Advocacy Group Sues to Compel DHHS to Release Documents

Public Citizen’s Health Research Group (HRG) recently filed a civil action in the U.S. District Court for the District of Columbia, under the Freedom of Information Act (FOIA; 5 U.S.C. 552: Public information; agency rules, opinions, orders, records, and proceedings), to compel the Department of Health and Human Services (DHHS) to produce records from two National Institutes of Health (NIH) funded clinical trials concerning “testing experimental treatments in extremely premature babies.”  HRG claims “the entirety of records” requested in its five FOIA requests on the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) and Transfusion of Prematures (TOP) trial have not been made available by DHHS.  From 2005-2009, the Neonatal Research Network (NRN) of the National Institute of Child Health and Human Development (ie, a NIH Institute) conducted the SUPPORT study, designed to determine how much oxygen should be used when treating premature babies to minimize health problems.  On 7 March 2013, the DHHS Office of Human Research Protections sent a letter to the lead institution in the SUPPORT study informing investigators that their “informed consent forms did not adequately warn about the risks of blindness, neurological damage, and death.”  Of interest, ruling in a 2015 class action suit, the U.S. District Court for the Northern District of Alabama determined plaintiffs had not shown the SUPPORT study caused injuries to premature infant subjects.  [Appeal pending in 11th Circuit.]  The NRN is currently conducting the TOP study, designed to determine “which of two strategies for treating anemia with blood transfusions is more likely to result in death or neurologic injury in extremely premature infants who develop anemia.”  On 22 August 2013, HRG sent a letter to DHHS asking it “to halt the TOP trial because the consent forms to not adequately disclose the potential risks to infants in the trial and because of ethical concerns about the design of the study.”  DHHS has not yet replied to HRG’s action.