaceutical industry in 2005. Interestingly, however, only 37% of pharmaceutical company respondents feel that way! 63% of these respondents felt declining profits would have a high or very high impact.
In the minds of pharma execs, lower drug prices equate to lower profits.It's a knee-jerk reaction.
I am sure Sam Walton, if he were alive today, would take issue with that thinking and would advocate cost-cutting measures to maintain profits while lowering prices -- a philosophy that has made Mal Mart extremely profitable. (Although I must say that I am not happy about some of Wal Mart's cost-cutting techniques, especially hiring illegal aliens and squeezing workers' wages and benefits).
Drug Firms Unveil Discount Program: The Wall Street Journal today reports that ten drug companies are launching a discount program for as many as 36 million low-income Americans who don't have health coverage. This is well and good, but will it improve the image of drug companies?
For more information on the Pharma Marketing perspective on drug prices, please see the Drug Prices Discussion Thread and the Oped piece "The Price of Drugs."
Big Pharma companies rely heavily on big brands ("blockbusters" with over $1 billion in worldwide sales). Brands are built primarily through direct-to-consumer (DTC) advertising, which is practically limited to the US market only (see "The End of DTC as We Know It").
Critics have claimed that the pharma industry is no longer innovative and strives to increase profits by copying other brands to produce "Me Too" drugs (see, for example, "The Truth About Drug Companies and What To Do About It" AND "Vioxx Withdrawal and the Me-Too Drug Domino Effect"). This leads to the problem of brand differentiation because of the similar indications and side effects of Me Too drugs. Vioxx and Celebrex are classic examples (see "Cox-2's Die Hard: With a Vengeance").
It's no wonder, therefore, that 67% of the pharmaceutical company respondents to our survey thought that brand differentiation would have a high or very high impact on the course of the pharmaceutical industry in 2005. This was much higher than the 41% of respondents overall. Only 20% of marketing agency or consultant respondents felt that brand differentiation would have a high or very high impact on pharma. This is not the first time that I have found a disparity between consultants/outside marketing pros and people within the industry itself.
You can take the survey and see more detailed results by clicking here.
Tuesday, January 11, 2005
The Wall Street Journal reports today that all is not well in the impotence-drug market.
"The growth since the competition came to the market has been modest and below expectations for the entire class," concedes Patrick Holmes, a Pfizer marketing vice president for drugs including Viagra. [See "Demand Lags For Viagra And Its Rivals"].This is despite huge amounts of money spent on DTC (direct-to-consumer) advertising for these drugs. Cialis and Levitra are #2 and #4 in terms of dollars spent on DTC in the first and second quarter of 2004. According to TNS Media Intelligence/CMR, Cialis's ad spending was $137 million for the first 10 months of 2004, followed by $133 million for Levitra, and $88 million for Viagra. (Viagra was much lower perhaps because of FDA criticisms of Viagra ads -- namely omission of risk information. See letter from DDMAC to Pfizer.]
Pharma Marketing Predictions On Target!
In February, 2004, Pharma Marketing News hosted a survey entitled "Cialis/Levitra/Viagra: Which Ad Campaign Has the Greatest Staying Power?" where we asked experts to determine the market share for Viagra, Cialis, and Levitra in six months. The predictions -- shown on the left -- have proven to be pretty accurate. According to data quoted in the WSJ article, Viagra had a 65% share in Oct/Nov 2004, whereas Cialis had a 21% share and Levitra had a 13% share. By all estimates, Levitra should have done better.
Lack of DTC Outside US the Culprit?
A Glaxo spokeperson in London claimed that it was tough to sell the drugs without the help of consumer advertising. That may be true. In the US, where DTC is allowed, some data does seem to indicate a blip in new prescriptions written for Cialis after the 2004 Superbowl ad (see "The New Written Prescription: Leveraging Technology to Measure Change in Physician Behavior as it Occurs"). However, it is difficult to separate DTC promotions from other types of promotions -- such as details to physicians -- and say with certainty that any increase in Rx writing is due to the ad rather than something else.
Perhaps Not As Many Men Have a Problem As Drug Companies Would Have Us Believe?
I remember being at a conference during which a presentation by the Cialis marketing director suggested as many as 1 in 2 men over 40 in the US suffer from some degree of Erectile Dysfunction. I looked at the guy on my right and the guy on my left and said "one of these guys can't get it up!"
Pfizer, in its FAQs on ED, says: "About 30 million men in the United States suffer from some degree of ED, including about half of all men aged 40 to 70 years."The WSJ article dutifully repeats this estimate: "Some estimates put the number of U.S. men with problems attaining or maintaining erections at 30 million." Where did they come up with this number? Well, they don't say; could it be Pfizer? Or perhaps some independent expert? In the next sentence the Journal authors quote Andrew R. McCullough, a urologist at New York University medical Center. The close proximity of an expert with data suggests a link between the two. Is this expert credible?
Just keep in mind that Dr. McCullough, according to Target Health, Inc. where he is an advisor, "has been principle (sic) investigator in numerous clinical trials in erectile dysfunction including the pivotal sildenafil trials. Currently he is conducting ED trials with Bayer, TAP, Liliy-ICOS and Pfizer ... and has served as a high level advisor and expert to many companies including Pfizer, Bayer, Bristol Meyers Squibb, Vivus, Schering-Plough, Smith Kline Beecham, and TAP."According to the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, "Incidence [of ED] increases with age: About 5 percent of 40-year-old men and between 15 and 25 percent of 65-year-old men experience ED."
NOTE: Some interesting data from Pfizer concerning Viagra was cited in a WSJ article published after I made this post (see "Medicare Plan to Cover Viagra"; WSJ, 2/3/2005). According to these data, the majority of Viagra prescriptions (61%) have been written for men UNDER 60: "Since it was approved by the FDA in 1998, about 16 million men have tried Viagra, according to Pfizer. Overall, according to a spokesman for Pfizer, men ages 60 to 69 account for about 22% of prescriptions for the medicine, while those 70 and over account for about 17%."
I think the marketers are drinking their own Kool Aid. They have overestimated the market and tried to put too many men in the ED category. Many men may have an inconsistent ability to achieve an erection or a tendency to sustain only brief erections, but they would not want to say they are "impotent," which is what ED implies. The ads, of course, skirt the issue by mentioning "ED" as quickly as possible so as not to call attention to it. This is why TV DTC cannot do the whole job. There needs to be more education. See yesterday's comments ("The End of DTC as We Know It") for more about that!
Monday, January 10, 2005
During the presidential election campaign of 2004, several pharma industry trade publications suggested that if Kerry/Edwards won the election, DTC (Direct to Consumer) ads for drugs would be banned. To be sure, Edwards did sponsor a bill that would have required DTC ads to include comparisions to competing products.
However, it may be the ads themselves that kill the golden goose.
Take for example ads for the Erectile Dysfunction (ED) drugs Viagra, Cialis, and Levitra. As I mentioned in a previous Pharma Marketing News editorial (see "Pushing the Envelope is Bad for DTC"), these ads are focusing on younger and younger men who are clearly not part of the typical ED demographic category with regard to age. I plotted the trend in a graph, estimating the age of the characters in these ads over the years (see graph at right).
A respondent to the survey "Are ED Ads Too Sexually Explicit" suggested that the "general rule of thumb in advertising" is to use spokespersons younger than your target.
Drugs Are Different Than Other Products -- the Ads Should be Different Too!
I think the pharma industry is hiring too many agencies and consultants with packaged goods consumer marketing backgrounds believing they can learn something from them about advertising directly to consumers. What they forget is that drugs are not like cars or cereal! They are products that directly affect our health and need to be used with caution.
If DTC is to survive it needs to change. Ads need especially to be more educational. Nowhere in any ED ad have I seen any information about what ED is, what the symptoms might be, and who is likely to suffer from it.
If you are going to be sexually explicit, at least make it educational and motivate potential ED sufferers to seem medical attention. But, DTC drug ads are neither motivational nor educational.
DTC advertising gurus often say that drug DTC ads play an important role in motivating people to seek medical help for conditions. But if you hardly mention the condition, how's the ad going to do this? As a matter of fact, according to a study by Prevention Magazine, the number of patients who talked to their doctors about an advertised medicine remained pretty steady at 31% to 32% between 1997 and 2001. That is, after several years of experience with DTC, the motivation needle hasn't really budged.
The FDA, for one, is paying more attention and has issued new draft guidances for DTC (see article "FDA Draft Guidance for Print DTCA: Less than Feared") that it hopes will help DTC ads better educate consumers about side effects of drugs and the medical conditions they treat. The draft guidance on disease awareness communications especially talks about this. It remains to be seen if any pharmaceutical company will follow these guidances.
Pfizer Missed An Opportunity
When Celebrex came under a cloud due to one or two clinical trials suggesting it might cause cardiovascular problems, Pfizer pulled Celebrex DTC ads from TV and shut down the celebrex.com Web site for a time. It is believed the FDA asked them to do this.
Pfizer could have used the opportunity to inform the public via DTC ads about the conflicting data and make it easier for the public and physicians to access the facts (e.g., the two clinical trials under discussion: the NCI APC cancer trial, which showed increased cardiovascular risk and the PreSAP cancer trial, which showed no problems).
Synergy Between TV and the Internet - Motivation and Education
Not enough effort or money, in my opinion, is spent to foster the synergy between DTC broadcast ads and the Internet. DTC ads focus on what may be a giant step for many people - go see your doctor. They don't emphasize enough an intermediate step - i.e., go to a website to learn more about the condition, the treatment options and find motivational tools.
The FDA has urged that DTC broadcast ads refer viewers to an 800 number, website, or print ad to find more information. Print ads can include the full prescribing information and you can get brochures by calling the 800 number (although you might have to wait a long time; see article "Beyond DTC: Consumer Relationship Satisfaction"), but only the Web can offer in-depth education, interactivity, and personalization. This, not repetition of 30-second TV ads, is what's needed to get more undiagnosed people to see a physician and to help motivate the diagnosed to stay on treatment.
Friday, January 07, 2005
The three-part measure would prohibit physicians in Canada from cosigning prescriptions from U.S. patients they have not examined, ban prescriptions for foreigners who are not in Canada, and compile a list of popular Canadian drugs that cannot be exported.Meanwhile, a new case of mad cow disease was recently confirmed in Canada. Nevertheless, this won't affect US plans to lift a ban on Canadian beef imports imposed after a 2003 mad cow incident.
"USDA remains confident that the animal and public health measures that Canada has in place ... provide the utmost protections to U.S. consumers and livestock," Ron DeHaven, Animal and Plant Health Inspection Service administrator said in a statement.While the USDA has no qualms about Canadian animal health measures, another agency -- FDA -- has lots of qualms about Canadian health measures when it comes to drugs imported by US citizens. Why else would a government task force, which included Acting FDA Commissioner Lester Crawford, conclude that importing prescription drugs from Canada would require costly safety measures?
[The report was ordered by Congress because several drug re-importation bills are currently being considered in Congress.Two Senate bills, the Pharmaceutical Market Access and Drug Safety Act of 2004 (S.2328) and the Safe IMPORT Act of 2004 (S.2493). GlaxoSmithKline recently ran a one-page ad in Newsweek, which specifically targeted S.2328: "Take a wild guess where your 'Canadian' medicine is actually coming from." To read more about these bills, see the Pharma Marketing News article: "Congress Fiddles While Reimportation Issue Burns"].
Canada is no doubt under tremendous pressure from the US FDA and the drug industry: "A spokesman for Canadian Health Minister Ujjal Dosanjh said their government will review the report and "will do what is necessary" to ensure Canadians have access to medicines." (Reuters as reported on Yahoo!) Looks like what is necessary is to make it much more difficult for Americans to import drugs from Canada because it they do not, drug companies have warned that they will limit supplies to Canadian pharmacies.
For you conspiracy people out there: Could it be possible that the lax US mad cow policy toward Canada is a carrot for a tougher Canadian stand against US drug importation?
P.S. Wouldn't you know? Soon after I made the above suggestion, a story in the Washington Post suggests that I am not the only one who thinks there was a connection between Canadian mad cows and drug importation.
"MacKay[executive director of an association of Canadian mail-order pharmacies] said Canadian authorities "turned on a dime" after that meeting [between Bush and Prime Minister Paul Martin]. He said he has learned that "President Bush threw out an ultimatum," demanding that Canada shut down the mail-order sales, possibly in exchange for U.S. concessions in lifting the ban on imports of Canadian beef. He said Bush did not want to publicly oppose the sales because many U.S. senior citizens and members of Congress are fans of the lower prescription prices." ["Bush Accused of Influencing Canada on Drug Exports"]
Thursday, January 06, 2005
- Public anger about soaring drug expenditures and prices, which is being reflected in grand standing by powerful politicians.
- Purchasing groups that are being formed by groups of states, which are trying to contain runaway drug spending by their underfunded and expensive Medicaid programs.
- A shaken FDA, which is being blamed for letting Vioxx, Celebrex and other drug mishaps go undetected and unregulated.
- Suspicious physicians, known for willingly taking gifts and grants from pharmaceutical companies detail people, but unhappy about being misled by the drug makers and about their direct-to-consumer advertising. They must believe that what they see as unethical marketing by drug companies has made them look unethical. It has.
- Price-conscious institutional buyers of drugs that will take advantage of any sign of weakness to demand price breaks and help in containing the use of high-priced, marginally more effective new drugs.
- Wary patients, worried about drugs side effects, high prices and the credibility of drug companies may be less likely to have their prescriptions filled.
- Scared senior employees who will abandon ship at the first opportunity unless they see an imminent turn around.
- Jilted investors who are on a buyers strike and will sell whenever Mercks stock rallies anywhere close to their break even points.
- Trial attorneys and patients with dollar signs in their eyes.
- Medical journal editors who believe that their credibility has suffered with Mercks and the drug industrys. They will be very reluctant to publish articles about any medical research if they believe that any company has had a role in writing, editing or approving a journal article.
The 2005 HOT ISSUE Survey
What impact will issues like drug reimporation, weak pipelines, decreasing profits, drug recalls, class action lawsuits, government regulation, etc., have on the course of the pharmaceutical industry in 2005? What do you think? Click here to take the survey.
See the Pharma Marketing Network Survey page for other surveys and results.
Wednesday, January 05, 2005
Merck's actions in the months and even years prior to the "voluntary" withdrawal of Vioxx from the market has come under scrutiny not because any laws were broken, but because these alleged "obstructionist" actions violate a tenet of former CEO George W. Merck who said: "We try never to forget that medicine is for the people. Not for the profits. The profits follow, and if we have remembered that, they have never failed to appear."
In a recent Pharma Marketing News opinion piece I suggested that "someone" should pay other than -- or more accurately -- in addition to the small stockholder (Merck's stock price declined precipitously after Vioxx was withdrawn). See Corporate Moral Values Anyone?
A reader responded: "You wanted someone to 'pay' for Merck's obstruction but in the same breath you find worrisome the decline in stock value? In our capitalist system this is exactly how company's [sic] pay for their transgressions! Adam Smith would say the system is working...."
I don't know if Adam Smith would be happy with today's corporate moral values or if he is turning in his grave, but not everything is "market driven" and measured in terms of dollars. Good will, respect, and trust are also important, especially in the pharmaceutical industry. As Mr. Merck implied, if you have these things, the dollars will follow.
No doubt Merck has lost a lot of trust and goodwill among consumers and this has hurt the entire pharma industry. This bothers me because a lot of people depend upon the health of this industry to make a living. I am sure many employees of Merck and other pharmacos will eventually suffer. So will the people that service the pharma industry -- ad agencies, consultants (including me), etc.
So Merck is paying, the pharma industry is paying, pharma employees and consultants will soon pay, but what about the people who consciously made unethical decisions to repress clinical trial data? And their superiors? Will they pay? Or will they get golden parachutes or simply move on to other positions?
I guess I am just an old-fashioned moralist that believes if you do something wrong, you should admit it and accept the consequences, which should include some kind of punishment.
Should someone go to jail? If it's true that thousands of people may have died while Merck knew of the cardiovascular effects of Vioxx and tried to hide the information, then, yes, perhaps someone should go to jail.
Maybe a good punishment would be to pay list prices for their own medications! But that's another tirade!
P.S. If you are a Merck employee and have an opinion, especially of your job is in jeopardy, I would love to hear from you. Your identity will be kept confidential.
Tuesday, January 04, 2005
No sooner had I said this than bad news about cardiovascular effects of Bextra came out. Shortly afterward, of course, Celebrex was put under a cloud followed by naproxen. This is the classic Me-To Drug Domino Effect -- drugs in the same class will be suspect until proven innocent (naproxen especially may be a wrongfully accused victim).
[See the PHARMA-MKTING discussion thread on the Celebrex issue: Celebrex Problems -- What Should Pfizer Do?]
BTW, the Me-Too Drug Domino Effect can also be positive. This happens after the first blockbuster in the class comes out and gives the Me Too drugs a boost in sales right off the bat (perhaps this low hanging fruit inducement is why it is so difficult NOT to develop Me Too drugs).
Will Celebrex Crash and Burn?
At the end of this post I make a prediction about Celebrex based upon a unique analysis. But first, let's see what the "experts" say.
Before a recent study revealed that Celebrex may also have negative CV side effects, Pharma Marketing News hosted a survey to access why Pfizer would risk testing Celebrex's ability to protect the heart (see the full text article with survey results: Will COX-2 Inhibitors Crash and Burn?).
At the time of the survey (Oct-Nov 2004) the negative clinical trial results regarding Celebrex were not publicly known. Surprisingly, a higher percentage of pharma company respondents than non-pharma respondents thought that, yes, Celebrex would crash and burn (25% vs. 15%, respectively). No marketing agency/consultant respondents thought so. Clearly, the marketing people are drinking their own Kool-Aid.
The Molecule's the Thing
Pfizer has said that Celebrex is "different" than Vioxx. Some clinical data are different and Celebrex does have a different chemical composition (combination of atoms). However, if you look at the molecular structures (arrangement of atoms in 3-D space) of Vioxx, Celebrex, naproxen and Mobic, you will see some are more different than others (click to see graphics).
Vioxx Molecular Structure
Celebrex Molecular Structure
Bextra Molecular Structure
Naproxen Molecular Structure
I studied biochemistry and specialized in building molecular models for X-ray crystallographers studying how drugs interact with proteins. So I know a bit about how inhibition of enzymes -- like the COX-2 enzyme -- works.
It is the shape (molecular structure or 3-D arrangement of atoms) of inhibitor molecules (e.g., drugs) that is critical. Drug inhibitors work by fitting into a crevice of the enzyme usually designed for its natural target molecule. This lock-and-key 3-D fit prevents the normal molecule from entering the active site of the enzyme. (If you want to learn more about this sort of thing, take a look at an NIH brochure: The Structures of Life.)
My Prediction: Celebrex Will Crash and Burn
While Vioxx and Celebrex (and Bextra) indeed do have different chemical compositions, their 3-dimensional molecular structures are very similar. This makes sense: drug patents are issued based on differences in chemical composition, not 3-D structure or even mechanism of action. Therefore, to produce a patentable Me-Too molecule, drug companies strive to keep the 3-D structure similar to the original molecule (thereby preserving its "fit" in the active area of the enzyme) while changing the peripheral, unimportant atoms hanging off the molecule (thereby making the chemical composition different and the molecule patentable).
If you rotate the molecular structure images (or molecular models) of Vioxx, Bextra, and Celebrex just right, you can practically superimpose one upon the other except for the odd atom bits hanging off.
Naproxen and Mobic, on the other hand, have completely different 3-D molecular structures, a fact not lost upon physicians who already have gone back to prescribing Mobic, which has been on the market much longer than Vioxx or Celebrex.
I predict, therefore, that Celebrex (and Bextra) will crash and burn and be pulled off the market or voluntarily withdrawn by Pfizer. Moreover, I predict that naproxen and Mobic will be vindicated and become the leading pain killers of choice to replace Celebrex and Vioxx.
Monday, January 03, 2005
Drug companies are among the biggest givers of aid to tsunami victims.
Pfizer will donate $10 million to local and international relief organizations operating in the region. Pfizer will contribute approximately $25 million worth of the company's healthcare products which includes the anti-infective products Zithromax, Zyvox and Diflucan.
PhRMA (Pharmaceutical Research and Manufacturers Association) member companies have donated money, medicines and healthcare products and also matched employee donations to assist the tsunami survivors. See the list below for some of the efforts by these companies to aid the victims. This list will be updated daily as information becomes available to PhRMA about additional companies and their activities.
Donations of America’s Pharmaceutical Companies to Tsunami Relief