Medical Research Fraud Risks Millions of Patients’ Lives in Europe

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At the center of a medical research scandal that is being compared to the Wakefield hoax that connected vaccines with autism is a disgraced German anesthesiologist, who has been stripped of his professorship, fired from his hospital post and now faces criminal charges for forging studies about a controversial class of drugs commonly used in surgery patients.

The doctor in question, Joachim Boldt, may have forged up to 90 studies on the safety and effectiveness of drugs known as colloids, which are used to boost blood volume in patients undergoing surgery. Boldt, 57, was the chief anesthesiologist at Ludwigshafen Hospital in Rhineland and the leading advocate of colloids. His studies were published in respected British medical journals and led to a wider application of the drugs, even though they had been shown in previous studies to be more dangerous than similar, cheaper drugs. (More on Autism, Vaccines and Fraud: Q&A With Author Seth Mnookin)

Officials first became suspicious of Boldt’s findings when readers of an article published in the U.S. journal Anesthesia and Analgesia noticed that the patterns of his data were “too perfect to be believed,” reported the U.K.’s Daily Telegraph.

Medical guidelines regarding the use of colloids, which were followed by a number of British medical groups, were withdrawn for re-evaluation after it was revealed that four crucial studies on which the recommendations were based would be retracted. “The profession I represent does not want to be associated with potentially fraudulent research,” John MacFie, president of the Association of Surgeons, told the Daily Telegraph, urging other doctors to stop using colloids.

German medical authorities are reviewing 92 of Boldt’s publications. Meanwhile, allegations that the doctor forged signatures of co-authors on his studies, tested drugs on patients without their consent and claimed payments for operations he had never performed are the subject of a criminal investigation. (More on Bruesewitz v. Wyeth: What the Supreme Court Decision Means for Vaccines)

Previous studies of colloids had suggested that they increased the risk of death in surgery, and caused kidney failure, heart failure and severe blood loss, but Boldt’s data consistently showed the opposite. Boldt is reported to have received funding from the manufacturers of his most favored colloid, hydroxyethyl starch (HES), including B. Braun, Baxter and Fresenius Kabi. The Daily Telegraph reports:

He was frequently paid to speak at international medical conferences where he hailed HES as “the holy grail” of fluid drugs. HES and other colloids are up to 10 times more expensive than the alternative fluid management drugs, crystalloids, which some experts believe are safer as they contain smaller molecules and are more easily absorbed.

According to the Telegraph, Boldt was unavailable for comment.

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