Angela Kennedy
Senior Member
- Messages
- 1,026
- Location
- Essex, UK
MY RECENT CORRESPONDENCE WITH THE LANCET ABOUT THE PACE TRIAL
PERMISSION TO REPOST
Below is my recent correspondence with a staff member of the Lancet about the PACE trial. I have decided to publish this in light of the recent, inappropriate attack, from the editor of the Lancet, Richard Horton, on the integrity of the critics of the PACE trial, on the ABC radio show The Health Report:
http://www.abc.net.au/rn/healthreport/stories/2011/3192571.htm
Here Dr Horton has, very worryingly, misrepresented the concerns of people who have critiqued the many discrepancies and flaws of the PACE trial, and his comments appear not in good faith, which, in my opinion does not bode well for the due process he has claimed he will be following to address these legitimate concerns. As is evident, my own concerns and criticisms, while necessarily addressed in a serious and robust manner, are reasonable in tone and content.
N.B. My request for information as per my final email in this correspondence has not yet been responded to by the Lancet.
Angela Kennedy
--------------------------------------------------
From: "ANGELA KENNEDY
Date: February 18, 2011 2:43:51 PM GMT
To: "Horton, Richard (ELS-CAM)"
Subject: The PACE trial
Dear Dr Horton,
I am writing in regard to the online publication of the 'PACE' trial by the Lancet today.
You may not be aware that there have been a large number of serious concerns and objections to this highly flawed study since its onset nearly seven years ago.
There are many and various discrepancies in methodology and potentially in ethical practice that have led to at least one (ongoing) complaint to the MRC.
My question to you today is: were you (are you) aware of these problems? Were the fact that objections to this study were present, and what those problems are, made aware to you when this article was submitted for publication, for example? Were peer reviewers made aware of these issues?
The ramifications of this flawed study, and the methodological and other discrepancies are likely to be major, and raised in the future, so I am writing to you in good faith to ask if:
1. If you are not aware of the above problems that have been identified prior to submission/publication of this article, will you consider discussing these problems with me?
2. If you are aware of the problems that have been identified prior to submission/publication of this article, would you please explain how these were assessed in order for this article to be published?
In addition, you should probably be aware that there is likely to be substantial correspondence to you in response to this study. Can you please advise the deadline for submissions of correspondence, bearing in mind the uncertainty of date publication at this stage due to the 'online status of this article currently.
Many thanks and best wishes
Angela Kennedy
---------------------------------------------------------------
From: Mullan, Zoe (ELS-CAM)
To: angelakennedy372@btinternet.com
Sent: Monday, February 21, 2011 9:38 AM
Subject: RE: The PACE trial
Dear Dr Kennedy,
You would be most welcome to write a letter for publication in which you outline your concerns about methodological and other discrepancies. Please submit your letter as Correspondence via http://ees.elsevier.com/thelancet/. The deadline for submissions would be March 18.
Best wishes,
Zo Mullan
Senior Editor
The Lancet
32 Jamestown Road
London NW1 7BY
UK
(T) +44 (0)20 7424 4910
(F) +44 (0)1865 853016
-----------------------------------------------------
From: ANGELA KENNEDY
Sent: 23 February 2011 10:22
To: Mullan, Zoe (ELS-CAM)
Subject: Re: The PACE trial
Dear Ms Mullan
Many thanks for your email. I should let you know I am not a medical doctor, nor a PhD as yet, so Ms before my surname (or Angela, my first name) will suffice when addressing me.
While I am grateful for your invitation to submit a letter, there are a host of people clamouring to bring to attention the cornucopia of discrepancies in the PACE trial, and I expect you will get a large amount of correspondence on this issue. I will therefore not be submitting correspondence in competition with others at this time, although I would be grateful if you would confirm to me that March 18 is the deadline for ALL correspondence submissions?
My reason for writing to Richard Horton is slightly different, and I do wish to find answers to the questions I posed. These are:
There are many and various discrepancies in methodology and potentially in ethical practice that have led to at least one (ongoing) complaint to the MRC. Was Dr Horton aware of these problems? Were the fact that objections to this study were present, and what those problems are, made aware to the Lancet when this article was submitted for publication, for example? Were peer reviewers made aware of these issues?
The ramifications of this flawed study, and the methodological and other discrepancies are likely to be major, and raised in the future, so:
1. If The Lancet are not aware of the above problems that have been identified prior to submission/publication of this article, will Dr Horton consider discussing these problems with me?
2. If Dr Horton (or other Lancet staff) are aware of the problems that have been identified prior to submission/publication of this article, would Dr Horton please explain how these were assessed in order for this article to be published?
I do have one further question also. Will the Lancet peer review process documentation be made available to the public, and if so, when?
Many thanks for your attention and assistance in this matter.
Best wishes
Angela Kennedy
---------------------------------------------------------------------------
----- Original Message -----
From: Mullan, Zoe (ELS-CAM)
To: ANGELA KENNEDY
Sent: Friday, March 04, 2011 12:18 PM
Subject: RE: The PACE trial
Dear Angela,
My apologies for the delay in getting back to you. We were not aware of any objections to this study, and we of course made sure that the trial protocol had been approved by an ethics committee before we decided to proceed with it. The trial received unanimous support from three clinical reviewers and a statistician. On this basis, we do not see a reason to deviate from the usual course of practice and make the peer review documentation public.
If you believe the journal has acted inappropriately over the publication of this trial, you should put your concerns in writing to our independent Ombudsman, Dr Charles Warlow, who can be contacted via ombudsman@lancet.com.
Best wishes,
Zo Mullan
Senior Editor
The Lancet
32 Jamestown Road
London NW1 7BY
UK
(T) +44 (0)20 7424 4910
(F) +44 (0)1865 853016
----------------------------------------------
From: ANGELA KENNEDY
To: Mullan, Zoe (ELS-CAM)
Sent: Friday, March 04, 2011 3:33 PM
Subject: Re: The PACE trial
Dear Zo
Thank you very much for getting back to me.
Now that you have been made aware that there were objections to this study, are you saying that you are not prepared to be advised what those objections were?
While your journal may have acted in ignorance over publishing the PACE trial results and editorial claims about safety and efficacy, I would advise you that post-publication, it may be that you do have a responsibility to investigate this issue more thoroughly and provide information to people with concerns about this problem.
I remind you of the issue of Andrew Wakefield et al. I do in all good faith believe the problem of claiming the PACE trial is safe for people suffering from a neurological condition (myalgic encephalomyelitis) could compromise the journal in this context, as the problems of the PACE trial become more publicly evident, and people seek avenues of redress for protection against the unsafe claims made in your journal about safety in particular.
I am grateful for your information about your independent Ombudsman, and may make use of this opportunity in the future.
In the meantime, I am writing here to request that peer review documentation be made accessible to me under the Freedom of Information Act. I understand that the usual procedure under this Act applies.
Best wishes
Angela Kennedy
CORRESPONDENCE ENDS
PERMISSION TO REPOST
Below is my recent correspondence with a staff member of the Lancet about the PACE trial. I have decided to publish this in light of the recent, inappropriate attack, from the editor of the Lancet, Richard Horton, on the integrity of the critics of the PACE trial, on the ABC radio show The Health Report:
http://www.abc.net.au/rn/healthreport/stories/2011/3192571.htm
Here Dr Horton has, very worryingly, misrepresented the concerns of people who have critiqued the many discrepancies and flaws of the PACE trial, and his comments appear not in good faith, which, in my opinion does not bode well for the due process he has claimed he will be following to address these legitimate concerns. As is evident, my own concerns and criticisms, while necessarily addressed in a serious and robust manner, are reasonable in tone and content.
N.B. My request for information as per my final email in this correspondence has not yet been responded to by the Lancet.
Angela Kennedy
--------------------------------------------------
From: "ANGELA KENNEDY
Date: February 18, 2011 2:43:51 PM GMT
To: "Horton, Richard (ELS-CAM)"
Subject: The PACE trial
Dear Dr Horton,
I am writing in regard to the online publication of the 'PACE' trial by the Lancet today.
You may not be aware that there have been a large number of serious concerns and objections to this highly flawed study since its onset nearly seven years ago.
There are many and various discrepancies in methodology and potentially in ethical practice that have led to at least one (ongoing) complaint to the MRC.
My question to you today is: were you (are you) aware of these problems? Were the fact that objections to this study were present, and what those problems are, made aware to you when this article was submitted for publication, for example? Were peer reviewers made aware of these issues?
The ramifications of this flawed study, and the methodological and other discrepancies are likely to be major, and raised in the future, so I am writing to you in good faith to ask if:
1. If you are not aware of the above problems that have been identified prior to submission/publication of this article, will you consider discussing these problems with me?
2. If you are aware of the problems that have been identified prior to submission/publication of this article, would you please explain how these were assessed in order for this article to be published?
In addition, you should probably be aware that there is likely to be substantial correspondence to you in response to this study. Can you please advise the deadline for submissions of correspondence, bearing in mind the uncertainty of date publication at this stage due to the 'online status of this article currently.
Many thanks and best wishes
Angela Kennedy
---------------------------------------------------------------
From: Mullan, Zoe (ELS-CAM)
To: angelakennedy372@btinternet.com
Sent: Monday, February 21, 2011 9:38 AM
Subject: RE: The PACE trial
Dear Dr Kennedy,
You would be most welcome to write a letter for publication in which you outline your concerns about methodological and other discrepancies. Please submit your letter as Correspondence via http://ees.elsevier.com/thelancet/. The deadline for submissions would be March 18.
Best wishes,
Zo Mullan
Senior Editor
The Lancet
32 Jamestown Road
London NW1 7BY
UK
(T) +44 (0)20 7424 4910
(F) +44 (0)1865 853016
-----------------------------------------------------
From: ANGELA KENNEDY
Sent: 23 February 2011 10:22
To: Mullan, Zoe (ELS-CAM)
Subject: Re: The PACE trial
Dear Ms Mullan
Many thanks for your email. I should let you know I am not a medical doctor, nor a PhD as yet, so Ms before my surname (or Angela, my first name) will suffice when addressing me.
While I am grateful for your invitation to submit a letter, there are a host of people clamouring to bring to attention the cornucopia of discrepancies in the PACE trial, and I expect you will get a large amount of correspondence on this issue. I will therefore not be submitting correspondence in competition with others at this time, although I would be grateful if you would confirm to me that March 18 is the deadline for ALL correspondence submissions?
My reason for writing to Richard Horton is slightly different, and I do wish to find answers to the questions I posed. These are:
There are many and various discrepancies in methodology and potentially in ethical practice that have led to at least one (ongoing) complaint to the MRC. Was Dr Horton aware of these problems? Were the fact that objections to this study were present, and what those problems are, made aware to the Lancet when this article was submitted for publication, for example? Were peer reviewers made aware of these issues?
The ramifications of this flawed study, and the methodological and other discrepancies are likely to be major, and raised in the future, so:
1. If The Lancet are not aware of the above problems that have been identified prior to submission/publication of this article, will Dr Horton consider discussing these problems with me?
2. If Dr Horton (or other Lancet staff) are aware of the problems that have been identified prior to submission/publication of this article, would Dr Horton please explain how these were assessed in order for this article to be published?
I do have one further question also. Will the Lancet peer review process documentation be made available to the public, and if so, when?
Many thanks for your attention and assistance in this matter.
Best wishes
Angela Kennedy
---------------------------------------------------------------------------
----- Original Message -----
From: Mullan, Zoe (ELS-CAM)
To: ANGELA KENNEDY
Sent: Friday, March 04, 2011 12:18 PM
Subject: RE: The PACE trial
Dear Angela,
My apologies for the delay in getting back to you. We were not aware of any objections to this study, and we of course made sure that the trial protocol had been approved by an ethics committee before we decided to proceed with it. The trial received unanimous support from three clinical reviewers and a statistician. On this basis, we do not see a reason to deviate from the usual course of practice and make the peer review documentation public.
If you believe the journal has acted inappropriately over the publication of this trial, you should put your concerns in writing to our independent Ombudsman, Dr Charles Warlow, who can be contacted via ombudsman@lancet.com.
Best wishes,
Zo Mullan
Senior Editor
The Lancet
32 Jamestown Road
London NW1 7BY
UK
(T) +44 (0)20 7424 4910
(F) +44 (0)1865 853016
----------------------------------------------
From: ANGELA KENNEDY
To: Mullan, Zoe (ELS-CAM)
Sent: Friday, March 04, 2011 3:33 PM
Subject: Re: The PACE trial
Dear Zo
Thank you very much for getting back to me.
Now that you have been made aware that there were objections to this study, are you saying that you are not prepared to be advised what those objections were?
While your journal may have acted in ignorance over publishing the PACE trial results and editorial claims about safety and efficacy, I would advise you that post-publication, it may be that you do have a responsibility to investigate this issue more thoroughly and provide information to people with concerns about this problem.
I remind you of the issue of Andrew Wakefield et al. I do in all good faith believe the problem of claiming the PACE trial is safe for people suffering from a neurological condition (myalgic encephalomyelitis) could compromise the journal in this context, as the problems of the PACE trial become more publicly evident, and people seek avenues of redress for protection against the unsafe claims made in your journal about safety in particular.
I am grateful for your information about your independent Ombudsman, and may make use of this opportunity in the future.
In the meantime, I am writing here to request that peer review documentation be made accessible to me under the Freedom of Information Act. I understand that the usual procedure under this Act applies.
Best wishes
Angela Kennedy
CORRESPONDENCE ENDS