Two critical caregivers at the National Institute of Health (NIH) are prevented by the agency's leadership from speaking to government researchers who are exploring concerns about a major NIH-funded clinical trial, according to a report yesterday in Wall Street Journal . The two doctors had raised concerns that the trial that tests treatments for the life-threatening blood infection sepsis was putting patients at risk.
Last year, the watchdog group Public Citizen in Washington, DC, sent a letter raising concerns about sepsis attempts at Office for Human Research Protections (OHRP) within the Department of Health and Human Services, NIH's parent agency. Public Citizen said it had sought expert advice from the two NIH doctors, Charles Natanson and Peter Eichacker, in the assessment of the trial, and concluded that it had been "unacceptable risks" based on that assessment. Public citizens accused in particular that the study, Crystalloid Liberal or Vasopressor's Early Resuscitation in Sepsis (CLOVERS), which began recruiting patients last year to test two new sepsis treatments, did not include a control arm for the usual standard of care, increased participants risk of injury.
The Wall Street Journal reports that OHRP then "launched a federal review of the clinical trial's behavior and sought to interview Drs. Natanson and Eichacker. NIH Director [Francis] Collin's Supreme Assistant, Deputy Director-General Lawrence A Tobacco confirmed that he forbade the two doctors to answer questions from OHRP investigators. "
Natanson has long spoken against major clinical trials funded by his employer who recruits critically ill patients – sometimes in connection with his colleague Eichacker . Natanson's goal has included a fan use survey suspended by OHRP in 2003 before being allowed to resume; an examination of oxygen support in infants, which OHRP also examined and against which Natanson testified; and recently called an NIH trial to treat more than 3,000 patients with heart attack, Myocardial Ischemia and Transfusion. In all these cases, as in the CLOVERS trial, Natanson has argued that the design of the trial puts the patients at high risk or otherwise makes serious mistakes.
It is not clear when OHRP will complete its review of CLOVERS trial. Meanwhile, recruitment of patients with a target of more than 2000 people continues.
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