With hindsight, the folly of trying to cure with mercury or an “ice pick” lobotomy is clear, but there was a time they reigned and patients were harmed. A new study takes aim at today’s ineffective medical practices, with an eye toward shortening their transition to obsolescence.
After reviewing 3017 randomized controlled trials (RCTs) published in the past 16 years in three high-impact medical journals, the investigators identified 396 medical reversals or practices found through RCTs to be no better than a previous or lesser standard of care. In 53% of cases, a systematic review confirmed the device, procedure, or practice was indeed a medical reversal.
“Large, well-done randomized trials are essential in helping to determine whether an intervention is effective or not. Studies that are poorly conducted or small in sample size produce spurious results, and these types of studies, because of their nature, can lead to the adoption of ineffective practices or medical reversals,” authors Alyson Haslam, PhD, and Jennifer Gill, MSc, Knight Cancer Institute, Oregon Health & Science University, Portland, told theheart.org | Medscape Cardiology via email.
Senior author Vinay Prasad, MD, Knight Cancer Institute, has published extensively on the topic, including a
previous report of 146 medical reversals published in the
New England Journal of Medicine (NEJM) from 2001 to 2010.
In the present study, 13% of all RCTs were medical reversals; 29% of reversals were found in the Lancet, 33% in NEJM, and 39% in the Journal of the American Medical Association.
Most studies (92%) were conducted in high-income countries, with the remainder done in low- or middle-income countries, such as China, Ghana, and India, according to the report,
published online June 11 in the open-access journal
eLife.
Reversals were found in every specialty, with cardiovascular disease (CVD) was the most common medical category (20%), followed by public health/preventive medicine (12%) and critical care (11%).
CVD examples include the still-debated use of off-pump coronary-artery bypass surgery and the reversal of pulmonary artery catheterization as a therapy for
congestive heart failure, identified via the
ESCAPE trial and a 2013 Cochrane review.
Interventional cardiologist Robert W. Yeh, MD, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, who was not involved in the study, said the concentration of reversals in cardiology reflects the nature of the specialty.
“What it means to me is that we are willing to subject our therapies to the test; we’re willing to do the hard work of conducting randomized trials,” he told theheart.org | Medscape Cardiology. “That really is the foundation of cardiology in many ways. It is, I think, if not the most evidence-based disciplines in medicine, certainly one of them.”
The finding also likely relates to the fact that heart disease is the number one killer globally and in the United States.
“Our denominator of therapies is probably larger, so that’s another reason I think we have a number of therapies showing up in this list,” Yeh said. “I don’t view it as a condemnation. I sort of wear it as a badge of honor.”
Direct and Indirect Costs
The study does not address how often the 396 medical reversals continue to be used. This can be very complex because some of the reversals are practices that patients or family can self-prescribe, such as vitamin A supplementation to improve newborn mortality or use of graduated compression stockings to reduce
deep vein thrombosis after
stroke, Haslam and Gill note.
Use of various practices is also inconsistent or they are being used off-label. Other reversals can be tracked more easily, such as
breast cancer screening in women 40 to 49 years of age, but will likely continue because of discordant recommendations.
Although it also was outside the scope of the study to determine whether the implementation of practices later identified as reversals was financially motivated, most reversals (63.9%) were identified because of a nonindustry funded study.
As for why some physicians may be slow to de-implement ineffective practices yet quick to adopt therapies without a strong evidence base, Haslam and Gill observe that it can be hard for physicians to keep up with the published literature because of time constraints. And it takes time to conduct a good randomized study, and “sometimes there isn’t the luxury of time when you have a very sick patient with few good options (e.g., patients with cancer).”
Nevertheless, continued use of low-value practices can erode trust in the medical system and means patients spend time and money on practices that are ineffective, they note. For example,
bevacizumab (
Avastin) was approved in 2008 for metastatic
breast cancer under the accelerated approval program, at a cost of about $88,000 per patient, but the indication was withdrawn in late 2011 after it was shown not to improve overall survival.
“In countries like the US, where there was a 20% increase in spending between 2013 and 2015, and drug prices alone surpassed the increase in aggregate healthcare spending, the identification and disuse of costly and ineffective (or possibly harmful) medications and practices are especially important,” the authors write.
Keeping interventions without a sufficient evidence base from becoming common practice will require systemic changes at all levels — from government to individual practice — and starts with holding treatments to higher standards when granting market approval, Haslam and Gill say.
“Practitioners can critically evaluate treatments, new and old, and choose what to adopt and how to practice to best serve their patients,” they add. “This is happening already but through this research, we hope that more develop critical eyes and demand well-done randomized trials before accepting treatments into their practice. While this may not directly affect systemic changes in companies and governmental agencies, it may influence future decisions and put pressure on these powers to come up with stronger evidence for new practices.”
Haslam and Gill report no relevant financial interests. Prasad reports receiving royalties from his book, Ending Medical Reversal; funding for his work from the Laura and John Arnold Foundation; honoraria for Grand Rounds/lectures from several universities, medical centers, nonprofit groups, and professional societies; serving as a writer for Medscape; and hosting the podcast Plenary Session, which has Patreon backers.
Elife. Published online June 11, 2019.
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