A medical reversal occurs when a better-designed study contradicts an accepted medical practice, such as a medication, diagnostic test, or procedure.
Medical Reversal
Over 50 years of medical practice, I have prescribed many well-established treatments that were the uniform standard of practice at a particular point in time. OB-GYN and primary care practitioners prescribed estrogen replacement therapy (ERT) widely to improve women’s life quality, and not prescribing them was considered an uncaring attitude on the doctor’s part and even substandard practice. Hormonal replacement therapy was widely used worldwide as OB-GYN Society recommended Estrogen Replacement Therapy (ERT) in the 1980’s, 1990’s and 2000’s for most women after menopause. However, a big shift regarding ERT occured in recent years, with a growing caution around long-term hormonal therapy after the publication of Women’s Health Initiative trial which began in 1992 and ended in 2015.The study enrolled 160,000 menopausal women and focussed on strategies to prevent heart disease, breast disease and colorectal cancer. Not only did the study demonstrate any benefits from lifelong ERT, but it had signficant side-effects and risks. These included increased clots ( venous thromboembolism), strokes, and a heightened risk for invasive breast cancer.This landmark study led to a re-evaluation of the risks and benefits of ERT, as well as a better understanding of the potential long-term effects. Primary Care providers and gynecologists previously ( before the publication of WHI trial) were all convinced that estrogens helped maintain a woman’s vitality after menopause, improved bone health, and provided protection from the progression of atherosclerotic heart disease and dementia. In the epidemiology of coronary artery disease, females in general developed heart problems ten years later than men during their postmenopausal years, and practitioners believed estrogens protected women until menopause and a decline in estrogen levels in menopause exposed them to the risk of coronary artery disease. Based on this belief practitioners prescribed estrogens on a long term basis after menopause. Pharmaceutical companies used aggressive marketing tactics, with dinners and educational events by experts for doctors to promote drugs like Premarin ( Conjugated estrogens ). In his heavily researched book PHARMA, Gerald Posner says that Prempro ( combined estrogen/progesterone) became a best seller in the 1970s (Wyeth-Ayerst won FDA approval without conducting a randomized clinical trial). There were a total of 90 million hormonal prescriptions annually at its peak. Thelma Wilson, a registered nurse, was the wife of Robert Wilson(gynecologist). Dr. Wilson was a passionate proponent of long-term hormonal therapy for women. It is a sad irony that Thelma died of breast cancer. She had breast cancer ten years previously and had a mastectomy. Despite that, Thelma continued taking hormones until her death ten years later from a recurrence of breast cancer with metastases. She confessed to her son just before her death that she, her husband, and the men at Wyeth did not want their children to know about this and for the story to become public!!
After the Final Evidence Review on November 1, 2022, The USPSTF recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal persons.
The widespread prescription of hormones by practitioners has now ceased. The current practice is to use hormones based on the balance of benefit versus potential harm in an individual patient for a limited period of time around menopause. This is a huge departure from the previous practice of lifelong therapy.
The second most prominent medical reversal occured in the management of coronary artery disease with balooning and stenting.
Through the 1990s and 2000, coronary artery stenting was done routinely for blocked coronary arteries in patients with stable angina. It was routine practice to open the blockages with balloon angioplasty and put stents on the premise that this would improve coronary blood flow and thus reduce the risk of future heart attacks.
The COURAGE TRIAL, a large randomized trial published in 2007, was a turning point in our understanding of the role of stenting. This trial showed that stented patients performed no better than patients who received optimal medical therapy, significantly challenging our approach to coronary artery disease treatment with invasive stenting.
During an extended follow-up of up to 15 years since 2007, researchers found no difference in survival between an initial strategy of stenting plus medical therapy and medical therapy alone in patients with stable ischemic heart disease. These findings have significant implications for our current treatment strategies.
When researchers presented the above trial’s findings, a reporter attended the American College of Cardiology’s annual scientific meeting. After the presentation and discussion among panelists, this reporter interviewed several cardiologists during the lunch break. The majority of the doctors interviewed still believed that stenting was like an “insurance” against future heart attacks, and indeed, some of the doctors had the procedures themselves. It’s crucial to note that these procedures are risky. As revealed by the research, the potential complications from stenting should raise concerns and prompt a reevaluation of such practices.
(Cautionary Note: Coronary artery stenting is of undoubted value in unstable angina patients and patients with acute symptoms of impending heart attack.) So, these circumstances are quite different from patients with stable heart conditions such as stable angina.
In Ending Medical Reversal ( published 2017), Drs. Vinayak Prasad and Dr.Adam Cifu narrate numerous examples of medical reversal -when doctors start using a medication, procedure, or diagnostic tool without a robust evidence base―and then stop using it when it is found not to help, or even to harm, patients. One example is a procedure called kyphoplasty in which medical cement was injected in a collapsed vertebra in patients with severe osteoporosis. Hundreds of patients went through these procedures until a high quality trial demonstrated that this procedure did not help control pain any better than a control group who did not have cement injected.
According to Vinay Prasad’s study, “A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices,” 146 medical practices were reversed in 363 articles published in the New England Journal of Medicine between 2001 and 2010, equivalent to 40.2% of the articles. So, medical reversal is quite common.
I might add that in 1960, as a first-year medical student at Guy’s Hospital (University of London, UK), I spent 3 months (required surgical rotation) with Sir Hedley Atkins (1904-1983), a world-renowned surgeon at his time. He advocated aggressive modified radical mastectomy with the entire removal of the breast, underlying muscular tissue ( pectoral muscles), and removal of nearby lymph nodes ( axillary nodes). While Atkins was famous in England, William Halstead (1852-1922 )was a pioneer breast surgeon at Johns Hopkins Hospital. He also advocated aggressive modified radical mastectomy. There were large galleries atop the surgery room for visiting surgeons from all over the world to learn Atkin’s surgical techniques.
Sir Hedley Atkins specialized in the scientific treatment of breast cancer, and the Hedley Atkins Breast Unit at New Cross Hospital acknowledges his contribution to the field. He was elected a fellow of the Royal College of Surgeons in 1934, became vice-president from 1964 to 1966, and President from 1966 to 1969.
Although Sir Hedley Atkins strongly believed in “cutting out” as much cancer as possible, he followed his patients meticulously for breast cancer relapses and published his findings in peer-reviewed Journals. His attitude and approach led to the current practice of breast conservation and the rejection of dehumanizing mutilating breast surgery procedures of the past.
In summary, scientific advances will always lead to medical reversals when better procedures and technologies become available.
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