HOW TO BLOCK A STUDY:
MAY CAUSE PATIENT DEATHS
Copyright 1997 by Ralph W. Moss, Ph.D.
We don't often discuss medical issues other than those relating to cancer
treatment, but we just couldn't resist this story. --Ed.
An article in the September 18, 1996 issue of the Journal of the American
Medical Association (JAMA) has raised serious questions about the use of
right-heart catheterization in patients with heart disease. This is of interest
not only to those struggling with heart conditions, but to all those who
wonder how important treatment decisions are made by "scientific medicine"
in the USA.
Every year, thousands of seriously ill patients are subjected to this invasive
procedure, which involves inserting a plastic catheter tube into a vein in
the neck or in the groin. The doctor must then slowly thread this tube through
the bloodstream. A tiny balloon at the tip is inflated to transport the device
into the pulmonary artery. Once there, the catheter device relays information
about blood pressure, blood flow, and oxygen concentrations to the doctors.
Its overall purpose is to tell whether the heart is pumping effectively.
Most cardiologists swear by the value of this procedure, so basic to their
art that it is now performed over one million times per year in the United
Few people are aware that the right-heart catheter has never actually been
proven safe and effective. But its use was established in medicine before
receiving rigorous scrutiny from the FDA or anyone else.
Is this "scientific?" You might think that vocal advocates of "scientific
medicine" would leap at a chance to prove that this pervasive technique is
both safe and effective. Oddly, this has never happened.
"There is no proof that the right-heart catheter offers patients any clear
advantage," wrote Science News, in a comprehensive review of the controversy
For years, in fact, there have been rumors of possible dangers from the
procedure. Because of such concerns, Alfred F. Connors Jr., a critical-care
specialist at the University of Virginia School of Medicine in Charlottesville,
sought to conduct a definitive study.
Naturally, he wanted to perform a randomized trial, the kind that most scientists
agree is likely to yield the most convincing results. However, he found that
all the US doctors he contacted simply refused to participate
in such a trial. They objected that participating in such a study would require
them to withhold this test from half their patients--and they were simply
unwilling to do so. And so Connors was forced to conduct a somewhat less
rigorous study. The one he finally did carry out involved collecting data
on 5,735 people, half of whom had been subjected to right-heart catheters,
half of whom had not.
But Dr. Connors and his colleagues arrived at a frightening conclusion: patients
who received right-heart catheterization ran a 21 percent greater risk of
dying within the following 30 days than people whose treatment did not include
use of the catheter. Astonished by these counter-intuitive results, they
ran an even more rigorous analysis. But this second test confirmed that there
was an even-greater, 24 percent chance of dying.
Projecting this onto the national scale, he concluded that "the right-heart
catheter may play a role in the deaths of 23,000 people in the United
States" each year.
The study was published in JAMA where an accompanying editorial in this
conservative journal stated, "We believe that it is imperative to determine
if catheterization benefits or harms critically ill patients."
What was the result? Consternation. The American Heart Association (AHA)
council on clinical cardiology immediately condemned the study as
"flawed." Why flawed? Because it wasn't a controlled trial. But remember
that it was the cardiologists themselves who had blocked a controlled trial
by refusing to cooperate in one!
JAMA also called on the National Heart, Lung, and Blood Institute (NHLBI)
of the NIH to fund a randomized, controlled trial of the right-heart catheter.
But while NHLBI director Claude Lenfant, MD agreed in theory that such a
trial was important, he explained that his agency refused to pay for it.
Instead, as he told the popular magazine Science News, "the organizations
representing critical-care doctors should undertake such a study." This sounds
like a runaround.
It may seem odd that a very common medical procedure, almost universally
believed to save lives, could somehow be taking such lives by the tens of
There are several possible explanations for this anomaly. First, there is
the possibility of bacterial infection. A previous study had shown that of
1,000 people catheterized, 60 developed infections and 18 died.
Catheterization may also be a "marker for a more aggressive style of practicing
medicine," says Science News. Perhaps it is not the catheter itself that
is dangerous, but some of the attitudes and practices of the person pushing
it. Gung-ho doctors "may submit their patients to other invasive, and risky
procedures." (ibid.). So perhaps it is more than just a little plastic tube
that needs re-examination, but an aggressive style of doctoring that has
reached the limits of its usefulness.
And why all the defensiveness on the part of the cardiologists? Well, nobody
likes to be proven wrong. (Crow is not a tasty dish.) The cardiologists as
a whole rely on this procedure. What if it turns out to do more harm than
good? It would be a blow to their whole specialty.
Second, catheterization is big business. More than one million catheter kits,
worth $2 billion, are sold every year in the US. The procedure also pumps
up the bottom line of many hospitals. The average cost of a hospital stay
was $35,700 for those heart patients who did not have catheterization, but
this jumped to $49,300 for otherwise comparable patients who had it performed
At one million procedures per year, that looks like an excess cost to
the consumer (and insurers) of about $15 billion per year. Isn't it enough
to break your heart?
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