(See parts 2 and 3 for perspectives from families impacted by the unethical HHS study and from other medical experts.)
On Wednesday, August 28, the U.S. Department of Health and Human Services held a rare public forum in response to growing controversy around an issue raised by Public Citizen - we are exposing HHS-funded studies that pose great risk to premature infants without the fully informed consent of the babies' parents. We held a 20 minute press conference outside HHS featuring our Health Research group experts, families of babies subjected to unethical testing, and experts in medical ethics and law - then HHS called police to have us leave the premises.
Below are some quotes from the press conference:
"Risks of harm including death weren't disclosed to the parents when they enrolled their children... because of these types of consent deficiencies, the parents who enrolled their babies in this trial were deprived of the opportunity to provide informed consent for the research -- and that fundamentally made the research unethical... The parents in the SUPPORT study deserve an apology, and they deserve to be told what actually happened in this experiment."
- Dr. Michael Carome, Director, Public Citizen's Health Research Group
"The conflict boils down to one thing -- is this standard of care, usual care, individualized care -- or is it research? By not informing patients what's going on, many of the patients thought it was individualized care, standardized care. None of the consent forms mentioned the risk of death from low oxygen... Carrie and Shawn Pratt were denied the autonomy, when they were asked to participate, to make an informed decision about participating in the SUPPORT study."
-- Dr. Sidney Wolfe, Founder/Senior Adviser, Public Citizen's Health Research Group
Last week, Public Citizen publicized the existence of another, similar trial that also poses known serious risks to premature babies, but researchers are not fully informing the parents about those risks when seeking consent. Called the Transfusion of Prematures (TOP) trial, it is 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 (low blood hemoglobin, which is found in red blood cells and carries oxygen to the body). The trial is just beginning. Read more about it here: http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3965
Public Citizen is calling for: 1) HHS to immediate halt the TOP trial and direct OHRP to open an investigation into the trial; 2) OHRP to develop a plan to contact the parents of subjects already enrolled in the trial and provide them with full information about the risks, purpose and nature of the research; 3) an independent investigation of the HHS system for review and oversight of HHS-funded human subject research; and 4) a suspension of any other similar studies currently being funded by NIH or any other HHS agency.
Go here for more about the days' events: http://www.citizen.org/hrg2152