Not at the same time. Two Boston items.
Public Citizen argues that a clinical trial of a new approach to sepsis is unethical. One of the lead investigators is at BIDMC. From NPR:
A consumer advocacy organization is asking federal health officials Tuesday to halt a large medical study being conducted at major universities nationwide.
Public Citizen says that the study, involving treatment for sepsis, puts patients at risk and will at best produce confusing results.
The CLOVERS study seeks to answer a key question about sepsis, which is a common and life-threatening response to infection. Sepsis kills more than 250,000 Americans a year, often by triggering the failure of multiple organs. As patients’ blood vessels get leaky as a result of sepsis, it becomes difficult to maintain safe fluid balance and blood pressure.
NPR reports that Dr. Nathan Shapiro, a professor of Emergency Medicine at Beth Israel Deaconess Medical Center and one of the principal investigators for the CLOVERS study, stands by it. He declined to talk to the reporter and instead issued a written statement.citing the input of “expert clinicians” who produced a study that “follows a well-accepted design.”
Public Citizen also had a written statement on a letter sent to Office for Human Research Protections at HHS.
An ongoing clinical trial involving seriously ill sepsis patients is deeply flawed, riddled with serious regulatory and ethical lapses, and must be stopped, Public Citizen said today in a letter (PDF) to the federal government.
In the experiment, patients are being given one of two treatments for sepsis, both of which are risky and neither of which is considered standard treatment. Because no other group of patients in the trial is receiving the usual treatment for sepsis, researchers can’t ensure that the experiment isn’t causing increased deaths and organ failure. Sepsis is a life-threatening condition in which bacteria or their toxins get into the bloodstream, causing shock and organ failure.
STAT also has a story on Public Citizen’s action, as well as a great video explaining the hard-to-explain condition.
Another item, this one in the Times:
Long-term care hospitals?
This little noticed approach to post-acute care is apparently delivering nearly $5 billion. Amy Finkelstein of MIT was one of the authors of a study that concluded:
There is substantial waste in U.S. healthcare, but little consensus on how to identify or combat it. We identify one specific source of waste: long-term care hospitals (LTCHs). These post-acute care facilities began as a regulatory carve-out for a few dozen specialty hospitals, but have expanded into an industry with over 400 hospitals and $5.4 billion in annual Medicare spending in 2014. We use the entry of LTCHs into local hospital markets and an event study design to estimate LTCHs’ impact. We find that most LTCH patients would have counterfactually received care at Skilled Nursing Facilities (SNFs) – post-acute care facilities that provide medically similar care to LTCHs but are paid significantly less – and that substitution to LTCHs leaves patients unaffected or worse off on all measurable dimensions. Our results imply that Medicare could save about $4.6 billion per year – with no harm to patients – by not allowing for discharge to LTCHs.
The New York times reports on the study here.