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December 2004 Archives


December 31, 2004

End of Year Wrap
In the arena of interventional therapy, certainly 2004 must be called the year of the drug-eluting stent. Johnson & Johnson's Cypher pioneered the use of this new device through the first quarter, then Boston Scientific's Taxus came on board and briefly snatched away 70% of the market until a one-in-ten-thousand glitch in the catheter-delivery system caused Boston Scientific to recall and replace most of its product over the summer. It looked for a while like they were in serious trouble; however, they regained a large part of their market-share and continued to dominate the field (Paul LaViolette, who guided the cardio division through this crisis, was recently rewarded for his efforts with the COO spot). Then J&J ponied up $24 billion and bought Guidant, one of the major interventional players -- the result of this mega-merger will be fleshed out in 2005: who will stay on, who will go -- stay tuned.

It was a good year for our site, Angioplasty.Org as well. We've doubled our monthly readership from a year ago. We currently are getting a quarter-of-a-million page views monthly and we continue to be a source of information to patients, media, investors, doctors and nurses worldwide. And, of course, I started this blog....

I'd personally like to thank all the people out there who've taken the time to share their experiences with us. We're basically a not-for-profit enterprise and a lot of what keeps us going is the knowledge that we're providing some help and comfort. A Healthy and Happy New Year to All.


December 16, 2004

Birthday Present
Guidant celebrated its tenth birthday as a company on Tuesday. It was formed from a number of small devices companies spun off by Eli Lilly in 1994, the major ones of which were John Simpson start-ups; Simpson originally learned angioplasty from Andreas Gruentzig, and then started inventing his own version of balloon catheters (ACS) and atherectomy devices (DVI) which revolutionized the field.

Anyway, Guidant turned ten -- and a day later became one -- with Johnson & Johnson. They plan to keep the Guidant name, a new division under which they'll merge the Cordis and Guidant companies. Once finalized, and they indicate they want this to happen quickly, J&J will become a major player in the ICD market, as well as having a large new stent design portfolio on which to develop future products (like second and third generation drug-eluting stents). I think they will also get a good boost of PR among the interventional cardiologists who might have been miffed by initial supply problems with the Cypher stent. Before drug-eluting stents, Guidant had the top-selling bare metal stent, and the Guidant reps were the interventionalists' best friends, so some of that "currency" is bound to rub off.

As for the antitrust worries that have been wafting through the various articles, I said a week ago that I didn't think it would be a problem. Evidently J&J agrees:

Officials saw no significant antitrust concerns in combining the two companies, which both have significant operations in heart stents. "We clearly do not see any material divestitures being required" by antitrust regulators in order to combine the companies, said Robert J. Darretta, chief financial officer of Johnson & Johnson.

So does Jim Tobin, Boston Scientific's CEO, as per yesterday's WSJ article, which noted:

If the companies are forced to divest themselves of part of their coronary-stent business, it is unclear who the buyer could be. Abbott Laboratories has said it isn't interested. Boston Scientific probably wouldn't be allowed to buy it. "We would have the same antitrust difficulties that J&J would have," said Boston Scientific's chief executive, James Tobin.


December 15, 2004

J&J to Buy Guidant
This just in...the deal everyone's been waiting for has happened. You can read all the news in our News Section. More about this tomorrow, but for those investors and other interested parties, there's gonna be a CC Thursday at 9:00am Eastern. Here's the info from the press release:

Johnson & Johnson and Guidant will conduct a conference call with financial analysts to discuss this news release on December 16, 2004 at 9:00 a.m., Eastern Standard Time. A simultaneous webcast of the call for interested investors and others may be accessed by visiting the Johnson & Johnson website at www.jnj.com and clicking on “Webcasts/Presentations” in the Investor Relations section or by visiting the Investor Resources section on the Guidant website at www.guidant.com. A replay will be available at both websites.


December 13, 2004

Addendum to Last Entry
On the heels of my comment that the military is going to have to study up on the diseases of the aging, comes this story from the Marion Ohio Star about a 70-year-old surgeon who has been ordered to Afghanistan.


December 11, 2004

On To More Serious Subjects
Mergers, acquisitions, market-shares...that's just great! But all that MBA "excitement" comes to a screeching halt when you get an email from a soldier who's been fighting the fight in Iraq. From the frontlines, I got a patient comment yesterday from a MedEvac -- a pilot whose job it is to pickup and fly injured soldiers from the Iraq "theater" to the military hospital in Germany. He's from my generation, the Vietnam generation; he flew casualties in Vietnam and he was doing the same for those in Iraq. Except he suddenly needed to have an angioplasty and was sent to a private hospital in Germany where they spoke no English and he wrote that he wished he knew more about what was going on. (My thought: if the U.S. military has men of my generation in the active war theater, they're going to need to study up on diseases of the aging!)

In my letter to him, I noted that Germany figures importantly into the history and development of angioplasty. Just as the Vietnam conflict was starting, Portland, Oregon-based radiologist Charles Dotter came up with the idea of using a catheter-based system to treat atherosclerosis from the inside-out. He was ridiculed by the vascular surgeons in the U.S. and it took a visionary compatriot like Eberhardt Zeitler from Nuremburg, Germany to see the brilliance of Dotter's concept. Zeitler taught Andreas Gruentzig, a fellow German, the technique. Gruentzig, now considered the father of coronary angioplasty, refined it for use in the heart in 1977. Gruentzig, by the way, was born in Dresden, Germany, only five years before it was totally incinerated by our Air Force in the final months of WWII. His mother got her family out in time. And now our soldiers go to Germany for medical treatment....

Then yesterday, an article in the Boston Globe was published, discussing the casualty/death rate in the Iraq War. It was titled, "Amputation rate for US troops twice that of past wars". But the point was that the death rate of American soldiers in the Iraq War has been far less than that in previous conflicts. Why? Kevlar! Actually it's a material that has been used in coronary guide catheters. The Kevlar vests have saved many lives. I already knew about this phenomenon -- Bill Blaisdell, one of the pioneers of vascular surgery, discussed this with me during an interview I did with him a couple of years ago. He was talking about the Afghanistan war and how he had been asked to consult for the U.S. military and how deaths were down, but amputations were up. The vests protected the vital organs, but extremities were unfortunately still vulnerable to bombs. While over 1,000 soldiers have been killed in Iraq, almost 10,000 have been injured, half seriously enough to be sent back home.

Hippocrates said, "If you want to be a surgeon, follow an army." You can see a "brief history" of vascular surgery and how it literally was advanced during the various wars the U.S. fought in Chapter 1 of my documentary "Vascular Pioneers: Evolution of a Specialty". The odd thing is that amputations were significantly reduced from WWI through Vietnam because of the development of vascular repair in the field (thank you, M.A.S.H., Frank Spencer, Norm Rich, etc.). But the advent of Kevlar vests, while saving lives, has increased the amputation rate to the extent that Brown University and M.I.T. have launched a research project to develop better prosthetic limbs for a new generation of returning soldiers. There is also a very comprehensive report in this week's New England Journal of Medicine about the role of the courageous surgeons who have been working under tremendous pressure and dangerous situations in the Iraq and Afghanistan wars.


December 10, 2004

Epilogue on My Merger Commentary
Okay. I'll try to stop discussing this as-yet-non-event, but today's Reuters article echoes my comments of yesterday. It quotes:

J&J's biggest medical device is its Cypher stent, which is coated with a drug, called sirolimus, that prevents it from reclogging with scar tissue. But Cypher's third-quarter U.S. sales plunged by one third to $269 million, hurt by fierce competition from Boston Scientific Corp.'s Taxus drug-coated stent.

Dr. Samin Sharma, head of interventional cardiology at Mt. Sinai Medical Center, said he and many other cardiologists are hoping J&J will buy Guidant and coat the smaller company's highly maneuverable bare metal Vision stent with sirolimus.

"It would be a marriage made in heaven -- the most flexible stent on the market coated with the best drug, and that's why J&J and Guidant need each other," said Sharma, who said he has no financial ties to either company.


December 9, 2004

Media Merger Swirl
Dozens of reports (read many of them in Angioplasty.Org's "news" section) about the impending acquisition of device-maker Guidant by giant J&J, first floated two days ago by the New York Times. The hometown newspapers of the other medical device industry players (Abbott, Boston Scientific, Medtronic, St. Jude) all have run articles on how this may affect sales, local jobs, etc. The biggest questions seem to be, "will Federal anti-trust regs force J&J to sell off part of Guidant to another company?", "Will the acquisition of the Guidant sales force help J&J regain their market share from Boston Scientific", "Will the acquisition of Guidant's bare metal stent designs give J&J a new and better platform for the next generation DES stent?" and "Will the removal of one player (Guidant) help the others?"

My thought on the anti-trust area, not being a lawyer (or a doctor -- guess I should have listened to my mom) is this: why would it not be an anti-trust issue for another device company, let's say...Medtronic, buying Guidant's stent business? After all, Boston Scientific greatly expanded when it was able to purchase SciMed in 1995 and then Schneider in 1998, both major players in the angioplasty field (Schneider actually manufactured the first PTCA balloons for Andreas Gruentzig in a garage). I'm not sure the acquisition of the sales force is that big a deal anyway, although I'm sure there will be a "consolidation" of the force. Getting a better platform design, however, may be very important to J&J. With Boston Scientific readying their Liberte' second-generation stent, J&J/Cordis are going to need to update their Cypher product -- and Guidant's Multi-Link, etc. designs were the market leaders before the advent of coated stents. Of course, such a new generation stent would not beat the Liberte' to market which is already in trials. But what I've mentioned before, about J&J obtaining Guidant's patent portfolio in the deal, might be one of the most important aspects -- these could be used to defend new products, as well as litigate against others.

Just a few thoughts.... Word is that a Board meeting has been scheduled for Sunday, so we should hear news very soon.


December 7, 2004

More on Merger Talks
More on the possible J&J/Guidant merger and what its implications might be. One criticism sometimes heard has been that J&J's CYPHER stent isn't as easy to position ("deliverable") as Boston Scientific's. A new J&J stent, using Guidant's very popular platform, now could be developed. Or, will anti-trust issues force the sell-off of Guidant's drug-eluting stent technology? Abbott has been discussed as a possible buyer, but they say they're happy with their own program and want nothing to do with Guidant's, or anybody else's stent. Regardless of the outcome, the impending J&J/Guidant venture, if it happens, would be a significant event -- Guidant owns many many important patents (read that, "ammunition for use in legal battles") and, prior to drug-eluting stents, Guidant was the leader in the bare metal stent market. They also make the first FDA-approved carotid artery stent/protection system, the RX AccuLink and AccuNet, plus a host of other interventional products. These new devices will be very important in the future of expanded endovascular therapies (please excuse the self-serving plug for our new website, VascularTherapy.Org...).

Moreover, eyes are on the upcoming REALITY trial data. J&J-sponsored this trial which puts their CYPHER stent head-to-head with Boston Scientific's TAXUS. Results to be announced in three months at the ACC in Orlando. What does the winner get (besides a trip across the street to Disney World)? If the data shows one stent to have significantly better restenosis results than the other, the winner will get lots. Of course, there will be big debates about what the results will mean. There are many measures; no doubt terms like late lumen loss, TVR, TLR, edge effect, etc. will be spun by both sides. While cardiologists will decide what they'll use based on a number of criteria, including something called "deliverability", ease of use and available sizes, the retail press is sure to amplify the announced results, not necessarily accurately -- remember the panic headlines of this past year -- and that will affect patients' preferences. Heart patients research their disease and procedures, using our site, Angioplasty.Org, and others; they're hip to the devices and, if they read a news article that says Stent A prevents restenosis better than Stent B, they're going to ask their cardiologist why he's using stent B. This already happens with pharmaceuticals -- and device companies have discovered DTC (Direct To Consumer).

So with a possible acquisition of Guidant and the upcoming REALITY trial, J&J should have an interesting quarter.


December 6, 2004

Merger Talks Heat Up
This just in...the New York Times reports that Johnson & Johnson is in "advanced talks" to purchase Guidant. $24 billion is the figure mentioned. With Cook having recently dropped out of the coronary stent business, this would represent a further narrowing in the field -- of course, there are only two "real" (i.e. drug-eluting) stents being marketed -- one by J&J (Cypher) and the other by Boston Scientific (Taxus) -- but Guidant is in clinical trials, as are Abbott and Medtronic, and a few smaller companies, like Conor.

I first coined the term "Stent Wars" almost three years ago (sorry, Motley Fool) -- and it's an apt metaphor, although we're not sure who are the Rebels and who is the Evil Empire. Guidant was one of the first to create a drug-eluting stent, a co-project with Cook -- only problem was it didn't work so well and they dropped development. That, plus legal issues brought against them by Boston Scientific, scrapped their anticipated merger with Cook. Then J&J got their approval, but stumbled when they couldn't supply enough product in enough sizes and subsequently experienced a media panic over the issue of stent thrombosis. Within months, Boston Scientific came in with their newly-approved Taxus and grabbed 70% of the market. Great going until they found a serious problem in a very small number of catheters this summer and, as a precaution, recalled virtually their entire inventory. Ouch! More media panic. But four months later, they report that their major market share is back.

Stay tuned.