The Voice in the Ear -- Burt's Blog
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July 2005 Archives:
21» Conflict of No Interest
18» House
17» Take a Yahoo! Shortcut to Misinformation
5» Patent Law to Follow Juice Break

July 21, 2005

Conflict of No Interest
Today's New England Journal of Medicine carries a major story about the Guidant ICD recall, The Controversy over Guidant's Implantable Defibrillators by Robert Steinbrook, M.D. (access for subscribers to NEJM only). The article deals mainly with the company's decision not to publicize the problem early on. It also raises this issue, as reported in the Twin Cities Pioneer Press:

The journal's story questions whether attempts to develop better guidelines on disclosing device problems will be effective given concerns "about potential conflicts of interest." That's because the Heart Rhythm Society, a professional association of medical specialists, gets a quarter of its $8.5 million budget from the medical device industry — and it is leading the reform effort, the story says.

Also last week was the Boston Globe story that the FDA has just cut back, rather than increased, its funding for medical device safety monitoring.

So let's get this straight: money from industry might cause prejudice and compromise objectivity; money from government, supposedly "cleaner", is being cut back or is non-existent. As for philanthropic dollars falling from the sky, please tell me where to stand with my bucket.

It's a problem we face in trying to maintain support for our website, Angioplasty.Org, and the reality is that most professional medical organizations and non-commercial websites (in the heart field anyway) get a substantial portion of their financial support from industry -- either directly, through support of specific programs, through exhibits at national meetings, etc.

Whether the motivation for funding such efforts is corporate social responsibility or self-interest (corporate giving to organizations like the Heart Rhythm Society is a PR decision) it doesn't automatically follow that studies, recommendations and reports will be compromised.

Medicine as business presents ethical challenges: for example, is medical research compromised when study investigators have a stake in the device they are testing? (See RealVideo clip, "Devices, Ethics and Money".)

Full disclosure and transparency are, of course, essential. Dogged reporting is required. It's fine to question motivations. But it's even more important to examine data -- it's up to those of us writing about and reviewing device safety information to parse "reform efforts" on their scientific merits.

The important thing is that someone assumes responsibility to monitor device safety and watchdog the device industry more aggressively than is occurring now (as reported in the Newark Star Ledger). But until the government steps to the plate (not likely in the near term) I for one am going to keep pressuring those who protect their stockholders' interests to financially support efforts to protect the public's interest as well!

We love to hear your suggestions....

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July 18, 2005

House
In today's New York Times, Dr. Sandeep Jauhar reviews the Emmy-nominated Fox TV series "House" (a show I very much like). Like Dr. Jauhar's spouse, who is an internist, I too am aware that doctors don't work the way they do on this show. One doctor does not perform all the various diagnostic tests, surgeries, catheterizations, etc. that the characters on this show do. The doctors, hospital, everything about this show is totally unrealistic -- surrealistic, if you will. But, unlike other TV fare which tries to be realistic, and almost always falls far short, "House" throws details to the winds and captures the true excitement, detachment, caring, curiosity and unreality that I have always seen in hospitals, especially surrounding doctors who are on the cutting edge, you'll forgive the pun.

I mean the first angioplasty balloon was fashioned on a kitchen table in a small apartment in Zurich using Krazy Glue (the apartment of Andreas Gruentzig also doubled as his wife's psychiatric office where she saw patients -- he had to be quiet so as not to disturb them while he was discovering his revolutionary therapy for heart disease). Julio Palmaz reportedly got the idea for his stent from looking at chicken wire. And the stent was financed by a fast food entrepeneur from San Antonio with a penchant for diamond pinkie rings and mink coats. In Syracuse, Charles Dotter used a guitar string for a guide wire. In France, Simon Stertzer, lacking the compressed air he needed to perform a RotaBlator procedure, bought a cannister off of a construction site across the street from the hospital. In fact, back in the early days of coronary angioplasty (circa 1979) Stertzer had mounted on the wall of his office a poster-sized photo of himself, wearing shades and dressed in black leather on a Harley-Davidson with the caption, "Would You Let This Man Stick a Balloon in Your Heart?"

"House" may be outrageous, but when compared with reality, you ain't seen nothin' yet....

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July 17, 2005

Take a Yahoo! Shortcut to Misinformation
I regularly search Yahoo! for information on "angioplasty" (mainly as a daily affirmation -- I like to see the name of our site, Angioplasty.Org: The Angioplasty/PTCA Home Page, in first position). But recently, a Yahoo! Shortcut has been added just above us. Billed as "a quick way to get to the information you want", this link gets you quickly to information that's so old, it's wrong.

The Shortcut takes you to a Yahoo! Health article, provided by their partner Healthwise. So, as a self-appointed deputy in the Internet Medical Police (is there any other kind?) I'll issue a few quick tickets to Yahoo! Health for moving violations.

Intracoronary radiotherapy (brachytherapy) is billed as "a newly approved therapy in which radiation is applied to the stented portion of the artery to treat restenosis that has already occurred." There's even a footnote citation from Dr. Martin Leon, dated 2001. Sounds good except it ain't right. Brachytherapy is so "newly approved" that 5-year followup studies were presented last fall at Dr. Leon's own TCT meeting, showing that patients fared no better with this treatment than with placebo. As we quote Marty in our TCT 2004 article:

"We view vascular brachytherapy as if you're basically exploding a bomb in the coronary arteries...You eternally alter the biology of the vessel wall, you affect endothelialization, you affect platelet absorption...and you affect the healing response...We have essentially ceased using vascular brachytherapy [in our hospital]."

So have most hospitals. What's more is the studies were not "breaking news". Most cardiologists already knew brachytherapy wasn't working so well and Guidant ceased manufacturing its system back in 2004.

Yahoo! Health again:

"Coated stents are being used at some large medical centers to help prevent restenosis after angioplasty and stenting."

Wrong. They're being used everywhere. The first drug-eluting stent was approved two years ago and instantly took over. Bare metal stents are hardly ever used anymore -- accept no substitutes.

And yet again:

"When a stent is also used, you may be given aspirin and another platelet inhibitor (such as clopidogrel [Plavix]). You will usually take the aspirin long-term; the second platelet inhibitor usually is given for at least 1 month after the stent is placed."

Nope, nope, nope. If you get a drug-eluting (drug-coated) stent -- and you will 98% of the time -- you'd better be taking Plavix or Ticlopidine plus aspirin for at least 3-6 months, and more like a year. Is this a petty mistake? No. Stent thrombosis (clotting) is a serious complication of the post-stenting period, not in numbers, but in severity. Only 1% or so of patients get it, but 45% of them die. Plavix or TiClid and aspirin do much to prevent this, but they must be taken way more than a month (aspirin for life).

And there are more mistakes, but what is disturbing to me is that I wrote about all these errors months ago when reviewing WebMD. It seems they "partner" with the same encyclopedic database, Healthwise, a company that claims:

"Since 1975 Healthwise has developed Prescription-Strength Information™ resources that doctors trust and consumers rely on because they are accurate and up to date."

I believe that the "Prescription" is past its expiration date.

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July 5, 2005

Patent Law Class to Follow Juice Break
The past month has seen several stent trials in the U.S. and Europe, attempting to determine who owns the patent on the coronary stent. Turns out juries have decided that Johnson & Johnson/Cordis has the patent for most of the way a stent is structured, but Boston Scientific has owns the technology for coating the stent with medicine. Is there a Solomon in the house?

Anyway, the whole question of "whose stent is it anyway?" takes me back to a story I heard from Dr. Spencer B. King, III (angioplasty pioneer and past president of the ACC). A number of years ago he visited his kid's third-grade class for "What Does Your Father Do?" day and he talked about coronary artery disease. He drew on the blackboard what a blocked artery was all about and then asked the 8-year-olds to draw on a sheet of paper an invention they could think of to fix this problem. "It was amazing," he said. "Right there, in just a few minutes, a class of elementary school kids invented bypass, angioplasty, atherectomy, everything we do today." Maybe the judge should rule that some of the proceeds of these stent cases should go to fund Science education in our elementary schools. Or at least better lunches!

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