In 2009, the U.S. Preventive Services Task Force (USPSTF) became the first major U.S. guideline organization to recommend screening mammography every other year -- rather than annually -- among women ages 50-74. This recommendation was based on modeling data suggesting that screening among younger women ages 40-49 and an annual screening may cause as much harm as good. Since then, our Slow Medicine position has been aligned with the USPSTF guidelines. We're now pleased to learn that the American College of Physicians (ACP) has revised its guideline for breast cancer screening to align with the USPSTF. The new ACP guidelines recommend every other year mammography for women at average risk of breast cancer ages 50-74. For women ages 40-49, the ACP guidance recommends a discussion to determine if screening is appropriate, although the ACP cautions that "the potential harms outweigh the benefits in most women" in the 40-49 age range. Limited Reporting of Adverse Events in Cancer Research In an important analysis published recently in the BMJ, investigators explored how adverse effects were described in phase II and III cancer drug trials published in 5 major medical journals in 2016. They found that 11% (14/122) of trials did not report any data on severe adverse events, 18% (22/122) had no data on serious events, and 2% (2/122) provided no data on deaths. The authors downplayed the harms of the intervention in 43% (53/122) of the trials. In one trial, for example, in which the safety profile of the drug was described as "manageable and mostly reversible," there were five deaths from drug toxicities among approximately 400 participants compared to none in the control arm. These findings build on a foundation of evidence highlighting the under-emphasis on safety in the medical literature. For example, a 2010 JAMA analysis (which MH co-authored) found that just 19% of randomized comparative trials published in 6 top general medicine journals focused on safety. These analyses are an important call for improved transparency in the reporting of toxicities and safety outcomes in the medical literature. The authors of this recent BMJ study suggest avoiding vague terms such as: "the drug was generally well tolerated ... [because] describing harms as acceptable or tolerable in trials ... makes a subjective judgment. Whether harms are acceptable is for individual patients to decide rather than physicians or trial stakeholders, and the threshold for tolerability to harms will differ from person to person." We agree, particularly in the case of novel chemotherapeutic agents that might provide modest prolongation of life but at the cost of potentially serious adverse effects that might significantly decrease the quality of a patient's final months. Should Specialty Societies Issue Guidelines? Despite more than a decade of attempts to create more transparency regarding conflicts of interest in medicine, serious problems remain. A series of excellent investigative reports by Katie Thomas and Charles Ornstein in the New York Times has uncovered a remarkable disregard for reporting potential conflicts of interest by leading researchers in oncology and other fields. Progress has been disappointing since discovering in 2009 that reviews of hormone replacement therapy had been ghostwritten by Wyeth employees. New evidence also comes from two recent studies in JAMA Internal Medicine. One study found that the majority of authors of 18 specialty guidelines had financial conflicts of interest -- a third of which were undisclosed. Many of the undisclosed payments were more than $10,000. In the second study, investigators found that the majority of authors of clinical practice guidelines in gastroenterology received industry payments, and many were undisclosed. And in a provocative opinion piece in Circulation, John Ioannidis argues that professional societies should refrain from even publishing guidelines and 'disease definition statements.' He argues that the individual authors as well as the professional society itself have conflicts of interest that do not permit an objective assessment of the data. We agree. This is one important reason that we almost never rely on specialty guidelines to guide our care. Whenever possible, we look to non-conflicted sources, such as the U.S. Preventive Services Task Force. Michael Hochman, MD, MPH, directs the Gehr Center for Health Systems Science at the Keck School of Medicine. Pieter Cohen, MD, is a general internist at Cambridge Health Alliance in Somerville, Massachusetts and associate professor of medicine at Harvard Medical School. Source
