Recent correspondence with the Lancet re PACE

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>
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

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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:  <mailto:Zoe.Mullan@lancet.com> Mullan, Zoe (ELS-CAM)

To:  <mailto:angelakennedy372@btinternet.com>
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/> http://ees.elsevier.com/thelancet/. The
deadline for submissions would be March 18.

Best wishes,

Zoë 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

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----- Original Message -----

From:  <mailto:Zoe.Mullan@lancet.com> Mullan, Zoe (ELS-CAM)

To:  <mailto:angelakennedy372@btinternet.com> 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
<mailto:ombudsman@lancet.com> ombudsman@lancet.com.

Best wishes,

Zoë 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:  <mailto:Zoe.Mullan@lancet.com> Mullan, Zoe (ELS-CAM)

Sent: Friday, March 04, 2011 3:33 PM

Subject: Re: The PACE trial

Dear Zoë

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