Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
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
- Christian Lehmann (14 October 2001)
-
Why not allow single measles vaccine?
- Michael Jarmulowicz (14 October 2001)
-
Re: MMR: Caught betweeen stools
- Peter English (16 October 2001)
-
MMR: An Immunologsts View
- Cynthia M Lewis (18 October 2001)
-
I'm a caring pragmatist not a statistician
- Stephen McCarthy (18 October 2001)
-
An informed decision to use MMR
- Ben Ewald (18 October 2001)
-
conflicting considerations
- David Rands (18 October 2001)
-
The true source of the golden rule
- Peter Saunders (19 October 2001)
-
mmr
- Stephen Ware (19 October 2001)
-
MMR-my line
- Ieuan Davies (24 October 2001)
-
MMR - no room for lingering doubts
- Nick Barnes (7 November 2001)
-
MMR debate - examination of the responses
- richard f heller, Tom Heller, Stephen Pattison (14 February 2002)
-
Deepen the debate and the research base
- John P Heptonstall (17 February 2002)
-
Reply to previous correspondence
- William D H Carey (5 March 2002)
|
|
|||
|
David Parry, On-line learning researcher AUT
Send response to journal:
|
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. |
|||
|
|
|||
|
Richard Fry, Consultant Child and Family Psychiatrist CFACS, Uxbridge, Middx
Send response to journal:
|
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. |
|||
|
|
|||
|
Nigel Calvert, Consultant in Communicable Disease Control Carlisle and District Primary Care Trust
Send response to journal:
|
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 |
|||
|
|
|||
|
James A Kaye, senior epidemiologist Boston Collaborative Drug Surveillance Program, Boston University School of Medicine
Send response to journal:
|
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 |
|||
|
|
|||
|
Lilian Somers, health visitor GP Practice-Kingston Surrey
Send response to journal:
|
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. |
|||
|
|
|||
|
Adam Finn, Professor of Paediatrics University of Bristol
Send response to journal:
|
"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) |
|||
|
|
|||
|
Christian Lehmann, GP, private practice Poissy, France
Send response to journal:
|
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... |
|||
|
|
|||
|
Michael Jarmulowicz, Consultant Histopathologist Royal Free Hospital, London
Send response to journal:
|
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. |
|||
|
|
|||
|
Peter English, CCDC Surrey
Send response to journal:
|
I am intrigued by Fry's statement that a GP 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". To my mind, at least when it comes to MMR immunisation, there is no problem at all: by encouraging MMR immunisation, they are protecting the best interests of their patient(s). The patient in front of the GP be more likely to benefit than to be harmed by the vaccination. In addition, the population benefits are significant. Because measles is so infectious, a high uptake of MMR vaccine is necessary if we are to maintain herd immunity. If rates drop to, say, 60%, then we will lose herd immunity, and nearly all the vulnerable 40% will get measles. There are over 600,000 births per year, so about 240,000 children would get measles each year, and, taking D Heller's more conservative figure, we should consequently expect to see 240 deaths. |
|||
|
|
|||
|
Cynthia M Lewis, Retired Former Snr Lect/Res. Charing Cross/Roy London
Send response to journal:
|
To reiterate the words of Dr Michael Jarmulowicz, "The controversy surrounding MMR won't go away". The direction of the debate will raise more problems than it solves and I would like to try and change the direction with a few points from the perspective of an immunologist: - 1. The phenomenon of "immune interference" is rarely discussed. Simultaneous immunisation with more than one antigen can both qualitatively and quantitatively change the response. (This fact leads me to suspect that a bureaucrat devised the “triple jab” and not someone well versed in immunological mechanisms.) 2. Nigel Calvert raised the issue of ITP and MMR. This was a Finnish study and I would respectfully like to point out that it is autism in the British population that concerns most parents. I don't pretend to know anything about the relative distribution of HLA antigens and associated antibody and T-cell receptor idiotypes in the Scandinavian population, but I would be prepared to guarantee that its spectrum is different from that in Britain. (This might be the underlying cause of the genetic predisposition that Lilian Somers raises) But I do support the concept of herd immunisation; and as an immunologist, I can suggest an alternative. Immunisation of pre-pregnant women would have exactly the same effect. We know that maternal antibodies protect infants for some time, (T-cell receptors probably also do by virtue of idiotypic networks). I would therefore suggest that the immunisation of all women between the ages of about 15 and 40 would protect both their own offspring and also the herd. As an additional measure, a second "jab" might be given at an age when the infant's neurological development is considered to be more "robust". The adoption of this practice would satisfy parental concerns and also those paediatricians and epidemiologists worried about a measles epidemic. I would suggest that NHS funding might even be reduced - after all, only 50 per cent of the population would need the first injection. But of one thing I am certain, if a clinical trial were to be initiated there would be no shortage of volunteers. Finally, I would like to declare that I have absolutely no competing interests but I do wonder about the opposing views of Tom Heller and Dick Heller. Should the declaration be "no relationship" or "sibling rivalry"? |
|||
|
|
|||
|
Stephen McCarthy, General Practitioner Wolverhampton
Send response to journal:
|
I remember having measles at the age of 5 in 1966; it was pretty horrible but it wasn't even that bad as measles goes. Later my wife worked on a paediatric unit where a child died of measles and was pretty horrified by it. I've seen the many thousands of words from the various studies and frankly the statistics pass over my head. When I see however, reports from the Dublin and Dutch outbreaks with 5 children dead out of 4300 infected, think about all the morbidities that go with that, and read Lesley Morrison's account of SSPE in this issue, my beliefs about measles vaccine are pretty easy to come by. Its not so easy to convince the concerned middle class parent. The difference is that to vaccinate is an act of commission; to leave the vaccination undone is an act of omission and a justification can be found for putting it off. Like-as-not nothing will happen as a result, unless everyone else in your community puts it off.... Change the act of omitting the vaccination into the same act of commision by asking parents to sign a disclaimer after explaining the facts and there is balance once more. Preferably both consent and disclaimer forms should be in the Parent Held Child Health Record. Change the target payments to payments for consultations about vaccinations rather than vaccinations given and we will never have this argument again. |
|||
|
|
|||
|
Ben Ewald, GP and academic Newcastle NSW
Send response to journal:
|
Like Dr Heller I am a GP, however my children are young, and still due for their second MMR dose. I have an interest in communicable disease issues, and in fact teach a course at the University of Newcastle NSW on communicable disease epidemiology. I have seen the evidence in support of a link between MMR and Autism, and feel compelled to say how I view it: To my trained eye, I feel the evidence for a link is weak, and the evidence for no link is moderatly strong. My children will be having their second MMR. If there is a causal link between MMR and Autism it is at a very low incidence, and a risk I am prepared to take because I know the risk of measles is significant. I have seen measles epidemics, and they can be terrible. In the future world who knows if current public health efforts will be maintained. I would not want my child to grow up susceptible to measles and then contact it either while travelling abroad, or in Australia when measles re establishes in response to declining immunisation. This decison does not come from blind enthusiasm for immunisation, and I have serious doubts about the introduction of varicella vaccine to the routine schedule. Chicken pox is a minor childhood illness that causes exremely rare fatalities, half of which are in immunocompromised children. The risk from immunisation is a shift to older age groups if coverage is not adequate to block transmission, and possibly the creation of susceptible adults if vaccine produced immunity wanes over many years. As disease severity is greater in adults the disease burden may in fact be increased by immunisation. On questions such as these the bottom line is a truly informed personal decision, but as the information is complex there are few parents in the lucky position to be fully indformed. |
|||
|
|
|||
|
David Rands, retired retired
Send response to journal:
|
As a GP who remembers a daily visiting list of 30 or more during a June measles epidemic, I am impressed with the results of routine immunisation: but we must recognise the need for every parent to weigh risks before submitting their infant to a recommended prophyllactic programme. How can they accept advice if they know that the adviser has a financial incentive to promote the programme? More important, this seems to be a classical example of the conflict between individual and community concerns. If the perception that the risk to the individual of contracting measles (and polio in the UK) is now negligible, ANY risk of ill-effect from immunisation is unacceptable to that individual. But the need to maintain "herd immunity" requires that each submit to the "common good". How often do we enter this debate with our patients? David Rands, general practitioner (retired) Competing interests: none |
|||
|
|
|||
|
Peter Saunders, General Secretary Christian Medical Fellowship
Send response to journal:
|
Stephen Pattison is incorrect in attributing the golden rule to Singer.1 The original source is Jesus Christ’s Sermon on the Mount,2 a fact which Pattison, as the head of the Cardiff University Department of Religious and Theological Studies, must have known. I wonder why he felt he couldn’t say it. Christ’s golden rule, that we should treat others as we would want them to treat us, was unique to him. Other moral teachers had put it negatively: ‘you should not do to others what you would not want them to do to you’, but to live one’s life by that ethic would simply lead to being remembered for ‘never doing anyone any harm’ - a far cry from the imaginative, costly love that Jesus Christ demonstrated and taught.3 Jesus Christ’s dynamic entry into first century Palestine was marked by eyewitness accounts of miraculous healing of many illnesses for which even today there are no known treatments. Together with the quality of his moral teaching these powerful acts of compassion were the ‘evidence-base’ for his claim to be the ‘Son of God’. Along with his compassion to restore health he brought a message of healing of broken relationships - between human beings, between human beings and the planet and most crucially between human beings and God. Doctors motivated by Christ’s teaching and example have been profoundly influential in shaping medical history. Pare, Pasteur, Lister, Hodgkin, Paget, Barnardo, Jenner, Simpson, Sydenham, Osler, Skudder and Livingstone are just a few examples of medical pioneers who were also professing Christians.4,5 Christians remain active in all fields of medicine today but particularly in AIDS care and education, drug rehabilitation, child health, palliative care, relief of poverty and in service to the developing world. The Christian Medical Fellowship has almost 5,000 medically qualified members in the UK alone and is affiliated to over 50 other similar national bodies through the International Christian Medical and Dental Association (ICMDA). Many of Christ’s values have been so absorbed by civilised nations that we take them for granted. Pattison’s misquote is a further example of ethicists stealing their best ideas from the Judeo-Christian tradition, without acknowledging the true source. Peter Saunders 1. Pattison S. Dealing with Uncertainty. BMJ 2001; 323:840 (13 October) 2. Matthew 7:12 3. May, P. Jesus - the pivot of history and medical care. Triple Helix 2000; 11:5-7 (April) 4. Beal-Preston, R. The Christian Contribution to Medicine. Triple Helix 2000; 11:9-14 (April) 5. Graves D. Doctors who followed Christ. Grand Rapids:Kregel, 1999. |
|||
|
|
|||
|
Stephen Ware, consultant paediatrician basildon
Send response to journal:
|
BMJ 323:838 sqq I was dismayed to see your "ethical debate" on this important subject. The expert debate is over, and I can't understand why you feel you must publish the ramblings of a woolly-headed GP and even a theologist. If Dr Heller is "uncomfortable" with the vaccine he should become an expert: review the literature, learn the skills of statistical analysis, and then tell us where we have gone wrong. It seems to me that his discomfort is simply a measure of the power of the popular press: from whence else does his uncertainty stem? Considering what he would do if his own family were involved seems to be a novelty for Dr Heller: I would hope that my own GP would always bring this into the equation when faced with a difficult decision. He reminds us that GPs are paid extra for vaccinating children. I sometimes feel that a hospital doctor could be forgiven for thinking that GPs have to be bribed to do almost anything. But what does Dr Heller think is the motivation behind the bribe? When he says "It is not easy to question authority these days", what on earth is he talking about? It seems to me that the only moral issue is of a senior professional with responsibilities for the care of children undermining public confidence in an important health measure which has a huge evidence basis and which is unequivocally endorsed by every relevant expert body. |
|||
|
|
|||
|
Ieuan Davies, SpR Paediatrics University Hospital of Wales
Send response to journal:
|
Sir, Like Heller1 I am often asked for advice regarding the combined mumps, measles and rubella vaccine (MMR). These inquiries come from different directions including the wives of university friends shortly before the first birthday of their child. Most concerned parents have a vague notion that the MMR will "hurt little immune systems" leading to a deluge of toxins that will leave their child autistic or dependent on an ileostomy. Parents are confused and a little frightened partly because the media run stories about the issue in a naive and unscientific way. An MMR piece invariably starts with a sensationally tragic story involving the home life of a disabled child whose symptoms appeared days after the fateful jab. This 'trial of one' is then expanded and used to add weight to the hypothesis put forward by Wakefield and colleagues and published in the Lancet2 3. My response to questions about the MMR varies little. I explain that based on the scientific evidence I have read4 there is no causal association between the MMR vaccine and inflammatory bowel disease or autism. I emphasise that mumps, measles and rubella are serious illnesses with potentially nasty complications including death in the case of measles. I stress that if sufficient children are not vaccinated then we can expect epidemics of these illnesses to which unprotected children will be vulnerable. I conclude my advice by swearing that doctors are not colluding with the State to hide the truth, I point out that the MMR is recommended by the litigation sensitive Americans5 and disclose that my son has had both doses of the MMR. References 1. Heller T, Heller D, Pattison S. Vaccination against mumps, measles, and rubella: is there a case for deepening the debate? BMJ 2001;323:838-40. 2. Thompson NP, Montgomery SM, Pounder RE, Wakefield AJ. Is measles vaccination a risk factor for inflammatory bowel disease. Lancet 1995;345:1071-74. 3. Wakefield AJ, Murch SH, Linnel AJ, et al. Ileal-lymphoid-nodular hyperplasia, non specific colitis and pervasive developmental disorder in children. Lancet 1998:351:637-41. 4. Elliman DAC, Bedford HE, Miller E. MMR vaccine-worries are not justified. Arch Dis Child 2001;85:271-74. 5. American Academy of Paediatrics. Evidence doesn't support autism/vaccine link. New report adds to mounting studies. 2001. http://www.aap.org/advocacy/washing/23apr01.htm Dr Ieuan Davies SpR Paediatrics University Hospital of Wales Cardiff CF4 4XN y.tarw@virgin.net |
|||
|
|
|||
|
Nick Barnes, Specialist Registrar, Paediatrics Royal Berkshire Hospital, Reading RG1 5AN
Send response to journal:
|
MMR-no room for lingering doubts Editor We write to commend and complain. Firstly, we refer to the recently published debate on the safety of MMR vaccine from a primary care perspective.[1] Ethical debate is a central part of the jigsaw of developing patient care and may undoubtedly serve as the patient's (in)visible advocate. However, we question the wisdom of the BMJ not in commissiong the debate, but in publishing the anecdotal response of Dr.T.Heller, whose 'lingering doubts remain' as to the safety of this vaccine. Such a reply risks some parents becoming indoctrinated by it as the final word on the subject. In paediatrics and primary care the uphill battle to increase vaccine uptake rate feels ever steeper. Countless, perhaps excessive man-hours are currently expended in both primary and secondary care counselling parents anxious about the safety of the vaccine. This is not because they are awkward,ignorant or ambiguous, more that they are becoming ever more 'informed'.Some of their information comes from the popular press, or on- line, including the well-known flawed research by Wakefield et al[2]. Furthermore, the BMJ is one of the most frequently quoted in the popular press, and available to all on-line. The list of professional groups that endorse the vaccine is exhaustive [3]. Why then publish alongside it at best anecdotal evidence from one GP 'and many others' that he has lingering doubts as to the safety of the vaccine? This adds nothing constructive in the way of ethical debate and only serves to scaremonger. We agree that 'informed refusal must remain an acceptable choice' but the overwhelming evidence currently available is that the vaccine is safe. To this end, until there is evidence to the contrary we in the medical profession must unite and encourage vaccine uptake. It is not a case of 'keeping one's head down', simply good practice. The Children Act 1989 highlights parental responsibility. We as health care providers would do well to follow this dogma in the setting of MMR vaccination. We have a responsibility to emphatically endorse it; any less is a failure, and a breach of our terms of service, visible or invisble. To finish on a positive note, the personal view by Lesley Morris tucked away towards the back of the same edition [4] was commendably honest and painted the darker side of measles in the context of SSPE. Honest yes, scaremongering not. In the setting of MMR, more of this and less of the lingering doubt. Nick Barnes Elizabeth James 1 Heller T,Heller D,Pattison S. Ethical debate:Vaccination against mumps,measles and rubella:is there a case for deepening the debate? BMJ 2001;323:838-840 (13 October) 2 Wakefield A, Murch S, Anthony A, Linnell J, Casson D, Malik M, et al. Ileal-lymphoid nodular hyperplasia, non-specific colitis, and pervasive developmental disease in children. Lancet 1998;351:1327-1328 3 CSM/MCA Current Problems in Pharmacovigilance 2001;27:3 4 Morrison L.Measles-a minor childhood illness? BMJ 2001;323:875(13 October) |
|||
|
|
|||
|
richard f heller, professor of public health university of manchester m13 9pt, Tom Heller, Stephen Pattison
Send response to journal:
|
Responses to the MMR debate in the BMJ Key points Publication of an ethical debate about MMR vaccination in the BMJ produced responses both through the electronic response option and directly to the authors by e-mail Those who responded to the authors were likely to have had a relevant personal experience, to be opposed to the use of MMR and to express gratitude that concerns about the vaccine had been aired in public Examining the views of those who respond in different ways to journal articles may offer insights into health controversies The BMJ published an ethical debate on MMR vaccination [1], which was followed by a number of responses to the authors individually (individual) and to the electronic response option (public) in the BMJ itself. The authors of the debate were interested in the extent of the response and the differences in the characteristics and motivation of those who responded personally or publicly. This report attempts to characterise the responses. We subsequently sent a request to all respondents asking if they had responded previously to a BMJ paper, what had been their motivation to send a response and why had they chosen the personal or public response mode. We received 14 individual responses by e-mail (as well as a further four responses by journalists which we have not considered further) and there were 17 electronic responses in the BMJ. Nine of the 14 individual respondents and 10 of the 17 public respondents replied to our request for further information. The Table attempts to characterise the respondents and the content of their responses. The characteristics of the respondents varied in that the personal respondents were less likely to be health professionals than the public respondents. Nine of the personal respondents mentioned an experience of MMR or autism in their family and 7 declared an anti-MMR stance. A number made positive comments about the courage of the authors (in particular the first author). “There are too few people who are prepared to speak out and I thought you should know that there are others out there who feel deeply about the issue” “Thank you for voicing your concerns about MMR!! It is refreshing to see a member of the medical profession voice a valid concern” “I hope that your refreshing (moderate and balanced) honesty on the subject may prove a kind of vaccination in the medical profession to what often looks like a blanket surface denial to any potential dissenters on the subject” “But you make important points and please don’t stop making them…with appreciations for your courage”. Among the 9 personal respondents who sent further information, 4 had previously responded to BMJ articles (compared with 7 of the 10 public respondents) and 6 stated that a personal or professional interest had motivated their response (compared with 4 of the public respondents). Reasons for sending a personal response to the authors included a feeling of a greater likelihood of getting a reply (4) and a preference for private, direct discussion (3). The majority of the public respondents wanted to join the debate and to seek a wider audience for this. None of the personal respondents made the point that ‘herd’ immunity is important and that ethics discussions should balance individual with public responsibility [2]. There do appear to be differences in the characteristics of those who responded personally and those who responded in public. Those who responded personally included a number with a personal family interest in the issue and those who stated their opposition to MMR vaccination. A number wrote to thank the authors (particularly the first author) for having the courage to air views that would be unpopular amongst medical colleagues. Of note is the lack of any comment amongst personal responders of the ethical responsibility to the community as a whole. While the electronic response option in the BMJ offers the opportunity to join debate over contentious issues such as MMR vaccination, it does not capture the responses of a small but important readership of the original publication. Those who responded to the authors appeared to share many of the concerns of the public as reflected in a focus group study on parents’ perspectives on MMR vaccination [3,4]. It may be useful to widen the debate to gain insights of those who have a different view on evidence and to capture these views. Examining the views of those who respond in different ways to journal articles may offer insights into health controversies. Medical journals might wish to explore the methods of doing this, as might health policy makers who could thus be informed about the concerns of members of the public which may influence the uptake of important health policies. Table. Characteristics of the respondents and their responses Personal (response to authors) N=14 Public (electronic response to BMJ) N=17 Health professional 5 14 Personal experience of MMR or autism in family 9 - Professional experience of MMR or autism - 3 Declared anti-MMR stance 7 - Personal positive comments on authors 5 - Comment on science 2 5 Comment on responsibility to whole community (‘herd’ immunity) - 4 Comment on concerns over ‘official’ cover-up of adverse evidence 3 2 Heller RF
Heller TD
Pattison S
References. 1. Heller T, Heller D, Pattison S. Ethical debate: Vaccination against mumps, measles and rubella: is there a case for widening the debate? BMJ 2001;323:838-840. 2. http://www.ephu.man.ac.uk/GrandRounds/2001_11/MMRPressRelease.htm 3. Jewell D. MMR and the age of unreason. Br J Gen Pract 2001;51:875-876. 4. Evans M, Stoddart H, Condon L, Freeman E, Gizzell M, Mullen R. Parents’ perspectives on the MMR immunisation: a focus group study. Br J Gen Pract 2001;51:904-910. |
|||
|
|
|||
|
John P Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre Leeds LS27 8EG
Send response to journal:
|
Sir Government appears to be using several pieces of research cynically to exclude MMR from consideration as a cause of autism - and has managed to convince professionals and public alike. Taylor 2002 (1), Gillberg 1998 (2), Kaye 2001 (3) are fine examples of this; they focus on MMR to the exclusion of the single antigen vaccines which were used for decades prior to MMR, such that the media and parents may have developed a false faith in these. The evidence for measles vaccines in any form causing autism is mounting and at least one study - as yet unpublished so one must ask why - Singh 1998 (4) found significant MMR antibody relationships with the brains of autistics and not controls! His previous study, Singh 1998 (5), found a strong relationship between measles antibodies and autistics' brains compared to controls, this was published. Is his second study (4) too hot to handle? Wakefield 1998(6) Singh 1998 (4 and 5)lead us towards understanding the role of measles vaccines, and MMR vaccines, in autism via the gut and brain; is Government not at least suspicious of these vaccines? Autism may have increased in frequency and quantity of diagnosis this past 30 years (3); one cannot be completely sure how much enhanced diagnosis (7), coupled with medical and political will, is responsible for this. If there has been a genuine rise in autism since the British Cohort Study of 1970 (BSC70) which showed a rate of 0.45/1000 children, measles vaccine alone cannot explain this, although measles vaccines were introduced into the UK in 1968 and, without a survey of autism prior to this date measles vaccines (and therefore MMR) CANNOT be excluded as causes of autism. If, as Huessler et al (7) suggests, the incidence of autism is about the same now as in 1970, measles vaccine (and hence MMR) remains a probable cause of autism when one also considers the findings of Wakefield and Singh; and this fact can only be refuted by studies with a time line way before the introduction of single measles antigen vaccines to look at any impact those vaccines had on autism. It would also demolish the impact of studies such as those of the Kaye, Gillberg, Taylor and Peltola teams whoso protocols (conveniently?) excluded consideration of the impact of single measles vaccines. A rather sinister consequence of this Government stance is that many parents now put their trust in single antigens and/or MMR, where neither may be safe. I tend to believe that autism has risen exponentially this past 30 years, partly as a result of changes in the diagnosis processes but also partly from measles vaccination in its various forms. I do not exclude other causes, from which one or a combination may be particularly related to the dramatic rise. A few years ago I carried out a small parental anecdote study via Communication, the journal of the National Autistic Society, of parents who believed that vaccinations had caused their childrens' autism. 30% blamed MMR but 36% blamed DTP. DTP has undergone changes during the last 20 years, between whole cell and acellular, and carries the adjuvant Thimerosal (a toxic mercury derivative) which is suspected of causing at least one variety of autism due to neurotoxicity. It is currently being tried in US courts of law. The poison is found in D, DT and T vaccines also. Furthermore, DTP has long been linked to Infantile spasms, a rare form of childhood epilepsy - which is common in autism. Congenital rubella is as a cause of autism, is this risk passed via through rubella vaccines? We do not know.Thalidomide was associated with autism yet this fact was obscured by the other handicaps (8). About a third of autistic persons develop epilepsy; valproic acid, an anti- convulsant, has been associated with inducing autism (9). Pitocin-induced labour is suspected of causing autism and is under investigation in the USA (10). Smallpox vaccine was linked to causing autism in a paper (12) that stated "vaccination is recognised as having a starter function for the onset of autism" as far back as 1976 - have we such short memories? Whatever the role of MMR in the onset of autism, scientists are closing in on this despite limited funding, even more limited political will most of which has spent the last few years trying to spin its way out of the issue using public funds and supporting scientific studies that must confuse, rather than clarify, this serious issue of child morbidity and mortality. We are bombarded with meaningless statistics about the dangers of wild organisms and safety of live attenuated ones, despite the former having been categorised as innocuous diseases of childhood in the past; some of the present dangers have more to do with population shifts in disease patterns induced my mass vaccination than by the wild diseases themselves. The poor uptake of the single measles vaccines here and abroad during the early 70s was acknowledged then by researchers as due to "people not fearing wild measles". These diseases had already lost their impact on the mrobidity and mortality of European populations before vaccines were introduced; by 1968 the mean annual death rate from wild measles in England and Wales had fallen steadily since 1900 from about 1000 per million to almost zero - due perhaps to improved sanitation and medication! However, the US Vaccination Adverse Events Reporting System collected 5799 adverse events reports of MMR vaccine between July 1990 and April 1994, including 3063 cases requiring emergency medical treatment, 616 hospitalisations, 309 who did not recover, 54 children left disabled and 30 deaths (12). The US National Vaccine Information Centre estimated that underreporting may be 10-15% so total ADRs to MMR could have been as much as 60,000 in those 4 years. One study described 80 cases of neurological disorders starting within 30 days after measles vaccination (JAMA 1973; 223 (13): 1459-62) and also reported cases of SSPE after vaccination. MMR is probably as unsafe as measles vaccines, and has the added potential dangers of mumps menigitis and rubella arthritis plus many other well-documented serious ADRs. All haste should be made to effect scientific research funded by Government with independent scientists to develop Wakefield and Singhs works; and to set in motion, across the vaccination board, investigations into their impact on the rising incidence of all types of childhood diseases from diabetes and IBD, through leukaemias and cancers, to arthritis, MS and ME, all of which have increased exponentially along with autism since live vaccines were introduced into an unsuspecting medical and non-medical public several decades ago. Regards John H. References 1. Taylor et al BMJ 2002 24 Jan;324 "MMR vaccination and bowel problems or developmental regression in children with autism: population study" 2. Gillberg et al The Int Jnl of Res. and Pract. 1998;2(4):423-4 "MMR and autism. Autism" 3. Kaye et al BMJ 2000 24 Feb;322:460-3 "MMR vaccine and the incidence of autism recorded by GPs: a time trend analysis" 4. Singh et al 1998; Univ of Michigan, College of Pharmacy, Ann Arbor MI 48109, "Positive Titres of Measles and MMR antibody are related to myelin basic protein autoantibody in autism". 5. Singh et al, Clin Immun and Immunopath Oct 1998;89(1): 105-108 "Serological association of measles virus & HHV-6 with brain autoantibodies in autism" 6. Wakefield et al Lancet 1998;351:637-41 "Illeal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children" 7. Huessler et al, Letters, BMJ 2001;322:633 15 September "Prevalence of Autsim in early 19702 may have been underestimated" 8. K Stromland, K et al "Autism in thalidomide embryopathy. A population study" Develop. Medicine and Child Neurol. 1994; 36: 351-6 9. and 10. The Scientist, Research, 14 May 2001; 15(10):16. "Rodier (Patricia, Prof. of Obstetrics and Gynaecology at the University of Rochester) has found that valproic acid, a common anti- seizure drug known to induce autism, causes brain damage in rodents, and precisely in the places expected, based on what's known about this disease". "Eric Hollander, Professor of Psychiatry at the Mt. Sinai School of Medicine and Clinical Director of the Seaver Autsim Research Centre, New York City.....noting that an unusually large number of women at his clinic had pitocin-induced labour, is currently conducting a survey of some 58,000 births...for a common connection between that drug and autism". 11. Eggers C, Klin Pediatr 1976 Mar;188(2):172-80 "Autistic Syndrome (kanner) and vaccination Against Smallpox". 12. What Doctors Don't Tell You, Sept 1994, Vol 5, No.6, page 2. "Measles Vaccine. Knee-jerk and jab-happy". |
|||
|
|
|||
|
William D H Carey, Clinical Pharmacologist Hammersmith Medicines Research, Central Middlesex Hospital, London NW10 7NS, UK
Send response to journal:
|
Editor-There are 2 issues under discussion here. Firstly that of parental right, secondly that of the relative safety and efficacy of MMR. Society has decreed (rightly in my opinion) that parents do not have absolute rights over their children. We have systems in place to protect children from parental violence, sexual abuse and exploitation. Parents do not have the right to deny education to their children, nor should they have the right to deny their children the best possible medical care, as that could lead to death. The role of doctors, medical scientists and government should be to provide the best medical cover possible to the population. This includes children, and in rare, but difficult cases, protection against their own parents. What would Dr Carey offer to an unvaccinated child with a known hypersensitivity to one component of 'the best available' MMR? At present the NHS offers NOTHING AT ALL... That is a case for single vaccines, but that is not the issue under discussion. For that child, the MMR is second best, and the doctor’s responsibility is to make that decision and give advice, in consultation with the parents. Would you allow a doctor to inject your child against your judgement? If the doctor were proposing to give an injection/treatment which was against established medical practice and current guidelines, I would want to know the reasons for his/her doing so. If such reasons were unforthcoming, or were unsatisfactory, I would not allow that doctor to proceed. If his /her reasons were woefully inadequate, I might consider reporting him/her to the GMC. If she/he proceeded without my permission, I would consider suing him/her and reporting him/her to the GMC which would have to take action since both medical guidelines and parental authority had been breached. If significant harm to my child resulted, I would definitely take such action. But this is likely to be academic as generally doctors do follow established practice and guidelines. Would you inject a child against a parent's valid and sound judgement? Strictly, no. But this question begs the question as to what constitutes valid and sound judgment. In the MMR context, is it valid and sound judgment to request a vaccine which is currently believed to be inferior to MMR? How can the decision of a layperson be as sound and valid as thousands of virologists, immunologists, doctors with thousands of years of training and experience between them? If it is as valid and sound, why do we bother training? Thus, I would inject if I considered the parent’s judgment to be invalid and unsound (see below). A more relevant and practical alternative question is: Would you ever treat a child against a parent's consent? Yes, I would. If a child is sliding into a diabetic ketoacidotic coma, I would inject with insulin even if the parents opposed it in spite of my trying to persuade them otherwise. If time allowed, I would speak with the MDU and try and get a court order, but if time were short, I would inject anyway. Children have to be protected, sometimes even against their parents. Would Dr Lewis not inject under such circumstances, knowing that the child would otherwise die? We currently are witnessing the case of the child with Goldenhar Syndrome at the Newcastle Royal Infirmary. How can a distraught non-medical parent make a decision about the need for a tracheotomy? The child’s interests have to be protected (I am, of course, assuming that the tracheotomy is the best medical option). The point here is that we are professionals, which, in this context, means that we sometimes have to make decisions drawing on our experience and training which override other considerations, which might include parental consent. But we have to then justify our action. We do not blindly follow rules, we do not blindly do what parents tell us to do no matter how stupid. Like a parent, a doctor cannot be loved all the time, and limits have to be set. The pertussis example is not appropriate as it is another example of the MMR dilemma and my question still stands, and applies to both cases. Currently the evidence is that the MMR will save more lives than the single vaccines, which in turn will save more lives than no vaccination. At present, there is no evidence of medical advantage to the single vaccines compared to MMR (except with specific exceptions as above). I think that the government and the medical establishment must continue to tough this out. However, if the uptake of MMR continues to slide, we might have to compromise, but if we are to do that, then those parents requesting the single vaccine must be made to understand that they are going against the opinion of medical experts. Therefore the BNF should state that single vaccines are currently considered to be not as good as MMR, and doctors must get parents to sign a declaimer to protect the doctor and NHS from future litigation from the parent should the child die or be seriously disabled, or from the child when she/he grows up. In future, we might have people suing doctors for failing to give them MMR when they were children. Doctors would be covered (though perhaps not definitely) by the disclaimer, and that person could sue their parents. After all, there have already been cases of people suing their mothers for her smoking when pregnant with that child. In this context, where a doctor should not overrule a parent is if, for example, it was medically established that there was a 0.1% chance of MMR causing autism, and a 0.05% chance of the 3 single vaccines leading to the death of the child because of the delay in getting full immunity. Here there is a balance to be struck, and there is no right answer and the choice would depend on one’s own perspective of risk and consequences. Here, the responsibility of the doctor is to explain the situation and discuss the options. For the adult, it is their decision (though often the patient will ask of the doctor: What would you do?) For the child, it is clearly the decision for the parent who has the responsibility for that child and the doctor must abide by the parent’s decision. One further point: What happens if we have a scare about the single vaccine? If large numbers of parents then refuse all vaccines (not inconceivable, since if MMR causes autism and bowel disease, so perhaps could the measles single vaccine, until proven otherwise), do doctors and the government agree not to vaccinate at all? There are circumstances, surely, in which vaccination, for example, is made to be a legal requirement. For example, if we have the vaccine and bioterrorists release smallpox, surely the government has to enforce vaccination to prevent massive loss of life. I am all in favour of doctors not being treated as all knowing gods, but it seems that the pendulum has swung and now some patients think that they know just as much as doctors and that their medical opinion is just as valid. If this results in detrimental treatment for themselves, so be it, they were warned, but children must be protected. Yours faithfully Dr William D H Carey Competing interests: None. |
|||