Basics of Sales Rep Watching

Yesterday, as I was waiting in my doctor's office, at least seven pharmaceutical sales representatives came into and through the office, all within a 30-minute time span!

That's about one rep every four minutes! At that rate, my doctor could have seen about 60 reps yesterday.

To amuse myself, I carefully observed these reps in their natural habitat. It was an exhilarating experience that I urge everyone to try. The beauty of it is, you don't need any expensive equipment like binoculars. You are immersed in the same habitat as your prey -- you can even engage them in conversation.

There are a few essentials for the serious Pharma Sales Rep Watcher.

First, you must be able to spot a rep amongst the crowd. Almost invariably, sales reps are much younger and way better dressed than the typical watcher/patient. It's not likely that the seventy year-old woman with the walker is a sales rep. Don't even waste your energy observing that one!

Second, you must be able to identify the rep's employer. There aren't any written guides for this -- reps are very circumspect about revealing their identities to rep watchers (aka, "patients") who may be lurking in their territories. So, you'll have to be very observant.

Often the rep carries a canvas bag with a drug logo on it. Yesterday, I spotted two reps that I could identify this way: one was carrying a Zetia bag and the other a Lamictal bag. The first rep, therefore, worked either for Merck or Schering-Plough. The other worked for GSK.

A rep's bag, however, often is one of those bulky black boxes without any discerning logo. The only way to identify a rep carrying such a bag is to perhaps challenge your prey with a direct query such as "So, you're a drug rep. What company do you work for?"

This tactic, however, may spook your prey to fly the coop!

Another tactic to employ is to sneak into the back office as the rep intercepts the doctor and overhear the 30-second detail spiel. However, often the rep merely shoves a sample receipt in front of the doc for a signature and then high tails it out of there.

Sometimes, you will be lucky enough to spot two reps from the same company working in concert. This is a very rare thing, however. I was lucky enough to spot such a pair yesterday, although I could not determine what company they represented. One was tall and rather good looking; the other was short and dumpy. My doctor is a BIG woman; any rep that hopes to bar her progress through the back office hallway must be equal to the task!

When there are several reps in the office simultaneously, you are in for a treat! I've only seen this a few times. Yesterday was one of those times -- at one point there were 4 reps in the office at the same time. Two were sitting in the waiting room working on their notepad computers and two were in the back office hallway waiting to intercept the doctor.

The two reps sitting in the waiting room engaged in conversation, which was amiable. I am not an experienced Pharma Sales Rep Watcher, so I am not sure if this is a common thing or not.

One rep -- the Zetia rep -- was an experienced denizen of the habitat. The other -- the Lamictal rep -- was a newbie, trying to stake out her territory. The Zetia rep was very helpful and explained the procedure reps follow in this habitat, which is:

1. If there are other reps, wait your turn just as if you were at a deli counter at the local Acme super market;
2. Before entering the back office, the sales rep ahead of you must leave the back office;
3. Ask the receptionist if it's OK to drop off your samples in the sample room;
4. After dropping off your samples, wait in the hallway until you can accost the doctor;
5. Get the doctor's signature and leave.

I saw this unfold before my eyes three times! It was a well-choreographed ballet!

The Zetia rep explained all these details to the Lamictal rep. She even pointed out where to find the sample closet. The Lamictal rep, however, flew out the door without ever dropping off any samples! Very unusual. I predict that her family will die of starvation, which, I am told, happens all too frequently in the harsh world of pharma sales reps.

When Pharma Sales Rep Watching, you should note carefully the sex of the rep and correlate that with the sex of the physician. The reason why this is important is that conventional wisdom says that sexual attraction between reps and doctors is exploited by the pharmaceutical industry (see "Sexy Reps Sell Rx").

In my case, six of the reps were female and one was male. The physician is female. This may have been a rare mis-matching and I am excited that I witnessed it!

At one point I couldn't help myself and I engaged the Zetia rep in conversation. I revealed that I was taking Zetia and Pravachol for my cholesterol and asked her if her company made a combination pill I could take. She mentioned Vytorin but wouldn't say any more. She suggested that my doctor could tell me more.

By watching pharma reps in their natural habitat, I learned a lot. For one thing, I was surprised at the camaraderie among reps. They all knew each others' names and shared experiences. I suppose, however, that these reps were not from competing companies. Still, this friendly repartee between reps belies the experience I had with reps on CafePharma (see "Banned from CafePharma!"), a notorious online pharma sales rep warren.

Which only goes to prove that in order to understand pharma sales reps, you must observe them in their natural habitats and you cannot believe everything you read on the Internet.

Acomplia Not for the Gun Totting Bikini Crowd

Sanofi's new anti-obesity pill is having problems gaining approval in the U.S. and is facing opposition in Germany and France, which have put limits on paying for the drug over there.

This, according to an article in today's Wall Street Journal (see "'Miracle' Obesity Pill Looks Less Miraculous"; subscription required).

It is rumored that the FDA is concerned about the drug's adverse psychiatric effects, including increased aggression. "Frederick West, a 64-year-old with diabetes in Hertfordshire, England, began taking the drug. He lost about 15 pounds in the first few months, but after about four months he started experiencing mood swings including periods of aggression. Mr. West works as a gamekeeper on a large English estate, where he is sometimes required to carry a gun."

But not only do gun-totting gamekeepers need to be carved out of the potential user pool -- so do women who wish to fit into their bikinis, according to Hanspeter Spek, Sanofi's head of pharmaceutical operations: "We have a strong, even vital interest to show that our patients are not those that take the product in order to fit into their bikini."

Thank you, Mr. Spek for giving me an opportunity to put guns and bikinis together into the same blog post title!

On a more serious note...

Sanofi has learned a lesson about how to position a product for the market. Acomplia was supposed to conquer fat, smoking, high cholesterol, and diabetes. When you try to be everything, you just leave the door wide open for critcism on all fronts, instead of just one front. Focus, focus, focus...

The FDA already was quick to reject the application for smoking cessation and is asking for more information about Acomplia's anti-obesity prowess.

The problem is the drug's adverse psychiatric effects: "Patients on the 20-milligram dose had a 6.2% rate of psychiatric disorders such as depression, compared with 2.3% of those taking a placebo," reports the WSJ.

The FDA is rightly concerned about such side effects of drugs that must be taken over long periods of time.

Sanofi is now trying to reposition Acomplia as a treatment for diabetes (or metabolic syndrome).

"Gérard Le Fur, who was Sanofi's head of research and development for more than a decade before becoming chief executive in January, now says, 'If we were to start again, we would say it's an antidiabetic agent' that induces weight loss."

Woulda Coulda Shoulda.

Dong-A PharmTech: New Erectile Dysfunction Drug

This just came into my email inbox:

"Dong-A PharmTech Co., Ltd. [a Korean drug company] announced today that it has completed a 340 patient phase 2b 'at-home' clinical study for udenafil, its new long acting (12 hour half-life) oral phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction (ED)."

See press release.

Does anyone else find this amusing?

Spend, Spend, Spend Before the End, End, End

It's ironic that at the same time that experts and pharma insiders are talking about the golden age of DTC being behind us (see, for example, "Dead DTC Golden Goose and Other Pharma Fears"), the drug industry has outpaced all other industries in ramping up ad spending in 2006, according to Nielsen Monitor-Plus.

"The pharmaceutical industry spent $719 million more on DTC TV, radio, magazines and newspaper ads in 2006 than in 2005, Nielsen Monitor-Plus data showed. The industry was the 'fastest growing' major media consumer ad category in 2006, with a 14.9% percent increase over the previous year, Nielsen Monitor-Plus said." (Source: MM&M Newsbrief.)

I chalk this up to the old maxim "spend it or lose it" or more accurately, "spend it while you can."

Or could it be that a few brands and categories -- Gardasil, sleep aids -- accounted for all the increase and then some, offsetting decreases across the board? Let's look at the numbers.

According to Nielsen Monitor-Plus: "The Pharmaceutical industry was the fastest growing in terms of percent increase over last year (14.9%) and in terms of actual dollar increase ($719 million). Pfizer increased spending 32% ($158 million), while Merck and Sepracor each increased their budgets 40%, $118 million and $95 million, respectively." (See "U.S. Advertising Spending Rose 4.6% in 2006, Nielsen Monitor-Plus Reports").

The three pharma companies mentioned that increased their spend dramatically contributed about $100 million to the total $719 million increase. Even if we add in Takeda's purported $100 million ad spend for Rozerem (see "Spend $110 million for $76 million in sales?"), that's just a fraction of the overall increase and therefore this spending spree is really industry wide rather than confined to a few outliers.

Johnson and Johnson bucked the trend, however, and decreased its ad spend a whopping 20%!

Here's the data for the top 10 industry categories (click to enlarge):


Is all this ad spending worth it?
I've already noted the negative ROI of Takeda's Rozerem DTC ad spend (see "Rozerem DTC Emperor (Still) Has No Clothes").

For every 10 percent increase in advertising for a given type of medicine, prescription sales for the category rise 1 percent, according to a 2003 study by the Henry J. Kaiser Family Foundation (see "TV DTC Educate Little, Increase Sales Less").

That was then. This is now:

"Global pharmaceutical sales grew 7% to $643 billion in 2006, according to IMS Health, while US drug sales were up 8.3% to $290.1 billion for the year, thanks to Medicare Part D and strong sales of specialty products -- particularly oncologics and autoimmune agents" (see "Drug sales post healthy gains for 2006").

In other words, increased sales can be attributed to non-marketing activities, namely Medicare Part D and biologics, which are not heavily advertised on TV. Centocor, for example, boasts that it's Innerstate disease awareness feature length documentary costs much less than a full-blown DTC campaign (see "Innerstate: The First Disease Awareness Documentary Film").

Ergo, I stand by my thesis that the drug industry is on a spending spree in anticipation of the spending drought to come.

Dead DTC Golden Goose and Other Pharma Fears

Yesterday, I participated in a panel discussion at the iiBIG Pharmaceutical Sales & Marketing Executive Congress now going on at Caesars Hotel & Casino in Atlantic City, NJ. The panel's title was "The Changing Landscape in Washington."

Unfortunately for attendees, the two scheduled panel members -- Bill Greenwood, president and ceo of BIO, and Frank Pallone (D-NJ), Chairman Health Subcommittee on Energy & Commerce -- cancelled at the last minute. In desperation, Don Buford, the conference producer, called me on Sunday to fill in.

Full disclosure: iiBIG paid for one night's stay and I ate the lunch. I had to provide my own transportation, and pay for my "gaming," Internet connection, and parking.

It was up to me and Katherine Binns, President, Healthcare Division, HARRIS INTERACTIVE, to pitch hit for these sluggers. I hope we did a good job -- at least a few people thought we did well.

Anyway, enough about me. I want to talk about what I learned from attendees and other speakers about what Pharma fears the most, how it plans to react, and how I suggest it react instead.

Guns, Butter, Drugs
Those are the issues in contention for top of mind among voters in 2008.

Binns, in her presentation on "Public Opinion Regarding Upcoming Healthcare Debates in the 110th Congress," highlighted survey data that suggested that healthcare (drugs et al) is not an election issue right now, but that it is a growing concern.

In the 2006 mid-term elections, healthcare was #3 behind Iraq (guns) and the economy (butter) as an issue affecting voters. The voting public, says Binns, tends to vote on one or two issues at a time. Thus, if the Iraq war were eliminated as a major issue among voters, healthcare could become the number 1 issue.

Presumably, if the Iraq war remains the #1 issue among voters in 2008, even more Democrats will be elected to Congress and, God forbid, even a Democratic president, who will sign anti-drug industry legislation into law, may be elected. That's pharma's #1 fear.

Re-importation Issue
One of these possible laws concerns re-importation of drugs from Canada (and other countries). I discussed this issue last week in a podcast interview with Cary Byrd of eDrugSearch.com (see "Can You Find Reputable Canadian Drugs Online?").

A pharma member of the audience asked who can help the industry speak to patients about how they should be worried about counterfeit and ineffective drugs ordered online. Binns suggested recruiting physicians to tell their patients that although they can order drugs more cheaply online, they should really order from the local pharmacy. Yeah, that will happen.

I pointed out two things:

1. The problem of counterfeit, adulterated, and ineffectual drugs is not just something we have to worry about when ordering online, but also when we get drugs through our neighborhood pharmacies, hospitals, or doctors. The industry should do more to focus on this home-grown problem with our drug supply.
2. Why does the industry always employ negative, scare tactics? PhRMA already tried this when it attempted to fund a novel linking terrorists to ordering drugs online (see "PhRMA's Terrorist Plot"). Stop scaring Americans! Aren't we too afraid already?

As Binn pointed out, even if new laws were enacted to allow drug re-importation from Canada, it is unclear if that would have any major impact on the market. Note also that Internet drug sales to the U.S. is down sharply in 2006. In light of that, I suggested the industry should support programs like eDrugSearch.com, which works with pharmacies accredited in the US and Canada to sell drugs online (eg, VIPPS program in the US).

Generics
A B&L executive in the audience asked a question that astounded me. She wondered how pharma could get the message out there that if it weren't for the pharmaceutical industry, generics wouldn't be as readily available and as cheap in the US.

I guess what she meant was, the industry develops these great drugs in the first place and then they go off patent and that benefits Americans. Never mind that patented drugs are priced much higher in the US than elsewhere and the industry is currently fighting tooth and nail to prevent generic manufacturers from competing with brand drugs.

State Laws Limiting Physician Access
A big concern, especially among specialty pharmaceutical companies with small sales forces, is the 1600 bills related to regulation of pharma marketing and sales that are wending their way through state legislatures. Some states have already passed legislation that affects marketing to physicians -- eg, New Hampshire (see "Whose Data Is It Anyway?").

The animosity against certain states by pharma was highlighted by Thomas Chen, VP Marketing at Oscient Pharmaceuticals, who referred to the good state of Massachusetts as "The People's Republic of Massachusetts." I believe his gripe with MA was the requirement that pharma companies limit spending on lunches, etc. for physicians to $50 per year. This is a big headache for the industry, which must audit where this money is being spent and report it.

But states' bark may be worse than their bite, as reported in JAMA (see "State Oversight of Industry Gifts to Physicians All Bark"). Either that or the industry has exploited loopholes that allow it to hide lunch money under within the trade secret database, which isn't easily accessible. JAMA author Joseph S. Ross, M.D., M.H.S., of Mount Sinai Medical School, contended the "trade secret" claim was often so broad that it "covered money spent for food brought into lunch meetings with detail men."

Chen and others revealed pharma's current strategy to deal with these state laws: Stop marketing to physicians in errant states. I wonder how long that strategy will work. It's all good for a company with limited resources, but sooner or later, as more states join the "People's Republic," there won't be any states left to marjet in.

This is an effective scare topic, however. Physicians depend on free samples, especially to help patients in need. When pharma threatens to boycott states with physician gift laws or boycott individual physicians that opt out of having their Rx data made available to pharma reps, that also means samples are cut off. This policy counteracts the industry's claim that it helps patients who can't afford medicines by giving away billions of dollars worth of free samples every year.

The DTC Golden Goose May Be Dead in the Water
A question was put to me from a member of the audience on how the world will change for pharma people making decisions about how to market directly to consumers. I answered first by quoting others who suggest that the golden era of DTC is over. DTC, I said, has suffered two much criticism from both sides of the aisle in Congress (see, for example, "Deconstructing Frist on DTC") to stand as it is.

TV DTC is very visible as a "poster boy" for what is bad about pharma marketing. Even the industry recognizes this. Some companies, including J&J, are pulling back from TV advertising. And whenever a product gets bad press as did Gardasil over the mandatory inoculation issue, its ads on TV are halted at least until the storm blows over.

I said that the industry always seems to push the envelope one step too far and as time goes on the envelope will rip. We may have reached that point when Takeda claims no responsibility for a TV ad cited as violative in an FDA letter (see "Back to School for Takeda, Rozerem, and Abe Lincoln!").

Add to that the lack of accountability of the industry for violation of its own PhRMA guidelines on DTC advertising; violations that I have documented numerous times in this blog. Perhaps if PhRMA were to reprimand violators by naming them in public, fining them, and suspending their membership for a time (all of which is done by ABPI, the UK equivalent of PhRMA), then we could say the industry is serious about policing itself.

Without that kind of self-regulation, pharma has no one but itself to blame, if Congress passes mandatory moratoriums on DTC advertising.

Unfortunately, it may be too late for the industry to reform. The only thing that will save it is the presidential veto, but that's not a strategy for the long-term. Which is another well-recognized problem of the industry: short-term thinking reigns supreme!

Dining at Pharma's Table

Last week, several bloggers met with J&J corporate PR people at a fancy NYC restaurant (see "Should Bloggers Dine at Pharma's Table?" also see my post here).

I was invited, but could not attend.

Even so, I was concerned about accepting a lavish dinner and open bar from a company I write about in my blog. Not that I or any of the bloggers that attended can be bought off by a "a piece of trout and a glass of wine" as Jim Edwards of BrandweekNRX noted (Steven Palter, MD of docinthemachine blog, who also attended, expressed it thus: "it takes a lot more than a steak and fries...to corrupt me.")

Trout and wine or steak and fries...yummm!

My main reason for posting this and making more of it than some think I should is to begin to establish standards for bloggers like myself who do not have a journalistic background. Journalists, in fact, do have policies for accepting free meals from organizations they may be writing about. Take Ed Silverman over at Pharmalot, for example. He stated his policy this way:

"The arrangement is this: J&J will send the bill and Pharmalot will send a check. Pharmalot does not accept industry funding. Surprised? We hope not."

If you cannot be influenced by trout or steak, why do journalists generally have a policy similar to Ed's? Should bloggers in general adopt a policy like Ed's?

Help me out by taking the following poll (we're talking about bloggers that write about the pharma industry):

Should bloggers accept free meals from pharma?
	Yes, no problem
	No, never
	Sometimes, it depends
Free polls from Pollhost.com

Whatever the policy should be, one thing is certain. Every blogger that attended that meeting should be transparent about it and tell their readers that they attended and what their policy about freebies from pharma is. IMHO.

von Eschenbach & Gonzales: Two Birds in the Same Bush

What do FDA commish Andy von Eschenbach and Attorney General Alberto Gonzales have in common besides being "loyal Bushies?"

Both believe it is within their right to fire employees for no other good reason than they are not "team players."

More on that below. But, first, a little history.

Dr. von Eschenbach's remarks about dissent within the FDA at a recent Center for Medicine and the Public Interest (CMPI) conference was quoted in the The Star-Ledger of New Jersey:

He said he is committed to insuring all different points of view within the agency are heard and part of the deliberative process. But he added he won't tolerate whistleblowers who go outside the agency just because they disagree with a final outcome.

"The people have to understand to go outside that process is not constructive. It is actually destructive," von Eschenbach said. (See "Ex-FDA chief: Pharma goal at odds with safety")

Now, according the Star-Ledger Pharmalot Blog, von Eschenbach claims "My remarks did not in any way shape or form address whistleblowers." This under oath a couple of days ago in testimony before the House Subcommittee on Oversight and Investigations.

The Star-Ledger stands by its reporting and invites readers to hear the audio recording of von Eschenbach's CMPI presentation on the CMPI Web site. "Not so fast, Andy," says Ed Silverman over at Pharmalot. "You were quoted correctly. But don't take our word for it. Go to the web site for the Center for Medicine in the Public Interest and listen for yourself."

I tried to locate the audio on the CMPI site, but could find neither hide nor hair of it there.

Could it be that CMPI -- the same folks that bring us stridently pro-industry Drug Wonks blog (see "Drug Wonks Are PR Wonks") -- expunged von Eschenbach's presentation from its Web site? If so, CPMI no doubt acted on its own, not under instructions from von Eschenbach.

Or did it? We'll never know.

OK, so this is a bit suspicious. Yet, there's more evidence that von Eschenbach is taking lessons on handling employees from the same source that instructed Gonzales.

Will Drug Safety "Take One for the Team?"
According to the Pharmalot blog, last June von Eschenbach told a group of agency employees that he expects "team players" who can be "traded" if they don't cooperate. "Committee members had to remind Andy that it's illegal to interfere or retaliate against employees who share info with Congress."

It's unfortunate that von Eschenbach wants a team that is cooperative rather than one that offers debate and checks and balances. Can such a homogeneous "cooperative team" both approve drugs for marketing and then be expected to do the right thing to protect us from unsafe drugs? Or will drug safety "take one for the team?"

For more on this story, see "FDA chief vows to defend whistle-blowers."

FDA Advisor Rule Loophole?

Yesterday, the FDA proposed a $50,000 limit on financial ties to industry of its advisory board members (see "FDA Proposes New, Tougher Procedures for Membership on Advisory Committees").

But, as anyone can clearly see in the following "Algorithm for Considering Advisory Committee Member Participation," there is a BIG loophole (outlined in red):

Click for an Enlarged View (Can you see me now?)

Still can't read it? [I certainly hope the folks at FDA have a wall-chart version of this algorithm.]

It says, "If the individual is an SGE, does the need for the individual's services outweigh the potential for conflict of interest?" If so, Pass Go and Collect your ticket to come on board!

OK, to be fair, there are only a very few qualified physicians among the 500,000 or so out there that would be willing to serve on FDA advisory committees. I'm sure the pay is not great. Therefore, FDA needs this lopphole. Right? [BTW, maybe if the pay was higher FDA might be able to close this loophole and simplify the algorithm.]

We can argue whether or not $50,000 is still a lot of money -- I think it is -- but at least the new proposed guidelines eliminate the much-criticized 2000 Waiver Criteria. Under those criteria, "the dollar value of the disqualifying financial interest including its value in relationship to the individual's overall assets" could be considered when granting a waiver. That was a pretty big loophole. $50,000 easily may represent only 1-2% of a successful physician's assets.

Rozerem Over There? Sic 'em Beav!

Abe and the Beav are off on a European vacation...or, should I say, invasion?


Just when Europeans thought they were safe and had no problems sleeping soundly -- except, perhaps for the UK (only nominally part of the EU) -- lo and behold! comes Takeda and its insomnia medication, ramelteon (aka, Rozerem here in the US).

"Takeda Pharmaceutical Company Limited (Takeda) today announced that, Takeda Global Research & Development Centre (Europe), Ltd. submitted a marketing authorization application for insomnia medication,ramelteon, to the European Medicines Agency (EMEA) through the centralized procedure." (Takeda Press Release)

Takeda goes on to claim that "Insomnia is a serious condition that affects the daily life of around 20% of the European population. There is an unmet need for effective treatment options..."

Statistics about the prevalence rate for insomnia -- like many other "life-style" "unmet" medical needs -- are difficult to come by and vary according to the source. I found this source interesting: "Wrong Diagnosis? See for Yourself." with a list of Worldwide prevalence rates for insomnia. That source cites 11.76% for the US.

20% vs 12% -- I knew that the afternoon siesta was being phased out in Spain, but who knew that EU citizens are twice as worried as US citizens and can't get enough sleep?!

The EU ramelteon marketing team, shown here on the left at a strategy meeting in Cannes, is contemplating how best to circumvent EU anti-DTC laws to promote the product directly to EU citizens.

They are being aided and abetted by the award-winning US agency for Takeda that has been so successful circumventing FDA regulations and PhRMA DTC Guidelines here in the US (see "Takeda -- Fire These Guys!").

"If my knowledge of history is correct," said Ken Erke, member of the Cramer Krasselt/AB Rozerem ad team, "Europe, and especially the UK, threatened old Abe with war during the US civil war. I hope the EU team takes our lead and uses Abe and Beav to soften the shores over there for the ramelteon invasion. Old Abe finally will get to settle an old score!"

J&J, You're No Elvis Presley!

According to TNS Media Intelligence, "the highest growth rate [in measured media ad spending] among the top 10 [advertiser] categories was registered by Pharmaceuticals which jumped 13.8 percent to $5.29 billion. This was due to the strength of Merck’s marketing launch of an HPV vaccine and increased advertising activity at Pfizer and Astrazeneca" (see "TNS Media Intelligence Reports U.S. Advertising Expenditures Increased 4.1 Percent in 2006").

NOTE: TNS data focuses on "measured" media, which includes network TV, cable TV, Sunday supplements, newspapers, free-standing inserts, radio, and Internet. It does not include search engine marketing, however.

Bucking this trend was Johnson and Johnson, which cut its ad spending by 19.8%!

Advertising Age suggests that J&J shifted $250 million from TV to the Internet -- presumably search marketing (TNS says J&J increased measured Internet ad spending by 31% to $32.1 million; that means only $7.6 million of the $250 was shifted to measured -- ie, non-search -- Internet ad spending):

"Overall, J&J reported global ad spending fell around 10% to $1.9 billion last year, even as sales rose 6% to $53.2 billion. But J&J's measured-media spending in the U.S. fell more than twice that fast, suggesting a big chunk of its marketing budget went to unmeasured media, such as search and other direct marketing, rather than away" (see "J&J Jolts 'Old' Media With $250 Million Ad Spend Shift").

We also know that at least one J&J company -- Centocor -- is proud it has spent less on producing the documentary film Innerstate than on a "full-blown" TV DTC campaign (see upcoming March issue of Pharma Marketing News).

AdAge is lauding J&J as the Elvis of marketing: "Staid Johnson & Johnson is proving to be marketing's Elvis Presley: While rivals talk up nontraditional marketing without changing measured-media spending habits much, J&J's adopting the King's refrain: 'A little less conversation, a little more action.'"

But who's to say that J&J hasn't just pocketed a portion or all of that $250 million it has "shifted"? J&J declined to comment on changes in its media spending for competitive reasons, a spokesman said.

It could be that J&J may be more like Scrooge McDuck than Elvis Presley. What do you think? Please participate in my poll:

Is J&J more like Scrooge McDuck or Elvis?
	Scrooge McDuck
	Elvis
	A little of both

Nominate Me to the 100 List of Most Inspiring People!

It's that time of year again! PharmaVoice is accepting nominations for its "list" of the 100 most inspiring people.

Instead of nominating your lousy boss, who you hate, but who promised you a box of Omaha Steaks if you nominated him or her, nominate somebody who really deserves it -- ME!

I really want to be on that list and have my mug on the cover of PharmaVoice! So, please, please nominate me!

Here's what the ad says: "This is YOUR opportunity to recognize the people who INSPIRE and MOTIVATE you and others; who are having the greatest influence on corporate leadership, research and development, technology, creativity, marketing, strategy, and more; and who are impacting the life-sciences industry through their actions."

Just a few days ago I received this accolade:

"I have become your fan because I'm studying Pharma Marketing News and Forum. You are doing an excellent work for us who are professionals in Pharma Marketing."

Here's another:

"Thanks for your continued enlightenment of the masses."

Need I say more?

Do I meet the Criteria?
You bet I do:

• "These individuals should view industry trends as challenges not burdens, as opportunities not obstacles." I have no idea what that means. Let's see...one trend is firing 10% of your employees. I view that as a challenge and an opportunity -- for ME! All these laid off people will be looking for a job and executive search people call me every day and I can recommend YOU! But, first, you'll have to nominate me.

• "They should embody panache and conviction." I looked up "panache" in wikipedia: "reckless courage." Ha! Look up panache in a regular dictionary and what do you see? A picture of ME! I am convinced I have reckless courage -- remember, I am the guy that outed the "Girl from Google" and took on PhRMA in the "The Adventures of PhRMA Intern!" and called for a boycott or Rozerem! If that's not reckless courage, then I don't know what is!

• "They should be leaders who plan for the future rather than respond to change." I'm not sure anyone is following me, so I can't say that I am a leader. But I do have plans for the future -- namely to get ME nominated that list!
  

• "They should be innovative, creators of out-of-the box and breakthrough strategies, products, and services." OK, I've got this one sewed up. I even wrote the book -- or at least the article -- on it: See "Out-of-the-Box Marketing: Will It Work for Pharma?" And while we're at, how about "YouPharma(tm): A Brave New World of Marketing?"

• "They should be pioneering new paths and lifting their companies to new heights." I don't have a company, but I'll be happy to pioneer new paths for you.

Nominate me here.

Takeda - Fire These Guys!

I finally get to see who's behind the Rozerem ads!

If there were any justice in this world and if the Takeda marketing team had any scruples, these guys would be out of work.

But, strangely, they continue to win accolades. The latest comes from Pharmaceutical Executive Magazine, which included these Cramer-Krasselt/Abelson Taylor big shots among its list of "Ad Stars" in the March 2007 issue.

"Pharma Exec honors the most innovative, creative, and thought-provoking ads of 2006--and the people who created them," says PharmExec.

Too bad there aren't any awards for most violative ads of 2006-2007, because these guys would win that one too! (see, for example,"Back to School for Takeda, Rozerem, and Abe Lincoln!").

It's no surprise that the team is all male -- I can't imagine an ad team with women members ever approving the use of a beaver as an ad icon. Since I've spoken on that subject ad nauseum before (see "Rozerem Ads Dis Lincoln, Show Beaver"), I won't say any more on that subject here.

I will note, however, that the beaver also got recognized by PharmExec as one of the "Intriguing Icons of 2007." "Need we say more?" quips PharmExec.

I am so disgusted that I have decided to take the rest of the week off and lie on the beach in Miami! If I get bored or drink too much some night down there, I might just rant some more here.

Meanwhile, have you joined my Rozerem Prescription Boycott campaign? Maybe that will motivate Takeda to shape up!

Do You Support a Rozerem Rx Boycott?

Yes No

Call for a Rozerem Prescription Boycott!

ATTENTION PHYSICIANS!
This is a call for an immediate Rozerem prescription boycott!

Dear Doctor:

You undoubtedly are aware of the sleep aid drug Rozerem marketed by Takeda. The company's sales representatives surely have paid you many visits extolling the so-called virtues of Rozerem. You may also have seen the big "Zero" logo at meetings and in print ads (if not, see "Rozerem Sleeper Cell at Pri-Med Conference").

But you may not have seen recent Rozerem DTC reminder TV ads that Takeda has run in violation of its pledge to abide by PhRMA's Guiding Principles for DTC Advertising, which specifically bans reminder ads on TV (see "Rozerem Reverts to Reminder TV Ads"). As you may know, reminder ads mention the drug name but do not mention the indication or side effects.

In addition to that questionable behavior, Takeda also received a Notice of Violation letter from the FDA that said some of these ads were aimed at children and were not reminder ads at all and should include side effect information (see "Back to School for Takeda, Rozerem, and Abe Lincoln!").

The worst offense, however, is Takeda's claim that no one in the company was involved in the "approval, release or broadcast of the advertisement in question" (see "Takeda Borrows Cephalon's Excuse for FDA Warning Letter").

I am sure that like most people, you find that excuse hard to believe and, if true, it must give you pause. That is, either Takeda is not trustworthy -- it lied -- or it is incompetent.

I am asking you, therefore, to refrain from writing prescriptions for Rozerem in protest. There are several other alternative drugs available for the treatment of your patients with insomnia.

The next time you see a Takeda sales representative, tell him or her that you are boycotting the product until you are assured that Takeda takes the necessary steps to (1) determine who in their company and/or ad agnecy was responsible for the violative DTC ads, and (2) terminates the employment of the responsible employee or cancels the contract of the responsible ad agency.

Only you have the power to make Takeda comply with FDA regulations, PhRMA DTC Guidelines, and minimal industry ethical standards. FDA and PhRMA appear to be ineffectual in this regard.

Sincerely,

John Mack

--------------------------
This grassroots boycott needs your help:

• Join the call for a Rozerem Rx boycott by posting the "Dear Doctor" letter on your blog or web site. You can also use the logo if you want.
• Ask your doctor if a Rozerem prescription boycott is right for him or her.
• Take the following poll:
  

Do You Support a Rozerem Rx Boycott?

Yes No

Back to School for Takeda, Rozerem, and Abe Lincoln!

FDA has sent Takeda a warning letter -- actually an "untitled" letter (merely a slap on the wrist) -- regarding it's Rozerem "reminder ads." Previously, I noted that by running these ads, Takeda violated its own pledge to abide by PhRMA's DTC Guidelines (see my original post, "Rozerem Reverts to Reminder TV Ads"). At that time, Takeda tried to claim that they were not reminder ads at all (see "Takeda: It Isn't a Reminder Ad --- Wha!!!").

Well, now Takeda is damned if the ads are reminder ads and also if they are not reminder ads, because according to the FDA, some of the ads are indeed "not reminder ads" and violate FDA regulations.

According to a Reuters story, the ads in question said said "Rozerem would like to remind you that it's back to school season" and included images of a chalk board, a school bus, books, laptops and school-aged children.

FDA suggested that Takeda itself go back to school and stop suggesting that Rozerem is approved for use in children: "The presentation is 'especially concerning' because Rozerem's prescribing information states that safety and effectiveness in pediatric patients have not been established, the FDA said."

See more on this at Pharmalot. The FDA warning letter is here. Thanks to Bruce Grant for the heads up!

Incompetent Reminder Ad at That!
Also, see Mario Cavallini's comment about what is what is not appropriate visuals to include in reminder ads.

Too bad this kind of nit-picking about reminder ads is not a moot point, which it would be if Takeda would only live up to its commitment to the PhRMA guidelines.

This just in...

The Dog Ate My Homework Excuse
According to BrandweekNRX: "Most interesting is Takeda's explanation: 'Our preliminary review of the situation indicates that no one internal to Takeda was involved in the approval, release or broadcast of the advertisement in question,' according to an email Takeda pr chief Matt Kuhn sent me this morning."

These Takeda people are some piece of work!

Innerstate Private Screening: Philadelphia Style

I spent the whole day yesterday in Philadelphia attending CBI's 6th Annual eMarketing for the Pharmaceutical Industry conference and a private screening of the documentary "Innerspace" at Dorland Global Public Relations.

I would like to focus on the Innerspace screening and reserve my e-Marketing remarks for another time.

Innerspace is a film produced by Centocor, which produces and markets biologics for the treatment of rheumatoid arthritis (RA), Crohn's disease, and psoriasis -- the three conditions described in the film. Here's how the film is described in Centocor's press release:

"...a first-of-its-kind documentary providing insight into the 'inner states' of three everyday adults facing chronic, life-altering inflammatory diseases. As they confront daily challenges and life's experiences, they tell the emotional stories of their journeys toward living 'normal' lives in a film that is sure to touch the hearts of all viewers, including the millions of Americans who suffer from these conditions. The premiere will take place on Wednesday, February 21, 2007 at the Directors Guild of America Theatre in New York."

In this press release Centocor invited the press to the initial screening and if I were more pro-active about reading every drug company press release ever written -- aren't you? -- I would have seen the invite and probably would have had a good time in NYC glad-handing Centocor PR people and the film's director Chris Valentino, whom I am told previously directed a film entitled "Brooklyn Mobster."

Being form Brooklyn and having known some Brooklyn mobsters personally -- a grade school chum of mine was shot dead at the age of 19 escaping from a bank robbery -- this immediately put Valentino on a high rung of my esteem ladder. I must admit, however, that I have not seen the film "Brooklyn Mobster." Maybe Valentino will read this and invite me to a private screening of THAT!

I have written about this film previously (see "No Oscar for Centocor PR Effort") where I stated that "I'm not going to be one of those who review this film without having seen it..." Because many bloggers had put down the film without every seeing it, I also suggested that the Centocor PR people should have reached out to bloggers and specifically invited them to the initial screening of the film held in NYC in February.

Shortly after I made that post, Michael Parks, Centocor's Director of Public Relations, and Executive Producer of Innerstate, submitted a comment to my post and invited me to a private screening. Obviously, an offer I could not refuse!

So, yesterday, I braved unusually horrendous Phily traffic to show up at Dorland's offices on South Broad Street -- thank you guy in pickup truck who allowed me to wedge in front of you to make that incredibly tight right-hand turn in front of City Hall!

When I got to Dorland and entered the conference room where the screening was to take place, who is sitting there but Michael Parks! He explained how the film got produced and what his goals were and graciously answered all my questions. He also stayed through the whole 58 minutes running time of the film and watched it again even though he's probably seen it a hundred times! I'm sure, however, like any executive producer, Parks never gets tired of watching his "baby."

When I first wrote about Innerstate I said: "I cannot trust that the words and stories told by the people in the film were not carefully scripted by the Centocor PR flacks."

First, I must admit that Parks does not appear to be your standard PR "flack." Parks took the initiative to invite me to a screening and then spent time answering my questions. That's a lot more than any other pharma PR person has done. Of course, it is the job of a PR person to deal with the "press," but many do not seem to have the time or inclination to deal with bloggers. I suspect this attitude is changing.

Second, I have to say now that the words definitely were NOT scripted. They are obviously true stories told by real patients in their own words. Undoubtedly, the scenes were carefully edited, but no one put words in these peoples' mouths.

A couple of other points about the people in the film -- "Jason, a restaurant manager living with psoriasis; Ray, a racecar driver and NASCAR® hopeful sidetracked by Crohn’s disease; and Janie, an aspiring country music artist living with rheumatoid arthritis (RA)." Not only are they real, they are refreshing real like the people you see in YouTube videos. They are not glamorous or even good-looking -- except to their moms and dads who also appear in the film.

Everything is shot on location, albeit a little bit too southern Americana for a former New York City-slicker like myself. There's lots of country roads signs, American flags, railroad crossings, pick up trucks, etc. Mostly in Texas, too! But there's no makeup and no fancy sets. The director, however, uses a special kind of cinematography to focus in on the people and keep most of the shabby backgrounds out of focus.

Cannot Escape DTC Roots
The only part that sounded scripted was when the physicians rattled off the serious side effects of the new "biologics" that are the film's unbranded heroes. This information, which is probably not necessary to provide in unbranded disease awareness productions such as this, was presented in the conventional manner that we are all familiar with from watching TV DTC ads. Parks emphasized that although not required, he was committed to present this information and even keep in a bit where one of the patients mentioned an adverse reaction.

Speaking of TV DTC ads, I asked Parks if he had any plans to use clips of the film in branded TV ads. He said "absolutely not" at least not as long as he has anything to say about it.

My good friend Harry Sweeney, Dorland's Chairman and CEO, who was in the room at that point, suggested that one should never say "never."

In fact, I agree with Harry. It's refreshing to see real people -- not actors -- talking in their own words -- not reading scripts. It's very appropriate in this day of consumer generated content (CGC), YouTube, and Myspace. I don't see why these clips and people cannot be used in real ads or on the product Web site.

Actually, I can think of one reason why not. According to Parks, none of the people in the film was paid, not even the docs. He said there were a lot of people who auditioned and all of them wanted to tell their stories without being paid. Not being paid for an unbranded disease awareness film is one thing, but not being paid for appearing in branded TV ads is another.

Still, there is precedent: note that CGC content was used in some Super Bowl ads and a recent Dove ad I saw. None of these people were paid, although "winners" did get some cash-equivalent rewards -- a Super Bowl ticket or perhaps a lifetime supply of Dove body wash!

Sorry, Michael! I said I wasn't going to write a review, but I just did! I guess I am suffereing from the same Blog addiction as Peter Rost (see "Rost Retires, Relapses, Returns, Redacts").

Are All Pharma Bloggers Biased Against the Industry?

Well, no! Duh! There are some blogs out there that are very supportive. But how supportive or critical are individual blogs in the pharma blogosphere and is there an overall bias one way or the other?

To answer that and other questions, Pharma Marketing Blog in associatioon with The Pharma Blogosphere Blog, hosted the First Ever Pharma Blogosphere Survey. The survey ran from 3 February 207 through 28 February 2007.

The purpose of this survey was to provide a baseline rating of readability, credibility, usefulness, and bias of 22 blogs that focus on the pharmaceutical industry. The blogs included in the survey were:

1. BrandweekNRX
2. Clin Psych Blog
3. Dr. Peter Rost
4. Drug Injury Watch
5. Drug Wonks
6. eDrugSearch Blog
7. EyeOnFDA
8. HealthcareVOX
9. impactiviti
10. In the Pipeline
11. On Pharma
12. OnThePharm
13. Pharma Giles
14. Pharma Gazette
15. Pharma Marketing Blog
16. Pharma Rag
17. Pharma Watch
18. PharmaEdge
19. PharmaGossip
20. Pharmalot
21. Rx Daily Dose
22. World of DTC Marketing

[To find links to all these blogs, plus gossip about the bloggers themselves, weekly summaries of what's happening in the pharma blogosphere, and reviews of blogs, visit The Pharma Blogosphere.]

The full results of the survey will be published in the April issue of Pharma Marketing News and released at the upcoming Healthcare Blogging Summit on April 30, 2007, in Las Vegas.

Paraphrasing Pfizer's defense for holding back data from its failed torcetrapib clinical trail (see "Look, Ma! No Torcetrapib Data!"), "it will take time to fully adjudicate the data and further understanding of the [survey] requires that the data be analyzed in full. As the data become available we will be working with investigators and experts to ensure a comprehensive analysis and will report through forums where scientific discussion and dissemination can occur."

But I can share some results now

Who Reads These Blogs and Why?
More than 150 people participated in the survey, but not all completed the survey or answered the most important questions. Some respondents also indicated that they never read ANY of the blogs! Obviously, these responses were discarded and we were left with 144 valid responses.

Who were these respondents? The survey asked each respondent to choose a principal affiliation from among a list provided. The following chart shows the affiliations of respondents.

Click on the image for an enlarged view.

Interestingly, the largest group of respondents are affiliated with drug, biotech, or medical device companies. The survey did not ask respondents for other information about themselves such as job title, so we cannot say much about what functional areas within these companies are interested in blogs. Next time, we may ask for that kind of information.

About 18% of respondents either were the author of or contibutor to a blog included in the survey.

Why Do We Read Blogs?
The survey asked repsondents to check off the reasons why they read blogs about the pharmaceutical industry. The choices were:

• To see what bloggers may be saying about MY company or blog
• To be entertained
• To learn more about industry business practices, regulations, etc.
• To keep up to date with industry news and gossip
• Other

Respondents could check more than one answer. The results are presented in the following chart:

Click on image for an enlarged view.

"Other" reasons included:

• Documenting Big Pharma's excesses
• Don't know why
• Follow competition
• For patient safety info
• I am interested in eDetail online programmes
• Looking for specifics
• Peter Rost posts some hot chicks!
• To contribute to the conversation
• To find story leads and comments
• To join discussion, push debate forward
• To learn broadly about the industry
• To see who is influencing whom
• Want to help demistify their dark side and change it if we can to the better

Obviously, some one needs to take up the sex appeal mantle that Peter Rost has worn until he pulled out! Maybe "Jack Friday" over at PharmaGossip will take it up?

Bias
Question #7 of the survey asked: "Please rate the following pharma-related blogs in terms of their industry bias -- very critical very support, or neutral." Respondents could answer Very supportive, Somewhat supportive, Neutral, Somewhat critical, Very critical, or No Opinion.

The results are shown in the chart below:

Click on the Image for an Enlarged View

This chart was prepared by Chris Pounds who works at Myriad Pharmaceuticals where he is responsible for marketing research, forecasting, competitive intelligence, financial modeling, and decision analysis. He really knows how to look at market research data and make some nice charts! Thanks for your help Chris.

According to Chris, the above graph "looks at Favorable (to industry) top 2 boxes (Very supportive and somewhat supportive) minus the Unfavorable to industry (bottom 2 boxes). If a blog were considered "completely balanced" then this would be zero. If everyone said the blog was pro-industry to some degree (and not neutral) this would be 100% positive."

I note that my blog, Pharma Marketing Blog, is on the "Unfavorable" side of the graph, but I think it's within the meaty "critical but helpful" to "supportive and helpful" range. That is, if you are too critical, who's going to listen to you and get ideas for improving? Yet, if you are too supportive, who's going to learn anything they already don't know? So the short range to the left and right of namby-pampy neutral is where you want to be IMHO.

Drug Safety - A Mere Asterisk to the FDA

What's in an "*"?

That's the FDA's chosen method of identifying drugs that have an "active safety alert." These asterisk'd entries can be found via an "easily accessible link" to the Index to Drug-Specific Information Web page. From there, "the public may access information about drugs that are the subject of a Public Health Advisory and/or an Alert regarding an important, and often emerging, drug safety issue, as well as established drug safety information."

The asterisk is virtually the only new piece of information revealed in the recent "Guidance on Communication of Drug Safety Information" issued by the FDA (see the press release).

First of all, this is a far cry from the Drug Watch Site proposed by the FDA in 2005 (see "FDA Drug Watch Site Guidelines").

Secondly, this is not an "easily accessible link" -- at least not from FDA's home page. On that page, I see a prominent link to "Recalls, Product Safety," which does NOT concern "emerging" safety information, but full-blown safety disasters! For the consumer and health care professional this is like closing the barn door AFTER the cows have left!

Go ahead -- try and find a link to the Index to Drug-Specific Information Web page on the FDA home page. I dare you! I also dare you to find a link there to the fabled MedWatch page, which is old wine that the FDA is recasting as new wine in this recent guidance. (The MedWatch link is there, but you'll have to look carefully for it.)

FDA abandoned the Drug Watch name and site "due to potential confusion between the proposed Drug Watch and FDA’s existing MedWatch program..." FDA no longer plans to use the name Drug Watch to describe the Web page that contains drug safety information. Instead it will use "Index to Drug-Specific Information."

OK, so now we've got an unwieldy URL, a forgettable name, and a "easily accessible" link that cannot be found. This is the new "transparency" that new FDA commish Dr. Andrew C. von Eschenbach is crowing about, albeit in a uncommunicative fashion according to Mark Senak over at Eye On FDA (see "Perception - Reality: The FDA and the Art of Communications"). Here's what mark wrote:

"The [New Jersey Star Ledger] interviewer asked Dr. von Eschenbach whether or not the criticism of the FDA over the past few years has been justified. His response: 'There is reality and then there's perception. Sometimes in this town those two things get confused. The point is, it doesn't matter. For me, if it is a perception, it is important....I want an agency in which people bring different points of view, divergent perspectives...At the end of the day, you make a decision.'

"Reality and perception aren't the only things confused. What the heck does that mean? Does it mean anything?"

Mark believes the FDA has a communications problem. He should know -- that's his business! I hope to talk about this during my podcast interview with Mark today at 1 PM Eastern time. For more about that, click here.

If the head of FDA cannot even communicate a simple idea, how successful do you think the FDA will be in communicating the complicated emerging drug safety information to the public? They offer nothing innovative, just a rehash and reorganization -- bad re-organization at that -- of what they've been doing for years. And what they've been doing for years is inadequate -- even according to the FDA!

One other small error in communication that I have found in the Guidance: an inaccurate URL for the MedWatch page. The Guidance directs us to "www.fda.gov/medwatch/safety" to find this page. Go ahead, click on it and see what you get.

FDA Confuses Perception with Reality

The "perception" -- in FDA's head at least -- is that it has achieved its "goal of issuing, in the first quarter of 2007, final guidance on communicating important drug safety information" (press release), but the "reality" is that it has done practically nothing to actually advance the communication of drug safety information to the public.

Pharma Marketing Sitcoms as Brand Extensions

ABC said Friday it had ordered a pilot for a comedy, tentatively titled "Cavemen," that features the characters used in a series of ads by Geico, the insurance company.

You know the ads: "So simple a caveman can do it."

"We sell car insurance; we don't make TV shows," says Ted Ward, Geico's vice president of marketing. He is obviously happy, however, to be given the opportunity to extend the brand: "We are excited to have an opportunity to do brand extension." The advertising copywriter who helped create the cavemen ads is writing the pilot.(See "Why Advertising's Cavemen Are Going Totally Hollyrock").

Recently, we learned that at least one pharmaceutical company has created a "documentary" film to appear in theatres near you (see "No Oscar for Centocor PR Effort"). So, it may not be too much of a stretch to envision TV sitcoms based on characters created for drug ads.

Here's a few project pitches for Drug Brand Extension Sitcoms that I hope CBS, Fox, or even HBO will "greenlight" and thereby make me rich.

Scenario: In exchange for ripping up the paper IOUs of a few deadbeat Hollywood directors I whopped in Texas Hold'em, I was able to get an appointment with a few TV studio execs to pitch my ideas. The following is a transcript of a recent pitch I made to "Sidney Greenlight," an executive at a TV studio to remain nameless.

Mack: Sidney, thanks for your time, which I won't waste with small talk. My idea is a sitcom featuring Abraham Lincoln and a beaver. I call it "Abe and the Beav," you know, sounds kind of like "the beav" from "Father Knows Best," so it's got that old-time homey appeal, right?

Sid: Hmm... sounds good. But I don't know about the beaver. Too sexual.

Mack: Yeah, right! Let's lose the beaver. In fact, forget Abe also -- too Republican, right? Here's another idea -- a bee with a French accent that's always bothering people around the home when they are doing chores or playing frisbee -- get it? Bee, frisBEE? Uhm...anyway, I think the French are back in favor, don't you think so?

Sid: I can't relate to no f**king insect!

Mack: Sure, sure, I get what you're saying. How about this? A moth! No,no, that's another insect, right? But it doesn't sting, does it? That makes it OK. See, the moth flits from house to house at night and there's a story in each house -- kind of a "24" thing -- each year's episodes represent one night in the life of the moth -- they only live one night, right? I think I'm right about that -- flitting from house to house, kind of a Desperate Housewives subplot going on. You know, the moth finds women in bed at each house?

Sid: Too late night. We need family stuff!

Mack: Yeah, yeah, late night sitcoms are not doing too well -- "Lucky Louie" sucks, right? How about this -- I call it "Pipe People of Paradise." Kind of a "Robots" movie knockoff, know what I'm saying? They're cute, not scary, and they like bird watching and they always have to take a leak! No, they're always afraid of leaking! That's it. What do you think?

Sid: Mack, I don't know where you come up with these characters and ideas! You must be nuts! Get the hell out of my office!

Are you happy to see me, or is that just your Exubera Bong?

Pfizer is getting hit from all sides regarding its clunky-looking Exubera inhaler.

It Ain't No iPOD!
Back in June, Amy Tenderich, author behind award-winning blog Diabetes Mine, wrote:

"Because for any PWD [person with diabetes] with an actual social life, Exubera inhaled insulin is looking like a bomb. As I told the reps at the ADA conference frankly, the science behind it IS revolutionary, and we PWDs are grateful for strides in alternative insulin delivery, of course! But the Exubera Inhaler Device really is as bad as it looks in pictures. Worse, because the bulky "white" plastic portions are not white at all, but that hospital-grade biege that reminds you of walkers and bedpans. An aesthetic nightmare, in the age of cool gadgetry." (See "Exubera 'Bong' OK for Older Folks?")

Recently, Amy quipped "Are you happy to see me, or is that just your Exubera Bong?"

Pfizer is said to be planning "to use television commercials to pitch the first inhaled insulin treatment directly to diabetics after the product failed to catch on with doctors." (See "Pfizer Risks Doctors' Ire Pitching Drug to Diabetics")

My advice to the people working on the DTC campaign: Don't use the video you have on the Exubera Web site showing someone using the device in a restaurant! I don't think it shows the device in the best possible light.

BTW, if the device fails as an insulin delivery system, Pfizer no doubt has plans to use the technology for other drugs. Here's a billion dollar idea: develop a version for delivery of "medical" marijuana and then lobby in support of the legalization of marijuana! Now that would make us old folks happy to see ya!

Does Merck Need a Vaccine for Bad PR?

You've got to feel sorry for Merck and its PR people -- not too sorry, however: Merck raised its 2007 forecasts yesterday and Shares of Merck were up $1.07, or 2.5%.

First, Merck got caught again with its hand in the cookie jar -- actually, it got caught opening its Gardasil lobbying cookie jar to politicians' hands (see "Who's Easier to Buy? A Physician or a Politician?").

Then, Merck's PR people had to work overtime putting a positive spin on a just-published study showing that the number of women exposed to the HPV viruse strains that are thought to cause cervical cancer is about half what Merck estimated it was:

"The study appearing today in the Journal of the American Medical Association looked at U.S. females aged 14 to 59. The combined prevalence of two high-risk strains of HPV, types 16 and 18, was about 2% in that population, which the paper called "relatively low," compared with other estimates..." (see "Higher Rate of Cervical HPV Found" -- don't be led astray by this article's title; the positive spin shows whose side WSJ is on.)

This does not help its case for mandatory Gardasil vaccinations; but it may have little effect on future sales of Gardasil.

It could be -- as I said before -- that all this attention brought on by the lobbying PR snafu is actually helping sales of Gardasil. Or, maybe we haven't yet seen the negative effects of bad publicity work its way through the sales cycle yet. But Merck seems optimistic.

So, was it bad PR or not?

Ellen Goodman of the Boston Globe seems to think it was bad and that drug companies need a vaccine for bad PR:

"Hasn't anyone ever told drug companies to put a warning label on their lobbying? You know, the kind you find on every little prescription bottle? Caution: Too much lobbying might result in an overdose of suspicion. Push too hard and you might experience political acid reflux." (See "Goodman: What Merck needs is vaccine for bad PR".)

Well, there's lobbying and then there's PR -- let's make that distinction. Any pharmaceutical exec will claim that both are educational activities. Lobbying, however, has a payola element to it as well. which is what got Merck into hot water.

Goodman claims that the "bad" PR harmed Merck's cause. In fact, Goodman claims "the real losers may be girls and women who need access to the vaccine against cervical cancer."

How are they losing? Nobody's stopping girls from getting vaccinated. In fact, all the publicity has made Gardasil a household word and more people than ever know about the vaccine and the link between HPV and cervical cancer. From that point of view, all the hullabaloo has achieved a level of awareness that no multi-million dollar disease education campaign could ever hope to do. And Merck got this windfall on the cheap (see "Who's Easier to Buy? A Physician or a Politician?").

This may be why Merck is so optimistic and is making such rosy forecasts to Wall Street analysts!

What do you think? Participate in the following poll and let me know.

Will the Controversy Over Mandatory Vaccination Help or Hurt Gardasil Sales?
	It will definitely help
	It might help
	I don't know
	It could hurt
	It definitely will hurt

Mandatory vaccination? We don't need no stinkin' mandatory vaccination!