Abstinence may not be safer

An FDA advisory committee convened to review the incidence of a severe adverse event in a French gene therapy trial has concluded that it was impossible to determine whether the risk of the treatment outweighed the risk of the alternatives.

In the end, last week's meeting of the Biological Response Modifiers Advisory Committee (BRMAC) reinforced that the nature and purpose of clinical trials is to determine the risks and benefits of new therapies, leading the panel to recommend that the agency no longer suspend trials of gene therapy to treat X-linked severe combined immunodeficiency (X-SCID)...