Report: NIH Prohibits Doctors Who Have Criticized a Sepsis Trial to Interview Investigators | Science

The agency's management has prevented two critical care physicians from the National Institute of Health (NIH) from speaking to government investigators, who are exploring concerns over a large NIH-funded clinical trial, according to a report published yesterday in The Wall Street Journal. Both doctors feared that the trial, which tested treatments for life-threatening infectious blood sepsis, put patients at risk.

Last year, the Citizen public watch group in Washington, DC, sent a letter expressing concern over the sepsis lawsuit at the Office of Health Protection Research (OHRP) of the Department of Health and Social Services, the parent agency of the NIH. Public Citizen stated that he had sought the advice of the two NIH physicians, Charles Natanson and Peter Eichacker, during the evaluation of the trial and that he had concluded that it posed "unacceptable risks". In particular, Public Citizen stated that the Crystalloid Liberal or Early Resuscitation of Vasopressive Septicemia (CLOVERS) study, which had begun recruiting patients last year to test two new treatments for sepsis, did not include a group. witness for the usual treatment, exposing participants to the risk of further harm.

The Wall Street Journal reports that OHRP then "initiated a federal review of the conduct of the clinical trial and sought to interrogate Drs. Natanson and Eichacker. Director of NIH [Francis] Collins' principal assistant, Lawrence A. Tabak, Senior Deputy Director, confirmed that he was barring the two doctors from answering questions from OHRP investigators. "

Natanson has long been vocalized against large employer-sponsored clinical trials that recruit critically ill patients, sometimes in conjunction with colleague Eichacker. Natanson's objectives include a fan utilization study that was suspended by the OHRP program in 2003 before it could resume use; a study of infant oxygen support, which OHRP also investigated and against which Natanson testified; and more recently, an NIH-led trial to treat more than 3,000 patients with a heart attack, called ischemia and myocardial transfusion. In all of these cases, as in the CLOVERS trial, Natanson argued that the design of the trial exposed patients to too high risk or serious defects.

It is unclear when OHRP will complete its review of the CLOVERS trial. In the meantime, patient recruitment continues, with a target of more than 2,000 people.