Martin J Walker MA
An Interest in Conflict?
The
'conflict of interest' policy of the General Medical Council
and
the fitness to practice hearing of
Dr
Andrew Wakefield, Professor Walker-Smith and
Professor Simon Murch.
Introduction
In 2004 Brian Deer, a
Sunday Times journalist who had previously written pro-vaccination articles,
wrote an 'expose' about Dr Andrew Wakefield and his work at the Royal Free
Hospital. Dr Wakefield's work had been criticised by pro-industry scientists
and civil servants since the early 1990's when he raised questions with the
Department of Health (DH) about the relationship between measles virus and
inflammatory bowel disease (IBD).
The cases that had
been referred to the Royal Free Hospital had mainly been referred by parents
who had heard from the media about Dr Wakefield's work. Many of the parents
reported that their children's bowel problems and regressive autism had begun
following their MMR vaccination. In 1998 Dr Wakefield and eleven others
published a peer reviewed paper in the Lancet.[1]
The main focus of the
case review series of 12 children sequentially referred to the Royal Free
Hospital was that the children who all had some inflammatory bowel problems,
had in the main developed regressive autism. Although the paper made reference
to the fact that parents reported the temporal coincidence of the MMR
vaccination, this vaccination and it's effect on children was not reported as a
cause of bowel disease or of regressive autism.
The very mention of
autism and MMR in the same paper, was enough to spark panic in the MMR
manufacturing companies and in the New Labour Government that had underwritten
any costs gained legally by claimants against the MMR manufacturers. On the
publication of the Lancet paper, a
press briefing was held, organised by Professor Zuckerman the head of the
academic unit of the university attached to the Royal Free Hospital. When a
journalist asked what parents might do in the face of the problems described in
the paper, Professor Zuckerman fed the question to Dr Wakefield who answered in
the manner that had been agreed prior to the briefing; he suggested that it
might be wise for parents to return to the single vaccine until research at the
Royal Free was finished.
Some months after the
publication of the paper, the most vitriolic campaign was begun to destroy Dr
Wakefield. This work this campaign came to a climax in 2004. A week after Brian
Deer's 'expose' article on Dr Wakefield appeared in the Sunday Times and on the
instruction of the then Minister of Health, the bones of the article were
submitted as a complaint to the General Medical Council (GMC).
Also in 2004, a legal
action by around 2,000 parents of vaccine damaged children against the
manufacturers of MMR had its legal aid withdrawn. The case had take almost 10
years to prepare and was only months away from it's most important hearing in
court. The withdrawal of legal aid brought about the complete collapse of the
cases. Considering that the New Labour government would ultimately have been
found responsible for compensation pay outs against the British company
involved in the claims (Glaxo Smith Kline), this move was seen by many to be a
defence by the government of it's own interests. Dr Wakefield was scheduled to
appear as an expert witness on behalf of the parents in this case.
The GMC took over
five years to prepare charges against Dr Wakefield, Professor Walker-Smith and
Professor Simon Murch. There were eventually almost 100 charges of dishonesty
and of experimenting on children without ethical committee or parental
authority. These charges were served on the defendants in 2003 and it was
another four years before the fitness to practice hearing began in 2007.
The GMC
fitness-to-practice hearing opened in July 2007 and is still continuing in the
autumn of 2008; it is expected that the hearing will not finish before June
2009. In the meantime and during the preparation of the charges and the
hearing, Dr Wakefield has been subject to a considerable campaign of attacks
and untruthful publicity in the papers, on television and other media, at the
same time the government has moved forward with it's MMR campaign, ignoring any
reports of adverse reactions. In 2002, after all his grants were withdrawn and
his contract was not renewed at the Royal Free, Dr Wakefield went to North
America where he set up a research establishment called Thoughtful House, where
he and others continue the research into the links between measles virus and
regressive autism.
The response to
parents claims of vaccine damage by the major North American and British
pharmaceutical vaccine manufacturers, mirrors the developing strategy used by
the pharmaceutical industry to combat claims for compensation for damage done
by other pharmaceutical products. In North America, claims have been fought
stubbornly in the courts and only when a number of test cases have been
successful have pharmaceutical companies conceded group claims.
In Britain, where no
claim has ever been successful in court against a pharmaceutical company, the
New Labour government has supported the industry in a complete refusal to admit
to the notion of adverse reactions being admitted or actionable. In the case of
the drug Vioxx which was reckoned on the first research to have caused the
deaths of 27,000 users in North America alone and from which Merck were making
$2.5 billion in 2003, British claimants were from the beginning denied legal
aid. As Britain moved into the 21st century, it is becoming clearer that the
pharmaceutical industry helped by New Labour have prepared for a strategy
zero-risk or 100% denial; industry, in order to protect and maximise profit, is
unprepared to admit to the adverse effect of any environmental challenge to
human health.
The case against Dr Andrew Wakefield and the
unit at the Royal Free Hospital, together with the media attack on any other
scientist who referred to the possible role of MMR in autistic spectrum
disorders has been bedeviled by instances of dirty tricks, propaganda and
particularly unrevealed vested interests. This essay looks at the conflict of
interests of the chair of the two year long fitness-to-practice hearing, Dr
Surendra Kumar. The
Panel is the jury in this hearing and all members were chosen by the general
Medical Council which is also the prosecuting authority in the case.
* *
*
Conflict of
interest has become a major area of regulatory, academic and legal concern over
the last decade. Most of the concern has focused on the links between
academics, experts, PR consultants and industry in a variety of legal and
medical fields.[2] The area
today does, however, stretch to the interests of newspaper and television
reports and politicians. To simplify, it is possible to say that conflict of
interest and declaration of conflict of interest, affects, or could affect
anyone who appears to be speaking independently.
Britain has not necessarily been
behind, in grasping the nettle of
declaration of conflict of interest but unfortunately the critical issue
has often been replaced by a rather blasé approach to the whole matter. When I
disclosed that the late Sir Richard Doll, perhaps the world's most famous
epidemiologist[3] had
taken large amounts of undeclared money from Monsanto, whilst working on
studies, and writing critical articles about other epidemiologists involved in
researching chemical causes of cancer, a number of 'eminent' scientists (some
of them intimate with Sense About Science) wrote to the Guardian newspaper
claiming that Sir Richard's research would not have been influenced by such
payments. In relation to pharmaceutical companies and regulatory bodies, it has
now become commonplace to take for granted a wide range of conflicting
interests.
In
1999, the Committee on Safety of Medicines, began publishing edited minutes of
its meetings on its website, including details of any members who declared links with
pharmaceutical companies. This came after a long and tenacious campaign by
Charles Medawar, a conscientious campaigner in relation to antidepressant
drugs. The committee is one of the independent advisory bodies that used to
give advice to the Medicines Control Agency. Under the Freedom of Information
act, Medawar demanded copies of the minutes of committee meetings held
during 1998.The committee refused to give Mr Medawar the information he requested and passed him on to the Medicines Control Agency.
After
an unsuccessful sixteen month battle for information Mr Medawar took his
case to the ombudsman, who ruled that there was no reason to justify withholding most of the information
requested.[4]
In 2002, the Daily Telegraph reported that the parents
of children damaged by MMR were concerned at the links that existed between
members of the Committee on Safety of Medicines
(CSM) and the Joint Committee on Vaccination and Immunisation (JCVI). An article
said that documents produced by two Department of Health committees responsible
for reviewing the safety and efficacy of measles- mumps-rubella triple
vaccine (MMR), revealed that a significant numbers of members have links with
manufacturers of the MMR vaccine. Fifteen of
the 36 members of the CSM have declared personal or non-personal links with
companies cited in a class action being brought by parents who believe
that MMR had harmed their children.
Six committee members had personal shareholdings
and/or held consultancy posts with MMR manufacturer GlaxoSmithKline and
nine have a past or present association, such as receiving research funding
from companies involved. Two members have declared interests in both
categories.
David Thrower, a parent who has campaigned for more
research into MMR, said: 'The tolerance of potential conflicts of
interest in the medical establishment has reached an extraordinary
level, both in terms of the scale of the interests involved and the apparent complete
disinterest of central government in this issue'. A spokesman for the
Department of Health said 'Anyone who declares any sort of interest in the
pharmaceutical industry cannot play a part in any decision relating to
those companies and has to leave the room when the subject arises'.[5]
Glaxo Smith Kline
lead the way in infiltrating organisations, handing out shares and generally
unbalancing the world of medicine and medical research. In April 2007, Bob Fiddaman of 'Seroxat Sufferers' posted this list of members’ interests from the
Committee on Safety of Medicines Annual Report in 2004. Fiddaman opened his
list with these words. 'I've looked through the pdf file for The Committee on
Safety of Medicines Annual Report for 2004 and will show you all those members
who have ties with Glaxosmithkline'. [6],[7]
Member - personal interests:
Professor A Blenkinsopp - GSK specific fees. Professor H Dargie - GlaxoSmithKline consultancy. Dr M
Donaghy - GSK shares. Dr J C Forfar -
GSK shares. Dr R Leonard - GSK fees/publicity work. Professor D J
Nutt - GSK consultancy psychotropics and
300 shares. professor J F Smith - GSK
Consultancy. Professor Christopher Bucke - SKB Shares. professor Nicholas Mitchison - GSK shares. Dr Brian J Clark - GSK
Phd. student funding. Professor Robert Booy - GSK consultancy. professor S
M Cobbe - GSK research grant. professor J E Compston - GSK consultancy. Dr A
Glasier - GSK Shares (£10,000). Dr Andrew A Grace - GSK consultancy. Dr P
Hindmarsh - GSK consultancy on growth. Professor P D Home - GSK consultancy. Dr R F A Logan - GSK Shares. Professor R MacSween - Smith Kline Beecham shares. Professor J
O'DMcGee - Smith Kline Beecham shares.
Professor David R Matthews - GSK
honorarium for advise. Dr A Smyth - GSK conference expenses. Professor A D
Struthers - GSK shares. Professor J C
E - GSK Shares. Dr A gerard Wilson - GSK consultancy. Dr Rosemary leonard - GSK Fees/publicity work. Mr David P S
Dickinson - GSK Fee paid work. Dr
Charlotte C D Williamson - GSK Shares. professor Anthony H Barnett - GSK Advisory work and lectures diabetes
related products. professor V Krishna K Chatterjee - GSK consultancy on preclinical research with a Vanillord Receptor
antagonist (consultancy end of 2004). Professor Albert - GSK Shares.
In the middle of
this discourse about conflict of interests, in 2001, the GMC set up what they
called a Register of Interests, part of which was described as giving access to
the following information:
Consultancies, directorships or advisory positions
relating to any medical, healthcare or pharmaceutical company or organisation,
NHS trust or authority, public body or political party.
This
would appear to cover a great deal of ground in relation to pharmaceutical
companies but in fact it misses out salient matters. Today, the GMC policy on conflict of interests appears to be
half-hearted. At the time the particular
focus was the Masons.
While the
adoption of this policy was obviously a step in the right direction, the rules
made no mention of work done in the past or previous remuneration received from
pharmaceutical companies, nor any mention for instance of the holding of shares in a
pharmaceutical company or a staff post or advisory role on a pharmaceutical
funded journal or for that matter a pharmaceutically funded patient group or
charity. What seems to have been missing was a signed
pro-forma which asked outright for a declaration such as is signed by the
committee membership of the MHRA or the DH. The new policy also appeared to
leave any declaration to the subject themselves.[8]
Being
a Council member or panelist for the GMC carries with it responsibilities.
People working in these roles are expected to act impartially and objectively,
and to take steps to avoid any conflict of interest arising as a result of
their membership of, or association with, other organisations or individuals
... a code of conduct, which includes a requirement to declare relevant
interests, as set out in that code. ... Fitness to Practice panelists must
notify the GMC as soon as possible if they have, or may appear to have, any
interest in or association or connection with any person (whether financial,
organisational
or personal), which may, or does, give rise to a conflict of interest or the
suspicion of a conflict of interest.[9]
As the GMC is
acting as the prosecuting authority in fitness to practice hearings, it would
seem that the primary responsibility for weeding out conflicts of interests lie
with them and not with putative panellists. I say this on the understanding
that industry will always try to infiltrate individuals into positions where
they can affect decisions in their interests. This being the case it seems
naive to allow the onus of responsibility to rest on individual panellist.
In relation to
panel members who might adjudicate in fitness to practice hearings it is
clearly important that all interests which might, however tangentially, have a
bearing on the panel’s findings are declared and stated on the papers for that
particular hearing.
At the bottom of
most vested interests in the field of medicine, are financial associations with
pharmaceutical companies. This is principally the case because it is such
connections that imply real conflicts of interest, where individuals receive
remuneration from the use of, the advertising for, or promulgation of drugs,
procedures or equipment. Of course, direct receipt of money is only half the
story because the promulgation of allopathic medicine itself can be a point at
issue in some GMC cases.
While looking at this matter, it might be wise
to ask ourselves why there is a need for this kind of transparency at the GMC,
especially in relation to Fitness to Practice panel members. The great majority
of cases that come before the GMC originate with patients, and complaints about
the way that they have been treated by doctors. Inevitably it would rarely be
the case, except on the level of personal association, that conflicting
interests were an issue in these cases. However, a small number of cases are
brought over issues of scientific research and issues around non-allopathic
therapies. Some of these cases entail questions of importance about the
competitiveness of pharmaceutical products and while the pharmaceutical
companies should be commended on cleaning up corruption - for instance doctors
who rig the results of drug tests on patients - in their industry by using the
GMC, there are clearly cases which they support for the sole reason that the
accused are people who challenge the pharmaceutical industry.
In all these cases the ABPI (Association of
British Pharmaceutical Industry) has its own 'police force' and investigators
who work with the GMC preparing cases; the company Medico Legal Investigations.
In relation to cases brought by the pharmaceutical industry against doctors
challenging it's competitiveness, it is clearly important that the integrity of
the hearing is not compromised by individuals who have vested or conflicting
interests. Of course many people would go much further than this and suggest
that the GMC should not be publicly washing the dirty laundry of the
pharmaceutical industry; that it should police itself and its own employees but
not be able to become involved on any level in bringing any kind of case
through the GMC against doctors who are directly working for them.
Obviously in any case that is brought by the
GMC having come from an outside body, rather than an individual patient or
group of patients, the onus on the GMC to investigate and then try this issue
and the people involved is considerable. Members of panels hearing cases which
even tangentially involve the pharmaceutical industry, should have absolutely
no connection with that industry. This is not something which should be open to
debate or polite discussion, the matter is clear and fundamental; in the case
of anyone brought before a GMC fitness to practice panel, whose case is even
tinted with pharmaceutical company involvement, in the substantial matter of
the case, in the investigation of the case outside the GMC or in the bringing
of the charges, the panel that 'judges' the case must be absolutely free of any
influence from pharmaceutical companies. As well as panel members clearly
stating their interests and them being printed and made public in detail, all
prosecution witnesses should, be
required to state their interests before giving evidence.
This matter might also be raised with the GMC
in relation to the very structuring of their prosecutions, for while some of
them are handled solely by in-house lawyers, a small number are put together by
Medico Legal Investigations working with the GMC. It has always been one of the
foundations of justice in European countries that the accused is aware in
detail of those making the accusation and with whom the prosecution originates.
It is of vital importance to the case for the defense that they have detailed
statements with regard to this aspect of the charges.
Clearly
statements of interests are relative, and while some interests might even
potentially aid justice in one hearing, those same interests might seriously
hamper justice in another. Take for example, a panel member working in some capacity for the
Department of Health (DH). While this would definitely be an interest that had
to be taken into account if the case in question involved issues upon which the
DH had very definite policies, it might not be a relevant if the issue at
hearing was something quite personal to the defendant such as sexual assault.
The
case of Dr Andrew Wakefield has been bedeviled by instances of unrevealed
vested interests, a number which have been investigated and written about by
John Stone, the father of an autistic child.[10]
It might of course have been expected that a case involving vaccines produced
by the largest pharmaceutical company in the world would inevitably draw its
unfair share of vested interest situations, especially because Glaxo SmithKline
appears to be taking over the world at the moment.
·
Brian
Deer, the journalist who tendered the initial complaint to the General Medical
Council, is described on his web site as a journalist who investigated claims
made by parents of vaccine damaged children. He has written a number of
articles in defense of vaccines manufactured by GSK and was aided in his research into Dr Wakefield
by Medico Legal Investigations, a company that is completely funded by the
Pharmaceutical Industry.[11]
There are clearly matters of conflict of interest here, even in the initial
stages of the prosecution.
·
Brian
Deer disclosed in his main Sunday Times article about Dr Wakefield,[12]
after he had presumably spoken to him, that the then Minister for Health, John Reed
had called for the 'case of Dr Wakefield' to be referred to the GMC. Given that
Dr Wakefield's research suggested a link between MMR and Inflammatory Bowel
Disorder (IBD) and a putative link between measles virus, IBD and states of
regressive autism in a sub-set of children and given that the New Labour
government had underwritten any costs against GSK claimed in damages for
adverse reactions caused by the MMR vaccination, Reed's shunting of Dr
Wakefield's case into the GMC represents the most serious conflict of interest
and manifest corruption.
·
In
2007, it was revealed that the Chair of the Panel for the Wakefield hearing, chosen by the GMC, was Professor
Dennis McDevitt. Just before the hearing began Professor McDevitt was
challenged by parents over undisclosed interests when previously unseen minutes
of a meeting revealed that Professor McDevitt had been present at the 1988 JCVI
meeting that approved Pluserix-MMR as safe for a product license. McDevitt
continued to sit on the JCVI through 1991 when SKB were forced to withdraw
Pluserix after serious adverse reactions were reported in a number of
countries.
·
In 2004, the High Court Judge Sir Nigel Davis, in a
closed hearing, rejected the appeals made on behalf of vaccine damaged children
whose legal aid had been withdrawn for a coming court case, which would
ultimately represent some 2,000 cases. Weeks after this decision had been made,
John Stone reported that the Judge had failed to disclose that his brother was
a non-executive board director of GSK, defendants in the case. The case had
been in progress for nearly ten years and was only months away from it's
hearing in the High Court. The science lobby groups funded by the drug
companies and especially Lord Dick Taverne the founder of Sense About Science
and previously a major PR handmaiden for the pharmaceutical industry had
campaigned heavily to get legal aid taken from the parents. After John Stone
publicised the conflict of interest, Brian Deer accused him of being 'cruel' to
the scions of the Davis family.
·
During Dr Wakefield's defense case the fact that
Richard Horton's line manager at the Lancet,
the Director of the Elsevier publishing company, was also a non executive
director of GlaxoSmithKline, was reinforced. Dr Horton gave evidence claiming
that Dr Wakefield had failed to provide him with evidence of his conflict of
interest in relation to money that the Legal Aid Board had granted the Royal
Free Hospital. This evidence did not appear to coincide with the historical
record.[13] Dr Horton made no declaration at the
beginning of his evidence that he was on speaking terms with one of the GSK
directors or indeed that such a person acted as his line manager at the Lancet.
·
In April 2000, the Scottish
Parliament responded to the campaigning on MMR safety organised by Bill Walsh a
relative of a vaccine damaged child who had set up the Autism Trust in
Scotland, by setting up an 'Expert Group'. This apparently independent Expert
Group was initiated by the Scottish Parliament’s Health and Community Care
Committee. Walsh researched the group and
found that it was 'packed with placemen and featherbedders'. He writes now,
'the Expert group's conclusion was, I now realise, a foregone
conclusion. The chairman of the group was an Episcopalian minister. I outed the
priest in the media as having a conflict of interest (shares) and did
the same to a number of others.' However, it made no difference to the end
result; the group decided that MMR was safe and no changes would be made in the
vaccine policy.'[14]
Dr Surendra Kumar
Dr Kumar is the Chair
of the GMC fitness to practice Panel hearing the case of Dr Wakefield,
Professor Walker-Smith and Professor Simon Murch. He was chosen by the GMC as
Chair following the 'stepping down' of the previous incumbent, Professor Dennis
McDevitt who had been exposed by parents of vaccine damaged children as having
serious conflict of interests. The full panel consists of five members, three
'medical' members and two lay members; they are aided by a legal assessor Mr
Nigel Seed who is a QC and a Recorder. There is no conflict of interest
information annexed to the papers which name the Panel and describe the charges
against the three defendants.
For anyone who takes
the trouble to go to the GMC web site and look at the declarations of putative
panel members, they can ascertain that Dr Kumar is connected to the following
organisations:
Principal General
Practitioner. President, British International Doctors Association (formerly
ODA). Interests: Medical Defense matters & Medico-politics. Member:
General Practitioner's Committee (BMA), UK National Screening Committee (Dept
of Health). Fellow: Royal College of GPs (FRCGP). Fellow BMA. Member
Independent Review Panels of MHRA (Medicine & Health Care Regulatory
Agency). Member of Clinical Executive Committee (CEC) of Halton & St Helens
PCT. Member of Medical Protection Society.
I want to make clear
from the start of this analysis of what I have called Mr Kumar’s 'vested
interests' that almost the sole responsibility for this state of affairs lies
with the GMC. I have no evidence at all to suggest that Mr Kumar himself has
been responsible for trading on any vested interests he might have and which
have not been disclosed by the GMC. The great bulk of Mr Kumar's disclosed
public work show him to be a dedicated and hard working doctor who is much
concerned with local, national and indeed international medical matters.
However, being the fair minded and honourable man he appears to be, I am sure
that he would not be happy to keep the following matters undisclosed in the
context of the particular 'fitness to practice' panel which he presently
chairs.
It was very
noticeable that at the beginning of this hearing in 2007, there was no
structured mechanism for introducing conflict of interest information, all of
which should have been provided by the GMC. Mr Kumar did make a point of
telling the hearing, in general terms and quite hastily, that he has previously
sat on committees that were part of the Medicines Control Agency (MCA).[15]
It also has to be said that at any point in the hearing when a named person
known to Dr Kumar, or a particular place of work, has cropped up, he has
immediately told the hearing that he knew or had worked in the vicinity of this
person or this location.[16]
It goes without
saying that the GMC, the prosecuting agency in this case was duty bound to
summon all its resources in testing all panel members in this hearing in great
detail in order to discover and make public any possible conflicts of
interests. This was inevitably the case after the debacle of Professor McDevitt
and the other circumstances of interest conflict that have come to light,
especially in relation to GlaxoSmithKline (GSK) in its present and previous
incarnations. It has also to be stressed, that from the beginning, the case
against Dr Wakefield has been perhaps the most contentious scientific and
medical case in Britain in the last half century. In this case, it was
obviously important for the GMC to consider, first, the current discourse in
Britain and the US about conflict of interests and second, the ironic fact that
non-declaration of vested interests in the mid nineties in Wakefield's peer
reviewed Lancet paper is one of the
most serious charges leveled against Dr Wakefield.
In looking at what
might be considered Dr Kumar's vested interests that might have been declared
at the start of the Wakefield, Murch and Walker-Smith fitness to practice
hearing, I will concentrate on four areas; his previous involvement with the
GMC, his work on two committees of the MHRA, his work for the Department of
Health, his work as Chairman of the British International Doctors Association
(BIDA -previously the ODA), and the previously declared information about his
shareholdings in GSK
The GMC
Dr Kumar has been a consistent activist within
the GMC between 1999 and 2003 and has, as he makes clear in his list of posts
and affiliations on the GMC site, prior to 2004 been a GMC council member and
served on the following committees; the 'registration committee', the 'health
committee', the 'professional conduct committee', and the 'racial equality and
diversity committee'. As an Associate of the GMC since 2003 has also been a
panel member on 'fitness to practice' hearings.
In this highly
sensitive case in which the General Medical Council is the prosecuting
authority - although Dr Kumar's
committee experience falls conveniently one year short of 2004, the time when the complaint was laid
against Dr Wakefield et al - we have
to consider, whether being so intimately involved with the business of the GMC
it is possible that he has not been au
fait with the GMC's position on the prosecution of Dr Wakefield. His choice
as Chairman is in effect no different from the Crown Prosecution Service
ensuring that it gets one of its staff on a jury in a criminal trial.
The
MHRA
Since the late 1990s Mr Kumar has been involved in two
British medicines regulatory bodies, the Medicines Control Agency (MCA) and its
main committee, the Committee on the Safety of Medicines (CSM). The MCA became The
Medicines and Health Care Regulatory Agency (MHCRA) and in 2005 the CSM became
the Commission on Human Medicines. Although it is quite difficult to back track
and gain a record of the participants on this and other similar committees, Mr
Kumar can be found to be definitely on the CSM in 1998 and this is probably the
committee membership that he alluded to at the beginning of the hearing[17]
This committee discussed the safety of drugs and vaccines.
Following the restructuring of the MCA after it became
the Medicine and Health products Regulatory Agency (MHRA), Dr Kumar began sitting on two of this bodies most
influential committees. The Independent Review Panel for Advertising
(IRPA). and the Independent
Review Panel for Borderline Products (IRPBP). [18] Both the
advertising of pharmaceutical products and the definition of what is a medicine
are two of the hottest topics presently involving pharmaceutical companies in
Britain and the first group is certainly relevant in relation to the
advertising of MMR. Meetings of both groups are held, in
virtual secrecy at the headquarters of the MHRA, in Nine Elms, South London.
The Independent Review Panel for Advertising,
primarily considers
written representations from pharmaceutical companies as to the conformity of
their advertising and promotional material with the Regulations, and to advise
Health Ministers on the conformity of advertising and promotional material with
the Regulations before a final decision is made by Health Ministers.
Both
the IRPA and the IRPBP has a policy of members declaring personal and non-personal interests.
The latest declaration of interests that can be found on the internet for both
these committees are for 2004 and 2005.[19]
It is frequent and common practice with both the MHRA and the DH, that they let
site access to declared interests lapse over relatively long periods.
In
the years 2004 and 2005 Dr Kumar, in the declaration of interests demanded by
these two committees, makes known shareholdings in GSK, although the number and
contemporary value of these shares is not stated. Of the ten members of IRPBP,
six had share holding in pharmaceutical companies, while five held GSK shares.
In 2005, the committee consisted of only five members. Three of these had
shares in pharmaceutical companies, Dr Kumar logged personal and non-personal
interests in four companies, including GSK. Two other members declared
interests in GSK, besides Dr Kumar. [20]
The IRPBP is an important committee within the
MHRA. The committee decides which
treatments are considered medicines and which are not allowed to call
themselves medicines. In terms of pharmaceutical industry competitiveness, this
committee is central. One of the issues in the fitness to practice hearing held
for Dr Wakefield et al, involves the
use and prescription of Transfer Factor. I do not know whether this product has
at any time been discussed by the IRPBP.
Dr
Kumar made a declaration for the IRPBP in 2004, however, it is not possible to
gain information of members interests on this committee after that date. There
are five members listed for this committee and two members, including Dr Kumar
have interests in GSK amongst other pharmaceutical companies. Two other members
have interests in alternative health companies.[21]
Membership of
committees overseen by the MHRA, and membership of previous committees overseen
by the MCA, raise considerable questions about conflict of interests,
independence, loyalty and truth. On
hearing of the MHRA for the first time, it might seem to many people that the MHRA
is a 'normal' government regulatory agency. Few people would guess that the
MHRA, while being the most important regulatory body for medicines in Great
Britain, the organisation which, for example, processes Yellow Cards that
notify the DH of averse reactions to drugs, is actually a trading company completely subsidised by the pharmaceutical industry.
The history of the medicines regulatory agencies in Britain is a
story of how the medical chicken crossed the road, from government
participation and control of regulation to total immersion in the
pharmaceutical industry. Thalidomide provoked drug regulatory legislation in
many countries. In Britain, the Medicines Act was published in 1968, originally
this Act was prosecuted by the Medicines Division of the Department of Health,
and it was not until 1989, that the regulation of pharmaceuticals was given its
own agency, the Medicines Control Agency (MCA). However, the Medicines Division
of the DH, even within its short life, became notorious for its ‘revolving
door’ approach to staff; long serving pharmaceutical executives happily swapped
jobs with top civil servants ensuring a continuity of protection for the
industry.[22] This
revolving door philosophy has continued throughout the latter development of
the regulatory agencies, until in fact with the MHRA the revolving door has
spewed out the whole department into the foyer of the pharmaceutical industry.
The MHRA took over from the MCA in 2003. The MHRA is a Government
Trading Fund; it might just as well be called a business or a corporation. A
Trading Fund is an almost entirely separate economic entity which earns money
by the provision of services and like any kind of company, it must balance the
books at the end of each year. A trading fund is a government department, or an
executive agency or part of the department, which has been established as such
by means of a Trading Fund Order made under the Government Trading Funds Act
1973 (as amend the Government Trading Funds Act 1973, 26th July 1990). Typically,
trading funds operate in very specialised fields and rely on their ability to
derive income from their activities in order to cover their costs. Examples of
trading funds are the COI and Ordnance Survey.
However, unlike a number of other Government Trading Funds, which
provide services, earn money and accept fees from diverse ‘beyond government’
sources, the whole of the MHRA income is provided by one funder; the
pharmaceutical industry. Further, a percentage of staff and executives of the
agency, have come into it from the pharmaceutical industry. It is therefore not surprising, that funded
and partly staffed by the industry, its policies are shaped to please this
sector.
The MHRA has the largest policing and enforcement department of any
European medicines regulation agency, a part of the Enforcement &
Intelligence Division (E&ID) of the Agency. Although contemporary
government in Britain is characterised by quangos, and the attachment to
Government of private vested interests, the MHRA is, as has been explained
above, a business in itself which makes profit from the provision of services
to the pharmaceutical industry. Inevitably there exists a high level of
cynicism and some anger in the world of alternative medicine that, in effect,
non-pharmaceutical treatments, which have not on the whole been proven harmful
and against which no complaint has been levelled, are now regulated by a
commercial concern which is managed, staffed and funded by the pharmaceutical
industry. The cynicism is inevitably greater amongst those who realise that the
pharmaceutical industry are also charged with overseeing the adverse reactions
of their own medicines, which kill and maim many thousands of people.[23]
From a legal point of view, perhaps the most worrying aspect of the
MHRA, is that like the Atomic Energy Authority,[24]
it has its own police force, in this instance, paid for by the pharmaceutical
industry. The two Divisions of the MHRA which are important in relation to the
tracking of supplements and compliance and legal enforcement are firstly, the
Medicines Borderline Section and the Enforcement and Intelligence Group, which
gathers information on individuals who promote 'suspected medicines'.
The Group raid premises, make and take statements and confiscate
products, computers and paper work. Although they are not police officers they
can obtain warrants for raids from Magistrates and Judges. Enforcement often
links up with Trading Standards Officers in local areas. ‘Officers’ in the
enforcement group have their own powers conferred by the Medicines Act 1968 and
subordinate legislation applying to the Act. These powers include the right to
enter any premises to inspect, to take samples, to require production of any
books or documents and to take copies of, or of any entry in, any such book or
document. ‘Officers’ are bound by the Police and Criminal Evidence Act (PACE)
and PACE codes of practice. It is a criminal offence to obstruct an enforcement
officer. However, this particular police service stands well outside the minimal,
discursive apparatus of accountability which exists either within the London
Boroughs or at County Police Committee level outside London. These enforcers
are literally a law unto themselves – or more specifically, the law of the
pharmaceutical companies.
When considering conflict of interests, the workings of the MHRA
have to be seen in light of the fact that the agency is completely beholden to
the multinational pharmaceutical industry.
The Department of Health
Dr Kumar sits on the UK National Screening Committee
that is chaired by the Chief Medical Officer for Scotland and advises Ministers
and the NHS in all four UK countries about all aspects of screening policy and
implementation. Screening programmes are of immense importance to the contemporary
drugs industry as the present embittered battle over the Gardasil vaccine
against human
papillomavirus (HPV) for pre-pubescent girls is showing. This of course is
in no way a reflection of Dr Kumar's work on this committee but I have pointed
to this to show how in certain circumstances the NHS can be deeply involved
with the pharmaceutical industry.
The most
important fact about Dr Kumar's involvement on this committee is that it shows
his access to the NHS and the Department of Health at a relatively high level. The Department of Health has been at the very forefront of the
battle against Dr Andrew Wakefield. Even the lowest grade officers in the
Department toe the government line. Anyone seeking information about MMR from
the DH web site, is directed through links to Brian Deer's web site and,
apparently speaking for the New Labour government and the Department of Health,
Deer gives his version of the crimes of Dr Wakefield. The DH gives no links to
other web sites of a similar kind and there is not the slightest attempt at
balance.[25]
If you go
to 'MMR the facts' and put Brian Deer in the search box, the site will serve
you 50 items which mention Deer's work. The first item is this:
'MMR news:14-Nov-04:
Sunday Times: MMR scare doctor planned rival vaccine, Doctor whose work provoked a worldwide scare
over MMR failed to reveal that he was developing his own commercial rival to
the vaccine.' 'MMR scare doctor planned rival vaccine, Sunday Times - Brian Deer. 'It has emerged that
a patent was filed on behalf of Dr Andrew Wakefield for a measles vaccine and
other products that would have stood a better chance of success if public
confidence in MMR’s safety was undermined. To read the full Brian Deer article in the
Sunday Times, please visit Times Online'.
Now
the fact is, this story is not true. Of all the allegations made by Brian Deer,
this is surely the most apparently prejudicial. The competitive vaccine was
Transfer Factor which Dr Wakefield experimented with in the hope that it might
help children overcome serious adverse reactions to MMR. The GMC enquiry, was
so little enamoured of this 'evidence' that it dismissed it almost entirely,
concentrating instead on whether or not Dr Wakefield, or either of the other
two defendants were acting ethically in prescribing Transfer Factor to one
particular child who had been referred to the Royal Free hospital by his GP.
The child was suffering from gastrointestinal problems that, his parents
reported, had begun immediately after he received the MMR.
If you move on past Deer into the DH MMR site,
everything becomes vaguely hilarious. It sights under its MMR research
time-line, first the Lancet paper.
You are prepared for this paper by a refutation of it by Professor Simon Murch,
one of the defendants in the ongoing Fitness to Practice Hearing.
The overwhelming weight of
evidence shows that MMR is the safest way to protect against measles, mumps and
rubella, and the number of studies demonstrating this is growing.
A list of the key studies
looking at MMR are listed below.
In November 2003 Dr Simon
Murch – one of the authors of the 1998 paper (Wakefield A J et al) suggesting a
possible link between MMR and autism - stated in a letter to the Lancet that there is now 'unequivocal' evidence that there is no
link between MMR and autism.
This
first citation of the Lancet paper,
which is incidentally headed 'Research suggesting link between MMR and autism' is then followed by pages of
references headed 'Key research showing no link between MMR and autism' - LOL! The
first page has 12 citations.
If you travel to Brian Deer's web site through
'MMR News' you will find an analysis of the Lancet paper by Professor Trish
Greenhalgh. This off the cuff analysis repeats almost word for word the
prosecution case put by the GMC. As anyone who has been following the GMC
hearing will know, the GMC prosecution, fell hook, line and Murdoch owned
Sunday Times for Deer's story that had been concocted with the help of
Medico-Legal Investigations. This fable suggests that the Lancet paper case-series review, is in fact a failed full blown
research project organised to prove that MMR causes autism in all vaccinated
children.
Greenhalgh's
explanation of the Lancet paper[26]
is quite extraordinary in that it follows Deer's line rather than the paper
itself. To be fair to her perhaps she hadn't read the paper or perhaps she's an
absent minded professor.[27] It is worth quoting some of Greenhalgh’s
sentences because they give a very clear view of how Dr Wakefield's detractors
from the beginning, tried to portray the Lancet
paper as the record of a full blown study, rather than a short 'case series
review'. It also gives us an insight into the case that the GMC is prosecuting
and how this case is broadcast by the DH.
Readers of the
passages below, should bear in mind that Dr Richard Horton, the editor of the Lancet contended in his evidence to the
GMC hearing, that the Wakefield paper was an excellent piece of scientific
reporting of a new syndrome. He compared it to early case reviews of aids
related illnesses, where various scientists and doctors had attempted to trace
the aetiology of the illness and detail a new diagnostic pattern. In Horton's
opinion there was absolutely nothing wrong with the science in the paper, which
was in his opinion only let down by Wakefield's lack of declaration of conflict
interest; that being money which he did
not receive from the Legal Aid Board.
If
the hypothesis was that there is a causal link between MMR and autism-bowel
syndrome, this study design was incapable of proving that link one way or the
other. [28]
This was not the hypothesis that the paper tested, in
fact the paper did not test a hypothesis, it reported on a series of cases.
The
sample was highly selected – that is, the authors deliberately picked out the
tiny number of children who had been referred to a major specialist centre
because they had both bowel symptoms and an autism-like syndrome. So the fact
that these rare conditions occurred together proves nothing at all.
There was no sample, just 12 consecutively referred
children who seemed to have similar gastrointestinal symptoms and a regressive
autistic disorder.
The
fact that children with diarrhoea or other chronic gastro-intestinal symptoms have
microscopic evidence of inflamed bowels is also, in itself, unsurprising.
This is an absolutely amazing statement because it
echoes in every nuance the words of the prosecutor Miss Smith. It is in effect
what the prosecution have based their whole case on and the main reason why
there has been no chance for the parents to give evidence; because they would
argue that this was not a true picture of their children's illnesses. And let's
not forget, that the evidence of inflamed bowels was at the time given and is
at the hearing being given by one of Europe's most experienced specialists,
Professor Walker-Smith. With 40 years paediatric work under his belt he might
just have more experience of these things than the newspaper reporter Deer and
the academic scientist Greenhalgh.
The
sample was extremely small. I would expect a scientific study claiming a causal
association between two events (in this case, giving MMR vaccine and developing
autism-bowel syndrome) to have a formal statistical calculation of the number
of individuals that ought to be looked at. This is known as a power
calculation. The reason why the Lancet
does not normally publish studies on just 12 individuals (the usual number of
research participants is several hundred, and not uncommonly, several thousand)
is that the smaller the study, the more likely it is that an apparent causal
link will turn out to be due to chance association.
The Lancet
paper did not set out to prove a causal link between MMR and autism or anything
else. It was a case series review which reported on 12 consecutively referred
children.
I'm afraid that we have to leave Brian and the Prof.
here because I am getting upset and we are drifting off the point of this
essay. Hopefully the above demonstrates how the NHS and DH vaccination sites
slavishly follow the prosecution line in the Wakefield story and how any
attempt to reason with them or engage in a dialogue that might uncover the
truth would be as the younger generation say, well pointless. We have to ask
ourselves whether or not a man working closely with the DH and NHS could remain
unaffected by this propaganda.
To show how far up the system this honesty paralysis
goes, we might quote John Stone:
After
the publication his (Brian Deer's) story the Chief Medical Officer, Sir Liam
Donaldson remarked to the BBC Today Programme (23 February 2004): 'Now a darker
side of this work has shown through, with the ethical conduct of the research
and this is something that has to be looked at'. On the same day the Prime Minister
said to ITV: 'I hope now that people see the situation is somewhat different
from what they were led to believe'.[29]
BIDA
Since 2002 Dr Kumar has been the National
President of the British International Doctors Association (BIDA). Prior to
that he was, from 1990-1996, the General Secretary of the organisation.
BIDA
was established in the United Kingdom with the objective of promoting the
medical, dental and allied sciences. The main objectives of BIDA are: to
protect and promote the interests of Ethnic Minority Doctors and Dentists
working in the United Kingdom, to highlight the current issues and problems
facing ethnic minority doctors and dentists, to grapple with all issues that
effect ethnic minority doctors and dentists and to promote better representation
of ethnic minority doctors and dentists on medical and national bodies.
However,
what doesn't become clear on the BIDA web site unless you look closely is the
fact that the organisation is funded not only with membership fees but also by
pharmaceutical companies. BIDA's magazine is also subsidised by drug company
advertising. This information is declared by Dr Kumar in his conflict of
interest declaration for the MHRA and no doubt would have been for the GMC had
they a thorough policy on conflict of interests.
GlaxoSmithKline
During 2003, 2004 and
2005, that is for at least two years after the complaint was made against Dr
Wakefield, Dr Kumar held shares in GSK. These shares are only traceable up
until 2005 because after that year, as often happens, the MHRA has failed to
post any information about the committees on which, Dr Kumar, amongst others,
sits.
Not only is it the
case that anyone adjudicating in the Wakefield fitness to practice hearing has
the power to raise or lower the price of the shares, there is inevitably a
question that has to be answered about the individuals commitment to that
company and how they came by these shares; it is well known that shares are
GSK's considered method of payment for work done for the company.
Clearly this matter
should have been cleared-up with the requisite declarations before the
beginning of the GMC hearing. It could, however, be the case that Dr Kumar has
got rid of his shares in the last three years. Although this would not exempt
Dr Kumar from a declaration about those shares, I am sure that a clear
statement from him to this effect would go some way towards satisfying those
critical of this GMC prosecution. Other matters will of course remain and
perhaps an inquiry into the other matters raised in this essay might be settled
by an independent investigation into how it was that both Professor McDevitt
and Dr Kumar came to be selected as
Chairmen for this particular fitness to practice hearing.
Posted: September
9, 2008
Scienza e Democrazia/Science and Democracy
[1] Ileal-lymphoid-nodular hyperplasia,
non-specific colitis, and pervasive developmental disorder in children. A J
Wakefield, S H Murch, A Anthony, J Linnell, D M Casson, M Malik, M Berelowitz,
A P Dhillon, M A Thomson, P Harvey, A Valentine, S E Davies, J A Walker-Smith. The Lancet, Volume 351, Number 9103 28 February 1998
[2] Hardell L, Walker MJ, et al. ‘Secret ties
to industry and conflicting interests in cancer research’ Am J Ind Med 2007 50:227-233
[3] Walker, M J. Sir Richard Doll: Death, Dioxin and PVC. published on the
Science and Democracy site http://www.dipmat.unipg.it/~mamone/sci-dem/sci&dem.htm.
[4] BMJ
1999;319:939 ( 9 October ) CSM takes small step towards openness Jacqui Wise , London.
[5] Parents unhappy with MMR safety experts'
links to drug firms. Lorraine Fraser, medical correspondent (filed:
25/08/2002).
http://www.telegraph.co.uk/news/main.jhtml?xml=%2Fnews%2F2002%2F08%2F25%2Fnm
mr25.xml
[6]
http://fiddaman.blogspot.com/2007/04/committee-on-safety-of-medicine-gsk.html
[7] Similar information from a wider group of
organisations dated at 2006, can be found in David Thrower's excellent unpublished
manuscript, MMR Vaccine, Thimerosal and Regressive or Late Onset Autism: A
Review of the evidence for a link between v.accination and regressive autism.
England 2006.
[8]
http://www.gmc-uk.org/about/register/panellists.asp
[9] Email to the
author from Sarah Crack, Media Officer, General Medical Council. 28th August
2008.
[10] Silenced
Witnesses, Slingshot Publications, London 2008.
[11] See, Walker, Martin J. The Complainant,
Brian Deer, the ABPI, Medico Legal Investigations and Dr Andrew Wakefield.
Martin Walker, 2007. www.cryshame.com.
[12]
http://briandeer.com/mmr/lancet-greenhalgh.htm
[13] Last year it was also revealed that the
present editor of the New England Journal of Medicine had share holdings in
Glaxo Smith Kline.
[14] The Scottish Parliament’s Health and Community
Care Committee, Expert Group, reporting in March 2001.
[15] As related below, in 2003, the Medicines
Control Agency (MCA) became the Medicines and Healthcare products Regulation
Agency (MHRA).
[16] This practice coincides with a note about
spontaneous declaration that I was sent by the GMC after making an equiry about
their policy:
There are,
however, occasions relating to Fitness to Practise hearings when a conflict, or
potential conflict, of interest may arise and which would not be recorded in
the Register of Interest. This would include occasions where the doctor
appearing before the panel, or a witness, was known to one of the panellists or
where one of the panellists had prior knowledge of the events that led to the
doctor's appearance before the panel. You will appreciate it is impossible to
list such conflicts in the Register of Interests. The procedure on those
occasions is that panellists are required to declare those interests as soon as
they are aware of them. Panellists are usually able to declare such interests
in advance of the start of the hearing but there are instances where conflicts
only become apparent during the course of a hearing e.g. as the evidence is
adduced or when a witness is called.
[17] 1998
SUMMARY OF THE MEETING OF THE COMMITTEE ON SAFETY OF MEDICINES HELD ON
11th FEBRUARY 1998.
[18] The Medicines (Advertising and Monitoring of
Advertising) Amendment Regulations 1999, SI No. 267, came into force on 5 April
1999 and completed the implementation of Directive 92/28/EEC Regulation 13 and
the Schedule contain a procedure for a review of the Health Minister's
preliminary decision on whether an advertisement complies with the Medicines
(Advertising) Regulations 1994, as amended ("the Regulations"). The
Health Ministers proposed that the review will be undertaken by an Independent
Review Panel.
[19] 15 Jul 2004 Independent Review Panel for Advertising. Latest documents for the Independent
Review Panel for Advertising
[20] 2005. Independent Review Panel for
Advertising: Declaration of members current personal and non-personal
interests.
http://www.mhra.gov.uk/Committees/Medicinesadvisorybodies/IndependentReviewPanelforAdvertising/AnnualReport/index.htm
[21] Independent Review Panel for Borderline
Products Declaration of Interests
PERSONAL INTERESTS
NON-PERSONAL INTERESTS.
http://www.mhra.gov.uk/Committees/Medicinesadvisorybodies/IndependentReviewPanelontheClassificationofBorderlineProducts/index.htm
[22] In another context, that of testing drugs
in North America, Monsanto engineered one of their top executives into a
regulatory post just for the duration of a drug trial which tested one of their
drugs, after which he left and returned to the company.
[23] The initiation of legal cases against
pharmaceutical companies for death and damage, is in Britain a matter of civil
claim, for which legal aid has to be provided, while prosecution for the use or
misuse of alternative treatments which have been labelled as medicines, even
without any complaints of death or damage, is a criminal matter prosecuted by
the MHRA.
[24] Other agencies such as London Underground
and British Rail have their own police service, but here these officers and
these laws are on the whole general criminal matters such as theft and assault
and the officers in these forces act with the national police in all matters.
The police of the AEA and the MHRA, not only have considerable power, but they
are in specialised areas normally not traversed by the accountable
constabulary.
[25]
http://www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/index.htm
....to.... MMR Explained ... to... http://www.mmrthefacts.nhs.uk/
[26]
http://www.mmrthefacts.nhs.uk/search.php?keywords=Wakefield
[MMR
news]: Analysis of the 1998 Lancet Wakefield paper
Professor Trisha Greenhalgh explains why the Wakefield
1998 Lancet paper should never have
been published on scientific grounds.
[27] http://briandeer.com/mmr/lancet-greenhalgh.htm
Full investigation available
at:
http://briandeer.com/mmr/lancet-summary.htm
[28] http://briandeer.com/mmr/lancet-greenhalgh.htm
[29] cited
by John Stone in his bmj response: http://www.bmj.com/cgi/eletters/328/7438/528#56300