WASHINGTON — The leadership of the National Institutes of Health has reversed course and will allow two senior doctors to speak with federal investigators regarding patient safety issues in a nationwide trial of treatment for the bloodstream infection sepsis.
The NIH, the U.S. government's premier health-research agency, has been blocking the two critical-care doctors from speaking with investigators about safety issues in the study of 2,320 patients. The NIH's stance, which has led to a dispute with dozens of its senior researchers about medical freedom of speech, was detailed by The Wall Street Journal earlier this week. An NIH spokeswoman said Friday the agency has reversed its position.
The two doctors, Charles Natanson and Peter Eichacker, have been critical of the conduct of the nationwide study of how fluids and blood-pressure medicines should be administered to desperately ill patients. The two doctors have maintained that the study, overseen by the NIH's National Heart, Lung and Blood Institute, or NHLBI, was unsafe in that it tested only two investigational treatment methods but didn't include a standard therapy control group.
A federal medical-safety office, the Office for Human Research Protections, or OHRP, has been seeking to interview Drs. Natanson and Eichacker for months. They had participated in a critical analysis of the nationwide study last summer, in cooperation with the nonpartisan consumer group Public Citizen. The study's protocol has changed some since then, but people familiar with the matter say the two doctors continue to have concerns with the way the study is conducted.
The office of NIH Director Francis Collins previously said the two doctors shouldn't be permitted to be interviewed. Dr. Collins's top assistant, NIH Principal Deputy Director Lawrence A. Tabak, confirmed he blocked their participation and said Dr. Collins was aware of his decision.
Dr. Tabak said he took that stance because he said that only officials of NHLBI were designated by NIH leadership to discuss the study. Michael Carome, director of Public Citizen's Health Research Group, said, “We're pleased they reversed course. It's something the NIH should have done long ago.” The NIH had no additional comment on Friday.
The study evaluates the usage of fluids called crystalloids, and of drugs called vasopressors, designed to keep patients' blood pressure sufficiently high. The question Drs. Natanson and Eichacker raised is whether the study effectively compared new treatments to a standard one, which in general is necessary for the ethical conduct of a clinical trial.
Sepsis can lead to septic shock, in which blood pressure plummets and blood flow to vital organs such as the kidneys and brain is reduced. It is fatal in up to about 40% of cases.
BY THOMASM. BURTON