Poor Mojo's Newswire

The first randomized clinical trial of bypass surgery’s efficacy, using data from a collaboration of Veterans Administration hospitals, was not published until 1977. Such trials were then becoming the gold standard of medical research (and still are). “Surgeons said trials were totally unnecessary, as the logic of the procedure was self-evident,” says Jones. “You have a plugged vessel, you bypass the plug, you fix the problem, end of story.” But the 1977 paper showed no survival benefit in most patients who had undergone bypass surgery, as compared with others who’d received conservative treatment with medication. “There was a firestorm of controversy,” Jones says. “There was lots of money, institutional power, and lots of lives at stake. The surgeons dismissed the trial for technical reasons. So, many other trials were done, all more or less showing the same thing: bypass surgery improved survival for a few patients with the most severe forms of coronary artery disease, but for most others it relieved symptoms but did not extend lives.” The results raise a philosophical question of the goal of medical treatment: alleviating symptoms or lengthening lives? “How much is it worth investing in a surgical procedure, with all its risks,” he asks, “if all you’re doing is relieving symptoms?”

The advent of angioplasty in the 1980s complicates the story. With angioplasty, instead of bypassing the plugged artery, “you use a balloon to compress the plug,” Jones explains, “and (as it’s done today) you leave a stent behind to keep the blood vessel open, and so restore blood flow to the heart.” Like bypass surgery, angioplasty went from zero to 100,000 procedures annually with no clinical trial to assess long-term outcomes—based on the logic of the procedure and patients’ reports of how much better they felt. Yet the first clinical trials, which appeared in the early 1990s, showed no survival benefit of elective angioplasty as compared with medication.

Moreover, because such trials assess patients’ outcomes several years after their treatments, they often end up reporting the results of outdated procedures. “A clinical trial on angioplasty published in 1992 might study a group of patients who had the procedure in 1985,” says Jones. “But angioplasty has been refined since 1985. So you start another trial in 1992 and publish in 1998; then, the cardiologists say, ‘Now we have fancy stents, not those old-fashioned stents they used in 1992.’ And so on. As long as you continue to innovate in a way that, at face value, looks to be an improvement, the believers can always step out from under the weight of negative clinical experience by saying that the research necessarily applies to an earlier state of medical technology.”