Agency Should Encourage Open, Evidence-Based Debates to Improve Safety of Studies, Public Citizen Says in Letter
June 13, 2013
Contact: Sam Jewler (202) 588-7779; Angela Bradbery (202) 588-7741
WASHINGTON, D.C. – The National Institutes of Health (NIH) should not censor one of its experts just because he might criticize ethical lapses in an increasingly high-profile study carried out on premature babies, Public Citizen wrote today in a letter to Health and Human Services Secretary Kathleen Sebelius.
Dr. Charles Natanson, senior investigator and chief of the anesthesia section in the NIH Clinical Center’s Critical Care Medicine Department, was invited by Bloomberg BNA to co-present an educational webinar in July regarding the SUPPORT study, a NIH-funded experiment that Public Citizen recently exposed as having risked the lives of premature infants without proper parental consent. Natanson is one of the world’s leading experts on safely designing clinical trials testing treatments in critically ill patients that are usually adjusted across a wide range — for example, oxygen therapy — and measuring death as one of the primary endpoints, as was the case with this study.
In response to the invitation request from Bloomberg BNA for Natanson to participate, NIH Public Affairs Specialist Renate Myles wrote, “We are declining participation in the webinar at this time due to a forthcoming public meeting announced by HHS on [institutional review board] process for trials randomizing participants within the standard of care.”
“We are dismayed by the hypocrisy that NIH has sought to gag a renowned expert such as Dr. Natanson, who has identified serious concerns about the ethics of the study design used for the SUPPORT study,” wrote Drs. Michael Carome and Sidney Wolfe, director and senior advisor/founder of Public Citizen’s Health Research Group, respectively, in their letter, “while at the same time allowing other NIH officials the freedom to speak publicly about the study as long as their position is favorable to the NIH party line.” The letter is available at http://www.citizen.org/hrg2135.
Their letter points to a commentary piece defending the SUPPORT study that was published in the New England Journal of Medicine last week by the NIH director and two senior colleagues, including the director of the NIH institute that funded the study.
“This concerted effort by NIH officials to publicly promote a one-sided, biased defense of the study and to suppress an alternative viewpoint voiced by a well-informed NIH expert ultimately undermines the mission and integrity of the agency,” Public Citizen’s letter says.
Public Citizen urges Sebelius to immediately investigate NIH’s policies regarding participation of agency scientists in legitimate public forums and direct NIH to stop censoring experts who have well-reasoned, evidence-based critiques of the SUPPORT study or any other NIH-funded research and allow Natanson to participate in the webinar.
Information about the ethical problems with the SUPPORT study is available at http://www.citizen.org/support-study.