Sunday, March 05, 2006
. To test whether federal health spending actually helps patients, Medicare has been requiring more and more of the nation's retirees to participate in clinical trials to measure the effectiveness of a growing range of treatments, before agreeing to pay for them. Now, the outcome of the first and most extensive Medicare trial yet indicates that the public, armed with the data developed, may make surprisingly conservative decisions.
It was a study of a risky but popular operation for patients with advanced emphysema, and after its results were announced in May 2003, Medicare agreed to pay for the procedure.
Some health economists were alarmed. The operation and months of rehabilitation can cost more than $50,000 and, they predicted, tens of thousands of patients could end up having the procedure. It could cost Medicare as much as $15 billion.
What happened instead was a complete surprise. After seeing the clinical trial's results - no lengthening of life for most patients and a nearly 10 percent mortality risk from the operation itself - many patients and the doctors who refer them to surgeons seemed to lose their enthusiasm.
Not everyone is happy with the outcome, however:
The main critics seem to be lung surgeons, who say that the study's findings are being interpreted in an overly negative light and that too many seriously ill people stopped seeking treatment.
The procedure in question is lung volume reduction surgery, and before Medicare required a formal study of its effectiveness, it was very popular, largey on the basis of anecdotal evidence:
The procedure's popularity was growing, as surgeons told of patients who had been tethered to oxygen tanks and so ill that they had to stop and rest every few steps. After the operation, according to the reports, many improved so much that they could walk steadily, even uphill, and breathe on their own.
Patients were posting testimonials on Web sites, hospitals were advertising, and doctors were referring their advanced emphysema patients to surgeons.
Some doctors, like Dr. Joel Cooper, a lung surgeon, published reports of his patients that were so promising that his medical center, Washington University, could hardly keep up with the demand. And Dr. Cooper, now at the University of Pennsylvania, still stands by the operation, saying in a recent interview that lung volume reduction surgery patients "are among the most grateful patients we have."
But back in 1997, noting the surgery's risks and the opinion of some doctors that it did not work at all, Medicare officials proposed a marked change in policy. There would be no more payments except for patients who enrolled in an agency-sponsored clinical trial.
Many surgeons and patients balked. Dr. Cooper refused to participate in the trial, saying he could not in good conscience randomly assign patients to the control group who would receive no treatment. Congress held hearings and listened to complaints that desperately ill patients would suffer. Representative Jim Ramstad, a Minnesota Republican, predicted the study would "negatively affect the lives of thousands of older Americans who suffer from the disease."
Patients and their families, along with reporters, called Medicare, an agency spokesman recalled, asking "Why aren't you paying for this lifesaving miracle?"
The study essentially proved that people who had the surgery could walk further without getting short of breath, but they died at the same rate as those without the surgery. The surgeons thought this was a good result, and they expected to see an influx of customers. And perhaps if their specialty society had hyped it more, they would have. But, for most people, performing surgery on the chest is a very big deal, and they want more improvement for the risk than the relatively small percentage differences shown in the study.
It just goes to show how important it is to have access to good data - and not just the hype - when making costly medical decisions. One reason it worked in this case is that the doctors who take care of patients with emphysema are not the same as the doctors who perform (and profit from) the procedure. The other is, that there's no large corporation that stands to benefit from putting the most positive spin on the studies. If pulmonologists were responsible for performing the procedure, or if the procedure required a special surgical device manufactured by only one company , chances are there would have been more emphasis on the positive than the negative and we would have seen an increase in demand. Just as we've seen with oncologists and herceptin.
Posession of the facts and of good data is essential to making good treatment decisions, but we still have to be on guard for the spin.
posted by Sydney on 3/05/2006 04:29:00 PM 2 comments
This post is one of many reasons why I love this blog. Debates about how to pay for health care seem to have an underlying presumption that most people are too ignorant to decide wisely on how to spend their health care dollars. Here, even though not financially responsible, patients are making the more conservative approach because they are fully informed of the risks and benefits. That the patient is fully informed is a key ingredient. Thanks for this.
I agree with cokaygne. We patients are smarter than we are given credit for and armed with complete information will make surprisingly good decision.
By 10:03 AM, at