Rapid Responses to:

LETTERS:
Terence Stephenson, Carl Henshall, Deborah Henshall, Andrew Wilkinson, Janet Rennie, Teresa Wright, Kate Lucking, David Hall, Penny Mellor, Brian Morgan, Edmund Hey, Edmund Hey, and Iain Chalmers
Investigating allegations of research misconduct
BMJ 2000; 321: 1345 [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] Are doctors grammatically challenged?
Penny Mellor   (9 January 2001)
[Read Rapid Response] Research Misconduct
Brian Morgan   (9 January 2001)

Are doctors grammatically challenged? 9 January 2001
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Penny Mellor,
Child Advocate
Home

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Re: Are doctors grammatically challenged?

Mr Hey yet again failed to answer one question in his response, how did he and Chalmers get to see consent forms that form part of a child's medical files without consent and who supplied them?

Secondly I find Mr Hey's choice of the words "independent statistician" interesting to say the least, as a search on Medline will show that Mr Alexander has been David Southall's "independent statitistician" on no less than 21 papers dating back to 1982.

Independent according to the Oxford Dictionary means " A person who is not affiliated to, or acts for another person" Affiliated means "to be associated with".

Penny Mellor

Ref:1: Samuels MP, Raine J, Wright T, Alexander JA, Lockyer K, Spencer SA, Brookfield DS, Modi N, Harvey D, Bose C, Southall DP. Related Articles

Continuous negative extrathoracic pressure in neonatal respiratory failure. Pediatrics. 1996 Dec;98(6 Pt 1):1154-60. PMID: 8951269; UI: 97108989

2: Richard D, Poets CF, Neale S, Stebbens VA, Alexander JR, Southall DP. Related Articles

Arterial oxygen saturation in preterm neonates without respiratory failure. J Pediatr. 1993 Dec;123(6):963-8. PMID: 8229531; UI: 94046271

3: Samuels MP, Poets CF, Stebbens VA, Alexander JA, Southall DP. Related Articles

Oxygen saturation and breathing patterns in preterm infants with cyanotic episodes. Acta Paediatr. 1992 Nov;81(11):875-80. PMID: 1467609; UI: 93104629

4: Poets CF, Stebbens VA, Alexander JR, Arrowsmith WA, Salfield SA, Southall DP. Related Articles

Hypoxaemia in infants with respiratory tract infections. Acta Paediatr. 1992 Jun-Jul;81(6-7):536-41. PMID: 1392369; UI: 93005331

5: Poets CF, Stebbens VA, Alexander JR, Arrowsmith WA, Salfield SA, Southall DP. Related Articles

Arterial oxygen saturation in preterm infants at discharge from the hospital and six weeks later. J Pediatr. 1992 Mar;120(3):447-54. PMID: 1538297; UI: 92166960

6: Poets CF, Stebbens VA, Alexander JR, Southall DP. Related Articles

Breathing patterns and heart rates at ages 6 weeks and 2 years. Am J Dis Child. 1991 Dec;145(12):1393-6. PMID: 1669667; UI: 94121023

7: Poets CF, Stebbens VA, Alexander JR, Arrowsmith WA, Salfield SA, Southall DP. Related Articles

Oxygen saturation and breathing patterns in infancy. 2: Preterm infants at discharge from special care. Arch Dis Child. 1991 May;66(5):574-8. PMID: 2039244; UI: 91247838

8: Stebbens VA, Poets CF, Alexander JR, Arrowsmith WA, Southall DP. Related Articles

Oxygen saturation and breathing patterns in infancy. 1: Full term infants in the second month of life. Arch Dis Child. 1991 May;66(5):569-73. PMID: 2039243; UI: 91247837

9: Southall DP, Janczynski RE, Alexander JR, Taylor VG, Stebbens VA. Related Articles

Cardiorespiratory patterns in infants presenting with apparent life- threatening episodes. Biol Neonate. 1990;57(2):77-87. PMID: 2310793; UI: 90181527

10: Southall DP, Bignall S, Stebbens VA, Alexander JR, Rivers RP, Lissauer T. Related Articles

Pulse oximeter and transcutaneous arterial oxygen measurements in neonatal and paediatric intensive care. Arch Dis Child. 1987 Sep;62(9):882-8. PMID: 3674942; UI: 88048463

11: Southall DP, Alexander JR, Stebbens VA, Taylor VG, Janczynski RE. Related Articles

Cardiorespiratory patterns in siblings of babies with sudden infant death syndrome. Arch Dis Child. 1987 Jul;62(7):721-6. PMID: 3632021; UI: 87325045

12: Stebbens VA, Alexander JR, Southall DP. Related Articles

Pre- and perinatal clinical characteristics of infants who suffer sudden infant death syndrome. Biol Neonate. 1987;51(3):129-37. PMID: 3567254; UI: 87185638

13: Southall DP, Richards JM, Stebbens V, Wilson AJ, Taylor V, Alexander JR. Related Articles

Cardiorespiratory function in 16 full-term infants with sudden infant death syndrome. Pediatrics. 1986 Nov;78(5):787-96. PMID: 3763293; UI: 87016104

14: Alexander JR, Southall DP. Related Articles

Cot deaths and the Sheffield Score. Lancet. 1986 Aug 16;2(8503):399. No abstract available. PMID: 2874396; UI: 86283871

15: Southall DP, Stebbens VA, Alexander JR, Cardle CM, Cogswell JJ. Related Articles

Cardiorespiratory patterns occurring in infants during and after recovery from respiratory tract infection. Pediatrics. 1986 Jul;78(1):37-43. PMID: 3725500; UI: 86258852

16: Southall DP, Arrowsmith WA, Stebbens V, Alexander JR. Related Articles, OMIM

QT interval measurements before sudden infant death syndrome. Arch Dis Child. 1986 Apr;61(4):327-33. PMID: 3707181; UI: 86214156

17: Wilson AJ, Stevens V, Franks CI, Alexander J, Southall DP. Related Articles

Respiratory and heart rate patterns in infants destined to be victims of sudden infant death syndrome: average rates and their variability measured over 24 hours. Br Med J (Clin Res Ed). 1985 Feb 16;290(6467):497-501. PMID: 3918648; UI: 85123600

18: Richards JM, Alexander JR, Shinebourne EA, de Swiet M, Wilson AJ, Southall DP. Related Articles

Sequential 22-hour profiles of breathing patterns and heart rate in 110 full-term infants during their first 6 months of life. Pediatrics. 1984 Nov;74(5):763-77. PMID: 6238275; UI: 85037765

19: Southall DP, Alexander JR. Related Articles

Sudden infant death syndrome. Pediatrics. 1984 Apr;73(4):567-8. No abstract available. PMID: 6709441; UI: 84169300

20: Southall DP, Levitt GA, Richards JM, Jones RA, Kong C, Farndon PA, Alexander JR, Wilson AJ. Related Articles

Undetected episodes of prolonged apnea and severe bradycardia in preterm infants. Pediatrics. 1983 Oct;72(4):541-51. PMID: 6889069; UI: 83299098

21: Southall DP, Richards JM, Rhoden KJ, Alexander JR, Shinebourne EA, Arrowsmith WA, Cree JE, Fleming PJ, Goncalves A, Orme RL. Related Articles

Prolonged apnea and cardiac arrhythmias in infants discharged from neonatal intensive care units: failure to predict an increased risk for sudden infant death syndrome. Pediatrics. 1982 Dec;70(6):844-51. PMID: 7145536; UI: 83064217

Conflict of Interest.

Still giving evidence to various inquiries into David Southall's work.

Campaigner against the use of the term MSbP.

Research Misconduct 9 January 2001
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Brian Morgan,
Freelance Journalist
Cardiff

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Re: Research Misconduct

It seems to me that Hey and Chalmers on the evidence of their latest responses are acting as proxies for the CNEP researchers. They have to some extent succeeded in diverting attention away from the deficiencies in the CNEP study to deficiencies as they see them in the Griffiths investigation of the prevailing research framework. The robustness of the health minister's defence of the Griffiths team in the House of Lords suggests that they may in the long run be wasting their time.

In my evidence submitted to the Griffiths team I said this:

'The safety of the ventilator in respect of the cerebral blood flow of seriously unwell preterm babies was not evaluated before this study began and the claim that this was done is manifestly untrue - I have checked the sources for this claim, read the papers and questioned the funders Action Research.

'Albeit that the purpose of the study could be claimed to be benign, and was to improve the outcomes for preterm babies with RDS, it appears to me to be so fundamental that no additional hazards should be created, when there was an established ventilatory technique without this risk that serious questions about reckless misconduct and culpability must arise. I frankly do not understand why action has not already been taken against the researchers at Queen Charlotte’s and North Staffordshire, and one now working at Whipp’s Cross, for putting these babies’ neurological health at greater risk than from their already vulnerable condition. The doctors did not know the equipment was safe, they clearly knew they needed to know - they got the funding from Action Research to find out after beginning the ventilator study. They did the studies to establish whether it was safe or not on the same babies they were evaluating the ventilator on and when they realised the safety studies did not tell them what they wanted to know, they clumsily tried to cover up with a blatantly false scenario - I don’t know any other way to describe it and if you do not have the evidence already it is easily obtained.'

And for the benefit of your readers this is what the researchers said about this in their own report of the CNEP study (1) on page 1155, final paragraph of the preamble:

'As our CNEP system produced no significant disturbance to the premature infants' cerebral circulation, 7,8 we decided to re-assess whether negative pressure had an effect on the clinical outcome of neonates with respiratory failure.'

This is a very positive statement denying risk of significant disturbance from the equipment - not the weasel worded defence offered by Hey a la BSE - 'that there is, as yet, no evidence that something is unsafe.'

References 7 and 8 [(2) and (3) below] report two studies with near infra technology which Hey now agrees did not became available until after the CNEP study began, as if they had already been completed.

'The advent of infra red technology while the trial was in progress made it perfectly proper to do further studies to confirm that cerebral blood flow was unaffected. Indeed, it would have been unethical not to do this.' says Hey.

These studies could not 'confirm' anything; the researchers did not have any data about cerebral blood flow to confirm.

So the positive claim in Pediatrics (1) that the CNEP system produced no significant disturbance was based on research that had not yet been done, using technology that was not yet available - and if Pediatrics peer reviewers or Hey and Chalmers for that matter had bothered to read reference 8 (3) of the Pediatrics report (1) they would have found that it did not give the reassurance the researchers were looking for (or the parents were entitled to). The protocol adopted was not even an appropriate one for such unwell babies - which begs another question as to how it was approved.

Apologists for the CNEP research team have joined them in the corner into which they are progressively painting themselves. The only question is how long before the authorities act.

References:

1. Samuels MP, Raine J, Wright T, Alexander JA, Lockyer K, Spencer SA, et al. Continuous negative extrathoracic pressure in neonatal respiratory failure. Pediatrics 1996; 98: 1154-1160

2. Raine J, Cowan F, Samuels MP, Wertheim D, Southall DP, Continuous negative extrathoracic pressure and cerbral blood flow velocity: a pilot study. Acta Paediatr. 1994;83:438-439

3.Palmer KS, Spencer SA, Wickramasingh YABD, Wright T, Southall DP, Rolfe P. Effects of positive and negative pressure ventilation on cerebral blood volume of newborn infants. Acta Paediatr. 1995;54:132-139