After an investigation lasting approximately 18 months and involving the examination of 91 scientific articles, the independent committee convened by Ludwigshafen Hospital to investigate allegations of scientific fraud brought against Dr. Joachim Boldt has published its final report. As a result of the allegations against him, Dr Boldt left the Hospital in November 2010. Following his departure an Investigation Committee, consisting of six investigators, was convened to examine allegations of scientific fraud and to investigate potential infringements of patients' rights and/or instances of patient harm. The Committee's report concludes that no patients were harmed as a result of the former consultant's professional and research conduct. However, the Committee’s report also establishes several instances of misconduct on the part of Dr Boldt.
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. However, the Committee was also able to report that no patients had been physically harmed in the process. The Committee was able to establish the identities of 455 patients whose data had contributed to Dr Boldt's research studies. These patients' medical records were examined for possible adverse events and serious adverse events as defined by current GCP (Good Clinical Practice) classification criteria. The majority of the patients identified in this manner were older patients with multiple comorbidities. Administration of the study drug, which at the time was in routine use within Ludwigshafen Hospital and other hospitals, was shown to be associated with only one such event. Fortunately, this episode was resolved without the patient suffering any lasting harm. A further patient was successfully treated following a serious adverse event and suffered no lasting harm. A possible causal relationship with the study drug, however, could not be excluded. Both patients concerned were duly notified by the appropriate clinical directorate.
"We strongly disapprove of the conduct of Dr Boldt and distance ourselves from his actions and regret that these incidents occurred,” said Ludwigshafen Hospital's Managing Director, Dr. Joachim Stumpp. “The independent inquiry's conclusion, that there is no evidence of any study-related adverse effects, has come as a great relief," The Hospital has also passed the Committee’s report on to the appropriate public prosecutor's office.
Shortly after the allegations against the former consultant anaesthetist were made public, Ludwigshafen Hospital responded by tightening procedural requirements relating to the conduct of clinical studies. Of particular significance was the decision to create a Scientific Steering Committee (Gremium der Wissenschaft, or GW). The GW's remit will be to monitor all clinical studies conducted within the Hospital, thus ensuring that appropriate quality standards are maintained, and that participating study doctors are able to access detailed guidance and support.
"The Hospital's response to this unfortunate incident has been to review internal processes and procedures,” said Dr. Stumpp. “We have done everything within our power to ensure that Ludwigshafen Hospital can meet the highest possible standards in terms of the statutory requirements pertaining to the conduct of research studies, including those relating to patients' rights,"