http://www.bmj.com/cgi/eletters/323/7317/838#EL11
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Electronic responses to:
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PRIMARY
CARE Tom Heller, Dick Heller, Stephen
Pattison, and Tom Heller |
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Electronic letters published:
![[Read letter]](./ElectRespEthicalDebateMMR_files/image007.gif){kind=small}
Dogma Based Medicine
David Parry (12 October
2001)
MMR: Caught betweeen
stools
Richard Fry (12 October
2001)
Quality of the evidence
for the safety of MMR
Nigel Calvert (12
October 2001)
Comments on two points in
ethical debate on MMR vaccination
James A. Kaye (12
October 2001)
Selected information?
Lilian Somers (13
October 2001)
Competing interests and
vaccine research
Adam Finn (14 October
2001)
No financial incentive for
vaccination
lehmann christian (14
October 2001)
Why not allow single
measles vaccine?
Dr Michael Jarmulowicz
(14 October 2001)
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David Parry, Send response to journal: Email David Parry: |
I sympathise with Dr. Hellers dilemma. Of course, uncertainty is the
defining feature of science as compared to many other belief-systems. It is
necessary to be uncertain, to devise questions, to attempt to answer them and
to understand the limits of those answers to be able to do science. Since
complete knowledge is never attained, then doubt is always present. This is
in contrast to a "revealed truth" which may obtain in religion.
However I feel that Stephen Pattison's comments include a particularly cheap
jibe. The comment about the financial inducements to GP's attempts to
introduce the concept that GP's are just keeping quiet because they get paid
more if the vaccinations are up-to-date. My experience is that GP's hold the
welfare of their patients above the (fairly small) amounts that are offered.
There is also the implication that these payments are somewhat secretive and
hence reprehensible. Presumably if there was a massive revival in religous belief, then Stephen
Pattison's department would get bigger and he would get paid more - does this
mean that any exhortations he may give to allow religous aspects to be
considered mean he is trying to feather his own nest ? I think not and I
think he should extend the courtesy to others. Finally, there is a regrettable confusion between science and policy. The
whole point of evidence based medicine ( as opposed to say dogma based
medicine or rumour based medicine) is to understand how much is known and
with how much accuracy. Just because the govt. policy coincides with the EBM
view in this case doesn't make the evidence any more or less convincing, or
worthy of being followed. Many anti-rationalists seem to belive that science
is just a big book of facts, believed by scientists - in fact it is a
process, in which any fact or theory is always up for challenge. Faith is
always more convincing than evidence because evidence always has to
acknowledge the limits to certainty. I agree with the final quotation, but I would emphasise that the state is
composed of all those other people who have faced this issue, and their
rights are just as important. |
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Richard Fry, Send response to journal: Email Richard Fry: |
Heller(1) articulates a dilemma facing many sectors of medicine and
crystalised in the MMR “debate.” There is a real attempt to stifle the debate
because of the undoubtedly overwhelming evidence-base in favour of immunisation.
In his response Heller comes closest to getting to the core when he refers to
the “balance to be struck between informed consent and the right of the state
to control an infections disease.” However I would posit that the reason he
feels so uncomfortable is that he is caught between his 2 roles: that of the
policeman / agent of the state that GPs and doctors are often unwittingly
asked to be, and that of protecting the best interest of their patients. It
is completely un-PC to put it like that, but that is what it is. The reason
this is even more uncomfortable than ever is because in post-Alder Hey and
Bristol a lot of central noise is being made about the need to put patients
first, and reverse what is seen as the historical imbalance in power between
doctor and client (see Pattison’s final paragraph (2)). Of course the fact
that there is an inherent need for a power-differential between experts and
clients and that there is an implicit contract between the parties in terms
of who delivers the expertise, is very out of vogue currently. If the
profession is to be shaken into “putting patients first,” (a concept
periodically rediscovered and trumpeted by governments) how does it also put
evidence or central government directives first? Doing it surreptitiously by
payments for immunisation targets helps no one in this debate. Therefore I
presume in its attempt to put patients first the centre will now revoke
immunisation targets and reincorporate the monies into GPs’ basic
remuneration – still time to include this in the new contractual
arrangements. If it is not going to do this then it will presumably support the view
that doctors will be given time to prepare their own leaflets on the
available evidence, to individualise their patient care, and then state that
once read it is entirely up to the parent to decide on the best course of
action for their child. The only other way to extract clinicians from this
mire would be to separate the functions of patient advocacy and protection
from central pronouncements and evidence based medicine. This might lead to
the evolution of new professions: those of expert (and remunerated) patient
advocates based in each surgery and accompanying patients to consultations,
and/or 2 strands of doctors. Those trained in evidence-based medicine and
those trained in person- centred medicine. They would work in pairs and
debate issues in front of patients who would then decide. This is not so far
from a model already adopted in the post-modern world of family therapy
called the “reflecting team” approach (3). It would cost more but it might
allow people to reoccupy positions of expertise that are reconcilable, and
put patients where the government wants them: in the driving seat. Of course
they might have to take responsibility for their decisions, and what would
that do to the sue-for-negligence system? 1. Heller T. How safe is MMR vaccine? BMJ 2001;838-9. 2. Pattison S. Dealing with uncertainty. BMJ 2001;840 3. Andersen T. The reflecting team: dialogue and meta-dialogue in clinical
work. Family Process, 1987:26;415-428. |
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Nigel Calvert, Send response to journal: Email Nigel Calvert: |
Sir - One of the studies Professor Heller cites is that by Patja et al
(1), and I was interested in his view that there are doubts about its
validity. This was a Finnish 14 year prospective study on 1.8 million vaccinees
which failed to demonstrate a link between MMR vaccine and
autism/inflammatory bowel disease, but did detect Idiopathic thrombocytopenic
purpura (ITP). This is a well- recognised rare side effect of MMR
vaccination, and for me this showed that the Finnish study was sensitive
enough to pick up rare events. I felt that Patja's research was of high quality and was the best evidence
yet of the safety of MMR. Ref. (1) Patja A, Davidkin I, Kurki T, Kallio MJ, Valle M, Peltola H.
Serious adverse events after measles-mumps-rubella vaccination during a
fourteen year prospective follow-up. Pediatr Infect Dis J 2000; 19: 1127-1134
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James A. Kaye, Send response to journal: Email James A. Kaye: |
We are writing to clarify two points regarding our study of MMR vaccine
and autism (1) that were made in a recent Ethical Debate in the BMJ. First,
Tom Heller characterized us as “researchers who declare funding from drug
manufacturers involved in manufacturing vaccines” (2). Most of the MMR
vaccine used in the UK until October 1992 was either Pluserix (manufactured
by SmithKline Beecham) or Immravax (manufactured by Merieux), and the
remainder was MMR II (manufactured by Merck Sharp & Dohme; now produced
by Aventis Pasteur MSD); after Pluserix and Immravax were withdrawn in 1992
due to a risk of aseptic meningitis attributed to the mumps component (3),
only MMR II was used (Elizabeth Miller, personal communication, 22 February,
2001). Our study of MMR vaccine and autism was not funded by any of these
companies. We did the study at the request of the UK Medicines Control Agency
(which also did not fund it). Second, we disagree with Dick Heller’s description of our study as
“ecological in design” (4). An ecological study is one in which "…the
units of analysis are populations or groups of people, rather than
individuals" (5). However, our study used data on individual subjects in
the General Practice Research Database. We contrasted the increase in
diagnosis of autism among 2- to 5-year old boys born in 1988-1993 with the
unchanging prevalence of MMR vaccination by age 2 in the corresponding birth
cohorts, and we noted that the vaccine prevalence for the boys diagnosed with
autism was similar to that of the general population. MMR vaccine prevalences
both in the general population and among the boys with a diagnosis of autism
were estimated from individual computer-based medical records. James A. Kaye, senior epidemiologist (jkaye@bu.edu) Boston Collaborative Drug Surveillance Program, Boston University School
of Medicine, 11 Muzzey Street, Lexington, MA 02421, USA 1. Kaye JA, Melero-Montes MM, Jick H. Mumps, measles, and rubella vaccine
and the incidence of autism recorded by general practitioners: a time trend
analysis. BMJ 2001;322:460-463 2. Heller T. How safe is MMR vaccine? BMJ 2001;323:838-9 3. Miller E, Goldacre M, Pugh S, Colville A, Farrington P, Flower A, Nash
J, MacFarlane L, Tettmar R. Risk of aseptic meningitis after measles, mumps,
and rubella vaccine in UK children. Lancet 1993;341:979-982 4. Heller D. Validity of the evidence. BMJ 2001;323:839-40 5. Last JM (ed). A Dictionary of Epidemiology (Third Edition). Oxford
University Press, New York, 1995 |
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Lilian Somers, Send response to journal: Email Lilian Somers: |
Having just recently been on an 'Autism' update run locally by the Speech
and language department, I was reminded again that Autism is familial with a
strong family history of one parent being on the autistic spectrum and
sometimes more than one sibling in the family being diagnosed 'autistic' Why
hasn't this fact been flagged up in the professional response as well as the
media response to Professor Wakefield's research on MMR? Surely these
statistics are vital in looking at the 'supposed links' between MMR and
autism. |
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Adam Finn, Send response to journal: Email Adam Finn: |
"What are we to make of... researchers who declare funding from drug
manufacturers involved in manufacturing vaccines?" asks Tom Heller(1).
He and others deserve some kind of general answer here as there is a danger
that such declarations may be being misunderstood. Virtually all new vaccines in use in developed countries today are made by
commercial companies. These vaccines have to be put through clinical trials
(usually in children) to demonstrate safety and efficacy prior to licensure,
the costs of which are paid for by the manufacturers (as no one else is going
to pay). Such studies are done by doctors and it is desirable that these
doctors should be independent rather than employees of the companies, so that
their aims should only be to do scientifically sound studies and to protect
the subjects enrolled, rather than to make a profit for the company.
Therefore it is standard practice that agreements between such researchers
and sponsoring companies exclude the former from personal financial gain, for
example, through investment in the sponsoring company. Nevertheless, a result of this system is that virtually all clinical
research studies on new drugs and vaccines coming to licensure are
commercially funded. The professional success of clinical researchers depends
principally on the research income they can generate. Thus researchers -
although they are usually not receiving personal financial inducements - have
a competing interest, which they correctly declare. In my view, readers should interpret such declarations as a qualification
to give a well informed opinion, as anyone unable to declare such competing
interests is unlikely ever to have had any direct experience of using new
vaccines in children. However, the main advantage of the system is that it
promotes transparency. Clinical researchers (and editors) are leading the way
here, and other authors should start to consider how they too can declare the
interests and motives which underlie the opinions they express in public. Adam Finn 1. How safe is MMR vaccine? BMJ 2001;323:838-40 Adam Finn Professor of Paediatrics University of Bristol UK (Competing
interests: substantial funding for research and academic activities received
from virtually all vaccine manufacturers during the last 5 years. Personal
income received from such sources, nil) |
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lehmann christian, Send response to journal: Email lehmann christian: |
I can well understand Dr Heller's qualms about MMR vaccination, but must
stress that in France, where I work as a GP, it is not an issue... Rather, it is the vaccination against Hepatitis B which is at the center
of a controversy that has been raging for up to five years, since the
Minister of Health ( Dr Bernard Kouchner, who recently deemed the NHS as
medieval...)decided to stop that vaccination in children's colleges but
maintained it in private practice. The big difference, in my opinion, is that here in France we have
absolutely no financial incentive for vaccination, so that, as far as non-
mandatory vaccinations are concerned, doctors ( even though they may be
mistaken in their views on the subject) can act according to their
understanding of the knowledge at hand, without any ulterior motives to
impair their judgment. And I guess that is what our patients await from us...
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Dr Michael Jarmulowicz, Send response to journal: Email Dr Michael Jarmulowicz: |
The controversy surrounding MMR won’t go away. The title of the series of
articles poses the question “is there a case for deepening the debate?”1 I
believe there is. Many of us are not in a position to evaluate critically all
the evidence presented and are further confused to find that well-qualified
experts stand in both camps of the debate. From the infant’s perspective immunisation against measles seems the most
pressing, as infection carries a small risk of serious and even fatal
complications. Mumps and rubella are far less serious for the infant and my
understanding is that the only scientific argument for immunising infants
against these two diseases is to establish a good herd immunity, which will
benefit society and reduce infections of non-immune older children and adults
where sequelae of mumps and rubella can be more serious. (I can also see the
practical and economic reason for providing an immunisation against more than
one disease in a single vaccine.) But should the benefit to society take
precedence over possible risks to an individual? My understanding of the
Wakefield hypothesis is that in a very small number of children the triple
vaccine may precipitate Crohn’s disease or autism. What I find puzzling is the adamant refusal of the authorities to
facilitate the availability of the single measles vaccine, to the point that
the Department of Health has banned its use within the NHS. How does this fit
with the growing acceptance of patient autonomy and patient choice? It is now
enshrined in case law that a pregnant women can, for rational or irrational
reasons, refuse treatment even if that refusal fatally jeopardises her unborn
child. I suggest that the medical profession should support a parent's wish
for single dose vaccine, however irrational the establishment might view that
wish. In addition there are some parents who are opposed to the rubella
component of MMR, on the grounds of conscience because of its manufacture on
cell lines extracted from an aborted fetus, but who would still wish their
child to be immunised using single vaccines available in other countries. I
find the arguments against use of single vaccines on grounds of safety and
efficacy weak and difficult to accept, particularly when other countries with
equivalent medical and ethical standards make them freely available. Yours sincerely Dr Michael Jarmulowicz FRCPath MBBS 1. Ethical debate: Vaccination against mumps, measles, and rubella: is
there a case for deepening the debate? BMJ 2001;323:838. |
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