Serious questions have been raised about the integrity and validity of research performed by a well-established German stem cell research group. A paper published in the International Journal of Cardiology exhaustively details a multitude of discrepancies and contradictions in papers from the researcher’s group. Further, the revelation of such widespread misconduct may lead to broader disturbing questions about the reliability of scientific publications and the ability of the clinical research system to police itself.
In “Autologous bone marrow-derived stem cell therapy in heart disease: Discrepancies and contradictions,” Darrel Francis and colleagues scrutinize 48 papers from the research group of Bodo-Eckehard Strauer. According to Francis et al, the 48 papers from Strauer’s group contained reports on only 5 actual clinical studies, or “families” of reports, and that duplicate or overlapping reports were common. The paper contains details about more than 200 errors in the papers, including contradictory descriptions of the design, protocol and results of the trials. Francis et al write:
“Readers cannot always tell whether a study is randomised versus not, open-controlled or blinded placebo-controlled, or lacking a control group. There were conflicts in recruitment dates, criteria, sample sizes, million-fold differences in cell counts, sex reclassification, fractional numbers of patients and conflation of competitors’ studies with authors’ own.
Contradictory results were also common. These included arithmetical miscalculations, statistical errors, suppression of significant changes, exaggerated description of own findings, possible silent patient deletions, fractional numbers of coronary arteries, identical results with contradictory sample sizes, contradictory results with identical sample sizes, misrepresented survival graphs and a patient with a negative NYHA class.”