When Evidence Says No, But Doctors Say Yes

Updated 38 weeks ago Special to HuntingtonNews.Net
When Evidence Says No, But Doctors Say Yes
Image: Medicine Plus

February 22, 2017

First, listen to the story with the happy ending: At 61, the executive was in excellent health. His blood pressure was a bit high, but everything else looked good, and he exercised regularly. Then he had a scare. He went for a brisk post-lunch walk on a cool winter day, and his chest began to hurt. Back inside his office, he sat down, and the pain disappeared as quickly as it had come.

That night, he thought more about it: middle-aged man, high blood pressure, stressful job, chest discomfort. The next day, he went to a local emergency department. Doctors determined that the man had not suffered a heart attack and that the electrical activity of his heart was completely normal. All signs suggested that the executive had stable angina — chest pain that occurs when the heart muscle is getting less blood-borne oxygen than it needs, often because an artery is partially blocked.

A cardiologist recommended that the man immediately have a coronary angiogram, in which a catheter is threaded into an artery to the heart and injects a dye that then shows up on special x-rays that look for blockages. If the test found a blockage, the cardiologist advised, the executive should get a stent, a metal tube that slips into the artery and forces it open.

While he was waiting in the emergency department, the executive took out his phone and searched “treatment of coronary artery disease.” He immediately found information from medical journals that said medications, like aspirin and blood-pressure-lowering drugs, should be the first line of treatment. The man was an unusually self-possessed patient, so he asked the cardiologist about what he had found. The cardiologist was dismissive and told the man to “do more research.” Unsatisfied, the man declined to have the angiogram and consulted his primary-care doctor.

The primary-care physician suggested a different kind of angiogram, one that did not require a catheter but instead used multiple x-rays to image arteries. That test revealed an artery that was partially blocked by plaque, and though the man’s heart was pumping blood normally, the test was incapable of determining whether the blockage was dangerous. Still, his primary-care doctor, like the cardiologist at the emergency room, suggested that the executive have an angiogram with a catheter, likely followed by a procedure to implant a stent. The man set up an appointment with the cardiologist he was referred to for the catheterization, but when he tried to contact that doctor directly ahead of time, he was told the doctor wouldn’t be available prior to the procedure. And so the executive sought yet another opinion. That’s when he found Dr. David L. Brown, a professor in the cardiovascular division of the Washington University School of Medicine in St. Louis. The executive told Brown that he’d felt pressured by the previous doctors and wanted more information. He was willing to try all manner of noninvasive treatments — from a strict diet to retiring from his stressful job — before having a stent implanted.

The executive had been very smart to seek more information, and now, by coming to Brown, he was very lucky, too. Brown is part of the RightCare Alliance, a collaboration between health-care professionals and community groups that seeks to counter a trend: increasing medical costs without increasing patient benefits. As Brown put it, RightCare is “bringing medicine back into balance, where everybody gets the treatment they need, and nobody gets the treatment they don’t need.” And the stent procedure was a classic example of the latter. In 2012, Brown had coauthored a paper that examined every randomized clinical trial that compared stent implantation with more conservative forms of treatment, and he found that stents for stable patients prevent zero heart attacks and extend the lives of patients a grand total of not at all. In general, Brown says, “nobody that’s not having a heart attack needs a stent.” (Brown added that stents may improve chest pain in some patients, albeit fleetingly.) Nonetheless, hundreds of thousands of stable patients receive stents annually, and one in 50 will suffer a serious complication or die as a result of the implantation procedure.

 

Brown explained to the executive that his blockage was one part of a broader, more diffuse condition that would be unaffected by opening a single pipe. The cardiovascular system, it turns out, is more complicated than a kitchen sink. The executive started medication and improved his diet. Three months later, his cholesterol had improved markedly, he had lost 15 pounds, and the chest pain never returned.

Now, listen to the story with the sad ending: Not long after helping the executive, Brown and his colleagues were asked to consult on the case of a 51-year-old man from a tiny Missouri town. This man had successfully recovered from Hodgkin’s lymphoma, but radiation and six cycles of chemotherapy had left him with progressive scarring creeping over his lungs. He was suffocating inside his own body. The man was transferred to Barnes Jewish Hospital, where Brown works, for a life-saving lung transplant. But when the man arrived in St. Louis, the lung-transplant team could not operate on him.

Four months earlier, the man had been admitted to another hospital because he was having trouble breathing. There, despite the man’s history of lymphoma treatment, which can cause scarring, a cardiologist wondered whether the shortness of breath might be due to a blocked artery. As with the executive, the cardiologist recommended a catheter. Unlike the executive, however, this man, like most patients, agreed to the procedure. It revealed a partial blockage of one coronary artery. So, doctors implanted a stent, even though there was no clear evidence that the blockage was responsible for the man’s shortness of breath — which was, in fact, caused by the lung scarring. Finally, the man was put on standard post-implantation medications to make sure he would not develop a blood clot at the site of the stent. But those medications made surgery potentially lethal, putting the man at an extremely high risk of bleeding to death during the transplant. The operation had to be delayed.

Meanwhile, the man’s lung tissue continued to harden and scar, like molten lava that cools and hardens into gray stone. Until one day, he couldn’t suck in another breath. The man had survived advanced-stage lymphoma only to die in the hospital, waiting until he could go off needed medication for an unneeded stent.

hat the patients in both storieshad in common was that neither needed a stent. By dint of an inquiring mind and a smartphone, one escaped with his life intact. The greater concern is: How can a procedure so contraindicated by research be so common?

When you visit a doctor, you probably assume the treatment you receive is backed by evidence from medical research. Surely, the drug you’re prescribed or the surgery you’ll undergo wouldn’t be so common if it didn’t work, right?

For all the truly wondrous developments of modern medicine — imaging technologies that enable precision surgery, routine organ transplants, care that transforms premature infants into perfectly healthy kids, and remarkable chemotherapy treatments, to name a few — it is distressingly ordinary for patients to get treatments that research has shown are ineffective or even dangerous. Sometimes doctors simply haven’t kept up with the science. Other times doctors know the state of play perfectly well but continue to deliver these treatments because it’s profitable — or even because they’re popular and patients demand them. Some procedures are implemented based on studies that did not prove whether they really worked in the first place. Others were initially supported by evidence but then were contradicted by better evidence, and yet these procedures have remained the standards of care for years, or decades.

Even if a drug you take was studied in thousands of people and shown truly to save lives, chances are it won’t do that for you. The good news is, it probably won’t harm you, either. Some of the most widely prescribed medications do little of anything meaningful, good or bad, for most people who take them.

In a 2013 study, a dozen doctors from around the country examined all 363 articles published in The New England Journal of Medicine over a decade — 2001 through 2010 — that tested a current clinical practice, from the use of antibiotics to treat people with persistent Lyme disease symptoms (didn’t help) to the use of specialized sponges for preventing infections in patients having colorectal surgery (caused more infections). Their results, published in the Mayo Clinic Proceedings, found 146 studies that proved or strongly suggested that a current standard practice either had no benefit at all or was inferior to the practice it replaced; 138 articles supported the efficacy of an existing practice, and the remaining 79 were deemed inconclusive. (There was, naturally, plenty of disagreement with the authors’ conclusions.) Some of the contradicted practices possibly affect millions of people daily: Intensive medication to keep blood pressure very low in diabetic patients caused more side effects and was no better at preventing heart attacks or death than more mild treatments that allowed for a somewhat higher blood pressure. Other practices challenged by the study are less common — like the use of a genetic test to determine if a popular blood thinner is right for a particular patient — but gaining in popularity despite mounting contrary evidence. Some examples defy intuition: CPR is no more effective with rescue breathing than if chest compressions are used alone; and breast-cancer survivors who are told not to lift weights with swollen limbs actually should lift weights, because it improves their symptoms.

A separate but similarly themed study in 2012 funded by the Australian Department of Health and Ageing, which sought to reduce spending on needless procedures, looked across the same decade and identified 156 active medical practices that are probably unsafe or ineffective. The list goes on: A brand new review of 48 separate studies — comprising more than 13,000 clinicians — looked at how doctors perceive disease-screening tests and found that they tend to underestimate the potential harms of screening and overestimate the potential benefits; an editorial in American Family Physician, co-written by one of the journal’s editors, noted that a “striking feature” of recent research is how much of it contradicts traditional medical opinion.

That isn’t likely to change any time soon. The 21st Century Cures Act — a rare bipartisan bill, pushed by more than 1,400 lobbyists and signed into law in December — lowers evidentiary standards for new uses of drugs and for marketing and approval of some medical devices. Furthermore, last month President Donald Trump scolded the FDA for what he characterized as withholding drugs from dying patients. He promised to slash regulations “big league. … It could even be up to 80 percent” of current FDA regulations, he said. To that end, one of the president’s top candidates to head the FDA, tech investor Jim O’Neill, has openly advocated for drugs to be approved before they’re shown to work. “Let people start using them at their own risk,” O’Neill has argued.

STORY CONTINUES: https://www.propublica.org/article/when-evidence-says-no-but-doctors-say...

 

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