
TIFFANY MCLEOD followed the advice to the letter. She has food allergies, and was worried that her children might too. Her doctor recommended that she avoid eating nuts while pregnant or breastfeeding, and to keep the kids away from them until the age of 3. “You want to do what’s best for your child,” she says. “And you figure that your doctor knows what that is.”
Her doctor was following American Academy of Pediatrics guidelines issued in 2000. But by 2008, the AAP had . Then last year, it reversed course. A large study had found that regular exposure to peanuts from 4 months of age . McLeod, who lives in Texas, had both of her babies in the years between the changing advice. She learned the hard way that her youngest has a life-threatening allergy. “We had to rush her to the emergency room. It was extremely scary,” she says.
It would be comforting to think the drastic change in advice with peanut allergy is unique. But this type of medical about-face isn’t rare. A recent analysis of research published in one medical journal over 10 years identified a whopping . To be clear, this is not just the process of upgrading advice as better evidence comes in. These are practices that became routine before we learned they didn’t actually work. And worse, before we knew if they could cause harm.
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In the era of evidence-based medicine you might assume most of your doctor’s advice is based on evidence obtained through rigorous testing. But it is becoming clear that is often far from the case. Fortunately, people are now shining a light on the problem, and devising ways to fix it.
They have their work cut out. In recent years official advice has reversed course on everything from broad issues such as diet and nutrition, to specific techniques like using stents to keep open the narrowed arteries of people with heart disease. There have also been dramatic U-turns on cancer screening and other major public health concerns.
What is at stake
For many of us, this isn’t an abstract worry. My mother was given hormone replacement therapy (HRT) in the 1990s to help ease her way through menopause. That was before it was found to . Nine years later, when she was diagnosed with bilateral breast cancer, and endured a gruelling year of surgery and treatment, we were left wondering if or how much HRT had contributed to her disease.
“The medical journals are filled with interesting ideas that get tested and fail. That’s science,” says at the University of Chicago, who wrote a book called with Vinay Prasad. “The problem is when that new technology or treatment or surgery has actually gotten out and is being given to millions of people before it’s found to not work.”
How does this happen? In the late 1990s, peanut allergies were on the rise and . At the time, the best theory about the cause was that feeding allergenic proteins to infants before the intestinal lining was mature allowed them to seep into the bloodstream. The baby then built up antibodies to these substances and later became allergic to foods containing them. This hunch was consistent with assumptions about how allergens affect the immune system, and studies showing few peanut allergies in countries where people don’t eat many peanuts. So steering clear of the potential allergens until children were older made sense – in theory.
“Much of what we do in medicine is theory-based. It’s only relatively recently that good quality evidence has been available for many things,” says , who develops guidelines for the American Board of Pediatrics (ABP) and is a long-time campaigner for evidence-based practice. “Peanut allergy is life-threatening – we were doing the best we could with the knowledge we had at the time.”
But no data backed up that theory. And now it seems just the opposite is true: exposure to peanut protein while the immune system is immature actually decreases the likelihood of developing an allergy.
“We spend so much time training people first and foremost in how the body works and how it breaks. So we get why things should work, and then we tend to adopt things because they should work before we know if they actually do,” says Cifu.
It’s no small concern. An of 3000 common medical practices categorised half as having “unknown effectiveness”, and 3 per cent as likely to be ineffective or harmful. Just a third were found to be “beneficial” or “likely to be beneficial”.
A major problem is that we often do the studies only after practices are widely adopted. There is a well-trodden path to developing new treatments, says , a medical historian at Harvard University. Someone gets some promising early results, a lot of people get enthusiastic about the innovation and get on board. “Then it is successfully marketed to a willing audience of patients who are generally dissatisfied with existing treatments,” says Jones.
Eventually, concerns surface and clinical trials are done. By then, though, the horse is out of the barn. People want innovation and ready access to new and better treatments. But, as Jones says, “it leaves open the door that you’ll get a lot of enthusiasm coming from small, poorly designed studies that drive unwarranted use of a new procedure before it has been fully validated.”
It’s tough to get the horse back in the barn. For instance, a treatment known as vertebroplasty, which involves injecting medical cement into broken vertebrae, is widely used for people with spinal fractures related to osteoporosis. In spite of that it is , the practice is still used, even at , one of the top ranked hospitals in the US.
“Once a treatment has been dubbed ‘standard of care’ it tends to persist,” says at Harvard Medical School, who studies the placebo effect. It isn’t that doctors are wilfully ignoring the evidence, it is likely they believe in what they’re doing. “The practitioners who perform vertebroplasty want to help people and probably continue to believe they are doing so,” he says.
Preventing untested practices from becoming standard care seems simple – just test them first. But even when studies are conducted early on, what they actually measure can be part of the problem. Because it’s simpler and faster, researchers often look at “surrogate outcomes”, not actual end points. So for instance, blood cholesterol levels are taken as a stand-in for the risk of heart attack or death.
Measuring what matters
For years, dieting and taking medication to keep a certain measure of blood sugar – glycated hemoglobin – below 7 per cent, was recommended for people with type 2 diabetes. This was after a with levels closest to those of non-diabetics had the best outcomes. But in 2008 a team led by at McMaster University in Ontario, Canada, discovered that those fighting to get their glycated haemoglobin below this threshold actually faced a .
“There comes along some piece of evidence that is definitive, so much better than the existing evidence, that you have to do a total 180 on something you once thought was the best way to go,” says , an oncologist at Oregon ҹ1000 and Sciences University.
“We adopt things because they should work before we know if they actually do“
The calibre of evidence can depend on who is paying for it. There are the perennial issues that plague medical research: the pressure on researchers to publish new and impressive findings, and medical journals’ tendency to publish positive results more than negative. But increasingly, the pharmaceutical and medical device industries – rather than public bodies – . Not only do they have vested interests in the initial outcomes needed to get drugs or devices approved, but once they are approved, little incentive to do the expensive, large-scale studies that could potentially upend their initial findings and hurt their bottom line.
The popularity of the anti-inflammatory drug Vioxx is one example. The US Food and Drug Administration (FDA) approved it in 1999, but later the manufacturer, Merck, was accused of concealing risks discovered in early studies. By the time independent research showed that , 20 million people had prescriptions. It was , but not before causing up to 140,000 preventable heart attacks. Merck pleaded guilty to criminal charges in 2011 and .
There is no simple fix. There are so many factors at play, and for some, there is no perfect way – this is what progress looks like.
“There are cases where we just haven’t done the research we need to do before a practice gets adopted,” says Moyer. “But there are also a whole host of reasons why the evidence for certain medical practices might change – and continue to change – over time.”
Among them is the fact that you’re often working on a moving target. “Diseases aren’t static – they can and do change over time,” says Gerstein. “Diabetes today is not the same as it was 50 years ago.” The number of people diagnosed with type 2 diabetes has more than doubled in the past two decades, and the age of onset has dropped. He says today’s type 2 diabetes is more likely to come with additional health issues like cancer, kidney problems and heart disease, compared with 50 years ago. “We call it by the same name but it behaves differently,” says Gerstein.

So where do we go from here? It is understandable that patients and their advocates want new options as soon as possible, especially those who are seriously ill. At the same time, it makes sense to have the highest quality of evidence for any treatment. Balancing these demands should be straightforward. It means providing early access to treatments, but ensuring that we gather the data at the same time.
“The most important message is that we, as a society, need to keep pushing for large, well-designed research studies and keep on reassessing,” says Gerstein. “If we’re treating people the same way we did 30 years ago, then we’re probably not treating them right.”
Efforts are underway to ensure that this happens. Medical specialty organisations, like the American College of Physicians, have an – and reassess them as new studies are published. Jones says that many medical conferences now insist on some form of peer review before new practices can be presented. And as part of its safety surveillance programme, the FDA has a comprehensive for drugs and devices.
In addition, researchers are trying to change the culture surrounding clinical trials to . at Stanford University is leading the push for medical journals to set more rigorous standards for the publication of results – and to have external groups monitor those standards. The aim is to highlight potential funding biases and stop flawed results from sneaking their way into everyday medicine.
There are also attempts to address the problem further upstream. It used to be that medical education was predominately an exercise in memorisation. But now teaching critical thinking has become central to the curriculum for doctors and other health professionals and there is a much greater focus on the need for evidence-based practice.
“If we’re treating people the same way we did 30 years ago, then we’re probably not treating them right“
“I give a lecture to the medical students every year where I tell them the most important thing they need to know is that, one day, they’ll learn everything they learned in medical school is wrong. Some of it may even be considered malpractice,” says Gerstein. “What we currently believe today based on the evidence will change – so every doctor, as much as possible, has to keep up to date with new research because things can and do change all the time.”
It may be too much to ask for our doctors to follow every incremental change. But they should be willing to examine the benefits and drawbacks of the therapies they are offering, says Cifu. “It should be okay for doctors to discuss options with each patient and say, ‘Look, I’m not completely convinced about this therapy because the data isn’t so good but it’s low risk and I think there’s a chance it could work for you and here’s why.’ That way patients understand they are taking a little bit of a chance but there are potential benefits.”
Patients can spur their doctors on as well. When a therapy or surgery is suggested, instead of immediately asking about side effects or cost, Cifu wants them to start at a more fundamental level. “The real questions are, how is this actually going to help me? Will this actually decrease my risk of having a heart attack?” He wants ordinary people to be empowered to ask about the evidence and possible alternatives.
It won’t be easy, and doctors can feel intimidated when their patients push back. But, as Cifu says, “That’s the job of a good physician – to answer those questions.”
10 Major Reversals
01. Hormone replacement therapy
Advice: HRT for menopausal women
Rationale: Observational studies and animal trials suggested protective effect on heart and bones
Adoption: Millions of prescriptions in 1990s
Reversal: In 2002, found . Largely discontinued, though later studies showed certain women may benefit
02. Peanut allergy
Advice: Withhold nuts from young children
Rationale: For immature immune system, exposure increases allergy risk
Adoption: Widespread in Western countries
Reversal: . New guidelines issued in 2015
03. Surgery for osteoarthritis of the knee
Advice: Surgical removal and smoothing of cartilage fragments
Rationale: Thought to reduce inflammation, improve motion and decrease pain
Adoption: By 2002, 650,000 surgeries per year in US
Reversal: Several trials over physical therapy alone. Surgery still common, however
04. Cancer screening
Advice: Routine early screening
Rationale: Early detection is a chance to intercept disease
Adoption: Mammograms and the PSA test for prostate cancer became routine in 1980s
Reversal: Early stage cancers do not always develop further, many treated unnecessarily. PSA test no longer recommended in US,
05. Heart stents
Advice: Stents for people with coronary heart disease and angina
Rationale: Clear benefit in cases of heart attack, so those with stable heart disease should benefit too
Adoption: Commonplace by 2004
Reversal: Shown not to reduce risk for future heart attack or death and . Practice remains common
06. Vertebroplasty
Advice: Inject medical cement to fix fractured vertebrae
Rationale: Thought to improve spine stability and reduce pain
Adoption: By 2009, 750,000 operations per year in US
Reversal: is no more , it is still widely carried out
07. Intensive blood sugar lowering for type 2 diabetics
Advice: Diet and drugs to get long-term blood sugar metric (glycated haemoglobin) below 7 per cent
Rationale: found lower risk for heart attack at 7 per cent. Aim became lower the better
Adoption: By early 2000s, advice was often to aim for under 7 per cent
Reversal: found that trying to keep levels too low increased risk of death. Aiming under 7 per cent now seldom advised
08. Pre-implantation genetic testing
Advice: Screen embryos for older women doing IVF
Rationale: Genetic screening should reduce pregnancy failure due to chromosome abnormalities in embryos
Adoption: Common for older women undergoing IVF
Reversal: 2007 trial found screening
09. Lowering body temperature for aneurysm surgery
Advice: Cool down body during surgery
Rationale: Animal studies suggested improved outcomes
Adoption: Common by 1980s
Reversal: and increased risk of infection
10. Ear tube surgery
Advice: Implant tubes in ears of children with persistent infection
Rationale: Fluid drainage would improve hearing and cognitive development, best to do surgery sooner than later
Adoption: Most often performed surgery in children
Reversal: Review in 2014 found if surgery is postponed. But surgery, which carries the risk of bleeding and ear drum damage, is still common in the early stages of infections
This article appeared in print under the headline “Misguided medicine”