Calls For Medical Paper Retractions Prompt NIH To Pause Experimental Stem Cell Treatment Trial

Stat: Heart Failure Study Paused Over Concerns About Disputed Cell Therapy Papers 
A government agency has paused a clinical trial testing an experimental stem cell therapy in heart failure patients, a move made public on Monday and sparked by recommendations to retract 31 journal articles from the lab of a controversial cardiac stem cell researcher. “Recent calls for the retraction of journal articles in related fields of cell therapy research have raised concerns about the scientific foundations of this trial,” the National Heart, Lung, and Blood Institute said in a statement posted Monday. (Cooney, 10/29)

The Washington Post: Heart Failure Stem Cell Trial To Be Paused After Calls For Retractions
The decision to temporarily pause the trial came “out of an abundance of caution,” said David Goff, director of the Division of Cardiovascular Sciences at the National Heart, Lung and Blood Institute, who said the trial’s scientific rationale is largely based on animal studies not conducted by Anversa. Goff said the board charged with overseeing the safety and integrity of the trial was convened last week and NIH leadership made the decision to pause the trial, which has enrolled 125 of 144 patients, to allow a thorough review. (Johnson, 10/29)

The New York Times: He Promised To Restore Damaged Hearts. Harvard Says His Lab Fabricated Research.
For Dr. Piero Anversa, the fall from scientific grace has been long, and the landing hard. Researchers worldwide once hailed his research as revolutionary, promising the seemingly impossible: a way to grow new heart cells to replace those lost in heart attacks and heart failure, leading killers in the United States. But Harvard Medical School and Brigham and Women’s Hospital in Boston, his former employers, this month accused Dr. Anversa and his laboratory of extensive scientific malpractice. (Kolata, 10/29)

Meanwhile, red flags have been raised regarding another study —

Stat: ER Patients Given Ketamine In Clinical Trials Without Their Consent, FDA Finds 
A Minneapolis hospital tested powerful antipsychotics and the potent anesthetic ketamine on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined. Based on those findings, a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital. In a letter to the Food and Drug Administration and the Department of Health and Human Services office that protects human research subjects, Public Citizen also called for regulators to immediately launch an investigation into the conduct and oversight of the studies and “impose severe sanctions for the serious ethical and regulatory lapses that have occurred in the ketamine clinical trials and other studies” at Minneapolis’s Hennepin County Medical Center. (Begley, 10/29)

The Star Tribune: FDA: Hennepin Healthcare Flouted Patient Safety Rules In Sedation Studies 
A board that approves research at Minnesota's largest safety-net hospital failed to follow federal rules designed to protect patients when it fast-tracked studies on powerful sedatives, including ketamine, according to inspection reports from the Food and Drug Administration (FDA). The Institutional Review Board (IRB) at Hennepin Healthcare expedited approval for at least four studies between 2014 and 2018 that did not require patients to consent beforehand, even though they included a likelihood of using "vulnerable subjects." (Mannix, 10/29)

And ProPublica reports —

ProPublica: “We Will Keep On Fighting For Him.”
This is Wilson.* His mother, Aline, took the picture to mark a happy and hopeful moment following a traumatic period when Wilson participated in a University of Illinois at Chicago clinical trial that tested whether lithium was effective in treating children with bipolar disorder. ProPublica Illinois reported in April that the UIC psychiatrist who oversaw several federally funded studies, Dr. Mani Pavuluri, violated research rules, failed to alert parents of risks and falsified data to cover up misconduct, and that UIC didn’t properly oversee her work. (Cohen and Jaffe, 10/25)

In other related news —

Stat: Conflicts Of Interest In Clinical Practice Guidelines An 'Intractable Problem'
Despite a parade of studies warning that treatment guidelines issued by professional medical societies fail to fully disclose potential financial conflicts, two new analyses report that the problem persists. In one analysis, researchers found that 57 percent of 91 authors who developed 18 different guidelines for several big-selling medicines had financial conflicts, and 25 percent of the authors did not disclose a conflict in the guidelines or supplemental materials. The median undisclosed payment was $522, while the average was $17,000. Moreover, none of the guidelines were fully compliant with disclosure requirements issued by the National Academy of Medicine. (Silverman, 10/29)