Public Citizen says US government must investigate clinical trials of a Novartis drug

The Food and Drug Administration and the Office for Human Research Protections (OHRP), which is housed in the Department of Health and Human Services, “should suspend studies of a dangerous drug and promptly investigate allegations that these studies are unethical and fail to comply with federal regulations that protect human subjects,” health advocacy Public Citizen said today in letters to the two agencies.

One of the studies involves children, which raises serious ethical concerns and appears to violate special federal regulations designed to protect children in research, said Michael Carome, deputy director of Public Citizen’s Health Research Group. The drug, Ilaris (canakinumab), is manufactured by Swiss drug major Novartis (NOVN: VX) and approved by the FDA only for treating a group of rare serious genetic disorders called cryopyrin-associated periodic syndromes, which cause widespread inflammation in the body.

Ilaris approved in EU, but got negative review from FDA advisory panel