KANSAS CITY, Mo. — For the millions of people who couldn’t get their high blood pressure under control even with handfuls of pills, a simple procedure was going to be the breakthrough.
Burn away hypersensitive nerves in the kidneys. Watch blood pressure readings go down.
The American Heart Association hinted that the procedure, renal denervation, might become a drug-free cure, even for mild cases of high blood pressure. Media reports highlighted great results of preliminary research.
Patients eager to get off their meds started calling hospitals.
“The potential benefit was huge,” said Kamal Gupta, a cardiologist at University of Kansas Hospital.
If only it had worked.
In March, doctors reported data from the first truly rigorous study. Patients’ blood pressure did drop, but it fell just as much among those who got a fake version. Device manufacturers canceled additional studies.
“This could be considered the biggest disappointment in cardiology of this century,” Gupta said. But, he added, “the medical community went about it right.”
If only that were always the case.
A combination of industry marketing, overly eager doctors, demanding patients and news media ready to cheer on anything that sounds like a breakthrough is popularizing many drugs, surgeries and other treatments long before they’re adequately tested. Far too often, they’re ultimately proved ineffective, no better than older, cheaper therapies, or even hazardous.
Billions of dollars are wasted and tens of millions of patients are put at risk.
Remember Vioxx, the pain pill for arthritis? It was prescribed to 80 million people worldwide from the time the Food and Drug Administration approved it in 1999 to 2004, when its manufacturer, Merck, withdrew it from the market as evidence emerged that it raised the risk of heart attack and stroke. The FDA said Vioxx caused an additional 88,000 to 138,000 heart attacks and sudden cardiac deaths in the U.S. alone.
Or consider arthroscopic knee surgery. Doctors were doing about 650,000 of these procedures per year at a cost of about $5,000 each. It seemed to relieve pain in about half the arthritis patients who had it done. Then in 2002, researchers compared results of the surgery to a sham version of the operation. Patients got just as much relief when the surgery was fake. As with renal denervation, it turned out to be a costly placebo.
“There’s a tendency by doctors and patients to believe that newer is better and more expensive is better and higher tech is better,” said Richard Deyo, a physician on the faculty of Oregon Health and Science University. “The truth is, it really is very difficult, even within the medical profession, to distinguish the really important advances from things that aren’t.”