The Voice in the Ear -- Burt's Blog
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October 2005 Archives:
29» The Numbers Game
28» The Live Demonstration Course
27» It Was Twenty Years Ago Today...
24» Pay Attention To That Wo/Man Behind The Curtain
15» Off To See The Wizards
» Dr. Jekyll, I Presume...

7» Four Minus Two Equals Two -- Hands, That Is

October 29, 2005

The Numbers Game
When millions and billions of shareholder dollars depend on tenths of a percent, it's understandable why companies play the drug-eluting stent "numbers game". Johnson & Johnson/Cordis played it at the ACC in March, citing a numeric trend in the REALITY trial that showed an increased risk of stent thrombosis in the competing Taxus stent -- I discussed this in detail back then ("Trials and Tribulations") but the bottom line was that, if you looked at the trial design, numbers of patients, p values, etc. there was no statistically significant thrombosis increase.

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

"Currently, in US real-world practice, sirolimus-eluting stents and paclitaxel-eluting stents appear to have comparable clinical and safety outcomes..."

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?

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October 28, 2005

The Live Demonstration Course
Just a quick addition to yesterday's remembrance of Andreas Gruentzig -- his other invention besides angioplasty was the "live demonstration course". He couldn't teach his technique to enough cardiologists by having them visit his lab in Zurich, so he used live TV and interactive audio and created a learning experience. From 28 docs in 1978 to 10,000 at this month's TCT, the live demonstration course has been one of the major ways physicians learn new techniques.

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.

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October 27, 2005

It Was Twenty Years Ago Today...
Well, if there were a Sergeant Pepper in the field of interventional cardiology, it would be Andreas Gruentzig. He most certainly taught the band to play -- he did the first coronary angioplasty (video clip) in 1977 and made his life's mission teaching the procedure to other cardiologists. And it was twenty years ago today that, at the age of only 45, he took off in his twin engine Beechcraft from his vacation home in the coastal islands of Georgia to get to his office at Emory Hospital in Atlanta and ran into the edge of a hurricane, and crashed -- tragically killing both him and his wife.

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.

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October 24, 2005

Pay Attention To That Wo/Man Behind The Curtain
"Aha!", you say. He's just taking the L. Frank Baum references too far (my last entry, anticipating my trip to the TCT, was titled, "Off To See The Wizards"). But imagine my surprise when one of my final meetings at TCT was a press conference featuring -- Dr. Oz!

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.

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October 15, 2005

Off To See The Wizards
I'll be traveling to Washington DC this week to attend the TCT 2005 -- can you say "Transcatheter Cardiovascular Therapeutics" three times fast? If so, you might find this annual meeting interesting.You and the estimated 10,000 other attendees who will be descending on the Convention Center for a week of live TV (angioplasty and stent procedures beamed from around the globe, ostensibly to show off a new piece of equipment, a new technique, but, as more than one cardiologist has told me, it's not unlike NASCAR -- you want to see the race, but everyone's waiting for the crash), PowerPoint lectures, simulation trailers where you can try your skill at placing a carotid stent in "Roger" (okay I made the name up -- I'll tell you the actual name later this week), PowerPoint symposia, "Sponsored Events" (breakfast or dinner meetings held outside the actual TCT, but within a couple blocks in a posh hotel, lotsa food, wine or espresso, mints, and more PowerPoint presentations, usually showing how the product of the particular sponsoring company is better than the one being shown in the hotel around the corner), highly anticipated presentations of clinical trial results (these are "blinded" -- the highly guarded results are only known to a few -- kinda like the Oscars -- did the stent work? did it meet its "end-point"? will the company get FDA approval? will the stock go up?), the Exhibit Hall with its scores of company booths, both big (giant video walls, entire cath labs, conference areas, espresso bars) and small (Joe, the Director of Marketing, will show you his latest brochure) and, did I say, PowerPoint presentations?

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.

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October 9, 2005

Dr. Jekyll, I Presume...
Today's New York Times Week in Review features an article, titled "When the Doctors Are Their Own Best Guinea Pigs" (the NYT article includes a link to Angioplasty.Org and our video about Dr. Werner Forssmann). The article, prompted by the recent awarding of a Nobel Prize to Dr. Barry J. Marshall for the discovery that bacteria caused ulcers, discusses how a number of important medical discoveries have been made through self-experimentation. The Times story also sports a still from one of the many "Dr. Jekyll and Mr. Hyde" movies to illustrate the self-experimentation concept.

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:

Marketing is at a much higher level today than it ever was before.... There are tremendous ethical conflicts that face physicians that develop products. When a physician aligns himself with industry, industry would like nothing more than for that person to champion their particular product. And, of course, there have to be inherent conflicts here that are financial in nature that can influence judgement. I think Andreas never succumbed to those pressures.
-- Geoffrey O. Hartzler, MD (first to treat heart attack patients with angioplasty, 1980)

We're having to study things where there's money behind it to study it. If you develop a new pill to do something, it's got to be a very expensive pill. I mean, we can't develop simple solutions because nobody's paying for them. And so research, as it's driven more and more by industry, entrepeneurial activities -- and there's nothing wrong with that -- but if that becomes over-balanced, where's the pure research going to come from to solve questions that may not be in the interests of a specific industry?
-- Spencer B. King, III, MD (Gruentzig's partner in Atlanta and former President of the American College of Cardiology)

There was no commercial venture in 1979 at all. A little company made it for Andreas but I know that the monetary part of this was negligible, in fact, probably negative, both for the doctors and maybe for the company. I know myself, for example, I never charged a patient for angioplasty for the first three-and-a-half years...because I felt that we still had a lot to learn. It wasn't to make money. This was an adventure! This was a scientific and intellectual challenge that we were possessed with! So what did money have to do with this? What did equity have to do with this? It wasn't any of those things.
-- Richard K. Myler, MD (performed the first angioplasty in the U.S., 1978)

[Andreas] was a person who had us look at technology in a lot of different ways and really understand the humanity of the technology and the implications of how it should be used appropriately, not simply for the greatest value for the shareholder.... That to me is a lesson that has been dimmed, I think, in the years, particularly since his death.
-- John E. Abele, co-founder, Boston Scientific

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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")

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October 7, 2005

Four Minus Two Equals Two -- Hands, That Is
Sounds like simple third grade arithmetic, but the profits of one of the largest device manufacturers may balance on such a simple equation. As reported by Reuters today, the success of Medtronic's Endeavor drug-eluting stent program is less dependent right now on whether or not the stent "works" than on obtaining the license to Rapid Exchange technology -- a design which allows one operator to perform a stent placement (i.e. "two hands") as opposed to the current configuration of two operators ("four hands").

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?

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