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May 15, 2008 -- 10:50am EDT "Life Wide Open": A Stent Cypher (By the way, in case you're not familiar with the term "DTCA", the commonly-used acronym is actually "DTC" which stands for "Direct to Consumer", but hey, DTCA rhymes with PTCA, a.k.a. angioplasty -- so why quibble?) The NEJM "Perspective", was penned by two clinical cardiologists, Buffalo-based Dr. William E. Boden, principal investigator for last March's COURAGE trial (a.k.a. "Spring Awakening" for interventionalists) and Dr. George A. Diamond of Cedars-Sinai in L.A., co-author of one of my favorite analogy-genre pieces from October 2006 about the danger of stent thrombosis being greater than that from E. coli-laden spinach. Regardless of one's opinion of optimal medical therapy or delicious green vegetables, both Drs. Boden and Diamond have made it clear that they oppose stent-evangelism and have cautioned regularly against the overuse of interventional procedures. (For some short-term historical context on the tensions between clinical cardiologists and the stent-evangelists, read my post from last year, "Banned in Boston ".) The authors say the ad is "deceptive advertising" and find the idea of marketing a stent brand directly to patients an "experiment in interventional psychology". Cute. As for the so-called ad campaign, according to this morning's New York Times, it is no longer running except, for some inexplicable reason, in Baltimore. Something to do with over-"The Wire", no doubt. Or possibly the fact that the Baltimore TV market includes Rockville, Maryland where today and tomorrow the FDA Risk Communication Advisory Committee is holding hearings, specifically about DTC. In point of fact, according to the New England Journal, the hearings are the reason for the editorial being published online yesterday, in advance of print. But what's up here? Even Boden and Diamond told the NYT that, “the notion that television viewers inspired by such an ad would go to their physicians and request not only a stent but a specific brand and model of stent is frightening, if not utterly absurd.” Absurd, yes. It's one thing when a DTC-TV ad tells you about a new allergy med or sleep-aid and you go to your GP and mention it and he/she just happens to have samples of the pill left by a pharma detailer. Gimme! A stent -- slightly different. No free samples for one; and tens of thousands of dollars for a procedure (with associated risks) to put one in. So who really is the audience? Dr. Boden was more on target when he was quoted back in December by the Wall Street Journal Health Blog. He said, "You’ve got to wonder whether it’s a sign of desperation." Desperation, hmmm. Let's see. In March 2007, Dr. Boden's own COURAGE trial was presented at the American College of Cardiology with tremendous fanfare and backstage intrigue. The heads of both the ACC and AHA declared the study as "shaking the foundations of interventional cardiology" and that "hundreds of thousands of Americans with stable angina who received coronary stents did not need them". Coming upon the heels of concerns over late stent thrombosis, drug-eluting stent use dropped precipitously, from 90+% to the low 60's. Over a billion in sales was lost. I call it "free-DTC". Study presented, pronouncements made, newspapers run stories, patients see news, get worried, call doctors, and so on. No expensive TV spot necessary. Yet in their editorial, Drs. Boden and Diamond write:
However, just ask any interventional cardiologist (I did) and they'll tell you that's exactly what happened last year. Patients were actually requesting the good ol' tried and true bare metal stent. ("I'll take restenosis over thrombosis, doc!") You can read ample evidence of these patient preferences in the Forums on Angioplasty.Org, as well. But back to J&J's Thanksgiving desperation. It's November 2007. Not only is the U.S. DES market down overall, but the duopoly in these devices, shared by J&J and Boston Scientific, is rapidly coming to a close. The FDA Panel has just recommended Medtronic's new Endeavor stent and scheduled a review for Abbott's XIENCE. In fact, exactly one week after J&J's spot aired, the XIENCE was recommended for FDA approval (final approval is expected later this quarter). So who was this egregious TV ad really aimed at? If it was solely for patients, it wasn't a very good campaign. Standard advertising wisdom is that ads must be repeated often to be effective. But the spot didn't run often, certainly not enough to sway consumers. It reminded me of the full page ad that Boston Scientific took out in the New York Times, Wall Street Journal, Boston and Minneapolis papers, etc. the Monday after the FDA Stent Safety hearings in December 2006. It "answered every question that Frank Kemp had about drug-eluting stents". Again, it was a one-time ad and it's my opinion that it, along with J&J's TV spot, were aimed as much at the investment community, and the citizens of towns where these companies did business, as they were at patients. And they certainly were aimed at these companies' actual customers: the interventional cardiologists and their hospitals. ("See our ad? We're supporting you in this difficult time!") Really more like PR than advertising. DTC for devices is certainly a valid issue for the FDA panel to discuss, but I have a novel idea. What about using the vast dollars spent on these TV spots and full page ads to deliver a much more important message about stents and angioplasty "direct-to-consumers"? Like this one:
It's not controversial. It's not deceptive. Every study done on the subject agrees that angioplasty is the gold standard of care for acute MI. Heart attacks used to be fatal -- now an amazing number of lives are saved through the emergency use of angioplasty and stents. But unfortunately, not enough people are aware of this. Besides the big problem of denial of symptoms, many patients still don't understand that "time is muscle" and that opening up a blockage within a couple hours of symptoms can prevent damage to the heart. The hospital you go to can have a major effect on how you'll spend the rest of your life. And TV is a perfect medium to communicate this message. (Disclosure: I produced such a spot a decade ago for the San Francisco Heart Institute at Seton Medical Center.) I've railed before about the terrible portrayal of heart attack treatment on TV ("Don't Have a Heart Attack in Stars Hollow"). Maybe it's time for real DTC! By the way, a short note to J&J -- if you're going to create a branded ad campaign, start with a better name. Sure, "Life Wide Open" is a shout-out to what the stent does and how much better you're supposed to feel if your arteries (and lives) are "wide open". But rather than hearing this from stent-evangelists, we've now entered the territory of actual evangelists: namely "Life Wide Open", the title of a popular book by conservative evangelical radio/TV pastor David Jeremiah of the Turning Point Ministries. Also the name of a popular Knoxville-based Christian Rock Band. J&J's campaign may have a registered trademark™, but it's swamped by the competition in a Google search. At least spring for the 10-cents-a-pop GoogleAd to support the campaign. This same type of name choice was recently made by the American College of Cardiology with their new "patient site", CardioSmart. Sounds good, especially if you want 60 Softgels at the amazing price of $11.85!! |
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