Out with the Bad, In with the Good

Two of the biggest, if not THE biggest, US-based pharmaceutical companies -- Pfizer and Merck --have made separate announcements in preparation for Wall Street analyst pow wows this week.

Pfizer announced a cut of 20% of its US sales force while Merck announced it plans to cut back on TV ads.

Pfizer Inc. signaled the end of an era in the drug industry by announcing plans to slash its domestic sales force by 20%, or more than 2,000 people. The deep cut by Pfizer, which has fielded the largest sales army for years, could lead to a broader retrenchment across the industry. Lehman Brothers drug analyst Tony Butler said in a research note yesterday that the layoffs could shave $440 million from Pfizer's annual expenses. For years, Pfizer has fielded the biggest sales force in the industry, about 11,000 people, including management. The company also has been among the most aggressive in sending multiple salesmen to call on the same doctor as a way to boost sales. Until recently, adding more sales reps translated into greater drug revenue. But Pfizer, and the industry, have faced a backlash from doctors as the number of representatives -- about 100,000 industrywide at its peak -- reached the saturation point. (WSJ: "Pfizer to Cut 20% of U.S. Sales Force, Signaling End of Era")

Merck plans to cut back on television advertising of new drugs in favour of more targeted media such as online internet communities, as part of the US drugmaker’s revamp of sales and marketing. The leader of Merck’s ambitious overhaul of its sales and marketing effort is testing “numerous pilot programmes” with new drugs such as Januvia, for diabetes, and Gardasil, a cervical cancer vaccine, to explore different ways of spending drug marketing budgets. Peter Loescher, Merck’s new second in command who is leading this drive, said in his first interview that changes in viewer habits as well more cost-effective use of resources could change drug marketing.
“The new model will also move away from a broad broadcast DTC approach in its classical sense. It has to. Because as a consumer we’re sitting in front of our TV, and we’re switching all the time,” he told the FT. -- FT

What do these two announcements have in common?

Out with the Bad
Both could be seminal events, signaling "Out with the bad." Excessive sales forces and excessive reliance on TV broadcast DTC advertising are currently experiencing diminishing returns as doctors push back sales reps and consumers switch off their TVs in favor of more interactive media.

In with the Good
Spending more on Internet-based communications -- whether it be to physicians or to consumers -- is an "In with the Good" trend.

Here's Google's way of looking at the disparity of media ad spend vs. consumer viewing habits:
So, it's about time that more attention be paid to the Internet in terms of reaching doctors and consumers where they are spending more time and saving bucks!

Drug companies lag other industries in online marketing: According TNS, Merck in 2005 spent $7.5 million on Internet advertising (not including search) vs. $769 million total; that's about 1% of the total budget.

Of course, these two changes -- if and when they come to pass -- may not amount to more than a hill of beans if other drug companies don't follow these leaders.

Off-Label Confusion

Results of the WSJ Online/Harris Interactive Health-care Poll regarding off-label use of drugs were recently published ("Adults Are Divided On Off-Label Use Of Prescription Drugs").

Looking at the numbers, I would say that American consumers are confused rather than divided.

Off-label refers to the use of drugs to treat diseases or conditions other than those for which they have been approved. Off-label prescribing is legal in the U.S. However, there are strict rules governing the marketing of a drug for treatment of a disease for which it hasn't been approved and several pharmaceutical companies have been caught aggressively promoting off-label use of their products (see, for example, "Why Drug Companies Promote Off-Label").

Some Fun Off-Label Facts
A 1992 American Medical Association study estimated that 40 to 60 percent of prescription drugs were given for unapproved uses.

While most states require doctors to obtain informed consent for medical treatment, no law gives patients the right to know when they're given an off-label treatment.

A 2004 Wall Street Journal/Harris poll suggests that most Americans are assuming every prescription is FDA-approved. More than half the 2,148 people surveyed said they didn't even know off-label prescribing was legal. Another 17 percent weren't sure.

Here's the summary of the 2006 poll results as reported by the WSJ:

Forty-five percent of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed.

However, there is less division on this issue when the question is phrased this way:

"Do you think doctors should or should not be allowed to prescribe a drug for diseases for which that drug has not been approved by the FDA?"

In this case, only 27% answered "Should be allowed" vs. 48% who answered "Should not be allowed."

I'm confused. Is it 45% or 27% who agree that off-label prescribing is OK?

Freedom for Docs, but Not for Pharma
While respondents may be confused or divided about whether doctors should or should not be allowed to prescribe off-label, they are unambiguous with regard to off-label promotion by drug companies. First amendment or no, they are agin' it!

Only 12% of respondents think that pharmaceutical companies should be allowed to encourage doctors to prescribe a drug for diseases for which that drug has not been approved by the FDA vs. 69% who say no way!

Look on the Sunny Side
Fifty-five percent (55%) of respondents believe that if "doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases. Thirty-five percent (35%) disagree."

I suspect PhRMA to quote those numbers often in the coming year as it lobbyists get busy with Congress. (I don't think they'll talk much about the 12% or 27% numbers, though.)

But even this result must be tempered by the fact that "nearly two-thirds say they would agree to prohibiting off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations." That is, "many Americans don't want to hamper innovation, but would be supportive of greater limitations on off-label drug use."

Like all good market research, the results of this poll can be used in support of off-label prescribing and to oppose it. Just cherry pick the results you wish to quote and Bob's your uncle!

Am I Dreaming, or Is This a Rozerem Ad?

Rich Meyer, author the World of DTC Marketing blog, drew my attention to a recent Wall Street Journal article entitled "Am I Dreaming, or Is This a Sleeping-Pill Spot?"

Maybe the article should have been entitled, "Am I Dreaming, or Is This a Rozerem Ad?" because it sure isn't jouranlism worthy of the WSJ.

The article is all about the Rozerem Lincoln and Beaver ad campaign, which I have been criticising in this blog for months (see, for example, "Rozerem Ads Dis Lincoln, Show Beaver").

The article serves mainly as a vehicle for the Takeda product team and its ad agency to give themselves credit for a job well-done despite what some Madison Avenue executive critics -- not to mention us bloggers! -- have to say, such as:

"I had to watch it a few times to really get it," says Terry Gallo, president of Euro RSCG Life Adrenaline, a Havas-owned health-care marketing agency. Takeda has to make sure that a consumer doesn't get "so wrapped up in the story" that he doesn't pay attention to the product and the qualities that make it distinctive, she says.

Hmmm...where have I heard that before? Oh, Yes! Right here on Pharma Marketing Blog and on World of DTC Marketing Blog.

Yet the main theme of the WSJ article is that the ad "breaks from convention" and despite that or because of it, "the ad is working." Kukdos to Chris Benecchi, Takeda's senior product manager for neuroscience marketing and to the ad agency, Cramer-Krasselt.

But is the ad really working?

The WSJ reports that "Rozerem's monthly sales have increased to $10.5 million in October from $6.31 million in July, when the ad went on the air." Excuse me while I whip out my calculator.

$4.2 million increase per month for 3 months post-ad not counting July (a generous estimate) equals $12.6 million additional sales attributable to the ad (if only it were that simple; what about promotion to physicians?).

Balance that gain against the ad spend for Rozerem. Let's say that's $25 million (Lunesta spends about $140 million per year on DTC). Spending $25 million to make $12.6 million -- that's a negative ROI, which I pointed out in a previous post (see "Rozerem Ads Innovatively Ineffectual").

Rich Meyer documents the failure of the Rozerem campaign by looking at product web site statistics. See "Ambien CR.com the clear winner in the sleep wars on the Web."

If only the WSJ reporter had done a bit more research, he would have learned all this and not allowed Takeda's PR agency to use the WSJ for damage control. He only had to do a Google search on "rozerem ad" and he would have found my posts to Pharma Marketing Blog occupying 8 of the top 10 natural search results (including #1).

BTW, you will also find a YouTube listing with link to a video of the ad (shown here).

This video was submitted to YouTube on October 17, 2006 by "lewisusauk," who said "New Rozerem Ad Campaign. Possibly the best prescription drug ad since the FDA relaxed the rules on drug advertising." lewisusauk is obviously a "sock puppet" playing the "social networking" game and trying to offset all the genuine negative buzz out there.

"A sock puppet, for those still boning up, is a false identity through which a member of an Internet community speaks while pretending not to, like a puppeteer manipulating a hand puppet. Recently, a senior editor at The New Republic got in trouble for some particularly colorful sock puppetry." See "Sock Puppet:NAILED".

But I digress. Back to the WSJ article, which appears to be part and parcel of the Rozerem buzz campaign itself!

I expected a more well-defined line between journalism and advertising/PR shill, especially from the WSJ. When the emperor has no clothes, it's up to reporters to point this out! I guess they are conceding that role to us bloggers!

Levitra Levity

A $190,000 Levitra "ad" campaign in Hong Kong--developed by Interpublic Group public-relations agency Golin Harris--increased sales of Levitra in Hong Kong by 244% from August through October, according to an article in the Wall Street Journal (see "A Dose of Laughter for Touchy Issue"). Bayer, the drug company that markets Levitra outside the US, must be laughing all the way to the bank.

I have no idea how much additional sales income a 244% increase over three months represents, but it must be at least $2 million, wouldn't you say? That's a return on investment of over $10! How'd they do it?

"Bayer reconfigured its ad approach specifically to persuade conservative Chinese to see Western doctors about their sexual problems," according to the WSJ article.

"The continuing series of colorful newspaper ads tell humorous stories about Hong Kong men's struggles for virility. All the ads star Chinese comedian Wayne Lai Yiu-Cheung as a man with a problem, such as excess smoking, stress, or old age, that gets in the way of his sex life."

"Part of the humor is that the ads leave embarrassing words and ideas up to innuendo and pun. Instead of mentioning erectile dysfunction specifically, most of them simply feature a photo of a limp, hot-dog-shaped balloon. One features a satisfied customer wearing a Superman costume with the "S" on his chest replaced by the Chinese word for "upright." That character also happens to be the first in Levitra's Chinese name."

Here's an example of an ad, which I scanned from the print edition of the article (the online version, see below, is not quite as funny):


I cannot read Chinese and the article did not translate the dialogue, but the people in the ad could be saying this:

Panel 1: She: "Welcome home from work, dear husband. It's kind of late, so no dinner for you! As you can see, I am ready for bed dressed in my most sexy and revealing pajamas."

Panel 2: He: "Yes, dear wife. Very sexy. I am almost turned on." She: "I hope you are not too excited!"

Panel 3: She: "What's it going to take to get a rise out of that limp-dog balloon of yours?"

Panel 4: He: "Lots of traditional Chinese medicine and this glass of wine should do the trick."

Panel 5: Doc: "Silly man, sexy bed clothes and alcohol are no match for this Western-style pill!" He: "A single pill?!"

Panel 6: He: "I think the dog is barking. Let's do it!"

Create Your Own Campaign!
Maybe some of my readers can offer better, more accurate (or at least funnier) translations?

Caveats: Your translation must adhere to local laws regarding DTC advertising, namely, "Hong Kong law actually forbids directly advertising prescription drugs. The Levitra ads hit a gray area in the law by neither specifically mentioning a medical problem nor specifically saying that Levitra can solve it. Instead, the limp balloon represents the problem, and an unmarked pill represents the solution. One recent ad that contains a photo of the Levitra box doesn't even have the brand name on it."

Also, you must be cognizant of local mores: As mentioned above, "leave embarrassing words and ideas up to innuendo and pun."

Is This PR or Advertising?
The Levitra campaign featured in the WSJ was developed by a PR agency rather than an ad agency. It was low budget (although I don't understand how it can feature celebrities and still cost so little). It appeared in newspapers, not TV. It got good coverage in the WSJ at no cost (probably). It's been blogged (here). These are all trademarks of a PR campaign. So is it PR? Whatever. As i said before, there is often no bright line between PR and advertising (see "Marketing Disguised as PR").

BTW, the following is the ad example used in the online version of the article:


As anyone can see, even someone like me who cannot read the Chinese characters, this is not as funny as the print version above. Why WSJ uses a different version in its online edition than in its print edition is a mystery to me.

Now, THIS (Viagra) ad is funny:

Chantix: Opportunity for Social Marketing Lost?

Chantix, Pfizer's new smoking-cessation drug, requires a different kind of marketing program, according to a recent article in the Wall Street Journal ("Marketing New Antismoking Pill Poses Challenges for Pfizer"):

"Aware of increased consumer cynicism and unfulfilled promises made for smoking treatments in the past, Pfizer has adopted a softer sell that it hopes will build Chantix steadily over time. Meanwhile, because insurers are slow to cover smoking treatments, it has priced Chantix so that consumers will be willing to pay for it themselves."

Pfizer's solution is a support program called the GETQUIT(tm) Support Plan, which includes the following components as described on the Web site:

Each day GETQUIT provides you with an email or phone call which gives you encouragement, advice, activities and information designed to help you through the quitting process. You will also have a personalized web page, which provides daily updates to help you track your progress. After twelve weeks your email or phone contacts will become less frequent. It's important to know that you can decide to stop being in the program or reduce the frequency of your contacts at any time.

The GETQUIT program is available to you for at least a year.
What to expect from GETQUIT:

* Daily help for the next 12 weeks, as you take your CHANTIX as prescribed by your doctor and ongoing support for up to a year.
* Activities that will help you prepare to quit. Strategies to help you cope with cravings, when you have urges to smoke. And help breaking your smoking routine.
* Encouragement, advice, and information to help you stay quit.
* A personalized web page designed to help you track your progress.
* Questions to help you measure your progress. Each day we’ll ask you if you've smoked, if you've taken CHANTIX as prescribed by your doctor, and if you've been having urges to smoke. Your honest answers will help you chart your progress and will help you get the right information

Despite the good intentions of this program and kudos given to Pfizer for tackling compliance head on (see World of DTC Marketing: "Pfizer listens to patients and may get a blockbuster as a result"), this is not as innovative a program as it could be.

Web 2.0
I think smoking cessation support is a perfect application for Web 2.0 (aka, social networking) technology. In fact, it has been done before with another smoking cessation drug.

First, what is Web 2.0? Here's what I found on Wikipedia:

"Web 2.0, a phrase coined by O'Reilly Media in 2004, refers to a supposed second generation of Internet-based services—such as social networking sites, wikis, communication tools, and folksonomies—that emphasize online collaboration and sharing among users."

The particular precedent I am thinking of used online bulletin boards where smokers who were attempting to quit could share stories, experience and encourage one another. There was even an online "buddy"--a fellow traveler so to speak who shared your characteristics. You could draw on your buddy for more personalized support. These bulletin boards were linked to the product information supplied by the sponsoring pharmaceutical company (I forget which company). It was a great way for a brand to interact with an online patient community.

It seems that the pharmaceutical industry has taken one step forward and two steps backward with programs like GETQUIT and Question Everything (a faux social networking site sponsored by GSK for Alli, an obesity medication; see "Question Everything").

These programs seem innovative, but are not as forward thinking as some Web programs that were pioneered ten years ago before the dotcom crash!

A Novel Idea
GETQUIT could be much better and perhpas ultimately more successful selling product if it honestly implemented a social networking environment where patients could post their own experiences, help others, and where the community could rate "buddies" according to how helpful they were.

Now there's a novel idea!

Lame-Duck Senate Roasts Eschenbach Turkey!

EyeOnFDA reports (see "Hold It!"):

"Senator Charles Grassley (R-Iowa) has gone and put a hold on the nomination of Dr. Andrew C. von Eschenbach. There was movement to try to get him approved in the lame-duck Senate session, but the hold would put that into doubt."

Interestingly, this is the third hold by Republicans classified as "political" vs. two Democratic holds classified as "legitimate" by my friend Mark Senak, author of EyeOnFDA:

"According to reports, this hold is rooted in concerns about the approval of Ketek, manufactured by Sanofi Aventis...other holds placed on this nomination were solely for political objectives - one regarding importation, one regarding abortion by Senators Vitter (R-Louisiana) and DeMint (R-S. Carolina), respectively."

For more on the Ketek issue, see "Celsius 3014: Ketek, Drug Safety, & Bioterrorism."

It appears that the von Eschenbach nomination is headed for turkeyville; I know I am.

Happy Thanksgiving!

Pay Per DTC Ad View Update

It's official -- well, all except for the rubber stamp from HHS and Congressional approval -- the drug industry has agreed to pay the FDA "$40,000 to $50,000 at the beginning of each year for each television ad campaign they planned to air that year," according to a Wall Street Journal report ("FDA Sets Deal With Drug Firms On TV-Ad Vetting Companies to Pay More Fees").

As I reported previously (see "Pay-(FDA)-Per-(Pre)View of DTC"), there's more here than meets the eye. For example, AstraZeneca proposed that any pre-approved ad should be exempt from a subsequent finding by the FDA that the advertisement is misleading or inaccurate. I don't know if this is part of the announced agreement or not -- the WSJ article was silent on that issue.

This agreement is part of a larger deal to increase "user fees" by about one-third (from $300 million currently) under PDUFA (Prescription Drug User fee Act), which expires soon and must be reauthorized by Congress next year. Unfortunately for the drug industry, that Congress will be a Democratic Congress and as the WSJ article points out "the proposed agreements are likely to be a first step in what will be a far broader debate over whether, and how, to reform the FDA."

Conflict of Interest Conundrum - "No Comment"
Other pundits -- such as Mark Senak over at EyeOnFDA -- have pointed out that user fees pose an "interesting conundrum" for the FDA:

"How does the agency demonstrate that, by collecting more funds from industry, it is better positioned to protect public health? It is an interesting question and one which, if the agency is going to seek these funds, the agency had better well address as they ask for them...to proceed to ask for funds without addressing the question of conflict of interest naturally opens the way for an opportunity for critics, even without a preponderance of evidence on their side, to prevail. The agency does not appear particularly thoughtful in organizing their messaging, but they should get their ducks in a row on this one."

And how is the FDA addressing this issue and getting its "ducks in a row?" As reported in the WSJ: "Spokesmen for PhRMA and BIO declined to comment. An FDA spokeswoman also declined to comment."

Take the Pharma Marketing News Online Survey
Pharma Marketing News is currently hosting an online survey to determine how likely these changes are according to pharmaceutical marketing experts. You can take the survey here. You will be able to see a de-identified summary of the current results after you complete the survey. I plan to also write up a summary of the results for the December issue of the newsletter. Your responses are held strictly confidential unless you give me permission to use your name.

Wooing Dems: Thank You Mr. Kindler!

According to the Financial Times (FT), the recent changing of the guard at several big drugmakers, including Pfizer, the world's largest, may make it easier for drug industry lobbyists to woo democrats.

"Democrats may be more willing to lend an ear to chief executive Jeffrey Kindler than former chief executive Hank McKinnell, who was a large donor to the Republican party," reported FT (see "Big Pharma on a mission to woo Democrats").

FT went on to report "Records collected by the Center for Responsive Politics show that Mr Kindler donated $10,200 in this election cycle. The beneficiaries were all Democrats."



That's about 0.2% of the $4.5 million Pharma donated to Democratic candidates (vs. $10 million lavished on Republicans). Some hedge bet!

Mr. Kindler's largesse notwithstanding, the drug industry is marshaling its forces to defend its gains. As I mentioned in yesterday's post (see "What's In Store from Congress?"), there are several proposed legislative changes that the industry is anticipating it must fight. What's your opinion?

Take the Pharma Marketing News Online Survey
Pharma Marketing News is currently hosting an online survey to determine how likely these changes are according to pharmaceutical marketing experts. You can take the survey here. You will be able to see a de-identified summary of the current results after you complete the survey. I plan to also write up a summary of the results for the December issue of the newsletter. Your responses are held strictly confidential unless you give me permission to use your name.

What's In Store from Congress?

Now that the elections are over, the pharmaceutical industry is left to ponder what the new Congress has in store for it. There has already been a lot of speculation in the general press and trade media (see this compilation of articles) as well as some shots fired across the bow by Congress.

It's not just democrats itching to get at Pharma. For example, the Senate Committee on Health, Education, Labor, and Pensions (HELP) chaired by Sen. Michael B. Enzi (R-Wyoming), met in full session on November 16, 2006 ("Hearing on Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation;" access audio and testimony from this hearing here) and Senator Charles Grassley (R-Iowa) has put a hold on the nomination of Dr. Andrew C. von Eschenbach for commissioner of the FDA (see "Hold It!").

One bill currently before the HELP Committee is S. 3807: Enhancing Drug Safety and Innovation Act of 2006: A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. This bill is also known as the Enzi-Kennedy after the senators that sponsored it. These same senators head up the HELP Committee.

Here's a synopsis of the issues and changes experts have predicted that the drug industry will be subjected to in the next legislative session:

Drug Price Related

• Medicare reform -- allow government to directly negotiate prices with pharmaceutical companies
• Allow drug importation from Canada
• Patent Reform -- set limits on whether big pharmaceutical firms can make deals with generic drug makers

Marketing Related

• Enact a mandatory 6-month, one- or two-year moratorium on ads for new drugs
• Require FDA pre-clearance of all DTC ads
• Wipe out or limiting tax deductions for advertising expense
• Require a "black triangle" in ads and labels for new drugs
• Set standards for risk presentation that make broadcast ads infeasible

FDA/Drug Approval/Safety Related

• Hold up of Prescription Drug User Fee Act (PDUFA) reauthorization
• Make FDA more powerful -- eg, create office of drug safety within FDA, give the FDA the power to fine companies to force them to do safety studies or change the labels of drugs (Grassley-Dodd and Enzi-Kennedy bills)

Recommendations to the Congress by the Institute of Medicine (see "IOM Report Calls for DTC Moratorium") and the Enzi-Kennedy Bill are top of the list items under consideration as reflected in the testimony before the HELP Committee. See highlights of testimony below. Meanwhile, please consider what your own opinion is:

Take the Pharma Marketing News Online Survey
Pharma Marketing News is currently hosting an online survey to determine how likely these changes are according to pharmaceutical marketing experts. You can take the survey here. You will be able to see a de-identified summary of the current results after you complete the survey. I plan to also write up a summary of the results for the December issue of the newsletter. Your responses are held strictly confidential unless you give me permission to use your name.

Testimony Highlights
Several witnesses at the HELP Committee hearing framed the issues and specifically discussed S.3807 and the IOM report. I pick two from "opposite sides of the aisle"; that is, a pharmaceutical company representative and a consumer representative.

Highlights from testimony by Dr. Adrian Thomas, Vice President, Benefit-Risk Management, Johnson & Johnson Pharmaceutical Group (see complete statement here).

On S.3807: "We support the use of Risk Evaluation and Mitigation Strategies proposed in S. 3807 to enhance safety, where these strategies are most needed. We believe the proposed Reagan-Udall Institute could be a valuable impetus to spur scientific innovation if consistent and adequate appropriations are provided. We support the provisions of S. 3807 and the IOM report regarding the registration and disclosure of results of confirmatory clinical trials. We support efforts to manage conflicts of interest in FDA Advisory Committees and to enhance transparency while retaining FDA’s access to expertise. Finally, we believe that Congress should adequately fund the Food and Drug Administration in the interest of all Americans."

On DTC Moratorium: "Another remedy that should be reconsidered is the proposed ability of FDA, under the legislation, to impose a moratorium on direct-to-consumer (DTC) advertising for up to two years. This restraint on advertising represents a troubling change. Many members of the industry, including Johnson & Johnson, have voluntarily agreed to exercise restraint with respect to DTC advertising, especially during the period of time after approval. But appropriate DTC advertising plays a valuable role in educating patients about diseases and treatments. The value of this education to patients, as well as the important First Amendment issues that arise from banning truthful speech, even for a period of time, must be carefully considered before legislating in this area. At a minimum, the standard for imposing DTC advertising restraints should be much higher than is currently articulated in the legislation, to ensure appropriate application of this new authority."

Highlights from testimony by Mr. Jim Guest, President & CEO, Consumers Union (see complete statement here).

On DTC Moratorium: "In light of the promotional nature of DTC advertising and the long history of abuses in DTC advertising, and given that such advertising strongly influences consumers, Consumers Union recommends a requirement that ALL advertisements be pre-cleared by the FDA for accuracy and honesty, including the growing use of ads in the Internet and other non-traditional sites. In addition, the FDA may impose a two (2) year moratorium on DTC advertising for drugs showing more serious safety concerns. Given the amount of influence this type of advertising has on consumers, and given the potential serious ADRs that may occur years after approval, Consumers Union recommends a moratorium on DTC advertising of three or more years for all new drugs. The history of ADRs and withdrawals shows that drugs cannot be assumed safe after just two years. Adding possible third year to the moratorium authorities in S. 3807 would be prudent and constitutional."

On Off-Label Use of Drugs: "S. 3807 is silent on the issue of off-label use. Given the potential for off-label uses to create serious safety problems, Consumers Union recommends that the FDA develop a program to scientifically study drugs widely used in off-label settings. We are not advocating a ban on such use. We are simply asking that some scientific study be brought to this area, so that the labels on these drugs may be expanded and improved in the cases where the scientific evidence is supportive."

What Do You Think: Take the Pharma Marketing News online survey.

Not Your Father's eDetail

The recent eyeforpharma eCommunications and eMarketing conference held in Philadelphia included an international mix of speakers and attendees. I met pharma people from China, Peru, Germany, UK, and Mexico as well as the US. Of course, all were proponents of "e" for marketing and the two most discussed topics were social marketing on the consumer side and eDetailing on the physician side. I covered the social marketing discussion in a previous post (see "The Girl from Google"). Here, I cover eDetailing.

Mark Bard of Manhattan Research moderated a panel discussion entitled "Using the Internet to Support and Evolve Sales." Panel members included Craig DeLarge, Associate Director of eMarketing at Novo Nordisk, and Clay Butterworth, eMarketing Manager at Shire.

Bard, as usual, opened with some numbers regarding physician use of the Internet and adoption of eDetailing. He summed up the current eDetailing situation succinctly by stating "Half our clients think eDetailing will be dead in 2 years, the other half says it will take off." He pointed out that for eDetailing to take off it has got to change and get more in sync with what physicians who use the Internet want, which is something Bard knows a lot about (see, for example, the report that Manhattan Research was handing out at its booth: "Trends Impacting Consumer and Physician eMarketing).

Bard presented some data showing that the percentage of physicians using eDetail programs in the past year has leveled off at around 40% -- no longer growing, in other words. However, only 20% of docs say they have absolutely no use for eDetailing. That leaves 20% who might have use for it if it offered them what they want. Unfortunately, a lot of them want money or cash equivalents. Although pharmaceutical companies have gotten away from a "pay for view" regime, which is frowned upon by the watchdogs, some have worked around this issue by paying physicians to take a short survey after the eDetail. Some doctors have their children press the forward button to get through the eDetail so that they can get to the money at the end.

To entice doctors to participate in eDetails without monetary rewards, some vendors have come up with hooky ways of engaging docs such as pretending that the eDetail is a soccer match. One presenter admitted that this wouldn't work in the soccer-challenged US market. It might just be as boring as the game itself! Maybe the doc's children will enjoy it though. (OK, have at me in the comments.)

The core problem with eDetailing remains: it's still a sales activity rather than an information sharing or communication activity that physicians prefer. It's worse than a live sales rep. A savvy physician can manipulate a rep to just deliver the goods -- essential prescribing information and samples. I suspect that manipulating computerized eDetails is not as easy -- and you don't get the samples at the end!

DeLarge agreed -- and I am paraphrasing him here -- that eDetails are too sales focused vs. customer insight focused. There is an opportunity, DeLarge said, through the eChannel, to get a better idea what physicians want vs. being another sales channel. "Companies that do this well will have a tremendous competitive advantage in the next 2-5 years," he said.

I also heard from pharmaceutical people at the meeting that eDetails "still cost too much" although they agree that the ROI is good.

A new vendor in the space asked what pharmaceutical companies wanted from eDetail vendors. What the best vendors offered were eyeballs (access to physicians) and analytics. Pharma companies actually want to own the physicians and are not content to "rent" lists from vendors. Some vendors have pushed back and refused to deal. That may be the Achilles heal of eDetailing.

One of the highlights of the conference was my live podcast during the lunch break on the second day.

Joining me for my podcast was Mark Bard, President, Manhattan Research, Harry Sweeney, CEO of Dorland Global Health Communications, Svetlana Toun, SVP, International Strategic Alliances, Alansis Media, Steven Krein, CEO of OrganizedWisdom, and Unity Stoakes, CMO at OrganizedWisdom. Fard Johnmar, Founder of Envision Solutions, L.L.C. and fellow blogger over at Healthcare Vox also joined in by phone.

Listen to what these experts have to say about social networking and how pharmaceutical marketers should get involved. Click here to listen to an archive of this podcast. You will need Microsoft Media player. Go to the Pharma Marketing Talk Host Page for other options and to listen to previous podcasts.

The "Girl from Google"

"I could strangle that girl from Google," said a friend of mine after a presentation by a Google operations specialist at the recent eyeforpharma eCommunications and Online Marketing conference held in Philadelphia. Of course, this was not a literal terroristic threat, just an expression of frustration by a long-time industry advocate.

What did the "Girl from Google" (GfG) say that upset this person so much? I will get to that in a moment, but now that I have your attention, let me recap a few highlights of this very interesting and dynamic meeting.

Live Podcast
One of the highlights of the conference was my live podcast during the lunch break on the second day.

Joining me for my podcast was Mark Bard, President, Manhattan Research, Harry Sweeney, CEO of Dorland Global Health Communications, Svetlana Toun, SVP, International Strategic Alliances, Alansis Media, Steven Krein, CEO of OrganizedWisdom, and Unity Stoakes, CMO at OrganizedWisdom. Fard Johnmar, Founder of Envision Solutions, L.L.C. and fellow blogger over at Healthcare Vox also joined in by phone.

Listen to what these experts have to say about social networking and how pharmaceutical marketers should get involved. Click here to listen to an archive of this podcast. You will need Microsoft Media player. Go to the Pharma Marketing Talk Host Page for other options and to listen to previous podcasts.

Social Marketing
Social networking was a common thread throughout the conference and many speakers, including the "Girl from Google", were extolling the virtues of this new phenom and encouraging pharma marketers to get involved or be left in the dustbin of Internet marketing.

Don't get me wrong. I think social networking is a great opportunity for marketers, but it's not something that pharmaceutical marketers should leave up to their agencies to handle without close adult supervision.

What marketers are being encouraged to do is to "insert themselves into the conversation" because conversations about their products are going on all the time. As the saying goes, when you are invited to a party and you don't show up, people talk about you.

I have blogged about several faux pas's committed by agencies in the employ of pharma companies attempting to insert themselves into the conversation (see "Influencing the Dialogue: Marketers Suck at It!" and "Question Everything"). Indeed, I covered this at the conference in my own presentation entitled "Clear Words, Obscure Benefits," which you can download here.

Consumer Opinion Leaders (COLs), product wikis, Computer-Assisted Persuasion (Captology) were some of the concepts that were discussed in some detail. Look for these concepts to be implemented by "innovative" pharma marketers soon.

Consumer Opinion Leaders
Jack Barrette, pharmaceutical category leader at Yahoo!, claims he coined the term Consumer Opinion Leaders (COLs) to describe ordinary people who influence what many other consumers believe and buy. He cited examples from Yahoo! Answers, which is a social network where people ask questions and Yahoo! experts – who can be any qualified person – provide answers.

COLs earn their status by getting good "grades" from the people that requested help. If you have ever ordered a book on Amazon.com, you may have seen reviews of books written by other readers. Amazon allows visitors to vote on how helpful reviews were to them. You can look up all the reviews that a person has written and see how they scored. This gives you an idea of how helpful this person is likely to be in future reviews.

When COLs speak, others listen.

Other pundits have spoken about these kinds of people. For example, Malcom Gladwell -- author of the book "The Tipping Point" -- calls these people "Mavens." "There is something about the personal, disinterested, expert opinion of a Maven that makes us sit up and listen," says Gladwell.

Just how pharmaceutical marketers can take advantage of COLs in the health arena remains to be seen. It could be similar to how they work with celebrities who are paid to appear in commercials or on talk shows. COLs might be paid to do podcasts, for example.

The "Girl from Google"
OK. Now that you've gotten a background in social networking, it's time to get back to Google. The "Girl from Google" (GfG) was up just before my presentation and the title of her talk was "The Importance of Interactivity: How multimedia technologies will change the way you Connect with Consumers & Physicians."

It was actually a nice presentation but it could have benefited from a little legal/regulatory review beforehand. GfG was one of those presenters who have little or no experience working within or for the pharmaceutical industry. Her bio in the conference brochure says only that she has worked with Google for three years (congrats on the stock options!) and graduated with a Masters Degree form the University of Southern California (party on!). I estimate that GfG joined Google straight from school.

I had only one little problem with her presentation.

As an example of how Google Health can help pharmaceutical companies engage consumers online, GfG used as an example a fictitious drug -- let's call it Xenaxa -- indicated for treatment of osteoporosis. The target consumer was a fifty year old woman concerned about osteoporosis. She does a search on Google Health and finds an AdWord for Xenaxa.

Would you believe that GfG's example used an Adword exactly like the Lunesta AdWord I talked about a few days ago on this blog (see "Lunesta, Google, and bAdWords")? Just like that Lunesta AdWord, the AdWord GfG used in her example included both the trade name of the drug (in the URL) and its indication.

As with the Lunesta AdWord, this example also violates FDA regulations, IMHO. Harry Sweeney agreed. I asked the audience what they thought. One person from a pharmaceutical company, perhaps playing the devil's advocate, contended that the ad may pass muster with the FDA because the package insert or brief summary is "one or two clicks away." His argument was that without specific guidance from the FDA, no one knows what is correct in this case.

One Click Away?
The "one click away" defense does not apply here. FDA says it's OK on an Rx product Web site to merely provide a link to the package insert or brief summary. In that case there is no need to provide that information on the same page that mentions the drug name and its indication.

Thus, an AdWord could be said to comply with the "one click rule" only if within the AdWord text there was a direct link to the package insert (PI) or brief summary. In the example that GfG used, there was only a link to www.xenaxa.com -- the product Web site, not the PI. Presumably, the user would have to find the link to PI once on the Xenaxa Web site. I don't think two clicks would pass muster with the FDA (more on that in future posts to this blog).

It is a shame that the FDA does not have any guidance for the industry as far as Internet advertising is concerned. This means that marketers can use lack of guidance as a defense for sneaking in ads that push the envelope. What are the chances that the FDA would ever notice. These ads are fleeting, here today, gone tomorrow!

However, that should not stop the industry from developing its own Internet DTC advertising guidelines, which it promised to do when PhRMA released DTC guidelines for broadcast DTC.

In this case, however, I think the issue is clear. Any AdWord that mentions a product by name plus the indication, must also include a direct link to the PI within the ad itself.

What do you think?
Consider the Lunesta Adword below:

Does this AdWord Violate FDA's DTC Rules?

Yes No Not Sure

She Just Doesn't See
What the "Girl from Google" just doesn't see is what the fuss is all about. "We don't think it's a problem and it's not our roll to enforce the law." This attitude is absolutely stunning. She claims Google is neutral, but as I pointed out before, Google does intervene when it thinks EU laws about DTC advertising are being violated. Why not when US laws are involved?

An Endorsement
In contrast to the "Girl from Google", the "Guy from Yahoo!" (aka, Jack Barrette) really knows the pharmaceutical industry! My advice to pharma: Go with number two on this one. Jack can really help you do social network marketing right.

Influencing the Dialogue: Marketers Suck at It!

My post to this Blog back in July, 2006 entitled "Rozerem Ads Dis Lincoln, Show Beaver" has generated the most comment and is top-rated on Google searches for "rozerem ad" or "rozerem commercial."

Interestingly, the Rozerem marketers or their "buzz" agency lackeys -- maybe even the folks at Abelson-Taylor, the lead Rozerem ad agency -- are attempting to hijack the conversation by submitting commercial messages (ie, ads) disguised as genuine comments from ordinary citizens. One example is the following anonymous comment:

"I found this page because I googled 'rozerem commercial' to find more information about the ad because I find it to be compelling and curious. I am just your average 44 year old woman and I can't get this ad out of my mind. The imagery is intriguing and each time I see the advertisement I try to catch things I may have missed before: the beaver is eating eggs and sausage, so it must be a morning after insomnia. The beaver's speaking voice is particularly attention getting and I don't see it as a sexual image. I think the ad is funny, thought provoking, and cute and represents the random nature of our dreams. The advertisement has worked for me..I take Ambien and have been considering switching to rozerem. I guess that says it all."

I don't for a minute believe this is a genuine comment from an "average 44 year old woman," do you?

Is this a genuine comment from a consumer?

Yes No

I have mentioned before that when marketers try to influence consumer or user generated content (UGC) on blogs and on bulletin boards they really, really suck at it (see, for example, "Question Everything").

Here's how I know the above comment is fake:

• What self-respecting, average 44 year old woman would bother searching Google for "rozerem commercial"? Only a self-absorbed ad agency guy who was involved with creating the commercial would ever do that!
• "compeling and curious" are two buzz words that a "creative" ad agency would use. Other ad agency buzz words used here include "imagery", "intriguing", "attention getting", and thought provoking". An ad agency measures its success by how "compelling" and "thought provoking" its ads are, not by how much product it sells. In the case of Rozerem, sales are definitely not compelling (see "Rozerem Ads Innovatively Ineffectual").
• Finally, the last sentence was the dead giveaway -- the call to action! It's what every ad should include. Obviously, it's just a bit of wishful thinking in this case.
  

In other words, this is an ad disguised as a genuine comment!

The Rozerem marketing folks have done a poor "impact vs. risk" analysis of this doomed attempt to slip in an ad as a genuine UGC comment. First, the impact on sales of Rozerem is pretty minimal, especially when the effort is wasted on submitting comments to this blog. Second, the risk is high because the marketer is not in control of this channel, I am! Did you guys think I would just roll over and allow the comment through? But it was even more risky because now I am "outing" you and exposing you to ridicule. All of which could have been avoided if you were just honest with me and my readers!

Pharma Marketing Blog perhaps is not as democratic as are some patient blogs or online discussion boards. Maybe many of these are not moderated and allow all comments through. Yet, my experience with such UGC venues -- I used to host a diabetes online discussion board -- is that they are much less forgiving than I of attempts to hijack their discussions by marketers or shills of marketers.

I suggest, therefore, that marketers engage in honest dialogue with consumers if they are going to insert themselves into the conversation. Here are a few simple rules:

1. Identify yourself. Don't try to hide behind anonymity. It doesn't work.
2. Acknowledge your true motive, which is to help sell more of product you believe in. You do believe in it, don't you?
3. Encourage dialogue. You might learn something you can use. Just think of it as a free focus group.
4. If things go wrong, don't argue. Change course or retreat to fight another day.

In other words, be transparent!

Unfortunately, this can never happen in the real world where pharmaceutical marketers engage outside agencies to do their bidding. The agency cannot be transparent; it's contrary to their very nature. Also, too much money and too many careers are at stake.

Upcoming "Pharma Marketing Talk" Podcast

I'm trying something new. It's Pharma Marketing Talk, which is a biweekly online and archived streaming audio talk radio show (podcast) that features interviews with leaders and innovators in pharmaceutical marketing. You can learn more about Pharma Marketing Talk, listen to past shows, or find out about future shows by clicking here.

The next show is Tuesday, November 14, 2006 at 1:00 PM Eastern US time. It will be broadcast live from the eyeforpharma e-Communication and Online Marketing Online conference being held November 13 to 14 at in Philadelphia. I will be talking with speakers and attendees and others who call in to the show. The following people are expected to stop by my setup at the conference or call in as guests:

Mark Bard, President, Manhattan Research and member of the Pharma Marketing Roundtable. Mark is moderating a panel on Tuesday morning entitled "Update your sales strategy: The Quality vs. Quantity dilemma and how to leverage the Internet to support and evolve your sales." Mark has a lot of insight into physician use of the Internet not only here in the US but in Europe as well.

Fard Johnmar, Founder of Envision Solutions, L.L.C. and fellow blogger over at Healthcare Vox. He's doing some work on the methodology of analyzing risks vs. benefits of online marketing, which will be the subject of my own presentation at the meeting on Tuesday, November 14 at 3:10 PM.

Harry Sweeney, CEO of Dorland Global Health Communications Marketing and member of the PharmaRoundtable. Harry's been a friend for years and knows a lot of people. He has been in the pharmaceutical marketing communications business for a long time and can offer a lot of perspective to any discussion on this topic.

Svetlana Toun, SVP, International Strategic Alliances, Alansis Corporation. Svetlana will be presenting a workshop entitled "Connect, Communicate, Hit your Target!" on Tuesday morning at the conference.

You can listen in live or download the archive afterward by visiting the Pharma Marketing Talk Channel Page. If you wish to callin during the live broadcast and ask questions of the quests or make your own comments, call this number: (347) 996-5894 (call in only if you have questions you want to ask on the air).

I pretty excited about this podcast, not only because it's new to me, but I think it's the first time something like this has been attempted live during a pharmaceutical industry marketing conference.

While Pharma Marketing Blog is all about my opinions, Pharma Marketing Talk is about other peoples' opinions.

I look forward to "hearing you there!"

The Long Road to DTC Excellence

Direct-to-Consumer (DTC) advertising will celebrate its official 10th anniversary in 2007.

On August 12, 1997 the FDA opened up the floodgates to DTC when it provided specific draft guidance for consumer-directed broadcast advertising. Since then, DTC has come a long way and you might say that the current period marks the "end of DTC as we have known it."

Changes in DTC advertising are evident to anyone who watches TV. Except for a few exceptions (eg, Botox: see, for example, "PhRMA Intern vs. BOTOX!"), there are no more 'reminder ads' on TV and ads have become more educational. Erectile dysfunction product ads, for example, actually talk about the medical conditions that may cause ED -- diabetes, high blood pressure, and high cholesterol. Imagine that!

TV ads also present side effect information more effectively. True, there may be an overuse of physicians or actors playing physicians. I’ve seen them in TV and print ads for Lipitor, Evista, Zetia, and Viagra to name just a few. Still, the benefit vs. risk dialogue is more balanced.

Back in June, 2005, I complained about print DTC ads that were creative with regard to presenting benefits but written in legalese mouse text when presenting the vital facts (see "Future of Drug Print Ads"). I suggested that drug companies prevent their lawyers from writing the so-called "brief summary" of the labeling, inclusion of which is required by FDA regulations.

Now we have Lipitor print ads with large type both front AND back! In fact, Pfizer’s new patient-friendly labeling information is almost as easy to read and understand as the as copy! Who could have imagined this?

Industry self-regulation -- specifically, PhRMA's Guiding Principles for Direct-to-Consumer Advertising -- has played a big role in bringing about these changes (see "PhRMA Finalizes DTC Principles"). However, these guidelines did not arise in a vacuum. Beginning with the withdrawal of Vioxx from the market by Merck in 2004, there has been a steady stream of criticism of pharmaceutical marketing practices from all corners, including traditional pharmaceutical industry supporters like Sen. Frist, former majority leader in the US Senate (see "Deconstructing Frist on DTC").

These changes have been chronicled here in Pharma Marketing Blog as well as in my publication Pharma Marketing News. Now, I have collected together articles and commentary on this subject into a Special Supplement: Emerging Issues in DTC Advertising. At $29.95, it's a great deal and I hope you buy it.

Go here for details and to buy by credit card online.

Description
This collection reviews in depth the issues and debates that have lead up to the industry's self-regulatory principles.

While we have come a long way and recent changes have changed the DTC landscape, there are still issues outstanding such as the communication of risk information. This collection, therefore, appropriately finishes on that note with the hope that further improvements are on the way.

Table of Contents

• Introduction: It's Been a Long Road! (pg. 1)
• Pharma Trends to Watch (pg. 2)
• To Ban or Not to Ban DTC, That is the Question (pg. 7)
• DTC Pros and Cons Presented at FDA Hearing (pg. 12)
• Marketing in the Post-Vioxx Era (pg. 19)
• Straight-Talking DTC (pg. 22)
• PhRMA Finalizes DTC Principles (pg. 24)
• Communicating Risk: Let the Dialog Begin (pg. 26)
• Merit of CHC Petition to FDA (pg. 33)
• Biotech DTC: Business Not As Usual (pg. 34)
• Print DTC: How Does It Measure Up? (pg. 37)

Only $29.95! PDF delivered to you by e-mail within minutes!

Click here for details and to buy by credit card online.

Do New Drugs Prolong Lives?

Billy Tauzin, president and CEO of PhRMA, the drug industry's US trade association, is a cancer survivor and gives credit to new expensive drugs for saving his life. He also believes that the best way to improve the health of all Americans is to continue to allow access to new therapies whatever the cost.

Tauzin gave a speech ("THE MIRACLE OF THE MARKETPLACE: HARNESSING ITS POWER – SHARING ITS BENEFITS") at the 2005 Competitive Enterprise Institute Annual Dinner in which he said:

Many countries use a form of "health-care rationing," coupled with price controls. Who, when, why, and how people get to use a drug doesn’t depend on whether they need it – it depends on whether or not the bureaucracy thinks it can afford it. These are policies that put government bureaucrats with a veto right in the examining room with patients and their doctors. Let me give you some examples.

Australians can only obtain a drug that can prevent osteoporosis after they have broken a bone. I guess no one ever told the bureaucrat in charge about an ounce of prevention being worth a pound of cure.

PhRMA often cites scary stories from other countries to make its point that the US has the best system for insuring that new, innovative medicines are available to people who need them to prolong their lives.

As reported in the PharmaGossip Blog, "the Association of the British Pharmaceutical Industry [ABPI; the UK equivalent of PhRMA] has issued a press release and published a manifesto ["The Right Medicine, The Right Patient, The Right Time"] that criticises the lower uptake of new drugs in the UK relative to other selected countries" (see "UK and new drugs: a dog market").

The ABPI press release states:

Patients in the UK are still being short-changed by a system that is slow to pick up on new medicines and reluctant to prescribe them even when they have been recommended by NICE [UK equivalent of FDA].

"The pharmaceutical industry researches, develops and provides medicines that relieve suffering and improve health. We want to make sure that patients receive and benefit from them," said Nigel Brooksby, President of the ABPI.

To prove its point that the UK is slow to bring new drugs to market, the ABPI provides the following data. For each country the percent of market share of new drugs (those available for less than 5 years) is shown in parentheses:

• USA (27%)
• Spain (24%)
• Australia (24%)
• Canada (22%)
• France (22%)
• Italy (20%)
• Switzerland (18%)
• UK (17%)
  
• Japan (16%)

As you can see, the US is number one on the list with the highest uptake of new drugs. This is no surprise. As critics of DTC advertising have often pointed out, DTC causes the prescribing of newer, more expensive drugs when less expensive, equally effective drugs are already available. Therefore, DTC is bad. No so, counters PhRMA and ABPI. Access to new drugs is good because it improves health.

As the British Blog Prescribing Advice for GPs points out: "It is unclear if these data are based on items prescribed or drug costs. Additionally, there is no information in this manifesto directly linking the lower use of new drugs to increased morbidity and mortality internationally."

That got me thinking!

Is there a correlation between the uptake of new drugs and life expectancy, which is a measure of the overall health of a nation?

Just like Billy Tauzin, what I want most from new innovative drugs is to assure I get to live as many years as possible.

So I went to the CIA data site and found the latest stats on life expectancy and plotted that against new drug uptake rates reported by ABPI. I came up with the chart on the left.

Lo and behold! there does seem to be a correlation between these data. Unfortunately, it appears that it is a negative correlation: the higher the uptake of new drugs, the lower the life expectancy!

What can account for this? Billy Tauzin hinted at one possible culprit: "No doubt about it, drugs like these carry potential risk." Billy is asking us to balance benefits and risks "People understand the concept of risk and reward -- otherwise, how do you explain marriage? [whaaaa?!] But that understanding seems to break down when it comes to drugs."

Hmmm... But if the benefits are not there, then I certainly don't understand how to balance benefit and risk.