Stent Blog of Burt Cohen (The Voice of The Ear)

Burt Cohen, Producer & Medical Editor, BA, Williams College; MFA, N.Y.U. Graduate Institute of Film and Television; post-graduate study, San Francisco State Multimedia Studies Program

May 17, 2008 -- 10:50pm EDT

Obama and Clinton Agree
A major story in tomorrow''s New York Times, titled "Doctors Start to Say ''I''m Sorry'' Long Before ''See You in Court''", discusses the problems of medical errors, malpractice suits and explores how "a handful of prominent academic medical centers, like Johns Hopkins and Stanford, are trying a disarming approach."

The article by Kevin Sack is a good read, and should be of significant interest to hospital administrators, physicians and patients. The "disarming approach" being put forward is that, if and when a medical mistake occurs, the doctor and hospital should immediately apologize to the patient, explain what happened and be forthcoming with all information instead of adopting the "deny and defend" strategy advocated by malpractice lawyers and insurers.

To bolster the argument is the case study of the University of Michigan Health System which, according to Richard C. Boothman, the medical center�s chief risk officer, saw a very large drop in lawsuits, settlement amounts and time to settlement after instituting such a program. Boothman is quoted that "Improving patient safety and patient communication is more likely to cure the malpractice crisis than defensiveness and denial."

So what does this have to do with Barack Obama and Hillary Clinton? Well, almost two years ago to the day, they co-authored an article in the New England Journal of Medicine titled, "Making Patient Safety the Centerpiece of Medical Liability Reform".

Yes, co-authored! They agreed on something.

And their 2006 article portrays precisely the program described in tomorrow''s New York Times story. It even used the University of Michigan as the prime example where this has worked. In fact, the NEJM offers an audio interview with the same Richard Boothman as part of the article online.

Back in May 2006, we featured the Clinton-Obama article on our news page because we thought it very forward of two highly regarded political leaders to promote such a carefully thought-out program in a peer-reviewed scholarly medical journal. It''s quite likely in fact that the "prominent medical centers" now experimenting with this strategy read the NEJM piece when it was published.

So how come the Times didn''t acknowledge this forward-thinking journal article from two years ago? The Times piece does briefly mention that Clinton and Obama had sponsored some legislation in this area, but the Senators'' NEJM article is not mentioned once in the NYT story, which seems a bit odd to me...


May 15, 2008 -- 10:50am EDT

"Life Wide Open": A Stent Cypher
Yesterday the New England Journal of Medicine published a commentary, titled: "DTCA for PTCA � Crossing the Line in Consumer Health Education?" The editorial piece was highly critical of Johnson & Johnson/Cordis'' TV ad campaign (called "Life Wide Open") first broadcast during a football game last Thanksgiving. The ad touts the advantages of the company''s CYPHER drug-eluting stent.

(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:

"It seems almost unimaginable that a patient would challenge an interventional cardiologist''s judgment about the use of a particular stent or that a cardiologist would accede to a patient''s request for a particular stent on the basis of the information gleaned from a television ad."

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:

If You''re Having A Heart Attack, Get To A Hospital That Performs Angioplasty Immediately!

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!!


November 12, 2007 -- 12:50pm EST

About Those Stents: Tiny Time Bombs in Your Heart...or Not?
This morning''s New York Times announces that the drug-eluting stent has been pardoned and taken off Death Row. In an article, titled "A Heart Stent Gets a Reprieve From Doctors", Barnaby Feder discusses the recent flurry of data that seems to be reversing the year-old panic that drug-eluting stents (DES) were "tiny time bombs in your heart". This phenomenon was dubbed the "firestorm of the ESC" because the first major presentations, pointing out a higher-than-reported incidence of potentially fatal late stent thrombosis in DES, were made at the 2006 European Society of Cardiology (ESC) meeting last September.

I reported on the misinformed flame-stoking press coverage at the time, and specifically the news report that started off:

"Millions of Americans could be walking around with tiny time bombs in their hearts."

In my blog entry of exactly one year ago, titled "Eentsy Weentsy Time Bombs -- or -- The Pen is Mightier Than the Clot", I critiqued that report and took its author to task for scaring the hell out of patients with incorrect information.

This morning''s NYT references the same report, attributing it to "a cable news network". In point of fact the author, Robert Bazell, is the Emmy and Peabody awarding-winning chief science and health correspondent for NBC, and his report appeared on the NBC Nightly News with Brian Williams. Bazell continued his thrust a month later in his broadcast about the FDA stent safety panel:

"Many cardiologists have gotten carried away with the new technology with results that could be very dangerous for some patients."

Or..."Watch out for that cowboy in your heart!"

The point being that much of the negative and incorrect news coverage appeared in the broadcast and mainstream media and had a very big impact.

As I look back and read my report from November 21, 2006, as well as the various DES articles we posted on Angioplasty.Org, in light of the new data presented at this year''s ESC, TCT and AHA meetings, I have to say nothing in my mind has changed. These stents work well, there is a very small, but serious complication involved, strict adherence to dual antiplatelet therapy is critical, patient selection is extremely important (don''t use DES in patients who won''t be able to comply with the Plavix/aspirin combo and consider using a bare metal stent in situations that have a low risk for restenosis), and statistically speaking, the small increase in complications from DES will be offset by the increased restenosis seen in bare metal stents (studies have shown that restenosis presents as a heart attack about 1/3 of the time).

All this was known a year ago, the new registries and studies have confirmed this knowledge.

So nothing has changed...except, oh yeah, the sales of drug-eluting stents have slumped, down over a billion dollars worldwide, and DES usage in the U.S. has dropped from 90+% to low 60% range. Boston Scientific and Cordis are laying people off and the field has been in turmoil.

Except that now multiple studies, including the oft-quoted SCAAR Registry from Sweden, are revising the view that DES are dangerous. It''s a billion-dollar Emily Latella gag.

So to me, the very interesting question was one raised by Rotterdam-based Dr. Patrick Serruys, during a panel at the TCT last month. In referring to the 2006 ESC presentations, he asked:

"How could such a small group of studies by a small group of people have such a big effect on the entire field of interventional cardiology?"

I have an answer. Tune in tomorrow....

(By the way, after I sat through almost a dozen studies presented at TCT, all showing no difference in heart attack or death between drug-eluting stents and bare metal stents, I asked the panel, "So would you conclude that there's no ticking time bomb inside patients' hearts?" And distinguished cardiologist, Dr. Sigmund Silber of Munich, replied, "No. Millions of patients are walking around with a ticking time bomb in their hearts -- it's called coronary artery disease!")


November 8, 2007 -- 11:14 EST

Headline Writers Play "Telephone" I've tagged these in past columns as "Dreadlines" -- an over-amplification of a news item (i.e. a distortion, as in old school "Heavy Metal"). But when you add misinformed medical reporting to the "anything for a thrill" MO of the headline writers at Fox News, you get things like this:

Super X-Ray Drawing Controversy for Super-Dose of Radiation

It's the game of "Telephone" -- you whisper a message in the next person's ear and by the end of the line...well, you get the idea.

That's exactly what happened to the study which I discussed in Tuesday's post. The CorE 64 trial, presented at the AHA this week, proved the extremely high accuracy of Multislice CT in ruling out coronary artery disease. To be sexy, AP dubbed it a "Super X-Ray". But in the story was a completely inaccurate line that the CT radiation dose was 10 times higher than a standard angiogram. I disputed this in my post, and yesterday an expert in the field, Dr. Michael Poon, President of the Society for Cardiovascular CT, confirmed to me that major studies have shown the radiation dose from CT to be 1-2 times that of a standard angiogram, and certainly the same as, if not less than, the dose from a nuclear stress test.

But facts shouldn't get in the way of selling papers (or, in the case of Fox News, selling...um, what is it that they're selling anyway?) So what started out on Monday as the scientific presentation of a very successful randomized clinical trial of Multislice CT, turned within 24 hours into the totally fear-mongering headline above -- which is great on Halloween, but not so much when people's healthcare is concerned.


November 6, 2007 -- 9:48 EST

The Super X-Ray Invisible RayOn Halloween night, Turner Classic Movies ran a Karloff-a-thon and I got to see a favorite sci-fi flick from my nerdy 8th grade years: "The Invisible Ray" -- a cautionary tale in which an unknown ray, emanating from a meteor that crashed in Africa long ago, was able to melt and destroy rocks and statues, yet also cure blindness and countless other diseases -- all, of course, at the expense of making Boris Karloff glow in the dark and instantly kill anyone he touches ("Pushing Daisies" anyone?).

So it was with amazement that, when I logged onto the news yesterday, I saw headlines everywhere proclaiming a medical breakthrough: the "Super X-Ray".

We had just posted an article about the results of the CorE 64 study, presented at the annual American Heart Association Scientific Sessions in Orlando by the investigators at Johns Hopkins. The goal was to compare the diagnostic accuracy of 64-slice CT angiography with the current "gold standard" of invasive cardiac catheterization in the detection of coronary artery disease. The results were excellent -- you can read more about the study in our article, "64-Slice CT Heart Scan Gets High Marks As Test for Blocked Arteries."

It quickly became clear that all the articles about the "Super X-Ray" were in fact about the CorE 64 study. In fact, most of the articles were feeds from the AP article by Marilynn Marchione.

I've discussed with cardiologists from the Society of Cardiovascular Computed Tomography the fact that this technology, which has been around for a few years now, needed a name. Sometimes it's called Multislice CT (CT stands for "computed tomography") or Multidetector CT or Cardiac CT or CT Angiography, CTA and so on. And there are generations from 16-slice to the current 64-slice and coming soon at your neighborhood imaging center, the 256-slice scanner.

But now the retail press has taken care of that: presenting the "Super X-Ray". I'll take two, please.

By the way, I'll be writing more on this subject -- because there are some serious inaccuracies in the AP article, for example, stating that Multislice CT scans "deliver 10 times more radiation to the patient than a standard angiogram". (Who wouldn't glow after one of those?) There are a number of studies that show the range of radiation doses to be anywhere from the same to about twice as much, depending on who does the study, what equipment is used and whether newer techniques such as gating and phasing are used (significantly reducing the radiation dose).

Even at its high end, the radiation exposure from CTA is similar or less than what the patient gets in a typical nuclear stress test -- a widely-used test that many imaging specialists feel will be replaced by CTA.

For more, and more accurate information and interviews with experts about this and other imaging technologies, visit Angioplasty.Org's Imaging Center.


September 3, 2007 -- 3:38PM EDT

"England swings like a pendulum do" The pendulum here is not the one that Roger Miller sang about in 1966, but rather, if you don't mind a major gear-shift, the one that Dr. Kirk Garratt of Lenox Hill Heart and Vascular Institute discussed with me recently -- namely the use of drug-eluting stents vs. bare metal stents. (I'll explain what England has to do with it later on, as well as gear-shifts.) Dr. Garratt told me that he felt the pendulum had swung too far in the direction away from drug-eluting stents (DES).

In 2004, DES were the darling of interventional cardiologists: these new devices were going to change the way interventions were done because they overcame the bug-a-boo of restenosis. DES became one of the fastest adoptions of a new technology ever and in the U.S. virtually replaced the older bare metal stent overnight.

Swing pendulum swing!

Everything was going along fine until the small but potentially catastrophic incidence of late stent thrombosis came to the forefront, most publicly one year ago at the European Congress of Cardiology. Was it a big problem? There was much heated debate, scary headlines and the convening of a 2-day FDA stent safety panel in December. At that panel, Dr. Lars Wallentin presented the SCAAR registry data from Sweden which concluded a 0.5%-1% increased risk of death or heart attack from drug-eluting stents per year, starting after 6 months.

Swing back pendulum! In just 6 months, the stent device industry experienced a thrombosis of their own: drug-eluting stent use in the U.S. had dropped from 90% to 70%. (In Sweden, DES use hovers around 20%.)

Now, yesterday in fact, longer follow-up and greater numbers have significantly revised the latest SCAAR registry data -- new conclusions have just been presented at this year's ESC and guess what? No discernible difference between DES and bare metal has been found in terms of higher risk of death and MI! The disparity seen at 1-year disappeared after 3 and 4 years, as the patients with bare metal stents caught up, and as cardiologists, concerned over stent thrombosis, began selecting patients more carefully and prescribing antiplatelet therapy for a longer duration.

(This trend of catch-up and evening out, by the way, was one which was vociferously advocated by Marty Leon and Gregg Stone at last year's TCT meeting. They were right.)

Various studies have also been presented showing long-term safety for the Taxus and Cypher stents. And Medtronic's Endeavor and Abbott's Xience second generation DES are expected to hit the U.S. market in the next year.

Stand clear. Pendulum about to swing back.

While many may seem astonished at the 360 that's occurred, the reasons are not that complicated and were totally predictable. In fact we at Angioplasty.Org have been writing about these factors for the past year. Immediately after last year's ESC, in the midst of the scare dreadlines from the press and the antidotal "they're okay, really" messages from the device industry, we posted a "Stent Advisory for Patients" to help our very concerned readers understand and make intelligent decisions.

In our exclusive interview with Dr. Antonio Colombo, he compared drug-eluting stents to a high performance race car:

It�s like if you were driving a faster car. If you know what you�re doing, it�s fine. But it�s more prone to make a mistake if you�re not very careful.

We would add that you also need to know where you can drive it safely, how long the trip is going to take, and make sure to check the oil regularly.

Cutting to the chase, DES work great, but they require at least a year or two of dual antiplatelet therapy (clopidogrel and aspirin) to prevent thrombosis. This is not a plus for patients who need or are likely to need surgery in that year. Also not a plus for patients who are at high risk for bleeding. Or for patients who might be allergic to the stent, the polymer, the drug, or Plavix.

Similarly, cardiologists need to take care in placing the stents accurately and expanding them fully -- something Dr. Colombo and others discuss at length and why they use Intravascular Ultrasound (IVUS) to guide them in these decisions.

Finally, there are patient populations who don't really see a large benefits from DES: those with large diameter arteries, for example.

In contrast, narrow arteries, bifurcation lesions, diabetics -- those at higher risk for restenosis, can benefit widely from the use of drug-eluting stent technology, since these devices can reduce the repeat procedures that have been necessary in the past, eliminating the risks inherent in any additional medical procedures and, saving the cost of repeat procedures.

Which brings me to England. The National Institute for Health and Clinical Excellence (NICE -- or as British cardiologists are now calling it, not-NICE) has recommended that the British Health Service cease reimbursing the use of DES because they are not cost-effective. Comments from the public on this proposal just closed last week and the decision as to whether to follow NICE's guidelines is imminent. Given the somewhat different news coming out of the ESC, perhaps England will also swing like the pendulum do, and deep-six this recommendation -- something strongly urged by cardiologists not only in Britain, but all around the world.


June 8, 2007 -- 7:14PM EDT

Consumer Retorts The magazine that tells you the best dishwasher to buy, which toaster gives you that nice overall even brown crispness, or which SUV is most likely to roll-over on a sharp turn, has now entered the cath lab. The Editors (and the experts they have consulted) are recommending against getting angioplasty, except in certain very specific cases, like a few hours after a heart attack (my recommendation: don't wait -- get that angioplasty now! WHILE you're having the heart attack!!).

CR also thinks that multislice CT angiography is "seldom worthwhile"; their number one recommendation: "In general, don't bother with CT angiography." You might think that this recommendation might slightly upset the 3,400 members of the Society of Cardiovascular Computed Tomography (SCCT) -- and it did. The CR piece was published online last week, but had been published in print back in March -- and the SCCT leadership wrote a strongly worded critique, taking Consumer Reports to task for maligning this new and valuable test. For example, CR mistook a CT angiogram for a Calcium Scoring test.

Well this new online version corrected that one error, but left in a slew of others. You can read all about it in today's feature on Angioplasty.Org.


April 19, 2007 -- 12:26pm EDT

Banned in Boston In today's news from theheart.org, Shelley Wood reports that the Boston-based New England Journal of Medicine has banned Marty Leon from its panel of peer-reviewers, and furthermore will not be inviting Dr. Leon, one of the highest profile interventional cardiologists in the world, to write reviews or editorials for the Journal for a period of five years.

This action was taken in response to Leon's alleged breaking of the press embargo around the COURAGE trial, which was scheduled to be presented on Tuesday morning, March 27, at this year's American College of Cardiology annual meeting in New Orleans -- and simultaneously published online by the New England Journal. The five-year COURAGE trial studied whether angioplasty/stents added to medical therapy provided any additional benefit in reducing death and heart attack in stable patients.

In the weeks leading up to the ACC, the trial had been the subject of much press hype and statements from non-interventional cardiologists that, if the results showed no benefit for stents over drug therapy, it would "shake the foundations of interventional cardiology" -- a throwing down of the gauntlet to stent-evangelists like Marty Leon, one of the builders of that foundation.

As for the embargo, the Thursday before the ACC began, the NEJM gave the results of the COURAGE trial to all health reporters, this one included, so that we could prepare our stories. We were allowed to reveal those results to anyone we interviewed for an article. We just weren't supposed to publish or discuss the results in public until Tuesday morning.

Fast forward to Sunday night the 25th at the Hilton New Orleans Riverside hotel. The first two days of ACC presentations and PowerPoints were now over and many interventionalists were attending a free reception (food with open bar) and an evening "satellite symposium" about drug-eluting stents, sponsored by Boston Scientific. The final speaker was Marty Leon.

As Keith Winstein reported two hours later in the Wall Street Journal's Health Blog:

Leon...tipped the audience of several hundred doctors to the embargoed conclusions of the Courage trial about stents...adding that he had reviewed the Courage study after it was submitted to a medical journal. "It was rigged to fail, and it did," he said...."There's going to be an onslaught.... A lot of people have been taking shots at us, and we need to go on the offense for a while."

Boom. The Battle of New Orleans had begun. Or was it just "Marty Gras"? In any case, the whiff of grapeshot wafted across Convention Center Boulevard. Monday morning's WSJ ran a more detailed story. The embargo was broken. ACC and NEJM leadership was furious. They hastily scheduled a press conference and made the following statement:

At 1 p.m. Central time on Monday, the American College of Cardiology lifted the media embargo on the COURAGE trial that was to be presented on Tuesday. The decision was made after the College discovered that information related to the study�s results was released Sunday evening and that information was made public in a media article.... We are extremely disappointed that this individual or individuals released this information, betraying the confidentiality of the scholarly process and the professional integrity of the scientific community. The American College of Cardiology will be considering strong sanctions against the individual or individuals involved.

Boom. Boom.

Dr. William Boden, lead author of the COURAGE trial, was very disappointed at having to scurry around and not present the results of his five-year's worth of arduous study at the appointed time and place.

Now, not quite four weeks later, the New England Journal of Medicine has levied its penalty -- the ACC has yet to announce what, if any, sanctions it will take.

As for Dr. Leon, he has denied breaking the embargo, saying that his comments had been misunderstood, taken out of context by a journalist, that he didn't reveal any results, that he was talking to a room of cardiologists and did not know who was in the audience.

And as for Keith Winstein, the Wall Street Journal reporter, the NEJM stated that it did not have a problem with his article, because he was only reporting on the embargo break. Winstein reported to us receiving a similar sentiment from Steve Nissen, president of the ACC.

This incident, however, has a bit more back story -- which I'll be discussing in short order.


April 7, 2007 -- 6:36pm EDT

New York Times: Angioplasty AND Drugs Are Important Gina Kolata's must-read entry in the New York Times health series "Six Killers" is in tomorrow's paper (on Easter Sunday?) and it's an important piece. Published online today, "Lessons of Heart Disease, Learned and Ignored", is a welcome addition to the many flawed articles that have hit the popular press in the past two weeks since the results of the COURAGE trial were announced.

Instead of pumping a false comparison about how "drugs are better than stents", or vice-versa, Kolata's piece is not only totally accurate, but a much-needed correction, showing both the importance of compliance with prescribed heart medications, and how angioplasty can literally stop a heart attack in its tracks and save a life.

One of our fears at Angioplasty.Org, one shared by most interventional cardiologists I've spoken to in the last week, is that the onslaught of anti-stent press would send a message to the public that angioplasty doesn't work. Forbes magazine even ran a headline, "Stent Shocker: They Don't Stop Heart Attacks" -- total crap! They do! And Ms. Kolata's article describes just how they do in a very compelling story.

BOTH drug and stents are important therapies. The real problem is that they are unfortunately not being delivered to a majority of the people who need them most -- which is the subject of our latest analysis of the COURAGE trial results.

Who are the Burst Cohen? Burt has been a pioneer in medical education for 25 years. He co-developed the multi-screen, live, interactive video demonstration course and produced dozens of courses in the U.S., Canada and Europe, training thousands of interventional cardiologists. He has worked with the physicians who created this field of medicine to educate the profession and the public about interventional treatments. His films and websites have been awarded the CINE Golden Eagle, Time Inc Health "Freddie", International Film & TV Festival Silver Medal, American Film Festival Red Ribbon and Art Direction Magazine Creativity Awards. He has been an editorial consultant to the American Heart Association and created multimedia educational projects from physician training CD-ROMs to medical history documentaries, for 45 corporate and nonprofit clients including hospitals and universities, device manufacturers, medical imaging and pharmaceutical companies