-----Original Message-----
From: barton.ip@pg.com [mailto:barton.ip@pg.com]
Sent: 14 June 2002 13:37
To: Richard Eastell
Subject: Re: HIP analyses

Hi Richard

Yes I didn get it and am sorry I didn't reply earlier. I'm snowed under
with other work.

Anyway, here are answers to your questions:

Adjustment for BMD can be done and I plan to perform this once the HIP
samples are available for analysis. Non-vertebral fractures can be divided
into meaningful groups and analysed, again I plan to perform this once the
HIP samples are available.

No, we do not intend for someone else to the analysis. As far as I'm
aware, the Alliance is very transparent in the analyses we perform. We always
clearly explain what statistical methods have been undertaken and are
happy to share with as many external people as possible. Resource wise it
wouldn't make sense for me to spend a lot of time training someone else to perform
the analyses. Also, the FDA never perform our primary analyses and write our
clinical reports.

Please don't take the last point the wrong way. I just feel that we're
being very clear in what we are doing and don't need to ask an independent person
to analyse the data just to make a few people happy. Phil Ross does a lot of
the MSD analyses and no one raises objections.

What I would say is that I want us to generate a prospective statistical
analysis plan. I would like to state that the analyses would look at
patients in the HIP trial who have confirmed osteoporosis as well as the ITT.
I would also like to mention that we include the VERT trials in a pooled-analysis
with the HIP trial. We can also include adjustment for BMD and dividing the
osteo-non vert fx data by skeletal-site subgroups.

Kind regards,
Ian

From: "Richard Eastell" <r.eastell@sheffield.ac.uk> on 12/06/2002 10:24
To: Ian Barton-IP/PGI
Subject: HIP analyses
Date: 12/06/2002 11:24

Dear Ian
I wrote to you a little while ago about the HIP analyses, but I haven't
received a reply. Did you get my message? I met Ralph Carter the other night
and asked him to remind you. I also copied you in on the message this
morning about the expected date of delivery of the reagents for the NTX
measurements, so there will be some delay in completing this study.
Richard

Professor Richard Eastell, MD, FRCP (UK, Edinburgh, Ireland), FRCPath,
FMedSci
Research Dean for the School of Medicine and Biomedical Science
Director of the Division of Clinical Sciences (North)
University of Sheffield Clinical Sciences Centre
Northern General Hospital
Herries Road
Sheffield
South Yorkshire S5 7AU
England
Telephone +44 (0)114 271 4705 (secretary, Gill)
Fax +44 (0)114 261 8775
e-mail r.eastell@sheffield.ac.uk