Royal Free
applied for patent on vaccine products
before unleashing MMR crisis
This page
is research from an investigation by Brian Deer for the UK's
Channel 4 Television and The Sunday Times
of London into a campaign linking the MMR
children's vaccine with autism.
| Go to part I: The Lancet scandal | Go to
part II: The Wakefield
factor |
In a
video and at a press conference in
February 1998, called - the Royal Free said - to launch
the Lancet article, Andrew Wakefield
advised parents to demand that the
component shots be given separately. What
parents weren't told, however, was that
Wakefield and the hospital's medical
school had already filed the first of what would
become a string of extraordinary patent
applications
(1)
05.06.97: Wakefield
lodges a product patent claim
Below
is a London patent office report on the
claim filed on 5 June 1997
- almost nine months before the press
conference - in the name of the Royal
Free hospital medical school and the
Neuroimmuno Therapeutics Research
Foundation. The foundation is the private
company of controversial immunologist
Professor H Hugh Fudenberg of
Spartanburg, South Carolina. Giving
evidence to the UK General Medical
Council in August 2007, the former dean
of the medical school, Professor Arie
Zuckerman, said the Royal Free had no
knowledge of the application, and that he
was "absolutely shocked" to
discover that Wakefield had lodged it.
The
patent title is "Pharmaceutical
composition for treatment of IBD and
RBD". IBD means
inflammatory bowel disease. RBD is
sometimes described in later documents as
"regressive behavioural
disease" and sometimes as
"regressive behavioural
disorder", or autism. This document
is the patent office notification, not
the claims supplied by Wakefield and
Royal Free to the office. The first
Wakefield MMR patent application, describing
an allegedly safer single measles
vaccine - a potential competitor
to MMR - is available in full at this
website.
(2) 02.02.98: Wakefield
tells hospital of vaccine idea
Nearly
four weeks before the press conference,
and as the hospital was preparing the
video to distribute to broadcasters,
Wakefield filed an ethics
committee application to test a
product based on the plans in the first
patent submission. It makes clear that
the idea of a possible vaccine was
already in Wakefield's mind.
(3) 28.02.98: Wakefield
launches MMR vaccine scare
Without
disclosing their ambitions for products
which could only find a market if MMR's
reputation was damaged, Andrew Wakefield
and the Royal Free medical school called
a press conference, backed by an
elaborate 20-minute video news
release, to announce a
low-grade Lancet paper, peppered with
errors and omissions, which has since
been substantially retracted. The press
conference triggered an unwarranted
global scare over Wakefield's
unsubstantiated claims and
recommendations, which purported to link
MMR with autism and advised parents to
ask for single vaccines
instead of the three-in-one MMR.
(4) 04.06.98: Wakefield
files anti-MMR claim in full
Under
patent law, applicants have twelve months
before they must publish the full
characterisation of their invention,
which must correspond with the initial
claim. The full Royal Free/Neuroimmuno
Therapeutics patent is filed on 4
June 1998 - just three months
after the press conference - with Andrew
Jeremy Wakefield and Hugh Fudenberg
(misspelt as "Fundenberg")
named as the inventors of a new kind of
single measles vaccine, plus apparently
revolutionary treatments for a disease
and a disorder they allege to be caused
by MMR.
The
patent title is "Pharmaceutical
composition for treatment of MMR virus
mediated disease comprising a transfer
factor obtained from the dialysis of
virus-specific lymphocytes".
It states: "Such a composition may
be used as a measles virus vaccine and
for the treatment of inflammatory bowel
disease and regressive behavioural
disorder." Talk of cures for autism
is found elsewhere in patent documents.
The key date on the document is the
"priority" date (32), which
dates the claim for a vaccine and
treatments to the beginning of June 1997.
There
is a large volume of patent documents,
with minor variations, including those
registered in various
jurisdictions,including the United
States, the European Union, Canada,
Australia and worldwide, at different
dates. Applications continued in the
medical school's name until Wakefield
left its employment in December 2001,
when all rights were transfered to him.
For space reasons, only the title page
and claims section of this UK document
are republished below, with other
extracts republished at this website.
(5) 14.11.04: Royal Free
issues statement on patents
In
response to Brian Deer's inquiries, the
medical school issued the following
statement:
"Universities
in the UK are the owners of any
intellectual property rights
(IPR) derived from work performed
by their staff and have an
obligation to ensure that
intellectual property of
potential commercial value is
properly assessed and if
necessary protected and
exploited.
"After Dr
Wakefield initiated patents in
1997, through a wholly-owned
commercial subsidiary of the
medical school, these avenues
were appropriately
explored. When expert
advice within the school
indicated that the scientific
basis and commercial
exploitability were poorly
sustained, the school’s
claim on the IPR was
relinquished, and all the
school’s rights to IPR
deriving from his work were
assigned to Dr Wakefield when he
left the school.
"Any
implication that the school had a
vested interest in supporting an
attack on MMR and raising public
concerns about its safety,
because it had commercial
interests in the development of a
rival vaccine and in a treatment
for inflammatory bowel disease
and autism, is ill-founded and
wrong.
"The school
never attacked, nor supported any
attack, on MMR. In all its
actions it consistently supported
the continued use of MMR,
including the repeated release of
press statements dissociating
itself from Dr Wakefield’s
comments and publications, urging
all parents to protect their
children with MMR and explicitly
stating that the Lancet paper
did not provide virological
evidence of associations between
inflammatory bowel disease,
behavioural disorders and MMR
vaccine."
In a
statement published on
the worldwide web after Brian Deer's
revelations in the Channel 4 documentary,
Wakefield asserted that the vaccine
claims, revealed above, were "an
afterthought". He said "my
genuine concerns about the safety of MMR
are wholly unrelated to any desire or
opportunity to develop a competing
vaccine". The full first application
is here
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