Aducanumab: the high costs of false hope

As our collective biomedical knowledge increases, we find ourselves increasingly reliant on the expert consensus of medical specialists in judging the thousands of new medical advancements made each year. We trust that our medical and pharmaceutical regulators will enlist those experts most qualified to judge the efficacy of increasingly complex medical therapies and render appropriate judgement in turn. We similarly trust that the interests and motivations of the medical community and regulators are aligned – in that both should want to protect patients from potentially harmful therapies. The recent United States Food and Drug Administration (FDA) approval of aducanumab (trade name: Aduhelm) serves as a reminder that these assumptions should not go unchallenged. Hailed initially as a breakthrough treatment for Alzheimer’s disease, subsequent randomised controlled trials of aducanumab disappointed all parties involved when they failed to clearly demonstrate clinical efficacy. Despite this, Biogen (aducanumab’s developer) was ultimately still able to bring the drug to market in the United States. Thanks to an increasingly complex and layered drug approval process, there are now avenues by which pharmaceuticals may be brought to market while clinical efficacy is either still in question or altogether lacking. Crucially, it is not clear whether the regulators we trust are making sincere efforts to safeguard patients against their misuse. </p

Non-invasive prenatal screening: invasive implications and technological overreach

Cell-free foetal DNA (cffDNA) screening, herein referred to as non-invasive prenatal screening (NIPS), has seen widespread uptake as a preferred prenatal screening tool over the past decade. NIPS examines maternal serum for foetal genetic material and is ultimately able to assign risk of aneuploidy to a given pregnancy with remarkable accuracy. Given the success of applying NIPS to aneuploidy screening, researchers and private laboratories have sought to expand its scope to include screening for rare genetic abnormalities. Despite the comparative immaturity of the technology in this latter application, NIPS is now often marketed directly to expectant parents as a way to screen for numerous non-aneuploid genetic conditions. Notably, this latter application is in direct contradiction of American College of Obstetricians and Gynecologists (ACOG) recommendations, and has resulted in clearly documented adverse pregnancy outcomes. </p

Who else but me?

Dr Hanna Mostovaya is the head of the obstetric department at Mechnikov Hospital in Dnipro, Ukraine, where she has practised since 2001. A graduate of Dnepropetrovsk Medical Institute, her special interests include reproductive medicine, resuscitation and intensive care in obstetrics and gynaecology, and healthcare organisation and management. A native of Dnipro, she made the decision to remain and practise in Ukraine through the course of two Russian invasions, initially in 2014, and again in February 2022. </p