A scientist’s fraudulent studies put patients at risk

10/29/2018 Science


A physician with nearly 100 retracted papers may have misrepresented risks of an intravenous fluid.

In biomedical science, most papers that lead to retractions don’t threaten anyone’s life. But medical studies published by a once-prominent anesthesiologist offer a troubling exception, a story of how flawed and fraudulent papers can put patients in danger.

By 2010, Joachim Boldt was a research leader at Klinikum Ludwigshafen, an academic teaching hospital in Germany. That year, a sharp-eyed reader noticed a suspicious figure in one of Boldt’s 2009 publications, in the journal Anesthesia & Analgesia. A later investigation revealed that Boldt had likely fabricated data, ignored ethics rules, and committed other kinds of misconduct in 98 articles he published with co-authors. All but two are now retracted.

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Many of those studies had supported the effectiveness of intravenous solutions containing hydroxyethyl starch, or hetastarch, which doctors use to stabilize the blood pressure of patients during and after surgery or trauma. Although hetastarch and related products have been in widespread use since the 1960s, they are controversial. Study findings have suggested such products can have side effects including kidney damage and death. But Boldt’s research appeared to show that a particular form, containing synthetic molecules called colloids, was safe.

That conclusion is now in doubt. In 2011, after the scandal, a group of medical societies in the United Kingdom withdrew their influential guidelines on intravenous fluid therapy—which endorsed colloids—because they included references to four of Boldt’s tainted papers.

Joachim Stumpp, Boldt’s former boss at Klinikum Ludwigshafen, told Science and Retraction Watch that, as far as he knows, investigators have found “no reported [cases] of serious impairment or injury of any patient” treated by Boldt (whose current whereabouts and work Science could not determine). But many other patients around the world likely were touched by the fraud, says Christian Wiedermann, an intensive care specialist at the Private University for Health Sciences, Medical Informatics and Technology in Hall in Tyrol, Austria, who has written several papers about the scandal. Although proving that particular patients suffered or died because of the misconduct would likely require expensive, large-scale studies, he says, “Logic dictates that, shamefully, patient harm must undoubtedly have resulted from Boldt’s actions.”

Researchers from the University of Manitoba in Winnipeg, Canada, have tried to assess how Boldt’s misconduct might have distorted the scientific literature. Their analysis, published in 2013 in The Journal of the American Medical Association, examined 38 published articles, including seven by Boldt, comparing the use of fluids containing hetastarch with three other types of volume expanders. Taken together, the findings of the studies—which involved nearly 11,000 critically ill patients—suggested hetastarch solutions were as safe as the other fluids. But when the researchers excluded the 590 patients in Boldt’s studies on hetastarch, a darker picture emerged: The fluids posed modest but statistically significantly greater risks of kidney damage and death.

The future of hetastarch treatments remains uncertain. This year, the European Medicines Agency, which has already curtailed the use of the products, proposed banning them outright.

German authorities reportedly considered bringing criminal charges against Boldt but have not.