Press Conference Wednesday: In Wake of Controversy Over Unethical NIH-Funded Premature Baby Trial, HHS Seeks Way Forward

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 [phone]; Sam Jewler [phone]

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 ...

Source: PharmaGossip - August 26, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs