Collated Correspondence with the
Journal of Bone and Mineral Research
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November 24, 2004 (Day 1) |
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First request to speak with Editor
Date: Wed, 24 Nov 2004 19:11:12 +0000
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Message-ID: <4365277.20041124191112@sheffield.ac.uk>
To: journal@jbmr.org,"Amber Williams" <amber@jbmr.o/public_html/rg>
Subject: Publication probity JBMR studies
I am writing with a query which I will place in general terms for the
moment.
There are really two related enquiries:
1) I have concerns relating to the probity of data analysis in
a pharmaceutical company
sponsored clinical paper in JBMR.
I was not an author on the paper. Is there a mechanism
for raising
such concerns?
2) I have similar concerns about two pharmaceutical abstracts which
were presented at
the ASBMR meeting and which appear in the JBMR.
I am first author on both abstracts and
have serious concerns about
the analysis which has been presented in my name (as first
author). Is
there some mechanism for comment of dissociation. The abstracts
concern a clinical issue of fundamental importance to the sponsor, I
believe that the readers have been seriously misled, and the sponsors
have thusfar refused to enable the correct analyses to be published.
I would be happy to speak with one of your editors in confidence
if appropriate.
Regards
Dr Aubrey Blumsohn
Senior Lecturer in Metabolic Bone Disease
Division of Clinical Sciences (NGHT)
Clinical Sciences Centre
Northern General Hospital, Herries Road
Sheffield S5 7AU, England
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December 24, 2004 (Day 30) |
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Second request to speak with Editor
Date: Fri, 24 Dec 2004 15:48:41 +0000
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Message-ID: <205681825.20041224154841@btinternet.com>
To: "Amber Williams" <amber@jbmr.org>
Subject: Re:Publication probity JBMR studies
Dear Amber [administrative staff in editorial office],
I think I would like to have a quiet and very confidential
chat with one of the senior clinical
members of your editorial staff about possible (im)probity of some JBMR manuscripts/abstracts.
I think this would be best before putting anything in writing. If this is possible, when might be a
good time to call?
Merry Christmas from the UK
Kind wishes
Aubrey Blumsohn
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December 27, 2004 (Day 33) |
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Holding respose with a promise of later response from Editor.
There was no later response.
Date: Mon, 27 Dec 2004 14:39:01 -0500
From: "Amber Williams" <amber@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
Subject: RE: Publication probity JBMR studies
Dear Dr. Blumsohn,
....
I would have to forward your query on to the editor-in-chief to get his view on this.
I will send your queries on to him and get back to you once I know anything.
Regards,
Amber
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May 20 , 2005 (Day 177) |
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Third formal request to communicate with the Editor.
Subject: Letter to Editor in Chief
Date: Fri, 20 May 2005 11:55:56 +0100
Message-ID: <37C81177A60CA749B0320C96CFF2E8D741C1B6@RHHEMAIL2.>
From: <aubrey.blumsohn@>
To: amber@jbmr.org
Cover E-mail 1 Dear Amber
Attached please find a letter to the Editor in Chief. It has also been sent by mail. I would appreciate it if you would acknowledge receipt of this.
I only use this particular work email address on Friday's, so please reply to my usual address which is ablumsohn@sheffield.ac.uk.
Yours Sincerely
Dr Aubrey Blumsohn
University of Sheffield
<20050518 JBMR letter re probity.doc>
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June 6 , 2005 (Day 194) |
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Promise of a conference call
Date: Mon, 6 Jun 2005 14:26:31 -0400
From: "Adrienne Lea" <adrienne@jbmr.org>
To: ablumsohn@sheffield.ac.uk
Subject: Follow up to your letter
Dear Prof. Blumsohn:
Thank you for sending us the letter re your concerns about material
published in the JBMR and in the ASBMR meeting supplement. Dr. Joe Lorenzo
(Chair, ASBMR Publications Committee) and Dr. John Eisman (Editor-in-Chief,
JBMR) would like to set up a conference call to discuss this matter with
you. If you can provide me some dates and times when you might be
available, I will try to set up a call. (You can just give me your local
time; I'll work out the time differences).
Thanks in advance -
Adrienne
Director of Publications
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June 6 , 2005 (Day 194) |
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Letter to Editorial office enquiring about promised conference call
See E-mail from AB 2 Date: Mon, 6 Jun 2005 20:32:42 +0100
From: Aubrey Blumsohn
Message-ID: <16210602445.20050606203242@btinternet.com>
To: "Adrienne Lea" <.adrienne@jbmr.org>.
Subject: Re:Follow up to your letter
Dear Adrienne,
Thank you.
.[List of available times]..
Aubrey
See Email from Editorial office promising conference call 3 Date: Mon, 6 Jun 2005 15:35:31 -0400
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
Subject: RE: Follow up to your letter
Message-Id: <200506061541592.SM02028@JBMR02>
Thanks very much; I'll let Joe and John know, and start working with them on
available dates/times.
Adrienne
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July 4 , 2005 (Day 222) |
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Day 194: Still no reply - why not?
Date: Mon, 4 Jul 2005 20:42:32 +0100
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
To: "Adrienne Lea" <adrienne@jbmr.org>
Subject: Re:Follow up to your letter
Dear Adrienne
Just enquiring whether there has been any
progress here? Unfortunately I am
rapidly
getting constrained in terms of routes to
raise this problem.
Aubrey
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July 5 , 2005 (Day 223) |
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Apology from Editorial office - will arrange the call
Date: Tue, 5 Jul 2005 08:14:39 -0400
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
Message-Id: <20050705081974.SM02028@JBMR02>
Subject: RE: Follow up to your letter
Dear Dr. Blumsohn:
This is my fault; I apologize. I was trying to find a time when both Joe
Lorenzo (our
Publications Chair) and John Eisman and you could talk -- as
you might imagine, with those
time zones, it was not possible.
John is now out of Australia traveling but I will get new times
from
Joe and
we'll set a time to talk, and then follow up with John separately if need
be.
Thank you.
Adrienne
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July 12 , 2005 (Day 230) |
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One week later - no response. Then a promised a response "tomorrow".
But tomorrow never came.
Date: Tue, 12 Jul 2005 15:48:00 -0400
From: "Adrienne Lea" <adrienne@jbmr.org>
To: ablumsohn@sheffield.ac.uk
Subject: Time for call
Dear Dr. Blumsohn:
I just wanted to let you know I am still awaiting word from Dr. Lorenzo's
assistant about his
available times; I will call her tomorrow if I do not
hear from her, and will be back in touch with you.
Thanks
Adrienne Lea
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September 11 , 2005 (Day 291) |
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Further two months later - no response.
Letter of disappointment to Editor.
On 9 September suspended from University position for communicating with media.
Date: Sun, 11 Sep 2005 07:15:02 +0100
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Message-ID: <1811585879.20050911071502@btinternet.com>
To: Adrienne Lea <adrienne@jbmr.org>, Amber Williams <amber@jbmr.org>, heather@jbmr.org
Subject: JBMR Probity
Dear Professor Eisman
I must say, I am disappointed in JBMR. I don't know your email address and I have thus
addressed to the various Editorial staff who have at various points responded on your behalf.
I wrote first on 24 Nov 2004 raising general concerns about probity of particular
publications in JBMR.
I wrote again on 24 Dec 2004, and had a response "I would have to forward your query on to
the editor-in-chief to get his view on this".
There was no further promised response for 5 months.
I Emailed and sent a formal letter on 20 May 2005 providing specific details of the
publications concerned, and an indication of the problem.
This was acknowledged by the editorial office. "Your letter raises some very
important concerns and we are following up with ASBMR staff and the Editor in Chief in order
to get a proper response for you."
On 6 June I received correspondence about a promised conference call to discuss the matter.
There was a trail of correspondence with repeated enquiries as to why there was delayed or
no response to the planned date for the promised telephone call. The last correspondence was on
13 July:
"Dear Dr. Blumsohn: I just wanted to let you know I am still awaiting word from
Dr. Lorenzo's assistant about his available times; I will call her tomorrow if I do not
hear from her, and will be back in touch with you. Thanks- Adrienne"
I then heard absolutely nothing.
This trail of correspondence is attached [below] in reverse order.
I am aware that there is some intense politics involved, that you know some of
those involved, and there is a suggestion from ...... ...... that you have had some knowledge
of this from third parties. You may have been provided with information to suggest that you
should not get back to me.
I can assure you that there is a substantial problem here. Even if you believed what you had
been told, I believe that this is inappropriate editorial practice which encourages
publication malpractice.
I would appreciate your comment on the procedure.
Kind Regards
Aubrey Blumsohn
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September 15, 2005 (Day 295) |
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First response from Editor! - day 295
[6 days after suspension from University position]
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: ablumsohn@sheffield.ac.uk, aubreyspecific1@btinternet.com
Subject: Request from Drs. Joe Lorenzo and John Eisman
Date: Thu, 15 Sep 2005 15:06:17 -0400
Dear Prof. Blumsohn:
In follow-up to Adrienne’s earlier e-mails of this week, we would like to meet with you to discuss
your concerns regarding material published in the Journal of Bone and Mineral Research.
Since we will all be attending the ASBMR Annual Meeting shortly it might be helpful for us to sit
down and discuss these concerns.
Would you provide Adrienne times when you are available to meet with us in Nashville and we
will try to work out a mutually convenient appointment time?
Thank you.
Joseph A. Lorenzo, MD
Chair, ASBMR Publications Committee
John A. Eisman, MBBS, PhD
Editor-in-Chief, Journal of Bone and Mineral Research
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November 25 , 2005 (Day 366) |
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Then an interesting statement by JBMR to the press (THES)
"despite several attempts to have these detailed, we have been unable to obtain
more than the hearsay comments to which you refer"
"JBMR, as with other Biomedical journals, takes the issues you raise very seriously.
We have had some communications that may relate to this issue but,
despite several attempts to have these detailed, we have been unable to obtain more
than the hearsay comments to which you refer.
You may be interested to know that we have conflict of interest procedures for authors.
These procedures include three checkpoints at which authors are instructed and
reminded to disclose any conflicts. Please feel free to review our conflict of interest policy
on our website (http://www.jbmr-online.org/) under the section entitled
“Instructions for Authors.”
As you will see, this policy places responsibility upon the authors
to disclose any conflicts
they might have.
We appreciate the invaluable support of the general media in encouraging all participants in
science and science reporting to actively seek to achieve the highest level of integrity.
However we are sure that you will understand that we could not respond to as yet
unsubstantiated statements. Thus, while we are endeavouring to address this serious issue,
we can not make any more useful comments.
We will certainly advise you, if you wish, when we have achieved some clarity on this matter."
Yours sincerely,
John Eisman
j.eisman@garvan.org.au
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December 8, 2005 (Day 378) |
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Letter to Professor Eisman (Editor) following his statement to the press that JBMR
would "investigate" the matter. Offer of evidence bundle and statistical report.
Date: Fri, 9 Dec 2005 00:32:58 +0000
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Message-ID: <1823586859.20051209003258@btinternet.com>
To: j.eisman@garvan.org.au,
Adrienne Lea <adrienne@jbmr.org>
Subject: JBMR Probity
Dear Professor Eisman
I note from todays news article that the JBMR editorial system is now happy to look into the
matter of process relating to publications and abstracts in the JBMR.
The full dossier relating to this matter will be conveyed to you next week. The same information
will also be in the hands of the General Medical Council here in relation to Professor Eastell, and
with the MHRA (the UK drugs licensing agency) following parliamentary discussion. There is also
a separate statistical report commissioned by the BBC and a set of partial data. As previously
stated, the intention was to submit this to the Lancet following preliminary discussion with
Richard Horton.
Many thanks
Aubrey Blumsohn
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December 19, 2005 (Day 390) |
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Request from Editor for evidence bundle and conference call
Date: Mon, 19 Dec 2005 16:07:09 +1100
Subject: Re: JBMR ethics
From: John Eisman <j.eisman@garvan.org.au>
To: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
CC: Adrienne Lea <adrienne@jbmr.org>, "Lorenzo,Joseph" <JLorenzo@nso2.uchc.edu>
Message-ID: <BFCC8B2D.432B%j.eisman@garvan.org.au>
Dear Dr Blumsohn,
Thank you for your recent email.
I would certainly appreciate receiving the dossier, you offered last week, as soon as you can send
it and would be happy to talk with you. I am asking Ms. Lea of the JBMR to kindly arrange
a teleconference call, before Christmas if possible, at a time that would be not too
unreasonable for both of us and our US-based colleagues.
If you can send the dossier in advance, that would be helpful.
Yours sincerely, John Eisman
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December 19, 2005 (Day 390) |
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Telephone conference arranged!
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
Subject: RE: Available times tonight from John Eisman and Joe Lorenzo
Date: Mon, 19 Dec 2005 15:40:08 -0500
Dear Dr. Blumsohn:
John, Joe and I will be joining the call today, at 10:30 pm
your time.
TOLL FREE INTERNATIONAL DIALING INSTRUCTIONS <snip of dialling account codes>
Adrienne
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December 27, 2004 (Day 398) |
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First refusal to open evidence bundle sent or to access statistical report (on the
supposed basis that acquisition of partial data by an author was somehow "ilegal")
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: "'John Eisman'" <j.eisman@garvan.org.au>, JLorenzo@nso2.uchc.edu
Subject: Follow up from Drs. Eisman and Lorenzo
Date: Tue, 27 Dec 2005 15:48:52 -0500
Message-Id: <200512271546692.SM04988@JBMR02>
Dear Dr. Blumsohn,
Thank you for taking the time last week to discuss your concerns about the JBMR article and
the abstracts in question.
Our lawyer has cautioned us to avoid opening and reviewing the information that you
have offered but have described, at least in part, as being obtained illegally.
......
Thank you,
John Eisman, JBMR Editor-in-Chief, Joseph A. Lorenzo, ASBMR Publications Chair
Email2712 From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: "'John Eisman'" <j.eisman@garvan.org.au>, JLorenzo@nso2.uchc.edu
Subject: Follow up from Drs. Eisman and Lorenzo
Date: Tue, 27 Dec 2005 15:48:52 -0500
Message-Id: <200512271546692.SM04988@JBMR02>
Dear Dr. Blumsohn,
Thank you for taking the time last week to discuss your concerns about the JBMR article and the abstracts in question.
Our lawyer has cautioned us to avoid opening and reviewing the information that you have offered but have described, at least in part, as being obtained illegally. Further, we want to maintain our focus on the JBMR and ASBMR issues (although you have apparently had to deal with many others).
You have indicated that some of the material is pertinent to JBMR. Would you be so kind as to extract that from the other information that is extraneous to our concerns, and send along any such legally-obtained information that would help our review of the extent to which there may have been inaccuracies or misrepresentations about the extent of access to the data in question. In addition, if you wish to separately send the information pertaining to any potential inaccuracies or misrepresentations about the data itself we will receive it and determine what JBMR can do to focus attention on any such problems.
Again, we appreciate receiving any information that we can use to correct any misimpressions made upon the JBMR readership about the authors' access and participation in the preparation of the JBMR article in question.
Thank you,
John Eisman, JBMR Editor-in-Chief
Joseph A. Lorenzo, ASBMR Publications Chair Read Full Email
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January 3 , 2006 (Day 408) |
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Email to editor asking the meaning of the assertion that "information was obtained
illegally" and whether this meant that the Journal too regarded partial data acquisition
by an author as "illegal"
Date: Tue, 3 Jan 2006 21:47:56 +0000
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
To: "Adrienne Lea" <adrienne@jbmr.org>
"'John Eisman'" <j.eisman@garvan.org.au>,
"'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>,
Subject: Re:On behalf of Drs. Eisman and Lorenzo
Dear Professor Eisman,
I forwarded full pertinent information to you on 20 December 2005 following our
discussion. This is attached again below (after your two subsequent E-mails also
below).
I am not clear what other information you mean and don't really know how to respond to these
two E-mails.
I am also not clear what you mean by "illegal information".
None of the information is illegal, and all is directly pertinent to understanding of the
problem. Much is already in the public domain. I may have said that P&G might
regard the fact that an academic holds the randomization codes of a study in which
he was involved as "illegal". If you agree with this then we do have an even more
serious problem.
After more than a year, it does seem to me that the JBMR do not wish to engage with this
problem properly or at all. I am also now aware of your press statement, which I find
distressing under the circumstances.
Please can I ask that you publish as a matter of extreme urgency (in the next available issue)
a disclaimer that I, as first author of the two abstracts listed in our previous correspondence
wish to dissociate myself from the content of those abstracts.
I asked about this previously but was ignored.
Please confirm this by return, and I will agree the form of words with you.
....
Dr Aubrey Blumsohn
4 Date: Tue, 3 Jan 2006 21:47:56 +0000
Subject: Re:On behalf of Drs. Eisman and Lorenzo
Dear Professor Eisman,
I forwarded full pertinent information to you on 20 December 2005 following our
discussion. This is attached again below (after your two subsequent E-mails which are also below).
I note that this information has not been accessed.
I am not clear what other information you mean and don't really know how to respond to these two E-mails. The only other relevant additional information is the independent statistical report by Professor Martin Bland commissioned by the BBC and Observer/Times Higher Newspapers. This can be obtained by writing to Mr Phil Baty who jointly owns this. It has been agreed that the report will be provided to you, and Mr Baty and others (details below) are expecting your request. I have not spoken with Professor Bland. His conclusions are however similar to my own (sent to you previously).
I also note that in Richard Eastell's recent response to the General Medical Council he admitted that P&G had denied access to the coding in these studies, and had again refused to supply such data when he had asked specifically about this again following a letter from my legal representative. I will as of tomorrow add this information to the dossier. I would refer you to the disclaimer at the end of the JBMR paper of 2003, disclaimers signed with that submission,
information in the dossier showing that at the time of JBMR submission and at all points afterwards authors were denied the randomization and event codes in the subset of patients with biochemistry data, JBMR's authorship requirements, and your own recent editorial. A similar submission had previously been made to the Lancet (they rejected the paper).
I am also not clear what you mean by "illegal information". None of the information is illegal, and all is directly pertinent to understanding of the problem. Much is already in the public domain. I may have said that P&G might regard the fact that an academic holds the randomization codes of a study in which he was involved as "illegal". If you agree with this then we do have an even more serious problem.
After more than a year, it does seem to me that the JBMR do not wish to engage with this problem properly or at all. I am also now aware of your press statement, which I find distressing under the circumstances.
Please can I ask that you publish as a matter of extreme urgency (in the next available issue) a disclaimer that I, as first author of the two abstracts listed in our previous correspondence wish to dissociate myself from the content of those abstracts. I asked about this previously but was ignored. Please confirm this by return, and I will agree the form of words with you.
Apart from above urgent matter, it does seem that the usual editorial approaches have been exhausted. Failing some rapid and appropriate response from JBMR, I will proceed to convey the full scientific process (including JBMR responses) in the public domain as a matter of legitimate
public interest. The corrected scientific data does need to be published, but my energies might be better spent elsewhere. It may be appropriate to discuss the editorial process through another independent Journal or through COPE.
Yours Sincerely
Dr Aubrey Blumsohn
Full Email
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January 6, 2006 (Day 411) |
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Editor implies that because some randomization codes may have been
obtained without consent from the company they will not review evidence.
Also suggests that tape recorded conversations may be illegal [they are clearly not].
Agrees to publish a letter of withdrawal and asks for one to be written.
Suggests that if the company would need to be asked for consent to review the evidence bundle!
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: "'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>, "'John Eisman'" <j.eisman@garvan.org.au>
Subject: From Drs. Eisman and Lorenzo
Date: Fri, 6 Jan 2006 10:14:11 -0500
Dear Dr Blumsohn:
We are willing to publish your wish to be no longer associated with the two abstracts you
mentioned. Please provide for our consideration a brief note in the form you wish to be
published.
As we discussed your information with you, you made it clear that certain of the
information on your website [this refers to the fact that evidence was
in electronic form] The word "website" refers to the fact that the evidence bundle provided was in part in HTML format given the part electronic nature of the evidence. It does not refer to a public website. was obtained without consent, particularly
recorded
conversations and also randomization codes.
We have been advised that there are significant legal issues involved with the use and
accessing of such information. ....
if you provide us your consent, we will contact the people whose information
was obtained under potentially illegal circumstances and ask their consent to
allow us to open the website and use the information.
It is not an issue, in the case of the randomization codes, that an academic researcher
should have such access but rather that you may have obtained it in this case
without the company’s consent.
....
John Eisman, Editor-in Chief, JBMR
Joseph Lorenzo, Chair, ASBMR Publications Committee
5 From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: "'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>, "'John Eisman'" <j.eisman@garvan.org.au>
Subject: From Drs. Eisman and Lorenzo
Date: Fri, 6 Jan 2006 10:14:11 -0500
Dear Dr Blumsohn:
We are willing to publish your wish to be no longer associated with the two abstracts you mentioned. Please provide for our consideration a brief note in the form you wish to be published.
As we discussed your information with you, you made it clear that certain of the information on your website was obtained without consent, particularly recorded conversations and also randomization codes.
We have been advised that there are significant legal issues involved with the use and accessing of such information. It is for that reason that we have not visited the site you mention. Rather we asked you to provide a summary of the matters relevant to ASBMR/JBMR. Again please allow us to pursue this serious matter effectively by providing a brief summary of information that we can formally put to the authors of the paper in question. That information may contain your views and opinions but should not contain information obtained without consent.
Alternatively, if you provide us your consent, we will contact the people whose information was obtained under potentially illegal circumstances and ask their consent to allow us to open the website and use the information.
It is not an issue, in the case of the randomization codes, that an academic researcher should have such access but rather that you may have obtained it in this case without the company’s consent.
This matter deserves changes in procedures and we are formulating procedural changes that will specifically address the underlying issues here.
We look forward to your prompt response.
Yours sincerely,
John Eisman, Editor-in Chief, JBMR
Joseph Lorenzo, Chair, ASBMR Publications Committee Full Email
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January 12, 2004 (Day 414) |
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Draft letter of withdrawal provided.
Agree that P&G should be asked whether they will consent to allow they will allow their actions to be investigated!
Date: Thu, 12 Jan 2006 23:23:19 +0000
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Message-ID: <910072568.20060112232319@btinternet.com>
To: "Adrienne Lea" <adrienne@jbmr.org>
CC: "'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>, 'John Eisman' <j.eisman@garvan.org.au>
Subject: Re:From Drs. Eisman and Lorenzo
Dear Dr Eisman
In terms of the urgent dissociation from the two abstracts:
I would regard the following statement as acceptable:
Header: Dissociation of authorship
Dr Aubrey Blumsohn has written to the Journal requesting that his name be
formally dissociated from the content and statistical analysis of two abstracts
written in his name, presented at the 2003 ASBMR meeting and published
in the JBMR(1,2). It appears that Dr Blumsohn was refused access to
the randomization codes and event codes underlying these analyses.
Subsequent irregularities have led him to believe that statistical analyses
were misleading. He feels unable to vouch for this work and has not been able to
verify the findings. This matter is under discussion.1. Relative Contributions Of The Early Changes In Bone Resorption And Later
Changes In Hip Bone Mineral Density To The Reduction In Vertebral Fracture Risk
With Risedronate. A. Blumsohn, IP Barton, A Chines, R Eastell.2. Relationship Of Early Changes In Bone Turnover To The Reduction In
Vertebral Fracture Risk With Risedronate - The HIP Study. A. Blumsohn, IP Barton,
A Chines, R Eastell.
....
You can certainly have my permission to ask Professor Eastell and
Procter and Gamble/The Alliance whether you can review the evidence
("contact the people whose information was obtained under potentially
illegal circumstances and ask their consent to allow us to open the website
and use the information.")
There is nothing in any way "illegal" albeit that you might regard this matter as
unpalatable,
as do I. Your lawyer will I am sure inform you that under UK law, and I
believe under
US law there is no legal problem with recording conversations of which
you are a
part
(except over the telecommunications network). This forms part of the
critical mass
of evidence, and includes at
least two admissions that the material
presented in the
abstracts was not correct.
Under the circumstances I believe this was not only ethical
but in the public interest.
I am not clear how to respond to the rest of your letter, but it
seems that my "consent"
above removes any difficulty.
....
Kind wishes
Aubrey Blumsohn
6 Date: Thu, 12 Jan 2006 23:23:19 +0000
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Message-ID: <910072568.20060112232319@btinternet.com>
To: "Adrienne Lea" <adrienne@jbmr.org>
CC: "'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>, 'John Eisman' <j.eisman@garvan.org.au>
Subject: Re:From Drs. Eisman and Lorenzo
Dear Dr Eisman
In terms of the urgent dissociation from the two abstracts:
I would regard the following statement as acceptable:
Header: Dissociation of authorship
Dr Aubrey Blumsohn has written to the Journal requesting that his name be formally dissociated from the content and statistical analysis of two abstracts written in his name, presented at the 2003 ASBMR meeting and published in the JBMR(1,2). It appears that Dr Blumsohn was refused access to the randomization codes and event codes underlying these analyses. Subsequent irregularities have led him to believe that statistical analyses were misleading. He feels unable to vouch for this work and has not been able to verify the findings. This matter is under discussion.
1. Relative Contributions Of The Early Changes In Bone Resorption And Later Changes In Hip Bone Mineral Density To The Reduction In Vertebral Fracture Risk With Risedronate. A. Blumsohn, IP Barton, A Chines, R Eastell.
2. Relationship Of Early Changes In Bone Turnover To The Reduction In Vertebral Fracture Risk With Risedronate - The HIP Study. A. Blumsohn, IP Barton, A Chines, R Eastell.
This should appear in the usual place reserved for letters in the journal under a heading of the usual form and indexed. This would be satisfactory in terms of the immediate problem, is urgent, and I hope will appear in the next issue.
You can certainly have my permission to ask Professor Eastell and Procter and Gamble/The Alliance whether you can review the evidence ("contact the people whose information was obtained under potentially illegal circumstances and ask their consent to allow us to open the website and use the information.")
There is nothing in any way "illegal" albeit that you might regard this matter as unpalatable, as do I. Your lawyer will I am sure inform you that under UK law, and I believe under US law there is no legal problem with recording conversations of which you are a part (except over the telecommunications network). This forms part of the critical mass of evidence, and includes at
least two admissions that the material presented in the abstracts was not correct. Under the circumstances I believe this was not only ethical but in the public interest. I am not clear how to respond to the rest of your letter, but it seems that my "consent" above removes any difficulty.
I could write a "summary", but this would simply reiterate what has appeared in the press, include no evidence and would not advance the matter. I should say for the record that I do not regard any of this process as confidential, and I believe that there needs to be continuing open and honest discussion.
Kind wishes
Aubrey Full Email
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January 19, 2006 (Day 421) |
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7 Date: Thu, 19 Jan 2006 18:55:47 +0000
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Reply-To: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Message-ID: <751150953.20060119185547@btinternet.com>
To: John Eisman' <j.eisman@garvan.org.au>
CC: "Adrienne Lea" <adrienne@jbmr.org>,
"'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>,
Phil Baty <phil.baty@thes.co.uk>, <v@vparry.co.uk>
Subject: Re:From Drs. Eisman and Lorenzo
Dear Dr Eisman
Please can you confirm that you received this mailing below a week ago today, and that this message of dissociation will be published as a matter of urgency.
I have not yet had a response.
Kind regards
Dr Aubrey Blumsohn Email to Editor asking for acknowledgement of minimal letter of withdrawal
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January 25, 2006 (Day 427) |
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8 Date: Wed, 25 Jan 2006 14:27:35 +0000
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Message-ID: <1295669048.20060125142735@btinternet.com>
To: John Eisman' <j.eisman@garvan.org.au>
CC: "Adrienne Lea" <adrienne@jbmr.org>,
"'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>,
Phil Baty <phil.baty@thes.co.uk>, <v@vparry.co.uk>
Subject: Re:From Drs. Eisman and Lorenzo
Please can you confirm that you received these
correspondences.
Kind regards
Dr Aubrey Blumsohn Repeat Email to Editor asking for acknowledgement of minimal letter of withdrawal
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January 26, 2006 (Day 427) |
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Reply from Editor redrafting letter of withdrawal - removing all content (reason
for withdrawal). Suggests P&G authors will be offered an opportunity to respond to
this!
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: "'John Eisman'" <j.eisman@garvan.org.au>,
"'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>
Subject: Response from Drs. Eisman and Lorenzo
Date: Thu, 26 Jan 2006 16:44:21 -0500
Message-Id: <200601261642448.SM02908@JBMR02>
Dear Dr. Blumsohn:
Thank you for your e-mail of January 13, 2006, requesting that your name be removed as an
author from two abstracts published in the 2003 ASBMR Annual Meeting Supplement and
referenced below. While it is a precedent for us to permit an author to remove his or her
name
from a published abstract, we would publish a statement to the following effect.
I request that my name be formally dissociated from the content and statistical
analysis of the following two abstracts which were presented at the 2003 annual
meeting of the American Society for Bone and Mineral Research and published
in the JBMR.
Relative Contributions Of The Early Changes In Bone Resorption And Later
Changes In Hip Bone Mineral Density To The Reduction In Vertebral Fracture
Risk With Risedronate. A. Blumsohn, IP Barton, A Chines, R Eastell
[J Bone Miner Res 2003;18(S2):S157 (Abstract #SA337)]
Relationship Of Early Changes In Bone Turnover To The Reduction In Vertebral
Fracture Risk With Risedronate - The HIP Study. A. Blumsohn, IP Barton, A
Chines, R Eastell [J Bone Miner Res 2003;18(S2):S89 (Abstract #F338)]
If you wish to submit this letter please do so. We will send this statement to the other
authors of the abstracts and allow them to submit a response for our consideration.
Yours sincerely,
John Eisman, Editor-in-Chief, JBMR
Joseph Lorenzo, Chair, ASBMR Publications Committee
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March 1 , 2006 (Day 434) |
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March 3 , 2006 |
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From Editor - ignoring all questions asked
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: "'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>,"'John Eisman'" <j.eisman@garvan.org.au>
Subject: Response from Drs. Eisman and Lorenzo
Date: Fri, 3 Mar 2006 16:23:46 -0500
Dear Dr Blumsohn,
Thank you for your letter of March 1st, 2006.
We again invite you to send two letters as suggested previously.
The first should be the one withdrawing your name from the abstracts [J Bone Miner Res 2003;18(S2):S157 (Abstract #SA33) and J Bone Miner Res 2003;18(S2):S89 (Abstract #F338)].
By all means use your own words but please write in the first person, “I.”
As always, we retain the right to determine what is published (but nothing different from what
you submit will be published with attribution unless you consent). The Journal will then
notify the other authors of the abstracts of your wishes and allow them the opportunity to respond.
The second letter must be a succinct version of the concerns you have expressed elsewhere
in various venues and in the media. We will not summarise what you have presented in a web
site
or in the other media. The Journal is not an investigative body and therefore will present your
letter to the authors of the manuscript and allow them the opportunity to respond to your
criticisms and concerns. We trust that this process will lead not only to clarity on this paper
but will also help to preserve and protect the rights and dignity of all concerned.
We look forward to receiving your letters.
Yours sincerely,
John Eisman, Editor-in-Chief Joseph Lorenzo, Publications Chair
[This email was sent by the editor four times]
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April 2, 2006 |
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Repeat request to editor to answer three straightforward questions.
Notification to Editor that P&G have now agreed to supply randomization and event codes
Dear Professor Eisman 2 April 2006
Following intense media criticism, Dr Larry Games
(P&G Vice President) agreed last week to
provide
the raw data to academic investigators involved in
these studies, and therefore to
allow proper
comparison of these data with all of the various
outputs produced by the
company (including taped
and other admissions of mis-analysis and
inappropriate
declarations to your Journal) as
well as the plausibility of the statistical
methods used.
This should have happened three
years ago.
This clearly changes matters as it will be
possible to publish the correct findings in
addition to the clear problems with the process.
Given the nature of the correspondence with JBMR
(I trust you will agree that the
attached
correspondence is a reasonably complete collation)
I will be quite frank and
state that I have little
faith in the Editorial approach. I have been let
down quite badly.
I would appreciate answers to
the three questions asked in my letter of 01 March
2006.
It also seems that JBMR have stimulated some
form of statistical analysis by an
unknown
statistician (? at the MHRA) in relation to the
overlapping Eastell 2003 paper.
It will be clear
to you that this data will not yet have been
compared to the various
outputs of the company,
and that such a statistician will not be aware
what has
transpired or what questions are being
asked. If you are aware of this procedure,
I would
ask why you consider it appropriate?
Pending your answers it will be necessary to
discuss both the science and what happened
in
proper detail, and P&G might then quite
properly respond as you suggest.
I agree with you that dignity of others is
important and will attempt to maintain that.
However we also have to consider the dignity of
our patients and research participants,
and the
need to discuss procedure so that the lessons will
be learned.
Kind wishes
Aubrey Blumsohn
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April 4 , 2006 |
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Repeat request to editor to answer questions
Date: Tue, 4 Apr 2006 14:27:07 +0100
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
To: "Adrienne Lea" <adrienne@jbmr.org>
CC: j.eisman@garvan.org.au
Subject: Re:From Drs. Eisman and Lorenzo
......
Again, I would appreciate it if you would answer
the three questions I asked on 1 March,
and the
one from my last letter. I will repeat these for
your convenience:
"I would appreciate some explanation as to
a) the nature of the "significant legal issues" you mention, and
b) an assessment as to the conflicts of interest
which you feel you and the society might
have in
this matter and
c) I would also appreciate an explanation as to
how you would propose to examine any
repeat
statement of concern if you are unwilling to
examine materials sent to you.
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April 7 , 2006 |
---|
Irrelevant response from Editor
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: "'John Eisman'" <j.eisman@garvan.org.au>,"'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>
Subject: From Drs. Eisman and Lorenzo
Date: Fri, 7 Apr 2006 07:46:43 -0400
Dr. Blumsohn,
Our focus in this matter is and will remain the content of the Journal of Bone and Mineral
Research. In that regard we continue to be willing to receive and consider for publication
your statement of withdrawal and (upon an opportunity for review and response) any
sufficiently-detailed information about the merits or demerits of the research and reporting
in the particular abstracts and article that you previously have expressed concern.
With kind regards,
John Eisman, Editor-in-Chief, JBMR
Joseph Lorenzo, Publications Chair, ASBMR
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April 7 , 2006 |
---|
Repeat request to editor to answer questions.
Date: Fri, 7 Apr 2006 13:07:09 +0100
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
To: "Adrienne Lea" <adrienne@jbmr.org>, 'John Eisman' <j.eisman@garvan.org.au>,
"'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>
Subject: Re:From Drs. Eisman and Lorenzo
Dear Professor Eisman
Thank you very much for this response. It bears no
relation to my concerns (reproduced yet
again
below). You mentioned "significant legal issues"
(which would influence what I write),
yet refuse
to tell me what these are. You have failed to let
me know as Editor how you
(or reviewers) will
examine such submissions if you are unwilling to
examine referenced
material. You have failed as
Editor to answer questions about conflicts of
interest involving
yourself, JBMR or ASBMR.
This really is not plausible.
Aubrey Blumsohn
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May 2 , 2006 |
---|
Communication with Editor following release of data by P&G underlying all three
publications
** See complete letter with all appendices here**
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May 5 , 2006 |
---|
From Editor - ignoring all questions asked
From: "Adrienne Lea" <adrienne@jbmr.org>
To: "'Aubrey Blumsohn'" <ablumsohn@sheffield.ac.uk>
CC: j.eisman@garvan.org.au, "'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>
Subject: From Dr. Eisman and Dr. Lorenzo
Date: Fri, 5 May 2006 16:20:03 -0400
Dear Dr. Blumsohn,
Thank you very much for your letter dated May 1, 2006. We have studied it carefully and we
are in agreement that your letter could serve as the summary of your criticisms of the
2003 manuscript, JBMR 2003;18(6):1051-1056, that we have been requesting.
With respect to your observations about the research in question, as set forth in
paragraphs 1, 3 (including the quoted statements), 4, 5, and 7 of your letter, we would be
pleased to treat them as a letter from you to the JBMR editor. Please let us know if you agree.
Kindly also feel free to adjust the language - or add to it in any way - to address the research
issues. As always, the authors of the manuscript in question will be offered the
opportunity to respond to your criticisms.
With regard to the points raised in your last paragraph, you told us yourself that some of the
material you placed on your website [the "website" referred to is in fact an extensive html
based dossier of electronic documents, not a public website] had been obtained “illegally.”
It is, in part, because the material had been obtained illegally that we have not and will not
access this information.
With respect to the issues you raised in paragraphs 2, 6, and 8 about JBMR not being
responsive, in addition to our note above, we can respond further and separately, if that
remains necessary.
We still welcome your letter requesting withdrawal of your name from the abstracts.
Kind regards,
John Eisman, Editor-in-Chief, JBMR,
Joseph Lorenzo, Publications Chair, ASBMR
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May 7 , 2006 |
---|
Date: Sun, 7 May 2006 19:45:22 +0100
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
Reply-To: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
X-Priority: 3 (Normal)
Message-ID: <75651068.20060507194522@btinternet.com>
To: "Adrienne Lea" <adrienne@jbmr.org>
CC: j.eisman@garvan.org.au, "'Lorenzo,Joseph'" <JLorenzo@nso2.uchc.edu>,
Dear Professor Eisman
Please confirm that the reason you have refused as
editor to read evidence pertaining to
concerns
about publications in JBMR is that you maintain it
was in part illegally acquired.
Please also confirm that the nature of this
supposed illegality is that authors obtained
partial
data relating to their analysis without
consent of the company involved.
Please also confirm that this is the reason you
have refused to access the associated
statistical
report.
I will certainly be happy to submit a proper
letter of withdrawal to JBMR in addition to
the
JAMA submission if this seems possible.
Yes, kindly do address my letters. I had written them for that reason.
Yours sincerely
Aubrey Blumsohn
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May 19 , 2006 |
---|
Termination of communication with editor
Date: Fri, 19 May 2006 23:28:46 +0100
From: Aubrey Blumsohn <ablumsohn@sheffield.ac.uk>
To: "Adrienne Lea" <adrienne@jbmr.org>,
CC: j.eisman@garvan.org.au,JLorenzo@nso2.uchc.edu
Subject: Re:From Dr. Eisman and Dr. Lorenzo
Professor Eisman
I informed you on 3 January 2006 that nothing was
illegal and I had no idea what you meant.
I
repeated this on 12 January 2006, 1 March 2006, 4
April 2006, and on multiple other
occasions. This
followed more than a year of failure of any
editorial response, and your removal
of
all
content from the one interim letter that I did
write.
The other questions asked more recently have
been unambiguous.
These include a query about
editorial conflicts of interest which you
seemingly regard as
having an "uncertain basis"
(and have therefore not answered).
I believe there has been clear editorial
misconduct which has served to delay discussion
of
of inappropriate procedure and scientific
fraud.
The intended submission will be elsewhere since
you are unwilling to examine referenced
documents
relating to straightforward editorial matters.
Of
course I would have wished to discuss this in JBMR
but you have not made it possible for
me to do so
in a comprehensive and documented manner.
The editorial approach of JBMR clearly merits
public discussion.
Raising such issues is
difficult, and I believe JBMR should be ashamed at
its participation
(together with others) in hiding
of serious problems in clinically relevant
research.
You will also be aware that the documentation you
were sent is electronic but is not a
publicly
accessible website. The form of the material is
irrelevant, and could just as easily be
printed.
Electronic format is most appropriate since the
source documents are largely in this
form.
This interchange is terminated given its
increasing absurdity.
I will however be happy to
receive the answers to the questions I have asked
at any time.
Sincerely
Aubrey Blumsohn
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6 June 2006 |
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Response to Press Statement released by JBMR 6 June 2006
Dear Professor J Eisman/Phil Baty
I thought I would make a few brief comments for
the benefit of the THES with
regard to your press
statement about which I was asked my views. In the
interests of openness I thought I would allow you
to see them and respond to the
THES if you feel I
am saying anything incorrect.
1) Eisman states that "We requested and have received
updated information that
clarifies the authors’
[Eastell's] earlier declaration"
Since you have declined to receive or examine
relevant information from me that is certainly
of
interest. Why would you receive actual information from
anyone else?
2) Eisman states that " JBMR has never seen or been
formally presented with the
specific criticisms of
this article by Martin Bland or Jane Hutton that
you quote
[statistical reports]."
That is because you have been offered these
reports several times by me, the BBC
and the THES
but have failed to accept them!
3) Eisman states that: "in the absence of a formal
written complaint that summarizes
in detail the
specific criticisms of this article....."
That is because you declined to accept specific
criticisms, only evidence free
undocumented and
unreferenced ones. I do not provide undocumented
criticisms for reasons which should be obvious to
a scientific editor.
4) Eisman states that: "We have taken the position that it is the responsibility of the supporting institution, in this case the University of Sheffield, to evaluate criticisms."
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxx?
It is obvious that the
University
of Sheffield cannot usefully comment on the matter
at hand (xxxxxxxxxxxxxxxxxxxxxxxx)
given
their vested interests in it. I would also comment
that in March and April
the University declined to
allow the new properly independent UK Research
Integrity
Panel to get involved or advise upon
the problem. xxxxxxxxxxxxxxxxxxxxxxxx
xxx
xxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxx?
7) In your "Note of Concern" on the JBMR website you state that "Upon reviewing these questions with the authors of the article, the authors have agreed to a statistical reanalysis of the data, upon which the article was based."
Since you have
refused to accept the documentary
evidence and the
statement as to what
those questions
are, it is
not clear how you can possibly make such
referral
to the authors
about these questions. To what
"questions" do you refer exactly?
8) I am delighted by your admssion that you have
declined to review any evidence related to
scientific fraud and the misleading of editors by
authors on the main basis that:
"You stated that you had obtained randomization
codes and data for the studies in dispute without
the consent of the "owners" of those codes". "This
is illegal in the United States."
This statement is important, coming as it does
from a medical journal editor. I shows I am afraid
how much we have lost in medicine. The fact that
denial of randomisation codes by a sponsor and
their misrepresentation of those data in my (and
Eastell's) name is the precise matter at hand (and
is an Editorial matter) also appears to have
escaped your notice. The fact that the data has
since been provided by the company following press
exposure seems to escaped your notice. The way in
which these codes were obtained also seems to have
escaped your notice (but you clearly wouldn't know
that without having opened the evidence bundle)
9) I am similarly intrigued by your comment that
"You had recorded conversations with third
parties without their consent" [this formed a
small part of the evidence bundle] - "Recording
conversations without the consent of all parties
involved is illegal in the United States".
You appear to have forgotten that you have already
been informed that tape recording of in-person
first party conversations without consent is not
"illegal in the United States" or in North
Carolina (home of the Journal) or Washington, D.C.
(home of ASBMR), or in the United Kingdom (home of
the conversations).
10) Most importantly you failed repeatedly to
answer a simple question about conflicts of
interest.
Kindly
Aubrey Blumsohn
Conflicts of interest statement
Professor Eisman was asked repeatedly to state conflicts of interest he believed might pertain in this instance involving himself, the ASBMR and its Journal (JBMR). he could simply have answered. After all, it is a question that Journal Editors routinely ask authors.
A smattering of the many conflicts he and his journal could have declared are here.
Professor Eastell served as councillor of the ASBMR (Past councillors of the ASBMR webpage
seems to have been removed - but is archived here Eastell past councillor of the ASBMR).
Eastell is Chair of the International Task force of the ASBMR.
Procter and Gamble/Aventis provide substantial funding to both the society and the Journal,
for example they were a 2005 Platinum Sponsor. or a gold level sponsor,
The corporate advisory board of ASBMR was listed here but appears unavailable - cached version here,
P&G supports meeting abstracts (Abstracts of the ASBMR supported by Procter and Gamble),
sponsor any ASBMR meetings e.g. here and here, and here.
Professor Eisman serves as paid consultant to Aventis pharmaceuticals, and Aventis
also supports some of the activities of his institute, the Garvan Institute,
Sanofi-Aventis Australia sells risedronate in collaboration with Procter and Gamble.
ASBMR notes that sponsors get quite a bit for their money: for their money.
The deal is:
"Special corporate support opportunities enable you to maximize your marketing
dollars.
Diamond, Platinum, Gold, Silver, Bronze and Friend Supporter Levels - Get
priority
Exhibit Booth placement and
many other benefits, including prominent acknowledgments
in meeting materials and signage, invitations to the
exclusive VIP dinner all and more."
JBMR gets extensive advertising revenue from P&G (advertisng rates, were at
http://www.jbmr-online.org/adoutline.html up until a few weeks ago
(cached version here).
List of rates was at http://www.jbmr-online.org/ratecard06.pdf, but is currently unavailable online.
A few of the countless cover advertisements in JBMR.