How to Piss Off KOLs

Key Opinion Leaders -- or KOLs as they are known by pharmaceutical marketers -- are physicians who influence their peers' medical practice, including but not limited to prescribing behavior. Pharmaceutical companies generally engage key opinion leaders early in the drug development process to provide advocacy activity and key marketing feedback.

Pharma companies devote considerable time and money cultivating KOLs, often treating them to dinner meetings and hiring them as paid consultants (see "Gifts That Keep on Giving"). In fact, a whole cadre of pharma employees -- called Medical Science Liaisons or MSLs -- are in charge of the care and feeding of KOLs.

It is a rare thing, therefore, for a pharmaceutical company to piss off KOLs they have employed as advisors, yet this is exactly what J&J may have done.

The Wall Street Journal reports that J&J has dragged its feet launching a study to test the safety of its "controversial" heart-failure drug Natrecor (see "Critics Assail J&J For Delaying A Safety Study" -- subscription required). This may be one of those FDA required "post marketing" studies that are stuck in "pending" limbo (see "Spinning Bad News about FDA & Drug Safety"). [Actually, I see from the WSJ article that the FDA hasn't even asked J&J to do the study. So much for the FDA's willingness, not to mention capability, to ensure the safety of our drug supply!]

Bad enough that J&J has been dragging its feet for a whole year -- "There are just a couple of details that we're putting the finishing touches on," said Roger Mills, vice president of medical affairs at Scios, the J&J unit that makes Natrecor -- but J&J has pissed off a panel of influential cardiologists (ie, KOLs) it convened. The panel "urged the company to proceed with a follow-up study to resolve the matter."

I think no one on the panel imagined that the recommendation would be followed by silence for a year," said Milton Packer, a member of the advisory committee and professor at University of Texas Southwestern Medical School in Dallas. "It's an unacceptably long period of time."

Discussing J&J's handling of Natrecor in a recent talk to blood-pressure specialists in New York, Dr. Nissen [an influential cardiologist at the Cleveland Clinic who opposed the drug as a member of the expert panel that advised the Food and Drug Administration on the drug's approval five years ago.] said: "After the incredibly good fortune of gaining approval of nesiritide with marginal efficacy and safety data, what did its manufacturer do? Did they design and launch a large, well-powered morbidity and mortality trial? No." Instead, he said, the company aggressively marketed Natrecor without performing the research that would settle questions about the drug.

I imagine the poor MSLs at J&J charged with the handling of cardiologist KOLs are not having a good time over this.

These days, MSLs are asked to contribute more to the bottom line of companies (see, for example, "The Changing World of MSLs: Determining Value"). What's the value of a KOL that is turned from a friend into a foe? That's got to be some huge negative number! KOLs sit at the top of a pyramid of physician influence:

The classic Pyramid of Influence is a power-based model, in which most key opinion leaders sit atop the pyramid by dint of their organizational (sometimes academic) position and strength. They are usually perceived to be worldwide influencers who do the most research and writing, and in turn, influence national, regional, and local clinical leaders. In this model, their influence runs downhill and in many instances, it is still how MSLs perceive the KOLs with whom they need to cultivate relationships. [From The Changing World of MSLs: Determining Value]

Although a KOL may not write very many scripts, each KOL influences the script writing of hundreds of high prescribers. It doesn't pay, therefore, to piss them off.

FDA Gets a "C" from the Public

Seems like a lot of Harris/Wall Street Journal polls are crossing my path lately (see, for example, "Doing a Good Job but Still No Respect!"). The latest one, about the public's rating of the job FDA is doing, was reported yesterday in the Wall Street Journal (see "Americans Growing Less Confident In FDA's Job on Safety, Poll Shows").

In 2 short years -- between 2004 and 2006 -- the public flipped from positive to negative on its perception of how well the FDA is doing to ensure the safety as well as efficacy of new prescription drugs (see chart).



This reversal of fortune might be easily explained: Vioxx happened and the FDA was publicly raked over the coals for a time by the Senate and the press. The latest rake was by the Government Accountabiliy Office (see "Spinning Bad News about FDA & Drug Safety")

The FDA, however, proved resilient and shrugged off making any real changes to shore up its oversight of drug safety. First, it quietly scrapped its plans for a "Drug Watch" web site, which would have kept the public up to date on "Emerging Drug Safety Information."

It also started cranking out more "Warning Letters" to manufacturers. In the first quarter of 2006, for example, the FDA issued 6 such letters (see Table complied by EyeOnFDA). If this rate continues, there will be 24 such letters issued this year compared to about 19 last year. Interestingly, every warning letter cites "omission" or "minimalization" of risk information as an infraction.

[If you want to keep track of warning letters written and other issues related to the FDA, I highly recommend the Eye on FDA Blog.]

While the FDA issues record numbers of warning letters about omission of risk information in drug promotions, the advertising industry calls upon the FDA to change its regulations so that even less specific risk information need appear in ads (see "DTC Without the Risk"). You can read a very interesting dialogue about this in the March 2006 issue of Pharma Marketing News (available for a limited time).

94% of respondents to the poll said it was very or somewhat important (75% said "very important") to them to have access to "Complete information about the safety issues associated with prescription drugs." Organizations like the Coalition for Healthcare Communication would say that the public has enough access to this information from a variety of sources and there is no need for DTC advertising to be burdened with it.

BTW, FDA Warning Letters are like closing the barn door after the cows have already left. The offending ads have already run and the promotional pieces have already been printed and mailed. The letters are addressed to the companies' CEOs as if that would make a bigger impression! The CEOs probably treat FDA letters much like the CEO of Sepracor treated my letter about his company's violation of the PhRMA DTC guidelines -- they basically ignore them! Oh yeah, they may mention in passing to the product manager: "Bad boy! Now stop that."

Politics
The poll also revealed that most people feel that the FDA are influenced more by politics than by science. 82% felt the FDA was greatly or to some extent influence more by politics. More declared Democrats felt this way than Republicans (87% vs 77%).

THIS JUST IN: Poltics undoubtedly was involved in the decision by the FDA (or should I say by the then FDA acting commissioner Lester Crawford) to withold approval of Plan B (see "Plan B FDAgate"). Also see "FDA chief took over Plan B." Testimony from FDA officials claerly indicate that politics more than science were involved.

What it Means for Pharma
Pharma needs to do a better job communicating risk information in DTC advertising and encourage and help the FDA frame guidelines/regulations for doing this. It should resist the suggestions from ad agencies to limit the communication of risk information in ads. Agencies are more concerned about crimping their creative style than in creating effective patient communications. IMHO.

Doing a Good Job but Still No Respect!

The late, great comedian Rodney Dangerfield made the phrase "I get no respect" his trademark. Some pharmaceutical executives these days have embraced the Rodney Dangerfield shtick. Henry McKinnell, Pfizer's CEO, for example, once commented that "we cure heart attacks and strokes and cancer, but we can't get any respect." (See "Can't Get Any Respect!")

I got a hearty laugh out of that one! I did not know that heart attacks, strokes, and cancer were cured! Where was I when this was happening? Imagine if such claims were made in Lipitor ads!

Never mind, though, I know what he means. McKinnell was lamenting the "sinking standing" of pharmaceutical companies in opinion polls.

Recently, however, pharmaceutical executives are pointing to polls, such as the Harris Poll, which purport to show the industry is becoming less unpopular (see "Pharma Industry Less Unpopular"). Some executives are even attributing the reversal to their own inspired PR campaigns (e.g. Merck and GSK).

The Harris Poll asked respondents if they think the pharmaceutical industry is generally doing a good job serving their customers. The percent who said "Yes" has risen the last 2 years.

Yet, another Harris Poll -- the Wall Street Journal Online/Harris Interactive Health Care Poll -- paints a different picture. This poll asked a different question; namely, How much do respondents trust the pharmaceutical industry to do the right thing for the health care of those whom they have a responsibility for. The percent answering "Yes" to that question is at an all-time low of 9%.

[This number was quoted to me by Peter Rost, an industry critic, in an interview I did for the May issue of Pharma Marketing News. I have not been able to find that data myself, but I did find the data from the 2004 poll, which showed that only 14% of respondents trust the pharma industry "a lot."]

In other words, consumers think the industry is doing a good job, but that it can't be trusted!

Doing a good job means delivering products that work and at competitive prices without gouging the public. Until the implementation of Medicare Part D consumers were not so impressed with pharma'’s handling of the price part of the job. This, I believe is why the industry'’s job rating is up right now -- Part D has relieved some of the pressure on pharma regarding the cost of Rx drugs.

Doing a good job is also tangible -- it can be measured in terms of sales and profits, which are at record levels for the pharmaceutical industry. You can't argue with success.

Trust, however, is intangible and is seemingly not linked to sales and profits. So why worry about it? As long as the bottom line is healthy, not many pharmaceutical executives may worry about it. But I think this is a mistake.

The less consumers trust the drug industry to do the right thing, the more pressure there will be to increase regulations and pass laws impeding the industry's business practices. We are already seeing this happen. A third Harris Poll (November. 2005) reveals that "Majorities of U.S. Adults Think Oil Companies and Pharmaceuticals Should Be More Regulated." In 2005, 51% of respondents thought the industry should be more regulated. Pharma is second behind oil companies, which 55% of respondents thought should be more regulated.

Eventually, this will affect the bottom line.

It does not serve the industry well to focus always on the good news (e.g., Harris Poll #1) while downplaying the bad (e.g., Harris Poll #2 and #3).

[P.S. Aside from McKinnell's "I get no respect" joke, perhaps there are others out there that readers of this blog would like to make up? Imagine the CEO of a Big Pharma company doing standup at the LA Improv on open mike night. Something like: "We pharma people get no respect. Why just the other day I was talking to my stock broker and he told me to sell my company stock short!" or "I get no respect. On Mother's Day I gave my mom flowers while visiting her at the nursing home. She asked for a lifetime supply of Boniva instead!" That kind of thing, only funnier!]

More Reminder Ad Sightings

Reports of the demise of pharmaceutical "reminder ads" (eg, "Reminder Ads - Pharma's Dodo?") have been greatly exaggerated.

Since PhRMA's Guiding Principles for Direct to Consumer Advertising became effective in January, 2006, there have been several sightings of reminder ads on TV. The latest such sightings involve Lunesta (see "Wake Up PhRMA! or Tilting at Windmills").

"Guiding Principle" #10 for Direct-to-Consumer Advertising states:

"DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised."

But this and other PhRMA principles do NOT apply to other advertising channels such as the Internet and, it now seems, outdoor billboards.

An anonymous Pharma Marketing Blog volunteer "DTC Stalker" found a misbehaving Levitra outdoor ad over the entrance to one of the most heavily trafficked sites in the world: Penn Station/Madison Square Garden in New York City. Our operative whipped out his camera-equipped cell phone and sent in the following photo to document the sighting:




Shift in Pharma Ad Budgets, Not Type of Ad
Many pharma advertising gurus have suggested that PhRMA's DTC guidelines would mean less spending by pharma on TV and the transfer of money from that budget to other channels -- especially the Internet and direct mail. Many of us thought that would be good because these channels offer more targeted, information-rich messages.

Not too many experts, however, suggested a windfall for outdoor advertising, which is even less targeted and information-rich than TV! More importantly, however, we did not think pharma advertisers would use their TV reminder ad budgets to continue saturating the market with these ads in other venues!

Where's the Education?
While Penn Station may not get as many visitors per day as the Yahoo! home page, this ad is equivalent to a banner ad on the Internet, EXCEPT there is no clickthrough to bring you to the "educational" information PhRMA says that DTC can provide:

"We know that DTC communications can be a powerful tool for reaching and educating millions of people, and we are committed to ensuring that our DTC communications provide accurate, accessible and useful health information to patients and consumers. DTC advertising of such important and powerful products as prescription drugs should be responsibly designed to achieve these goals and to encourage the appropriate use of these products." -- PhRMA DTC Guiding Principles [my emphasis]

The Levitra ad certainly is not educational, does not provide useful health information, and is not responsibly designed to achieve any other purpose than brand recognition. As advertising, it is no better and no worse than an ad for Coca-Cola or Pepsi!

Bayer, one of the marketers of Levitra, is a signatory to PhRMA's Guiding Principles and, like all pharma companies who signed on, made a big deal of it and had their highest ranking executives make "sound-bite" commitments, which in light of these reminder ad sightings that violate the letter or spirit of the guidelines, ring hollow indeed. Arthur Higgins, Chairman of Bayer HealthCare's Executive Committee and member of the PhRMA Board of Directors, said the following:

"These guidelines will help DTC better promote disease state awareness, provide consumers broad access to important and accurate health information -- including the benefits and risks of medicines -- and encourage important discussions between physicians and their patients."

The Levitra ad outside of Penn Station does none of that!

Mister Higgins, tear down this ad!

Proper Pharma Use of Rx Data

Yesterday I posted a critique of an article in the May 2006 issue of the venerable Pharmaceutical Executive Magazine, affectionately known as PE to its loyal readers, of whom I consider myself one (see "Specious Arguments in Favor of Rx Data Use").

In response to that post, Terry Nugent, a very knowledgeable member of the PHARMA-MKTING online discussion group, had this to say:

"John, I think you are a bit rough on AMA and IMS. In fact, prescribing data does accomplish much of what the authors claim. I speak from first hand experience. The data to target high prescribers for CME, trials, etc.

"The PE document includes talking points designed to appeal to various
constituencies, most notably legislators Thus it is always part of the proces to bring in public interest arguments. While they may not be compelling to industry insiders, they are useful for friendly politicians to derail ill-advised regulation.AMA usually vets these arguments rigorously so that they are defensible in such debates. Sometimes the sheer number of arguments is helpful.

"If Rxdata is banned, marketing costs will increase. You are ight that they could be lower now if the industry used the data wisely."

Terry points out some good uses that physician Rx data could be put to by pharma. Unfortunately, the authors of the PE article do not mention these at all, which just proves my point that the arguments they do make were specious.

But Terry points out perhaps the REAL reason why the authors make the arguments they do -- to promulgate "talking points" that can be used to arm friendly politicians who can help fight pharma's battles. In other words, the PE article is merely a lobbying effort.

Not that there's inherently anything wrong with providing this kind of information to friendly politicians who we need to keep bad laws at bay.

But is a venerable publication like PE merely a vessel for communicating PR/lobbying "talking points?" PE does have a section for news and analysis, including opinion pieces where talking points are presented all the time. The remainder of the publication, I thought, is supposed to be devoted to articles that inform and educate pharmaceutical executives. I don't think mere talking points are helpful in that context.

Pharma's use of physician Rx data deserves a more informative analysis that could help pharmaceutical executives understand better the concerns of their clients so that they will better be able to explain to these clients what's at stake. This should be the role of a publication like PE.

Where's the Dialogue?
Pharmaceutical executives these days seem overly concerned with circling the wagons and with confronting their political adversaries. Publications like PE are becoming tools for that battle. In the meantime, physicians, not getting any satisfaction with direct dialog with pharmaceutical companies, are becoming antagonists and going to their societies to change laws.

What's Your Opinion?
Take the following survey, which solicits your opinion on the benefits of pharma access to prescribing information, physicians ability to opt-out, and appropriate uses of Rx data by pharmaceutical companies.

Click here to take this survey.

Survey Results:

• After completing the survey you will be able to see a summary of results (de-identified, excludes open-ended responses and comments that may identify the respondent). You can also use filters to examine results from different subsets of respondents (e.g., pharma company employees vs. non-pharma people, etc.).

Specious Arguments in Favor of Rx Data Use

IMS Health -- the company that sells physician prescribing data to pharmaceutical companies -- is working overtime these days to stem the rising tide against the use of physician prescribing data for pharmaceutical marketing purposes. New Hampshire, for example, has just passed a bill to make the sale of physician prescribing data illegal for marketing purposes (see "Who's Data Is it Anyway?").

To combat further erosion of their business, IMS has teamed up with the AMA to write a Pharmaceutical Executive Magazine article extolling the virtues of the AMA's Prescribing Data Restriction Program (PDRP). You can download the article ("More Than a Game of Keep-Away") here.

The article states flatly:

"If the industry cannot police itself effectively, state legislatures are likely to pass laws banning reps'’ access to prescriber data. Legislation has been introduced in several states this year, but the prospect of the PDRP program has stalled most of the bills. Only effective self-regulation can keep such laws off the books."

I have no beef with that goal. I do believe, however, that the authors (Hunkler is Director of Professional Relations at IMS and Musacchio is CIO at AMA) are not presenting the best arguments to support their case. In fact, some of their arguments may be counterproductive and at least one is laughable.

As I have said elsewhere, physician prescribing data can be useful to target specific promotions to physicians and offer them more relevant information and thereby improve pharma-physician relationships. Considering the poor state of this relationship, I believe this argument is a sufficient defense of the use of Rx data for marketing (assuming, however, that the data is actually used that way).

The authors of the PE paper, however, go much further. I think they go too far, in fact. They argue, for example, that use of Rx data by pharma actually LOWERS healthcare costs!

"Opponents of prescribing data have argued, erroneously, that using prescribing data to support pharmaceutical sales and marketing somehow burdens the healthcare system with additional cost. The facts suggest just the opposite. Prescribing data allow pharmaceutical promotion to be relevant and specific, making the whole process more cost-effective (and sparing physicians from being bombarded with extraneous promotional materials and sales calls)."

I don't know who has said that use of prescribing data by pharma for marketing purposes burdens the healthcare system. Yes, there are those people who say that pharmaceutical marketing, in general, increases drug costs, but that's a different issue. Nevertheless, by using this argument, the authors admit that "bombarding" physicians with "extraneous promotional materials and sales calls" adds cost to the healthcare system!

To accept the authors' argument, you have to believe that high-prescribing physicians are visited LESS by pharma reps and this just isn't generally true. Much of pharmaceutical marketing is aimed at "high decile" physicians. Of course, it may not be marketing originating from the brand that the physician prescribes frequently. Generally, if a physician is a high prescriber of drug X, then competitor drug Y's sales reps will set upon him/her like flies on dung. Also, I'm not so sure that drug X salespeople ignore these high prescribers.

Another argument in favor of pharma use of Rx data the authors of the PE paper make is that it allows pharma companies to more quickly notify physicians of product recalls.

"[Physician prescribing data can] Help prioritize the release of public safety news alerts Based on physician prescribing details, companies can identify which physicians need to be contacted first in the event of a newly identified side effect or a product recall."

PhRMA makes a similar argument:

"Foreclosing all access to prescribing data could also hamper manufacturers' ability to alert physicians of important new information about medicines in a timely fashion." See "PhRMA Statement on New Hampshire Prescribing Data Legislation."

Yes, prescribing data could be used that way and it could make drug safety surveillance much more efficient. Unfortunately, the information is not used that way. Pharmaceutical companies notoriously engage in non-targeted physician marketing (see, for example, "A Crisis in Professional Detailing"), so why would they be any better when it comes to notifying physicians of problems with their drugs? The best they can do is send "Dear Doctor" letters to ALL physicians who may (or may not) prescribe their drugs. In fact, this is what the FDA requires!

The PE article authors also argue that physician prescribing data can:

"Give physicians a unique view of their own practice HIOs [ie, IMS and companies like them] are piloting information products to physicians (as recommended in the 2004 AMA board report) that can reveal important facts about a physician's own practice: the degree to which patients comply and persist with treatment, patients'’ use of generics, and how the physician'’s prescribing practices compare with those of his or her peers. The data can also be used to provide valuable information for pay-for-performance systems that drive improved clinical practices."

This is true, but irrelevant to the case of use of Rx data by pharma companies for marketing purposes (the NH law, for example, would not prohibit use of Rx data for these purposes).

Use of Rx data to measure physician performance and pay for that performance is a whole 'nuther can of worms that IMS should have been smart enough to leave unopened! Physicians hate HMOs and performance measures probably more than they hate pharma marketers. This issue, in fact, is one which aligns pharma and physician interests -- pharma is leery of evidence-based performance measures because they could hurt sales of their expensive drugs, which may be no more effective than generics. IMS and AMA, by using this argument, are not doing the industry any favors nor does it help the industry build better relations with its physician customers.

OK. Those were the unproductive arguments. Here's the laughable argument:

"...what is not widely known is that the pharmaceutical industry's commercial interest in the data ultimately makes possible a variety of other research applications. The industry underwrites the substantial costs that HIOs incur when collecting and processing the information. Without this support, the data would not exist for use in:

• Evidence-based drug safety studies
• Public health monitoring to set and promote public health policy
• Outcome studies and pharmacoeconomic analyses that look at value vs. cost
• Bioterrorism surveillance
• Development of clinical practice guidelines
• Disease management programs
• Analysis of changes in government healthcare programs (e.g., the uptake of Medicare Part D coverage)."

OMG! The whole healthcare system would come tumbling down! If the pharma industry is the only payer for these data, then we are surely going to Hades! Where's government? Where's the insurance companies? Isn't their money any good? What is IMS saying? That it overcharges the pharma companies to subsidize giving away this information to the government and insurance companies? And the pharma industry has never crowed about this and taken credit for it? What's up with that PhRMA?

My conclusion: The cafeteria of arguments IMS and AMA offer against limiting use of Rx data for marketing purposes goes beyond the real issue (marketing) and is more self-serving than it serves the pharmaceutical industry.

What's Your Opinion?
Take the following survey, which solicits your opinion on the benefits of pharma access to prescribing information, physicians ability to opt-out, and appropriate uses of Rx data by pharmaceutical companies.

Click here to take this survey.

Survey Results:

• After completing the survey you will be able to see a summary of results (de-identified, excludes open-ended responses and comments that may identify the respondent). You can also use filters to examine results from different subsets of respondents (e.g., pharma company employees vs. non-pharma people, etc.).

Why Drug Companies Promote Off-Label

Recently, the Archives of Internal Medicine published an article about the off-label prescribing of drugs by physicians (see "Off-label Prescribing Among Office-Based Physicians"). Here's the data:

In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (P<.05), few other drug characteristics predicted off-label prescription.

According to an article is USA Today ("Study: Off-label drugs often prescribed"), the authors were not sure why certain drugs were prescribed more often than others:

It's not clear why some drugs and types of drugs were more likely to be prescribed for unsupported off-label uses than others. The age of the drug, direct-to-consumer advertising or the company that made it made little difference, researchers said.

One explanation might be that "both physicians and patients have misunderstood the role of the FDA," Stafford says. "I think there's sort of a presumption that if a drug has made it onto the market, the FDA has vouched for its safety and efficacy for all of its potential uses."

Market Influence on Off-Label Prescribing
Too bad the authors didn't consider the influence of the market on off-label prescribing -- especially when the market is smaller than the one anticipated by the marketers.

Take for example, the case of Lilly's drug Evista, which is approved by the FDA for the prevention and treatment of osteoporosis in post-menopausal women. Back in December, I posted information about the case that the DOJ brought against Lilly for the illegal off-label promotion of this drug (see "Lilly's Off-Label Promo Shenanigans"). In that case, to which Lilly pleaded guilty, Lilly was pressured to promote off-label use of Evista because the on-label sales just were not meeting their expectations:

According to the information provided by DOJ, unrealized Evista sales forecasts spurred Lilly's new off-label promotion business plan.

"...the first year's sales of Evista in the U.S. were disappointing compared to Lilly's original forecast. According to the information, in October of 1998, the company reduced the forecast of Evista's first year's sales in the U.S. from $401 million to $120 million." [DOJ press release]

I don't expect that you can use this to predict what the next class of drugs will be subject to off-label promotion abuses, but if I had to guess, I would say it will be the erectile dysfunction (ED) class of drugs (Viagra, Levitra, Cialis). And it may already be happening.

The market for ED drugs is not nearly what the drug marketers in these companies thought it would be (see "ED Drug Sales Limp"). Perhaps responding to that fact, you are seeing more ED drug ads that are focusing on diabetes and high blood pressure as potential causes of ED. I notice in the Levitra ads, for example, men with diabetes and high blood pressure express concern that they did not know their medical conditions could result in ED. These men do not say, however, that they have experienced the problem. Now they are concerned about developing ED.

One might interpret the message of such ads as: "If you have diabetes or high blood pressure, you are in danger of developing ED. You should talk to your doctor about Levitra." That borders on off-label promotion because none of the ED drugs is approved for pre-emptive treatment to prevent ED (for more on this topic, see "Pre-emptive Drug Marketing?").

Another piece of evidence I have that there may be more off-label promotion of ED drugs comes from the book "Selling Sickness." The author points out that a prominent urologist -- a paid consultant to Pfizer -- said he was a "strong believer" in taking Viagra on a daily basis to "prevent impotence."

Professor Irwin Goldstein of Boston University, Massachusetts, said at a recent continuing medical education event (sponsored chiefly by the drug's manufacturer, Pfizer) that he was a "strong believer" in taking sildenafil on a daily basis to "prevent impotence."

Before a large audience of primary care doctors and others attending a sexual function update at New York University in December, Professor Goldstein said he had "hundreds of men" using Viagra for prevention: "If you would like to be sexually active in five years' time, take a quarter of a pill a night---we have data to show that will facilitate and prolong nocturnal erections."

His comments were made during a panel session, in response to a question from one of the event's directors, Dr Natan Bar-Chama, a urologist from the Mount Sinai School of Medicine, New York, who also told the meeting "I'm a strong advocate of proactive prevention as well." [reported in BMJ]

A Rose is a Rose is a Rose
Several industry conferences are devoted to off-label promotion by pharmaceutical companies. The term "promotion," however, has now been dropped in favor of "usage" as in the "5th Annual Off-Label Usage Conference." This reflects the fact that a lot more attention will be focused on off-label promotion these days by OIG, FDA, and individual states attorney generals (see, for example, "Off-label Marketing: Next State Issue").

Whenever the pressure is high to meet sales numbers -- especially to meet Wall Street expectations -- there will be a danger of crossing the line into illegal off-label promotion, even if it is called by another name.

We Were Hoodwinked!

In a front page Wall Street Journal story, New England Journal of Medicine Executive Editor Gregory Curfman said "We Were Hoodwinked" ("Bitter Pill: How the New England Journal Missed Warning Signs on Vioxx"; subscription required). He was defending himself and his journal against accusations that the journal should have published corrections to a pivotal VIOXX study report it published. The report omitted critical heart attack data (see "Merck's Hand in the Cookie Jar"). Only 5 years after the fact did the NEJM publish a "Expression of Concern" to correct the record.

It turns out, however, that it was the NEJM that hoodwinked us, and by us I include the Wall Street Journal and other press.

Hoodwink -- "Back in the 16th century, 'wink' meant to firmly close the eyes, not the brief, jaunty wink we know today. To 'hoodwink' someone was to literally blindfold them with a hood, often the sort used by executioners. Hoodwinking was also a tactic of thieves, who would throw a hood over their victims' heads before robbing them. This literal sense of "hoodwinking" was joined in the 17th century by the metaphorical sense of "hoodwinking" we use today -- to blind someone by trickery or deceit in order to take advantage of them." [Word Detective]

When the NEJM published its "Expression of Concern" it denied that the timing was related to a planned release of Dr. Curfman's deposition at the first Vioxx trial in Texas.

Although the New England Journal wasn't on trial for anything, the deposition produced a number of damaging admissions by Dr. Curfman. He acknowledged that neither the peer reviewers nor journal editors challenged the authors' heart-attack theory about naproxen as it was presented in the article. "Yeah, we signed off on this," he said, according to a transcript of his testimony. "And I have many times had second thoughts about having done that." [WSJ]

Now NEJM concedes the timing was connected to the trial. This tells all about how the NEJM hoodwinked us:

A public-relations specialist who has advised the journal since 2002 predicted the rebuke would divert attention to Merck and induce the media to ignore the New England Journal of Medicine's own role in aiding Vioxx sales.

"I believe that given what a public punching bag Merck has become, there is more than enough information and more than enough context in the statement to drive the media away from NEJM and toward the authors, Merck and plaintiff attorneys," wrote Edward Cafasso, a Boston-based public relations consultant, in a late-night email to journal staffers hours before the expression was released. Mr. Cafasso later added, "In my view, this disclosure may very well be seen as the final straw for Merck on the Vioxx matter." [WSJ]

That was the "trickery" part of the hoodwinking process. Here's the "deceit" part. In its "Expression of Concern" NEJM claimed that the authors of the paper in question -- Merck employees -- had deleted data days before the publication. It was widely reported by the press (and bloggers like me as well) that the missing data concerned the number of heart attacks suffered by participants in the trial. This, however, was not the case.

The statement was ambiguous about what data the authors deleted, hinting that serious scientific misconduct was involved. "Taken together, these inaccuracies and deletions call into question the integrity of the data," the editors wrote.

In reality, the last-minute changes to the manuscript were less significant. One of the "deleted" items was a blank table that never had any data in it in article manuscripts. Also deleted was the number of heart attacks suffered by Vioxx users in the trial -- 17. However, in place of the number the authors inserted the percentage of patients who suffered heart attacks. Using that percentage (0.4%) and the total number of Vioxx users given in the article (4,047), any reader could roughly calculate the heart-attack number.

Dr. Curfman says it would have been easier on readers to give the exact number and admits "both the authors and the editors slipped up" in not including it. [WSJ]

"Slipped up" indeed! What the f**k are you paid for?

NEJM's "Thirty Pieces of Gold"
Dr. Curfman and the NEJM sold out to Merck for a pittance and have clearly done everything in their power to prevent damaging evidence about VIOXX from coming out (from them at least). The journal sold "more than 900,000 reprints of the article, bringing in at least $697,000 in revenue. Merck says it bought most of the reprints."

Repeatedly in the WSJ story, Curfman refuses to take any responsibility for not catching the errors in the article (the article did leave out data on heart attacks; this data was available on the FDA Web site for years). In fact, he passes the buck to the FDA: "The data were in the hands of a regulatory agency and we felt it was now up to them to take appropriate action."

This kind of cowardly "blame the other guy" tactic seems endemic to our higher institutions, including the federal government. I have yet to hear, for example, "the buck stops here" regarding the Katrina or the Iraq weapons of mass destruction debacles.

It's All About PR

The day after the expression of concern, Mr. Cafasso emailed colleagues: "The story is playing out exceptionally well."

PR people probably study the tactics and insights of P.T. Barnum who used exotic phrases to mislead people (such as "This Way to the Egress", which fooled people to exit an exhibit when they thought they'd be treated to another side show). Barnum is also famous for pointing out that "a sucker is born every minute." Shame on us for being suckered.

PR professionals, however, should remember this piece of advice attributable to Barnum: "You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all of the time."

DTC's Placebo Effect

Get this:

"The impact of DTCA [Direct-to-Consumer Advertising] on patient expectations has important implications for evaluating its role in the health-care system. While these expectations can lead to inappropriate and excessive prescribing, they also may induce a placebo effect that might increase the clinical effectiveness of the advertised products. [my emphasis] This seldom-discussed effect of DTCA should be taken into account in discussion of policy approaches to this form of marketing." (See "What Are the Public Health Effects of Direct-to-Consumer Drug Advertising?" in the March issue of PLoS Medicine.)

I haven't heard that one before!

It should be noted that of the two authors of this statement, Elizabeth A. Almasi and Randall S. Stafford, at least one (Stafford) has received financial support (of the worst kind) from several pharmaceutical companies: "RSS has received current or past research funding from Merck and Company, GlaxoSmithKline, Bayer, and Proctor and Gamble. Speaking honoraria and travel expenses [my emphasis] have been provided by Merck and Company, Bayer, and GlaxoSmithKline."

I say the "worst kind" because on the gifts-to-physicians-conflict-of-interest-scale, payment for speaking and travel signifies the highest conflict. For more on this, see "Gifts to Physicians Survey Results" and "Free Gifts to Physicians: What's the Big Deal?" (PMN Reprint)

The other author, Elizabeth Almasi is a student at Stanford University presumably working under the tutelage of Stafford. The research that led to this thesis was paid for, however, by grants from the US government.

The placebo effect is a known factor in healthcare: "about one-third of patients report relief from postoperative pain, cough, headache, depression, and other conditions when given a placebo," say the authors. OK, I'll buy that.

Of course, in order for a DTC ad to trigger such a placebo effect, the ad must show how effective the product is, even exaggerate that effectiveness. The authors site an example of such an ad:

"DTCA offers conditioned stimuli to associate each product with positive emotions: the joy of playing in beautiful fields for allergy sufferers (loratadine commercial) or the relief conveyed by elderly patients with arthritis participating in their favorite activities (rofecoxib commercial). Patients who take the advertised medication may be conditioned to elicit the positive feelings that were portrayed in the advertisement, which could enhance the medication's clinical effect."

Such ads have been widely criticized -- and some have resulted in FDA warning letters -- for going over the top as far as fair balance is concerned. For example, according to Mark Nolan, senior VP, creative director, Medical Broadcasting Co., a more respectful approach to conveying the fair-balance information in DTC ads emerged in 2005. "For so long we were treated to the smiling happy people dancing through a field of flowers every time we heard the fair balance," he says (see "DTC Takes a Back Seat" in MedAd News). But that's not all, DTC ads once showed arthritis sufferers skateboarding (I believe it was a skateboard) after taking a well-known Rx product!

Recently, there has been a shift by drug advertisers to use physicians as authority figures in broadcast TV ads. The Otho-McNeil ad for Ortho Evra is an example (see "DTC Straight Talk"). This has been characterized as "creative" (see "DTC Takes a Back Seat" in MedAd News), but it could also be a deviously clever ploy to enhance DTC's placebo effect!

It always amazes me how intelligent DTC ad people are! Imagine having developed techniques that not only motivate people to see their doctors, but that also draw upon classical conditioning theories to increase the placebo effect of the advertised product?

Actually, I don't think the ad people are that smart or even that devious. However, I can envision some of them applying Pavlovian conditioning theory to ads after reading the Almasi and Stafford paper. For that reason, the pharmaceutical industry should strongly rebuff the DTC placebo effect theory. Besides, the industry prides itself on producing products that are at least somewhat better than placebos!

DTC Takes a Back Seat?
In the report about DTC previously cited, experts claim that in 2006, DTC ad spending will shift somewhat away from branded ads to unbranded disease awareness ads, from TV to the Internet, and from the consumer to the patient. The report also cites a survey predicting that DTC spending will be flat or decrease somewhat in 2006 vs 2005.

A 2004 survey of DTC marketers predicted that DTC spending would increase in 2005 vs 2004; 41% of respondents said the increase would be more than 5% (see "DTC in 2005: Old Dogs, New Tricks?"). It turns out that DTC spending increased about 8% in 2005 vs 2004 ($4.86 billion vs $4.51 billion, respectively). The chart below shows the Top 10 DTC ad spenders in 2005:




I note with interest that Sepracor's Lunesta was the product most advertised to US consumers in 2005. And, in 2006, it is being advertised in violation of PhRMA's Guiding DTC Advertising Principles, which Sepracor pledged to obey (see "Wake Up PhRMA! or Tilting at Windmills").

Pharma and Republicans Part Ways

Yesterday, I posted a chart showing the pharmaceutical industry's approval ratings, which improved nicely in the last two years (see "Pharma Industry Less Unpopular"). Unfortunately, the popularity of the Republican party has not kept pace. The latest New York Times/CBS News poll, published today in the New York Times, Gives Bush Worst Marks Yet on Major Issues (registration required).

I thought it would be fun to plot data from the two polls on the same graph and I came up with this:





The plots look amazingly complimentary as if "approve" was being plotted against "disapprove" on the same issue asked of the same people; the totals for each year -- except 2002, which is a special, post 911 case -- are approximately 100%! Could there be a negative correlation between Bush's approval rating and pharma's?

It's interesting that the chart shows Bush -- and by extension the Republican party -- and the pharma industry parting ways. From the looks of it, you certainly cannot say "As goes Pharma, so go the Republicans."

It should be noted that the Republican party fared no better in the Times/CBS poll on a number of issues, including health care and the price of drugs for the elderly: only 19% of respondents felt that Republicans are more likely to improve the health care system (vs. 62% for Democrats) and only 18% felt that Republicans are more likely to make prescription drugs for the elderly more affordable (vs. 61% for Democrats). See the NYT chart.

But, you don't need a chart to see that. In the 2 years, notable Republican Congressman have distanced themselves from the drug industry in very public ways. First, presidential hopeful Senator Frist lambasted the industry on DTC advertising (see "Deconstructing Frist on DTC"). Then there's Senator Grassley constantly launching investigations of industry practices.

The NYT/CBS poll results suggest that all this anti-industry grandstanding hasn't helped the Republicans much. Maybe they need a less "less unpopular" target, like the oil industry?

Pharma Industry "Less Unpopular"

According to the most recent Harris Interactive poll the "Reputation of Pharmaceutical Companies, While Still Poor, Improves Sharply for Second Year in a Row."

"Every year, Harris Interactive measures the public's perceptions of approximately 20 industries. Specifically, we ask people to say if they think each industry is generally doing a good or a bad job of serving their consumers. It is clear that answers to this question reflect not just the specific wording, but many general public feelings about the different industries. If people feel good about an industry, they tend to say it is doing a good job of serving its consumers and vice versa."

Here's a chart of the poll results since 1998:



The recovery is no fluke, but what could possibly be the cause of this reversal of fortune? According to Harris Interactive:

"First of all, it is important to recognize that the pharmaceutical, managed care and health insurance industries are stilled rated very near the bottom of the list in terms of public approval. They are not popular, but they have become less unpopular. A plausible explanation of their upward trend is that they have been receiving less unfavorable media coverage and publicity over the last two years than previously."

"In the case of the pharmaceutical industry, the massive decline from plus 60 percent in 1997 to minus four percent in 2004 was surely a direct result of the constant drumbeat of unfavorable publicity about their prices. While drug prices are still a major issue for many people, there has probably been less negative publicity on this issue over the last two years than previously."

Medicare Part D
I believe that the new Medicare Part D drug benefit had a big role in both the "dip" in the ratings data in 2003/2004 and the recovery in 2004/2005.

In 2003 and 2004, the drug price debate was in full swing primarily because the Medicare bill was wending its way through Congress. Everyone was talking about the high cost of drugs.

That was then. Now that Part D is "fully operational," there is less direct talk about drug prices -- most of the current criticism of the drug industry is at least one layer away from the pocket book (DTC, gifts to physicians, etc.). Moreover, despite the criticisms leveled against the program, now that it is law, Medicare Part D represents a drug price safety net for many people. The program also is endorsed by AARP, which was once an outspoken critic of prescription drug prices, and now touts the program as saving money. Medicare Part D also serves to deflect attention away from the drug industry and onto the government and insurers as far as drug prices are concerned.

Drug Safety
Harris Interactive says "Another interesting point is that the bad publicity in relation to drug safety problems does not seem to have had much impact." I don't know how they can say that. There is no doubt in my mind that the Vioxx withdrawal debacle had something to do with the continuation of the rating dip in 2004. In 2005 and 2006 there were no major drugs pulled from the market due to safety concerns and therefore drug safety was not top of mind as far as the general public was concerned. The FDA even pulled the plug on its plan to implement a Drug Watch Web site that would have listed drugs with safety issues. No one raised any hue and cry over that. [For more on the FDA's proposal, see "FDA Drug Watch Site Guidelines."]

Other factors to consider with regard to the rise in the favorable rating in 2005 and 2006 include:

• Increased Lobbying (see "Activists: Drug firm lobbyists 'blanket' Congress", Boston Globe)
• Grassroots campaign by industry representatives (see "GSK Strikes Back with a Grassroots Campaign" and "GSK's 'Plain Talk' Flawed")
• Merck's "Patients First" TV campaign (see "Patients Come First?")
• DTC Guidelines issued by PhRMA in 2005 (see "PhRMA Finalizes DTC Principles" and "Less DTC, Better Public Image?").
  

Lobbying is a Factor
According to a Center for Public Integrity investigation ("Drug Lobby Second to None: How the pharmaceutical industry gets its way in Washington"), 2003 and 2004 were banner years for pharmaceutical lobbyists:

"In 2003 alone, the industry spent nearly $116 million lobbying the government. That was the year that Congress passed, and President George W. Bush signed, the Medicare Modernization Act of 2003, which created a taxpayer-funded prescription drug benefit for senior citizens.

"That figure was not anomalous. In 2004, drug makers upped their reported expenditures on lobbyists to $123 million, a record amount for the industry. Of the 1,291 lobbyists who were listed that year as presenting pharmaceutical corporations and their trade groups, some 52 percent were former federal officials."

All this lobbying paid off in 2005 and especially in 2006 when Medicare Part D became effective.

Another target of pharmaceutical lobbyists that has paid off with good public relations concerns bioterrorism. The pharmaceutical industry has been called upon to protect the American public from biological attack by producing vaccines and other pandemic protective drugs. Drug industry lobbying, according to Public Citizen, was effective in getting the federal government to shield it from lawsuits over products used to treat pandemic illnesses (see "Willful Misconduct: How Bill Frist and the Drug Lobby Covertly Bagged a Liability Shield").

I am glad that the pharma industry is there to provide this protection, although I am not sure about the shield. Obviously, the industry has scored good PR points for the former while the latter has been swept under the PR rug.

Industry Counterattack
Meanwhile, the drug industry is counterattacking to directly influence public opinion. Mike Pucci, Vice President of External Affairs at GlaxoSmithKline (GSK), for example, heads a program whose goal is to get the word out about the good that the pharmaceutical industry is doing (or, as Pucci expressed his goal: to "Restore the reputation of the industry by communicating the value of our products, our research and our hope for the future"). In presentations on his tactics, Pucci claims a lot of the credit for the improved public perception evidenced in the Harris Interactive survey poll numbers (see "GSK Strikes Back with a Grassroots Campaign").

Merck also is fighting back. The company is spending at least $20 million on its "patients come first" campaign which I criticized in this blog some time ago. "The ads seek to counter perceptions among skeptical consumers that Merck in particular -- and giant drug makers in general -- are more interested in profits than in people" (see "Merck to spend $20 million to buy your trust").

I've read that Merck considers this campaign effective in improving its public image. If the campaign has helped Merck, then it no doubt has helped other drug companies as well. After all, Merck is the poster boy for the bad, the ugly, and now (apparently) the good side of the industry.

PhRMA and DTC Principles
Part of the counterattack by the industry has been PhRMA's Guiding Principles on DTC Advertising. While these principles have no enforcement teeth (see "Wake Up PhRMA! or Tilting at Windmills"), they have been a boon to the industry's public image and quelled a lot of the debate about DTC -- especially in Congress. As time goes on, however, I expect less and less attention will be paid to the "spirit" of these principles (e.g., less unbranded disease awareness ads, for example). In fact, the battle is on to make DTC even more effective by simplifying the risk information they need to communicate (see, for example, "DTC without the Risk").

Aside from the DTC guidelines, PhRMA is playing a larger role in cleaning up the industry's public image since Billy Tauzin became president of the organization in January, 2005. Since then, for example, the PhRMA Web site has had a major overhaul and is much more consumer friendly.

Is this as good as it gets? Or will the positive ratings continue to rise? It's hard to tell, but I suspect that a 60% positive rating is just about right for the industry these days. After all, how many Republicans are there?

Pfizer Imitating Art or Vice Versa?

Sometimes "life imitates art" completely by happenstance as when Mandy Patinkin -- the actor that plays a doctor in some Crestor TV ads -- was saved by the Heimlich maneuver in a NYC restaurant. It so happens that he also stars in a movie called "Choking Man" whose "primary plot concern is the trauma, both literal and metaphorical, of tracheal blockage" (New Yorker Magazine, May 8, 2006). In that movie, a customer in a restaurant owned by Patinkin's character chokes on a fish bone and is saved by a dishwasher using the Heimlich maneuver after everyone else does the wrong thing. In real life, Patinkin's family also tried to help him by doing the wrong maneuvers until someone did the right thing and saved his life.

When I first saw the movie "Constant Gardener" I thought it was another unfair casting of the pharmaceutical industry as villain -- murderous villain at that -- and although good art, not a very believable portrayal of real life. But then I read the Washington Post story yesterday about a report by a panel of Nigerian medical experts that "concluded that Pfizer Inc. violated international law during a 1996 epidemic by testing an unapproved drug on children with brain infections at a field hospital" (see "Panel Faults Pfizer in '96 Clinical Trial In Nigeria. Unapproved Drug Tested on Children").

"The report concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug [Trovan] to nearly 100 children and infants. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis. At the time, Doctors Without Borders was dispensing approved antibiotics at the hospital."

The movie is based on a book by the same name written by John le Carre -- the famous author of several spy novels.

"The Constant Gardener does offer something new. Le Carre's earlier novels painted a bleak picture of the abuses and corruptions and betrayals of power; here that is augmented with a hard look at a specific issue -- the abuse of power by pharmaceutical companies. The integration of this into the plot is occasionally awkward but mostly effective, touching on the testing of defective drugs in Third World countries, the corruption of governments and corporations, and the twisting of scientific research agendas." (A book review by Danny Yee)

The Nigerian panel report, which remained unreleased for 5 years, "concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis."

Pfizer says that "local nurses explained the experiment to Nigerian parents and obtained their 'verbal' consent."

"Pfizer contended that its researchers traveled to Kano with a purely philanthropic motive, to help fight the epidemic, which ultimately killed more than 15,000 Africans. The [Nigerian] committee rejected that explanation, pointing out that Pfizer physicians completed their trial and left while 'the epidemic was still raging.' "

Pfizer was testing Trovan in Africa before it was approved for use in the US. According to the Post story: "Trovan was later associated with reports of liver damage and deaths, leading the FDA to severely restrict its use in 1999. European regulators banned the drug." The pharma industry has long been accused of testing unsafe drugs in poor countries before they are approved.

The Smoking Letter
What lends credence to the report's accusations is the fact that a letter "purporting to show that the test had been approved in advance by a Nigerian hospital's ethics committee" was a fake, written by the lead investigator AFTER the experiment, backdated to a week before the trial began. It turns out that the hospital had no ethics committee at that time.

"Pfizer used the letter as a key justification for the trial in discussions with reporters and submitted it to the FDA. U.S. regulations require the sponsors of foreign medical research seeking FDA approval to show that the tests have been reviewed in advance by an ethics committee."

Pfizer now admits that the letter was "incorrect" and "regrets" that it was written.

There are many intriguing plot elements here that could be the basis of a book and movie like "Constant Gardener." I notice, however, that this book -- as well as the book "The Karasik Conspiracy" (see "Celsius 3014: Ketek, Drug Safety, & Bioterrorism") -- cast pharmaceutical executives as murderous conspirators. In the movie, the deaths of the children are covered up by secretly disposing of the bodies. The heroine is also murdered by pharmaceutical company hired thugs because she is learning too much about these cover-ups.

In real life, children did die, but the deaths didn't need to be hidden in a garbage dump. They only had to be explained away statistically:

"Five children died after being treated with the experimental antibiotic and others showed signs of arthritis, although there is no evidence the drug played a part. Six children died while taking a comparison drug."

Life is complicated with shades of gray and arguments pro and con. Art, on the other hand, is simple with just black and white. Outright murder and lies are easily understood devices that convey the message in art. In life, things are not that simple. That's why prosecutors have a hard time convicting executives of complicated financial crimes and opt instead to catch them lying about it.

Meanwhile the Nigerian report continues to be suppressed. "A report like this does not get suppressed without someone high up being involved," said Elaine Kusel a New York City attorney for the families of the Nigerian children. In the movie, diplomats and executives at the highest levels were involved in the coverup. Pfizer, which gains by the report's unofficial status, said "The Nigerian government has neither contacted Pfizer about any of the committee's findings nor are we aware that the committee has approved a final report. Therefore it would be inappropriate for the company to respond to specific points in the document."

This real life story imitates art in other ways -- the head of the Nigerian panel has received "unspecified death threats." This is where it becomes closer to art and easy to understand.

Whose Data Is It Anyway?

"Doctors Object to Gathering of Drug Data" says an article in yesterday's Business section of the New York Times:

"Although virtually unknown to consumers, the information has long been considered the most potent weapon in pharmaceutical sales -- computerized dossiers showing which physicians are prescribing what drugs. Armed with such data, a drug sales representative can pressure a doctor to write more prescriptions for a name-brand medicine or fewer orders for a competitor's drug.

"But now a rebellion is under way by some doctors, who consider the data-gathering an intrusion that feeds overzealous sales practices among the nation's estimated 90,000 drug company representatives. Public officials are also weighing in. A vote on a state bill to clamp down on the practice is scheduled for today in New Hampshire, and similar bills have been introduced in other states, including Arizona and West Virginia.

"A Gallup Poll commissioned by the A.M.A. in 2004 found that two-thirds of doctors surveyed were opposed to the release of such data to pharmaceutical representatives, and that 77 percent felt that an opt-out program would alleviate concerns about the release of data. Nearly a quarter of the doctors were not even aware that the pharmaceutical industry had access to such information."

New Hampshire HOUSE BILL 1346 states:

Records relative to prescription information containing identifiable patient and prescriber data shall not be used, transferred, licensed, or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order, or Internet pharmacy, or other similar entity, for any commercial purpose, except for the limited purposes of pharmacy reimbursement, care management, and utilization review by the patient'’s insurance provider or the provider'’s agent. Commercial purpose includes, but is not limited to, advertising, marketing, promotion, or any other purpose that could be used to influence sales or market share of a pharmaceutical product, influence or evaluate the prescribing behavior of an individual health care professional [my emphasis], except for evaluation by an insurance provider or the provider'’s agent for the purpose of compliance with the provider'’s formulary, or evaluate the effectiveness of a professional detailing sales force.

Once in a while I feel the pain of pharmaceutical marketers who are being challenged on every front and who think that there's an organized effort by "woolly-headed" (ie, liberal) critics to stop pharmaceutical marketers in their tracks (see, for example, "Clash!"). In this case, however, I feel the pain of physicians but agree with Robert A. Musacchio, the A.M.A.'s senior vice president for publishing and business services, who said "What we've always stressed is that physicians have rights and they can always tell pharmaceutical representatives that they don't want to be called upon."

Of course, the A.M.A. isn't exactly a disinterested party. They make plenty of money -- $40 million a year -- selling physician data to third parties (most of which ends up for use by pharmaceutical companies). While this is not prescribing data, it is useful demographic and business data that can be combined with prescribing data to segment physicians for marketing and sales purposes. Some physicians might argue that such segmentation helps pharmaceutical companies deliver the most relevant information to them.

Just as there is a way physicians to limit the release of AMA's data about them, there should be a way for physicians to opt out of having their Rx data sold for marketing purposes. This may be a better solution than a blanket law -- such as NH HB 1346 -- which prevents it outright.

Wake Up PhRMA! or Tilting at Windmills

A week or so ago I reported that Sepracor was "sneaking" in Lunesta "reminder ads" despite being a signatory to PhRMA's Guiding Principles for DTC advertising (see "Sepracor Sneaks In Lunesta Reminder Ad").

Since then I've become aware that Sepracor is continuing to run Lunesta reminder ads on prime time cable and network TV. While I am no Don Quijote anxious to tilt at windmills, I decided to make this is a test case of Pharma's (and PhRMA's) commitment to the DTC Principles and report back to readers of Pharma Marketing Blog.

First, I tried calling Jonae Barnes, VP of Investor Relations and Corporation Communications at Sepracor (her number is 508-481-6700). I've left several voice mails -- no response. I also sent her an email directly as well as through the online form located on the Sepracor Web site. No response.

I tried Amy P. Trevvett, Sr. Manager, Investor Relations & Corporate Communications, by phone and email as well. At least I got a return email receipt form her and I will treasure it the rest of my life! Otherwise, nada.

OK, that windmill was a waste of time! Might as well go through appropriate channels and try PhRMA's Office of Accountability. Today, I sent that office a letter by certified (you can download it here), which points out the violations that I am aware of.

The following are approximate dates, times, and TV stations where these ads have appeared:

• Friday, April 21, 2006; approx. 10 PM; History Channel (Channel 53 in Philadelphia)
• Saturday, April 22, 12:54 PM, WCVB (Channel 5 in Boston)
• Tuesday, May 2, 2006; 7:55 PM; FOX; show: Seinfeld (Channel 2 in Philadelphia)

I also sent copies to Ms. Barnes as well as Timothy J. Barberich, Chairman of the Board and Chief Executive Officer at Sepracor.

You can track these letters and be sure they were delivered by going to the USPS web site and entering one of these tracking numbers:

7005 1820 0005 2547 4505: Letter to Barberich
7005 1820 0005 2547 4482: Letter to Barnes
7005 1820 0005 2547 4499: Letter to PhRMA

At least this establishes a public record. Let's see if PhRMA is awake or asleep at the wheel (sorry, that's an Ambien side effect, not a Lunesta one) .

Pre-emptive Drug Marketing?

"Findings from the first long-term trial of the concept of prescribing drugs to young people at risk of schizophrenia, but not yet exhibiting the disorder, raised more questions than they answered, experts said" (see FDLI SmartBrief, May 2, 2006).

According the New York Times article on this subject "Critics have charged that treating people for a disorder that has not yet been diagnosed is not only premature but stigmatizing, especially for adolescents. The new study was intended in part to clarify the trade-off between the risks and the potential benefits of preemptive treatment."

It was difficult to enroll subjects for this study, but the investigators "eventually enrolled 60 people, most of them adolescents, who scored highly on a scale that assesses risk for psychosis. The scale rates severity of more than a dozen symptoms, including suspiciousness, grandiosity and bizarre thoughts."

The clinical investigators might have been able to recruit a few thousand more subjects if they rated pharmaceutical company marketers on that scale. Pharma marketers are a suspicious bunch to begin with ("Congress is out to get us!") and are known to be grandiose ("The market for this drug is huge!"). Add now bizarre thoughts -- "We could treat people with our product before they even exhibit symptoms!"

First there was "Disease Mongering" whereby drug companies are said to attempt to "enlarge the market for a treatment by convincing people that they are sick and need medical intervention" (see "Disease Awareness or Disease Mongering?"). Now there's pre-emptive treatment!

What's next? How about "pre-emptive marketing?"

Soon, we may be required to have our children undergo genetic testing at birth to reveal possible future medical problems. There will be no need for pre-emptive clinical trials -- "it's in the genes!" -- just pre-emptive marketing to convince people that they will someday have aq condition that should be treated now!

They'll have us treating children starting at the age of 2 not just for schizophrenia, but for high blood pressure, high cholesterol, erectile dysfunction (ED)... you name it!

Of course, kids cannot "ask their doctors if this treatment is right for them." Therefore, pre-emptive drug ads would be aimed at parents. I envision these ads appearing in parents' magazines and on daytime TV talk shows. Imagine the creative possibilities! It will be a golden time for ad agencies.

Drug companies are considering these "bizarre thoughts" because they have very few new drugs to offer and must ever expand the market for the old ones, for which they "grandiosely" set unrealistic marketing goals, which they "suspect" will be met with opposition by regulatory authorities unless they lobby the hell out of Congress.