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October 2005
Archives: The Numbers Game That did not stop J&J/Cordis from proclaiming "REALITY Trial Data Suggest Drug-Eluting Stents Differ Significantly in Rate of Blood Clot Formation-Stent Thrombosis" in a press release during the ACC. However, we and others have consistently stated that there really is no proven safety advantage of one stent over the other -- this group now seems to include Cordis' own clinical vice president, Dr. Dennis Donohoe, who admitted to Barron's during last week's TCT 2005 that there was no significant difference in safety between Cypher and Taxus. Of course, the damage to Boston Scientific had been done and their market share in the U.S. declined from a high of 70% (and that was after the recall of summer '04)) to about 55% last quarter. Boston Scientific, having been "caught flat-footed in terms of medical marketing at the ACC", according to its interventional cardiology President Hank Kucheman, has since put into place a "medical affairs group that works in conjunction with its selling organization to better clarify data messaging to physicians". They've also started a "drug-eluting stent Speakers' Bureau" so doctors can "talk about the facts in a data-driven fact-based way in the marketplace". So this striving for no-spin clean empirical scientific data must be why Boston Scientific claims in its latest press release that the data from the recently reported STENT Registry "revealed a numerical trend favoring the TAXUS stent", even though lead investigator Dr. Charles Simonton concluded (quoted in theheart.org):
Yes, it is true that the data showed slightly better numbers for the Taxus stent, but the "p value", a number which helps show whether or not the actual numeric differences have any "significant statistical difference", given the population studied, did not show any statistical differences between the two stents. "So what!" you say? Well the problem here is that these Stent Wars have civilian casualties when the marketing feud spills over into the population at large -- especially when the combatants issue public press releases that find their way into the headlines of local papers and TV news throughout the country. Take the example of Bill from Illinois who wrote into our site very worried about his upcoming stent procedure -- having read some negative news articles about the Taxus, should he demand that the doctor use a Cypher? Or is Taxus okay? (We've gotten similar emails worrying about the Cypher.) The civilian casualties I am speaking of are less physical and more psychological. It's one thing to "dis" the competition's laundry detergent in public, but quite another when you're discussing a metal sleeve that is going to be placed permanently inside your customer's heart. How does a patient feel when he reads that the Cypher is better one week after having a Taxus inserted in his left coronary artery? Regarding the Stent Wars, Dr. Gregg Stone has stated, "I think the winner is patients. I think both these devices perform very, very well, are overall safe and very effective." Wouldn't it be reassuring if we could data-message that in a fact-based way to Bill from Illinois? « send comment » « back to top »
The Live Demonstration Course Gary Roubin of Lenox Hill Heart & Vascular Institute of NY worked with Gruentzig at Emory in Atlanta -- in this video clip, Dr. Roubin, who will be conducting his own live demonstration course in November, discusses not only the role of this educational tool, but his thoughts on how Gruentzig might view today's developments (stents, etc.) in the field he started. « permalink » « send comment » « back to top »
It Was Twenty Years Ago Today... I had interviewed Andreas on video only a few weeks before, getting his "take" on the current state of angioplasty. This was all before the era of stents -- a device that changed the procedure significantly, virtually eliminating the problem of emergency bypass surgery. The video I was working on (for USCI -- does anyone remember them?) was going to be Andreas' answer to the expansion of angioplasty and its movement toward more and more complex cases, some say led by the "cowboys" of interventional cardiology. Parts of that interview can be viewed on his bio page here. I edited the video and sent him a copy via fedex. It arrived on his desk on Monday morning October 28th. That same day, Dr. Richard Schatz had scheduled an appointment with Andreas to show him his new device: the Palmaz-Schatz stent! You can see a video clip of Dr. Schatz discussing his excitement about presenting his stent to the "father of angioplasty". Unfortunately Gruentzig never got to see either the video or the stent. And ironically, over the following decade, the introduction of the stent expanded Gruentzig's procedure to the point where it overtook surgery as the treatment of choice for coronary artery disease. In September of 1985 I attended Andreas' last course at Emory and he gave tribute to the three great "fathers" of interventional cardiology: Charles Dotter, Mason Sones and Mel Judkins. Each had contributed to the process that culminated in angioplasty. All three had passed away in 1985. When Andreas paid tribute to them, the last thing anyone thought was that he would join them within a few weeks. « permalink » « send comment » « back to top »
Pay Attention To That Wo/Man Behind The
Curtain No kidding. Dr. Mehmet C. Oz, Professor of Surgery and Director of the Columbia University Cardiovascular Institute in the Emerald City of NY. And we must remember that one of the great accomplishments of the fictional Oz was to give the Tin Man a heart. Dr. Oz has been preaching his philosophy (which merges surgical and complementary medicine) in several books, on many talk shows (yes, on Oprah!) and on this particular Thursday, at the TCT. He brought along his new book, "YOU: The Owner's Manual", and the subject of this presentation was "The Critical Role of Nurses in Patient Education". With him were three nurse/administrators from the same hospital. They work alongside of the well-known interventional practice of Marty Leon, Gregg Stone, Jeffrey Moses, et al whose group puts on the annual TCT. And they are part of a model program for patient care/education. In the title of this entry, I say "pay attention", because the message of this small presentation (only a dozen of us press were in attendence) was for me one of the most important I heard. All week long thousands of cardiologists, marketing managers, stock analysts, device manufacturers, etc. had been gathering in vast, darkened theaters, watching live broadcasts of procedures from around the world, featuring the latest hi-tech equipment; they had been attending the multitude of symposia and presentations, discussing which drug-eluting stent is better, whether carotid stenting is as good as surgery, and so on -- all extremely important clinical topics that will affect the lives of millions of patients. But this one-hour talk, given in the press meeting room, explored a problem which affects every patient who has a procedure -- education, follow-up, compliance -- in short helping the patient achieve a better outcome; I believe the phrase is "nursing back to health". And unlike the device/drug/doctor-based solutions being projected throughout the giant halls of the Washington Convention Center, what was being discussed here was the kind of low-tech, people-based program that could have very significant benefits in patient outcomes. The nursing staff and Dr. Oz detailed a program that is in place at their hospital and, as I listened to them, I kept thinking about all the patients who write into our Forum, asking basic questions that their healthcare providers should be but aren't answering: when can I start exercising? why do I have a fluttering in my chest? how long do I have to take this prescription? what do I need to do to prevent this from recurring? I listened and asked my question to the panel: "Your program is terrific. It does so many things that need to be done. And while there are some other hospitals that have similar programs, there are all too many places where patients get little or no help post-procedure? How can a program like this be exported and (here's the kicker) who will pay for it?" There was no quick or complete answer to this question, and it's one I hope to explore in a future article. But as I left and walked through the halls, through the half-city-block exhibit area, now feverishly being dismantled and packed for travel to the next medical extravaganza, past the waiting transport buses paneled with ads for statins and stents, I couldn't help but think how it wouldn't take but a small percentage of all these budgets to invest in a patient education/prevention initiative. A funded campaign to give information, education and support to patients, especially those who are having an intervention, would indeed save lives, or at least improve quality of lives, to equal the effect of all the sparkling technology surrounding me. « send comment » « back to top »
Off To See The Wizards Curious to me is that there are 10,000 attendees but, according to the American Board of Internal Medicine, there are only 4,796 certified interventional cardiologists in the U.S. -- total. And hopefully, for angioplasty patients, a percentage of them will not be in Washington this week. (Hint: maybe you want to schedule your stent procedure for next week.) So who else is there? Well, it's an international event, so some non-U.S. cardiologists are there. Then there are the cardiologists who don't actually do interventional procedures, and other healthcare professionals, nurses and technicians. And let's not forget the press -- you no doubt will be seeing heart-related stories in the news this week. But more and more, there are the "related" professions: device manufacturer marketing teams, company executives, sales reps, venture capitalists, stock analysts. For them the TCT is a bit like what the patients face when they are wheeled into the cath lab -- the TCT is their cath lab: will their new device succeed? will the doctors like the way it handles? will their company be healthy or will it need a long recovery period? The business of medicine is big business, and many dollars are spent promoting various therapies and products at this meeting (and the others held around the world -- but this is the biggest in this field). Just stand in the Exhibit Hall as the TV monitors start to beam the presentation of a major clinical trial for the latest drug-eluting stent. Most of the docs are in the assembly room where the presentation is occurring, but in the Exhibit Hall, the sales reps suddenly all migrate to their home booths and, if the results are good for their company, a cheer goes up or applause...yay for us! Monday morning some results from the Endeavor drug-eluting stent trials will be presented and these will to a great extent determine the speed with which Medtronic can get approval and market their stent in the U.S. They've been talking 2007. I've heard opinions that the results may not be that substantial and that they may be looking at 2008. But these are only opinions because no one knows until...well you get the picture. More to follow. « permalink » « send comment » « back to top »
Dr. Jekyll, I Presume... But there's another side to the Jekyll and Hyde reference (ironic, eh?) because, like poor Dr. Jekyll, many doctors and scientists today who discover new treatments will soon be face-to-face with their own "other selves". And I guess "poor Dr. Jekyll" was a not a good word choice, because in modern times the material rewards of discovery are great, and the temptations to succumb to the glitter are enormous. Research, innovation and discovery in the medical world share this complex Jekyll-Hyde duality: the motivation of so many is to the "pure" discovery of truth, to help others and treat diseases; intertwined is the baser reality of the world of capital, marketing, business, money -- which, of course, must be credited with distributing and making these innovations available to us all. In the novella, Dr. Jekyll, having discovered his Mr. Hyde, found himself increasingly unable to stop from becoming him, until ultimately Mr. Hyde became permanent.This past summer saw several major product recalls of life-saving heart devices, replete with accusations that company officials and/or government regulators knew of the problems and failed to disclose them to doctors and their patients. The courts will ultimately decide fault, damages, etc. (Utterson, the lawyer, is the character who discovers the truth about Dr. Jekyll in the novella) but it might be useful to try and separate the good/bad Jekyll/Hyde components and to mull over some of these issues -- maybe we can come up with a better system. To wit, there's another video on our website, titled "Devices, Ethics and Money: 20 Years Later" and in it a number of pioneers in the field of angioplasty looked back at the changes that have occurred since its invention in 1977 by the very charismatic Andreas Gruentzig. You can view the seven-minute RealVideo clip, but here's a sampling:
* * * * By the way, as regards Dr. Jekyll, Scottish author of the story Robert Louis Stevenson insisted it be be pronounced"Gee-kill". And my favorite film rendition of the tale was the 1941 movie starring Spencer Tracy and directed by Victor Fleming ("Gone With the Wind", "Wizard of Oz") « send comment » « back to top »
Four Minus Two Equals Two -- Hands, That
Is Medtronic developed the Endeavor stent which has received the CE approval of the European Union. Results from the Endeavor III trial, which will compare the performance of the Endeavor to that of the Johnson & Johnson/Cordis Cypher stent, are scheduled to be presented at this year's TCT meeting on October 17. And the preliminary results have been very good. According to Dr. Jean Fajadet, Clinique Pasteur Unité de Cardiologie Interventionnelle, Toulouse, France, “Endeavor represents a very important addition to the options we can offer our patients undergoing stent procedures.” So here's the deal. Traditional angioplasty requires four hands: the cardiologist places one hand on the introducer sheath and the other on the balloon/stent catheter while his/her assistant manipulates the guide wire that everything else is anchored around. It's a complex four-handed procedure that requires precise coordination between the cardiologist and the assistant. The RX or rapid exchange system allows one person (two hands) to perform the entire procedure.This advance, pioneered by Swiss cardiologist Dr. Bernhard Meier and California-based Dr. Paul Yock, is currently the "property" of three companies: Guidant, Johnson &Johnson, and Boston Scientific. It has obvious advantages, economic being at the top (one person vs. two). The FTC may require that in order to pass muster to acquire Guidant, J&J must divest itself of exclusive RX technology and license it to other companies. And the thought is that J&J will license RX technology to Abbott and not Medtronic. Why? Because Medtronic is a more serious competitor to J&J than Abbott is. The final irony? The drug that Medtronic has licensed to coat its stent is ABT-578 -- ABT being short for "Abbott", the drug's manufacturer. Costello anyone? |