Remember that thing that we said was good for you, then we changed our minds telling you it’s now bad for you. And now? We’re changing our minds again…umm, maybe it is good for you again.
Medicine that claims to be ‘evidence-based’ is never static. It changes. Sometimes quickly and sometimes slowly and so too do our doctor’s suggestions about what they think is right to keep us healthy.
In that light, sometimes medical recommendations around screening, surgery, or treatments like drugs or vaccines follow a certain pattern: widespread Enthusiasm based on promising early evidence, a Reversal when rigorous trials reveal limited benefits or unexpected harms, and then a Revival driven by new interpretations, technological tweaks, manufacturer greed, or good old advocacy. Here are six examples of ERRing, which no doubt confuses patients and clinicians alike:
Tonsillectomy (Especially in Children)
Enthusiasm: For about 40 years, from the 1930s to the 1970s millions of tonsillectomies were done annually, often bundled with adenoidectomy and was viewed as a near-standard childhood rite. I am old enough to remember feeling envious when many of my friends in elementary school were getting their tonsils removed. This was the early 70s where tonsillectomy was one of the most common surgeries worldwide, routinely performed for recurrent sore throats, enlarged tonsils, or even preventive reasons. After all, better safe than sorry, right? Sure my brother and sisters and I went through bouts of sore throats but my mother, a nurse, didn’t buy into the tonsillectomy hype, so we all still have them. Here’s how that worked out…
Reversal: It wasn’t until the PARADISE study, (PAtient-centered outcomes Research and ADvanced Intervention for the Surgical treatment of Ears, Nose, and Throat diseases), a randomized trial published in the New England Journal of Medicine in 1984 found the surgery might have some benefit for kids suffering recurrent and severe infections, but overall most kids improve spontaneously. Surgery-related complications which are rare were manageable. Soon tonsillectomies were history, falling by more than 50% in many countries and guidelines became highly restrictive.
Revival: In the 2000s it was recognized that obstructive sleep apnea could be treated with tonsillectomy so there was a major revival. Today about 500,000 tonsillectomies are performed annually on US children alone, and widely promoted for quality-of-life and neurocognitive benefits. Let’s just say, even today, doing tonsillectomies can be lucrative for those doing them, whether they are warranted or not.
Hormone Replacement Therapy (HRT) for Menopausal Women
Enthusiasm: In the 1980s through early 2000s, systemic estrogen (often with progestin) was widely prescribed for menopausal hot flashes. Pharma-funded campaigns pushed HRT as an anti-aging elixir that could also help prevent heart disease, osteoporosis, and dementia. Observational studies and heavy pharmaceutical marketing positioned HRT as essential for women’s health. That was until real science stepped in.
Reversal: One of the largest and best randomized trials ever conducted of HRT, the Women’s Health Initiative (WHI), was published in 2002 and found increased risks of breast cancer, heart attack, stroke, and blood clots, with no net preventive benefit in older postmenopausal women with the exception of slightly reduced osteoporotic fractures. Prescriptions plummeted more than 50%, and guidelines shifted against routine use. There was a lot of major ass-covering and finger-pointing in drug company circles, but at least we had some high-quality science to point to.
Revival: In the last five years, no doubt aided by Big Pharma trying to revamp markets, the WHI was ‘reanalyzed’ and women are now told that the benefits of HRT may outweigh risks if started near menopause for moderate-to-severe symptoms. Newer guidelines and women’s health advocates are now pushing individualized low-dose, short-duration HRT as firstline for symptom relief. Fair enough, but does that renewed enthusiasm go too far? I agree with those who are knowledgeable about the importance of a high -uality RCT like the WHI and think this revival is nonsense. Clearly there’s an unexploited market yet the estrogen pushers are just putting more lipstick on a pig.The very real harms related to breast cancer, blood clots, and heart attacks are not to be dismissed and journalists reporting on the HRT revival should do their homework and “Follow the money, honey.”
Breast Cancer Screening with Mammography
Enthusiasm: From the 1970s to the 2000s, widespread breast cancer screening was promoted as life-saving, with campaigns urging annual mammograms starting at age 40 or earlier. Early trials and observational data suggested substantial mortality reductions. A notable ad by the American Cancer Society read: “If you haven’t had a mammogram, you need more than your breasts examined,” basically employing fear-based, direct messaging to encourage women to undergo regular breast cancer screening.
Reversal: Better randomized trials and reviews in the 2000s–2010s highlighted significant false positives, and very modest mortality benefits for healthy middle-aged women. Estimates are that one-third to one-half of all breast cancers are overdiagnosed and guidelines (e.g., USPSTF 2009/2016) recommended later and less frequent screening, starting at 50 every two years. Some countries cancelled their mammography programs altogether due to the high rate of overdiagnosis.
Revival: Let’s just say the breast cancer screening industry is big, lucrative, and not going away anytime soon. Since about 2015, advocacy groups and breast cancer societies redoubled their efforts for broader and earlier access, citing improved technology (e.g., 3D tomosynthesis) and getting political in pushing for younger and younger screening. The science, however, hasn’t changed and mammography, despite testimonials to the contrary, has an extremely low yield. Healthy, symptomless women undergoing regular mammography screening are ten times more likely to be overdiagnosed than to have their lives saved by screening. Overdiagnosis leads to unnecessary surgery, drugs, and avoidable psychological impacts.
COX-2 Selective Inhibitors (Celebrex, Vioxx, Bextra)
Enthusiasm: Drugs for arthritis pain are notoriously hard on the gut, so finding a pain-relieving drug that would be easier on the stomach could be a major cash cow. In the late 1990s, COX-2 inhibitors (Celebrex, Vioxx and Bextra) were launched as major advances, promising equivalent pain relief and dramatically lower risks of gastrointestinal bleeding. Aggressive marketing drove COX-2s into blockbuster drug territory, widely recommended as first-line therapy for arthritis and chronic pain.
Reversal: Vioxx was withdrawn in 2004 and Bextra in 2005 after trials and meta-analyses confirmed increased cardiovascular risks; black-box warnings were added classwide and doctors were urged to go back to traditional NSAIDs. In 2007, Merck paid $4.85 billion to settle thousands of lawsuits related to Vioxx which was illegally marketed using manipulated trials. An estimated 60,000 Americans died from heart attacks in the five years that Vioxx was on the market (about the same number of Americans who were killed in the Vietnam War). That was, however, not the end of the COX-IIs.
Revival: The 2016 PRECISION trial reported that celecoxib (the generic name of Celebrex) had similar cardiovascular risks as other arthritis drugs but less harmful effects on stomachs in high-risk patients. This was used to revamp the reputation of Celebrex as safer even though strong limitations with that study and the longstanding cardiovascular risks of the COX-IIs would suggest caution. Even though celecoxib is generic, Pfizer’s marketing firepower still lingers and likely contributes greatly to the revival of Celebrex.
Percutaneous Coronary Intervention (PCI/Stenting) for Stable Angina
Enthusiasm: From the 1990s to the mid-2010s, PCI with stenting was routinely done to reduce symptoms in people with stable coronary artery disease. It was viewed as superior to medical therapy, such as drugs and lifestyle modifications alone, and became one of the most common procedures, credited with better quality of life and better outcomes.
Reversal: Then the shoe dropped. The 2017 ORBITA sham-controlled trial showed no significant improvement in exercise time or symptoms over placebo procedure. These results combined with earlier trials (COURAGE, ISCHEMIA) showed no advantages in hard outcomes, thus causing a rethink of the overall value of stenting.
Revival: In some circles, stenting still ruled. Manufacturers of PCI devices funded big marketing campaigns aimed at both healthcare providers and patients, pushing the benefits of stents. This marketing, plus the introduction of drug-eluding stents, no doubt emphasized the potential to restore blood flow and alleviate symptoms. Let’s face it, in the contest between doing little and doing a lot (ie conservative medical management vs stenting) medical activity pays the bills. Today PCI remains widely performed for stable angina symptoms, even though stenting is not without its risks, especially stent thrombosis (clots), narrowing of the arteries, and infections which likely result in thousands of adverse events and deaths annually.
Rotavirus Vaccination in Infants
Yes, the rotavirus vaccine fits the ERR pattern reasonably well, though with a nuance: the initial vaccine (RotaShield) underwent a clear reversal and withdrawal, while the concept of rotavirus vaccination was revived with new vaccine formulations (RotaTeq and Rotarix).
Enthusiasm: In 1998–1999, the first oral rotavirus vaccine (RotaShield) was enthusiastically rolled out and recommended by the US CDC for all US infants to prevent severe gastroenteritis. It was hailed as a major advance, expected to dramatically reduce hospitalizations and deaths from rotavirus diarrhea worldwide. In developing countries where there are shortages of clean water and poor hygiene, rotavirus is more endemic. But how bad is the problem in modern, developed countries?
Reversal: By late 1999, RotaShield was withdrawn from the market after it was found to increase the risk of intussusception (a rare but serious bowel obstruction). For several years, no rotavirus vaccine was available in North America. Skeptics rightfully asked: Is universal vaccination for rotavirus really all that necessary given the incredibly low mortality in high functioning health care systems?
Revival: Newer vaccines (RotaTeq in 2006, Rotarix in 2008) were launched and showed some better safety profiles. They are now routinely recommended and administered to nearly all infants in the US, Canada, and most developed countries. There was a brief hiccup in 2013 when contamination of rotavirus vaccines temporarily halted vaccination programs. While public health authorities claim rotavirus vaccines have basically wiped out hospitalizations due to rotavirus, there lingers the potential problem of intussusception which can be fatal. All vaccines have some level of harm and while the harm/benefit profile of rotavirus vaccines look promising, nothing is guaranteed.
There you have it. Enthusiasm, Reversal, and Revival. It’s hard to generalize here, but when reversals and revivals are based on better quality evidence, and clearer understanding of harms and benefits, we should presume they’re in the public interest. However, when they are based on manufacturers pushing for a new market or promoters and other financially invested agencies, eager for new customers, can we be really sure?
If you are being offered a new drug, surgical procedure, or screening program, you might want to think of its history. Where does it lie in the continuum of Enthusiasm, Reversal or Revival?
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