Family of a Baby Enrolled in the Trial to Attend; Outcome of Aug. 28 HHS Public Meeting Could Weaken Rules for Protecting Human Research Subjects
August 26, 2013
Contact: Angela Bradbery (202) 588-7741; Sam Jewler (202) 588-7779
What: Press conference to highlight the need for the U.S. Department of Health and Human Services (HHS) to strengthen the ethical standards by which human experiments are conducted and halt any ongoing trials in which parents were not properly informed of the risks to their babies or of the purpose and nature of the research.
Publicity in April over an unethical trial conducted on premature infants, called the SUPPORT study, sparked the convening of an unusual, daylong Aug. 28 public forum at (HHS). Public Citizen’s press conference will be held during the lunch break; speakers will include parents of a baby enrolled in that controversial trial, now a six-year-old who suffers from serious health problems. At the forum, Dr. Michael Carome and Dr. Sidney Wolfe, director and founder/senior adviser of Public Citizen’s Health Research Group respectively, will be the first two witnesses to testify when it starts at 9 a.m.
In the SUPPORT study, funded by the National Institutes of Health (NIH) and conducted from 2005-2009, premature infants were exposed to an increased risk of blindness, brain injury and death. In contrast to usual clinical care, the extremely premature infants enrolled in the SUPPORT study were randomly put in two groups that each received a different experimental target range of oxygen saturation. None of the consent forms signed by parents mentioned the risk of death, and only two out of 22 noted the risk of eye damage.
Since Public Citizen publicized that study, a controversy has raged in the scientific community over what kind of consent is needed in certain kinds of clinical trials. The debate goes to the heart of how research is conducted in the U.S. and could have far-reaching, negative implications if changes are made to weaken the ethical and regulatory standards by which trials are run.
Last week, Public Citizen publicized another, similar, NIH-funded trial that has just started and that also poses known risks to premature babies without fully informing the parents about those risks or the purpose and nature of the research. 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.
Wednesday’s meeting will be livestreamed at www.HHS.gov/live.
When: Press conference: Noon (estimated time of lunch break) EDT, Wednesday, Aug. 28
Meeting runs 9 a.m. - 5 p.m.
Who: Dr. Michael Carome, director, Public Citizen’s Health Research Group
Dr. Sidney Wolfe, founder and senior adviser, Public Citizen’s Health Research Group
Carrie Pratt and Shawn Pratt, with their six-year-old daughter Dagen Pratt, who as a baby was experimented upon in the SUPPORT study
Alice Dreger, Ph.D., professor of clinical medical humanities and bioethics at the Feinberg School of Medicine at Northwestern University
George J. Annas, JD, MPH, the William Fairfield Warren Distinguished Professor and Chair in the Department of Health Law, Bioethics & Human Rights at the Boston University School of Public Health; professor at the Boston University School of Medicine and School of Law
Where: Press conference will be held outside the front of the HHS building, 200 Independence Ave SW, Washington, D.C.