January 2005 Archives

January 15, 2005

Judging AMI
Last Tuesday's episode of "Judging Amy" featured mother Maxine's long-awaited "big one" -- during her treadmill test yet -- this should put at ease all viewers whose cardiologists want them to take a treadmill test! I had been predicting for three weeks that this story-arc would end in the cath lab, but no! Her cardiologist announced to the family that she was going to have open heart bypass surgery (CABG) instead. They had been prepping her for an angioplasty, but found that she had three narrowed arteries and "angioplasty won't work for that" -- which would be news to the patient who wrote into Angioplasty.Org just today. He had four Taxus stents inserted into three blocked arteries (100%, 80% and 70%) during his heart attack in April. He was asking that we post more "testimonials" from patients whose heart attacks were successfully treated with stents. We will, but meanwhile stay away from TV.

Emergency CABG, while certainly an appropriate treatment for Acute Myocardial Infarction (AMI) in some cases, has become less common with the advent of angioplasty/stenting, as well as thrombolytic therapy (dissolving the clots causing the heart attack). And while the writers obviously felt that bypass surgery sounded so much more dramatic, I've seen thousands of audience members glued to giant TV screens at various live angioplasty demonstration courses, waiting to see if the guide wire can negotiate the next eccentric curve in the LAD -- oh sorry -- they were all interventional cardiologists....

Speaking of which, as is often the case on TV, the medical roles in the "Judging Amy" episode merged. The same cardiologist who gave the stress test, also performed the patient's angiogram AND was scrubbed in on the open heart surgery AND was in the hospital at all hours of the night to talk to the family, with nary a nurse-educator or assistant to help. No wonder they needed Tony-nominee Kate Burton to play the multi-tasking cardiologist.

January 14, 2005

Newsletters, We Get Newsletters...
Today's email brings another opportunity to enhance/correct the most recent HeartCenterOnline newsletter, which features the following news article, "Johnson & Johnson withdraws 300 heart stents". In the article, a J&J spokesperson specifically states that this was NOT a recall. Yet HeartCenterOnline continues:

"In the recall, six stents out of a lot of 300 were discovered to lack enough polymeric coating." (my emphasis)

Was it a recall? Not only does HeartCenterOnline seem to think so, but I would also have to ask, what does the article mean by "enough polymeric coating"? Enough for what? Turns out that the weight of a few stents was very slightly less than spec, and so, in a precautionary move, the entire lot was taken off the market. Not known if any had been used in patients, but J&J says they did an internal test and that, if they had been used, the clinical performance of the stent would be unaffected. We'll have to wait and see if this "withdrawal" turns into a recall, but it isn't right now.

Then HeartCenterOnline goes into the past, specifically last summer, stating:

"Last year, rival drug-eluting stent maker Boston Scientific Corporation had to recall almost 100,000 drug-eluting stents after they were linked to three deaths and 43 serious injuries. The Boston Scientific stents, called Taxus, were causing injury during implantation."

I'm not exactly sure what their point is here, but there was no "had to" -- the company voluntarily recalled virtually all of its existing product, as a precaution, and the stent did not cause injuries "during implantation". The problem was a laser weld in the delivery catheter which, in a small number of instances out of a million, did not allow the balloon, on which the stent is mounted, to fully deflate. A serious problem, absolutely...but not a problem with the stent itself. (For more -- and more accurate -- information, read our special report on the Taxus recall.)

I'm not trying to be a device industry apologist here. I'm just wishing that a patient/professional-oriented health site like HeartCenterOnline would be a bit more precise in its reporting than what one gets in the "retail press".

January 6, 2005

Issues Ahead
An increasingly large issue in the coming year will be the process by which medical innovation finds its way to the patient -- and this involves the HMOs, FDA, the Internet, news media and the rapidly growing marketing endeavor called DTC, or Direct-To-Consumer. It's a complex mix, already filled with controversy, certainly in the pharmaceutical area (e.g. the recent "House of Coxibs" salvo fired by Dr. Eric Topol of the Cleveland Clinic at the over-promotion of COX-2 inhibitors).

Traditionally (i.e. in "the past") new procedures got invented, tested, prescribed by and sometimes even delayed by physicians. Innovative therapies often had to scale the high castle walls built around medical specialties: I've previously described how radiologist Charles Dotter who invented the concept of angioplasty in 1964 was called "Crazy Charlie" and scorned by the vascular surgeons of his day. Even when coronary angioplasty achieved some small success in the early 80's, many cardiac surgeons considered it quackery, possibly useful in only a few percent of patients. Needless to say, "what goes around, etc.", today both vascular and cardiac surgeons face a marked reduction in patients due to the success of angioplasty and related catheter-based technologies.

To a very large degree patients have discovered these innovations through the news media and, in recent years, the World Wide Web. A senior citizen I recently interviewed related to me with tears in his eyes how he was told by surgeons at a very prominent NY area hospital that his breathing problems made surgery on his abdominal aortic aneurysm (AAA) impossible, and that there was no treatment they could recommend. "They told me I should just go and die," he cried. Then his friend went on the Web and found that only a few miles away, at Montefiore Hospital in the Bronx, doctors were pioneering endovascular AAA repairs for patients like himself who could not tolerate open surgery. They contacted Dr. Takao Ohki and now over a year later, he was telling me his story, his "inoperable" aneurysm fixed.

Patients taking an interest in their own health care and researching their options, often independently of their doctors -- this is a rapidly growing trend. And it's a positive one for all, as long as the information patients are finding is accurate and balanced. But so much "breakthrough health news" is about as reflective of reality as, well, the rest of the news.

This was a fact not lost on the founder of coronary angioplasty, Andreas Gruentzig. When he performed the first angioplasty back in 1977, the patient, Adolph Bachmann, was so excited it worked that he called the local paper from his hospital bed. But Gruentzig did not allow the press to report it -- he promised the reporter from the Zurich newspaper an exclusive, but later on, when he had done more cases. He knew that if the procedure were publicized prematurely, too much pressure would be put on total success. There was already considerable skepticism about it so, even after a few successful outcomes, the first failure could have dire consequences for development of the procedure. So his achievement was not just the invention of the procedure, but the careful "fathering" of it. He was cautious, careful, scientific, his claims were modest, yet he was completely charismatic. He believed that patients were partners in this new field and when he ran live demonstration courses, broadcast by closed circuit TV to thousands of physicians, he joked with the patients and at the end had the patient wave to the audience while the assembled cardiologists loudly applauded the patient's courage and Gruentzig's invention.

Talk about Direct-to-Consumer!

So should one conclude from my "stories of days gone by" that advertising a new medical procedure is a bad thing? Well, no. My friend with the AAA would most likely not be alive if Tak Ohki had not been "promoting" his endovascular approach on the Net. Even for pharmaceuticals, a somewhat different situation from procedures, is all TV drug promotion a negative? Not if it opens new possibilities for patients, or helps them understand the importance of compliance. The Center for Business Intelligence is, in fact, holding a conference on this very subject. After all, some of the problems and complications with drug-eluting stents come from patients failing to adhere to the necessary antiplatelet regimen of clopidogrel (Plavix) for at least 3-6 months post-procedure, preferably longer. Reinforcement for compliance is a worthy endeavor.

That being said, Eric Topol (who I've heard referred to as a "naysayer" by some in the profession -- so I should remind readers that when I met him, he was one of the "nouvelle vague" of pioneering interventional cardiology Fellows in the early 80's) has opened up what I feel is a valuable debate. And it's not a new one. In fact, on our web site, you can see a video clip of prominent physicians, inventors and device manufacturers discuss the difficulties in balancing innovation, ethics, research and marketing in the field of interventional cardiology.

Anyway, here's but one small attempt at defining the issue: my experience in being around new and innovative therapies, and seeing some succeed brilliantly, some more modestly, and some totally fail, is that in every failure there's often a positive side: finding out the "why". After all, an artery that has been treated with angioplasty closes up again 25-30% of the time. Not forgetting that this means 2/3's of patients have been spared major surgery, it's important to recognize that the scientific investigation into discovering the "why" of the restenosis process has led us much much closer to the root causes of coronary artery disease, especially to the complex genetic and biologic processes. So followup and "post-market" tracking is not just important for safety reasons, but for reasons of science. What could be more informative than seeing how well a therapy or new drug actually works, and finding out, when it doesn't work, why?

Seems to make sense, but while I'm writing this, I've just looked up at my personal LCD screen on the flight to New York, and CNN's headline reads, "New Heart Villain!" -- no doubt a "report" on the C-Reactive Protein studies published today. Gee, CRP used to be called a "marker" -- now it's "the villain!" Kill the messenger, I guess. Ah...the news....

I'll be talking more in this blog about this whole issue of patients, education and marketing, and would very much appreciate your comments.