HOW TO BLOCK A STUDY:

RIGHT-HEART CATHETER
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 States alone.

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 (12/14/96).

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.

LOSING LIVES?

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 thousands.

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 on them.

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?


Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.



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