Supplementary Memorandum submitted by
British Biotech plc
1. INTRODUCTION
We are writing to the Committee following the
oral evidence given to the Committee by Drs McCullagh and Jensen
on 1 July 1998.
The purpose of this supplementary submission
is to ensure clarity on a small number of issues raised during
the oral hearing where we believe some confusion may have remained,
as a result of the brevity of the session.
2. UNAUTHORISED
UNBLINDING BY
DR MILLAR
During the oral evidence, the Company's representatives
were questioned as to why the Company endured continued unauthorised
and unethical unblinding by Dr Millar after the episode in May
1997 when Dr Millar was reprimanded for such action. We believe
that there was some lack of clarity over this issue.
The Company was, in fact, aware only of those
unblindings—of Study 215 (Zacutex) and Study 128 (marimastat)—carried
out by Dr Millar prior to May 1997 and which he disclosed in a
memorandum to Dr McCullagh dated 15 May 1997. Dr Millar was at
that time orally requested to stop such unauthorised unblindings
by Dr McCullagh. The Company only became aware of further possible
unblinding carried out by Dr Millar of Study 215 and Study 128
following Dr Millar's suspension from duty. An external regulatory
audit was then commissioned by the Company which confirmed repeated
unblinding and occurred (see (3) below). If the Company had evidence
that Dr Millar was continuing to unblind studies with the potential
danger both to patients and to the integrity of the studies which
is inherent in such unauthorised unblinding, decisive action would
have been taken against Dr Millar.
3. EXTERNAL AUDIT
OF UNBLINDING
Following Dr Millar's suspension and the Company
learning that he claimed to have carried out further unblinding,
the Company commissioned an external audit by independent experts,
qualified in the running and management of clinical trials, to
confirm whether and what unblinding had taken place and the implications
of such unblinding.
This audit confirmed consistent unblinding by
Dr Millar of studies 215 and 128 but no other studies. It confirmed
this unblinding breached all guidelines on Good Clinical Practice
(GCP), the Company's internal guidelines and international health
and regulatory guidelines. The audit also sought to clarify to
what extent the studies might have been jeopardised by the unblindings.
The results of the audit have been shared with the MCA, EMEA and
the FDA.
4. DR MILLAR'S
MOTIVATION
The company would like to make its views on
Dr Millar's motivation for his various actions very clear.
There can be no sensible explanation for his
consistent unblinding other than as the original designer of the
clinical programme he was anxious to see whether the trials were
performing in the way expected.
Whilst Dr Millar may have had a justifiable
safety concern regarding Study 128 in late 1996 and early 1997,
this was proved unfounded by his own analysis. Should any safety
concerns arise, there is a proper procedure within GCP guidelines
to be followed. At no time did Dr Millar follow the guidelines.
Had any safety concerns arisen, they would have been discussed
openly and appropriate action taken, as happens as a matter of
course in all clinical studies. The Company remains bewildered
as to why Dr Millar undertook actions which had no apparent justification
or excuse whatsoever; and which, by their very occurrence, carried
potential risks to patients and the Company.
Dr Millar's motivation for his actions in taking
alleged complaints to an external sell-side stockbroking analyst,
Jane Henderson of Goldman Sachs, is, the Company believes, abundantly
clear. Dr Millar's personal ambitions and his opinion of his own
value have been clearly expressed, including in writing as indicated
in the Company's previous submission to the Committee. Dr Millar
had been told that he was not to be considered for the Group Board
position of Development Director but that his current role was
still important to the Company. The allegations he made to Ms
Henderson were made, the Company understands, within approximately
one week of the announcement of Dr Jensen's appointment to the
role of Development Director and Dr Jensen's arrival to take up
this role. The Company has been unable to confirm the precise
date on which Dr Millar's first conversations with Ms Henderson
took place, what disucssion if any Ms Henderson held with her
employer, Goldman Sachs, and when and why Ms Henderson subsequently
approached yet another external party, Perpetual plc, as opposed
to bringing the perceived problem to the attention of the Company.
In respect of Dr Millar's motivation, the Company
is very clear, on the basis of the evidence already submitted
to the Committee, that Dr Millar:
(a) was very disappointed that his ambitions
to be appointed to the Board of British Biotech had been frustrated;
and
(b) that Dr Millar had subsequently developed
a greater ambition, namely to find a means of removing the existing
management of the Company and obtaining his own appointment as
Chief Operating Officer of the Company.
5. ADDITIONAL
INFORMATION
The Company has also provided to the Clerk to
the Committee the following additional information:
(a) written evidence relating to the Company's
relationship with HSBC circular which the Committee requested
(Annex 1);
(b) copies of the letter from Dr Peter Lewis
to the Chairman of British Biotech plc (Annex 2) and the minutes
of the London Gynaecological Oncology Group of 15 January 1995
(Annex 3);
(c) a copy of the latest version (November
1997) of the Company's procedures governing press releases and
external announcements (Annex 4); and
(d) copies of the relevant international
guidelines relating to the management and design of clinical trials
including circumstances when unblinding is permitted (Annex 5).
13 July 1998
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