DAVID GREENE, HOST:
Today, a consumer advocacy organization is asking federal health officials to halt a large medical study that's being conducted at major universities nationwide. Public Citizen says this study involving treatment for sepsis puts patients at risk and will at best produce confusing results. NPR's Richard Harris has the story.
RICHARD HARRIS, BYLINE: First, it's important to note that sepsis is a huge problem. It arises when the body tries to fight back infection and overreacts. Sepsis is a leading cause of death, killing more than a quarter of a million Americans a year, and doctors don't agree about the best way to treat it. A large new study addresses one open question, which is, what's the right combination of IV fluids and drugs to maintain a safe blood pressure?
CRAIG COOPERSMITH: So trying to find the sweet spot, or the Goldilocks place, is important.
HARRIS: Dr. Craig Coopersmith, a sepsis expert at Emory University, says the CLOVERS trial is an attempt to do that. He's not involved in the study, but he reviewed a complaint about the trial lodged by the Public Citizen Health Research Group. Dr. Michael Carome, who heads that group, says his main concern is that the study is comparing two treatments - either using a little fluid or a lot - without comparing that to usual care.
MICHAEL CAROME: The problem is both of those experimental ways of treating sepsis may do worse. There may be higher mortality rate for both groups compared to usual care.
HARRIS: That might not be obvious. And if one turns out to be better than the other, that doesn't mean it would be better than usual care, he says. The study won't answer that question. He's also alarmed that in certain unusual circumstances, the protocol calls for holding off on treating dangerously low blood pressure for several hours.
CAROME: And no one caring for a sepsis patient would normally do that as part of usual care.
HARRIS: The study, designed at Harvard and funded by the National Institutes of Health, went through multiple reviews to conclude that it didn't pose an undue risk to patients.
CAROME: But the fact that it got through these layers of review with these serious design flaws signals that our system for protecting human subjects is broken.
HARRIS: Craig Coopersmith at Emory doesn't share that sense of alarm. Yes, studies are typically supposed to compare an experimental practice with standard of care, but in the case of fluids for sepsis...
COOPERSMITH: There's no clear standard of care for the first 24 hours.
HARRIS: So that direct comparison is not possible. He agrees with Carome that the study won't clearly show that one of these experimental treatments is better than a more middle-of-the-road approach to fluids and blood pressure medications, but at least the findings might help nudge doctors in one direction or another. As for the concerns about how to deal with a patient with very low blood pressure...
COOPERSMITH: In a very narrow patient population for a narrow period of time, there is a theoretical chance that somebody could have what I would consider to be too low of blood pressure.
HARRIS: And if he were a doctor involved in this trial, he would deviate from the protocol and treat that patient, as he expects his colleagues would as well. The study isn't designed the way he would have done it, Coopersmith says, but...
COOPERSMITH: I would be comfortable enrolling patients in this trial.
HARRIS: One of the scientists at Harvard who developed the study declined an interview request, but defended its design in a written statement. A spokesperson for the federal Office for Human Research Protection (ph) says it has not seen the complaint but expects to review the allegations. Richard Harris, NPR News.
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