Outrage of the Month: NIH Gags Its Own Scientific Experts, Interferes with Probe of Unethical Sepsis Trial

Health Letter, June 2019

By Michael Carome, M.D.

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Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

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On April 28, The Wall Street Journal published a bombshell news report that senior National Institutes of Health (NIH) officials, including Principal Deputy Director Lawrence A. Tabak, explicitly forbade two senior scientists at the NIH Clinical Center from communicating with the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) about alleged serious ethical and regulatory lapses involving an NIH-funded sepsis clinical trial, despite a direct request from OHRP to interview these scientists about the trial.

The Wall Street Journal report prompted Public Citizen to call for an immediate U.S. HHS Office of Inspector General investigation into the actions taken by senior NIH officials to muzzle the agency’s own scientific experts, thereby effectively interfering with the OHRP’s compliance oversight evaluation of the allegations regarding the sepsis trial.

In the trial, known as the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) trial, patients are being given one of two risky experimental treatments for sepsis, neither of which is considered standard treatment. Because no other group of patients in the trial is receiving the usual treatment for sepsis, researchers are unable to ensure that the experiment isn’t causing increased deaths and organ failure. Sepsis is a life-threatening condition caused by serious infections that leads to shock and organ failure.

Public Citizen filed a complaint with the OHRP in August 2018, with publicly disclosed input from Dr. Charles Natanson and Dr. Peter Eichacker, two senior scientists at the NIH Clinical Center who are internationally recognized sepsis and critical care medicine experts, demanding that federal regulators halt the unethical sepsis trial.

The Wall Street Journal reported that Tabak confirmed to the newspaper that “he prohibited [Natanson and Eichacker] from answering questions from OHRP investigators” and that “[NIH Director Francis] Collins was aware of [this] decision.” The newspaper also noted that the Council of the Assembly of Scientists, an internal NIH committee of 24 doctors and researchers representing the scientists on the NIH campus, wrote a memo to Tabak telling him “that they were ‘extremely concerned’ that the two doctors ‘have been forbidden by NIH leadership to respond to OHRP, either as an official duty activity or an outside activity.’”

The OHRP — formerly the Office for Protection from Research Risks (OPRR) in the NIH Office of the Director — was administratively relocated 20 years ago from NIH to the HHS Office of the Secretary in large part because of the conflicts of interest that existed between NIH, the largest federal funder of human subjects research, and the OPRR. Consistent with the purpose of that relocation, the NIH must have no role in determining with whom OHRP staff speak when the watchdog agency is conducting compliance oversight evaluations of NIH-funded research.

The Wall Street Journal‘s April 28 news report also caught the attention of U.S. Senate Finance Committee Chairman Charles Grassley, a long-standing advocate for transparency in government and protection of government whistleblowers. In a May 6 press release, Grassley said, “Transparency is critical to good government and necessary to prevent waste, fraud and abuse of taxpayer dollars. I’m deeply concerned about the initial attempts to silence these doctors by the National Institutes of Health. Secrecy is the enemy of good government. If there are any indications that patients participating in a taxpayer-funded clinical trial may be injured or harmed, those concerns must be brought to the forefront and addressed. I urge Director Francis Collins and his agency to take these and any similar red flags seriously at the first step to ensure the safety of patients and the integrity of the trial.”

On May 3, The Wall Street Journal reported that NIH leadership had reversed course and granted permission for Natanson and Eichacker to speak with OHRP investigators.

Nevertheless, as we said in our recent letter to the OIG, the reported actions by senior NIH officials to gag the agency’s experts constituted gross misconduct and corruption at the highest levels of the NIH, tantamount to an obstruction of ethical justice for the subjects of the CLOVERS trial. It is imperative that the OIG proceed with an investigation of this matter despite the belated NIH decision to allow Natanson and Eichacker to speak to OHRP.

All NIH employees who have concerns about ethical or regulatory violations related to the protection of human subjects in any NIH-funded (or other) clinical trial are free to communicate with the OHRP about those concerns without fear of reprisal. The actions of the NIH leadership to prohibit such communications with OHRP undermine the protections for human subjects who are enrolled in NIH-funded research and, ultimately, public trust in NIH. Restoring that trust will require a change in leadership at NIH. Collins and Tabak therefore must go.