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Case 3a :

Human Subjects Compliance: He's no Usain Bolt! The Ignominious Record of Joachim Boldt

Usain Bolt may be the fastest man on Earth, but another Boldt—disgraced former Professor of Critical Care, Joachim Boldt—has a record of his own. He has the ignoble honor of having the second highest number of journal articles retracted due to research misconduct.

While Professor Boldt's infamous deception includes telltale research misconduct, such as data fabrication and data falsification, Professor Boldt's case is unusual in that he also failed, frequently, to obtain ethics review of human participants research. Unfortunately, Professor Boldt's unique research into anaesthetics and surgical recovery has had potentially lethal consequences for participants in his trial and may have indirectly harmed patients whose physicians mistakenly believed his falsified research offered legitimate guidance for the improvements of anaesthesiology.

Below is a brief account of the accusations against Professor Boldt.

According to the investigations committee at the Klinikum Ludwigshafen,

"The Committee's findings are based on the examination of 91 articles authored or co-authored by Dr Boldt, and published between 1999 and 2011. Examination of these articles revealed that study files were either missing or incomplete for the large majority of the studies concerned, suggesting that Dr Boldt failed in his duty as principal investigator to comply with current regulations pertaining to the retention of study data. None of the studies examined had received an ethical opinion from the Rhineland-Palatinate Medical Association (Landesärztekammer Rheinland-Pfalz). In the majority of these cases, the principal investigator had failed to register planned research projects with the Rhineland-Palatinate Medical Association, and the relevant office at Ludwigshafen Hospital. Many cases revealed no record of formal consent by study participants or indeed evidence that study participants had been provided with sufficient information prior to enrolment.

The Committee reports that in a large number of the studies investigated, the conduct of research failed to meet required standards. False data were published in at least 10 of the 91 articles examined, including, for instance, data on patient numbers/ study groups as well as data on the timing of measurements.

The Committee's findings include clear evidence of procedural irregularities and research misconduct on the part of Dr Joachim Boldt" (Klinikum Ludwigshafen 2012; quoted by Marcus, 10 August 2012).

In at least four clinical trials, Professor Boldt failed to obtain ethics review of his research from his employer, the Klinikum Ludwigshafen. Failure to secure ethics approval is a violation of German medical ethics regulation—the Code of Deontology—and a violation of the rules of conduct at the Klinikum Ludwigshafen.

In a recent meta-analysis of the literature discussing the risks and benefits of the use of hydroxyethyl starch (HES), Steen (2011) recounting Zarychanski et al (2009) found that, "After exclusion of the studies by Boldt et al, Zarychanski et al found that hydroxyethyl starch was associated with a significantly increased risk of mortality (risk ratio [RR], 1.09; 95% CI, 1.02-1.17) and renal failure (RR, 1.27; 95% CI 1.09-1.47)" (Steen 2011, page XX, quoted in Oransky 19 February 2013). Although Zarychanski et al were reasonably circumspect in their evaluation of possible harms based upon Boldt's research, there is reason to suspect adverse patient care outcomes based upon well intentioned use of HES.

Citations:

Steen, R. Grant. 2011. "Retractions in the medical literature: how many patients are put at risk by flawed research?" Journal of Medical Ethics doi:10.1136/jme.2011.043133

Zarychanski, R., Turgeon, A.F., Fergusson, D.A., Cook, D.J., Hebert, P, Bagshaw, S.M., Monsour, D., and MacIntyre, L., (2009). "Renal outcomes and morality following hydroxyethyl starch resuscitation of critically ill patients: systematic review and meta analysis of randomized trials". Open Med. 2009; 3(4): e196–e209

• Might research integrity training for either Professor Boldt or members of his research team prevented these misconduct incidents?