Volume 112, Issue 6, Pages 973–977
Jack Wilkinson, Ph.D., Phillipa Malpas, Ph.D., Karin Hammarberg, Ph.D., Pamela Mahoney Tsigdinos, M.A., Sarah Lensen, Ph.D., Emily Jackson, F.B.A., Joyce Harper, Ph.D., Ben W. Mol, M.D, Ph.D.
Add-on treatments are the new black. They are provided (most frequently, sold) to patients undergoing in vitro fertilization on the premise that they will improve the chances of having a baby. However, the regulation of add-ons is consistently minimal, meaning that they are introduced into routine practice before they have been shown to improve the live birth rate. Debate on the adequacy of this light-touch approach rages. Defenders argue that demands for a rigorous approval process are paternalistic, as this would delay access to promising treatments. Critics respond that promising treatments may turn out to have adverse effects on patients and their offspring, contradicting the clinician’s responsibility to do no harm. Some add-ons, including earlier versions of preimplantation genetic testing for aneuploidy, might even reduce the live birth rate, raising the prospect of desperate patients paying more to worsen their chances. Informed consent represents a solution in principle, but in practice there is a clear tension between impartial information and direct-to-consumer advertising. Because the effects of a treatment cannot be known until it has been robustly evaluated, we argue that strong evidence should be required before add-ons are introduced to the clinic. In the meantime, there is an imperative to identify methods for communicating the associated risks and uncertainties of add-ons to prospective patients.