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Narrative reviews from a fraudulent author: reasons to retract

  • Christiane S. HartogEmail author
  • Anders Perner
Editorial

Clinical studies from fraudulent authors are retracted, but narrative reviews are not. We believe that reviews should be considered for retraction, too. J. Boldt is number 2 on the top list of fraudulent authors; currently, 96 of his clinical studies have been retracted since 2010. Earlier trials from the 1990s are also suspected for fraudulence, but the ethics boards no longer keep the documents, making it difficult to prove [1]. Fraudulent clinical studies generate false evidence that may harm patients [1, 2]. Narrative reviews based on falsified data generate false messages that may also result in patient harm. The effect of narrative reviews on clinical practise should not be underestimated. We believe that narrative reviews may be quite influential especially in contentious fields. Readers may prefer narrative reviews because they are easy to follow and contain clear recommendations [3], while systematic reviews, though considered to be of higher quality, may appear “boring and sometimes unimplementable” [4] and contain no or limited recommendations. Indeed, leading journals publish more narrative than systematic reviews [5].

Boldt published numerous narrative reviews. We previously found that he alone authored 21 of all 124 reviews supporting the use of hydroxyethyl starch (HES) published between 1975 and 2010 [6]. From the 1990s onwards, favourable reviews increased from two to eight per year and HES’s share of the artificial colloid market tripled from 20 to 60% [6]. We believe this association implies that narrative reviews contributed to the increasing use of HES. Table 1 shows an overview over 23 reviews written between 1998 and 2010 (21 previously identified reviews [6] plus 2 reviews identified during an update in November 2018). Closer scrutiny reveals that all reviews cite retracted studies and contain misleading statements supporting the use of a substance that is less effective and clearly harmful in some patient groups. The misleading messages (Table 1) can also be found in reviews written by leading medical officers from a manufacturing company [7, 8]. Boldt admitted to financial payments from the fluid manufacturer to himself and his department [9]. However, the sheer multitude of reviews is astounding (not counting the numerous clinical studies by Boldt) as is the fact that several reviews contain the results from different MEDLINE searches, complex graphs and reference lists with more than 100 references. It may therefore be questioned whether Boldt wrote all these reviews himself.
Table 1

Overview over 23 narrative reviews of HES by J. Boldt

References no.

Year

Times cited

Focus

Reference to own studies

Misleading messages and unsubstantiated claims

All

2011–18

Re-tracted

Not re-tracted

1

1998

n.a.

n.a.

ICU

2

6

Deprecates albumin

Denies HES class effect, i.e., “modern” HES is less harmful and has more benefits than “older” HES preparations

Claims “modern” HES is safer

Claims additional beneficial effects of “modern” HES (microcirculation, inflammation, coagulation)

Claims Crys-coll ratio 3 or 4 to 1

2

1999

8

2

Surgery

2

2

Claims colloid more effective

Deprecates albumin

Claims HES more effective and safer than other synthetic colloids

Denies HES class effect

Claims additional beneficial effects

3

1999

11

1

Cardiac surgery

0

10

Deprecates deprecates crystalloids

Denies HES class effect

Claims “modern” HES has no harmful effects on coagulation

4

2000

28

7

Surgery

1

3

Deprecates crystalloids

Deprecates albumin

Denies HES class effect

Claims additional beneficial effects

5

2000

22

4

ICU

1

2

Deprecates albumin

Denies HES class effect

Denies mortality is important outcome in fluid trials

Claims additional beneficial effects

6

2002

12

1

Renal failure

2

1

Claims “modern” HES is not nephrotoxic

7

2003

37

7

Renal failure

1

2

Claims “modern” HES is not nephrotoxic

Claims adequate hydration can protect from nephrotoxic HES effects

8

2003

53

8

General

5

3

Deprecates albumin

Denies HES class effect

Claims additional beneficial effects; claims safety and efficacy of modern HES is proven by numerous studies

9

2003

20

2

Renal failure

1

2

Denies HES class effect

Claims “modern” HES is not nephrotoxic

Claims adequate hydration can protect from nephrotoxic HES effects

10

2004

7

1

General

4

4

Deprecates albumin

Denies HES class effect

Claims additional beneficial effects; claims spurious new research questions

11

2004

52

9

Trauma

4

3

Claims that colloids are more effective for resuscitation

Deprecates albumin

12 Claims that better HES are on the market in Europe than in North America

12

2005

50

17

General

3

0

Deprecates albumin

Denies mortality is important outcome in fluid trials

Claims additional beneficial effects by direct action of the HES molecule

13

2005

16

1

General

2

0

Optimum colloid should be defined by physiological criteria, not by mortality in clinical trials

14

2006

14

3

Cardiac surgery

3

1

Deprecates US meta-analyses because they ignore claimed additional beneficial effects of HES

Claims safety and efficacy of modern HES is proven by numerous studies

15

2006

33

12

General

4

3

Deprecates crystalloids

Deprecates albumin

Claims additional beneficial effects of the HES molecule

16

2006

30

12

Abdominal surgery

3

0

Deprecates crystalloids

Claims additional beneficial effects of the HES molecule

17

2007

10

1

Cardiac surgery

3

0

Deprecates albumin

Claims modern HES is not harmful to coagulation

Claims additional beneficial effects of the HES molecule

18

2008

16

6

Balanced HES solutions

3

1

Claims additional benefits through balanced carrier solution

19

2009

23

11

ICU, renal failure

3

0

Claims modern HES is not nephrotoxic

Nephrotoxic effects can be avoided by proper hydration

20

2009

43

33

General

7

0

Denies HES class effects

Claims additional beneficial effects of the HES molecule

Claims numerous studies have proven safety and efficacy of “modern” HES

Claims mortality is not influenced by choice of fluid

21

2010

6

4

General

2

0

Claims spurious new research problems

22

2010

37

37

Microcirculation and tissue oxygenation

1

0

Suggests additional beneficial effects of the HES molecule

23

2010

63

59

Albumin vs. HES

2

0

Deprecates albumin

Claims “modern” HES is equally effective and safe

References 1–23 are listed in the Online Supplement

The false claims have been refuted by the results of clinical trials and meta-analyses [10, 11, 12, 13]. The EMA (European Medicines Agency) has issued clear constraints for using HES in critically ill patients, including new measures introduced this year to protect patients further (https://www.ema.europa.eu/en/medicines/human/referrals/hydroxyethyl-starch-hes-containing-medicinal-products). However, HES is used widely outside Europe, and Boldt’s narrative reviews continue to be cited. Web of Science Citation reports show 591 citations overall and 238 since 2011. In his reviews, Boldt bases his misleading claims on his own fraudulent studies (Table 1). Only one review was withdrawn as it contained Boldt’s retracted contribution to German guidelines on blood product use [14]. Not surprisingly, Boldt had deprecated albumin in favour of starches.

Narrative reviews relying on falsified data should therefore be retracted too.

Notes

Compliance with ethical standards

Conflicts of interest

CSH reports grants from the German Federal Ministry of Education and Research (BMBF) via the Center for Sepsis Control and Care (CSCC; FKZ: 01EO1002) and the Innovations Funds/Federal Joint Committee FKZ 01VSF17010 and ESICM (European Society of Intensive Care Medicine). AP reports that his ICU receives funds for research from Ferring Pharmaceuticals. He holds grants from the Novo Nordisk Foundation and Innovation Foundation Denmark.

Ethical approval

An approval by an ethics committee was not applicable.

Supplementary material

134_2019_5558_MOESM1_ESM.docx (14 kb)
Supplementary file1 (DOCX 13 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Anesthesiology and Intensive Care MedicineCharité Universitätsmedizin BerlinBerlinGermany
  2. 2.KLINIK BAVARIA KreischaKreischaGermany
  3. 3.Department of Intensive CareRigshospitalet, University of CopenhagenCopenhagenDenmark

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