July 2005
Archives:
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....
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....
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.
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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