Rapid Responses to:

REVIEWS:
Annabel Ferriman
Have editors got their priorities right?
BMJ 2003; 327: 1113 [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] Keep blowing your whistle....
Iain D Beardsell   (7 November 2003)
[Read Rapid Response] Research should be monitored by “local research approval committees”
Akheel A Syed, Magdalena J. Turzyniecka   (9 November 2003)
[Read Rapid Response] Local monitoring? Why not a demand for internet data?
Neville W Goodman   (12 November 2003)
[Read Rapid Response] Priorities: what editors really need
John H. Lange   (13 November 2003)
[Read Rapid Response] Raw data - Publishing raw data and real time statistical analysis on e-journals
David J R Hutchon   (15 November 2003)
[Read Rapid Response] We need whistleblowers
John S Garrow   (17 November 2003)
[Read Rapid Response] External scrutiny is required for protection of the public
Peter T Wilmshurst   (1 December 2003)

Keep blowing your whistle.... 7 November 2003
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Iain D Beardsell,
Registrar, Emergency Medicine
Sydney, Australia

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Re: Keep blowing your whistle....

People may assume from this article that Peter Wilmshurst is nothing more than a troublemaker: a thorn in the side of ambitious medics. This is simply not true.

I have worked with Dr Wilmshurst in years gone by (although I am not a personal friend, nor he my referee; we have even clashed on certain occassions) and I can say that he is a doctor with the patient's best interests at heart.

I find it hard that a doctor, or for that matter anyone, who is willing to stand up against 'the establishment' should have been treated in the way he has in the past. It is sad that he feels his career has suffered for his commitment to honesty. I can only say that St Thomas' loss is Shropshire's gain.

Junior Doctors, like myself, need role models like Dr Wilmshurst, who inspire us to question, rather than accept meekly all we are told. I hope he continues his work and I am glad that he has received some recognition for his efforts.

I hope the eBMJ and its readers do not mind me blowing this 'whistle- blower's' trumpet.

Competing interests: None declared

Research should be monitored by “local research approval committees” 9 November 2003
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Akheel A Syed,
Specialist Registrar & Clinical Research Associate
University of Newcastle, Newcastle upon Tyne NE2 4HH,
Magdalena J. Turzyniecka

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Re: Research should be monitored by “local research approval committees”

Editor - Research fraud is of serious concern. However, random checks of raw data by journal editors, as proposed by Wilmshurst [1], are both inadequate and unworkable – inadequate because, to maintain the highest standards of scientific integrity and reduce potential risks to human lives, the possibility of letting slip past even a single fraudulent report should not be entertained; and unworkable not only because it would introduce further delays in the publishing process but also because editorial boards are not best placed to examine raw data, which should include scrutiny of laboratory records whilst the work is in progress.

Universities perform regular assessments in the case of students who undertake research for a higher qualification such as an MD or a PhD. Although such assessments could be extended to all research activity, remotely placed departments may find this inaccessible for geographical or administrative reasons.

A simpler scheme would be to involve local research ethics committees in the monitoring of research. These committees are well established in all health districts in the UK and have a broad-based make up that includes lay members [2], thus ensuring accessibility, and credibility in the public mind. In their new role as local research approval committees (LRACs), their remit should be extended to monitoring of work in progress by periodic and random checks, and finally approving concluded work prior to submission for publication as a condition to granting ethics approval. Journals could then insist on a ‘research approval form’ signed by an LRAC representative to be submitted alongside copyright assignment forms. For such a scheme to work, researchers would have to be assured of quick response times and no undue or excessive interference from committees that are free of the structural and logistic problems seen currently [2, 3].

Closer monitoring of research may not identify unintentional fundamental errors in methodology such as were seen in the recently retracted Science paper on ecstasy [4], but it should weed out serious research misconduct such as was seen in King’s College a few years ago [5].

Akheel A. Syed

Specialist Registrar & Clinical Research Associate, University of Newcastle, Newcastle upon Tyne NE2 4HH

Magdalena J. Turzyniecka

Specialist Registrar, Northern General Hospital, Sheffield S5 7AU

References

1. Ferriman A. Have editors got their priorities right? BMJ 2003;327:1113.

2. Alberti KGMM. Local research ethics committees. BMJ 1995;311:639- 40.

3. Alberti KGMM. Multicentre research ethics committees: has the cure been worse than the disease? BMJ 2000;320:1157-8.

4. Pincock S. Science forced to retract article on "ecstasy". BMJ 2003;327:579.

5. Wilmshurst P. Institutional corruption in medicine. BMJ 2002;325:1232-5.

Competing interests: None declared

Local monitoring? Why not a demand for internet data? 12 November 2003
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Neville W Goodman,
Consultant Anaesthetist
Southmead Hospital, BS10 5NB

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Re: Local monitoring? Why not a demand for internet data?

I agree that inspection by outside agencies risks being too cumbersome. The idea that research ethics committees monitor research in progress has been suggested before by, among others, Julian Savulescu, who is editor-in-chief of the Journal of Medical Ethics. While superficially appealing, I think it would be more trouble than it was worth. At the least, it would need vastly increased support for these committees, which at the moment simply do not have the means to carry out any inspections.

What about a requirement that all original data be posted on the internet? While it is, of course, possible to invent data, this would at least make it hard work to invent sets of data that were fully believable, which would discourage many from fraud.

Competing interests: Chair of Local Research Ethics Committee; Executive Committee Member, HealthWatch

Priorities: what editors really need 13 November 2003
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John H. Lange,
Consultant
Envirosafe Training and Consultants, P.O. Box 114022, Pittsburgh, PA 15239

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Re: Priorities: what editors really need

The comments by Ferriman (1) raise very important issues. As the Associate Editor of a specialized journal this is always a concern. I can not review papers for the issues raised by Ferriman; simply there is no time. Much of my time in this process is spent on other duties. What I would like to make readers aware of is their importance in the scientific process. They also have duties. The best science is done when all of us participate. It has become very difficult to get reviewers. Recently, I submitted a paper to another journal and after a considerable period of time I received comments from the editor that they received from reviewers. I was informed that the time delay was do to having to send the paper to six different reviewers just to obtain two reviews. Unfortunately, I experience the same problem. Those in science need to be involved in science, when you are sent a paper for review, please review it; and if not notify the editor immediately that you are not able to do so. This will relieve some of the burden off the editor and associate editors and allow better consideration and evaluation of Ferriman’s issues.

1. Ferriman A. Have the editors got their priorities right. BMJ 2003; 327: 1113

Competing interests: Associate Editor of a generally non-competing journal

Raw data - Publishing raw data and real time statistical analysis on e-journals 15 November 2003
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David J R Hutchon,
Consultant Obstetrician
Darlington Memorial Hispital. DL3 6HX

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Re: Raw data - Publishing raw data and real time statistical analysis on e-journals

Publishing raw data and real time statistical analysis on e-journals

I entirely agree that published trials should include the raw data made available on the internet. I have shown how this is feasible, practical and can include the statistical analysis of the data. (Ref 1) As pointed out there are a number of advantages of this approach including

· Raw data remain available in the foreseeable future for other workers to analyse further

· The data can be easily copied into other applications, making analysis by others a practical proposal

· The data are available for effective meta-analysis

· The statistical analysis is available to be checked by peer reviewers and readers

· Internet publication has in practical terms unlimited capacity for data storage

· Most journals will support a web version in the next few years.

Such an approach allows every reader the opportunity to peer review the paper and scientific fraud would be extremely difficult. Further, sloppy data collection or inaccurate statistical analysis becomes transparent. Before this is adopted wholesale a code of conduct is needed for the use of such raw data by other researchers. (2)

1. Hutchon, DJR, Publishing Raw Data and Real Time Statistical Analysis on E-Journals, British Medical Journal (2001) 322, 530, 3/3/01.

2. Gunther E and Eun-Ryoung Sa Code of conduct is needed for publishing raw data British Medical Journal (2001) 323: 166.

Competing interests: None declared

We need whistleblowers 17 November 2003
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John S Garrow,
Chairman, HealthWatch
93 Uxbridge Road, Rickmansworth, WD3 7DQ

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Re: We need whistleblowers

I have followed the rapid responses to the report [1] of the HealthWatch Award address by Peter Wilmhurst. Having worked with wilmshurst (he was my registrar 30 years ago) I can confirm Beardsell's opinion that he is not just a troublemaker, but an unusually honest doctor who has his patients' best interests at heart.

Syed suggests that local research committees should monitor experimental data, and Goodman and Hutchon that the data should be available on the internet. This may detect fraud in formal clinical trials, but would not work well for other types of dishonesty. For example Banerjee reported a falsely increased number of rats on which he experimented, and a falsely large number of senior colleagues who were associated with the research [2]. Pearce falsely reported a successful outcome with an extrauterine pregancy, but the case was fictitious. Neither experiment would normally be monitored by a local ethical committee, and data on the internet would not necessarily expose the fraud.

Different types of dishonesty need different methods of control. Wilmshurst suggested checks of publication honesty analogous to dope testing in athletes. This is a false analogy, because dope testing is relatively simple. The athlete does / does not provide a sample, which does / does not show evidence of illegal drugs. An innocent athlete then has minimal interference with training or lifestyle. By comparison the investigation of dishonesty in medical research is difficult, disruptive, and fraught with the danger of devastating liability for libel damages.

The key to detection of dishonesty in this situation is someone like Wilmshurst who has the courage to blow the whistle and persist until the matter has been properly investigated. That is why I am so pleased that HealthWatch has honoured him, in contrast to the vilification he has received from other quarters.

[1] Ferriman A. Have editors got their priorities right? BMJ 2003;327:1113

[2] Wilmshurst P. Institutional corruption in medicine. BMJ 2002;325:1232-5

Competing interests: formerly colleague of Wilmshurst, formerly editor-in-chief of European journal of Clinical nutrition, formerly member of BMJ hanging committee and of COPE, currently chairman of HealthWatch

External scrutiny is required for protection of the public 1 December 2003
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Peter T Wilmshurst,
Consultant cardiologist
Royal Shrewsbury Hospital, SY3 8XQ, UK

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Re: External scrutiny is required for protection of the public

I was greatly honoured to receive the Health Watch Award and I am grateful to Professor Garrow and Dr Beardsell for their kind comments.

I believe that there should be an inspectorate with powers to undertake random checks on research in progress and after completion, despite the difficulties this might cause for researchers, because we currently have no adequate means to detect and deter research fraud. All the existing methods have failed. Dr Syed suggests that insuring research integrity should be one of the roles of universities. I agree that it should. Unfortunately, as the case of Banerjee and many others have shown, academic institutions have repeatedly failed to deal with research misconduct brought to the attention of the authorities.[1,2] Universities and hospitals (albeit in the USA) have even turned a blind eye to murder of patients by doctors.[3] Can we trust those in the UK (or elsewhere) to deal with research misconduct when they have failed so often before?

I do not think that Local Research Ethics Committees have the resources or inclination to deal with research fraud. Internet publication of raw data may help, but there have been well documented cases of research fraudsters, who produced falsified "raw" data.[4] Furthermore, if one realises from inspecting the raw data of a paper on the internet that the paper was dishonest, what is your remedy? Do you complain to the institution? It is my experience from a number of cases that universities will refuse to act against the researchers concerned. What about the journal? In my experience, even when convinced of misconduct editors will try to avoid retraction.

I accept that inspection by an external agency could affect the running of research projects, but I anticipate that a system used sparingly but effectively will have a deterrent value. We accept such checks in other activities, particularly when misconduct might affect public safety. We gain comfort from the knowledge that aeroplanes, ships, coaches and trains that we travel on may be inspected by independent agencies, even though it may create difficulties for operators. I am reassured that random alcohol breath-testing reduces drunk driving and increase safety for other road users. I am pleased that my hand luggage is x-rayed at airports, even though I have to get to the check-in earlier. I am reassured that environmental health officers inspect the kitchens of restaurants, even though their inspections may upset the chef. In nearly every walk of life worker are checks to ensure that they behave honestly and conscientiously, even though the checks upset their work routine. I am afraid that the public cannot have confidence that doctors and researchers are all honest and decent and that employers will weed out those that aren’t. I am afraid that external checks need to be imposed.

Peter Wilmshurst

1.Wilmshurst P. Institutional corruption in medicine. BMJ 2002;325:1232-5.

2. Wilmshurst P. The code of silence. Lancet 1997;349:567-9.

3. Stewart J B. Blind eye. How the medical establishment let a doctor get away with murder. Simon and Schuster, New York. 1999.

4. Broad W, Wade N. Betrayers of the truth. Fraud and deceit in science. Oxford University Press. 1985.

Competing interests: I was the subject of the article, because I received the Health Watch Award.