Friday, May 27, 2005

"You'll Go Blind!"


Guys -- did your mother ever tell you'd go blind if you masturbated? That's an "old wives' tale" -- there's never been any scientific evidence to support it. Turns out, however, that there may be scientific evidence that you actually could go blind if you take Viagra!

Pfizer may have to tell users of its impotence drug Viagra that it may cause blindness, according to an article in today's WSJ online (see "
Impotence-Drug Users' Reports Of Blindness Are Examined").

WSJ: "Researchers at the University of Minnesota Medical School in the US identified seven men who developed vision problems after taking Viagra ... The seven men, aged between 50 and 69 years old, had all suffered from a swelling of the optic nerve within 36 hours of taking Viagra for erectile dysfunction."


This is a good case study for FDA's plan to notify the public of "emerging" drug risks on a Drug Watch Web site (see "
FDA Drug Watch Site Guidelines").

Would this situation merit the placement of Viagra and Cialis, which also had a couple of blindness cases associated with its use, on the Drug Watch site? Pfizer and the FDA are "taking these reports very seriously" and the FDA is "still investigating." According to FDA's draft guidance, this is exactly the scenario during which a drug would be placed on the Drug Watch site.


But, how serious is the risk?
After all, 20 million men have taken Viagra since its launch in 1998 and there has been only 14 documented cases of blindness reported. Vision problems are already listed as side effects on the drug's label. The problem with the FDA's plan is that it does not allow nuisances -- either a drug is listed on the site or it is not.


Under the color-coded scheme I proposed recently (see "
Proposed Drug Risk Advisory System"), drugs on the Drug Watch site would be assigned a risk level ranging from GUARDED to ELEVATED to HIGH to SEVERE. Following this scheme, I would give Viagra an "ELEVATED" risk rating to start with. This would alert physicians and patients that it may be a good idea to perform some tests for vision problems; e.g., check for a swelling of the optic nerve within 36 hours of taking Viagra, which was what the
University of Minnesota Medical School reserachers did with their subjects. I really don't know if this is practical in a clinical setting, but consumers could be urged to see their physicians if they experience any vision problems and their physicians can determine what, if any, tests should be done.

If, upon further investigation, more convincing evidence of this dangerous, although rare, side effect is found, then the risk level could be raised to HIGH, but only if the FDA determines that a black box warning is warranted. This is where restrictions on DTC come into play. Drugs with a black box warning cannot run ads that mention the product without mentioning also the condition it treats and known side effects. Of course, in all other DTC ads, the new side effect would have to be mentioned.


Drug Risk Survey Is the Drug Watch program necessary? Does it go too far? Not far enough? What do you think of the proposed Drug Risk Advisory System? Learn More Take the Survey: Click Here

Wednesday, May 25, 2005

PEED: A New Viagra Franchise?


Just when men thought it was safe to take a Viagra and engage in sexual intercourse with confidence, along comes another sexual stigma that "experts" say affects up to 30 percent of us guys.


Yes, I am talking about premature ejaculation, or PE as marketers are now calling it! And, of course, we are hearing about this now because several drug companies are working on a treatment for this "medical condition" and several recent news stories have reported on clinical studies presented at scientific meetings. What a coincidence!
It turns out that Viagra may be a player in the PE market as well as the ED -- erectile dysfunction -- market. If so, it could breathe new life into a brand which otherwise will be going off patent in 7 years or so, not a long time in terms of drug-development years.

Besides, if enough men and their doctors fall under the spell of the buzz about Viagra and PE, it could help Viagra sales, which have been limp of late (see "
ED Drug Sales Limp"), right now.
PE and ED: A Great Combination!Pfizer may be hoping that PE will be a new indication for Viagra, but Johnson & Johnson is pursuing a new drug entity, called dapoxetine, for PE. (See "After Viagra, tackling another sexual taboo").

This leads me to consider an interesting alternative scenario for how Pfizer can extend the life of Viagra; i.e., develop a PE/ED, or, as I like to call it, PEED "combination drug." Pfizer could develop its own version of dapoxetine and combine it with Viagra, thus extending the patent life of Viagra and protecting the franchise. Better yet, Pfizer could buy J&J and get dapoxetine. Hey, it could happen!Using combination therapy to protect a franchise would not be a new ploy for Pfizer, which is planning to extend the patent life of Lipitor -- due to go off patent in 2010 -- by combining it with a new drug, called torcetrapib (see NYT Times article "Pfizer Stirs Concern With Plans To Sell Heart Drugs Only as Pair"). While Lipitor works on lowering the bad cholesterol level, torcetrapib raises the level of good cholesterol. Seems to be a win-win to me!

Pfizer, however, does not plan to market torcetrapib alone and some have criticized this plan because it gives doctors fewer options to do their own combinations, perhaps with competing products. Besides, "By tying Lipitor to the new drug, Pfizer can extend its life and perhaps emerge with an even bigger blockbuster." (See NYT editorial, "A Troubling Drug Combination"). "Authorities on drug development say that the F.D.A. may have no choice but to approve a combination treatment if it proves more effective at preventing heart disease than Lipitor by itself," says the NYT article.

But I digress. Let's get back to PE...

Laugh Out Loud Unscientific
The clinical trials designed to measure time to ejaculation in men taking dapoxetine vs. those on placebo are laughingly unscientific in my eyes. The women partners measure how long it takes their mates to come using stopwatches, which presumably dangle from their necks similar to horse trainers measuring quarter-mile times.

I could not imagine a more difficult scenario for measuring male performance. Also, there seems more incentive for the women to "fake it" than not -- that is, make the time to ejaculate longer than it really was.


Speaking of faking it, why aren't drug companies developing a drug for another "sexual taboo"; i.e., the so-called problem women have coming? This issue is so ingrained in our culture (think of the Sienfeld sitcom: "fake, fake, fake") that I'm sure experts could be found to interpret data somewhere to support a claim that 20-30 percent of women "suffer" from this non-PE problem.


Bullshit Meter: HIGHBullshit Level: HIGH
Is PE really a "medical condition" that needs correcting? Is the number of men actually "suffering" from this "condition" being blown out of proportion the same way that I claim the numbers of ED suffers are being inflated?


Of course the numbers are being inflated! These are "lifestyle drugs" that are not really meant to treat a medical condition. Claims otherwise are a lot of bullshit (see "Is Pharmaceutical Marketing a Lot of BS"). Therefore, I have to rate the claims regarding number of PE sufferers very high on my "Bullshit Meter" (see FIGURE, left).


Non-premature ejaculation may be the real medical problem.
Has anyone considered that PE may be an advantage in terms of natural selection? The faster a male animal can get its seed into a female partner, the more likely its genes will survive by being passed on to offspring. As evidence, I offer every video I've seen showing animals doing it. It's always "wham, bam, thank you ma'am." That is, it's over in about 2 seconds flat. Neither the male nor the female think much of it.
Of course, times have changed since the glory days of human evolution. Marriage was invented to allow men and women to have several shots at conceiving and knowing who sired whom. Within the course of a typical marriage, there is plenty of opportunity to mate. Recreational sex is also an option and occasional problems with erections and/or achieving orgasms should not be cause to swallow another pill. But nobody, it seems, has the time to pursue other solutions.

Sunday, May 22, 2005

Is Pharmaceutical Marketing BS?

After watching a 60 Minutes show that featured a story on a book titled “On Bullshit,” I just had to go out and get the last copy in my local bookstore, especially since the commentary also noted that marketing is one of the most notorious sources of bullshit.

The book, which is a 67-page tongue-in-cheek treatise, was written by one Harry G. Frankfurt, a Princeton University professor of philosophy. Frankfurt, who is well-known in academic philosophy circles but probably unknown to you, makes a distinction between liars and bullshitters.

In which category are marketers? What are some noteworthy examples of pharmaceutical marketing bullshit? How does marketing bullshit hurt the industry?

The idea that marketing is somewhat less than truthful should not surprise anyone. Some people would even claim that marketers are liars. For example, Seth Godin, author of the book “Permission Marketing: Turning Strangers Into Friends And Friends Into Customers,” which was previously reviewed in Pharma Marketing News (see “Out-of-the-Box Marketing: Will It Work for Pharma?”, PMN Reprint #27-02), has written a new book titled “All Marketers are Liars.” The book is scheduled for release on May 23, 2005. According to one reviewer, “this is a book about doing what consumers demand—painting vivid pictures that they choose to believe.” Sounds like bullshit to me!

Carefully Wrought Bullshit
Frankfurt puts marketing into the category of “carefully wrought bullshit.” According to him, “the realms of advertising and of public relations, and the nowadays closely related realm of politics, are replete with instances of bullshit so unmitigated that they can serve among the most indisputable and classic paradigms of the concept.”

The important point is that all marketers are NOT liars. All Marketers are Bullshitters! One wonders if Godin’s book will sell more with that title, but I don’t think so. It would lose its shock value because everyone knows that marketers are bullshitters and, what’s more, everyone expects bullshit from marketers. Lying, however, would be shocking and even illegal! The distinction, therefore, between lying and bullshitting is critical from a pharma-ceutical marketer’s point of view, not to mention the FTC and FDA.

The Essence of Bullshit
The difference between a bullshitter and a liar, claims Frankfurt, is that the bullshitter has a complete disregard for facts. “His eye is not on the facts at all, as the eyes of the honest man and of the liar are, except insofar as they may be pertinent to his interest in getting away with what he says…this indifference to how things really are—that I regard as of the essence of bullshit.”

A good example of this is how Merck instructed its sales force to bullshit their way around questions by docs about Vioxx.

At a recent Congressional committee hearing, confidential Merck documents were released that provide details about how Merck aggressively cast Vioxx in the best possible light before it was pulled from the market because of cardiovascular risks.

“When doctors asked about those risks,” according to a May 6, 2005 AP story, “the Merck sales reps were to refer to a ‘cardiovascular card’ with data suggesting that Vioxx could be safer than other anti-inflammatory drugs. Yet the card… doesn't include the very study that raised the first warning signal that Vioxx could harm.”

In other words, the reps were instructed to paint a picture that perhaps the doctors wanted to believe—i.e., they engaged in some “carefully wrought bullshit.” The Merck marketers were not lying and their eyes were definitely on the facts, just not the right facts. This, as Frankfurt would say, is the essence of a bullshitter.

The bullshitter “does not reject the authority of the truth, as the liar does, and oppose himself to it. He pays no attention to it at all,” says Frankfurt. “By virtue of this, bullshit is a greater enemy of the truth than lies are.”

Although bullshit, according to Frankfurt, is produced “without concern for the truth, it need not be false. The essence of bullshit is not that it is false but that it is phony.” Got the distinction yet?

All Brands are Bullshit
Frankfurt looks at the motives of a liar and a bullshitter to help delineate one from the other. Whereas the lair is trying to deceive, the bullshitter is not. The bullshitter doesn’t care about the truth. “What he cares about,” says Frankfurt, “is what people think of him.”

If the brand personifies the marketing message, then the brand is the bullshitter. The marketer strives to build a brand that is trusted by the consumer, that is well thought of, that impresses the consumer. That is what matters. The brand, therefore, is bullshit.

The Marketer as Bullshit Artist
Frankfurt suggests that there are “exquisitely sophisticated craftsmen”—although later on he calls them artists—in the realm of politics and marketing “who—with the help of advanced and demanding techniques of market research, of public opinion polling, of psychological testing, and so forth—dedicate themselves tirelessly to getting every word and image they produce exactly right.” Sound like anyone you know?

Advertisers often reward themselves with prestigious awards for creativity. This is an appropriate accolade for the bullshitter and his or her product, because the creativity upon which bullshit relies, says Frankfurt, “is less analytical and less deliberative than that which is mobilized in lying. It is more expansive and independent, with more spacious opportunities for improvisation, color, and imaginative play.”

That is frequently how marketers and advertisers describe their product. Just look at the Viagra “devil Bob” ad that was pulled from the market not too long ago. This is what Kelly Simmons, executive vice president and chief creative officer at Tierney Communications in Philadelphia, who studies sex issues in marketing, had to say: “I like the new tone; I think it’s playful.” (See “The Two Bobs: Enzyte vs. Viagra”).

Bullshit is a matter of art and marketers think of themselves more as artists than as craftsmen. In other words, they see themselves as “bullshit artists.”

Why Is There So Much Bullshit?
Frankfurt contends that there probably is no more bullshit today, relatively speaking, than at other times. It’s just that there is more communications of all kinds today.

The pharmaceutical industry has been guilty of increasing communications to doctors and consumers to such a degree that the bullshit level, like the level of spam in your e-mail inbox, has reached such a height that it cannot be ignored and is no longer tolerated (see FIGURE below). That is why doctors won’t let sales reps into their offices anymore and why lawmakers are proposing bills to limit DTC advertising.

Pharmaceutical marketing bullshit could be lessened either by cutting back on all forms of marketing communications to doctors and consumers, which would lead to a depression in our industry, or by decreasing the amount of bullshit in those communications. The critics in Congress will force the former solution upon the industry unless pharmaceutical marketers volun-tarily adopt the latter.

BS Chart
FIGURE: The relative amount of bullshit in pharmaceutical marketing communications may be the same today as it was 8 to 10 years ago before DTC advertising burst upon the scene and pharmaceutical companies dramatically increased their sales forces. The absolute level of bullshit today, however, far exceeds the tolerance level of docs and their patients.

MACK’s MARKETING BS MAXIM
If the percentage of bullshit in marketing communications were decreased, pharma marketers could still maintain or even exceed the current level of communications with their audiences and not exceed their BS tolerance levels.

Thursday, May 19, 2005

Preview of May Issue of Pharma Marketing News

Vol. 4, No. 5: May 2005 - PREVIEW

The following are summaries of articles planned for the upcoming May 2005 issue of Pharma Marketing News.


Article Summaries

A Proposal for a Drug Risk Advisory System
By John Mack

Recently the FDA published guidelines for a Drug Watch program to provide emerging drug safety information to the public. While it is laudable that the FDA intends to make this kind of information available on its web site, the public may not be aware that a drug has been added to the list unless they proactively visit the web site.

It is essential that the information from the FDA about drug risks and side effects get out to consumers as quickly as possible and that the risks are communicated effectively.

Taking a page from the Homeland Security Advisory system, the author proposes a color-coded system for notifying the public about drug risks and links the levels of risk with levels of restrictions on DTC advertising.

Full text coming soon...
Watch for the May issue in your e-mail inbox on or about 23 May 2005.
If you are not a subscriber, SUBSCRIBE TODAY! and get this issue FREE!


Thought-Leader Management: A Challenge Met
By John Mack

Pharmaceutical companies are continually working to establish and maintain relationships with thought leaders -- influential physicians who play an important role in communicating a new therapy's benefits for other physicians. Thought Leaders -- also known as Key Opinion Leaders, or KOLs -- help pharmaceutical companies identify unmet medical needs, shape clinical studies, launch products and understand critical lifecycle issues.

However, across the medical device and pharmaceutical industries, thought leader management programs have not been as effective as internal management would like, particularly in the age of the Internet, when the dissemination of information should be easier than ever, according to John Estafanous, President of Bethesda, Maryland-based Estco Medical.

This article reviews Web-based Medigent(R) Thought Leader, a software solution for managing KOLs.

Full text coming soon...
Watch for the May issue in your e-mail inbox on or about 23 May 2005.
If you are not a subscriber, SUBSCRIBE TODAY! and get this issue FREE!


Marketing in the Post-Vioxx Era: Quality vs. Quantity
By John Mack

At a recent Pharmaceutical Executive (PE) Annual Marketing Summit in Philadelphia, a panel of experts moderated by Patrick Clinton, Editor-in-Chief of PE Magazine, discussed pharmaceutical marketing in the "post-Vioxx" Era. The panel, titled "The Post-Vioxx Era: Shedding New Light on Drug Safety, Risk Communications, and Advertising," examined shortcomings in the current regulatory system and discussed opportunities for improvement. This article summarizes the discussion. Topics include:

  • What can the industry learn from the experience and how can we respond?
  • Does DTC advertising drive unnecessary drug use? If so, what are the implications for DTC advertising?
  • How can we accommodate products with complex safety profiles?
  • Can we inoculate products against this type of response?
  • Is the problem drug safety, risk communications, doctor/patient education, the effects of advertising-or all of these?

Full text coming soon...
Watch for the May issue in your e-mail inbox on or about 23 May 2005.
If you are not a subscriber, SUBSCRIBE TODAY! and get this issue FREE!


Return on CME: Are Pharma Companies Getting Desired Outcomes?
By Lisa S. Berger

Measuring the outcomes of medical education is increasingly important in Continuing Medical Education (CME) and cannot be ignored by the CME provider or industry sponsor. The Accreditation Council for Continuing Medical Education (ACCME) requires the provider to evaluate the effectiveness of its CME activities in meeting identified educational needs. In addition, measuring the effectiveness of a particular program is crucial to matching the right program to participant needs and to future program design for the provider, and evaluating the money spent for the sponsor.

This article summarizes a presentation by Sharyn Lee, CEO and cofounder of Medical Educational Broadcast Network (MEBN), a medical education communications and publishing company, who spoke on outcomes-based CME and the importance of selecting the best assessment tool at a recent Medical Education Congress.

Full text coming soon...
Watch for the May issue in your e-mail inbox on or about 23 May 2005.
If you are not a subscriber, SUBSCRIBE TODAY! and get this issue FREE!


Is Pharma Marketing a Lot of BS?
By John Mack

After watching a "60 Minutes" show that featured a story on a book titled "On Bullshit," I just had to go out and get the last copy in my local bookstore, especially since the commentary also noted some of the notorious sources of bullshit, including marketing.

The book, which is a bit tongue-in-cheek, is written by a Princeton University professor of philosophy and is only 67 pages long. The author, who is well-known in academic philosophy circles but probably unknown to you, makes a distinction between liars and bullshitters. In which category are marketers? What are some noteworthy examples of pharmaceutical marketing bullshit? How does marketing bullshit hurt the industry?

Note that Seth Godin, author of the book "Permission Marketing : Turning Strangers Into Friends And Friends Into Customers," which was previously reviewed in PMN, has penned a new book called "All Marketers are Liars." This book is scheduled for release on May 23, 2005. According to one reviewer, "this is a book about doing what consumers demand -- painting vivid pictures that they choose to believe." Sounds like bullshit to me!

Full text coming soon...
Watch for the May issue in your e-mail inbox on or about 23 May 2005.
If you are not a subscriber, SUBSCRIBE TODAY! and get this issue FREE!


###

Monday, May 16, 2005

Pull Back from DTC on TV?


An article in Today's Wall Street Journal suggests that some drug makers are starting to cut back TV ad spending (see "
Some Drug Makers Are Starting To Curtail TV Ad Spending"). Pfizer and TAP were cited as examples.

TAP pharmaceuticals, for example, which spent "about $91 million advertising heartburn drug Prevacid on television in 2004, pulled the plug on TV commercials for the treatment late last year to focus on print media."


Chalk it Up to the Need to Explain Risks vs. Benefits?

"Print advertising allows consumers to take their time reviewing important risk-benefit information," Katherine Stueland, spokeswoman for TAP Pharmaceutical Products Inc., said. "Additionally, it gives us ample space to include that information." (See "
TV ads for heartburn drug Prevacid pulled").

Back in January, I suggested that 30 or 60-second TV ads could not adequately communicate drug risk information (see "
Can Drug Ads Communicate Risk?" Also, see PMN article: "Numbers, Math and Communicating Risk")


Other Factors

Other factors may be at play here. How effective are TV ads anyway? Do they really increase drug sales? I don't think the pharma industry (or any other industry for that matter) can actually prove that TV ads sell more products. The old adage "Half of my ad dollars are wasted, I just don't know which half" is as true today as it ever has been.


"The pharmaceutical industry spent $4.45 billion on advertising to consumers in all media last year, a 27% increase over 2003," according to the WSJ article. It spends a whole lot more on physician advertising. It's difficult to determine, therefore, which channel of advertising is effective.


When DTC ads first ran on the Super Bowl in January, 2004, it was possible to measure an increase in newly written prescriptions for ED drugs immediately afterward (see "
The New Written Prescription: Leveraging Technology to Measure Change in Physician Behavior as it Occurs"). However, physician details also increased during that time.

As the WSJ article points out "drug sales don't necessarily rise or fall as TV ads are boosted or reduced. One reason is that, unlike with other products such as cars or fast food, a consumer can't buy a prescription drug without a doctor's signature."


The article also mentions Pfizer's cut back on Viagra TV DTC ads. There are multiple factors at play here -- criticism by the FDA of a previous campaign is one. Pfizer also indicated it will be cutting back on marketing anyway (see "
Pfizer to Slash 30% of its Sales & Marketing Staff").

But most likely it has to do with market saturation. I believe that the drug industry has over-estimated the size of the DTC market and sales are not nearly what they anticipated they would be. Pfizer et al drank their own Kool Aid on this one (see "
ED Drug Sales Limp").

"Broadcast TV, I believe has to be part of the overall media mix," says Stuart Klein, president of Quantum, a unit of ad giant WPP Group PLC that specializes in health-care products, including prescription drugs. "What I'm seeing is the recognition by companies that the last 5% to 10% of TV spending is much better spent on relationship marketing or on the Internet, where you can have a deeper dialog with people."


I have noted before that surveys indicate there would be a shift away from broadcast TV ad spending by pharma and an increase in Internet (e-mail mostly) spending to improve compliance (see, for example, "
DTC in 2005: Can You Teach Old Dogs New Tricks?").

Synergy Between TV and the Internet - Motivation and Education

Not enough effort or money, in my opinion, is spent to foster the synergy between DTC broadcast ads and the Internet. DTC ads focus on what may be a giant step for many people - go see your doctor. They don't emphasize enough an intermediate step - i.e., go to a website to learn more about the condition, the treatment options and find motivational tools.


The FDA has urged that DTC broadcast ads refer viewers to an 800 number, website, or print ad to find more information. Print ads can include the full prescribing information and you can get brochures by calling the 800 number (although you might have to wait a long time; see article "
Beyond DTC: Consumer Relationship Satisfaction"), but only the Web can offer in-depth education, interactivity, and personalization. This, not repetition of 30-second TV ads, is what's needed to get more undiagnosed people to see a physician and to help motivate the diagnosed to stay on treatment.

Saturday, May 14, 2005

Terror Politics vs drug Importation

obnBack in September, 2004, I noted that the FDA recently played the "terrorist trump card" in the battle against the legalization of the reimportation of drugs. Acting U.S. Food and Drug Administration commissioner Lester Crawford suggested that "a source of continuing concern" is that terrorists might tamper with prescription drugs imported from Canada.

Crawford's remarks may strike some as politically motivated and Brian Roehrkasse, spokesman for the Homeland Security Department responded to Crawford's remarks by saying "While we must assume that such a threat exists generally, we have no specific information now about any al-Qaida threats to our food or drug supply."

For the complete OpEd piece, see "Drug Importation Crisis: Terror Politics to the Rescue!"

Obviously, the FDA did not have credibility, even among other government agencies. PhRMA (the Pharmaceutical Research & Manufacturers Association), which represents more than two dozen of the world's top pharmaceutical firms, recently solicited the aid of someone who's credibility with regard to terrorism is unparalleled (even if he does lack certain moral values such as fidelity to his wife). That person, of course, is former New York City Mayor Rudy Giuliani.

PhRMA commissioned Guiliani Partners to produce a report that called for an immediate moratorium on drug importation legislation (see PhRMA press release: "Giuliani Report Calls for Immediate Moratorium On Drug Importation Legislation."

Credible Sources
According to Giuliani, "opening U.S. borders to prescription drugs could provide an unfortunate opportunity for terrorists. “Several credible sources have identified links between counterfeit goods, including pharmaceuticals, and organized criminals and terrorist groups,"” he said. “"It is not difficult to imagine a scenario in which terrorist groups could use this system to either finance operations or, worse, as a vehicle of attack.”"

These "credible sources" may be of the same ilk that gave us Iraq's weapons of mass destruction. I can "imagine" many scenarios of terrorists using our "systems" to attack us. How about our food distribution "system?" Tommy Thompson, the former Secretary of Health and Human Services, suggested this threat as he was leaving his office one day. "“For the life of me," said Thompson, "I cannot understand why the terrorists have not attacked our food supply because it is so easy to do.”" (See "Thompson resigns with grim warning") Want to worry about something? Worry about that!

If fear mongering can get us to war in Iraq, it surely can also be useful for other political purposes! And it is all about politics, protecting the drug industry against consumer choice, not about protecting consumers. Else wouldn't we be reading a Guiliani report about terrorist threats to our food supply system?

Let's not try to win every policy argument by bringing terrorism into the equation. I think it undermines our vigilance against real terror threats. Remember the moral of Aesop's fable about the little shepherd boy:

There is no believing a liar, even when he speaks the truth.

Thursday, May 12, 2005

Proposal for a Drug Risk Advisory System


Recently the FDA published guidelines for a Drug Watch program to provide emerging drug safety information to the public (see "FDA Drug Watch Site Guidelines").

Drug Risk Advisory System
Drug Risk Advisory System
Taking a page from the Homeland Security Advisory system, I propose a similar color-coded system for notifying the public about drug risks. You can see my color chart on the left.

This system is explained in my comments submitted to the FDA. (You too can submit comments on the proposed Drug Watch program. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
www.fda.gov/dockets/ecomments. Refer to Docket No. 2005D-0062, DOCID:fr10my05-95.

This system has been scoffed at when used by Homeland Security, but I think it would be a useful system to communicate drug risk information to the public. Think of it as FDA's "Food Pyramid" -- a useful chart with layered information behind it. That is, the chart itself only gives a high-level summary of risk that even health jargon "illiterate" consumers can understand at a glance. Behind it, however, are other levels of information including: (1) recommended actions for patients (e.g., see your physician immediately; stop taking the medication if you experience any chest pains, etc.); (2) patient package inserts where all the risks are laid out; (3) clinical details relating to the risk; etc.

Comments on Draft Guidance for Industry on the Food and Drug Administration's
``Drug Watch'' for Emerging Drug Safety Information

Submitted by:

John Mack
Executive Editor
Pharma Marketing News
PO Box 760
Newtown, PA 18940
215-504-4164
11 May 2005

Introduction
As the Publisher and Executive Editor of Pharma Marketing News and the owner of Pharma Marketing Network, I have access to thousands of pharmaceutical marketing professionals inside and outside the pharmaceutical industry.

Pharma Marketing Network™ brings together into a single online community pharmaceutical marketing, advertising, and sales professionals from pharmaceutical companies, communications companies, and marketing service providers. Pharma Marketing Network includes an e-mail and Web-based monthly newsletter (Pharma Marketing News), an opt-in e-mail list of Pharma Marketing News subscribers, an online discussion forum, a topical no holds barred Blog (www.pharmamarketingblog.com) and an informational Web site packed with resources for marketers (www.pharmamarketingnetwork.com).

Pharma Marketing Network's mission is to help pharmaceutical marketers increase their knowledge, network with their peers, advance their careers, promote their business, and gain access to new clients.

Comments
My comments can be broken down into two categories: (1) Comments relating to specific issues raised by Guidance and (2) a proposed Drug Watch Advisory System based on the color-coded Homeland Security Advisory System (see above).

General Comments
The guidance states: "Our goal with the Drug Watch," says FDA "is to share emerging safety information before we have fully determined its significance or taken final regulatory action so that patients and healthcare professionals will have the most current information concerning the potential risks and benefits of a marketed drug product upon which to make individual treatment choices."

Use “Pull” as well as “Push” Tactics to Bring Consumers to Site
While it is laudable that the FDA intends to make this kind of information available on its web site, the public may not be aware that a drug has been added to the list unless they proactively visit the web site. While many consumers undoubtedly visit the FDA site, they may not be aware of the new Drug Watch site or may not visit often enough.

It is essential that the information from the FDA about drug risks and side effects get out to consumers as quickly as possible. The FDA has limited resources to publicize each time a drug is added to the site, but there is a way to enlist the aid of other organizations to get the word out and drive the proper segment of the population to the Drug Watch site.

I propose the following: Rather than relying on a “build it and they will come” strategy, the FDA should follow a more pro-active strategy as it has with the traditional MedWatch program, which notifies doctors about drug safety issues. That program requires pharmaceutical companies to send "dear doctor" letters to all its physician clients. It also enlists professional organizations and web sites focused on physicians to notify their members and visitors about Medwatch notices.

It is not practical for drug companies to notify all patients who may be taking their products listed on the Drug Watch site. The FDA, however, could ask companies to notify physicians through the MedWatch program and physicians can notify their patients.

Another suggestion is for pharmaceutical companies to notify affected patients that they have in their e-mail databases. This is feasible and not expensive as more and more pharmaceutical companies are collecting consumer information and sending out newsletters and product information to consumers via e-mail. The companies often know what products these consumers use.

In analogy with the MedWatch program, I suggest that the FDA solicit consumer-focused and patient advocacy organizations to join a Drug Watch program through which they are given advance notice that a drug is being added to the list. These groups can then notify their members and direct them to the Drug Watch site.

No FOIA Request Required
The guidance states: "Most of the information that will be posted on our Web site is information that is now made available to the public (after proper redaction of confidential commercial and personal privacy information) in response to Freedom of Information Act (FOIA) requests. Because of the importance of this information to healthcare professionals and patients, we have decided to take steps to make such emerging information available without waiting for a FOIA request..."

Getting information from some government agencies under the Freedom of Information Act (FOIA) has sometimes been a difficult and long process. "[I]n practice, the Freedom of Information Act has not always lived up to the ideals of that Act," according the Findings section of the OPEN Government Act of 2005. It is commendable, therefore, that the FDA intends to post information to the Drug Watch site that, until now, was only available under a FOIA request: It is hoped that this will speed up the delivery of critical information to the public.

How will FDA decide which drugs will be included on the Drug Watch?
This is the million dollar question. The decision will be left up the Drug Safety Oversight Board, which the agency recently created, to decide when drugs are to be added to the list. I can't comment on that until I see how it works in practice. It is worrisome, however, that the Board has the appearance of the fox guarding the hen house as it were.

What About Removal?
Deciding when drugs should be removed from the list is also very important. The Oversight Board will be responsible for that decision as well according to the following guidelines:

1. FDA has determined that, despite the initial signals, there is no new safety concern.

2. When its labeling has been revised to address the safety concerns or when FDA has taken other steps to adequately communicate information to healthcare professionals and patients.

Once a drug is listed on the site, the entire history should be archived so that patients and physicians can follow the decision-making process. Perhaps doctors read the black box and adhere to its warnings -- perhaps some do not. But if patients as well as physicians are expected to weigh the benefits vs. risks, then there needs to be a forum through which the risk information is continuously available. Patients will seldom see the black box on the package insert.

To Make it Work, Re-Purpose Homeland Security’s Color Code System!
The question about when to remove a drug from the Drug Watch site is akin to when a notice of terrorist risk should be withdrawn by Homeland Security. Clearly, there is always some level of risk of terrorist attack and, as has often been said, there is always some risk associated with prescription drugs.

Drug Risk Advisory System Therefore, I suggest that once a drug has been put on the Drug Watch site, it should always be listed on the site. However, as with the Homeland Security Advisory System color code, I suggest that the FDA use the following color-coded system on the Drug Watch site:

RED – Severe Risk
If severe side effects (e.g., CV events, death) have been reported and these side effects are not part of the current labeling, the drug should be placed in this category. The drug would remain in this category while the FDA and/or the pharmaceutical sponsors are doing further investigation and evaluation of the data.

Furthermore, while a drug is in this "severe risk" category, DTC ads for the drug should be prohibited. Pfizer voluntarily did this with Celebrex, for example, when asked by the FDA. The drug could still be marketed to physicians who presumably would be getting the latest information about side effects through the Medwatch program.

I propose this because DTC is very effective in getting consumers to demand drugs by name from their physicians and 70% of the time the physician – who may be as uninformed about the drug’s risk as is the patient – writes a prescription for the drug. Clearly, this could unnecessarily put more people at risk than would otherwise be if DTC were allowed during this period.

Perhaps drug companies should be required to perform more post launch surveillance studies to help evaluate the safety of drugs listed in the RED category of the Drug Watch site. The restriction on DTC can be provisional upon completion of those studies.

When the evaluation is complete, the drug is either proved to be safe or is relabeled so that risk is addressed. At this point the DTC restriction should be lifted and the drug should be removed from "severe risk" zone and placed at a lower alert level. If it proved safe, it could drop down to the green "safe zone" with its history still available. If it gets a black box warning, it may only drop down to one of the other colored zones (e.g., orange) indicating high risk.

ORANGE – High Risk
Drugs in this category have black box warnings. FDA already restricts DTC of drugs in this category (i.e., no reminder ads allowed).

YELLOW – Elevated Risk
Drugs in this category have serious side effects requiring blood tests or other periodic monitoring of patients. These drugs do NOT require a black box, but may have been previously listed in the RED category and relabeled after review by the FDA.

BLUE – Guarded Risk
Drugs in this category have mild side effects that were known at the time of approval and properly labeled at launch. A drug previously listed under the RED category could only be relisted in the BLUE category if all allegations of serious side effects were proven to be false,

GREEN – Low Risk
All other drugs would be in this category, but do not have be specifically listed on the Drug Watch site. This reflects the concept that ALL drugs carry some risks.

For each category the FDA should explain, in general, what patients should do if they are taking a drug in that category (e.g., “Recommended Actions for Citizens”).

The use of the color-coded system that I describe here, although often derided as used by Homeland Security, would be an excellent way to help consumers evaluate the real risk posed by prescription drugs. Also, it would prevent DTC from unduly influencing the prescribing of drugs under active evaluation by the FDA.

Monday, May 09, 2005

FDA Drug Watch Site Guidelines


As reported in today's Wall Street Journal ("FDA Issues Guidelines For 'Drug Watch' Site, Details on Oversight Board") , the FDA issued a Gudiance (i.e., draft guidelines) last Friday on a "Drug Watch" web site for "Emerging Drug Safety Information" (see "Guidance: FDA’s 'Drug Watch' for Emerging Drug Safety Information" and FAQs).

As the FDA says, "Sometimes after a drug is approved, rare but serious side effects emerge as the drug is more widely used or is prescribed for off-label uses." Vioxx is a case in point (see, for example, Cox-2's Die Hard: With a Vengeance).
The proposed web site "is intended to identify drugs for which FDA is actively evaluating early safety signals."

There are a few notable aspects of this proposal that I think deserve commentary.

"Our goal with the Drug Watch," says FDA "is to share emerging safety information before we have fully determined its significance or taken final regulatory action so that patients and healthcare professionals will have the most current information concerning the potential risks and benefits of a marketed drug product upon which to make individual treatment choices."

While it is laudable that the FDA intends to make this kind of information available on its web site, the public may not be aware that a drug has been added to the list unless they go the web site. This may or may not happen.

Rather than relying on a “build it and they will come” strategy, I think that the FDA should follow a more pro-active strategy as it has with the traditional MedWatch program, which notifies doctors about drug safety issues. That program requires pharmaceutical companies to send "dear doctor" letters to all its physician clients. It also enlists professional organizations and web sites focused on docs to notify their members and visitors about Medwatch notices.

Perhaps the FDA should solicit consumer-focused and patient advocacy organizations to join a Drug Watch program through which they are given advance notice that a drug is being added to the list. These groups can then notify their members.

No "Stinking" FOIA Required
"Most of the information that will be posted on our Web site is information that is now made available to the public (after proper redaction of confidential commercial and personal privacy information) in response to Freedom of Information Act (FOIA) requests. Because of the importance of this information to healthcare professionals and patients, we have decided to take steps to make such emerging information available without waiting for a FOIA request..."

Getting information from some government agencies under the Freedom of Information Act (FOIA) has sometimes been a difficult and long process. "[I]n practice, the Freedom of Information Act has not always lived up to the ideals of that Act," according the Findings section of the OPEN Government Act of 2005. It is commendable, therefore, that the FDA intends to post information to the Drug Watch site that, until now, was only available under a FOIA request:

I suspect that this will make some pharmaceutical companies nervous.

Off-label Risks Too!
The FDA says that it will include emerging safety information that may relate to "new risks, new information on known risks, or risks associated with off-label uses."

As you know, a physician can prescribe a drug for any condition, not just the condition for which it was approved by the FDA. This is termed "off-label" use. Drug companies generally are not permitted to promote off-label uses to physicians. However, off-label use may account for a significant fraction of a drug's total prescriptions. See "Guidelines for Off-label Communications" for more information. Therefore, including information about off-label adverse side effects could be very critical information for many people taking drugs for "unapproved" conditions.

How will FDA decide which drugs will be included on the Drug Watch?
This is the million dollar question. The decision will be left up the Drug Safety Oversight Board, which the agency recently created, to decide when drugs are to be added to the list. I can't comment on that until I see how it works in practice. It is worrisome that the Board has the appearance of the fox guarding the hen house as it were.

What About Removal?
Deciding when drugs should be removed from the list is also very important. The Oversight Board will be responsible for that decision as well according to the following guidelines:

1. FDA has determined that, despite the initial signals, there is no new safety concern. I got no beef with that.

2. When its labeling has been revised to address the safety concerns or when FDA has taken other steps to adequately communicate information to healthcare professionals and patients.

Once a drug is listed on the site, I think the entire history should be archived so that people can follow the decision-making process. Perhaps doctors read the black box and adhere to its warnings -- perhaps some do not. But if patients as well as physicians are expected to weigh the benefits vs risks, then there needs to be a forum through which the risk information is continuously available. Patients will seldom see the black box on the package insert.


To Make it Work, Re-Purpose Homeland Security's Color Code System!
During the phase in which a drug is listed on the Drug Watch site and the FDA is doing further investigation, I propose that the drug be placed in a "high alert" zone that is assigned a special color such as red. This would be a good way to re-purpose The Homeland Security Advisory System color scale!

While in this "high alert" zone, DTC ads for the drug should be prohibited. Pfizer voluntarily did this with Celebrex, for example, when asked by the FDA. The drug could still be marketed to physicians who presumably would be getting the latest information about side effects through the Medwatch program.

Perhaps, as I proposed before (see "How the FDA Can Fix DTC"), drug companies would be required to perform more post launch surveillance studies to help evaluate the safety of drugs listed in the "high alert" zone of the Drug Watch site. The restriction on DTC can be provisional upon completion of those studies.

When the evaluation is complete, the drug is either proved to be safe or is relabeled so that risk is addressed, the DTC restriction should be lifted and the drug should be removed from "high risk" zone and placed at a lower alert level. If it proved safe, it could drop down to the green "safe zone" with its history still available. If it gets a black box warning, it may only drop down to one of the other colored zones (orange or yellow) indicating intermediate risk.

Not only would this be a good way to help consumers evaluate risk, it would prevent DTC from unduly influencing the prescribing of drugs under investigation.

Friday, May 06, 2005

Get a Load of Those Gams!


"A group of Congressmen publicly released a set of pharma company sales documents yesterday. The House Committee on Government Reform published the Merck documents, obtained last year during the Vioxx investigation, on its website. For healthcare providers, especially physicians, there is some interesting reading here on pharma marketing strategies. Details revealed include the length of a time a rep is supposed to shake hands (three seconds) and how one is to eat when dining with a physician. Also covered: what to say if a physician asks you if the health risks associated with your product is overblown." -
Fierce Healthcare

If my cursory glance at a *single* document is any indication, Merck is going to be either raked over the coals or ridiculed for a long, long time.


Just look at page 2 of the "Needs Based Selling" document.
Training Continuum
This "Training continuum" chart is stunningly primitive. It categorizes sales reps along 2 dimensions: Selling skills and product knowledge. I had to enlarge the image to read it, and when I did I was drawn to the image of the sales rep in the lower right quadrant ("I have the sales skills but not the knowledge"). Get a load of the gams on that dame, as a Raymond Chandler hard-boiled detective might say!


Is this a freak of repeated Xeroxing? Or did some Democratic congressional staff member engage in a little whimsical graffiti?


Anyway, that's just funny. What's not so funny is what these documents might reveal about Merck's marketing and selling tactics, which can probably be extrapolated to the entire pharma industry. I intend to download all these documents and get a good idea of how Merck does business.

If I were a conspiracy freak -- and I am -- I'd say these documents will mysteriously disappear pretty soon. So hurry up and get your copies!


See www.democrats.reform.house.gov/features/vioxx/documents.asp for the list of documents.

Thursday, May 05, 2005

The Two Bobs: Enzyte vs. Viagra


I read -- with sadness, I must admit -- that the offices of Berkeley Premium Nutraceuticals, the company that brought us Enzyte, the "natural male enhancement pill," was raided by no less than four federal agencies in March. The agencies were the U.S. Postal Service, the FBI, FDA and the IRS. A pretty damn intimidating lot, I'd say! (See "Feds Raid Herbal Supplement Company").

"We received information that there could be evidence of criminal activity in the location, and for that reason we're executing a search warrant," said FBI Special Agent Michael Brooks. So far there are no charges, no arrests and no indictments, just an ongoing investigation.


You've probably seen the ads for Enzyte on TV, which features a nerdy guy named "Bob." From the very beginning, the Enzyte ads were a take-off on the Viagra "Bob" ads, which featured a non-nerdy guy with a smile on his face and women (men too!) that looked upon him with reverence or slightly wicked smiles. Recently, Viagra brought Bob back in the "He's back" series of ads in which devil's horns -- arising from the Viagra logo -- pop out the guy's head as he pushes his compliant wife into a negligee store.


The parallels between these products, how they are marketed, and how they have been or not been regulated is very interesting. We can start by looking at the two "Bobs" shown below.


Two Bobs


You can probably guess which is which, so I don't bother to label the images.

I don't know which Bob I relate to more. The nerdy Bob seems to be having fun with his friends. The other Bob is all involved with his wifey, but is pretty macho. Whatever. In any case, neither appear old enough to suffer from erectile dysfunction. I've made this point before about inappropriate targeting of ED drug ads (see "ED Drug Sales Limp"). At least Enzyte doesn't claim to treat ED, it just enhances. Yeah, baby.

Pharmaceutical advertising professionals seem to like the Viagra guy ads, but disparage the Enzyte guy ads.

Regarding the Viagra ads, this is what Kelly Simmons, executive vice president and chief creative officer at Tierney Communications in Philadelphia, who studies sex issues in marketing, had to say: "I like the new tone; I think it's playful." (As reported in the New York Times, "Viagra, With a Wink and a Nudge, Joins Its Racier Rivals on Their Turf," August 17, 2004; see also "New Viagra Campaign to Go Naughty").

Indeed. Personally, however, I think the Enzyte Bob is more playful. However, Patrick Clinton, Editor-in-Chief (I
love that title!) over at Pharmaceutical Executive Magazine, finds a "Problem With Bob" - the Enzyte Bob, not the Viagra Bob.

In a recent editorial, Patrick said that "we can always hope" that the Enzyte ad campaign will be shut down as well as the offices of Berkeley Premium Nutraceuticals. He goes on to say "It's a nasty, leering piece of work, and all the worse because it tarnishes the already less-than-sterling reputation of drug advertising." (See "The Problem With Bob," Pharmaceutical Executive, April 2004).

Talk about the pot calling the kettle you-know-what! This is a good example of how the industry blames everyone but themselves for their problems. I mean how long can they expect to use that tactic and get away with it?

Firstly, I've said before that the industry is "pushing the envelope" with DTC ads (see "Pushing the Envelope is Bad for DTC"). Secondly, the FDA has already told Pfizer to pull it's naughty Bob ads (see "Viagra Ads Ordered Off Air, Company Begins Anti-Counterfeit Program"; also see the FDA Warning Letter).

Who's undermining Pharmaceutical Trust?
Patrick also says that the Enzyte ads "exploit the trust that pharmaceutical companies have earned and then undermine it." Patrick, Patrick, Patrick. A better example, I would think, about squandering public trust could be taken directly from the pharmaceutical play book: namely, Merck continuing to run Vioxx DTC ads while upper management knew of SERIOUS problems -- like death -- attributable to Vioxx (see "Who Should Pay for Merck's Obstructionism?" and "Vioxx Redux").

I don't seem to recall editorials about "undermining pharmaceutical trust" when the Vioxx story broke. If I am wrong, why don't you tell me about it.


Monday, May 02, 2005

Innovative Marketing for Innovative Drugs


According to an article in today's Wall Street Journal, "Pfizer Inc., the maker of Lipitor, blames the German health ministry for a significant drop in sales..." (See
German Curbs On Drug Costs Rile Big Brands.)

It seems that new German legislation that went into effect in January has given the German health ministry more power to decide how much the state will pay for drugs.


"The ministry decided last year it would no longer cover the higher prices of branded drugs that it deemed to have the same medical efficacy as available generics. So the commission drew up a list of drugs that it won't pay full price to cover, including many popular treatments for stomach acid and high blood pressure, as well as Lipitor, the world's best-selling drug."


"It's actually a pretty disastrous thing for us," says Philip Burchard, the head of AstraZeneca PLC's business in Germany. "In a way, it's like losing your patents because you are being forced to reduce your price....Basically, this methodology puts you in the same bucket with generics and says, 'You're not better than any generics.' "


"The German reimbursement system rewards imitation and penalizes innovation," says GlaxoSmithKline's Mr. Garnier.


The industry is fighting back.


According the WSJ, drug companies tried last year to head off the legislation, and are currently "campaigning privately with politicians and publicly to patients," putting executives on popular TV talk shows, sending out sales reps to docs, collecting signatures from docs, and retaliating by relocating research facilities in other countries.


Some of this activity must have been focused on "educating" the public and healthcare professionals on the benefits of the brand name drugs over the generics; trying to prove that they are truly innovative. However, the health ministry commission of experts still did not see any difference between some brand drugs like Lipitor and its generic equivalent (simvastatin).


So what make a drug innovative?


Innovation, according to the International Society of Drug Bulletins (ISDB), is "a strategic concept for drug companies whose innovations are important for their profitability and competitiveness. If we want robust points of reference, patients’ needs should come first, and innovation should be defined in terms of comparative advantage over existing treatments." (See "
What is a truly innovative drug?")

Drugs could be considered innovative based upon
  • efficacy,
  • safety, or
  • convenience.
"New drugs are generally approved on the basis of efficacy studies; safety outcomes are considered a secondary issue. Safety concerns include frequent as well as rare and serious adverse effects. At time of first approval, we must be skeptical of the apparently acceptable safety profile of a new drug. Rare adverse effects can be recognized only after a large population has been exposed to the drug. Many regulatory bodies and national and international pharmacovigilance organizations publish little or no safety information for health professionals and the public on the pretext that this information is commercially sensitive."

"Convenience is helping patients, physicians, nurses, and pharmacists to use drugs well. It includes easy-to-use medications and administration devices, as well as reliable packaging. Greater convenience, resulting in better adherence to a drug regimen, can in itself be an advance."


How many new drugs are actually "innovative?"


Many critics have a dim view of the drug industry's track record on innovation:

According to ISDB, for example, "about 80% of new products or new clinical uses approved each year in developed countries provide no advantage over existing treatments. About 2% of drug treatments offer a real advance to patients, and 5% provide minor benefits."

Marcia Angell ("The Truth About the Drug Companies: What To Do About It") claims that seventy-seven percent of the industry’s output consists of "leftovers" or me too drugs classified by the FDA as being no better than drugs already on the market to treat the same conditions. She cites a "crucial weakness" in the law that new drugs only have to be proved “effective” and not "more effective than (or even as effective as) what is already being used for the same condition." She favors head-to-head comparisons rather than showing that a drug is better than nothing at all (placebos). "The last thing drug companies want," says Angell, "is a head-to-head comparison."

The German commission, it seems, defines "innovative" a bit narrowly. According the WSJ, the commission "examines each drug's chemical properties and effects. An innovative drug is one that works 'so specifically that you can't use another drug,' says Ulrich Dietz, head of the drug-regulation department at the health ministry. If a branded drug is simply more convenient to take -- if it can be swallowed as a pill rather than injected, or taken once a day instead of three times -- that likely wouldn't be considered innovative enough, Mr. Dietz adds."


Innovative Marketing for Innovative Drugs
Efficacy is probably the most important criteria for judging innovation. However, safety and convenience should also be considered, especially if the problem of adherence is to be solved. Drugs don't work if you don't take them. Duh!

The industry needs to do more to prove the safety of branded drugs (see "Drug Safety: A Matter of Trust!" and "How the FDA Can Fix DTC") as well as convenience and show that their "innovative" drugs improve compliance and adherence. Then marketing can be innovative as well. That is, evidence-based marketing (see the previous post: "Evidence-based Marketing") should also promote safety and convenience as well as efficacy. That assumes, of course, that evidence is available to back up the claims.

Some other time, I might take on the subject of "evidence." For now, you can read the sources I quote above.