Does scientific misconduct cause patient harm? The case of Joachim Boldt

If you wanted to minimize the real-life effects of misconduct, you might note that some of the retractions we cover are in tiny obscure journals hardly anyone reads. But a new meta-analysis and editorial in JAMA today suggests — as a study by Grant Steen did a few years ago — that the risk of patient harm due to scientific misconduct is not just theoretical.

As the editorialists note, hydroxyethyl starches (HES) are “synthetic fluid products used commonly in clinical practice worldwide:”

Synthetic colloids received market approval in the 1960s without evaluation of their efficacy and safety in large phase 3 clinical trials. Subsequent studies reported mixed evidence on their benefits and harms.

There has been controversy over the use of HES for decades, with the most recent high-level review showing “no significant mortality increase.” But one of the reasons for that review — by the prestigious Cochrane Collaboration — was to see if the dozens of now-retracted studies by Joachim Boldt

Boldt inquiry concludes: False findings in at least 10 studies, but no harm to patients

Ludwigshafen Hospital, via Wikimedia http://bit.ly/Qnt9wS

It has been a while since we heard about Joachim Boldt, the German anesthesiologist whose 90-odd retractions briefly put him at the top of the heap until Yoshitaka Fujii kicked him off earlier this year.

Now, Boldt’s former institution, the Klinikum Ludwigshafen, has released a report on its investigation into the disgraced critical care expert, and the results aren’t pretty. Here’s a press release about the report, in its entirety:

Not so fast! Journal retracts paper from Boldt group over author hijinks, more

We knew we hadn’t heard the last of Joachim Boldt, whose nearly 90 retractions make him the putative record holder for a single author in this indistinguished club. But we didn’t expect this:

The European Journal of Anaesthesiology has retracted a paper, “Supplemental oxygen reduces serotonin levels in plasma and platelets during colorectal surgery and reduces postoperative nausea and vomiting,” from Boldt’s former colleagues at the Klinikum Ludwigshafen after determining that the authors were trying to hide their association with the disgraced anesthesiologist.

Joachim Boldt retraction tally drops by one, editors say (but record’s still safe)

As the news of Joachim Boldt’s staggering number of retractions leaps from Retraction Watch into the mainstream press, the consortium of journal editors retracting his studies has backtracked ever so slightly, announcing today that one of the 89 studies for which the German anesthesiologist lacked ethics approval in fact had such sanction.

According to the now-16 (Updated 3/7/11, as it is up from 11 several days ago) editors, LÄK-RLP,  the German body investigating the ethics component of the Boldt case:

Ladies and gentlemen, we have an apparent retraction record holder: Joachim Boldt, at 89

It’s official.* Joachim Boldt now holds the record for the most retractions by a single author.

As we reported the other day, a group of anesthesia journals was on the verge of revealing a list of 89 articles by Joachim Boldt that would require retraction because the German researcher had failed to receive proper approval from ethics officials for his studies. Today, the coalition issued a letter making the retractions official.

The 89 papers join an earlier retraction in October.

Of note:

22 papers by Joachim Boldt retracted, and 67 likely on the way

Self-plagiarism alert: A very similar version of this post is being published online in Anesthesiology News, where one of us (AM) is managing editor.

Anesthesia & Analgesia has retracted 22 papers by Joachim Boldt, the discredited German anesthesiologist whose prolific career as a researcher has unraveled with stunning rapidity — and 67 more retractions are likely on the way from 10 other titles  that have published his work.

The 22 retractions, announced Feb. 25 on the journal’s website, come less than a month after the state medical board overseeing an investigation into Boldt’s publications said that it was looking into more than 90 of his articles out of concern that he had failed to obtain proper approval from an institutional review board for the work.

The board, Landesärztekammer Rheinland-Pfalz (LÄK-RLP), investigated 102 articles. Investigators could not find evidence of adequate IRB approval for 89 papers; for the remaining, 11 had IRB approval and two did not require it, according to the A&A notice, which was signed by  editor-in-chief Steven L. Shafer:

Unglaublich! Boldt investigation may lead to more than 90 retractions

Ludwigshafen Hospital, via Wikimedia http://commons.wikimedia.org/wiki/File:Klinikum_Ludwigshafen_Nordseite.jpg

Self-plagiarism alert: A very similar version of this post is being published online in Anesthesiology News, where one of us (AM) is managing editor.

Unglaublich is the German word for unbelievable, and it’s an apt description for the latest development in the case of Joachim Boldt.

Boldt, a prominent German anesthesiologist, has been at the center of a research and publishing investigation since last October, when the journal Anesthesia & Analgesia retracted a 2009 article of his over concerns of data manipulation. This morning, the German medical board overseeing the case, the Landesärztekammer Rheinland-Pfalz (LÄK-RLP),  released its findings — and they are truly stunning.

According to LAK, somewhere in the neighborhood of 90 of Boldt’s published articles might require retraction because the investigator failed to obtain approval from an institutional review board to conduct the research.

We don’t read German. But, fortunately, the LÄK-RLP announcement was accompanied by a joint letter posted to the websites of 11 major anesthesia journals. We do read English, and here’s what that letter says:

Boldt under investigation for drug trial death

As we’ve previously reported, German anesthesiologist Joachim Boldt has been under investigation for apparent misdeeds — including lack of proper informed consent and possible data fabrication — that led to the retraction earlier this year of an article in Anesthesia & Analgesia. We’ve just learned that Boldt also has drawn scrutiny from German prosecutors for his role in a clinical trial earlier in the decade that led to the death of one patient and the near-death of another.

According to an article in the Weinheimer Nachrichten, that incident occurred when Boldt was at the University Hospital Giessen. Officials there told us there was an investigation into the matter but declined to comment further.

Here’s Google’s translation of the Weinheimer Nachrichten piece:

After misrepresentation allegations, German anesthesiologist Joachim Boldt out as hospital’s chief physician

Ludwigshafen Hospital, via Wikimedia http://commons.wikimedia.org/wiki/File:Klinikum_Ludwigshafen_Nordseite.jpg

Joachim Boldt, a leading German anesthesiologist who had a 2009 paper in Anesthesia & Analgesia retracted last month* amid allegations  that he had misrepresented parts of the study, has been relieved of his duties as chief physician at Ludwigshafen Hospital.

A press release from the German Society for Anesthesiology and Intensive Care Medicine (DGAI) condemns Boldt’s actions. The press release goes on (translated from German):

Top German anesthesiologist’s cardiac surgery paper retracted over “very serious misrepresentations”

Self-plagiarism alert: A very similar version of this post is being published online in Anesthesiology News, where one of us (AM) is managing editor.

A leading German anesthesiologist with more than 200 papers to his name has been accused of misrepresenting critical aspects of a paper  — possibly including the data itself — published late last year in the journal Anesthesia & Analgesia.

In a retraction notice published online today, Steven L. Shafer, editor-in-chief of the journal, writes that Joachim Boldt and his coauthors failed to obtain approval from an institutional review board, did not get patient consent and did not follow up as promised with volunteers in their study, reported in the December 2009 article, “Cardiopulmonary Bypass Priming Using a High Dose of a Balanced Hydroxyethyl Starch Versus an Albumin-Based Priming System.”

In addition, the journal said, it has reason to suspect that data in the paper were fabricated, a possibility that is being investigated by German authorities. As the notice states: