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Fri Jan 5 14:26:38 GMT 2007

I don't think it's hard to understand what happened.  It's just
difficult to politely discuss.  

Credit where it's due: Cochrane's investigation of Dr. Cruz' research is
both tragically disparaging and strenuously fair.  Brilliant and
otherwise honorable people are not immune to profound ethical lapses,
especially when their core interests are at stake.  Either Dr. Cruz
fabricated research in the defense of his deep beliefs, or circumstances
have conspired to make it convincingly appear as such.

For myself, the most interesting part of CRASH2 message is the insight
it provides into research ethics and peer-review editorial standards.
In that respect the correspondences speak for themselves.  Cruz's
co-authors and the JoNS editorial board have much to regret.

Sad indeed.

Pret Bjorn, RN
Bangor, ME USA

-----Original Message-----
From: trauma-list-bounces at trauma.org
[mailto:trauma-list-bounces at trauma.org] On Behalf Of Rangraj Setlur
Sent: Thursday, January 04, 2007 10:20 AM
To: Trauma &amp, Critical Care mailing list
Subject: Re: High Dose Mannitol

I read the correspondence on http://www.crash2.lshtm.ac.uk/Mannitol.htm
.Its
a little hard to understand what happened, do you have any further
details
about the concerns of fabrication?
rangraj
On 1/4/07, Coats Tim - Professor of Emergency Medicine <
Tim.Coats at uhl-tr.nhs.uk> wrote:
>
> Dear all,
>
> Prof Ian Roberts, who chairs the Cochrane Injuries Group, has asked me
> to pass on the information below, which has led to the withdrawal of
the
> Cochrane review on high dose mannitol. Details are available on the
> CRASH2 website.
> My interpretation is that this is a sad story and that we will
probably
> never know the truth. However it does seem that the data in the three
> published papers cannot be verified, greatly reducing the body of
> evidence for high dose mannitol therapy.
>
> Tim. Coats.
> Professor of Emergency Medicine.
> Leicester University
>
> Dear Tim
> The Cochrane Injuries Group conducted an investigation into some head
> injury trials by Cruz et al - the details should be of interest to the
> trauma community.
> We have put the key correspondence on the trial website to make it
> available to our collaborators but I wondered if you could let the
folk
> at trauma.org know about it as well.
> Between 2001 and 2004, three reports were published by Dr Julio Cruz
and
> colleagues presenting the results of three clinical trials comparing
> high dose and conventional dose mannitol in the treatment of head
> injury. They appeared to show that high dose mannitol was dramatically
> effective in reducing death and disability after head injury.
> Cruz C, Minoja G, Okuchi K. Improving clinical outcomes from acute
> subdural hematomas with emergency preoperative administration of high
> doses of mannitol: a randomized trial. Neurosurgery 2001;49(4):864-71.
> Cruz C, Minoja G, Okuchi K. Major clinical and physiological benefits
of
> early high doses of mannitol for intraparenchymal temporal lobe
> hemorrhages with abnormal pupilary widening. Neurosurgery
> 2002;51(3):628-38.
> Cruz J, Minoja G, Okuchi K, Facco E. Successful use of the new
high-dose
> mannitol treatment in patients with Glasgow Coma Scores of 3 and
> bilateral abnormal pupillary widening: a randomized trial. Journal of
> Neurosurgery 2004;100(3):376-83.
> The trials were included in a systematic review of the effectiveness
of
> mannitol in head injury and published in the Cochrane Library in July
> 2005. The review concluded that "high dose mannitol appears to be
> preferable to conventional dose mannitol in the acute management of
> comatose patients with severe head injury."
> The Cochrane Injuries Group later discovered that there were concerns
> about these trials and an investigation was made the results of which
> are available on the CRASH-2 website (www.crash2.lshtm.ac.uk
> </exchweb/bin/redir.asp?URL=http://www.crash2.lshtm.ac.uk> ). We know
> that mannitol is widely used in the management of patients with head
> trauma and felt that you should be made aware of the Injuries Group
> investigation as soon as possible. Please pass this message on to your
> colleagues in trauma care.
> Ian
>
>
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