Response from Mount Sinai to allegations against Maria New:
In 2010, the Department of Health & Human Services (HHS) Office for Human Research Protections investigated Dr. Maria New’s work and found complaints against her to be unfounded, and that there was no evidence that Dr. New violated HHS regulations for the protection of human research subjects. They also found that her research had been conducted according to the rules of ethical oversight at Weill Cornell Medical College and Mount Sinai School of Medicine.
It is very common for medication for children to be prescribed ‘off label.’ The Food and Drug Administration has also issued a waiver in this case for an Investigational New Drug application. Thus, the charge of using an off label drug for research purposes without proper oversight is unfounded.
Dr. New has been defended by numerous prominent bioethicists, who in September 2010 published in The American Journal of Bioethics an article saying that the damage done to Dr. New’s reputation by her critics ‘is derived from an illicitly borrowed presumption of scholarly due diligence.’ Dr. New continues to work toward improving the quality of life of patients with congenital adrenal hyperplasia.