BLOGSCAN - Direct-to-Consumer Device Advertising on YouTube Sans Adverse Effects Information

On the PostScript blog, the Prescription Project announced the discovery of direct-to-consumer marketing videos released on YouTube by three device companies. The video from Abbott advertised the XIENCE-V drug eluting stent. That from Medtronic advertised the Prestige cervical disc. That from Stryker advertised its Cormet hip resurfacing technology. Apparently none of these brave new advertisements bothered to put in the discussion about adverse effects mandated by the US Food and Drug Administration (FDA). The new media obviously presents new opportunities for marketing, including marketing that gets around rules usually applied in other media. Kudos to the Prescription Project for blowing the whistle on this one.

According to this post, soon after the three companies pulled these ads. The issue of new media DTC advertising produced quite a bit of internet buzz. Amazingly, among those agreeing with the Prescription Project's position was none other than Mr Peter Pitts of the DrugWonks blog, the Center for Medicine in the Public Interest, and the Manning, Selvage and Lee public relations firm.

BLOGSCAN - FDA Hires Pharmaceutical Marketing Agency to Educate Consumers About Drug Advertising

On the GoozNews blog, Merrill Goozner posted about how the US Food and Drug Administration (FDA) set up a program to educate consumers about direct-to-consumer (DTC) advertising. It seems that the organization the FDA hired for this purpose is nominally a not-for-profit, but not registered as such with the federal government, and is run by the president of a pharmaceutical marketing agency. The not-for-profit was funded mainly by the marketing agency, and its leadership all have connections with pharma. Sometimes, you just can't make this stuff up.

Meanwhile, on the PostScript blog, this post assessed the content of the web-site provided by this program. The site is, shall we say, not terribly skeptical about how the pharmaceutical industry advertises drugs. But what did we expect, given who provided the content?

The Rower Mis-Impresses? - Pfizer Ends its Lipitor Advertising Campaign

We posted last week about misleading aspects of the Pfizer Inc US television advertising campaign for Lipitor (atorvastatin), some of which were recently discovered by NY Times reporter Stephanie Saul. The ads centered on Dr Robert Jarvik. They touted him as a physician with great expertise about the heart. However, although Dr Jarvik does have an MD, he never was an intern or resident, never got a medical license, and never practiced medicine. Dr Jarvik's career is that of an inventor and biomedical engineer. Furthermore, the ads gave the impression that Dr Jarvik is tremendously fit, showing him jogging and apparently rowing a racing scull. However, a body double, not Dr Jarvik, was rowing the boat.

This week, Pfizer cancelled the advertising campaign. As reported again in the NY Times by Ms Saul, "Under criticism that its ads are misleading, Pfizer said Monday it would cancel a long-running advertising campaign using the artificial heart pioneer Dr. Robert Jarvik as a spokesman for its cholesterol drug Lipitor."

Meanwhile, further information came out suggesting that the campaign was even more misleading than previously thought. The ads originally touted Dr Jarvik as the inventor of the artificial heart. However, this is actually in dispute. Ms Saul also reported that

at least one former colleague of Dr. Jarvik’s ... contends that he was not the actual inventor of the artificial heart, as stated in the ads.

In a letter to Pfizer in August 2006, three former colleagues of Dr. Jarvik’s at the University of Utah complained that the ads erroneously identified Dr. Jarvik as 'inventor of the artificial heart.' That distinction, they said, should go to Dr. Jarvik’s mentor, Dr. Willem J. Kolff, and his associate, Dr. Tetsuzo Akutsu.

Pfizer subsequently changed its ads to identify Dr. Jarvik as the inventor of the 'Jarvik artificial heart,' but Dr. Jarvik’s former colleagues, members of a large team that worked on the heart, were not entirely satisfied, according to Dr. Donald B. Olsen, a veterinarian who worked on the heart and is president of the Utah Artificial Heart Institute.

In addition, the ads present Dr Jarvik as someone who actually takes Lipitor. However, Dr Jarvik really is not a long-term user of Lipitor. A NY Times editorial stated "that Dr. Jarvik only started taking Lipitor about a month after he started touting its virtues under a contract that would pay him a minimum of $1.35 million over two years."

Pfizer's decision to stop the advertisements drew praise from some US Congressmen who are now investigating direct to consumer (DTC) drug advertising. Bart Stupak (D - Michigan) said, "I commend Pfizer for doing the right thing and pulling the Lipitor ads featuring Dr Jarvik. When consumers see and hear a doctor endorsing a medication, they expect the doctor is a credible individual with requisite knowledge of the drug."

I agree that it is good that this particular advertising campaign has stopped. However, it is not clear whether the leadership of Pfizer, or of any pharmaceutical company has learned anything from this case. Here is how Pfizer explained its actions (again, per the NY Times article by Ms Saul),

'The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to mis-impressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world — cardiovascular disease,' Pfizer’s president of worldwide pharmaceutical operations, Ian Read, said in a statement. 'We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople.'

First, note that Mr Read's pledge of clarity seems limited only to "the presentation of spokespeople." Second, and more importantly, note that Mr Read, and through him, Pfizer really never admitted any fault, particularly not for fielding an advertising campaign that had multiple misleading elements. Instead, he seemed to spread the blame among television viewers and print media readers, that is, those who developed "mis-impressions and distractions." Note that Mr Read did not even admit that the advertisements were meant to market Lipitor. Instead, he portrayed them as an educational exercise meant to encourage "patient and physician dialogue."

It may be that it is hard for Pfizer leadership to move on from a two-year plus advertising campaign orchestrated by the Kaplan Thaler Group ((a unit of the Publicis Groupe) that cost more than $258 million since the beginning of 2006 (again per the Times article).

In my humble opinion, though, this inability to admit any fallibility on the part of Pfizer leadership underscores a central problem affecting the leadership of many health care organizations. Much current business thinking seems to support the concept of the infallibility and omniscience of "imperial CEOs," presumably partly to justify their pay so enormous it could not be due to mere mortal men and women. The infallible, by definition, do not make mistakes. So many organizations seem unable to admit mistakes, much less worse misconduct, by their leaders. Of course, inability to admit mistakes makes it likely that even worse mistakes will be made in the future.

The NY Times editorial called this case "a telling reminder that consumers, besieged by drug promotion ads on television and in print media, need to take what they see, hear and read with a very large grain of skepticism." It also suggested "drug companies would be wise to find pitchmen who have the credentials - and the athletic skill - to back up their claims, without having to rely on stunt doubles."

I say, as long as drug companies continue to be lead by "imperial CEOs," and hence by people insulated from criticism and immune to self-doubt, their emphasis on marketing ahead of science will continue. Furthermore, as long as drug company marketers are convinced that they are providing education, they will continue to make misleading pitches, no matter who the pitchmen are.

Rowing Aground - More on Dr Jarvik's Misleading Advertisements

On US television, the ads for Lipitor (atorvastatin, by Pfizer) featuring Dr Robert Jarvik are hard to avoid. In them, Dr Jarvik introduces himself as "Doctor," attests to the years has spent "studying the heart," attests to the value of Lipitor, which he takes himself, and is shown jogging, and apparently rowing a racing scull.

Concerns about these ads yhave now hit the big time. Stephanie Saul reported in the New York Times that not only, as we briefly mentioned, is Dr Jarvik "not a cardiologist and is not licensed to practice medicine," but that he does not know how to row. The images that seemed to be of Jarvik rowing the boat were combined from videos of a "body double," and of Dr Jarvik in a boat held fixed to a platform.

Why is this a serious matter? Pharmaceutical companies contend that they spend a great deal of effort "educating" physicians and the public. The NY Times article quoted a company email, "Pfizer stands behind its consumer advertising for Lipitor and our work with Dr. Jarvik to deliver important information on managing heart health."

Yet the deceptive elements of the advertising - Jarvik's identification as "doctor" implies he is a practicing physician, the body double in the scull implies Jarvik is especially vigorous and athletic - are the opposite of "important information."

Furthermore, the public may and should know Dr Jarvik as an innovative scientist and engineer(corroborated by Ms Saul's reporting that he is currently working on a miniaturized cardiac assist device for heart failure). As such, his words should be trusted. The public's trust is violated when he allows the words to be delivered in a deceptive context.

Finally, a separate report by ABC news alleged that Dr Jarvik received $1.35 million dollars for doing the advertisements. Obviously, that is a lot of money, and may have influenced Dr Jarvik to think and speak more favorably about Pfizer and Lipitor. The public's trust is further violated when someone who appears as a trusted scientist fails to disclose that he is being paid to deliver a pitch.

Maybe this high-profile case will lead to at least more honesty in direct-to-consumer health care advertising, and at least full disclosure by physicians and academics when they are paid by pharmaceutical/ biotechnology/ device/ etc companies to deliver "education." But physicians and academics ought to rethink whether it really fits their professional values to end up being viewed as salespeople employed by marketers.

NOTE - See also coverage by Ed Silverman in the PharmaLot blog, (also here) and on the WSJ Health Blog.