Tuesday, March 29, 2005

John Mack Rebuffs Merck’s CEO Offer

Sources close to the situation say that John Mack, the 48-year-old President of VirSci Corporation and publisher of Pharma Marketing News, rebuffed an offer to run Merck & Co., the $23 billion pharmaceutical giant.

"I have other mountains to climb,”" said Mack, according to these sources.

When asked about the situation, Mr, Mack would not specifically comment on the Merck offer, but did say he planned to climb the 8,611m K2, the world’'s second highest mountain located on the border of Pakistan and China, in June.

"One Great Mountain is enough for me,”" said Mack. As an aside, he noted that K2 is much more of a challenge than Denali, a 20,000-foot peak in Alaska. “I understand that J.R. [Lodewijk J.R. de Vink, the former chairman, president and chief executive officer of the old Warner-Lambert Co.] will be climbing Denali at about the same time. Of course, he is much older than I am, so I think that mountain is appropriate for him.”

J.R. couldn't be reached for comment, but a report in today’s Wall Street Journal quoted him as saying "I am climbing Denali in the month of June. I'm not going to give that up for the Merck job." (“
Heavy Hitters Rebuff Overtures So Far to Run Ailing Merck,” WSJ, 3/29/2005).

"I think everybody views Merck as an extraordinary management challenge," said Richard Evans, an analyst at Sanford C. Bernstein. "Everyone's going to want to see a real athlete named to the job." (WSJ)

Finding an athlete who is not already committed to climbing another mountain, however, may not be easy. Fred Hassan, chief executive of Schering-Plough, for example, was once considered a possible successor to Mr. Gilmartin, Merck’s outgoing CEO. But he’ is booked to climb Kangchenjunga, the 8,586m Nepal peak, this fall.

Failing to attract alpha male mountain climbers, Merck is reaching out to female athletes with experience climbing lesser mountains. According to the Wall Street Journal, “Judy Lewent, Merck's 56-year-old finance chief and president of its human health business in Asia, is among the Merck insiders being considered.”

“Not to belittle her prowess,” quipped Mack, “but I know for a fact that Judy has only managed to climb the diminutive Wazespitze in Austria. I don'’t see how that makes her qualified for the job.”

Asked about an approach to Ms. Lewent, a Merck spokesman says, "The company doesn't comment on rumor and speculation."

Tuesday, March 22, 2005

DTC Straight Talk

According to an article in yesterday's
Wall Street Journal ("In Switch, J&J Gives Straight Talk"):
"Johnson & Johnson is unveiling a new approach to TV and print campaigns that deals head-on with safety, putting drug risks on more-equal footing with drug benefits."
The "new" approach shows a split screen with a doctor on one side and a woman patient on the other. While the patient seems enthusiastic ("I'm in!"), the physician counters with a "Let's talk" response and goes on to talk about risks. The product is the Ortho Evra birth-control patch and the ad is supposed to air for the first time later this month.
"The future of DTC advertising depends on its ability to inform, and the balance between persuasion and information is likely to shift towards information," said Mr. Pounder [chief executive and president of Alchemy, a unit of Interpublic Group of Cos., which produced the Evra campaign]. He wouldn't divulge details of focus-group tests for the new J&J ads, but said they were well-received and not off-putting, despite the frank talk about dangers.
I've always been a proponent of more information and education in DTC ads (see, for example,"Is DTC Educational or Motivational?") and I applaud this kind of approach to DTC.

It's interesting that the lead is coming from J&J, a pharmaceutical company with the most experience in consumer advertising -- it has been marketing health products like band aids and shampoo to consumers for decades. J&J has been admired by professionals in the industry for its consumer experience and operations, but is often disparaged within the industry as the least innovative with regard to R&D and the development of new products.

Instead of emulating the marketing techniques of packaged goods manufacturers with less of a pharmaceutical pedigree (e.g., Proctor and Gamble), traditional pharma companies should take the lead from J&J.

Drugs should NOT be marketed like packaged goods (see "Marketing Drugs Like Packaged Goods at the Super Bowl"). Drugs are serious products and require a doctor to close the sale. It makes perfect sense therefore to include doctors within the DTC ads to communicate risks.

Johnson & Johnson Chief Executive William Weldon said in an address to PhRMA: "I believe we should start by recognizing that the framework we call ‘DTC advertising’ may inadvertently minimize the importance and power of medicines and their risks. Our communication with patients should really be thought of as Direct to Consumer Education.”" -- "New PhRMA Leaders Discuss Future of the Industry, Need for More Public Education." He also said:
"If our industry is to retain the important right to talk directly to consumers [my emphasis], each of our companies in its own way must work to make DTC [direct to consumer] what it very definitely can be -- a way to educate and counsel consumers in improving their health."

What do you think? Take the Pharma Marketing News "DTC Straight Talk Survey."

* Will the rest of the pharma industry follow J&J's lead?
* Should they?
* Should all DTC ads be done this way?
* What impact will adding more risk information to DTC ads have on your business?

Click here to take this survey. You will be able to see a summary of the de-identified results immediately after completing the survey.

It's not likely that the industry will follow J&J and do the right thing on its own. The threat of stricter government regulation of DTC has brought the industry to a fork in the DTC road. One thing is certain: when they come to that fork in the road, they will take it. Either they do the right thing or they lose that "right" of which Mr. Weldon speaks. Only pressure from the government can force them to take the right fork.

The industry trade group, Pharmaceutical Research and Manufacturers of America, however, is rabidly opposed to any government regulation and tries to paint a horrible picture of government interfering in our healthcare:

"In that very profound human moment when we sit with our doctor and our principal caregiver to make a life or death decision on a medicine or surgical procedure, the last person anyone should want in that room is some federal bureaucrat telling us what we can or cannot choose. That is totally unacceptable for America and for the patients we serve." (Statement of Billy Tauzin, President and Chief Executive Officer, Pharmaceutical Research and Manufacturers of America, PhRMA Annual Meeting, Washington, DC.)

It's no secret, however, that the pharma industry supports the current Republican regime, which just passed a federal law that very much interferes with a single person's right to choose and put the government in the room in the most scary way imaginable.

Monday, March 21, 2005

Give Docs What They Want

Last week I attended a pharmaceutical industry conference focused on the problem of physician access or lack thereof by sales representatives. I heard a lot of advice from consultants as well as from physicians about how pharmaceutical companies need to change the number and kind of interactions between sales reps and physicians.

An article in this month's Pharma Marketing News, “Marketing’s Role in Limiting Physician Access and What to Do About It,” for example, offers useful insight on how marketing can help sales reps communicate more effectively with physicians. The expert consultant cited in that article, Mr. Jerry Acuff, says that physicians want better relationships with sales reps and he cited a study showing that physicians ranked friendliness higher than scientific knowledge.

Physicians in a keynote panel at the same meeting, however, emphasized that they value a rep’s product knowledge over the relationship with the rep. The panel moderator also cited a new, unpublished study that supported this preference (when asked “What do you like about sales reps?” respondents cited product knowledge first, relationship second, and samples third).

The docs on the panel worried that the impending downsizing of the pharma sales force (see “Cost-Cutting Strategies for the Pharmaceutical Industry”) will remove the highest paid and most knowledgeable reps and leave behind the younger, less knowledgeable ones and thus exacerbate the “dumb rep” problem.

What the docs want are pharma representatives that keep them informed, protect them from prescribing the wrong drug, talk to them without regulatory constraints, and keep them stocked with samples. O yeah, they also wanted someone who talks like they do. In other words, they want another health professional and not a sales person at all! I’ve heard the same from other doctors at other industry meetings (see, for example, “A Crisis in Professional Detailing”).

What if pharmaceutical companies actually listened to these physicians? Instead of talking about gaining “physician access” for sales reps, pharmaceutical companies might provide more access to the kind of representative physicians seem to want -- the medical science liaison or MSL. Except let’s drop the liaison part and just call them medical science representatives.

While I am not an expert on the current roles of MSLs and how often they are employed, I do sense a rivalry, let’s say, between sales and marketing and the medical sciences department. I have been to conferences and had lunch with pharma medical education people and heard a few things. MSLs play, at best, second fiddle to the sales reps. That situation should, IMHO, be turned on its head. The MSL should be the primary contact and call in the rep when the physician asks for samples. After all, sample delivery is the primary reason sales reps gain access to physicians anyway.

I think this idea could also save pharmaceutical companies money. A lot fewer MSLs would be needed than the current number of reps. Docs would be more eager to see MSLs and not make them wait in the office or turn them away. Less time would be spent on unproductive calls and each MSL could service many more docs than a sales rep. The sales rep’s time would also be better managed because the docs would request their visit for the samples. At that time, the rep can still make the pitch without having to explain the value of the product -- the MSL would have already done that.

This does not necessarily mean less of a role for marketers. There are many channels for physician marketing aside from the sales rep detail aid these days. As physician access by reps becomes more difficult, these other marketing channels offer better ROI. Maybe, at last, eMarketing might gain a foothold and provide further cost savings to pharma.

Or maybe not. It’s not easy turning the pharmaceutical sales and marketing juggernaut on its head. But the “game’s afoot,” as Sherlock Holmes never said. Cuts in pharma sales and marketing spending are underway. Whether or not structural changes also are afoot I cannot say.

NOTE: Most of the articles cited in this post can be found in the March 2005 issue of Pharma Marketing News. You can obtain a complimentary copy of that newsletter by clicking here.

Tuesday, March 08, 2005

"Ethnic Drugs" and "Genetic Marketing"

Last week the FDA issued a warning about Crestor -- the cholesterol-lowering drug marketed by AstraZeneca. Among other things, FDA specifically suggested that lower doses of Crestor should be prescribed for Asian-Americans.

"In a pharmacokinetic study involving a diverse population of Asians residing in the United States, rosuvastatin drug levels were found to be elevated approximately 2-fold compared with a Caucasian control group. As a result of these findings, the “Dosage and Administration” section of the label now states that the 5 mg dose of Crestor should be considered as the start dose for Asian patients and any increase in dose should take into consideration the increased drug exposure in this patient population." (See "FDA Public Health Advisory on Crestor (rosuvastatin)").
This is an interesting sidebar to the Crestor story.

You've Heard of Ethical Drugs, But What About Ethnic Drugs?

The Crestor Asian sidebar issue will no doubt add fuel to the debate about racial differences and "racially based drugs and treatments."

An article in the March 3, 2005 issue of
Christian Science Monitor explores the "place for race" in medicine:
"Ever since the fall of the Nazis, the world has tried to keep the biology of racial disparity under wraps. It has been acceptable to link racial differences to social and cultural factors. One race might underperform another because of upbringing or poverty. But suggesting biology as the cause for those differences - like 'The Bell Curve' did a decade ago when it looked at academic achievement - was strictly taboo.

"Now, a new and unexpected force - medicine - is pulling back the covers. By taking a close look at minute differences in people's genetic codes, researchers and drug companies are beginning to create racially based drugs and treatments.

"Given the prospect of targeting treatment, some scientists argue that the subject at least ought not to be taboo. Even if race eventually proves to be a crude and insufficient means of understanding genetic differences, it can play an important interim role, they say."

(See "A place for race in medicine?").
Whether or not race is a useful measure of genetic differences, pharmaceutical companies should not ignore the biological consequences of genetics in the development, testing and marketing of new drugs.

Traditionally the industry has focused on "blockbusters" and mass marketing in which one size fits all. Crestor is an example of perhaps the general rule -- mostly ignored until now -- that one size does NOT fit all. Not only does the same drug work differently in different people, but variations of a drug may be developed that are "targeted" or tailored to specific types of people based upon their genetic differences.

There has been much lip service paid to "targeted therapies" over the years (see, for example, "The New Branding Model: From Blockbusters to Targeted Therapies"), but very few drugs have been consciously developed to exploit genetic differences.

BiDil, which is expected to be approved for the treatment of congestive heart failure, has been cited as an "ethnic drug" in the
Christian Science Monitor article. An initial trial revealed "much data comparing the Caucasian and African-American responses." (see the presentation of the BiDil NDA before the EIGHTIETH MEETING OF THE CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE).

It turns out the BiDil wasn't especially effective in Caucasians, but was very successful in increasing survival rates among African-Americans suffering from congestive heart failure (see "First Heart Failure Study in African Americans Shows 43 Percent Improvement in Survival"). African American patients with heart failure experienced a 43 percent improvement in survival after taking BiDil in this study. The results were so stunning that the trial was halted so that all participants could continue the therapy. Results of this drug trial will be presented at the 6th Annual Multicultural Pharmaceutical Marketing, Media, & Public Relations.

The Japanese have long contended that approval of drugs for use in Japan requires specific trials with Japanese participants because, they claimed, the Japanese physiology was different. My impression was that this attitude was always regarded as prejudiced and unscientific by Western drug companies.
It is interesting to note that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved CRESTOR in Japan in December, 2004, at a dose range of 2.5-20 mg. According to an AstraZeneca Press Release, "The Council’s recommendation is contingent on final agreement of a post-marketing surveillance program. The recommended starting dose of 2.5 mg is in line with normal clinical practice in Japan where, compared to the western world, lower dose ranges of drugs, including statins, are made available."
Multicultural Marketing
If drugs are tailored to specific genetic profiles, how will they be marketed to the public? Depending upon the size of the targeted group, mass marketing techniques (e.g., DTC on network TV) might not be effective, or at least would be very wasteful. The only feasible method of segmenting the market is to use race and cultural differences to target specific groups of people whose genetic makeup fits the profile of the drug; i.e., multicultural marketing.

Once BiDil is approved, for example, the DTC ads undoubtedly will be specifically targeted to the African-American audience segment. Such audiences "self-segment" themselves by patronizing specific media channels, TV shows, publications, etc. The advertising dollars, I am sure, will be much welcomed by media that service this audience.

Multicultural marketing has always had a place in the pharmaceutical industry, which targets specific populations depending upon the drug's indication (e.g., diabetes and African-Americans--African Americans are twice as likely to have diabetes as white Americans of similar age; see Diabetes in African Americans).

Genetic Marketing
In the future, with more drugs tailored to individual genetic differences that are not necessarily based upon race or ethnicity, there will be a need for marketing techniques that go beyond multicultural marketing; i.e., "Genetic Marketing." Genetic Marketing would target specific individuals based upon their genetic profiles. That would be a whole other level of personalization!

Wednesday, March 02, 2005

Pharma Marketing Mensa Invitational

The Washington Post's Mensa Invitational once again asked readers to take any word from the dictionary, alter it by adding, subtracting, or changing one letter, and supply a new definition.

Here are some of this year's winners:

  • Bozone (n.): The substance surrounding stupid people that stops bright ideas from penetrating. The bozone layer, unfortunately, shows little sign of breaking down in the near future.
  • Sarchasm: The gulf between the author of sarcastic wit and the person who doesn't get it.

  • Osteopornosis: A degenerate disease.

  • Karmageddon: It's like, when everybody is sending off all these really bad vibes, right? And then, like, the Earth explodes and it's like, a serious bummer.

  • Ignoranus: A person who's both stupid and an asshole.

You can see all the winners at the George W. Bush "Officious Forum."

I thought it would be fun to try and come up with with some pharma related terms. The best I could come with was:
  • Adhorence: the deep hatred of advertising (compare to adherence).
I then asked members of the Pharma Marketing Online Discussion Forum to come up with some more. Here's what they submitted so far:

DTP: Direct to Plaintiff -- the art and science of creating plaintiffs with puffery enticing them to try dangerous drugs they would be better off without.(Submitted by Terry Nugent). James Gardner submitted DTC : Direct-to-Courthouse, which doesn't follow the rules, but what the heck!

Relationslip Marketing: Establishing an initial connection with a consumer and then never doing anything meaningful with it.
(Submitted by David Reim). Compare to Relationship Marketing.

Derail Aid: A tool to confuse physicians. (Submitted by David Reim). Compare to Detail Aid.

Charmaceutical: An SSRI taken by someone who thinks they have a genuine diagnosis, but in reality are simply unpleasant. (Submitted by Paul McNiven).

Byotech: A small, specialty pharmaceutical company whose stock rises paradoxically whenever they announce failed clinical trials
. (Submitted by Paul McNiven).

Contrasindication: A DTC ad deliberately designed to generate controversy, so as to get aired on cable news 10 times for every paid slot
. (Submitted by Paul McNiven). How about this variant: Controindication? Compare to contraindication.

Salety Study: Which proves that the drug is worth selling, whether safe or not. (Submitted by Sanjay Virmani).

Generich Companies: Which make plenty of $ with somebody else's innovations.
(Submitted by Sanjay Virmani).

Phate III: Which concludes that the drug can be sold, the fate of a certain % of the target population being left to a higher power.
(Submitted by Sanjay Virmani).

Pharmasuitickle: An overall pleasant tingling a personal trial attorney gets when contacted by a former Vioxx patient.
(Submitted by Jim Weidert). I think Jim stretched the rules a bit there. How about this variant: Pharmasuitical?

Complieance: what patients tell their doctors about whether they are taking their pills. (Submitted by Matthew Holt).

CEA: A term used to describe a ranking officer whose public utterances remind one of a pejorative or disdainful reference to a bodily part normally used to express intense disagreement with another's expressed opinion. (Submitted by Harry Sweeney).

Antibositics: Therapies undertaken to antagonise bosses' criticism. (Submitted by Kamran Shamsi).

Adverstising - The fine art of promoting adverse reactions through the use of realistic images of afflicted patients to target audiences consisting of physicians and consumers in a repulsive, yet memorable fashion. (Submitted by Mario Nacinovich).

That's all for now. Feel free to add your own as a comment to this post.

Tuesday, March 01, 2005

DTC Laissez-faire: A Bankrupt Policy

Some experts are worried that the recent COX-2 FDA advisory committee vote to ban direct-to-consumer (DTC) advertising of COX-2 drugs is a harbinger of stricter DTC regulation by the FDA across the board.

Every few years it seems the FDA is motivated to come up with new regulations for DTC advertising. In February 2004, for example, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. This included guidance concerning the acceptable alternatives to the lengthy, detailed, and technically-written brief summary of risk information for consumer-directed print advertisements for prescription drugs. The industry breathed easier after seeing the guidances issued because they expected much worse (see "FDA Draft Guidance for Print DTCA: Less than Feared").

Do pharma marketers have more to fear this time around?

The Vioxx debacle is seen by many as a turning point for DTC advertising (see, for example, an article in Sunday's San Francisco Chronicle "HARD SELL: HOW MARKETING DRIVES THE PHARMACEUTICAL INDUSTRY: The side effects of drug promotion"). Several members of Congress and industry critics are calling for FDA reform. Even most pharmaceutical marketing executives agree that some kind of reform is necessary (see the latest results of a Pharma Marketing News poll summarized in the article "Does the FDA Need to be Overhauled?"). Who knows, reforms may lead to new FDA powers to limit or ban DTC.

Defenders of DTC laissez-faire posit that many beneficial and powerful drugs (e.g., statins that treat high cholesterol, cancer drugs, and anti-depressants) have serious side effects, yet they are allowed to be advertised. If FDA restricts one category of drugs, what's to stop them from restricting all? It's the classic slippery slope argument.

The "better solution," some experts say, is to "explain risk in DTC ads in an understandable way using realistic odds of occurrence." (I should mention that these "experts" are not unbiased but have substantial financial interests in the continuance of DTC as is; in fact, they would rather see more DTC, not less.)

Let me argue against this solution. At least let me suggest that it is not the only better solution (there may be others) and that it may not be a solution at all!

There are Other Solutions
First, there are other solutions such as the one I suggested about banning DTC advertising of newly-approved drugs until the risks are better known through required post-approval surveillance (see "How the FDA Can Fix DTC").

When Vioxx came on the market and was heavily advertised to the public, its risks were not known (or the risks were covered up by Merck, see "Who Should Pay for Merck's Obstructionism?"). So the ads had no risk to communicate even as thousands of people taking Vioxx may have been dying from side effects.
As reported in the SF Chronicle article cited above: "The way it used to be, if a drug got approval, its use would increase gradually over time,'' said Kessler, who is dean of the UCSF School of Medicine. Thus, when unexpected side effects surfaced, he said, relatively few people had been exposed to the risk.

In recent years, though, new medicines explode into widespread use before they build up a safety track record, said Kessler, who prevented the widespread use of drug commercials on television when he was FDA commissioner. "Many more people are going to be exposed. That's the nightmare.''
Banning DTC -- even in the limited fashion that I suggest -- is probably not something the FDA can do. It can make it very hard to do DTC and put pressure on drug companies to voluntarily stop DTC advertising (as it did with Pfizer). But it would take additional authority for the FDA to actually ban DTC.

AN ASIDE: I note with interest an opinion piece ("Dose of caution for new cures") by Michael Castleman, a San Francisco medical journalist, who suggested a "probationary drug approval" scheme similar to the reform I suggested back in January ("How the FDA Can Fix DTC"). "The FDA could institute two-tier approval," says Castleman. "Initially, new drugs could be granted probationary approval, meaning that they look safe and effective based on studies involving a few thousand users. But final approval would have to wait for, say, five years. That's enough time for a clearer cost-benefit picture to emerge. Currently, nearly all drug recalls take place within five years of approval."

Given the limited patent life of new drugs, five years without advertising is a long time. My scheme calls for extending the patent life of drugs to make up for this lost time and to give drug companies an incentive to support the post-approval surveillance studies that will be necessary to determine risks, if any.

Communicating Risk in DTC is Not a Solution
My second criticism of the communicate risk solution is that communicating risk in a 30-second or 1-minute TV ad is a tricky proposition at best (see "Can Drug Ads Communicate Risk?" and "Numbers, Math and Communicating Risk").

In the current conservative, so-called "ownership" political environment, we consumers are being asked to assume more and more risk while the government is being phased out of the consumer-protection business. However, I don't think consumers are ready to go it alone to determine their drug side effect risk profile. The information they need can't be easily communicated in an unbiased fashion and even if it could, consumers are not mathematically trained to evaluate the risk.

I tested this out on subscribers to Pharma Marketing News, the vast majority of whom are college-educated pharmaceutical experts. I asked them to take a Clinical Trials Brain Teaser, which was based upon a recent article published in the press (I won't reveal the source because I want you to try the math).

So far, out of a dozen responses, none got the mathematically correct answer and only 2 (17%) were close (but no cigar)! If these people cannot calculate risk, how can you expect your mom to do it?

Of course, you do not have to be a math whiz to determine if the risk of a drug is worth the benefit to you. But who should you depend upon to communicate risk to you -- mathematically or not? Should it be DTC advertisers who have a financial interest in the success of the drug? Should it be the FDA with its ties to the drug industry? Should it be your physician? I would vote for the latter, but with the caveat that the physician not be beholden to the drug company selling the product. But that's a sub-topic of another post (see "FDA Advisory Panels: Elephants in the Room").
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