Anyone who has leafed through the latest issue of Critical Care and Resuscitation, or Intensive Care Medicine, or Critical Care Medicine, or by now the Daily Telegraph, the BBC or Wikipedia, will have seen the flood of responses being published regarding one Dr. Joachim Boldt. He’s a German anaesthetist who, until November 2010, held the chief physician position at Ludwigshafen Hospital and, until February of this year, was a Professor at the University of Geissen (Gießen). These titles have been stripped from him – Oh dear! |
In December 2009 one of his many trials comparing 6-Hydroxyethyl starch to an alternative fluid in various perioperative settings (in this case, during cardiopulmonary bypass) was published in the journal Anaesthesia and Analgesia (Vol 109, No 6, Dec 2009; pg 1752 – 1762). In a letter to the editor, a reader pointed out that the results were better than could be supported by the given data. This observation prompted a review of the paper, which found that much of the results appeared to have been fabricated, as apescts of the trial such as laboratory or patient data were not available and no follow up appeared to have been conducted. Oh dear, oh dear!
The journal retracted the article last October and contacted the relevant authorities which has ultimately led to a joint letter by 18 prominent editors-in-chief, including Joseph E Parillo of Critical Care Medicine, and Massimo Antonelli of Intensive Care Medicine, having conducted a review of all Boldt’s 102 articles published in their respective journals. They outline the steps taken as a result of finding that 88 papers did not meet publication standards, particularly, failing to gain review board approval for clinical research. All 88 of these articles, listed in the joint letter, have since been retracted by the individual journals – Yipe!. Although Boldt’s latest trial is alleged to have been fabricated, these other 87 have withdrawn due to lack of verification of appropriate approval and the 18 editors-in-chief have not stated that the research outcomes themselves are false … yet. They are undergoing a review of all 88 articles and will notify their readership of any further developments. The number of tainted articles may grow!
And Boldt himself? Well, the Ludwigshafen Hospital has relieved him of his chief physician duties and the University of Gissen has stripped him of his professorship for failing to meet his educational responsibilities. In addition, he is potentially facing criminal charges, with a possible prison sentence or heavy fine if convicted.
And it doesn’t end there. He was apparently well liked and quite a charismatic speaker. His career though, is now in tatters. No doubt the multiple co-authors who share the 88 suspicious articles with him will be a touch nervy right now. Whether directly or indirectly, their reputations are on the line as well. And there are all of the patients who were included in his studies and those whose management by others may have been affected by the purported outcomes of the trials (Hence the possibility of criminal charges).
Many will be aware of the CHEST trial being conducted in Australia and New Zealand, which is attempting to recreate the SAFE study, but using 6-Hydroxyethyl Starch instead of 0.9% saline, for resuscitation. The origins of the trial are influenced by Boldt’s work, though he is not himself involved in CHEST; so what should happen now? The ANZICS-CTG has reviewed the trial proposal and protocol, along with the relevant literature and examined the results of the first planned interim analysis of the data at 2000 recruited patients and has determined that CHEST should continue (due to be completed in November) and, in fact, is even more important now. However, the rigour with which the trial is conducted and published will be under even greater than usual scrutiny due to the tarnish from the mere mention of 6-Hydroxyethyl Starch, as Boldt was a significant contributor to the existing body of evidence.
Joachim Boldt is not the first (think Andrew Wakefield and MMR vaccine), though he now has the dubious honour of being the author of the greatest number of publications retracted. Whether to protect his own reputation, or under pressure to produce, or feeling the pinch of funding, his alleged actions have potentially caused great harm; to individuals, to institutions and to the medical community.
So if you are conducting a trial at the moment, or considering one, especially if you have yet to cross the Formal Project hurdle, be sure you comply with your ethics board’s directives, any advice from your consultants and run it by the book. You don’t want to be the next J. Boldt.
Sources
- Retraction Watch
- Anaesthesia and Analgesia
- Critical Care and Resuscitation
- The Daily Telegraph (UK)
- Wikipedia