Is there “Institutionalised Corruption” in Science? (Part 3 of 3)

(March 14th, 2016) In part 3 of our series on corrupt publication practices, Jeremy Garwood wonders whether large publication numbers are suspicious.





How much personal responsibility for research results can authors claim to have when they publish more than 1 paper a week? There are already doubts they have enough time to read all the papers they are co-authoring, let alone to fully understand the research they are putting their names to. Such questions are rarely posed openly unless serious doubts are raised about the research involved.

We looked in more detail at how these LT publication analyses are compiled (see Part 1). As an example, we considered the very high numbers of pulications authored by the most-cited researchers in Cardiovascular & Circulation Research. The top author from LT’s Publication Analysis of‘Cardiovascular & Circulation Research was Jeroen Bax who authored 579 papers between 2007 and 2013 that had received over 24,000 citations by February 2015.

In Part 2, we looked at how additional statistics might place this achievement in different perspectives, for exmple, on average, Bax authored a new paper every 4.4 days over a period of 2557 days. Peter Lawrence suggests that such numbers are a sign of “institutionalised corruption”. He argues that it is not possible to justify such frequent authorship – if we consider the scientific norm for responsible authorship to include all four of the criteria laid down by the ICMJE, i.e. a substantial contribution to the work; drafting or revising the work critically; final approval of the version to be published; and agreement to be accountable for all aspects of the work (discussed in Part 1) then he says it is simply not credible that such frequent authors can claim personal (or professional) responsibility for the published research.

As it happens, the case of Jeroen Bax has already drawn wider attention. In her publication analysis of Cardiovascular & Circulation Research, Kathleen Gransalke noted some suspicious contributions to the publication numbers for this highly-cited researcher whose speciality is non-invasive imaging techniques, including echocardiography, and multi-slice computed tomography. During the period under study, one of Bax’s closest collaborators, Dan Poldermans, was found guilty of scientific misconduct by Erasmus University in The Netherlands. Poldermans, professor of perioperative cardiovascular care at the Erasmus Medical Center since 2004, was sacked in 2011.

During the time frame of her LT Publication Analysis, 2007-2013, Kathleen noted that Bax and Poldermans had co-authored 117 publications (i.e. 20% of Bax’s total - at an average rate of one paper every 22 days for 7 years). One article has been retracted thus far, several medical journals have published “expressions of concern” and there have been calls for more retractions of discredited papers.

Poldermans’ successful career to that point was closely associated with his so-called “DECREASE” research (“Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography”). He was first author on the influential (but controversial) 1999 New England Journal of Medicine DECREASE study on the use of the beta-blocker drug (i.e. beta adrenergic receptor antagonist) bisoprolol, during vascular surgery. Jeroen Bax was second author on this seminal 1999 publication that “dramatically elevated the careers of its authors, including both Poldermans and Bax” (Forbes.com). The results of this research introduced new clinical guidelines for the treatment of cardiac patients in Europe and Poldermans became chairperson of the European Society of Cardiology guidelines committee on “pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery”.

In its investigation of Poldermans’ research, in particular the on-going clinical trials for DECREASE, Erasmus university concluded (among other charges) that Poldermans had performed research on patients who had not given written consent and had taken blood samples without permission. The investigation also found that Poldermans had invented research data, stating that he created fictitious survey forms that “can not be traced back to the data in the relevant patient records”.

Links between big numbers of research papers and clinical deaths?

However, questions were also posed about the responsibility of some of Poldermans’ co-authors, notably Jeroen Bax. Larry Husten has been following the Poldermans scandal since 2011. According to Thomson Scientific’s Web of Knowledge, he says “Poldermans and Bax were co-authors of 638 papers…22 of the papers have been cited at least 100 times while the 1999 New England Journal of Medicine paper has been cited more than 800 times”.
 
The close publication relationship of Bax and Poldermans resulted in another investigation. A few weeks after the Poldermans affair became public, Leiden University Medical Center announced that it was conducting its own investigation specifically looking at “a professor who had published frequently” with Poldermans. Although no names were publicly disclosed, it subsequently became clear that the primary focus of the investigation was Jeroen Bax. When Bax became Professor of Cardiology at Leiden University Medical Center, he expressed gratitude to Poldermans in his inaugural lecture. He even stated at the time that “although I was frequently asked to reduce cooperation (with Poldermans), I have never done so.” In the lecture he expressed nothing but pride in his relationship with Poldermans: “Nowhere in Netherlands’ cardiology can one find such a great partnership as we have built.” Subsequent to the investigation and dismissal of Poldermans, Bax refused to comment.

However, other researchers have estimated that Poldermans’ flawed “Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography” (DECREASE) research (co-authored with Bax) may have resulted in clinical practices that resulted in upto 800,000 deaths in Europe.

The DECREASE family of trials authored by Poldermans and Bax in a succession of papers since 1999 claimed that cardiac patients were less likely to die if they were given beta-blockers prior to surgical operations. This had resulted in European and American clinical guidelines that recommended “the perioperative initiation of a course of β-blockers in those at risk of cardiac events undergoing high- or intermediate-risk surgery or vascular surgery”. However, a meta-analysis published 2 years after Poldermans’ DECREASE studies had been “discredited” found “a statistically significant 27% increase in mortality from the initiation of perioperative β-blockade that guidelines currently recommend”. This meant that UK doctors may have caused as many as 10,000 deaths a year when following Poldermans’ clinical guideline. Bouri et al. concluded that “Guideline bodies should retract their recommendations based on fictitious data without further delay.”

Two of the authors of that study, Graham Cole and Darrell Francis, extended their analysis to the whole of Europe. They published an article in the European Heart Journal alleging that Poldermans’ scientific misconduct led to the deaths of some 800,000 Europeans over the past five years by tainting clinical guidelines. However, their article was “unceremoniously” retracted from the journal’s website resulting in another scandal. Despite the forced retraction, Cole and Francis told Retraction Watch that they would be shortly publishing another article in the European Heart Journal – “Our second article moves on to how we can all act to improve integrity in clinical science. We focus not on the principal researchers, but on their many unwitting accomplices: co-authors who take an untimely vow of silence, co-workers knowing a trial to be nonexistent, universities desperate to proclaim 'no patient was harmed', teachers who forget that 'focus invites fraud', journal editors who feign impotence, and crucially readers who hurry past a catastrophe looking the other way.”

This article – ‘The challenge of delivering reliable science and guidelines: opportunities for all to participate’ - finally appeared in the European Heart Journal in September 2014. In it, Cole and Francis discuss the responsibility of Poldermans’ co-authors, noting that co-authorship “brings status and metrics but no harm when the study is found misconducted. A university can accept hundreds of shared publications simultaneously to have enough involvement for co-authorship yet not enough to carry responsibility for integrity.” However, they insist that co-authors are far better placed than readers, editors, or even institutions, to identify misconduct. “If we made them all share the consequences when research is misconducted, they would try harder to prevent it: ‘crowdsourcing’ scientific integrity.” They identified “45 authors, reviewers and additional contributors” in the DECREASE trials plus “18 additional supervisors and coordinators”.

Relatively concerned?

It took the EHJ just 48 hours to ‘retract’ Cole and Francis’ first article, but they were not in such a hurry to retract Poldermans’ discredited papers. Instead, in September 2014, they published an “Expression of concern” relating to Poldermans’ 2001 DECREASE paper. The editors of the European Heart Journal had decided not to retract this paper because they said that the investigation by Erasmus University had found that the “written documentation of the research process” for the conduct of the DECREASE-1 study was “largely lacking”. Therefore, it had been “unable to confirm or dispel doubts about neither the care with which the DECREASE-1 study was conducted – and thus about the study’s integrity – nor about the reliability of its results.” 

Jeroen Bax is the third author on the paper in question and deputy editor of the European Heart Journal, a publication of the European Society of Cardiology (ESC). In September 2014, the ESC also announced Jeroen Bax was its new President Elect.

If the DECREASE patient trials were deeply flawed due to deficiencies in study design and execution, the lack of traceability of patient files and, worst of all, completely fabricated data, then surely there is a case for correcting the published scientific record? Retracting these papers may reduce the very large numbers of publications that some of Polderman’s co-authors have accumulated, but isn’t it more important to publish responsible research, especially when it can have direct effects on human health?

Jeremy Garwood

Picture: www.publicdomainpictures.net/Dawn Hudson




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