FDA's Chang and Eng: Benefit vs. Risk

As reported in the Wall Street Journal, "A Food and Drug Administration advisory committee found that GlaxoSmithKline PLC's diabetes drug Avandia is tied to a risk of heart attacks, but it stopped short of voting to pull the medication off the market."

Behind that story, however, is the open discord between FDA's Office of New Drugs (OND), which approved Avandia for sale in the US, and the Office of Surveillance and Epidemiology, which is responsible for monitoring drug safety.

"At the meeting," WSJ reports, "officials of the FDA publicly clashed over what the evidence said about Avandia. Before the votes, two drug-safety officials -- David Graham and Gerald Dal Pan, who oversees the safety office -- said evidence signaling Avandia's risk outweighed its apparent benefits. But Robert Meyer, director of the FDA office that reviews diabetes drugs before they are approved, said he hadn't yet made up his mind and acknowledged a 'fundamental disagreement' among FDA staff."

It's as if the FDA had two heads!

FDA's Chang and Eng
But just like Chang and Eng Bunker, the original "Siamese Twins," the two heads are not equal. Like Chang, the OND side of FDA, is the stronger one -- only it has the power to force a drug off the market. It, of course, has a vested interest in keeping a drug on the market once it's reputation is at stake for having approved it for sale in the first place!

Just like Chang and Eng, the two heads of FDA have, until now, lived together in the same house with their wives -- or, in the case of the FDA, their staffs.

Eventually, however, the wives of the twins complained about the arrangement and Chang-Eng were forced to set up two homes and the twins would alternate spending three days at each home.

That is precisely the kind of arrangement Congress would like the FDA to adopt by giving more power to the Eng of FDA; specifically, more power to recall drugs for safety reasons.

I am not clear about the details of Chang's and Eng's sexual lives. All I know is that they had a total of 22 children -- 10 attributable to Chang and 12 to Eng!

See, that's what worries the drug industry about making FDA's Chang and Eng more equal -- Eng -- FDA's Office of Surveillance and Epidemiology -- may be more prolific than Chang! They fear that for every 10 drugs approved by Chang, 12 would be black-boxed or taken off the market by Eng. Can't have that!

It's interesting that Chang -- the stronger twin -- died first. It was said that he had a drinking problem, perhaps due to his insecurity about fathering fewer children than Eng. Who knows?

In the end, Eng refused to acquiesce to an emergency separation from Chang and he died just a few hours after Chang did.

According to some, separation of Chang and Eng would have been extremely easy, even with 19th century medical technology. But that never happened and both Chang and Eng were destined to live and die together.

That makes for a fascinating human interest story that will someday be brought to a movie screen near you. Unfortunately, FDA's Chang and Eng story does not make for good entertainment, just frustration over a dysfunctional agency that can't seem to agree on how to both serve and protect the public good.

GSK's Race-based Herpes Awareness Campaign

Both the Department of Health and Human Services and the American College of Obstetricians and Gynecologists reject routine screening for genital herpes. A federal survey in the early 1990s found that 21 percent of American adults had the infection and a follow-up survey this decade found that the national prevalence had fallen to 17 percent, according to a recent article in the Washington Post.

So why is GlaxoSmithKline, maker and marketer of Valtrex, an expensive brand name drug for the treatment of herpes symptoms (not a cure), running a campaign that includes an advertisement in publications and on radio stations with largely black audiences in cities including Baltimore, Detroit and Atlanta?

According to the Post story:

The "Say Yes to Knowing" campaign partners Glaxo with the National Medical Association, the country's main society of black physicians, and the American Social Health Association (ASHA), a nearly century-old organization devoted to fighting what used to be called "venereal disease." Each has received money from Glaxo in the past, although no donations were made in connection with this effort.

The campaign was introduced last month in Detroit, where it had the support of the local health department. In Baltimore the health commissioner has declined to endorse it.

So why is there this division among healthcare experts about the campaign? Has it something to do with race?

"Consider the facts specific to African Americans and genital herpes," says Jay Bolling, President of Roska Healthcare Advertising:

• Blacks have greater than twice the rate of infection by herpes than whites (48% vs. 21%)
• Only 10% who tested positive knew they were infected (asymptomatic)
• People without symptoms can transmit the virus
• Infection triples the risk of acquiring AIDS from an HIV-infected person
• Treatment cuts the odds of transmission in half

[Note: I have interviewed Bolling in a recent Pharma Marketing Talk podcast: Faith-based Unbranded Marketing: How to Educate, Engage and Empower members of the African American Community.]

"If these statistics were associated with hypertension, high cholesterol, asthma or breast cancer -all disease states for which African Americans are at considerably higher risk - would we even be having this conversation??", asks Bolling. "Just because people are 'uncomfortable' talking about sexually-transmitted diseases, should we bury our heads in the sand and avoid the discussion? Have we learned nothing from the success of raising AIDS awareness and its significant impact on diagnosis/treatment/death rates?"

It seems that the main benefit of treatment of herpes with Valtrex is the claim that it "cuts the odds of transmission in half." Sounds like a big deal, except when you look at the actual data. Without treatment: 4%, with treatment: 2%.

An axiom of pharma marketing is: When speaking of benefits, use relative terms ("decrease by half", etc.), but when discussing risks, use absolute numbers ("4% vs. 2%", for example). If the odds of having a heart attack using Valtrex were higher than placebo, I am sure absolute numbers would be trotted out.

Besides, there are other ways of decreasing the rate of transmission, including use of condoms:

Do condoms protect from Herpes and is their a vaccine for herpes? I believe that black folks need to get together amongst our selves and have serious and real conversation about health.

One aspect of the conversation on health should include teaching that all unmarried black people having sex should be using condoms. Period.

It is the only way to cut the rate of aids I believe the preachers (many of whom carry on extra marrital affairs) should start advising the brothas in church to use condoms if they dont wait until marraige. A female elder in the church should advise very strongly that unmarried women having sex make sure their partners use condoms during sex.

The church needs to start talking about responsible sexual behavior as well as the monumental importance of brothas taking care of their children but black parents being proactive and talking to their children honestly about responsible sexual behavior and protection.

I think the black church needs to start talking about herpes and all other sexually transmitted diseases, they need to set up hiv testing and treatment centers in all of their churches they can teach each other how to set up these services one by one.

Black people really need to stop living in denial and do something to change our all to often sad realities.

- a comment posted to "Mirror On America: The Black Community and Herpes"

"Kudos to GSK for investing in an effort that raises awareness of a significant health issue that plagues the African American community (48% rate of infection!)," says Bolling. "By making it a public health issue and concentrating dollars/efforts on the communities at greatest risk, the only outcome is a positive one. And, with the National Medical Association (NMA) on board, they’re raising awareness among healthcare professionals and providing them the tools they need to counsel patients and diagnose/treat the disease."

Obviously, GSK's intentions are not altogether altruistic. It has a vested interest in getting more people using its product.

Another organization with a vested interest in this is the National Medical Association (NMA) -- "the largest and oldest national organization representing the interests of more than 25,000 African-American physicians" -- which receives funding from GSK for a number of projects NMA is "on board" with.

Bolling doesn't agree with ANY of the arguments the Washington Post has against the herpes awareness campaign:

1. Telling people they have an incurable, sexually transmitted disease can have serious social and emotional consequences. "Are we saying that it’s better for people to have and spread this disease, but not know it, to spare them the social/emotional consequences??"
2. Whether testing and treatment of a subpopulation, such as black adults, are useful and cost-effective has not been studied. "Regardless of the facts (see above), I guess we shouldn't do anything unless we've studied it; and since we're not going to do anything, I guess there's no reason to study it..."
3. Treatment can be expensive. While generic acyclovir costs as little as $9.96 for a month's supply, Glaxo's Valtrex costs $192.88. "GSK's efforts can't dictate whether patients get generic acyclovir or Valtrex – last I knew that role is specifically in the hands of healthcare professionals (and insurers)."

GSK may not be dictating what white patients are prescribed by their doctors, but if the herpes campaign gets more black patients into offices of black doctors -- whose medical association is generously supported by GSK and who are targeted by GSK sales reps about the herpes campaign -- I am sure Valtrex will get the lion's share of NRx.

Measuring the ROE or Should I Say ROI?
According to the Post article, Glaxo officials describe the campaign as largely an educational experiment. "The company is surveying about 100 people in each city before and after the campaign to see if they learned anything about genital herpes." Can't wait to see the results!

This is what's often called "return on education (ROE)" in non-branded marketing arenas.

I bet that's not all they are going to look at after the campaign. In the real world of pharma marketing, there's really only one important measure of success: ROI as in $ returned for every $ invested.

I would like to be the fly on the wall when the Valtrex product team reviews the prescribing behavior of the black doctors in Baltimore, Detroit and Atlanta where the campaign is running vs. those in Los Angeles, for example, where it is not.

"I only wish they [GSK] had gone further to engage the faith-based communities, initiate target marketing efforts across all 'grassroots' media and support screening/health events to promote action and 'connect' patients with healthcare professionals," says Bolling.

"As a healthcare community all of us need to focus our energies in areas we can make a significant difference -- and the under-served, under-diagnosed, under-treated, at-risk patient populations are a damn good place to start. Congratulations to GSK, the NMA, ASHA and the local health department in Detroit for 'getting it' -- one can only hope that the Health Commissioner in Baltimore retires soon..."

Hmmm.. I am not sure Jay is not keen on Baltimore's health commissioner, Joshua M. Sharfstein, because he turned down Glaxo's request to become a local partner in its campaign or because Sharfstein formerly was a senior aide to U.S. Rep. Henry A. Waxman, a long-time drug industry foe.

According to the Washington Post story, Sharfstein turned down GSK's offer "because of the lack of evidence to support, as a public health strategy, screening for herpes in people without symptoms." He added that "the racial targeting was not an issue that we needed to address to make a decision."

Social Network Analysis Good for Obesity Drug Marketing and Beyond!

You've probably played the game Six Degrees of Kevin Bacon in which players attempt to connect any film actor in history to Kevin Bacon as quickly as possible and in as few links as possible.

Now there is a new study on obesity that may lead to a new game I call "Six Degrees of Bacon Fat!"

In this game, a contestant is shown a photo of a fat former Hollywood starlet taken from the pages of National Enquirer and must connect himself or herself to that starlet through other obese people in as few links as possible. Like... I know X, who is obese, and he works in a PR firm hat has this starlet's agent as a client. That agent is obese too! I win!

According to the Wall Street Journal's Health Blog:

"Among more than 12,000 people in a decades-long study of heart disease, a person’s chances of becoming obese increased by 57% if he or she had a friend who also became obese, and by 37% if a spouse became obese. In a twist reminiscent of the pop-culture game six degrees of Kevin Bacon, researchers found that if your friend’s friend became obese, it increased your chances of becoming obese by 45%. If your friend’s friend’s friend became obese, it increased your chances by 20%."

According to that Blog's author, "It may be time to start thinking of obesity as an infectious disease."

"Obesity appears to spread from one person to another like a virus or a fad," says a Washington Post article, "researchers reported yesterday in a first-of-its-kind study that helps explain -- and could help fight -- one of the nation's biggest public health problems."

Oh, Ho!

That, my friends, must be music to the ears of drug companies working on obesity medications! If obesity is an infectious disease, and spreads from person to person like a virus, then there really is an "obesity epidemic" in this country! Ka-ching!

Social Network Analysis
The method used in the study is social network analysis, which is a special interest of Nicholas Christakis, M.D., the principal author of the study:

Currently, [Christakis] is principally concerned with health and social networks, and specifically with how ill health, disability, health behavior, health care, and death in one person can influence the same phenomena in a person's social network. Some current work focuses on the health benefits of marriage and on how ill health in one spouse can have cascading effects on the other spouse. It seems likely that improving the health of one partner in a marriage can have meaningful effects on the health of the other, [my emphasis] and that both parties would value this -- in a way that influences health policy. Other work examines a very large social network (of 12,000 people, including family, friends, and neighbors) followed for over 30 years to look broadly at the role of networks in health and health care. This work involves the application of network science and mathematical models to understand the dynamics of health in longitudinally evolving networks. To the extent that health behaviors such as smoking, drinking, or unhealthy eating spread within networks in intelligible ways, there are substantial implications for our understanding of health behavior and health policy.

This field of study may have some application in pharmaceutical marketing and advertising beyond helping obesity drug marketers hawk products that, in themselves (without lifestyle changes), offer very little relief. Here are two ideas for marketing applications that come to my mind:

1. Framing the right kind of educational message in DTC advertising, and
2. Exploiting online social networking tools

How much better would Viagra DTC ads be if they somehow connected the wife's sexual health with the husband's? I'm not sure how to do this on network TV, but this is the kind of thing Pfizer should be studying how to do rather than how to connect Viagra with recreational sex and a good time as in its "Viva Viagra" campaign (see "Viva Viagra Ad is No Cure for Morte Sales").

As for #2, I don't think anyone has connected the dots that exist between Christakis's work and the dynamics of online patient support communities. Pharmaceutical companies are very interested in partnering with these communities, influencing the discussion, or advertising within them. They are not quite sure which approach to use and are very afraid of open discussions about their products.

No one is considering, however, if the same dynamics Christakis sees in the real world operate in the virtual world and if they do, how to exploit that.

I'm just thinking out loud here and hoping to get a discussion going. It's summer, it's slow, what more can I say?

Why Do DTC Ads - "Viva Viagra" included - Stink?

Lately, we've been witnessing a regression of sorts in the quality of DTC (Direct-to-Consumer) Rx drug ads. The recent "Viva Viagra" ad, for example, is a throwback to the days before Congress was serious about banning DTC or imposing more restrictions on DTC (see "Viva Viagra Ad is No Cure for Morte Sales").

The Viva Viagra campaign also reneges on Pfizer's pledge back in 2005 to focus more on disease awareness in its DTC advertising. At the time, I said that erectile dysfunction (ED) ads would be the litmus test for this change in policy (see "Pfizer DTC Pledge: ED is Litmus Test"). Well, it seems that Pfizer has failed the test.

Viva DTC Old-school Style!
It should be noted, however, that in the Pfizer press release about its pledge (which no longer can be found on Pfizer's site), the phrase "in 2006" was used to qualify the terms of the pledge. I guess now that we are well into 2007 and Congress has removed any mention of mandatory DTC moratoriums in the PDUFA legislation, there's no longer a need to look good in public. So party on, you DTC marketing animals!

"Unfortunately," says Richard Meyer of World of DTC Marketing, "Viva Viagra is another reason that real good DTC is on life support and maybe DOA."

Not only do these ads fail to live up to promises of educating the public about medical conditions, they also STINK! At least in terms of delivering return on marketing investment. Rozerem is definitely spending more on marketing than it is getting in return (see "Rozerem Ad Spending Exceeds Sales!"). The same fate may await Viagra -- it's difficult to imagine the ad enticing more men to talk about erectile dysfunction with their physicians, which is Pfizer's stated goal for the ad.

"I worked with the DTC team on the launch of Cialis and learned first hand the barriers that many face to seeking treatment for this condition that effects couples. These barriers cannot be overcome with a jingle of images of couples in bathtubs." -- Richard Meyer.

Why Do DTC Ads Stink?
Why do these ads stink at delivering ROI although they are highly memorable and score highly in typical focus groups?

Lee Weinblatt, CEO of The PreTesting Company, which tests the ads and commercials of over 300 of the world’s largest companies, thinks he knows why. The typical methodology for measuring DTC effectiveness, claims Weinblatt, "is leading pharmaceutical DTC advertisers down the wrong path."

What, then, is the right path?

Podcast Today at 1 PM!
Tune in today to a live podcast interview of Weinblatt in which he will answer that and the following questions:

1. What major problems have you seen with DTC ads? Are drug ads too much like package goods ads?
2. What about the agencies that drug companies use to create their ads? Are they up to the task? If not, why not?
3. Why are recall and likability of ads meaningless?
4. What should be the measure of ROI for DTC campaigns? Does increase in market share figure into that calculation?
5. What does the Pharma marketing executive need to know about how ad performance? How does Pretesting deliver on that? How do Pretesting Company's techniques differ from other company's techniques?

• Live Podcast Date: Wednesday, July 25, 2007, 1 PM Eastern US time
• Duration: Approx. 35 minutes
• Go to the Pharma Marketing Talk Channel Page to listen LIVE at the designated time or afterward to listen to the audio archive on the Web with your browser. After the live podcast you can also click on a button below to listen to the streaming audio archive on your computer or to download the show for playback on your iPod or other portal audio player.

Smell ya later! Ha, ha!

Viva Viagra Ad is No Cure for Morte Sales

According to a report on Bloomberg.com, "Pfizer is struggling to boost sales of Viagra, which have fallen 11 percent to $1.7 billion since 2003, when Eli Lilly & Co.'s Cialis and Bayer AG's Levitra became available." (See "Pfizer Sings `Viva Viagra' to Boost Sales of Impotence Drug")

Once again, Pfizer turns to direct-to-consumer (DTC) advertising to reverse it's loss of market share. The latest ad ran last night on NBC Nightly News. It featured a boomer boy band (see screen shots below) singing to the Elvis tune of "Viva Las Vegas" only this time it was "Viva Viagra" they were shouting.

"Viva" now adorns the viagra.com website and all ads for Viagra online.

Of course, some naysayers accuse Pfizer of playing up the link between Sin City (Las Vegas) and recreational use of Viagra. Viagra, they say, is a treatment for a serious medical condition -- erectile dysfunction. Viagra ads, they say, should focus on educating consumers about this condition, explain the treatment options, and encourage men to ask their doctors about the symptoms and treatment.

That, after all, is the benefits of DTC according to PhRMA's Guiding Principles, which claim:

"A strong empirical record demonstrates that DTC communications about prescription medicines serve the public health by:

• Increasing awareness about diseases;
• Educating patients about treatment options;
• Motivating patients to contact their physicians and engage in a dialogue about health concerns;
• Increasing the likelihood that patients will receive appropriate care for conditions that are frequently under-diagnosed and under-treated; and
• Encouraging compliance with prescription drug treatment regimens."

Unfortunately, there's not enough time in 60 seconds to do the song and ALSO explain ALL this! Something had to give and the Viagra ad agency went with the catchy song instead of the boring education.

Instead of education, viewers only got to hear the indication, a sales claim, and the standard "Talk to your doctor" statement as in: "Talk to your doctor about Viagra, America's most prescribed treatment for erectile dysfunction. Learn more at viagra.com." The words "erectile dysfunction" (ER) appeared in small type and no mention was made that ER may be a condition associated with more serious medical conditions like high blood pressure and diabetes.

In contrast, Lilly continues to run more serious Cialis ads that discuss the causes of ED. So while Viagra marketers fiddle with the Viva theme, Cialis sales continue to burn up the ED market! At this rate, Viagra soon may NOT be America's "most prescribed treatment for erectile dysfunction."

No Women Here!
In a departure from previous Viagra ads and most other ED ads I've seen, there are NO women in the Viva Viagra ad. It's just a bunch of good old (well, not so old) guys in what looks like an abandoned roadhouse having some fun with their instruments -- not that there's anything wrong with that! At the end of the ad, they all SEEM to go their separate ways -- home to their "honey's" I suppose.

Along with the recent Exubera ad, this ad firmly places Pfizer in my League of Undistinguished DTC Advertisers.

Screen shots of the Viva Viagra video as seen on viagra.com Web site

VIVA VIAGRA LYRICS

Got me a honey gonna set my soul,
gonna set my soul on fire!
At the end of the day
I'm not a guy to stray
because she's my heart desire.

Now this lonesome toad
is sick of the road
I can't wait

CHORUS; Can't wait!

I can't wait to go home.

CHORUS: Viva Viagra! Viva, VIva, VIVA VIAGRA!

###

Mandatory Vaccination Controversy Did Not Hurt Gardasil Sales!

According to the Wall Street Journal health Blog:

"Looking at the numbers Merck is posting for sales of its cervical-cancer vaccine Gardasil, the Health Blog can’t help but wonder whether Merck really needed to even try its controversial lobbying push to boost the vaccine’s sales." (See "Gardasil Gives Merck Shot in the Arm").

Although sales of Gardasil were $358 million in the second quarter, following a first-quarter showing of $365 million, this doesn't mean that the slight decrease was due to the controversy that erupted in February after it was discovered that Merck was lobbying state legislatures for mandatory vaccination program for preteen girls (see "Gardasil: To Be Mandatory or Not To Be Mandatory -- That is the Question").

As pointed out by the WSJ blog, "A fall in Gardasil sales was not a surprise from the first quarter to the second this year, though, since many states were stocking up on the vaccine in the first quarter as part of a federally funded vaccine program."

In any case, it seems that the mandatory vaccination PR snafu hasn't hurt Gardasil sales.

Back in March, I suggested that rather than hurting Gardasil sales, the controversy might actually help sales (see "Does Merck Need a Vaccine for Bad PR?"). A survey asked readers their opinion, which is shown in the following chart:

Only 23% thought of Pharma marketing Blog readers who responded to this poll thought that the controversy would hurt sales. Ah! The wisdom of the crowd! Gotta love it!

Proximity Marketing: From Urinals to Doctors' Offices, Track Your "Target"

I never liked using urinals and now I have more reason not to: something called "proximity marketing."

An interesting example of this technique was highlighted in a recent post at Pharmalot. It seems that "the bathrooms at city hall in Bayonne, NJ, a working class town across the Hudson River from Manhattan, had framed notices and promotional brochures for Uroxtral, a drug for treating enlarged prostate that’s sold by Sanofi-Aventis."

Ed Silverman goes on to note that Bayonne and the proximity marketing agency it rode in on (TSN Group) have agreed that city hall was the wrong place for this campaign and that the materials will be transferred to the Fourth Street Senior Center where "they would be more apt to be seen by seniors."

The "photo" at the left shows what seniors may be seeing while pissing away their remaining hours at senior centers.

But a urinal-based proximty marketing campaign for a prostate drug is sure to fall on deaf ears -- or should I say non-streaming penises. Men with enlarged prostates have problems getting a stream started and maintaining it -- something they are not likely to want to call attention to by using a urinal. My guess is that they would prefer to pee while sitting, not standing.

Of course, I am being flippant. Enlarged prostate is a serious condition and the Bayonne campaign doesn't involve branded urinal cakes -- but, who knows, maybe I've given the TSN folks an idea for future campaigns!

But give me a break! Placing marketing materials for drugs like this in bathrooms! Sure the idea sounds good on paper. But I don't think it will play in Bayonne! Besides, isn't there enough crap in men's rooms? Do we have to add marketing BS as well?

NOTE: What does Bayonne get from this deal? A measely $200 per year! At first I thought that was a typo, but it ain't! Of course, it remains to be seen how many "eyeballs" Bayonne can deliver in order to calculate the CPMP (cost per million penises).

Proximity Marketing Today and Tomorrow
The TSN website defines proximity marketing as bringing "brands closer to consumers through programs that reach consumers in the context of their daily lives – in places where they shop, recreate, work out, socialize, and seek healthcare information." [They should ad "where they sh*t and pee" to the list!]

The future of proximity marketing technology was showcased in the Speilberg film "The Minority Report." Sensors in virtual billboards identified people as they walked by and displayed ads customized for that person. Of course, this was a world without privacy. Either that or Tom Cruise was stupid enough to "opt-in" and give away his personal information to an ad network.

CNN's Bid for Pharma's Proximity Marketing Dollars
But it's not just boutique agencies like TSN that are getting into proximity marketing. CNN, for example, wants to put flat-screen TVs in doctors' offices and beam in health-related and drug-sponsored programming featuring that beacon of objectivity: Dr. Gupta! [See ad at left. Click to enlarge.] Remember Gupta from his confrontation with Michael Moore (see "Moore's Blitzer Krieg")? He didn't strike me as a credible source of health information!

According to the "Accent Health CNN" ad copy, which I found in this month's Pharmaceutical Executive Magazine:

First, it defines what proximity marketing is all about:

"Just as it's vital to reach your target at the right time, you've got to reach them at the right place, and in the proper state of mind." [My emphasis added.]

Then, it tells you the benefits:

"In the trusted environment of their doctor's office, our viewers are watching our health-related programming -- and absorbing your health-related advertising." [My emphasis added.]

I can imagine no better way to ruin the "trusted" environment of a doctor's office than to bring in CNN, the most notorious untrustworthy source of news, and especially health news. Adding insult to injury, CNN obviously thinks patients are more like targets into which ad arrows are shot or sponges "absorbing" anything put in front of them rather than actual people who deserve unbiased information vetted by their physicians. The latter, to me, seems a much better approach to office-based "proximity marketing" by pharmaceutical companies.

I predict that Accent Health CNN eventually will join the junk heap populated by all the other technology-based in-office marketing initiatives, but not before the pharmaceutical industry spends a bundle on "pilot programs." They are that desperate!

DTC Believability Scoring
BTW, the CNN ad claims that "50% of our viewers [find] your message more believable when they see it on AccentHealth than when they see it at home..." [That must mean 50% DO NOT find the messages more believable. But I digress...]

This stat is based on a Roper Public Affairs DTC "average believability score." I am not sure how they measure this, but in this week's Pharma Mmarketing Talk podcast ("Your DTC Ads Stink!"), I will be talking to Lee Weinblatt, an expert in measuring DTC effectiveness. He may have some insights about whether or not CNN's viewer claims are believable. He won't comment, however, on CNN's believability.

Exubera TV Ad Lacks Bong, er, I mean Bang!

Pfizer's Exubera ad campaign has begun, not with a bong, but with a whimper!

July is turning out to be a cruel month for Pfizer, which just recently announced a 48% drop in net income amid predictions that sales of Exubera -- its new treatment for type-2 diabetes -- are far from what was expected and won't pick up much even after DTC advertising starts (see "What do Abe Lincoln, a beaver, and a bong have in common?").

After seeing the new Exubera ad on TV last night, I would have to agree with the above assessment. The ad neither addressed the main advantage of Exubera -- it can replace the needle -- nor did it educate anyone on how it is used. It never shows anyone "taking a hit" -- that is, you don't see anyone actually using the thing! Thus, it hasn't directly confronted the main criticism a lot of people with diabetes have, which is that it is embarrassing to use in public (see "Are you happy to see me, or is that just your Exubera Bong?").

The ad does show someone in a restaurant who has just finished using the device. It merely shows him closing it happily and from a distance so that the thing doesn't look too huge.

In contrast to that, take a look at the following video of a news story about Exubera, which clearly shows how it is used and points out the advantage over taking insulin by needle.


Perhaps Pfizer's PR people helped place this story. If so, the marketing people have not integrated their ad message with the PR message.

Eventually, Pfizer may fix its Exubera DTC ads and may even start a Bong Blog as I suggested half-jokingly (see "Pfizer's Exubera Strategy Needs a Bong Blog!"). But it appears that Wall Street, not to mention type-2 diabetics, lack the patience to wait.

What do Abe Lincoln, a beaver, and a bong have in common?

If you guessed negative Return on Investment, you win!

Pfizer, the largest pharmaceutical company in the world, is about to join the League of Undistinguished DTC Advertisers (LUDA) upon the launch of its the much-anticipated Exubera DTC campaign.

According to a recent post on Phamalot, at least one Wall Street Analyst has "lowered [his] Exubera estimates dramatically for 2007-2010; we now forecast 2007 worldwide sales of $20 million, down from $296 million and peak sales in 2012 of $326 million from $1.4 billion."

"We think [the DTC campaign] may produce an uptick, but Exubera sales are on a whole different trajectory than we and the Street had been modeling."

"Yes," says Pharmalot author Ed Silverman, "that would appear to be straight down. And the cost of a few TV ads will easily eclipse recent sales. What a promotional bargain." (See "Pfizer's Exubera: $4M In Sales! Bongs Away!")

Given this, Pfizer will likely join ranks with Takeda Pharmaceuticals whose Rozerem ads have long languished in negative ROI territory (see "Rozerem Ad Spending Exceeds Sales!").

But could Exubera ads pull Pfizer out if its Exubera hole by leading to more than a mere uptick in sales? Not unless those ads take a path different than that of Rozerem's.

"Pharmaceutical companies are wasting millions of dollars on ads that aren't delivering their products' key messages!," says Lee Weinblatt, founder and CEO of PreTesting.

"And it has nothing to do with FDA rules. In the good old days, only pharmaceutical specialist agencies handled medical ads, most of which were directed at physicians. Now they are using the matrix that packaged goods ads use to measure effectiveness such as acceptance and so on. This is leading pharmaceutical DTC advertisers down the wrong path," according to Weinblatt.

Weinblatt cites the Rozerem ads as models of the "wrong path." "Talking about dreams means nothing to older people who cannot sleep through the night," says Weinblatt.

Podcast: Your DTC Ads Stink!
I will be interviewing Weinblatt in an upcoming Pharma Marketing Talk podcast on July 25, 2007. See "Your DTC Ads Stink! " You can listen live or you can listen to the audio archive afterward. Either way, I am sure you will enjoy Lee's comments -- he's quite outspoken about the current state of DTC advertising and he has tested the ads and commercials of over 300 of the world’s largest companies.

The "RLS Gene" Story: Requip Ad Disguised as News on ABC

I couldn't believe my eyes and my ears last night when ABC News devoted significant air time to a story that it claimed "will put an end to criticism of Restless leg Syndrome" or something to that effect.

[I wish I had the video to prove to you that was exactly how this story was introduced. I need a TiVO if I am going to continue in this business!]

In reality, this "news" item was a direct to consumer ad (DTC) for Requip, except without the fair balance! Prominently featured in the opening segment of the ad, er, I mean "news story," were clips from the infamous Requip ads showing the specially-made green chair and a physician mouthing the single word "Requip."

Contrary to ABC News's prediction viz-a-viz shutdown of criticism, there is so much to criticize here that I am at a loss where to begin my renewed criticism! But I will give it a stab.

First, the story is about a scientific study published in the New England Journal of Medicine (NEJM) that claims to have found the gene for Restless Leg Syndrome (see "Restless Legs Scientists Find Sleep-Kicking Gene").

Follow the Money
Let's first follow the money to see if we can catch a "tricky dick" here.

The study, "A Genetic Risk Factor for Periodic Limb Movements in Sleep," was sponsored in part by the Restless Leg Syndrome Foundation, which, as I have pointed out before, is an "astroturf" non-profit established and virtually run by GlaxoSmithkline (GSK), the company that markets Requip for the treatment of RLS.

GSK and Boehringer Ingelheim (BI, maker and marketer of Mirapex, another RLS treatment) are "Gold Level Sponsors" of the Foundation (see "Restless Pharma Marketing"). These companies have an even more incestuous relationship with the RLS Foundation:

The first RLS Foundation Science Award went to Ronald L. Krall, MD, Senior VP of Worldwide Development at GSK! That's a first! Pipe money into a foundation and viola! you (or a VP in your company) gets an award!

Not only that, Dr. Richard Allen, a member of the RLS Foundation's Medical Advisory Board, proudly reveals in the press release that he had the "pleasure" of "collaborating" with the research team selected by Dr. Krall to do studies supposedly supporting the data on the prevalence of RLS in the US and in Europe.

Undoubtedly, the RLS gene study, which originated in Iceland, was one of those "collaborations." (See the RLS Foundation press release.)

OK, we have an industry-created and supported astroturf foundation laundering GSK and BI money to support RLS research in Iceland. It doesn't look good, but the researchers could still be independent and credible, right?

Wrong!

Here's the authors' conflict of interest statement at the bottom of the NEJM article:

"Dr. Rye reports receiving consulting fees from or serving on paid advisory boards for GlaxoSmithKline, Boehringer Ingelheim, Ortho-McNeill, and Sepracor and lecture fees from GlaxoSmithKline and Boehringer Ingelheim; Dr. Bliwise, receiving consulting fees from or serving on paid advisory boards for Takeda, Neurocrine, Sepracor, and Cephalon and lecture fees from Takeda and Boehringer Ingelheim. Dr. K. Stefansson is chief executive officer and Dr. Gulcher is chief scientific officer of deCODE Genetics, and both have equity in the company. The company has a financial interest in the results of this study, including diagnostic products and patents. No other potential conflict of interest relevant to this article was reported."

OK, so we can't trust some of the authors either. But, maybe the science is still OK.

Forgive me for not wishing to delve too deeply into the science, particularly about how strong the connection is between the newly discovered gene and RLS. Let's just say that I don't question the connection between a gene and the condition that the researchers actually studied, which was NOT RLS.

The study was initially done with 306 Icelanders who fit the criteria for RLS and who kicked their legs once they fell asleep -- an action known as periodic limb movements in sleep, or PLMS.

OMG, another acronym for a "real medical condition"!

They also studied 108 Americans in Atlanta.

Quite a convincing N, don't you think? And here I am criticized for my "unscientific" survey with N=145!

The researchers attached a gizmo to the legs of subjects and measured twitches during sleep. The ABC News report showed a graph of someone suffering from PLMS who twitched 60 times an hour during sleep. I am not sure where the cutoff is -- how many twitches per hour is considered "periodic" enough to be PLMS? This is the level of detail I refuse to sink to.

Anyhoo, what does PLMS have to do with RLS?

That's either the Archille's heel of this study or the genesis of a new indication for Requip and a whole new marketing campaign. I envision late-night DTC ads showing scantily-clad babes like that pictured above kicking in their sleep.

NOTE: The photo above is taken from the ABC News Web site version of the story. In the broadcast -- aired during family hours -- a decidedly less attractive woman in jammies and unsexy white socks(!) was used to illustrate what they dubbed "sleep-kicking."

A supposed physician ("docpiner") commenting on the ABC piece had this to say:

"This disease [RLS] has nothing to do sleep kicking. Kicking in sleep is NOT restless leg syndrome. Feeling an uncomfortable sensation in the legs and needing to consciously move the legs to get relief is what this [is] about. This howevere (sic) does not get you your snappy title. You do a disservice to your readers with this type of shoddy reporting."

Indeed, even physicians on GSK's and BI's payroll admit the same:

"It is not a gene per se for RLS, but rather for leg movements seen in individuals and families with RLS," said Dr. John Winkelman, medical director of the Sleep Health Center at Brigham and Women's Hospital. "Whether the same gene is associated with periodic leg movements in [other] contexts, we have no information from this study."

[According to ABC News, Dr. Winkelman "has reported receiving financial support for research, as well as consulting and lecture fees, from Boehringer Ingelheim and GlaxoSmithKline."]

The RLS Foundation, however, has no qualms about playing up the connection between RLS and PLMS:

"PLMS are present in about 90% of people with RLS and are considered a typical expression of RLS."

The Foundation doesn't cite its source for this tidbit of information.

It's interesting that the gene associated with PLMS is found in 65% of all Icelanders and maybe as many Americans.

Whoa boy! Imagine Requip having an new indication for PLMS! Is that a marketer's wet dream or what?!

New Requip Ads Coming Soon?
But new indication or not, I envision new Requip TV ads showing more twitching in sleep than twitching during dinner at a restaurant. GSK already has the YouTube video prototype out there (see "GSK's YouTube Disease Awareness Sponsorship"). Will FDA allow this in branded advertising? Inquiring minds want to know.

Meanwhile, this study sets the stage for the greatest off-label promotion scandal to come. I am sure GSK and BI sales reps and/or Medical Science Liaisons will be out there talking this up to physicians who undoubtedly will be led to equate PLMS with RLS.

Another commenter to the ABC News story shows how easy it will be to confuse RLS with PLM:

I too agree with docpiner it is not sleep kicking. I have had RLS since my last child was born (19 years ago) and it is very annoying. I hated to see evening come. As soon as I would sit or lie down for the evening my legs would start. I finally found Requip about 3 years ago and has provided me with relief so that I could get to sleep. It wears off for me around 6am. My legs get me awake then I have to get up. My legs ache (from the knees down) and also wonder if other RLS sufferers have the same problem.

DTC Industry Check-Up or Cherry-Pick?

The best way to counteract an argument based on data -- like Avandia side effect data from a meta analysis of clinical trials -- is to accuse your opponent of "cherry picking" the data to suite his/her argument.

CNN's Dr. Gupta did this to counteract Michael Moore's citation of HHS longevity data (see video here). It seems that Gupta preferred WHO cherries over HHS cherries.

Definition of cherry picking according to Wikipedia:

"In the literal case of harvesting cherries, or any other fruit, the picker would be expected to only select the ripest and healthiest fruits. An observer who only sees the selected fruit may thus wrongly conclude that most, or even all, of the fruit is in such good condition.

"Thus, cherry picking is used metaphorically to indicate the act of pointing at individual cases or data that seem to confirm a particular position, while ignoring a significant portion of related cases or data that may contradict that position."

For a long time now, consultants with a vested interest -- ie, financial interest -- in eMarketing have repeatedly cherry-picked data to support the notion that Big Pharma is on the verge of shifting massive amounts of marketing dough to online venues. See, for example, my OpEd piece from 2002: "What Stands in the Way of the Mainstream Use of the Internet by Pharmaceutical Companies?"

Annual DTC Industry Checkup
The latest "Annual DTC Industry Checkup" (download it here) survey published by Dendrite is a case in point. The press release "DTC Marketing for U.S. Prescription Drugs Moves Online" says it all -- all, that is, if you actually believe the opinions of 134 "DTC Marketers," 94 (70%) of whom are vendors, consultants, or ad agency people, are unbiased. The remaining 40 (30%) are employed inside the drug industry. Even they are not likely to be unbiased.

Actually, this press release says it all only if you cherry pick the data!

Figure 9 in the survey white paper summary (below), includes ALL the data. Although it shows "Websites" leading the pack in where most respondents said pharma should increase spending, other decidedly non-online, channels like Dr. Office Programs and Pharmacy Programs are close behind.

Click on the image to see enlarged view.

DTC Moves to Pharmacy Shelves
If I were a pharmacy promotion vendor, I could easily pick some other cherries and write a press release that said "DTC Moves to Pharmacy Shelves!" Hmmm... maybe it's time to bring high-tech to THAT channel. If you want to meet some people who can do that for YOUR brand, email me (johnmack@virsci.com) and I will put you in touch.

Don't Count These Pharmacos Out of the New Mix
Although I might question the scientific accuracy of the Dendrite survey and criticize the self-aggrandizing cherry picking promotion, some pharma companies may actually be planning to do much more marketing online in the near future than they have down in the recent past.

I would put Johnson and Johnson, GSK, and Merck in that category.

J&J and GSK, for example, have recently dipped their toes into social network marketing by starting up blogs (see "'Round the Sphere: Pharmaco Blogs and Carlat's Crusade"). Merck recently announced a plan to reformulate its marketing mix and put new emphasis on technology (see "Rejiggering the Marketing Mix a la Merck").

alli Marketer Explains "Treatment Effects"

Back on June 12, 2007, I noted that the alli marketers applied newspeak principles to direct-to-consumer (DTC) advertising by referring to the drug's oily spotting side effects as "treatment effects." (See Alli Newspeak: Oily Spotting is "Treatment Effect".)

Joe Cadle -- official alli marketing director and self-proclaimed "Mr. Marketing Guy" over at the alliConnect blog -- argues that "calling them side effects is actually misleading."

Here's his "actual" logic:

"Side effects are generally unrelated to what a drug is trying to fix and often are harmful.

"For example, I take a calcium channel blocker to lower my blood pressure. It also makes me dizzy. But I don't take the channel blocker to get dizzy. If I wanted to get dizzy, I could chase around my 4 kids and 2 dogs.

"When you take alli, the blocked fat goes out the only exit available. If you eat too much fat, the fat excretion is ugly. That's how the drug works! The exiting fat isn't a side effect, it's the actual treatment of the drug. Hence, 'treatment effects.'"

[See Why'ja call them "treatment effects"?]

Such logic is a good example of what I have often called "carefully wrought marketing BS" (see "Is Pharmaceutical Marketing BS?"), which, unfortunately, may not be easily recognized as such by your average consumer who, I believe, would consider ANY UNWANTED effect of a drug, a side effect. In fact, this is how the Texas Heart Institute defines side effects when describing the calcium channel blockers that Cadle is taking (see here).

I suspect that if alli were an Rx drug rather than an OTC drug, the FDA would NEVER allow Cadle to whitewash side effects as "treatment effects." Otherwise, marketers of Xenical -- the Rx equivalent of alli -- would have been using this ploy a long time ago!

In a comment posted to the alliConnect site, I said:

Since Alli is the same chemical entity as prescription drug Xenical -- which is required to list side effects by the FDA -- we can see that what are called "treatment effects" by Alli marketers are simply called "side effects" in the Xenical label.

See the table of "side effects" in the Xenical label here.

GSK and the alli marketing folks are to be commended for how they are managing the alliConnect blog. They posted my comment without much delay and I have seen several posted comments that are much more negative than mine.

There are also several comments from All team members, who clearly identify themselves as such.

However, you have to balance this against the fact that the blog allows alli marketers to promulgate their marketing BS to a wider audience in pertpetuum without interference from bothersome regulators at FDA who have their heads in the digital sand anyway (see "Where's DDMAC's Head At?").

No Side Effects, No Adverse Events: QED!
Speaking of FDA, Mark Senak over at Eye On FDA comments that pharmaceutical product blogs are so unusual primary because of risk-adverse pharmacovigilence folks within drug companies:

"...some companies have told me that they refuse to monitor blog content for fear of seeing an adverse event reported on their drug which would require pharmacovigilence to step in and investigate. Yet, here is GSK going ahead with a blog that presumably has some spontaneity to it and where comments that are posted can most certainly talk about adverse events." (See "A Look at GSK's alli Blog").

The ability of GSK to do all this is made possible by the lack of FDA regulation in the OTC market. Correct me if I am wrong, there is no need, for example, for OTC manufacturers and marketers to report adverse events to the FDA. There's even less of a need if there are no side effects, but just "treatment effects."

One benefit of this ability to allow comments from anyone and to monitor these comments, is the ability for alli marketers to interact with and LEARN from their consumer audience. And there is nothing wrong with that, especially if they keep the dialoque open and honest!

I'm Non-Objective and Proud of It!

Looking for an objective POV of pharma marketing practices? Forgettaboutit! as they say in my native hometown of Brooklyn, NY. You won't find that here!

Bob Ehrlich, in his weekly DTC in Perspective "e-Column" entitled "Beware of Objectivity," covered the topic of objectivity in pharmaceutical-land in his uniquely non-objective fashion. Of course, he admits he himself is non-objective. BTW, you may be able to find his remarks here, although it may take awhile for Bob's Web folks to update this page.

Bob talks about the non-objectivity of pharma industry folks, the press, physicians, and himself; but he devotes the most space to bloggers. Here's what Bob says about bloggers:

"Bloggers always have some strong point of view, frequently angry and antagonistic. They usually do not like the drug industry because they are ex-employees with some complaints of unlawful activity, health practitioner critics of drug companies, or marketing “gurus” who feel qualified to critique DTC marketing practices. They also frequently represent some new media vehicle and bemoan the fact that the drug industry still uses mass television and print as their main media.

"Bloggers are good at making you believe they are heroic in their mission to protect the public. But check behind most blogs and there is a hidden agenda related to fame seeking, product selling, whistle blowing, or revenge. There is nothing wrong with any of those motives as long as the reader recognizes the reason behind the blog. Unfortunately many bloggers will not disclose their affiliations, biases or even their name.

"So next time you hear or read someone who says they are telling an objective story on the drug industry, ask what lies beneath. It is rarely objectivity and those who can admit their slant have more credibility than 'heroes' with a hidden agenda."

Thanks Bob, for you vote of confidence in my credibility.

For those of you who don't read my Pharma Blogosphere Blog, let me quote from a recent post I made there on the topic of objectivity (I think this was Bob's inspiration for his piece):

Don't Confuse Blogging with Journalism
... Blogging is everything that journalism is not and more so. What blogger wants to be "fair"? What does that mean, anyway? ... BTW, I started my blog primarily to present my biased view, which is, by definition, unfair! Live with it!

Hidden Agendas
Bob mentions hidden agendas and freely exposes his: "without the health of DTC advertising my business would not exist. I feel I can be fair, albeit subjective, since I support the right of drug companies to do DTC as it currently exists."

It's OK to have a hidden agenda:

He who is without a hidden agenda, let him cast the first stone!
-- John (Mack) 07:13:07

I think what Bob is saying is to look out for bloggers who claim to be objective, but who have hidden agendas.

Since I do not claim to be objective, this maxim does not apply to me. Still, what's my "agenda"? Is it hidden?

I don't think so. I have often made my agenda plain and have done so recently: see "The Drug Industry Needs Constructive Criticism, Not Pugilistic Put Downs." That is the best expression of my mission if not my "agenda."

Like everyone else, I also wish to make a living and promote the things I do that fulfill my mission.

So, please

• subscribe to my newsletter,
• advertise to my subscribers and readers,
• listen to my podcasts,
• join me and your peers in social networking,
• participate in my Roundtable discussions,
  
• hire me as a consultant,
• and continue to read and submit comments to my blog!

Why Grow Your Own Drugs When You Can Buy Them Off the Street?

According to a report on Pharmalot, Merck is expanding its move into oncology by striking a deal with Ariad Pharmaceuticals to buy the cancer drug AP23573 mTOR from Aiad Pharmaceuticals.

"Here's the deal: Ariad will receive an initial payment of $75 million, up to $452 million more in milestone payments based on the successful development in different cancer indications, and up to $200 million more based on sales thresholds. Ariad can also expect at least $200 million in estimated contributions by Merck to global development, and up to $200 million in repayable advances from Merck to cover its share of global-development costs, after Ariad has paid $150 million of those costs. (See "Merck Invests $1B In A Cancer Pill")

So this is what the pharma industry means when it says it costs $1 Billion to "develop" a new drug!

I've argued that the $1 Billion number is based less on actual costs than on a Tufts' analysis, which includes about $400 million in "lost opportunity" costs (see "Tufts Hangs Tough on Opportunity Cost Analysis").

Merck's deal with Ariad is a wonderful example of an "opportunity" that Merck is pursuing instead of putting that $1 Billion in its own development effort!

Increasingly, Big Pharma is turning to "buying" drugs from smaller, more innovative companies rather than developing them on their own!

No doubt, Big Pharma will continue to portray themselves as innovative companies that need to cover the costs of innovation with higher drug prices. In reality, Merck had to out bid competitors to make this deal with Ariad. One has to wonder how much of that money goes to actual development efforts versus Ariad's bottom line? I'm no accountant, but it looks like everything after the initial $75 Million and $452 Million is pure gravy for Ariad to sock away for investors.

Advice to All Pharma PR Bloggers Out There

Jim Edwards over at BrandweekNRX recently likened the J&J corporate blog JNJ BTW to the erstwhile commie newspaper Pravda. Here's what Jim had to say (read his post "J&J's New Corporate Blog: Is It Any Good?"):

"Think of it this way: One of the reasons TASS and Isvestia were so closely read in the West during the Cold War was that the publications were as interesting for what didn't appear in them as for what did. If a rising star communist official's name suddenly stopped appearig (sic) in Soviet news accounts, Western intelligence could deduce that he had fallen out of favor with the Politburo. Or been killed. Judging by this item, Christine Poon won't be getting an icepick in the head anytime soon.

"NJN (sic; he means JNJ) BTW is similar: It's a handy guide to the topics that J&J finds so controversial it dare not speak their name: So far, that's lawsuits, acquisitions, and "internal" corporate matters.

"There you have it: JNJ BTW is the Pravda of J&J."

Ouch! Tough love indeed!

But let's look at the glass half-full instead of half-empty, shall we?

Did you know, for example, that Pravda is the Russian word for "The Truth"? I bet you dinnit! Marc Monseau, the author of JNJ BTW, might take some comfort from being labeled "The Truth of J&J." At least he wasn't called the "CNN of J&J," which might be a much less flattering comparison.

DISCLOSURE: I know Marc personally and have had several confidential discussions with him about blogging. I have discussed some of the following ideas with Marc from time to time. Usually the discussion goes like this: "Hey, Marc! How you doing? BTW, you need a much BIGGER photo of yourself on your blog!"

Of course, "truth" is such a relative term. It's never really possible to be absolutely sure when someone is telling you the truth or what is the truth! Marc seems to be truthful when he is laying out the reasons why he cannot say this or that, or why he cannot respond to certain allegations, etc.

But Jim has a point. If a corporate blog remains silent on issues roiling around it, then suspicions are aroused. It's best to say something, even if it is to refer to the official company press release, which is some form of "truth" if not absolute truth. I suspect that's what Pravda would do.

Of course, this is not what we expect of blogs. But what should we expect from a blog like JNJ BTW?

Here's what I think J&J and other pharmaceutical corporate blogs should focus on: giving employees a voice.

Typically, the PR person is the sole "voice" of the top-down organization, whether it's J&J, Merck, or the White House. Blogging, however, is a bottom-up medium allowing the "common Joe" to have a voice equal to anyone else in the organization. Thus, corporate blogging is akin to hammering a square peg into a round hole. Something's got to give!

Here's my suggestion. Listen up!

Most of you have backgrounds in journalism or view journalists as your primary audience. Journalists look at you as someone to get around in order to get the real story. Don't run your blog that way. Instead, make it easy for journalists and other readers of your blog to get around you and hear from real people in your organization. And I don't mean just the CEO, CFO, General Counsel, Head of R&D, etc. Save those people's stories for your traditional PR role.

Your blog should include the voices of people much lower down in your organization. I've said many times that the best and most credible spokespeople pharma has are the scientists working within R&D (see "A Primer on Pharma Employee Blogging", for example). Put these people front and center in you blog.

I know, I know, you just can't let them say anything they want in a blog. But here's a way that you can do it and not be afraid of what they might say.

Let's use a recent post to JNJ BTW as an example. The post was about "Similar Biologics," which are generic versions of large-molecule patent drugs. In that post. Marc used a J&J example to illustrate how a small change in a non-active ingredient could lead to problems. Here's the main point I think Marc was trying to make:

"These products [biosimilars] would be 'similar' to a branded product, but they would not be the 'same' and therefore, scientists do not consider them to be generics. Since laboratory testing isn't enough to detect many of the clinically important differences in biologics, testing in humans will be necessary to ensure their safety and efficacy."

He mentions "scientists." Boing! which scientists? How about some scientists at J&J who had specific experience in this area? Why not get the scientists who were involved in the J&J product that Marc mentioned to tell their stories?

Imagine a pharma PR blogger acting like a reporter within his or her own organization. The task is to write a story about biosimilars, but it needs a human touch. Let's take a page from many Wall Street Journal articles that start with a person and rewrite Marc's piece:

"Clarence, a research scientist at Otho Biotech, in 1998 noticed a problem with Eprex (epoetin alfa). Post-marketing data showed an increase in reported immunogenetic responses, including a rare form of anemia called Pure Red Cell Aplasia — or PRCA — in patients receiving the product. 'It took us awhile,' said Clarence, 'but after about five years at a cost of more than $100 million, we ultimately identified the most likely cause to be ..."

Go on from there quoting Clarence's personal account about how he and his colleagues worked diligently to find the problem and solve it. It sunds like a good story! How Clarence may have lost many nights' sleep over it. How many false trails were followed. How he knew the reputation of J&J was on the line. Etc., etc.

Note: Drop the cost analysis -- that's a corporate concern. Your readers don't give a sh*t; J&J makes billion$! I am sure Clarence worried somewhat about cost, but his main focus probably was on saving lives. That's the story!

In other words, do what journalists do: interview real people in your organization and tell their stories. These people can be scientists like Clarence or they can be maintenance workers or administrative assistants -- the rank and file that your company depends on to get the job done.

That's my advice to ALL pharma PR bloggers -- not just Marc Monseau. Take it or leave it. No charge!

CME: Continuing Marketing thru Education

Dr. Daniel Carlat, author of The Carlat Psychiatry Blog, and coiner of the phrase "CME Laundromat" (see "Welcome to the CME Laundromat"), pointed out one way that CME (Continuing Medical Education) programs can legally do what marketing and sales cannot: make head to head comparisons between two drugs without approved clinical trial data.

Dr. Carlat will be my guest this afternoon on my LIVE Pharma Marketing Talk podcast. For more information about listening live or to the audio archive after the show, click here.

Carlat examined a CME program funded by AstraZeneca entitled. The program presented a case study about a man with bipolar disorder who was being treated unsuccessfully with Lamictal, then switched to AtraZeneca's Seroquel, and gets better. Surprise! Here's how Carlat describes the case (see "Biased Education: A Summer's Cornucopia with CME, LLC"):

The second case is where things get more interesting, and where our summertime feast of CME bias really begins. This is a 30 year old man with bipolar disorder, already on lithium monotherapy, who presents with symptoms of major depression. The patient is started on Lamictal, which is TIMA's first line recommendation for treating bipolar depression. However, unfortunately for GlaxoSmithKline (maker of Lamictal), the patient suffers unspecified "side effects" on Lamictal, and is therefore switched to AtraZeneca's Seroquel, and gets better.

Case studies are a favorite technique used by medical education communication companies, because they are a way of spotlighting a particular product without appearing biased.

[This] case study takes place in a bizarre parallel universe in which patients have more side effects on Lamictal than on Seroquel, exactly the reverse of what we psychiatrists commonly see here on Earth. Unrealistic, perhaps, but it serves the sponsor well, telling the story of a patient who likes Seroquel. We don't hear anything about Seroquel's famous side effect of sedation, because that would reflect poorly on the company footing the bill.

Two interesting insights:

1. Case studies like this one do not have to be based on real-life cases, as Carlat points out. I am ashamed to admit that years ago, when I worked for a CME company doing computer-based programs sponsored by pharma companies, I developed interactive case studies by working with physicians who made up cases out of thin air -- but, presumably, based on their real experience. I never documented whether or not such cases actually existed in the real world (ie, by looking at patient charts). I just took the doctor's word for it. We paid the doctor for his case studies and, of course, told him who was paying for it.

2. This kind of "head-to-head" comparison of two drugs cannot be made by marketing or sales people UNLESS there is a specific clinical trial in which the efficacy of the two drugs are actually compared.

Recently, AstraZeneca was embarrassed by allegations that at least one sales manager instructed his sales reps to make head-to-head comparisons of 2 drugs: Arimidex and Femara (see "AZ Group of 7 Believe OIG Probe of Arimidex Marketing Is Stalled").

Although we are talking about different drugs, we see that what AZ could not get away with via sales and marketing, it can easily do via CME. Reps cannot make the head-to-head comparisons, but they can inform their physicians that there is a CME program out there that does by handing out BRCs physicians (see this AZ Memo).

Thus, CME enters my MOM ("Marketing by Other Means") pantheon along with public/press relations.


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Moore's Blitzer Krieg

SiCKO' Truth Squad Sets CNN Straight

DR. SANJAY GUPTA, CNN:
"(Moore says) the United States slipped to number 37 in the world's health care systems. It's true. ... Moore brings a group of patients, including 9/11 workers, to Cuba and marvels at their free treatment and quality of care. But hold on - that WHO list puts Cuba's health care system even lower than the United States, coming in at #39."

THE TRUTH:

• "But hold on?" 'SiCKO' clearly shows the WHO list, with the United States at number #37, and Cuba at #39. Right up on the screen in big five-foot letters. It's even in the trailer! CNN should have its reporter see his eye doctor. The movie isn't hiding from this fact. Just the opposite.
• The fact that the healthcare system in an impoverished nation crippled by our decades-old blockade (including medical supplies and drugs) ranks so closely to ours is more an indictment of the American system than the Cuban system.
• Although Cuba ranks lower overall than the United States, it still has a lower infant mortality rate and longer life span. (see below)
• And unlike the United States, Cuba offers healthcare to absolutely everyone. In an independent Gallup poll conducted in Cuba, "a near unanimous 96 percent of respondents say that health care in Cuba is accessible to everyone." ("Cubans Show Little Satisfaction with Opportunities and Individual Freedom Rare Independent Survey Finds Large Majorities Are Still Proud of Island's Health Care and Education," January 10, 2007.
  http://www.worldpublicopinion.org/pipa/articles/brlatinamericara/
  300.php?nid=&id=&pnt=300&lb=brla)

CNN: "Moore asserts that the American health care system spends $7,000 per person on health. Cuba spends $25 dollars per person. Not true. But not too far off. The United States spends $6,096 per person, versus $229 per person in Cuba."

THE TRUTH:

• According to our own government – the Department of Health and Human Services' National Health Expenditures Projections – the United States will spend $7,092 per capita on health in 2006 and $7,498 in 2007. (Department of Health and Human Services Center for Medicare and Medicaid Expenditures, National Health Expenditures Projections 2006-2016. http://www.cms.hhs.gov/NationalHealthExpendData/downloads/proj2006.pdf)
• As for Cuba – Dr. Gupta and CNN need to watch 'SiCKO' first before commenting on it. 'SiCKO' says Cuba spends $251 per person on health care, not $25, as Gupta reports. And the BBC reports that Cuba's per capita health expenditure is… $251! (Keeping Cuba Healthy, BBC, Aug. 1 2006. http://news.bbc.co.uk/2/hi/programmes/newsnight/5232628.stm )
• As Gupta points out, the World Health Organization does calculate Cuba's per capita health expenditure at $229 per person – a lot closer to $251 than $25.

CNN: In fact, Americans live just a little bit longer than Cubans on average.

THE TRUTH:

• Just the opposite. The 2006 United Nations Human Development Report's human development index states the life expectancy in the United States is 77.5 years. It is 77.6 years in Cuba. (Human Development Report 2006, United Nations Development Programme, 2006 at 283. http://hdr.undp.org/hdr2006/pdfs/report/HDR06-complete.pdf)

CNN: The United States ranks highest in patient satisfaction.

THE TRUTH:

• True, but even when the WHO took patient satisfaction into account in its comprehensive review of the world's health systems, we still came in at #37. ("World Health Organization Assesses The World's Health Systems," Press Release, WHO/44, June 21, 2000. http://www.who.int/inf-pr-2000/en/pr2000-44.html ).
• Patients may be satisfied in America, but not everyone gets to be a patient. 47 million are uninsured and are rarely patients - until it's too late. In the rest of the Western world, everyone and anyone can be a patient because everyone is covered. (And don't face exclusions for pre-existing conditions, co-pays, deductibles, and costly monthly premiums).
• It's not that other countries are unhappy with their health care – for example, "70 to 80 percent of Canadians find their waiting times acceptable." ("Access to health care services in Canada, Waiting times for specialized services (January to December 2005)," Statistics Canada, http://www.statcan.ca/english/freepub/82-575-XIE/82-575-XIE2006002.htm )

CNN: Americans have shorter wait times than everyone but Germans when seeking non-emergency elective procedures, like hip replacement, cataract surgery, or knee repair.

THE TRUTH:

• This isn't the whole truth. CNN pulled out a statistic about elective procedures. Of the six countries surveyed in that study (United States, Canada, New Zealand, UK, Germany, Australia) only Canada had longer waiting times than America for sick adults waiting to schedule a doctor's appointment for a medical problem. 81% of patients in New Zealand got a same or next-day appointment for a non-routine visit, 71% in Britain, 69% in Germany, 66% in Australia, 47% in the U.S., and 36% in Canada. (The Doc's in, but It'll be AWhile. Catherine Arnst, Business Week. June 22, 2007 http://www.businessweek.com/technology/content/jun2007/
  tc20070621_716260_page_2.htm)
• "Gerard Anderson, a Johns Hopkins health policy professor who has spent his career examining the world's healthcare, said there are delays, but not as many as conservatives state. In Canada, the United Kingdom and France, 'three percent of hospital discharges had delays in treatment,' Anderson told The Miami Herald. 'That's a relatively small number, and they're all elective surgeries, such as hip and knee replacement.' (John Dorschner, "'SiCKO' film is set to spark debate; Reformers are gearing up for 'Sicko,' the first major movie to examine America's often maligned healthcare system," Miami Herald, June 29, 2007.)
• One way America is able to achieve decent waiting times is that it leaves 47 million people out of the health care system entirely, unlike any other Western country. When you remove 47 million people from the line, your wait should be shorter. So why is the U.S. second to last in wait times?
• And there are even more Americans who keep themselves out of the system because of cost - in the United States, 24 percent of the population did not get medical care due to cost. That number is 5 percent in Canada, and 3 percent in the UK. (Inequities in Health Care: A Five-Country Survey. Robert Blendon et al, Health Affairs. Exhibit 5. http://content.healthaffairs.org/cgi/content/full/21/3/182)

CNN: (PAUL KECKLEY-Deloitte Health Care Analyst): "The concept that care is free in France, in Canada, in Cuba - and it's not. Those citizens pay for health services out of taxes. As a proportion of their household income, it's a significant number … (GUPTA): It's true that the French pay higher taxes, and so does nearly every country ahead of the United States on that list."

THE TRUTH:

• 'SiCKO' never claims that health care is provided absolutely for free in other countries, without tax contributions from citizens. Former MP Tony Benn reads from the NHS founding pamphlet, which explicitly states that "this is not a charity. You are paying for it mainly as taxpayers." 'SiCKO' also acknowledges that the French are "drowning in taxes." Comparatively, many Americans are drowning in insurance premiums, deductibles, co-pays and medical debt and the resulting threat of bankruptcy – half of all bankruptcies in the United States are triggered by medical bills. (Medical Bills Make up Half of Bankruptcies. Feb. 2005, MSNBC. http://www.msnbc.msn.com/id/6895896/)

CNN: "But even higher taxes don't guarantee the coverage everyone wants … (KECKLEY): 15 to 20 percent of the population will purchase services outside the system of care run by the government."

THE TRUTH:

• It's not clear what country Keckley is referring to. In the United Kingdom, only 11.5 percent of the population has supplementary insurance, but it doesn't take the place of NHS insurance. Nobody in France buys insurance that replaces government insurance either, although a substantial amount buys some form of complimentary insurance. ( Private health insurance and access to health care in the European Union. Spring 2004. http://www.euro.who.int/document/Obs/EuroObserver6_1.pdf)

CNN: "But no matter how much Moore fudged the facts, and he did fudge some facts…"

• This is libel. There is not a single fact that is "fudged" in the film. No one has proven a single fact in the film wrong. We expect CNN to correct their mistakes on the air and to apologize to their viewers.

Marketing's New Maxim: At Least Do No Harm!

The most famous phrase never uttered in the Hippocratic oath taken by physicians is "First, do no harm." (See "Not in the Hippocratic Oath").

Marketing should have its own "Hippocratic Oath" and its first principle or maxim should definitely be "Do no harm."

As far as pharmaceutical marketing is concerned, this principle needs to cover at least two different types of harm:

1. Financial Harm, and
2. Reputation Harm

Everyone assumes that marketing benefits a company's bottom line. But a recent study summarized in AdvertisingAge failed to demonstrate this. Instead, the study could only conclude that marketing does not harm the bottom line:

A study to be published in the Journal of Marketing that covered 167 companies including Procter & Gamble, Microsoft and Apple over a five-year period concludes that CMOs [Chief Marketing Officers] on top management teams don't have any effect on a company's financial performance.

At least CMOs don't do harm: "It is important to note that CMOs do not have a negative impact on performance," the study found. (See "CMOs Rapped for Having Zero Impact on Sales").

I doubt the study included many pharmaceutical companies. I am virtually certain that it did not include Takeda, the company whose marketing is definitely doing harm to the bottom line (see "Rozerem Ad Spending Exceeds Sales!").

The study's authors and other marketing performance experts suggest we focus on other benefits of CMOs and, by extension, marketing in general, including:

• embracing and understanding how to use new media;
• aligning with the rest of the organization's imperatives;
• and making sure the consumer is at the heart of marketing.

With regard to these non-financial measures, I would say that pharmaceutical marketers are doing harm in at least two of these areas: NOT embracing new media and NOT putting the consumer first. Merck could be moving in the right direction here (see "Rejiggering the Marketing Mix a la Merck"), but whether or not other pharmaceutical companies will follow remains in doubt.

Reputation: One More Measure of Marketing
For the pharmaceutical industry, the most important non-financial measure of marketing's impact is, IMHO, its impact on the company's and the industry's reputation.

It's easy to see the impact of pharmaceutical marketing on pharma's reputation by reading the minutes of Senate and House hearings in the US Congress. Even industry supporters like former Senator Frist referred to drug ads when criticising the industry (see "Deconstructing Frist on DTC").

Most times, however, it is difficult to link marketing practices with industry reputation. That's because a lot of pharma's promotional activities are not coming directly from marketing budgets. Thus, PR and government relations, are not considered marketing. However, I beg to differ.

These days, it's difficult to see any difference between pharma PR and pharma marketing (see, for example, "Marketing Disguised as PR", "Chantix: PR First, Launch & Ads to Follow", and "PR Marketing: Mystery Wrapped in a Riddle"). Centocor's PR people created a feature-length movie that many people considered marketing and was later integrated into a marketing campaign (see "The Innerstate DVD. Is TV Next?").

Was Merck's campaign to get state legislatures to pass mandatory HPV vaccination laws marketing or government relations?

If we could follow the PR and government relations money allocated to specific products like Chantrix and Gardasil, I am sure it all comes from the marketing budgets of these products. These funds, like claims made about CME funding, may be laundered and untraceable, but I think there's at least a trail of crumbs.

Whatever! Take Responsibility!
By whatever standard we measure marketing, pharmaceutical marketers must be held accountable when they do do financial harm and reputation harm.

The first marketing team I would hold accountable for doing financial harm -- and maybe reputation harm as well -- is the Rozerem ad team (see "Takeda - Fire These Guys!").

I would also censure the Merck person, team, or agency whose idea it was to pay outside interest groups to influence politicians to vote for mandatory HPV vaccination programs. Although this promotional program and the press it received probably aided sales of Gardasil, it further eroded the industry's reputation.