Anesthesiologists and other clinicians in Europe and the United States are re-evaluating their use of hydroxyethyl starch for fluid management in surgery as investigators continue to probe the veracity of nearly 90 studies authored by now-disgraced German anesthesiologist Joachim Boldt, MD, PhD.
On March 1, the Association of Surgeons of Great Britain and Ireland announced that citations referring to six studies authored by Dr. Boldt, who was forced out of his position at the Klinikum Ludwigshafen late last year, had been withdrawn from the British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients.
“The references by Boldt should not now be regarded as valid evidence pending their review,” a statement posted on the association’s Web site read. “We shall undertake a thorough review of the recommendations of the guidelines to determine whether any adjustments to them are needed.”
In Europe, changes in practice are evolving, said Jukka Takala, MD, PhD, director of intensive care medicine at University Hospital Bern, Switzerland. But “it’s clearly too early to evaluate this in any objective manner,” he told Anesthesiology News.
Dr. Boldt, who has published nearly 350 articles, was a leading proponent of hetastarch (HES) as a volume expander for surgical and trauma patients. Many of his studies formed the basis of clinical guidelines for HES therapy worldwide. But other studies have documented adverse effects from HES, including increased risk for bleeding, heart and kidney failure and anaphylactic shock (Anesth Analg 2011:112:635-645). As a result, the debate over the efficacy and safety of colloid, crystalloid and even albumin solutions has been intense and long-standing.
Dr. Boldt was thrust into the research and publishing scandal in October 2010, when the journal Anesthesia & Analgesia retracted a 2009 article of his over concerns of data manipulation and ethical lapses. Since then, investigators have been reviewing his research results. In March, a German medical board released a list of 88 articles for which it could not find evidence that Dr. Boldt had obtained proper approval from an institutional review board.
An international group of 16 anesthesiology journals subsequently announced that it was retracting those papers (Anesthesiology News, March 2011, page 1). Dr. Boldt faces criminal charges for allegedly fabricating research results and forging the signatures of other scientists on submitted papers. Dr. Boldt has not responded to the allegations.