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NIH Blocks Doctors From Speaking Out To Investigators

National Institutes of Health keeps scientists critical of clinical trial from responding to U.S. agency inquiry. NIH Blocks Doctors From Speaking Out To Investigators

The National Institutes of Health, the U.S. government’s premier health research agency, is refusing to allow two of its doctors to respond to government investigators looking into the quality of a continuing clinical trial of new blood-infection treatments on thousands of patients, according to NIH documents and multiple interviews.

The resulting tensions within the NIH have pitted the office of the agency’s director, Francis Collins, against an internal NIH committee of 24 scientists, who are raising questions over the freedom researchers are afforded to critique the work of colleagues. That freedom has long been a crucial form of quality control in the safe development of new medicines and therapies. Barring doctors from commenting on a safety inquiry curtails that freedom, the committee contends.

The NIH director’s office maintains that the decision to keep the researchers from talking with investigators concerns choosing the right people to speak for the organization, not scientists’ freedom to critique.

Behind the standoff is a multiyear clinical trial to be completed in 2021, a test of new procedures to treat the often-lethal bloodstream infection known as sepsis, which affects more than a million Americans each year. The trial, funded by the NIH, is known as the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial, or Clovers, and involves testing two treatment approaches on some 2,320 patients.

A clinical trial typically benchmarks a new treatment against an existing one, allowing researchers to assess whether the new approach improves outcomes, has little impact, or makes things worse. But, among other issues, the Clovers trial didn’t adequately compare the new treatment against accepted methods, raising red flags, according to critics of the trial.

At the center of the clash are two NIH doctors, Charles Natanson and Peter Eichacker, both of whom have published frequently on the topic of sepsis, medical research and critical-care medicine. Last year, they raised concerns about the way the sepsis study was being conducted, resulting in a critical report on the trial by the nonpartisan consumer group Public Citizen. The group said the Clovers study “predictably will expose many subjects to dangerous deviations from critical care.”

That publication caught the attention of the Office for Human Research Protections, a federal agency mandated with assuring American patients aren’t harmed in clinical research. The OHRP launched a federal review of the conduct of the clinical trial, and sought to interview Drs. Natanson and Eichacker.

NIH Director Collins’s top assistant, Principal Deputy Director Lawrence A. Tabak, confirmed he prohibited the two doctors from answering questions from OHRP investigators.

The Council of the Assembly of Scientists, an internal NIH committee of 24 doctors and researchers representing the scientists on the NIH campus, wrote in a memo to Dr. Tabak 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.”

Dr. Collins, the NIH director who is also a well-known geneticist, declined to comment. His assistant, Dr. Tabak, who ordered the blocking of the two doctors’ testimony, said: “The agency has the responsibility to choose people to respond on behalf of the NIH. This has nothing to do with freedom of speech.” He said Dr. Collins was aware of the decision.

James Kiley of the NIH’s National Heart, Lung, and Blood Institute, which oversees the study, said, “This protocol was developed through a deliberative process and underwent multiple external, independent reviews.” All “found the scientific question important and the approach ethical,” he said.

The two doctors said they were prevented from commenting for this article.

OHRP Director Jerry Menikoff declined to comment.

The National Institutes of Health, a collection of 27 institutes and centers focusing on all aspects of human health, is the world’s leading funder of medical research, with a budget of $39 billion annually. Most of that money is allocated as grants to academic institutions around the U.S.

Funding a clinical trial like Clovers is a core part of the mission of the NIH to help drive progress toward new treatments of diseases like sepsis. A fundamental ethical concern is how to balance the potential long-term benefits of such clinical research against the immediate risks to the human subjects of the test.

One university, the Washington University School of Medicine, in St. Louis, declined to participate in the Clovers study for some of the same reasons cited by Drs. Natanson and Eichacker, according to a person familiar with the issue and email correspondence reviewed by The Wall Street Journal. Washington University confirmed it had declined to participate, but didn’t specify why.

The Clovers trial continues, encompassing about 50 hospitals, although the protocol for the study has changed somewhat. The two doctors are still troubled by the study methodology making it more imperative they speak with OHRP officials, people familiar with the issue say.

Sepsis is an infection of the bloodstream that results from simpler infections, like pneumonia, urinary-tract infections or even skin infections. By the time sepsis worsens into the more dire septic shock, it causes death in about 40% of cases. An estimated 270,000 U.S. sepsis cases end in death each year.

In severe sepsis, blood pressure plummets. Internal organs shut down. Standard treatment includes antibiotics, fluids and drugs to support blood pressure.

The trial seeks to test two approaches to sepsis care, one that emphasizes early blood-pressure medicine and the other offering extensive fluids. But the study’s protocol didn’t compare those methods to the standard protocols for sepsis treatment, Public Citizen said.

“The trial includes two experimental groups that each involve strategies for the early management of severe sepsis that to our knowledge have never been tested previously in any clinical trial,” said Public Citizen in its report.

The issue came to a head two months ago around an NIH conference table, with a half-dozen of the 24 senior scientists and senior NIH officials, including Dr. Tabak, convening to discuss the underlying issues like research freedom of speech. Dr. Tabak repeatedly contended that Dr. Natanson’s and Dr. Eichacker’s actions and commentary were inappropriate, according to people present at the meeting.

Now, with OHRP evaluating the study, said Michael Carome, the president of Public Citizen, the official NIH stance is particularly unacceptable. “These two doctors have identified what we think is a serious problem,” he said, adding that the OHRP “should take a precautionary approach. They should stop the trial.”

In Reversal, NIH To Allow Doctors To Speak To Investigators

Federal probe is looking into patient-safety issues in sepsis study.

The leadership of the National Institutes of Health has reversed course and now 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 government 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 over medical freedom of speech, was detailed by The Wall Street Journal earlier this week. An NIH spokeswoman said Friday the NIH has reversed its stance.

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 since last summer. They had participated in a critical analysis of the nationwide study, 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 had 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 multiyear clinical study of sepsis treatments goes by the acronym Clovers, which stands for Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis. The Clovers trial 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.

James Kiley, who helps oversee the study for the NIH’s NHLBI, said the protocol was decided on by numerous expert critical-care doctors and that all “found the scientific question important and the approach ethical.”

Sepsis is a serious condition, and can lead to septic shock, in which blood pressure plummets and blood flow to vital organs like the kidneys and brain is reduced. It is fatal in up to about 40% of cases.

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