Journal retracts article about age of transfused blood three years after publicationBMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2057 (Published 20 May 2009) Cite this as: BMJ 2009;338:b2057
All rapid responses
Dr. Joshi has not been entirely forthcoming.
His extensive comments fail to mention that Columbia University initiated an investigation immediately upon learning of the loss of original research records. Their investigation took nearly three years. I personally met with the investigating committee, and subsequently made all of our files on the impugned manuscript available to the committee. I prepared the retraction letter, in consultation with the study authors, within 24 hours receiving the recommendation from the investigating committee that the manuscript be retracted.
Dr. Joshi has also not shared that he brought exactly the same concerns to the investigating committee at Columbia University. Dr. Joshi received an e-mail from the committee on August 19, 2009, stating “You also raised questions about research misconduct. A finding of fraud for research misconduct requires a factual finding of an intentional fraudulent act. Circumstantial evidence such as the loss of data or the inability to replicate results does not usually rise to this level.”
Dr. Joshi is welcome to disagree with the view of the investigating committee. I do not have that option. Journal editors do not have the resources, authority, or responsibility to investigate research fraud. That responsibility rests with the institution. When the institution accepts that responsibility, and launches a good faith investigation, Journal editors must defer to the findings of the investigating committee.
Steven L. Shafer, MD
Professor of Anesthesia
Anesthesia & Analgesia
Competing interests: Editor in Chief of Anesthesia & Analgesia
Far from clarifying the situation, Dr. Shafer’s response to Ms.
(1,2) raises more scientific and editorial questions about the editorial
handling of the Basran paper particularly when there seems to be an
conflict of interest.(3)
• An important question it raises is regarding the significance of
the loss of
data while defending a scientific paper? The Basran paper was questioned
Rothmann et al. soon after publication, well within the Office of Research
Integrity (ORI) guidelines that recommend data and techniques to be
preserved for at least three years, or longer if they are considered
significant.(4,5) When the Anesthesia and Analgesia (A&A) decided not to
retract the paper Dr. Shafer wrote, “How embarrassing!”(6) More recently
his comments to the Anesthesiology News he considered retraction of the
Ruben papers to be a case of fraud but the Basran paper he said was
different, a case of lost data that ‘“did not involve fraud”.(7)
Dr. Shafer is correct that loss of data by itself does not amount to
scientific misconduct. The current definition of scientific misconduct
93.103) does not specifically include loss of data even when there is a
challenge immediately after publication, while "falsification" and
are clearly defined (http://law.justia.com/us/cfr/title 42/42-
18.104.22.168.71.1.29). If we accept the loss of data as a valid excuse for not
defending the results, then it will be virtually impossible to
investigate any allegations of falsification or fabrication. The lack of
for not archiving data for any length of time seems to provide a loophole
the definition of scientific misconduct that needs to be addressed by the
• Dr. Shafer says, “the era of written laboratory notebooks has
problem will likely recur because investigators archive data on
hosted on their laptop computers.” Dr. Shafer’s excuse that the data were
lost because they were on missing laptops does not apply to the Basran
paper. The Basran paper was a retrospective analysis of clinical data
still available through hospital, blood bank and US social security death
databases, page 16.(3) The original data is not experimental data that was
archived on a notebook or a laptop. With some effort it should possible
replicate the data set from the very same databases that were used by the
authors. Furthermore, it is impossible to accept that all key authors,
the research coordinator, statistician, first author and the corresponding
author, all those who should have had copies of this large data set, had
files on missing laptops. The Bennett-Guerrero/Frumento team published
several papers, many of them in the A&A, and should have been familiar
the importance of preserving data.
Dr. Shafer’s explanation for the lost data to the BMJ, is slightly
that in his editorial the Occam’s razor.(6) In the editorial he had
the data were lost as the authors moved. Although at the time when
Rothmann et al. questioned the study, five of the nine authors, including
first author, were at their respective institutions.
• Dr. Shafer says that “Retraction sends a strong message about
responsibility for archiving data” but he makes an exception in this case
because the publication did not describe a new drug, device or a procedure
so he let it stand "albeit" weakly. Not true! In 2007, the range of
that the A&A could impose on an author for "academic misconduct" could be,
"Sanctions against authors range from requesting a Letter to the Editor
acknowledging the error and voluntarily withdrawing a manuscript, to a
ban on publication in Anesthesia & Analgesia." (14) When it came to
Basran paper the journal applied the least possible penalty for not
data, by merely requesting a “letter acknowledging the error”. In the
the authors did not even have to disclose how the data were lost within
of publication. The penalty imposed for the loss of data then was more was
line with the “How embarrassing!” comment than it was to send any strong
message. The message “Occam’s razor” sent was contrary to the
commitment to data archiving that Dr. Shafer now apparently supports.(6)
In addition, Dr. Shafer seems to be arguing for a two-tier system for
review based on the contents of the publication (devices, drugs and
procedures vs. others, such as basic science papers) that is fundamentally
unfair and potentially dangerous in the long run. Be as it may, the
publication by Basran et al. was not an insignificant one for the A&A.
paper’s findings could have huge impact on the operations of (procedures
the blood banks and it could also increase liability of medical
The New York Times (15), Science Now (16), the Red Cross (17), and the FDA
(18) quoted this paper! How many papers in the A&A achieve such
recognition? If this paper did not merit scrutiny, will any other paper
• Dr. Shafer says the findings of this study have been “verified” by
paper(19). The significance of the Basran paper is not just in pointing to
hazards of blood transfusion but when they are likely to occur. The
paper draws that line at >30 days while the Koch paper draws it at
days.(3,19) Not the same results. The difference in the results could
huge impact on the operations of the blood banks.(20,21) In May 2008, a
joint statement by the American Association of Blood Banks (AABB),
Red Cross (ARC) and America’s Blood Centers (ABC), pointed to the problems
with the Koch’s study and recommended no changes in blood transfusion
practices based on these publications.(17)
• Dr. Shafer says that, “Journals have neither the authority nor the
to investigate questions that arise regarding the conduct of research.
responsibility lies with the academic institution." Certainly true,
readership of the journal and the larger society expects the editors to do
their job, to ask pertinent questions and to demonstrate some curiosity as
'how" and "why" did something happen not just report the "what". If the
criteria for accepting a publication is the belief that the finding can be
trusted (6), sooner or later A&A will permit fraudulent research to get by
Note that contrary to what the authors repeatedly emphasize that
there is “an
error in our paper”, suggesting a single error, (13,23) there are many
in the paper beyond those that Rothmann et al. were concerned with.(24)
There are unusually strong P-values such as "P = 0.000" (page 18) or "P
0.000" (Page 17), the data in text and tables are internally inconsistent
several places, whether this is poor editing, sloppy rounding, or
errors is hard to determine.(3) Although disturbing, these are not the
problems with the paper.
• The major problems with the Basran study are that data presented in
final manuscript are incompatible with the preliminary data presented as
earlier in abstracts.(3,9,10) While the underlying data are missing, we do
access to preliminary results published as abstracts from the same cohort.
(9,10) In their retraction letter (13) the authors have acknowledged, the
was retracted because the number of patients with acute renal dysfunction
(ARD, 58 cases) was the same for the 392 patients reported in the abstract
(9) as it was for the 321 patients that were reported in the final
There was not a single case of ARD in the 71 patients that were excluded
from the final analysis. Exclusions in the final analysis were mostly due
patients receiving "irradiated blood".(3) With 18% overall incidence of
the chances of this happening is exceedingly remote, less than 1:1000,000.
Alternately, if we accept the data in the abstract and the paper, then we
come to the stunning and improbable conclusion that “irradiated blood”
provides absolute protection against renal failure during repeat cardiac
Furthermore, there were a total of 434 patients with cardiac re-
the abstract and the paper. According to the abstracts, 42 patients were
excluded because they were not transfused.(9,10) Of the remaining 392 that
were transfused, "Ninety-two patients were excluded because they received
≥1 U of irradiated RBCs." (3) Therefore, there could be no more than
eligible patients in this cohort, even if we ignore the other exclusion
criterions. Yet, the study describes results from 321 patients! Where did
these 21 additional patients come from?
The apparent incompatibility between the data presented in the
the final manuscript is not some simple error as the authors (13,23), and
Shafer (6), refer to but they raise the possibility of a compromised data
Either the inclusion and exclusion criteria were not properly applied, or
were serious data entry errors, or there was "cherry picking" of the data
particularly with regards to patients with renal failure. The absence of
effort on the part of the authors' to replicate their results - when they
apparently have done so – under these circumstances, also challenges one's
• What has really made the Basran paper unique is the editorial
the issues. One thing Dr. Shafer does not categorically state is whether
has/had any conflict of interest in the defending the Basran paper
he has commented on the paper several times by now.(1,6,7,25) An
unambiguous statement in the matter will help us understand what he and
the journal consider to be a conflict of interest?(26) A recent article
accompanying editorial in the Proceedings of the Mayo Clinic points to
complex bidirectional issues regarding the conflicts of interest
medical journal editors.(27,28) Under the usual circumstances, if Dr.
was seeking a job or transitioning into one, at the department of origin
the paper (2) he should have at least declared his conflicts of interest
ideally should have excused himself from intervening in the process.(29)
In his closing comments Dr. Shafer certainly wants to put all this
However, Dr. Shafer’s comments and actions are deeply concerning whether
he is providing changing reasons for data loss,(1,6) applying a rhetorical
argument “Occum’s razor” to correct statistical errors,(6) or "apparently"
ignoring his conflicts of interest.(2) Instead of proposing new rules, the
under Dr. Shafer should be more alert and less gullible, and it should
the existing rules. A good starting point for Dr. Shafer will be to
lead of the Basran paper and retract his editorial “Occam’s razor” that in
opinion undermines the significance of data loss. (6) For the rest of us,
for the regulatory authorities, we should address the deficiencies in the
definition of research misconduct and find methods to enforce at least
over-sight of medical editors from the ground up and top down.
Shailendra Joshi, MD
1. Shafer SL. Editorial Responsibilities. The BMJ 2009;Rapid Response:b
2. Lenzer J. Journal retracts article about age of transfused blood three
years after publication. The BMJ 2009;338:b 2057.
3. Basran S, Frumento RJ, Cohen A et al. The association between duration
of storage of transfused red blood cells and morbidity and mortality after
reoperative cardiac surgery. Anesth Analg 2006;103:15-20.
4. Steneck NH. ORI Introduction to the Responsible Conduct of Research: US
Government Printing Office, 2007.
5. Coulehan MB, Wells JF. Guidelines for Responsible data management in
Scientific Research. Clinical
6. Shafer SL. Occam's razor. Anesth Analg 2007;104:1597-8.
7. Editorial. Burned by Fraud, Anesthesia Journal Grids Author Rules.
Anesthesiology News 2009; 35 :1 and 70.
8. Lenzer J, Brownlee S. Government Orders Columbia to Tell Patients 'True
Nature" of Drug Study. Huffington Post
9. Basran S, Frumento R, Cohen A et al. Association between Length of
Storage of Erythrocytes and Postoperative Acute Renal Dysfunction in
Undergoing Reoperative Cardiac Surgery. Anesthesiology 2004;Proceedings of
the Annual Meeting of the American Society of Anesthesiologists 2004:A205
10. Frumento R, Basran S, Cohen A et al. Association between the Length of
Storage of Transfused Red Cells and Length of Stay in Patients Undergoing
Reoperative Cardiac Surgery. Anesthesiology 2004;Proceeding of the Annual
Meeting of the American Society of Anesthesiologists 2004:A-179
11. Girshin M, Frumento RJ. Pediatric Mortality Related to Anesthesia
of the Operating Room. ASA abstract (A-1408) 2007;American Society of
Anesthesiologists Annual Meeting Abstracts (abstract index)
12. Jindal M, Frumento R. Can ASA Grade Predict QA Respiratory Events in
Bariatric Surgery? An Analysis of 1,625 Patients (A-925). Annual meeting
the American Society of Anesthesiologists (abstract index)
13. Basran S, Frumento R, Cohen A et al. Request for Retraction. Anesth
14. Editorial. Guide of Authors 2006-07. Anesth Analg 2007;105:187-99.
15. Balakar N. Age of Trasfused Blood May Play Part in Recovery New York
Times. New York,
16. Gray B. Blood Gone Bad? Science 2006;Science
17. Triulzi D. Clinical Significance of Red Cell Age in Transfusions.
Before the Advisory Committee on Blood Safety and Availability 2008;May
18. He P. FDA's Criteria for Evaluation of Red Blood Cell Products.
Proceedings of the Blood Products Advisory Committee (91st) Meeting,
Rockville MD 2008:http://www.fda.gov/ohrms/dockets/AC/08/slides/2008-
19. Koch CG, Li L, Sessler DI et al. Duration of red-cell storage and
complications after cardiac surgery. N Engl J Med 2008;358:1229-39.
20. Pereira A. Blood inventory management in the type and screen era. Vox
21. Owens W, Tokessy M, Rock G. Age of blood in inventory at a large
care hospital. Vox Sang 2001;81:21-3.
22. Shafer SL. Tattered threads. Anesth Analg 2009;108:1361-3.
23. Basran S, Frumento R, Cohen A et al. Author reply. Anesth Analg
24. Rothmann M, Braun MM, Ng TH. On the hazard ratios and corresponding
confidence intervals that appear in Basran et al. (2006). Anesth Analg
2007;104:1597; author reply.
25. Shafer SL. Notice of Retraction. Anesth Analg 2009;108:1953.
26. Shafer SL. Full disclosure matters! Anesth Analg 2008;106:1017.
27. Lanier WL. Bidirectional conflicts of interest involving industry and
medical journals: who will champion integrity? Mayo Clin Proc 2009;84:771-
28. Hirsch LJ. Conflicts of interest, authorship, and disclosures in
related scientific publications: the tort bar and editorial oversight of
journals. Mayo Clin Proc 2009;84:811-21.
29. Editorial. International Committee for Medical Journal Editors:
Requirements for Manuscripts Submitted to Biomedical Journals: Writing and
Editing for Biomedical Publication. 2008 :http://www.icmje.org/icmje.
Competing interests: No competing interests
To the Editor:
A recent BMJ News article "Journal retracts article about age of transfused blood three years after publication"1 describes how Anesthesia & Analgesia handled a manuscript by Basran and colleagues2 when alert readers noted an error in the tables3 and the authors were unable to find their original spreadsheets. As Editor-in-Chief of Anesthesia & Analgesia, I analyzed the published tables and concluded that the error was likely in the calculation of the confidence intervals. The authors disclosed the loss of their data,4 and my accompanying letter noted that the "findings stand, albeit weakly".5 The authors' correspondence and my response were judiciously handled by Dr. Lawrence Saidman, Correspondence Editor for Anesthesia & Analgesia and former Editor-in-Chief of Anesthesiology. A query from the BMJ in February 2009 was the first correspondence of any kind received by the Editorial Board regarding the decision.
How should a journal respond when data are lost? The era of written laboratory notebooks has passed. This problem will likely recur because investigators archive data on spreadsheets hosted on their laptop computers. As Harvey Marcovitch, former chair of the Committee on Publication Ethics, observed in the BMJ report,1 "the data having gone missing is not satisfactory." True, but what does one do when spreadsheets can't be found? Again quoting Dr. Marcovitch, "the best approach is always one of transparency."1 I agree - there was no question that the authors had to disclose the loss of the data.
Should the article be retracted? Retraction sends a strong message about authorship responsibility for archiving data. Had the manuscript touted a new drug, device, or procedure, then we would have retracted it. However, retracting a manuscript precludes access to the report. The manuscript raised an important safety concern, subsequently verified,6 that mortality might increase following transfusion of old blood. We allowed the paper to stand, "albeit weakly", in the interest of patient safety, and to encourage repetition of the study.
Journals have neither the authority nor the resources to investigate questions that arise regarding the conduct of research. That responsibility lies with the academic institution. In January 2009 we were informed that there was an inconsistency between the conclusions of the manuscript and a prior abstract by the authors. Without original data these differences could not be explained, so the manuscript was retracted.7,8
These are serious issues. Learning from this experience, Anesthesia & Analgesia now requires identification of an "archival author" responsible for safekeeping data following publication.9,10 This requires investigators to designate an individual to accept this responsibility. The archival author will be identified on every published research report.
Our decision in this case should not be viewed as a precedent for how journals should handle loss of research data. Rather, the precedent we would hope to set is the process of carefully examining the available data, considering all options, and making a responsible editorial decision that weighs the implications of all possible courses of action.
- Lenzer J. Journal retracts article about age of transfused blood three years after Publication BMJ 2009;338:b2057
- Basran S, Frumento RJ, Cohen A, Lee S, Du Y, Nishanian E, Kaplan HS, Stafford-Smith M, Bennett-Guerrero E. The association between duration of storage of transfused red blood cells and morbidity and mortality after reoperative cardiac surgery. Anesth Analg. 2006;103:15-20
- Rothmann M, Braun MM, Ng TH. On the hazard ratios and corresponding confidence intervals that appear in Basran et al. (2006). Anesth Analg. 2007;104:1597
- Basran S, Frumento RJ, Cohen A, Lee S, Du Y, Nishanian E, Kaplan HS, Stafford-Smith M, Bennett-Guerrero E. Authors reply. Anesth Analg. 2007;104:1597
- Shafer SL. Occam's razor. Anesth Analg. 2007;104:1597-8
- Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med 2008;358:1229–39
- Basran S, Frumento R, Cohen A, Lee S, Du Y, Nishanian E, Kaplan HS, Stafford-Smith M, Bennett-Guerrero E. Request for retraction. Anesth Analg. 2009;108:1991
- Shafer SL. Notice of retraction. Anesth Analg. 2009;108:1953
- 2008–2009 Editorial Board, Anesthesia & Analgesia. 2009 Anesthesia & Analgesia Guide for Authors. Anesth. Analg. 2009 109: 217-231.
- http://www.aaeditor.org/Authors/home.html (last accessed September 4, 2009)
Editor in Chief, Anesthesia & Analgesia
Competing interests: No competing interests