The German State Medical Association of Rheinland-Pfalz has issued the results of an initial review of more than 100 scientific articles by German anesthesiologist Joachim Boldt, MD, PhD, indicating 90 of them lacked proper institutional review board (IRB) approval, according to industry reports, a joint statement issued by 11 anesthesiology and critical care journal editors and a news release from the International Anesthesia Research Society.
The inquiry follows the retraction in Oct. 2010 of Prof. Boldt's 2009 Anesthesia & Analgesia article, "Cardiopulmonary bypass priming using a high dose of a balanced hydroxyethyl starch versus an albumin-based priming strategy", because it was possibly based on a study which never occurred and lacked IRB approval.
Prof. Boldt was fired last year from his job as head of anesthesia at the Klinikum Ludwigshafen following investigation into the article.
Law requires these clinical studies to undergo such review and approval. Although the articles claimed they had received approval from IRB, the initial review was unable to document such had occurred.
If this is confirmed or articles are found with fraudulent data, the editors indicated they would retract the articles.
A final report on the investigation is expected in several weeks.
To read the statement on the investigation from the IARS, click here (pdf).
To read the joint statement from the 11 editors, click here (pdf).