Montel Says Goodbye to TV! May Leave PhRMA's PPA Program Also

According to an AP story, "Syndicated talk show host Montel Williams is being replaced by a younger version of himself. CBS Television Distribution announced Wednesday that 'The Montel Williams Show' will cease production after this television season, his 17th on the air. Instead, stations that carried his show will be offered a series of Williams reruns."

Recall that not too long ago Montel was in some hot water after he threatened an intern working for a local newspaper in Savannah, GA (see "Montel Williams: Zero Tolerance for a Pharma Celebrity Spokesperson Gone Bad"). This was of interest to us bloggers in the Pharma BlogosphereTM because he made the threat while working for PhRMA as the celebrity spokesperson for the Partnership for Prescription Assistance (PPA) program.

The question is, will PhRMA soon announce that Montel's PPA gig will also be canceled? And does all this have anything to do with the "blow up" incident?

I think the answer is "Yes" to the first question and "No" to the second.

Although 84% of people who responded to my poll thought PhRMA should fire Montel over the blow up incident, I think he will be let go because,in general, his behavior is a bot erratic lately -- he's acting like a "loose cannon."

Here's an example from a Fox show where he was asked his opinion about the death of movie star Heath Ledger. He was asked this, the anchor-person said, because he was a "some who knows how it can be under the glare of the celebrity microscope." Here's the video:



Montel was "repulsed by all the coverage" and rightly suggested that Fox was not spending enough time about deaths of other young people. "How many people have died in Iraq since January 1?" he asked. Of course he meant only American troops, not Iraqi civilians.

Anyway, he was way off subject and at one point said "I don't need them," referring to ratings. That seems strange for a celebrity to say.

Personally, I think Montel's meds are making him "mad as hell and he won't take it any more!" That along with the loss of the celebrity "creds" that having his own TV show gave him, leads me to believe that Montel will soon retire as the PhRMA spokesperson.

If you are interested in reading more about the the 'dos & don'ts' and 'pros & cons' of using medical and non-medical mouthpieces for pharma PR and DTC advertising, please read the article "Use of Celebrities for PR and DTC Advertising," which appeared in the January, 2008 issue of Pharma Marketing News.

Caucuses, Coffee Shop Focus Groups, and Cholesterol

I'd like to explore the connection between the current presidential campaign--including its caucuses and coffee shop interviews--with the direct-to-consumer (DTC) marketing of drugs like cholesterol. An Avodart print ad found in the February 11, 2008 issue of Forbes brought this connection to mind, although Avodart treats enlarged prostate and not high cholesterol:

Click on image to enlarge! and read why this is an optical illusion.

Obviously, this ad is politically incorrect, since for the first time in US history, a woman may be the Democratic candidate for president and women--even Hillary--do not have prostate glands. I guess the Avodart ad people we thinking of McCain, who probably does have a prostate issue; after all, one in three men will have such issues according to an ad for a different product I have seen on TV.

According to the Avodart Web site, "Nearly half of all men over the age of 50 have an enlarging prostate." Great! Along with the 40% of men over 50 who have erectile dysfunction, I have a lot to worry about! I am doomed!

You Call This Educational?
I love the little "educational" graphic down on the bottom right of the ad (image on left, below).


Aside from insulting my intelligence, this image immediately reminded me of the famous two-circles optical illusion shown on the right.

I'm sure I'm not the only guy with shrinkage on his mind that has made the optical illusion, smoke and mirrors connection. Which leads me to ask, don't they test these ads in consumer focus groups?


Coffee Shop Focus Group Discussion of Cholesterol
Back to politics, where everything is tested in focus groups, even if just gabbing with a few people in a coffee shop.

Not only is politics the topic of discussion in coffee shops around America these days, but so is high cholesterol and drugs that treat it. If a cholesterol drug were running in the Rx drug primaries, it would be the Giuliani of candidates! Vytorin and Zetia have dropped out of the race (see "Vytorin and Zetia Are Dead in the Water") and Crestor has re-emerged, phoenix-like, as a contender (see "Crestor Print Ad Touts Plaque Buildup Advantage").

In this month's Pharma Marketing News, I published the following article by Jim Avery, professor of advertising at the University of Oklahoma. He recounts his conversation with college-educated friends at a local coffee shop on the subject of cholesterol.

At breakfast last week in one of my favorite coffee shops, I was talking with some friends who I knew had some health problems. I mentioned that there were a couple of recent articles in newspapers on cholesterol drugs and clinical trials. No one had seen or even heard of these articles and I was a bit taken aback that I was the only one who had seen what I judged to be fairly important information on healthcare.

Impromptu Focus Group
One thing led to another and pretty soon we were having an in-depth discussion about their high cholesterol, general healthcare, the FDA, and what they think when they read news stories or advertising that relates to their ailment. Obviously, being a professor of advertising at the University of Oklahoma, I took the opportunity to turn our breakfast meeting into a little impromptu focus group.

All three of my friends--Jack, Rose, and Steve--are over the age of fifty, are college graduates, and two of the three have master's degrees.

Jack had a heart attack a few years ago. Prior to that time he did not go to a doctor on a regular basis. When he was in the hospital, he learned his triglycerides were too high and his doctor recommended that he start taking medication to bring them in line.

Rose found that her cholesterol level was high during a routine blood test. It appears to be a family heritage. At first, she tried to increase her exercise. She found it improved her test scores, but she was still just borderline. She decided to start taking the prescription recommended by her doctor in order to give her a margin of safety.

Steve has had several "episodes" with his heart, has been to several doctors in two different states, and has tried everything his doctors have recommended. Even with his diligence, he still did not have his high cholesterol under control. His wife found a program offered at a hospital that required total diet control, medication, and exercise. She said it is time for them to "take the offensive." He believes it saved his life. He recognizes that it is very stringent. No butter, no fat of any kind, can be included in his diet, ever.

Cholesterol Treatment in the News
I gave each of them copies of the articles on cholesterol, which I just happened to have with me. I had read these earlier in the week and gave my friends some time to read them while we enjoyed our coffee and doughnuts. One article was on new ways to treat cholesterol and the other revealed that a reduction in cholesterol does not necessarily lead to a reduction in heart disease.

In the first part of our discussion afterward, all three said was that their cholesterol medication is working for them. Rose and Steve commented on their latest blood work as evidence. Jack was certain that he was improving, too. When I challenged him on whether the medication is working or if he is just getting better on his own, Jack said there was no way for him to know, but he is confident that his improved health is directly related to the medicine.

All of them had done individual research on their ailment, diagnosis, and the treatment of medicines recommended by their doctors. After a short period of time, however, Rose and Jack soon left the details of their ailment and its treatment up to their doctors.

However, Steve, who is retired from both the Air Force and a management position, took more control of his heath. He monitors everything he eats—he didn’t have any doughnuts like the rest of us did that day—and he exercises regularly. He also sees his doctor regularly, and often takes articles from magazines or details from advertisements to show his doctor and asks for a recommendation.

I was surprised at how little Jack and Rose knew of their medical condition. Neither knew the difference between HDL and LDL. I suspect that they quit investigating when they felt confident that they were getting better physically and chose to therefore trust their doctors.

Surprising Lack of Trust
We are all aware that consumers do not trust big corporations, but I was surprised at how distrustful all three of these friends were of pharmaceutical companies. I never even brought up the subject of trust or reliability. Rose just commented that these companies are not trustworthy. I understood their distrust of advertising, but was surprised to find out that this distrust extended to the news media, doctors, and hospitals as well. Rose went so far to say that "drug companies lie to me" and both Jack and Steve agreed. They each had a comment to express their distrust, and each related a story about a doctor who gave bad advice. Steve said that it took him several years to correct a situation caused by a poor doctor.

On the positive side, they all had praise for their pharmacists. Rose and Steve both related personal experiences when their pharmacist had corrected a mistake their regular doctor had made. Both spoke of a prescription that might have caused harmful effects with another medication they were taking at the time. I shared my own story about being prescribed a penicillin based drug even though my chart noted my allergy. The pharmacist caught the error for me, also.

Surrogate Endpoints “Miss the Point”
One article I gave them referenced limited FDA requirements for drug testing, It flabbergasted all three of them. That the FDA does not require testing results to show a change in heart disease, but only requires that the research show that there is a reduction in cholesterol, seemed to miss the point to them. Steve noted that it is as if cholesterol has become the disease instead of the symptom.

FDA Not Doing Its Job?
They were all disappointed that the FDA permitted the sale of drugs that could have negative effects. Jack said that he had read that the FDA is a stickler for testing and that it often takes longer to get new drugs approved in our country than elsewhere in the world. He pointed out that this does not seem to be consistent with the current practice.

All three were disappointed with how long it takes to get a new drug to the market.
Jack brought up his distrust of insurance companies. Rose and Steve immediately agreed. Each related an experience when their HMO did not allow something they thought would have improved their health. Steve gets his prescriptions at the Air Force base. He has a list of what is available. His doctor told him that he could recommend a drug from the list, but it wouldn't help him. So now, Steve often pays for medication that is not covered under his plan.

Overall, I continue to be surprised at what little trust people have for anything that has to do with the healthcare industry. I knew, as I am sure you do, that consumers do not trust the pharmaceutical companies. My surprise is in two areas. First, the intensity of that distrust, and second, that this negative halo extends to the FDA and to virtually any news associated with these companies or with the government agencies responsible.

We Haven’t Reached Bottom Yet
It is likely that the distrust started with insurance companies and HMOs, but every time the news media report that a drug doesn't do what it was intended to do, or that people who took what had been tested to be a perfectly safe drug may have a serious side effect, the "bad will" meter goes up. This "bad will" is rubbing off on medical practitioners, marketers of pharmaceuticals and medical devises, and the FDA more all the time.

My small group discussion indicates to me that the situation is getting worse and that we probably have not yet hit bottom.

Note: The two articles referenced here were:
1. New Questions on Treating Cholesterol, New York Times, January 17, 2008
2. Study Reveals Doubt on Drug for Cholesterol, New York Times, January 15, 2008

Jim Avery is Professor of Advertising, and holds the Gaylord Endowed Professorship, at the University of Oklahoma. The meeting of “friends” in a coffee shop was a fictional embellishment of an actual focus group Avery recently held. Except for that and the names of the participants, everything else reported here is an accurate summary of the results of the focus group discussion.

You can learn more about professor Avery and his teaching techniques by listening to this Pharma Marketing Talk podcast: “Teaching New Dogs Old Tricks.”

Crestor Print Ad Touts Plaque Buildup Advantage

Click image to enlarge.

Have you seen this new Crestor print ad from AstraZeneca? Crestor is one of the newer anti-cholesterol drugs that recently gained the right from FDA to claim it slows the progression of atherosclerosis (plaque buildup in arteries). That new indication is clearly the focus of these ads, a sample of which -- taken from the February 4, 2008, issue of Time Magazine -- is shown above.

Recall that with all the hullabaloo over Vytorin/Zetia and the failure of the ENHANCE clinical trial (see "Should I Stop Taking Zetia?"), Merck and Schering-Plough have pulled direct-to-consumer (DTC) ads for these products from TV. I haven't seen any Crestor ads on TV lately either.

As I suggested previously, I believe these ads will be back on TV after Merck/Schering figure out how to spin the benefits of Vytorin/Zetia in light of the failure to demonstrate any effect on plaque. Clearly. they will have to make a case that LDL cholesterol is the leading cause of plaque buildup in arteries even though this wasn't proven by the ENHANCE study.

But NEW Crestor TV ads -- like the print ads -- will be able to bypass the cholesterol-lowering message, which consumers now suspect is the lesser benefit compared to lessening plaque buildup (see "Cholesterol Drug Users Discuss Their Medication").

The basis of Crestor's FDA-approved claim that it "slows" plaque buildup is data from 876 patients in the "METEOR" -- Measuring Effects on Intima Thickness: An Evaluation Of Rosuvastatin 40 mg -- study (see excerpt for the Crestor PI below).

Click on image to enlarge and read.

The interesting difference between this study and the Vytorin Enhance study is that it compares Crestor to NOTHING (placebo) whereas the ENHANCE study compared Vytorin to simvastatin, the generic version of Zocor, which is the non-Zetia component of Vytorin.

See, folks, this is why the drug industry doesn't like to do "head-to-head" clinical trials that some critics say need to be done to justify the extra expense of newer drugs compared to older ones.

Note the Irony
The ENHANCE and METEOR studies are similar in one respect: each studied only a few hundred people over a limited time period. Merck and Schering-Plough are trying to say we shouldn't place too much emphasis on a clinical trial involving only a few hundred people. Yet, a clinical trial involving only a few hundred people was good enough for the FDA to approve a new Crestor indication worth hundred of millions of dollars to AstraZeneca!

The take-away message from the METEOR study is this: 52.1 % of the Crestor-treated patients in the study demonstrated an "absence of disease progression," compared to 37.7% of patients in the placebo group. That's a net difference of 14.4%. So, of the 876 patients studied, 126 more were helped by Crestor than by placebo. Or, to use the number needed to treat (or NNT) statistic (see "The Statin Lottery: Number Needed to Treat Statistic"), for one person to benefit from Crestor, about 7 people have to be treated (NNT=6.95). Still, we're only talking about "absence" of progression of plaque buildup, not prevention of heart attacks, which is the ultimate endpoint.

Women Need More Love, Less Drugs

There seems to be a proliferation of "real" diseases that "primarily affect middle-aged women." That, for example, is how fibromyalgia is described (see "Drug Approved. Is Disease Real?"). The "real" adjective figures prominently in Pfizer's TV ad for Lyrica, which was recently approved by the FDA for the treatment of fibromyalgia (see "Living with Fibromyalgia, First Drug Approved").

You've probably seen the commercial -- if not, you can find it on the official Lyrica product site here.

On the left/above is a frame from that video showing a woman in distress after reading from her diary about the pain she suffered "all over." (God, look at the signs of distress in her face and neck!)

She also took the time to write in her diary "But until June 2007 there were no medicines approved by the FDA to manage fibromyalgia." I notice she used the word "manage" instead of "cure" or even "treat." If she used anything else than the FDA approved language, I am sure she would have gotten a letter from the FDA. Damn that FDA! Haven't they heard about the "free speech" rights of patients?

But I digress, as usual.

It's not just this woman who I see suffering in TV drug ads. There's that poor woman suffering from pain caused by depression in the Cymbalta TV ad and the woman who suffers from the "needles and pins" pain of restless leg syndrome (RLS).

As I think more about these women, I'm beginning to believe they suffer more from lack of love than a "real" medical condition. Take that woman suffering from RLS ... please (bada boom). At first I thought she was blaming it all on her poor husband over whom she threw the bed sheet in disgust. But then I noticed that he was sleeping with his back to her. Wouldn't she feel better if they slept like spoons in a drawer -- you know, in a loving embrace?

I notice that other women in some drug ads are very happy and pain-free, especially the ones in the Cialis and Levitra ads (surprisingly, women are missing in the recent Viagra ads --- see "Viva Viagra Ad is No Cure for Morte Sales"). And don't forget that woman in the Amitiza ad (see "Amitiza DTC Ads Won't Win Any Awards, But..."). She obviously has a loving relationship with her husband and looks VERY happy. Of course, she's just "dropped the boys off at the pool," but we don't see her blame her husband who obviously stays at home while she goes off to work. Maybe that's the key to a great marriage?

Of course, the happiest women of all are the ones in the Botox reminder ads! They "remind" me of The Real Housewives of Orange County. They are beyond love and sex with their husbands and have the money to sublimate their desires through cosmetics, shopping, and eating lunch out every day.

I think women like the fibromyalgia sufferer could benefit from more love, not drugs. But then, I'm a product of the "make love, not war" sixties, which makes me biased (although some of us did use "drugs" back then -- but NOT me. Kids, in case you're reading this, get back to your books!).

P.S. I am ready to be pilloried in your comments!

Jarvik Falters in His Own Defense

While all of us bloggers were either blasting or defending Dr. Robert Jarvik for promoting Lipitor as an unlicensed "doctor," he appeared on the "Good Morning America" show to answer critics who say he should not be pitching a drug as a doctor who cannot prescribe medicine because it's misleading consumers.

He made some pretty revealing comments such as:

• Lipitor ads are educational ("Our ad campaign with Pfizer is an educational one")
• Prescribing Lipitor is good preventive medicine
• Yet he didn't start taking Lipitor until AFTER he became a spokesperson
• He wouldn't say how much he or his son got paid, but "it would be considered a lot by most people."

He began to falter when asked "What about generics? Why don't you mention generics?"

There was a long pause ... then the response:

Jarvik: "I don't know. We have talked about generics in the ads..."

"You have?"

Jarvik: "Well maybe there's an ad that hasn't come out yet that you haven't seen." (smirk) "So, we do address those issues."

New Lipitor-Jarvik Ads in the Works?
Either he doesn't know what he's talking about, lying, or leaked information of an upcoming "non-branded" TV ad by Pfizer that "talks" about generics. Or it could be a branded ad similar to the Celebrex ad that compares the Lipitor to a generic statin.

I wonder if he'll ever be called to testify before Congress? If so, he'll need better coaching!

See the video of the interview here: "Medical Pitchman Under Fire".

Vytorin and Zetia Are Dead in the Water

Physicians have virtually stopped writing new prescriptions (NWRx's) for Vytorin and Zetia since the bad news about the ENHANCE trial became public. This is evident in the chart below compiled by ImpactRx.

Click to Enlarge.

I first saw this chart over at the WSJ Health Blog, but they forgot to include the key that would allow you to identify the drugs. Seems I was the only person who caught this and cared enough to contact the people at ImpactRX, who kindly supplied me with my own version of the chart, key and all.

If physicians continue to NOT write NRx's for these drugs -- they have increased NRx's for simvastatin, the cheap, generic version of Merck’s Zocor -- then that would mean trouble for Merck and Schering in the Lipid drug market.

It seems that Lipitor may also be in trouble, according to the WSJ Blog. U.S. sales of Lipitor were down 8% from 2006, and world-wide sales were off 2% ("The End of the Lipitor Era").

New Vytorin TV Ads Are in the Works - IMHO

According to an AP report, Merck & Co. and Schering-Plough Corp. have suspended TV ads for Vytorin a week after a study revealed the cholesterol drug is "no more effective than a high dose of one of its components available generically at a third of the cost."

They made this decision, said Skip Irvine, a spokesman for Merck/Schering-Plough, "in light of mischaracterization and misinterpretation of the enhanced (sic) trial results."

There's just a few observations about this decision that I'd like to make before I discuss why I believe that NEW Vytorin TV ads are in the works.

Observation # 1: It's ENHANCE, Skip, not ENHANCED! Is that a misquote Skip, or are you trying to put some subliminal spin on it? If you can't even get the name of the trial right, why should I swallow your "mischaracterization and misinterpretation" remarks, which is the real spin?

Observation #2: It's about time the ads were pulled! Let me offer a poem as introduction [apologies to e. e. cummings]:

I told
Schering:it couldn't
believe it [...]
(it didn't believe it, no
sir) it took
an over-hyped bit of
the old ENHANCE
clinical
trial:which hit its stock price: to tell
it

Nearly a year ago, I suggested that the "Vytorin Ads Are Getting Old -- and Disturbing!" I didn't suggest that Schering-Merck pull the ads altogether, but I had enough of the silly food-people comparisons, especially when it was becoming a bit racial (yes, I'm introducing race into the mix) as illustrated in this ad:


New Vytorin Ads on the Way
I noted a week ago -- as soon as the ENHANCE news broke -- that the Vytorin ads were missing from TV and suggested there would be a revamping of the ads should they return:

P.P.S. Since this blog is really all about pharmaceutical marketing, I should say something about how the ENHANCE trial failure may affect the advertising of Zetia and Vytorin.

Obviously, these brands are probably maintaining a low profile these days. I don't remember seeing the usual ads on TV last night. Perhaps the ads are being revamped in light of the ENHANCE trial news and will soon re-appear addressing the issues raised by the study's failure. But why weren't these damage-control ads rolled out IMMEDIATELY? Maybe it's best to say nothing to the public -- No way! Merck and Schering-Plough should have PSAs explaining their take on the situation and NOT just depend on issuing a press release!

See "Should I Stop Taking Zetia?"

Personally, I don't think there's a snowball's chance in hell that the people-food comparison ads will come back. They are as dead as dodos. SP-Merck will have to come up with new ads like Pfizer did for Celebrex after Vioxx (a similar NSAID) was pulled from the market (see "Celebrex Ad: Let's Dive Deeper").

The new Vytorin ads cannot look like the old ones because that branding is now too closely associated with the ENHANCE debacle. The new ads will have to "dive deeper" -- and maybe run for more than 1 minute -- to explain the nuances of the ENHANCE results and make a strong case why Vytorin is better than just simvastatin alone.

But don't expect to see these new ads soon. As someone once said: "Oh Lucy! - You Gotta Lotta 'Splainin' To Do" and that may take some time.

UPDATE: My cardiologist still has NOT returned my call to answer my question about Zetia!!!! (See "Should I Stop Taking Zetia?")

Sleep Aid Drug Print Ad Triptych

I found the following 3 full-page ads for sleep medications in the January 28 issue of Time Magazine (click for an enlarged view):


I think I arranged these in the order of market share in the US from left (highest) to right (lowest): Ambien CR, Lunesta, and Rozerem. I posted the following pie chart back in June (see "Rozerem DTC Ads: New Paradigm or Paradox?"). I doubt much has changed.


Let's play the Sesame Street game "What's Different, What's the Same" and see if there is any connection with how well these drugs are doing. Maybe the "kids" at Abelson-Taylor should also play this game.

I notice that both the Ambien CR and Lunesta ads prominently feature someone enjoying a nice snooze or night's sleep and they look happy. The Rozerem ad, on the other hand, does not have any image showing the main benefit of a sleep aid medication. It sticks with Abe and the beaver, a theme that by any standard is wearing thin.

The Ambien CR and Lunesta text tag lines enforce the same message conveyed by the images. The tag line of the Rozerem ad, however, is not synergistic in any way with the image. It does at least try to tell us what Rozerem's main competitive claim is: you won't get "hooked."

"Hooked" is a very strong word that conjures up images of crack addicts. But this is toned down somewhat by the phrase "Ask your doctor about the only prescription sleep aid that shows no potential for abuse or dependence in clinical trials." "Abuse" is another drug addict word, but I'll let that slide.

The Ambien CR and Lunesta ads both say something about "dependency" in the small print: "It's non-narcotic; however, like most sleep medicines, it has some risk of dependency" (Ambien CR) and "Most sleep medicines carry some risk of dependency" (Lunesta).

The Ambien and Lunesta ads kind of shrug off the dependency side effect and at the same time paint "most" sleep medicines (read between the lines "Rozerem included") in the same category.

At least the Rozerem ad is focusing on what distinguishes it from its competition. That's good. However, by sticking with Abe and the beaver and NOT showing a sleep benefit--ie, someone enjoying a night's sleep--it is not effectively competing with Ambien CR and Lunesta. Maybe that's why it is the Rudy Giuliani of sleep medications--a distant third.

Different Views of Pharma and its Critics

Last week, I posted this view of the pharmaceutical industry vs. its critics over at Pharma Blogosphere:


I called it "Rope-a-Dope-a-Pharma" primarily because I thought the industry played right into the hands of its critics through a series of blunders, which I summarized as rounds in a fight:

Round 1: Lipitor's Jarvik is outed
Round 2: Vytorin Trial Ends In Failure - Patients Left Out in Cold
Round 3: Congress Investigates Vytorin Ads
Round 4: Congress To Probe Vytorin Insider Stock Sales
Round 5: Study Says Patients, Doctors Get Distorted View of Antidepressants
Round 6: FDA Won't be Previewing TV DTC Ads!
Round 7: Taking Statins no Better Than Betting the Lottery!

Announcer: "Big Pharma is reeling! Is this the final round? There are deep cuts over both Big Pharma's eyes (R&D and Marketing)! How much more pummeling can it take? Is this fight over?"

Proving that great minds think alike -- in a Bizarro-World kind of way -- I noticed that my January issue of Pharmaceutical Executive Magazine featured a story where Little Red Riding Hood (representing Big Pharma) is at the mercy of Wolves (representing regulators, whistle blowers, physicians, prosecutors, politicians, and media). Here's PE's image of what it calls the "Year of the Wolves":


I will contend that my image is much more accurate for several reasons:

1. It does not depict Big Pharma as some weak, innocent lamb bringing the goodies to granny,
   
2. on the contrary, it depicts pharma as a strong opponent making a tactical blunder, and
3. I include me and you (ie, consumers and patients) among the anti-pharma combatants, whereas those groups are not among PE's wolves.
   

In so far as PE Magazine is the mouthpiece of the pharmaceutical industry, its depiction of the industry's predicament illustrates yet again that it has no clue how to manage the crisis. If it sees its adversaries as wolves then all its options are limited to kill or be killed.

Consumer Reports Rip Rozerem Ad -- A New One!

Consumer Reports has just posted the second in its series of CR AdWatch videos that add commentary and context to widely seen pharmaceutical advertisements. You’ll recognize this ad immediately: It’s the one that has Abe Lincoln and a talking beaver offering consolation to an unfortunate insomniac.

According to Consumer Reports: "The ad -- the latest in a series -- is memorable not only for its quirky cast of characters, but also because the drug it promotes (Rozerem) does not appear to pose the same risk of chemical dependency as other prescription sleeping pills. Yet as our commentary notes, that doesn’t mean your first move after a sleepless night should be to beg for a prescription. I’ll let the AdWatch crew tell you the rest themselves."

See the video commentary here.

The Statin Lottery: Number Needed to Treat Statistic

Suppose I invited you to join this contest:

250 people are recruited to participate in the contest. Each person gives me $1,000 and after 1 year one person in the group--selected at random--will receive $250,000 (250 people x $1,000). I keep the interest earned.

Would you participate?

That's similar to the wager that people who are taking statins like Lipitor are engaged in according to Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles, who was quoted in a recent BusinessWeek article (see "Do Cholesterol Drugs Do Any Good?").

He based his analysis of statins on a little-known but useful statistic, the number needed to treat (or NNT). Here's how to calculate the NNT for Lipitor based on Pfizer's claim in those Jarvik-endorsed Lipitor ads: "Lipitor reduces the risk of heart attack by 36%...in patients with multiple risk factors for heart disease."

Here's what that means in terms of NNT:

"...for every 100 people in the [Lipitor] trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit. Or to put it in terms of a little-known but useful statistic, the number needed to treat (or NNT) for one person to benefit is 100."

But that's based on one clinical trial involving several hundred or a few thousand high-risk people, not millions of people in the real world. According to the BusinessWeek, "several recent scientific papers peg the NNT for statins at 250 and up for lower-risk patients, even if they take it for five years or more."

BusinessWeek also published this table show NNT statistics for several Rx drug treatments (click to enlarge):


Dr. Hoffman used the Lipitor NNT of 250 statistic to make this analogy:

"What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising? How many would take that?"

Meet me in room 101 and bring your $1,000!

Duluth Bans Tchotchkes -- That's Snot Funny!

According to a report in the The Minneapolis Star-Tribune, a Duluth-based health system is declaring a ban on drug-logo freebies, no matter how small. That includes, according to the report, a disembodied stuffed nose from Allegra that exclaims, "That's snot funny!"

I guess the pharmaceutical industry also doesn't find it funny that more and more hospitals and health systems are banning freebies (aka tchotchkes) that their sales reps give to physicians. See also "Minnesota Limit on Gifts to Doctors May Catch On."

Pharmaceutical companies claim that many "freebies" are actually educational. Perhaps the "snot funny" nose with the Allegra logo on it is educational; after all, it coveys an important message that allergies are not funny and may a major cause of the dreaded Runny Nose Syndrome (RNS), which sadly afflicts many millions of Americans. No doubt it's secondary purpose is to remind docs to prescribe Allegra (isn't there a generic version? Oh yeah, generic companies don't give away tchotchkes).

Tchotchkes can also make subtle claims about a drug's efficacy or indication that may violate FDA regulations. In November 2006, for example, J&J's Scios unit was cited for "inappropriate reminder labeling" by the FDA for distributing a Natrecor heart failure drug computer mouse pad and pen to physicians (see "The Natrecor Waterboard Tortured Tchotchke").

Not too long ago, I hosted an online survey and a Pharma Marketing Expert Roundtable discussion on the topic of gifts to physicians. The article "Free Gifts to Physicians: What's the Big Deal?" summarizes the findings of that survey and includes comments and insights from Roundtable members.

In case you're too cheap to buy the reprint, you can access the de-identified survey results here.

BTW, I tried to find a photo of the talking Allegra nose tchotchke via a Google search and over at the Drug Rep Toys blog, but could only come up with this YouTube Moose video, which I hope you enjoy:

FDA Won't be Previewing TV DTC Ads!

The FDA has announced in the Federal Register that it was canceling its program to preview broadcast DTC ads submitted to it by the drug industry. This program was inserted in the FDA Amendments Act (FDAAA), but the FDA was not given authority to charge user fees to cover the program over a 5-year period (see "FDA DTC Payola Out, You Pay In!").

To date, 31 companies committed to submit 151 TV ads for pre-review and the fee that FDA would have charged per review was set at $41,390.

Here's the FDA statement:

User Fee Program for Advisory Review of Direct-to-Consumer
Television Advertisements for Prescription Drug and Biological
Products; Program Will Not Be Implemented

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not ``provided in advance in appropriations Acts'' as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the previously issued notice establishing user fee rates for the program for fiscal year (FY) 2008 is being withdrawn.

....

SUPPLEMENTARY INFORMATION: On September 27, 2007, the President signed into law FDAAA (Public Law 110-85). Title I of FDAAA reauthorized the Prescription Drug User Fee Act for FYs 2008 to 2012. In addition, Title I created new section 736A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h-1), which authorized a new and separate user fee program for the advisory review of DTC prescription drug television advertisements. The DTC user fee program would have been available to companies interested in voluntarily submitting to FDA for advisory review a DTC television advertisement, as defined in section 736A(h)(4) of the act. FDAAA provided, however, that if FDA fails to receive at least $11,250,000 in advisory review fees and operating reserve fees combined by 120 days after the legislation is enacted (i.e., by January 25, 2008), the program shall not commence (section 736A(f)(1) of the act). FDAAA also provided that the fees authorized for the DTC program ``shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts.'' (section 736A(g)(1) of the act).

On December 26, 2007, the President signed the Consolidated Appropriations Act, 2008 (Public Law 110-161). The law does not appropriate user fee funds for the voluntary review of DTC television advertisements. As a result, under section 736A(g)(1) of the act, FDA does not have the authority to collect and spend user fees for this purpose. Furthermore, as noted previously, section 736A(f)(1) of the act provides that if FDA has not collected at least $11,250,000 in advisory review fees and operating reserve fees combined by 120 days after the legislation is enacted (i.e., by January 25, 2008), the program shall not commence. Therefore, no invoices will be sent. Advertisements voluntarily submitted for FDA review will be reviewed in as timely a manner as resources permit. In addition, FDA is withdrawing the previously issued Federal Register notice establishing the user fee rates for this program for FY 2008 (72 FR 70334, December 11, 2007).

Dated: January 10, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-740 Filed 1-15-08; 8:45 am]

Damn! I guess I won't be getting that $240,000 per year job as a FTE DTC ad reviewer!

My Cardiologist is on Vacation - "I'm as mad as hell, and I'm not going to take this anymore!"

It's been nearly 48 hours since I called my cardiologist's office to ask him about Zetia, which he prescribed to me long before the recent news of the ENHANCE trial flop (see "Should I Stop Taking Zetia?"). There's been no return call from him or any other healthcare professional/nurse in his office to answer some of my questions. OK, he's on vacation and this is not a emergency. But you would think that SOMEONE would get back to me.

Today, I will try my primary care physician and see what she says, if she's there.

Meanwhile, not only have I lost faith in Zetia, I have lost faith in the whole notion that lowering my bad cholesterol numbers is necessarily a goal that should be achieved at all costs.

Today, in an article in the New York Times, Alex Berenson writes:

For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol.

But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say.

I've already stopped taking the statin drug I was first put on 12 years ago! My cardiologist didn't blink when I told him, but he did suggest Omega-3 Fatty Acid capsules. I am also taking niacin (recommended by my primary care doc) and Red Yeast Rice capsules that Dr. Weil recommended in an AARP magazine article I read (a friend also recommended it).

Thus, I am slowly turning my cardiovascular treatment oil tanker away from Big Pharma's Bermuda Triangle and heading towards the calm shoals of "Alternative Treatment." Let's see what my LDL level is when I next test my blood. Maybe my liver enzymes won't be so high!

This is what the drug industry has wrought! They have no-one else to blame but themselves. In striving to add one more efficacy claim to their DTC ads and failing so dramatically, Merck and Schering-Plough may be in danger of losing many other customers like me.

But striving for additional profits and failing is not the real shame. Throughout this whole ordeal, these companies have tried to pull the wool over doctors' and patients' eyes by first hiding the data, then manipulating the data. When that failed, they had nothing to say to me, the consumer, except issue a press release!

Screw them! I've had enough already! "I'm as mad as hell, and I'm not going to take this anymore!"

Look Out for Sexier Cialis Ads -- Maybe Including Beaver!

Now that the FDA has approved Cialis for once daily use for the treatment of erectile dysfunction (ED; see Lilly press release), expect to see a twist to direct-to-consumer (DTC) ads for the drug: sexier late- night ads!

Lately, almost all ED drug ads -- especially Cialis and Levitra ads -- are focusing a lot more on the women in the ads. Not in any kind of prurient manner as yet, but showing them fairly jumping on their male companions' bones, if you know what I mean. They're acting like horny teenage girls! But it's still very sweet and loving.

ED ads have progressed from older celebrity male endorsers (eg, Bob Dole) to younger male actors only hinting at having a better sex life (Viagra's Joe commercials) to ads that include couples on the verge of having sex. Now, we are about to progress to the next level.

I just learned that Abelson-Taylor (AT) -- the agency that brought us Abe Lincoln and the beaver in the Rozerem ads (see "Rozerem Ads Dis Lincoln, Show Beaver") and Cialis' consumer agency of record -- may be developing a campaign "geared toward men who plan to have sex twice a week or more." This according to my Richard Meyer over at the World of DTC Marketing (see "Cialis to encourage more sex between couples").

AT -- as regular readers of Pharma Marketing Blog know -- is not my favorite ad agency, although they have won numerous awards and kudos from their advertising buddies for creating ads that "break through the clutter" (see here). The most famous AT DTC campaign, of course, are the Rozerem ads that feature Abe Lincoln and a beaver.

So, how can AT "break through" the current clutter of ED ads for once-daily Cialis? You just cannot have the same old doting women clinging to their men and attempting to guide them to the bedroom. That's the clutter right now. No, you have to go to the NEXT step -- women and men together in the bedroom or women wearing sexy Victoria's Secret-style lingerie or, better yet, both!

According to Lilly, "wholesale pricing for Cialis for once daily use will be comparable to Cialis for use as needed such that patients who currently use two or more pills per week of Cialis for use as needed should not experience higher treatment costs with Cialis for once daily use."

Given that marketing must be consistent with this pricing, any DTC campaign MUST appeal to men who want to have sex 2-3 times per week.

What kind of ED ad would appeal to these guys? Not the kind we've been seeing where couples are engaged in pre-coitus romancing. Guys who want sex 2-3 times per week don't have time for leisurely baths, going out to dinner or strolling down a country lane with their partners. They're not the mull cider types -- they want hard liquor and get drunk fast!

We already have Victoria Secret TV ads, sexual encounter pizza ads ("What do we do for the other 28 minutes"), and girl-on-girl mud-fight beer ads. Why not sexy ED drug ads?

I don't think, however, that there will be any "beaver" in the new Cialis ads. I just threw that in the title of this post to get your attention -- to break through the clutter as it were.

Join Me After Lunch for a Chat and Live Podcast about Getting Virtual Face Time with Physicians

Virtual Face Time with Physicians
A discussion with Asheesh Gupta, M.D., M.P.H., CEO and co-founder of eHyppo, an independent online health care community created by and for health care professionals.

Guest: Asheesh Gupta, M.D., M.P.H., CEO and co-founder, eHyppo

Live Podcast Date: Tuesday, January 15, 2008, 2 PM Eastern US time

Duration: Approx. 15-30 minutes

Go to the Pharma Marketing Talk Channel Page to listen live to the podcast on the Web with your browser. You will also be able to participate in an online chat with the host and speaker to ask questions!

More information here: http://www.talk.pharma-mkting.com/show040.htm

Should I Stop Taking Zetia?

After Merck & Co. and Schering-Plough Corp. admitted that Vytorin -- a combination of Zetia and Zocor (simvastatin) -- worked no better than an older, generic medication to reduce plaques in arteries, Dr. Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio, immediately called for a "moratorium" on the use of Vytorin and Zetia, according to a story on Bloomberg.com (see coverage here).

My question is this: Should I stop taking Zetia, which was prescribed to me by my cardiologist, who--although I respect his judgment--is no head of cardiology at a renowned medical center?

The problem is that I haven't heard from MY CARDIOLOGIST or MY FAMILY DOCTOR about whether or not I should continue to take Zetia. I guess I should call them.

But why is it that the my Volkswagen service center calls me soon after buying a new car, whereas I have never received a call from any doctor about service for my body?

I know that Nissen is not my doctor and is not giving individual medical advice to all those patients like me out there who are on Zetia or Vytorin and whose doctors are mum on the subject. Whether or not I should continue my medication depends upon my personal medical history that only me and my doctor can evaluate.

But where is my doctor? Why isn't he more pro-active? Why hasn't he contacted me a long time ago and either re-assured me about Zetia or told me to hold off until the ENHANCE study data were reported? Why didn't he tell me about the study a long time ago and what it might mean for ME personally? I know you will say that he should have and I should find a doctor who is more proactive. Hey, it may be possible to find one. But who has the time for all that due diligence and switching medical records around!

There's all kinds of cardiologists these days advising me what to do. There's Dr. Jarvik, for example. He's telling me that Lipitor is good for my cholesterol. Oh! Wait a minute! He's not REALLY a cardiologist. In fact, he doesn't even have a license to practice medicine at all (see Jarvik -- Lipitor spokesperson -- "outed" as an unlicensed physician!).

Then there's Dr. Nissen, who IS a practicing cardiologist. He's quoted all the time in the media. I respect his opinion although I know he's every pharmaceutical executive's worst nightmare.

I am sure there will be many more cardiologists weighing in with their opinions in media stories to come. But MY doctor probably won't be one of them.

Of course, I will be calling my cardiologist today and asking him about all this. I will report back to you when I hear something from him.

P.S. Don't worry about me. While my cholesterol is a bit high, I have recently passed my high-tech stress test, which cost my insurance company about $13,000 (thanks be to God that my wife has a real job with good benefits. My laid-off neighbor with 2 small children, however, is not so lucky.)

P.P.S. Since this blog is really all about pharmaceutical marketing, I should say something about how the ENHANCE trial failure may affect the advertising of Zetia and Vytorin.

Obviously, these brands are probably maintaining a low profile these days. I don't remember seeing the usual ads on TV last night. Perhaps the ads are being revamped in light of the ENHANCE trial news and will soon re-appear addressing the issues raised by the study's failure. But why weren't these damage-control ads rolled out IMMEDIATELY? Maybe it's best to say nothing to the public -- No way! Merck and Schering-Plough should have PSAs explaining their take on the situation and NOT just depend on issuing a press release!

What about the product web sites? Perhaps they have some information. I checked both www.zetia.com and www.vytorin.com -- both the patient and doctor sites -- and found NOTHING about the recent news. I looked in patient education areas where doctors are supposed to find information to hand out to their patients, I looked in the FAQ areas, the "Questions to Ask Your Doctor" areas, the "Studies" areas -- NO WHERE COULD I FIND A WORD ABOUT THIS!

That's a shame in my book. Shame on you Merck! Shame on you Schering-Plough! Shame on you MY DOCTOR!

Then they wonder why patients go to other sources on the Internet and other patients they do not even know on the Internet to find information they need about their medications!

Did Pfizer Run a Chantix "Bookend" Ad During 60 Minutes?

Last night, while watching 60 Minutes on CBS, there was an "NFL Today" playoff update break with James Brown.

As the spot came on, Brown first mentioned that the break was sponsored by CHANTIX, Pfizer's smoking cessation pill and program (see "A Pill, a Plan, a Profit? -- Chantix!"). He did NOT mention its indication, however. The CHANTIX logo was right next to him, very visible, fairly large, and near the center of the screen (see my representation at left).

After about 30 seconds of playoff scores came the ad, which was a "non-branded" Pfizer ad for the "My Time to Quit" web site (http://www.mytimetoquit.com).

My question is this: is the sequence [brand sponsorship message -- 30 seconds of show -- non-branded ad associated with the previously mentioned brand] a "Bookend Ad"?

FDA has issued guidance saying such ads violate their direct-to-consumer (DTC) ad regulations (see "Guidance for Industry: 'Help-Seeking' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms."

To answer my question, you first have to determine if the first sponsorship message is a "Reminder Ad" and if the second is a "Help-Seeking Ad," which are two types of ads defined by the FDA in its guidance.

In a Reminder Ad, a product name is mentioned but NOT the indication. According to the FDA, reminder ads are exempt from the requirements for adequate directions for use and adequate warnings (see more on this here).

A Help-Seeking Ad, on the other hand, discusses a particular disease or health condition, but does not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device (see here).

Neither a Reminder Ad nor a Help-Seeking Ad is subject to the requirements for the disclosure of risk information and other requirements under the Federal Food, Drug, and Cosmetic Act. But, as I mentioned above, when used in combination -- even with a short interval between them -- these ads would raise red flags at the FDA.

Letter vs. Spirit of the Law
Pfizer and many other drug companies have said that they will no longer run reminder ads on TV. I believe it is commonly-accepted among pharma advertising experts that sponsorship mentions of product names that include a prominent image of the brand name/logo are not technically reminder ads.

Also, an ad that encourages viewers to visit a Web site like www.mytimetoquit.com rather than a doctor for help in dealing with a specific medical condition may not technically be a Help-Seeking Ad.

Technically, therefore, Pfizer probably has not violated the letter of FDA law nor PhRMA Guidelines on DTC advertising. But did Pfizer violate the spirit of these laws and guidelines? Does it matter whether or not drug companies are spiritually aligned with these laws and guidelines?

What do you think?

FDA DTC Payola Out, You Pay In!

Recent changes to how FDA will be paid to review DTC TV ads forces us to ask: What's worse? Drug companies paying the FDA to preview TV ads for approval or you paying for it?

Instead of the FDA charging drug companies to review their ads, it will now get the money from US citizens. That's because the DTC User Fee Program authorized by the FDA Amendments Act in September, 2007 was replaced by the fiscal year 2008 omnibus appropriations legislation signed into law Dec. 26 by President Bush (read more about this here). This allocates $6.5 million for the review program for 2008. Unlike the User Fee Program, which would have guaranteed funding for the program for 5 years, there is now no guarantee that funds will be available in 2009 or thereafter.

In a previous post, I said that the User Fee Program funded by the industry was "pure payola" (see "PDUFA Payola!"). Obviously, Congress agreed:

"...user fees give the impression drug makers are buying FDA approval," according to a House staffer interviewed by the "Pink Sheet," an industry publication (July 23, 2007, p. 14).

Instead, you and I are now paying for the FDA to review the ads, which IMHO is better than having the industry pay for it.

Fate of the Get-Out-Jail-Free Card
Aside from the appearance of payola inherent in the User Fee Program, it also came with the guarantee that once the FDA "approved" an ad through the preview process, it could not request that the ad be discontinued if it later considered it violative (see "DTC Here to Stay; Pet Turtles Too!"). Now that you and I are paying for the previews, does this guarantee still stand? Or will the FDA be free to OK ads and later change its mind?

The approved PDUFA legislation, which hasn't been rescinded, states:

"(B) Upon the request of the applicant to be assessed a civil penalty, the Secretary, in determining the amount of a civil penalty, shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors: Whether the applicant submitted the advertisement for prereview if required under section 505(o)(5)(D)."

and...

"Subject to subparagraph (B), no applicant shall be required to pay a civil penalty under paragraph (1) if the applicant submitted the advertisement to the Secretary and disseminated such advertisement after incorporating any comment received from the Secretary."

I guess, therefore, that the industry still has its Get-Out-of-Jail-Free card and it doesn't even have to pay for it! Sweet!

BTW, my original estimate on how much it cost to review each ad was way off. I thought FDA might have to review about 3,000 ads for $6.5 million, which works out to about $2,000 per ad.

In fact, DDMAC received commitments from industry to submit 151 ads for review at a cost of $41,390 each. Whoa! That's about 2/3 of the median annual income of a US family of 4 ($60,298) or enough to support 2.28 US citizens for a whole year!

Yet, PhRMA suggests it will be difficult for FDA now to hire reviewers -- 27 FTEs planned, which works out to $240,000 per FTE -- because job security is not assured. I dunno. Seems there would be a few good people -- eg, recent college grads -- that would like that kind of money, job security be damned! Especially since it will look very good on their resumes when they go the pharmacetical industry following their 1-year stint! I'm sure drug companies would hire these people to get an insider's view of FDA's DTC ad review process.

Rozerem Deep Sea Diver Debuts in New Yorker Cartoon Contest

I was relaxing leafing through the latest New Yorker magazine while watching Extra on TV, when I came upon this week's New Yorker cartoon caption contest selection (on left).

This has GOT to be the biggest PR coup ever for Takeda's Rozerem marketing team! Obviously, that's the deep sea diver often seen in the background of those Rozerem ads featuring Abe Lincoln and the beaver (see "Rozerem Ads Dis Lincoln, Show Beaver").

I submitted the following caption on the official contest web page.

"He's the sleep-aid medication celebrity spokesperson who will explain the side effects to you while I play golf with the sales rep."

If you have a caption along similar lines, please submit it as a comment to this post. But be sure to also submit it to the New Yorker first, lest someone else submits it and wins. Don't worry; I can't rip you off -- only one entry per person or e-mail address is allowed.

Jarvik -- Lipitor spokesperson -- "outed" as an unlicensed physician!

Lately, I've been seeing a lot more of those Dr. Jarvik Lipitor ads on TV and in magazines. When the first version of these ads aired, I thought Jarvik looked like a "fop" because of his fastidious attire -- including a purple tie -- and swishy style (see "Lipitor's Jarvik: Fop or Flop?").


I didn't think this was an image that a successful practicing physician and especially heart specialist should have and wondered if Jarvik would flop as a credible DTC spokesperson for Lipitor.

As it turns out:

• The Jarvik ads were NOT a flop (although the jury is still out about Jarvik being a fop), and
• Jarvik is NOT a practicing physician.

It is the second point that I would like to focus on.

I learned yesterday that Jarvik never had a license in any state to practice medicine. This was revealed in a letter to Pfizer from the House Committee on Energy and Commerce, which is investigating the use of celebrity endorsements in DTC advertising (see "Congress Investigates Use of Dr. Jarvik in Lipitor Ads").

When the Jarvik ads first aired, he was touted as the first "real" doctor to be used in a drug ad -- as opposed to fake doctors like the one suggested by Mandy Patinkin (who played Dr. Jeffrey Geiger on CBS's Chicago Hope TV show) in the Crestor ads.

I and many other "experts" believed that Jarvik was a real doctor, which to me means that he has or once had patients that he treated. Bob Erhlich, Chairman of DTC Perspectives, also seems to have been fooled. He wrote in April, 2006:

"In their new Lipitor ad campaign Pfizer followed the trend of using a doctor. In fact, Pfizer decided to find a real doctor known for his heart expertise. His name is Robert Jarvik, inventor of the artificial heart."

I am not belittling the contribution Jarvik has made to medicine, but it does appear to me that the Lipitor ads are misleading consumers into believing that Jarvik is a doctor similar to the doctors they are used to seeing in real life -- one that treats patients and has experience with cholesterol medications. Why else would we believe him as an endorser of Lipitor?

The recent spate of Jarvik Lipitor ads may have been in anticipation of the letter from Congress "outing" him as an unlicensed physician. Or the increased visibility of the ads could have precipitated the letter from Congress.

Either way, it will be interesting to see if Pfizer puts the Jarvik DTC ads back into cold storage until this flap fizzles out or if it continues to air them defiantly. Keep in mind that this is an election year!

Promotion vs. R&Deja vu all over again!

It's deja vu all over again in the ongoing debate of R&D spending vs. promotional spending by the US pharmaceutical industry.

Critics are out again to "prove" that the industry spends much more on promotion than it does on R&D.

Back in 2004, I reviewed the book "The Truth About the Drug Companies: How They Deceive Us and What to do About It," in which the author Marcia Angell, MD, offered proof that R&D takes a back seat to promotion in the drug industry.

Now, there's a "new" study by two Canadian authors entitled "The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States," which was recently published in PLoS Medicine.

Their conclusion: The pharmaceutical industry spends almost twice as much on the marketing and promotion of drugs than on research and development (see the story here).

"For the last 50 years, say the authors, there has been an ongoing debate as to which image [see left] of the drug industry is most accurate. The industry promotes a vision of itself, say the authors, as 'research-driven, innovative, and life-saving,' but the industry's critics contend that the drug industry is based on 'market-driven profiteering.'"

To prove this, the authors use data from 2 different sources: IMS--recently reported to be laying off staff (see "IMS to Cut Jobs")--and CAM as shown in this table:


Is anyone troubled by the methodology of the authors?

I mean, what could be easier than cherry picking which data to use and to make sure to always use the highest estimate to prove your point, which you obviously believed was true before you even did the "analysis?" I know that certain countries have gone to war based on similar data cherry picking tactics, but to use such techniques to defame the pharmaceutical industry? That's a crime!

In essence, the authors place more value on the CAM data then on the IMS data. I'm not sure why, since both companies provide services for a fee to the pharmaceutical industry. The main difference between the two company's methodology is that IMS surveys the industry whereas CAM surveys doctors.

If you ask me, one methodology (IMS's) overestimates R&D costs and underestimates promotional costs, while the other (CAM's) is prone to exactly the opposite.

The biggest differences between the datasets involve cost of samples, cost of detailing, and "unmonitored promotion."

Cost of Samples
There is a large difference between the IMS (US$15.9 billion) and CAM (US$6.3 billion) estimates for cost of samples. Essentially, IMS bases its estimate on the retail value of samples, whereas CAM bases it on the Average Wholesale Price.

Which number would you use?

The PLoS authors use the IMS retail cost estimate because that is how the drug industry itself estimates the value of free samples it gives away! This is just another case where the industry shoots itself in the foot. It's hard to argue with the PLoS authors' statement that "it is inconsistent for donations to be reported in terms of retail value and samples in terms of wholesale value."

Cost of Detailing
The authors point out that "There is a significant discrepancy between the two sets of data in the cost of detailing: US$7.3 billion for IMS and US$20.4 billion for CAM."

IMS only considers the "cost to field the rep" and doesn't include in its estimate--as CAM does--indirect costs like costs for the area and regional managers, the cost of the training, and the cost of detail aids such as brochures and advertising material.

The authors claim that "relying on physician-generated data to estimate the amount spent on detailing [which is CAM's data collection method] is likely to give a more accurate figure than using figures generated by surveying firms [which is IMS's method]. Companies may not report some types of detailing, for example, the use of sales representatives for illegal off-label promotion, whereas doctors are not likely to distinguish between on- and off-label promotion and would report all encounters with sales representatives."

I dunno. If it were up to me, I would use a number somewhere in between the IMS and CAM estimate--say $10 billion.

"unmonitored promotion"
I am especially troubled by the $14.4 billion estimate for "unmonitored promotion." All that the PLoS authors have to say about this is:

"We believe that it is appropriate to correct for unmonitored promotion and that the figure we used is a reliable estimate. The 30% correction factor is based on a direct comparison that CAM is able to make between the data it collects through its surveys and the amount reported by companies."

May I say that this hardly rises to the level of objective analysis of available data? My analysis would completely discount this number as something that cannot be known and therefore should not be used. Besides, the same could be said for R&D spending and the two estimates would cancel one another.

My "NEW NEW" Estimate
Instead of the estimate of $57.5 billion that the PLoS authors use for promotional spending in the US, my NEW NEW estimate is $32.7 billion, which is pretty close to the $29.6 billion the PLoS authors use for the R&D estimate. This would lead me to conclude that--within the sampling margin of error, the US pharmaceutical industry spends about as much on R&D as it does on promotion. There! Everyone's happy!