Healthy Skepticism Library item: 19716

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Publication type: news

Gever J
New Twist in Colloids-Crystalloids Tussle
MedPage Today 2011 Mar 4
http://www.medpagetoday.com/Anesthesiology/Anesthesiology/25198

Full text:

The long-standing debate over whether colloid or crystalloid solutions make better volume-expanders for surgical and trauma patients has taken a surprising turn, with allegations of research fraud engulfing a well-known proponent of certain colloids.

Joachim Boldt, MD, PhD, until recently of the Klinikum der Stadt Ludwigshafen in Germany, has been accused of having fabricated entire studies, failing to obtain IRB approval for studies that were conducted, and forging names of co-authors on manuscript submissions.

A report by the state medical board in the German region of Rheinland-Pfalz backed up the charges, leading to his dismissal from the hospital, European newspapers reported.
This week, nearly 90 of Boldt’s published papers were retracted by editors of 16 surgery and anesthesiology journals because of the failure to document IRB approval. News reports indicated that Boldt may face fines or imprisonment because research on human subjects without IRB approval is a crime in Germany.

Because Boldt’s research was so extensive and frequently cited, practice guidelines on fluid management are now being revisited.

The Association of Surgeons of Great Britain and Ireland, for example, has removed its guideline on the topic from its website. A statement indicated that the references to Boldt’s work would be removed, and the guideline recommendations will undergo “a thorough review … to determine whether any adjustments to them are needed.”

Such guidelines have generally indicated that physicians can use either colloid or crystalloid solutions, although in the U.S., crystalloids have generally been favored.

A 2004 guideline from the American Thoracic Society on use of colloids in critically ill patients urged caution because of possibly higher rates of adverse effects, especially with synthetic colloids such as hydroxyethyl starches (HES), which were a major focus of Boldt’s publications.

Surgeons and anesthesiologists contacted by MedPage Today and ABC News were divided on the degree to which the revelations about Boldt may alter practice in the U.S.

Howard Nearman, MD, of University Hospitals in Cleveland, said in an e-mail that, although most of the HES solutions championed by Boldt are not available in the U.S., some similar products are.

“Since all the hydroxyethyl starches are related and have the potential to share common side effects, I think it may be prudent for U.S. clinicians to also follow the stance taken by our British colleagues and use other available volume expanders until further investigation is done,” he wrote.

Even more disturbed was Thoralf Sundt III, MD, chief of cardiac surgery at Massachusetts General Hospital in Boston.

“We use colloids all of the time in heart surgery — routinely,” he said in an e-mail. “I would say that this is very important … if true, this has placed real people at risk of death and complications.”

On the other hand, another cardiac surgeon said HES colloids had become unpopular in the specialty.

Aubrey Galloway, MD, of NYU Medical Center in New York City, told MedPage Today and ABC News in an e-mail that “increased risks of bleeding and other complications” had led most surgeons to prefer albumin.

“The findings of this report further reinforce these trends,” he said.

Irregularities in Boldt’s research were first noticed last year by readers of the U.S.-based journal Anesthesia and Analgesia, which had published a Boldt study of interleukin-6 levels associated with colloidal albumin and HES solutions.

According to the journal’s editor, Steven L. Shafer, MD, three readers contacted the journal to say that the standard deviations in the paper’s reported IL-6 concentrations seemed too small to be believable.

Shafer, describing the events in an editorial in the journal, said he checked with experts on IL-6 biology who agreed that the standard deviations were not plausible. He indicated that a close reading disclosed other suspicious findings.

He took his concerns to the Rheinland-Pfalz medical board, which performed a thorough investigation disclosing that, in fact, no actual study appeared to have been conducted.

Hospital records contradicted many of the paper’s claims.

For example, although half the patients in the study supposedly received albumin-based priming solutions, no albumin solutions had been used or bought by the hospital in nearly 10 years.

Additionally, there were no records to support the paper’s assertions of having received IRB approval or patients’ written consent, and Boldt admitted to board investigators that he had forged co-authors’ signatures on the manuscript submission.

Anesthesia and Analgesia retracted the paper and, later, 21 others on which Boldt was an author. In an editorial announcing retraction of the IL-6 paper, Shafer declared flatly that “the study is fabricated.”

The Boldt scandal is particularly embarrassing for the anesthesiology community because it’s the second case of research fraud to hit the field in as many years.

In 2009, a Massachusetts anesthesiologist, Scott Reuben, MD, was accused of fabricating data in 21 studies published over a 15-year period.

Shafer told MedPage Today and ABC News in an e-mail that the Boldt scandal was significant less for its impact on practice — which he said would be minimal in the U.S. — than for the public distrust in science that it will sow.

Noting that the scandal first hit the mainstream press in Britain, he said online comments there had linked the Boldt fraud charges to the alleged “pseudoscience” of global warming.

“Very obviously Dr. Boldt has nothing to do with global warming. However, to the person with an agenda of scientific skepticism, this is just one more piece of evidence against the validity of science. That affects all of us, and may be a more far reaching consequence than the clinical implications of the fraud,” Shafer wrote.