Rapid Responses to:

EDITORIALS:
David Elliman and Helen Bedford
MMR vaccine: the continuing saga
BMJ 2001; 322: 183-184 [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] Peculiar to Persons
Alan Challoner   (27 January 2001)
[Read Rapid Response] Post vaccination surveillance
Diane McQuade   (28 January 2001)
[Read Rapid Response] MMR queries
Stephen Hughes   (29 January 2001)
[Read Rapid Response] Alarm and sorrow
Andrew Hutchinson   (29 January 2001)
[Read Rapid Response] Irrational Support for Flawed Studies
John P Heptonstall   (30 January 2001)
[Read Rapid Response] Family members also get vaccinated again?
R J Orme   (30 January 2001)
[Read Rapid Response] Disseminating Information about MMR
Nigel Calvert   (30 January 2001)
[Read Rapid Response] Measles: Ocuous
Adrian Midgley   (1 February 2001)
[Read Rapid Response] MMR and autism
Brian C Morrow   (1 February 2001)
[Read Rapid Response] Re: MMR and autism
A P Jackson   (3 February 2001)
[Read Rapid Response] Re: MMR and autism
Zubair Kabir   (3 February 2001)
[Read Rapid Response] Re: MMR and autism
Joseph Watine   (5 February 2001)
[Read Rapid Response] Re: Re: MMR and autism
John P Heptonstall   (6 February 2001)
[Read Rapid Response] MMR vaccine: the continuing saga
Arun Mukerjee   (6 February 2001)
[Read Rapid Response] Safety of Vaccines
Zubair Kabir   (9 February 2001)
[Read Rapid Response] Re: Safety of Vaccines
John P Heptonstall   (11 February 2001)
[Read Rapid Response] A battle of 'hearts and minds'!!
Zubair Kabir   (15 February 2001)
[Read Rapid Response] Re: A battle of 'hearts and minds'!! against the odds.
John P Heptonstall   (21 February 2001)
[Read Rapid Response] Viagra vs MMR
Lisa Blakemore-Brown   (22 February 2001)
[Read Rapid Response] Cause-effect relationship: a scientific judgment or an old tired argument?
Zubair Kabir   (23 February 2001)
[Read Rapid Response] Re: Cause-effect relationship: a scientific judgment or an old tired argument?
Alan Challoner   (25 February 2001)
[Read Rapid Response] Re: Cause-effect relationship: a scientific judgment or an old tired argument?
John P Heptonstall   (1 March 2001)

Peculiar to Persons 27 January 2001
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Alan Challoner,
Retired

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Re: Peculiar to Persons

My personal experience is with the DPT triple antigen vaccine. The concerns about this vaccine were also decried by many in the medical profession as well as of course those in the pharmaceutical industry. History can repeat itself and it behoves all who see the honest concerns of some parents and professionals as “idiosyncratic” to have the sackcloth and ashes ready in case they are wrong.

Idiosyncrasies are peculiar to persons, and it seems possible that particular children will respond in an ‘idiosyncratic’ way to their vaccinations. That is not their fault. However much more research is required to find out why they react in that way.

From my now ancient files, I have a letter from the Department of Health, written in 1957 to all local health authorities. It includes the following, “Some … risks have not been measured … these include the combined DPT antigens. These antigens should, in general, be used separately.”

In addition, your venerable journal published a letter (and I believe a paper) from Dr J M Berg (BMJ 5/7/1958), in which he mentions that if a child suffered a reaction to the first dose of DPT vaccine, under no circumstances should a second dose be given.

These warnings were frequently ignored and, consequently, we had the 700 (at least) very severe reactions to the DPT vaccine. These, in many cases, induced severe disability that amounted to an eighty-percent loss, and therefore led to an award under the Vaccine Damage Payments Act 1979.

Despite research that began in 1974 on the acellular vaccine, and the advice that local reactions and pyrexia occur less often than after administration of the whole-cell vaccine, this advice was not included into the Department of Health Memorandum, “Immunisation against Infectious Diseases”, until the 1996 edition. Some of the papers are noted at the end.

As recently as 1998 a batch of whole-cell DTP vaccine was withdrawn by the Bath and West Community NHS Trust. It will also be remembered, by those who have been around as long as I have, that some of the batches of DPT, manufactured in the late 1950s, were subsequently found to be faulty. Some of those who claim to have had those faulty batches used in their vaccination and who had serious reactions to them have a special case in negligence. I find myself repeating— parents do not need reminding about the positive contribution of vaccination. Those who are seeking to sweep aside objections and suspicions do nothing to promote financial support to families who have a vaccine damaged child. There can be no doubt that vaccinations have been beneficial to children and communities, but neither the medical profession nor the pharmaceutical industry has accepted any responsibility for the long-term disability of those who have been deemed to be seriously affected by vaccination.

So is it no wonder that parents are apprehensive about taking-up vaccination for their young babies? It is quite clear to them that if a serious reaction disables their child to the degree required to qualify for the Vaccine Damage Payment, several things will follow. Normal education will be impossible; socialisation will be impaired; employment is unlikely; and to cope with the financial implications of that they will get just £7,000 a year from investing the award. Add to that the potential for the disability to cause medical or mental health complications, their costs and the stress on the family, it is not unsurprising that faced with such uncertainty of outcome, many are saying ‘no’ to vaccinations.

If families want reassurance, it is not about the ‘safety’ of vaccinations, but about an adequate and effective compensation to help their child make the best of a disabled life when it responds ‘idiosyncratically’.

===========

Gustafsson L et al. A controlled trial of two-component acellular, a five-component acellular and a whole cell pertussis vaccine. N. Engl J. Med 1996; 334:349-55.

Olin P et al. Randomised controlled trial of a two-component, three-component, and five-component acellular pertussis vaccines compared with whole-cell pertussis vaccine. Lancet 1997; 350: 1569-77.

Schmitt H-J et al. Efficacy of acellular pertussis vaccine in early childhood after household exposure. JAMA 1996; 275: 37-41.

Liese J.G. et al. Efficacy of a two-component acellular pertussis vaccine in infants. Pediatr Infect Dis J. 1997; 16: 1038-44.

Heininger U. et al. Comparative efficacy of the Ledele/Takeda acellular pertussis component DTP vaccine and Lederle whole-cell component DTP vaccine in German children after household exposure. Pediatrics 1998; 102: 546-553.

Post vaccination surveillance 28 January 2001
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Diane McQuade,
Parent
Home

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Re: Post vaccination surveillance

I am the mother of a 5 yr old boy who is also autistic.I believe my son was damaged by his MMR vaccine.I was not provided with any information on the vaccine and I know if I would have had the opportunity or the advice to read some of this information I would not have had my child vaccinated with any triple vaccines,not just his MMR.There are posters in the waiting room telling us how important it is to have your child vaccinated because of the danger of measles,mumps and rubella but nothing to tell you of ANY risks with the vaccination and we all know that no vaccine can be said to be 100% safe.It should be the responsibility of the vaccine distributors to make sure parents are informed and can then make an informed decision by choice.My son got his MMR in September 1996 and sadly four years later parents are still no better informed.

MMR queries 29 January 2001
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Stephen Hughes,
GP principal
Market Deeping ,nr Peterborough

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Re: MMR queries

On the same day as reading the BMJ editorial I came across a thought provoking article in Private Eye on the MMR vaccine debate . This may not be the standard peer reviewed journal but we do have to thank the author for his role in the Bristol heart surgery debacle and many other serious points concerning current practice . The point of the Finnish study being a passive reporting concentrating on a few weeks after vaccination is well made and if true confirms that the study was not adequately looking for and unable to detect an increased incidence of autism . What are we to make of the increased incidence of diagnosis of autism since the introduction of the MMR vaccine ? I am not sure the editorial looked at this point in detail . Even if Wakefield's research is flawed what of the Japanese findings of measles virus genetically identical to MMR vaccine strains in some of his patients ? I would be interested in more expert opinion !

competing interest : daughter with autism

Alarm and sorrow 29 January 2001
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Andrew Hutchinson,
Prescribing Adviser
South Leeds Primary Care Group, Fountain Medical Centre, Little Fountain Street, Morley, Leeds LS 27

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Re: Alarm and sorrow

As a former drug information pharmacist, now prescribing adviser, and father of a two-and-a-half year old boy (who had his MMR), I have watched the MMR saga with a mixture of alarm and sorrow. Alarm that so much hype and partial information has surrounded coverage, particularly in the lay media, and sorrow that some parents may very well end up with a child dead or damaged from wild-type measles because they wanted to do the best by them and decided not to have them vaccinated.

Two things strike me. The first is to ask how Wakefield's papers have come to be published. As others have commented, if the accompanying editorial to the first Lancet paper had been reviewer's comments one can't quite see how the paper could be published in one of the world's leading medical journals. Now, according to your editorial today, there were basic errors in interpretation of some primary literature in the review in Adverse Drug React Toxicol Rev, omission of a key paper supporting the contrary view and errors of fact about the years in which MMR was licensed. The best scientist or doctor could write a bad paper - but the rest of us rely on the peer review process to screen out major problems before we do our own critical appraisal.

Secondly, we face a major public health problem in that most people - lay people and health professionals alike - do not understand risk, or at least, not in the terms that some epidemiologists and government departments portray them. All life may be six to five against, but I suspect most people find the risk of a "sin" of commision (having a child vaccinated) far more difficult to contemplate than a one of ommision - which they may not recognise as something over which they have any power.

The audience for reassurances about MMR is a mixed bunch. Some people want the figures, some distrust figures and would prefer a more "human" approach. Most of us would like a mix of both, to varying proportions. Of course there can rarely be adverse reactions to vaccine, and I am sure that once the doubt has been raised, parents of a child who develops autism must be racked with guilt and fear that they were responsible, at least in part. To vaccine-damaged children and their parents, and children with autism or Crohn's and their parents one must extend deepest sympathy and argue with them and others that all the resources we can muster should help them. But memory is short and people forget how serious wild-type measles can be. Those of my generation and younger probably have no direct experience. I recall, during my paediatric clerkship at UHW in Cardiff 10 years ago, a local pertussis outbreak. I remember a particularly harrased SHO talking to the parents of a child admitted for something else. On being told that they hadn't had the child vaccinated against pertussis for fear of vaccine risks, the SHO told them in no uncertain terms to "go down the corridor and talk to the parents of children who nearly died" and then come back and think again about having it. Perhaps explaining the risks of not vaccinating, in similar terms that most people can relate to, might help the message get across.

Andy Hutchinson

Irrational Support for Flawed Studies 30 January 2001
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John P Heptonstall,
Director of the Morley Acupuncture Clinic and Complementary Therapy Centre
West Yorkshire

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Re: Irrational Support for Flawed Studies

Editor

I find it quite disturbing that so many scientists can support obviously flawed research material in a domain said now to be desirous of 'evidence-based' medicine.

The authors labor, and support, points already described as deeply flawed by various eminent observers such as Prof. Pounder of the Royal Free.

For example:-

How can they consider the FIN study as scientifically valid for determining the potential adverse effects of MMR vaccine, autism and inflammatory bowel disorders, when the study failed to identify even ONE case in 1.8 million children in a country where statistical probability suggests there must be around 1800 children so afflicted with autism alone?

How can they suggest the SWEDISH study is a valid medium to consider a relationship between MMR and autism when it ignores the fact that most autistic children would not be diagnosed until over 8 years of age, therefore for MMR vaccines given in 1982 any recipients checked in 1988 for autism would be below the normal age of diagnosis and have been missed by the researchers?

I think the Swedish study contains a more sinister message; the autistic children discovered by that study pre- and post-1982 MMR vaccinations may more likly owe their autism to their 1970's measles jabs than the 1982 MMRs, thus questioning the argument that a single antigen measles vaccine ought to be safer than a triple, or indeed ANY measles vaccine.

This point is reinforced by

V. K. SINGH et al's study (Serological Association of Measles Virus and Human Herpesvirus-6 with Brain Autoantibodies in Autism, Clinical Immunology and Immunopathology, Vol 89, No. 1, Oct, pp 105-108, 1998) which was the first to report an association between virus serology and brain autoantibody in autism, supporting the hypothesis that a virus- induced autoimmune response may play a causal role in autism and, more importantly,by

V K SINGH et al's follow up study (which was refused publication in the Lancet for some reason) but which is to be published soon, and was reported to the 1998 annual conference of the American Association of Immunologists in abstract form by V. K. SINGH. The team used MMR vaccine and showed it's presence, by antibodies in the brain of autistic persons, significantly against controls.

The Sunday Express yesterday reported V.K.SINGH as saying "I strongly suspect MMR is not safe in certain children whose immune systems cannot cope with it and this is causing autism".

This scientist has spent a great deal of the last 10 years closely involved in autism research and, apart from the Japanese and Dr. Wakefields team, together with his own team, is probably the only scientist who has actually researched using the MMR vaccine on autistic persons to assess results. His warning should be taken seriously by all observers of whatever polarity, especially when the dearth of, and invalidity of, any opposing research provides for no alternative scientific view.

When my son was diagnosed autistic 10 years ago, aged 8 years (which was the typical age for children who obtained a diagnosis - and then as now many could not even obtain a diagnosis), reports said that 4 in 10,000 children would develop the condition, more boys than girls. Reports now say that autism may affect 1 in 1000 children while autistic traits affect 1 in 100 children, a dramatic increase in just a few years. Finland (the land of nil autism!) has seen a four-fold rise in a few years and has now, I believe, the highest childhood diabetes rate in the world. The USA has also recently reported a dramatic increase in autism.

Where has this epidemic come from?

The authors say that vaccines have been safely administerd worldwide in 250 million doses without major problems.

That is idiosyncratic nonsense, no one can claim safety anymore than efficacy on such a scale. Any deliberations are totally dependent on ADR reporting systems, which have been shown on so many occasions to be completely unsound - MORIDE et al 1997 showed the ommission rate could be as much as 24,500 to 1!

The 'truth' would therefore, according to the only argument left in the authors' article, lay in the Governments GREEN BOOK, not the scientific validity of available research but government propaganda based on flawed research; they assert that this should be accepted by medical professionals and parents alike.

I think the best immediate solution would be to remove the MMR completely, quickly assess whether the measles vaccine single antigen is safe, and suspend its use also until this has been done; a hidden scourge of this vaccine is highly probable due to serious abuses of the ADR reporting system by medical & pharmaceutical professionals and health advisors for years. The Government should provide strong surveillance for measles, rubella and mumps (all innocuous diseases of childhood when I was a lad and all of which I suffered along with all other kids I knew of my age without serious problems) until safe and efficacious vaccines can be produced that satisfy public and professions alike.

Those who scaremonger the public into believing that such a measure would be more dangerous than maintaining the current vaccine drive that appears to be disabling and destroying the lives of so many children through unreported ADRs should have to produce viable statistical proof that such a scenario will develop. All graphical representations of deaths and disability from such innocuous childhood diseases prior to and after the introduction of vaccines show they were already in rapid decline and had been since the turn of the last century.

Some children will suffer serious consequences from these diseases, but with proper surveillance, diagnosis and treatment, these effects will be minimised; we may then see a reduction of the newer so-called 'normal diseases of childhood' I rarely if ever saw when I was a lad - asthma, RA. ME, IBS, epilepsy, autism, diabetes, meningitis, cancers and leukaemias - from which so many children do now DIE.

Regards

John H.

Family members also get vaccinated again? 30 January 2001
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R J Orme

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Re: Family members also get vaccinated again?

I wonder how many other parents and members of the family of babies vaccinated against MMR, have caught the viruses?

Disseminating Information about MMR 30 January 2001
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Nigel Calvert,
Consultant in Communicable Disease Control
North Cumbria Health Authority

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Re: Disseminating Information about MMR

Dear Sir,

I wished to respond to two points raised by Eliman and Bedford in their editorial on MMR vaccine.

I agree wholeheartedly that health professionals need to be given time to digest research before it reaches the public domain. Time and time again, the first I know about some new piece of research is when I hear it on the radio on the way in to work. This often leaves little time to collect my thoughts before the media are asking for opinions and interviews. The widespread practice of giving advance copies of papers to the media before the health community has seen them needs to be reviewed.

I was also interested in the authors's statement that "We need urgently to identify and use the most effective methods for training and updating health professionals so that they can respond promptly and appropriately to parents' concerns". I have developed a website which is widely used by local health professionals, and others ( www.ncbugs.com). I have found this to be a useful and speedy way of getting information disseminated.

Yours faithfully

Dr Nigel Calvert
CCDC North Cumbria

Measles: Ocuous 1 February 2001
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Adrian Midgley,
GP, Exeter

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Re: Measles: Ocuous

Two children died of Measles in Dublin last year. Not inoccuous.

MMR and autism 1 February 2001
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Brian C Morrow,
Consultant Anaesthetist
Altnagelvin Hospital, Londonderry

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Re: MMR and autism

Dear Sir/Madam,

I would like to make some comments concerning the recent editorial about the on-going MMR controversy that have a more visceral than scientific basis.

Firstly would the authors give the MMR to one of their own children if there was an older sibling already affected by autism or if the infant had had behavioural or gastrointestinal effects after the first MMR vaccine?

Secondly in this age of non-paternalistic medical care is it not reasonable for parents to have a choice and be allowed to give a course of single vaccines? The health authorities will only state that all the current evidence points to no definite link with autism but they cannot state this with total certainty.

To a large extent most of the advances in autism have been parent- driven against a background of medical therapeutic nihilism. In the absence of definitive randomised double-blind placebo-controlled trials parents' fears about MMR should not be lightly dismissed.

Re: MMR and autism 3 February 2001
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A P Jackson,
University Lecturer
Department of Biochemistry, Cambridge, UK

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Re: Re: MMR and autism

Dr Brian C Morrow says: "the health authorities will only state that all the current evidence points to no definite link with autism but they cannot state this with total certainty". But of course they can't - it's logically impossible to prove a negative. It is fundamentally impossible to say that MMR doesn't cause autism for the same reason that it is impossible to prove that fairies don't exist. All that one can ever say is that no one (at least no one who is sober) has ever seen a fairy and the existence of fairies is highly unlikely on a priori grounds. Now admittedly, the "MMR causes autism" scare is not at the same level of improbability as the existence of fairies. But the similarities are nonetheless closer that many people seem to realise. Firstly, no rigorous epidemiological study has ever detected a convincing link between the MMR vaccine and autism. Secondly, the proposed mechanism by which this link is supposed to occur seems highly contrived. According to Dr Wakefield, the MMV vaccine is supposed to somehow allow peptides from the gut to cross into the circulation and hence to cross the blood-brain barrier and cause precise neurological damage leading to autism. Frankly, this theory seems to have been plucked out of thin air. What peptides? Have they been isolated? What is their sequence?

Re: MMR and autism 3 February 2001
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Zubair Kabir,
Research Officer
St James's Hospital, Dublin 8

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Re: Re: MMR and autism

Sir/Madam.

A double-blinded randomised controlled trial is more 'scientific' than 'visceral'. Such 'gold' standard experiments need human volunteers for carrying out trials. Parents' fears can only be allayed when they consent to volunteer their children for such trials and wait for the results rather than being 'back-seat' drivers. As of now, the current body of evidence related to studies such as MMR vaccine may be considered 'scientific' until such 'gold' standard experiments are 'engineered'.

Regards,

Zubair Kabir

Re: MMR and autism 5 February 2001
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Joseph Watine
Hôpital de Rodez, France

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Re: Re: MMR and autism

Being the father of a 19 year old autistic boy, I have had the opportunity to observe not only my boy, but also a number of other boys and girls categorised as being autistic. What has always puzzled me is the extreme variability of these boys’ and girls’ clinical pictures. Wouldn’t it be difficult for MMR vaccine alone to account for such a wide range of symptoms?

Re: Re: MMR and autism 6 February 2001
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John P Heptonstall,
Director of The Morley Acupuncture Clinic and Complementary Therapy Centre
West Yroskhire

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Re: Re: Re: MMR and autism

Editor and Joseph

Having an interest in autism for some years now (my 18 Years old son) and studying the potential for vaccines to induce autism witness the large amount of anecdote, I wrote to 'Communication' the journal of the National Autistic Society to enquire of ther parenst whether they believed vaccines had caused their childrens' autism.

The responses I received suggested that other vaccines may also play a part. Could this be one of the reasons for variability in autistic traits?

The split of parents who clearly believed that DTP, or MMR, caused their childrens' autism was about 50:50. A small proportion thought BCG may have been the cause.

A Singapore lady contacted me and said that autism there seemed to be timed later than the UK's, and this followed the pattern of vaccination which is later than ours; I informed our local CCDC Head of this and auggested he may like to enquire of the Singapore Health authorities. I do not know if he did.

I suspect that a child's inability to cope with certain viruses plays a part in autism, and the increase in 'virus' attacks synonymous with mass vaccination has probably increased the number, variety, and perhaps susceptibility, of children to wild and attenuated viruses.

Autism has been linked to congenital rubella, to measles, and encephalopathies are an accepted result of mumps, DTP, MMR, etc. both through research and anecdotally.

Perhaps the resulting outcomes, short and long-term, of 'attentuation' of viruses are little understood and the whole of 'vaccine sciebce' needs loooking at very carefully; my own impression is that we have reached a stage where vaccines are considered a potenial panacea for virtually any condition yet basic vaccine science is poorly described.

Regards

John H.

MMR vaccine: the continuing saga 6 February 2001
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Arun Mukerjee,
Consultant in Public Health Medicine (Communicable Disease) and Immunisation Coordinator
Grampian Health Board, 2, Eday Road, Aberdeen AB15 6RE

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Re: MMR vaccine: the continuing saga

MMR vaccine: the continuing saga.

EDITOR - The editorial by Elliman and Bradford1 is reassuring but will not provided enough information to the general practitioners to change parental attitude towards the safety of MMR. Parents are asking why the scientific evidence put forward by Wakefield and Montgomery2 in favour of the safety of single antigens should not be accepted and why their children should not have what is considered as the safest option i.e.single antigen doses of MMR. MMR factsheets3 quote safety statistics on MMR but do not provide the information the parents are asking for.

Instead of rejecting parental concern as idiosyncratic it is important to find out the reason for their concern. Wakefield and Montgomery2 have recommended single antigens on the assumption that the administration of combined measles, mumps, rubella vaccine would replicate the effects of co -infection with wild viruses. Parents and professionals need to understand that infection with wild viruses results in invasion of the immune system that may lead to immune-suppression, as rightly stated by Wakefield and Montgomery2. Vaccination with the attenuated virus strains (used in MMR) interact with the immune system and induce immunity against infection.

Many parents have spent more hours studying the paper2, which questioned the safety of MMR than most of the busy health care professionals but failed to grasp the subtle difference between infection and immunisation. Joint Committee on Vaccination and Immunisation should produce fact sheets that would enable health care professionals to respond to parental arguments for single antigens in scientific terms as well as educate both the parents and professionals about the safety of MMR vaccine4.

Arun Mukerjee,
Consultant in Public Health Medicine (Communicable Disease) and Immunisation Co-ordinator,
Grampian Health Board, 2, Eday Road, Aberdeen AB15 6RE.
arun.mukerjee@ghb.grampian.scot.nhs

1.Elliman D, Bedford H. MMR vaccine: the continuing saga. BMJ 2001; 322:183-84 (27 January).

2. Wakefield AJ, Montgomery SM. Measles, mumps, rubella vaccine: Through a glass, darkly. Adverse Drug Reactions and Toxicological Reviews 2000; 19(4):265-83.

3.Public Health Link. Update on MMR vaccine, CEM/CMO/2001/1, 12 January 2001.

4.Petrovic M, Roberts R, Ramsay M. Second dose measles, mumps and rubella vaccine: questionnaire survey of health professionals. BMJ 2001, 322:82-85 (13 January)

Competing interests: None declared

Safety of Vaccines 9 February 2001
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Zubair Kabir,
Research Officer
St James's Hospital, Dublin 8

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Re: Safety of Vaccines

Dear Editor

Immunisations are one of the most cost-effective and widely used public health interventions. No vaccine is perfectly safe or effective. As the incidence of vaccine-preventable diseases is reduced by increasing coverage with an efficacious vaccine, vaccine adverse events become increasingly frequent and prominent. The adverse events may be caused by vaccines or may be associated with vaccination by coincidence. In such ‘maturing’ immunisation programs, monitoring and assessment of suspected vaccine adverse events are critical to prevent loss of public confidence, decreased vaccination coverage and likely return of epidemic diseases with intermittent outbreaks. Hence, research in vaccine safety can help distinguish ‘true’ vaccine reactions from coincidental events. Nonetheless, ‘substantial gaps and limitations’ exist in knowledge and research infrastructure for vaccine safety, despite two centuries of vaccinations.

The reason that a higher standard of safety is generally expected of vaccines than other medical interventions is the administration of vaccines to ‘healthy’ people unlike the medications given to ‘ill’ people. Tolerance of adverse reactions to vaccines given to healthy people (healthy infants, in particular), is substantially lower than to medications given to people who are already sick. This lower risk tolerance for vaccines necessitates investigations into the possible causes of much rarer adverse events. The medical maxim ‘first do no harm’ may apply more in public health than in clinical medicine, where decisions affect fewer people. Immunisation is unlike most other medical procedures (e.g. surgery), however, in that the consequences of the decision affect not only the individual, but also others in the society. Moreover, vaccine safety investigations should be accurate and timely because of their extremely narrow margins for error. In contrast to many classes of medications for which other effective therapy may be substituted, vaccines generally have few alternatives. Consequently, several countries have established ‘compensation programs’ for people who may have been injured by vaccinations.

In pre-immunisation era, vaccine-preventable diseases were so prevalent that the risks and benefits of disease versus vaccination were readily evident. As immunisation programs successfully reduced the incidence of vaccine-preventable diseases, an increasing proportion of health care providers and parents have little or no personal experience with vaccine-preventable diseases. For their risk-benefit analysis, they are forced to rely on historical and other more distant descriptions of vaccine-preventable diseases in textbooks, or educational brochures. Combined with media that seek controversy and information posted in the Internet, the art of handling vaccine safety concerns has ‘emerged’ as an increasingly important skill for health managers of today. Individuals differ in their perceptions of risk depending on their personality, education, and life experience. Perceptions of risk may differ dramatically depending on whether the ‘stakeholder’ is a member of the government, the industry, the average parent, or the parent of a vaccine- injured child. Voluntary risks (e.g. driving a car) are usually more acceptable than involuntary risks (e.g. mandated immunisation). For quantitatively equivalent risk that is due to action (e.g. vaccination reaction) versus inaction (e.g. vaccine-preventable disease caused by non- vaccination), many people have an omission bias in that they prefer the consequences of ‘inaction’ to ‘action.’

In many countries, people who believe they or their children were injured by vaccine have organised to provide information that highlights the risks of and the alternatives to immunisation. These consumer activists argue that even if the vaccine risks are rare, if you are the person with the reaction, the risk is 100%. They have been increasingly successful in airing their views in both electronic and print media, frequently with ‘poignant’ individual stories. Materials to counter the misconceptions and allegations about immunisations are developed and made available via the Internet ( www.cdc.gov/nip/vacsafe). This battle for the ‘hearts and minds’ of the public in need of vaccination will clearly continue to be waged for some time. A healthy dose of ‘empathy, patience, scientific curiosity and substantial resources may be needed in dealing with vaccine safety concerns. The increasing computerisation and centralisation of health care services may facilitate epidemiological studies to reassure the public about the safety of future vaccines. Vaccine safety studies cannot be studied directly unlike other areas of safety (e.g. food, blood, transport, etc), but can be only inferred by the sum of its ‘inverse’. This approach requires a systematic accumulation of negative findings, which may be more difficult to publish than positive findings. Scientifically, it is also more challenging to prove than disprove a concept, especially proving a negative concept. Nevertheless, vaccines are the most important instrument in the medical armamentarium and the potential of the biotechnology revolution in providing the medical profession with new tools to prevent disease, indicates that the 21st century will be known as the ‘Century of the Vaccines’.

Regards,

Zubair Kabir

Re: Safety of Vaccines 11 February 2001
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John P Heptonstall,
Director of The Morley Acupuncture Clinic and Complementary Therapy Centre
West Yorkshire

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Re: Re: Safety of Vaccines

Editor

I agree with much of Zubair Kabir says, particularly that it is extremely important that the public and scientists are fully aware of the risk/benefit status of all vaccines, and that parents and recipients are fully informed and have complete choice about vaccines.

I would ask

1. How does one really assess true risk of vaccine?

2. Are the current practices for assessing risk adequate, and accurate?

3. If they are not, how does one make valued judgement about safety of vaccines such that one can state with any degree of surety that 'vaccines are safe'?

4. Do you accept that ADR reporting is abysmally poor, and this is the main system relied upon by science to assess safety of vaccines once mass-prescribed?

5. Is there any ongoing, or indeed any serious, research into the potential for 'preventable by vaccine' diseases to be transforemd into other disorders as a direct result of vaccination other than the autism/IBD scenario? For example MS and ME have reached epidemic proportions coincident with mass vaccination and some observers have linked these with Polio vaccine, Hepatitis B vaccine and others; could this be resulting 'fallout' due to those mass vaccinations?

These questions seem to be fundamental if one is to be able to offer reliable advice on the safety and efficacy of vaccines; I wonder if Zubair can answer them?

Regards

John H.

A battle of 'hearts and minds'!! 15 February 2001
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Zubair Kabir,
Research Officer
St. James's Hospital, Dublin 8

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Re: A battle of 'hearts and minds'!!

Dear Editor,

Despite highlighting the ‘risk communication principles’ of vaccine safety in my eletter, I again ‘empathise’ with the risk perception of John Heptonstall (a parent of a vaccine-injured child). To my mind, his ‘understanding’ of immunisation in general, and vaccine safety in particular, appears to be ‘limited’. This is consistent with a recent survey showing that "25% of parents believed that their child’s immune system could actually be weakened by too many immunisations. Nearly the same proportion of parents thought that their children were already getting more vaccines than was good for them". (1) "Traditionally, questions regarding the safety of vaccines came from members of the scientific community and were addressed by laboratory scientists, regulators, and epidemiologists during the course of vaccine development, clinical trials, and post-licensure surveillance. In recent years, however, stimulated by anecdotes and provocative stories highlighting the temporal sequence of events, concern has arisen about possible causal relation between immunisation and such disorders as sudden infant death syndrome, diabetes and autism". (1) Unfortunately, I belong to the former community and coincidentally, John is influenced by the latter. The questions, however, raised by John, surprisingly, are not only ‘fundamental’ but also ‘scientific’.

PubMed- a scientific database, hope John admits, shows ‘2625’ peer- reviewed journals on entering the search words ‘vaccine safety’ as of now. The numbers boil down to ‘35’ and ‘3’ on entering ‘vaccine safety & MMR’ and ‘vaccine safety, MMR & autism’, respectively. I wonder if the extent of John’s understanding is limited to the last category. Not only this, I wonder if his ‘information’ is updated ‘scientifically’ and ‘regularly’, if not, the latest edition of a peer-reviewed journal (The New England Journal of Medicine), of which the whole scientific community is proud, adequately addresses John’s Question Nos 2, 3 & 5.(1, 2, 3) In fairness, the concluding three paragraphs of the editorial of the same journal are ‘keys’ to John’s ‘ignorance’.(1) Question No ‘5’ is ‘extensively and scientifically’ addressed in two successive articles of the same journal.(2,3) Moreover, the study area as well as the study group of the respective articles, are all from reputed and proven scientific community. Question No ‘1’, I am afraid, is normally beyond the reach of general public. However, it is explained in the most simple terms in one of the text books, as a self-explanatory table. (4) The remaining, question no ‘4,’ is again addressed in the same text-book, recently reviewed by the Lancet (5) as a ‘must-read’ for EVERYONE including John. (4)

Response, such as, the recent one by John, is a ‘re-awakening’ to the ‘sleeping’ scientific community. To quote the concluding few lines of the recent editorial in NEJM, "we need to make a concerted effort to educate everyone about what vaccines do and do not do and about the fact that temporal sequence does not demonstrate causality. The voice of science is important, but we cannot expect that scientific facts alone will be persuasive, especially since proving the absence of harm is the ultimate goal of studies of vaccine safety. If improved education is not successful, the fruits of our investments in immunisation- both now and in the future-are likely to be viewed with scepticism, and necessary vaccines may remain on the shelf." (1) I wonder if John has any clue to the ‘questions’ raised in the same editorial. Nonetheless, I will be happy to answer further ‘fundamental’ questions.

Regards,

Dr Zubair Kabir MBBS MD MSc

References:

1. Gellin BG, Schaffner W. The risk of vaccination-the importance of "negative" studies. (Editorial). The New England Journal of Medicine 2001; 344: 372-373. 2. Ascherio A, Zhang SM, Hernan MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. The New England Journal of Medicine 2001; 344: 327-32. 3. Confavreux C, Suissa S, Saddier P et al. Vaccination and the risk of relapse in multiple sclerosis. The New England Journal of Medicine 2001; 344: 319-26. 4. Chen RT. Safety of Vaccines. In: Plotkin SA, Mortimer E, Orenstein WA (ed). Vaccines. London: WB Saunders, 1999; 1154: Table 49-5. 5. Quadros CA de. Roadmap for vaccinations in the new millennium. The Lancet 1999; 354 (9194): 2006-7.

Re: A battle of 'hearts and minds'!! against the odds. 21 February 2001
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John P Heptonstall,
Director of The Morley Acupuncture Clinic and Complementary Therapy Centre
West Yorkshire

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Re: Re: A battle of 'hearts and minds'!! against the odds.

Editor

I thank Zubair for attempts to answer some of my questions.

As, according to Zubair, a parent whose "concerns are consistent with a recent survey showing 25% of parents believe their child's immune system could be weakened by too many immunisations; a similar proportion thinking their children were getting more vaccines than was good for them" I admit that the basis for this comparison eludes me, scientifically, and is worrying when Zubair continues apace with more apparent inconsistencies...

Zubair's response appears to be a regurgitation of the Editorial (1) statements, which are more opinion than fact where evidence of vaccine safety is concerned. He uses the quote "traditionally, questions regarding the safety of vaccines came from members of the scientific community.....post licensure surveillance.....recent years, however, stimulated by anecdotes and provocative stories highlighting the temporal sequence of events......" as though one should exclude public experience, anecdote and opinion let alone scientific analysis of the situation by the public, from vaccine safety concerns. He says I am informed by the latter and not the former - I can quickly assure him that I am informed through collation, analysis and conclusions based on several thousand abstracts, articles, research papers and other avenues of direct and circumstantial evidence I have read this past 7 or 8 years. I have not restricted myself to PubMed or the New England Journal of Medicine or Editorials thereof to seek the truth.

I am influenced by objective well-reasoned, scientific, empirical and compelling anecdotal evidence from whatever source comes my way; I do not exclude anyone or anything - as a trained scientist, I see that as good scientific practice.

I found Zubair's answers to my "surprisingly scientific questions" surprisingly lacking in scientific clarity:-

- I admit that I do not see PubMed as a "scientific database" but as a database FOR scientific data, not always OF scientific data (and not necessarily the fault of PubMed).

- Zubair's use of (1) to support his answers to my questions failed; it appears to avoid tackling evidence of vaccine damage and merely regurgitates tired old arguments "perceptions of risk are amplified", "causes remain unknown", "only well designed, well conducted epidemiological studies can determine which events are causally related"...yet where are these studies? I particularly like the statement "the fact that temporal sequence does not demonstrate causality" and will bear this in mind the next time I hear of yet another child who died within a few hours of immunisation, and for whom the pathologist and coroner decide on a verdict of death by unexplained or natural causes.

- Zubair's reference to (2)(3) ought to question why Hepatitis B vaccine is tested for induction of MS and not measles vaccine, as measles had been causally related to MS. One might say these were 'expected negative result studies'.

- Consequently Zubairs references 1-3 not only fail to answer my "fundamental" questions but actually throw additional doubt on the science and scientific acumen used to answer such questions posed regularly by the public.

- as to the paragraphs Zubair claims are "keys to my ignorance" I would quote the great scientist Alexander Fleming....."it's not very scientific but it helps"; unfortunately it doesn't help the public very much.

- to clarify issues of vaccine safety Zubair refers me to a book written by Pasteur Merieux Connaught and USA CDC scientists, and a paper written by an esteemed scientist of the Pan American Health Organisation, all of whom are dedicated to the spread of vaccines worldwide. I would prefer a more variable and potentially more objective authorship - no offence to the authors - and as such have analysed many scientific papers to move towards the truth.....

Zubair appears to have avoided the main question posed

How does one assess the true risks and safety of mass prescribed vaccines, and is an effective accurate ADR reporting system the main tool upon which these issues currently rely? (7)(8)

Perhaps I can help in deliberations over this question:-

1. Surely the major objective scientific and virtually unquestionable method to assess true risk and safety of vaccines is a prospective study of a large cohort of vaccinees of a particular vaccine, set against an equal cohort of completely unvaccinated (and there is a growing number) where accurate ADR reporting is enforced and seen by all medical praticipants as essential, and this is performed over complete lifetimes of the cohort with as detailed follow-up as possible. MORIDE et al (1977) showed in Bordeaux, France, that accurate ADR reporting can be obtained (it increased ADR reports by physicians by 24,500 times!).

2. Certain UK vaccines are potentially contaminated with BSE products over several years; pharmaceutical companies supplying those products knew this and did little about this leaving hundreds of thousands, perhaps millions of British children now under threat of nvCJD some time in the future. Can we really trust pharmaceutical companies and their research? Should parents be concerned?

3. New Zealand and other countries have used inadequate research to support 'vaccine safety'. A study referring to the period 1990-95 "confirmed the overall safety of vaccines and the value of an ADR monitoring system" which apparently only looked at immediate reactions to vaccine registered by the vaccinators (rash, fever, pain at injection site, headache etc.). Was there NO evidence sought through long term follow-up? If not how can those vaccines be declared safe? (4) A Turkish study arrived at similar conclusions for their vaccines with only 7 days 'active surveillance'. (9)

4. The WHO is developing greater vaccine safety measures since large areas of failure have been found globally, particularly in Africa where mass vaccinations have been carried out for decades under conditions of serious logistical failure (poor sterilisation, reused needles, improper disposal of used materials, failure to instigate nursing practices, transport, vaccine supply and quality etc.). (5)(6). Just how safe has the mass vaccination of Africans really been this past few decades and how many African children have been mortally wounded by 'safe vaccines' in that period? Are African parents allowed a voice, or must they also subjugate themselves to the measured voice of 'scientists' such as Zubair?

5. "Relatively little is known about immunopathogenesis of even the best characterised vaccine-associated ADR...In the developed world the paediatric immunisation schedule is becoming crowded with pressure to administer increasing numbers of antigens simultaneously in ever simpler forms......the available epidemiological tools to address issues (of immunopathogenesis, ADRs) are somewhat limited" (8). Immunotoxity, the effect of ADRs to drugs, industrial chemicals , environmentals and biological materials on the immune system has little scientific method from which to be defined. (13). Clearly scientists do not understand vaccine immunotoxicity? Should parents be concerned?

6. SV-40 contamination of the Salk polio vaccine prior to 1962 has left hundreds of millions of people at risk in later life from various forms of cancer; should the public consider this in their quest for truth and safety with vaccine science? (10)(11) Should they be concerned?

7. ADR reporting is abysmally inadequate (MORIDE et al 1997); Countries such as the USA depend to a large extent on ADR reporting to assess the risk/benefit status of vaccines. The passive surveillance system VAERS picked up the following ADRs during a study into acellular pertussis vaccines in the USA for the first two years data collection:-

From January 1995 to June 1998.

285 deaths, 971 non-fatal serious ADRs, and 4514 less serious ADRs. Assuming the ADR reporting system is as abysmal as it may be, what would true figures reveal when adjusted for ADR reporting system failings? (12)

8. Vaccines have been passed as safe and licensed (perhaps supported by entries in PubMed and the NEJM) only to be withdrawn months or years later. (14). Should parents be concerned?

The "sleeping scientific community" to which Zubair refers must be those involved in vaccine research this past few decades. Like Zubair they probably hoped the public would 'stay asleep' so they could continue to bumble along decade after decade, gradually refining (and redefining)their science whilst trying to ignore the devastation caused through contamination, inadequate science to explain what they were doing, seriously fatal logistical failures, transmutation of attenuated viruses, reversion of such viruses back to wild once DNA is available, and little understanding of the immunotoxicity or immunopathogenesis of their products which governments have readily inserted into an unsuspecting, trusting public; all this and a reputation for medical interventions which create the 3rd or 4th biggest killer and maimer of mankind. It is easy to see why parents and the general public are begining to read the literature and apply logic, as well as scientific acumen, to what they find.

My heart goes out to all those dedicated, objective and compassionate medics and medical researchers who suffer the fall-out from such 'scientific mumbo-jumbo' that tars them with the same brush.

My heart also goes out to all the children and their families who, through vaccine contamination, adverse reaction, reversion, logistical inadequacies, an abysmal ADR reporting system, pseudoscientific papers extolling the virtues of vaccines later recalled, have died or are suffering chronic debilitating iatrogenically induced disorders.

I suppose it is really for them that I write this.

Regards

John H.

References

1. NEJM 2001; 344: 372-373

2. NEJM 2001; 344: 327-332

3. NEJM 2001; 344: 319-326

4. Mansoor O, Pillans PI, NZ Med J 1997 Jul 25; 110 (1048): 270-2

5. Dicko M et al, Bull WHO 2000; 78(2): 163-9

6. Mehta U et al, Bull WHO 2000; 78(2) : 170-7

7. Collet et al, Bull WHO 2000; 78(2): 178-85

8. Ward BJ, Bull WHO 2000; 78(2):205-15

9. Kanra G et al, Turk J Pediatr 1999 Oct-Dec; 41(4): 421-7

10. Sierra-Honigmann A, Krause PR, Bilogicals 2000 Mar; 28(1): 1-4

11. Lambert SM, Markel H, Arch Pediatr Adolesc Med 2000 May; 154(5): 512-7

12. Braun MM et al, Pediatrics 2000 Oct; 106(4): E51

13. Burns C, Burns P, Holsapple M, Ann Epidemiol 2000 Oct 1; 10(7): 471-2

14. Coffin SE, Curr Infect Dis Rep 2000 Feb; 2(1): 68-72

Viagra vs MMR 22 February 2001
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Lisa Blakemore-Brown,
Independent Psychologist -Specialising in Autism
UK

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Re: Viagra vs MMR

Forgive my cynicism - you will know that I KNOW children who have been vaccine damaged - and I don't need to wait for many more years of study and cost to pass to confirm that - but I cannot help wondering why there is s rapid concern about fatalities reported by GP'S about men who choose to take Viagra - but not about children who are FORCED to take MMR. The health fears relate to 73 deaths in 3 years in men who have taken Viagra. I'm certain there can be absolutely no connection at all. After all - temporality does not equal causality...I'm certain that this is just a perceived risk - even in those with heart problems, like those children with allergies.

Keep taking the tablets boys, you're in safe hands.

Cause-effect relationship: a scientific judgment or an old tired argument? 23 February 2001
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Zubair Kabir,
Research Officer
St James's Hospital, Dublin 8

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Re: Cause-effect relationship: a scientific judgment or an old tired argument?

Editor,

I thank John for his ‘wealth of information’, which he loves to ‘regurgitate’ passionately.

Information is not knowledge. Knowledge is not always an art, and art is never a science. Alternatively, science is the ‘judicious’ application of one’s basic knowledge and skills conceived ‘subjectively’ but mastered ‘objectively’ over a period of rigorous training in a proven scientific community. A well-informed man is not ‘always’ knowledgeable or scientific. Epidemiology is a science and ‘demands’ training as well as respect. Epidemilogic studies are not only ‘scientific’ but also assessed ‘objectively’. Sorry, I was ‘never’ a teacher good at ‘communication skills’. However, I think a quick ‘discourse’ may help resolve some misunderstandings and clarify misconceptions. A well-conceived scientific research is ‘never’ a collection of bones from different graveyards. It also functions as a human ‘heart’ pulsating with dedication, devotion and application of skills ‘objectively’ to the betterment of the whole mankind down the ages. The gist of arguments in my earlier ‘eletters’ was very clear- the importance of ‘negative’ findings in epidemiologic studies, such as safety of vaccines. Unfortunately, John missed them in a ‘regular’ but ‘consistent’ fashion, possibly due to his ‘tubular and constricted’ vision. To my mind, John is also treatment (argument)-resistant.

Conceptually, to arrive at a ‘cause-effect relationship’, is not everybody’s cup of tea. For a ‘trained scientist’, surprisingly, it may be an ‘old tired argument’. Epidemiologically, a causal relationship is based on a matter of belief or judgment not only in accordance with some ‘guidelines’ but also on the best possible evidence available at the moment. The guidelines do not limit to the ‘temporal sequence’ of events, the strength of association, biological plausibility, consistency and specificity of association must also be considered in inferring a causal link. I am sorry to say that John is trying to cross the table and make ‘judgments’ on cause-effect relationship, which I think is generally ‘reserved’ for a specific section of the society. This was more evident when John ‘seriously’ confused between ‘association’ and ‘a causal link’stating that measles was 'causally related' to MS. Even Dr Andrew Wakefield did not claim a ‘causal’ relationship, rather an ‘association’ between MMR and autism in his report in 1998. Hence, the moot point, who is to blame for this goof up?

Secondly, I am surprised at John’s ‘attempt’ to ‘design’ a scientific research to assess ‘true’ risk and safety of vaccines. I wonder if the scientific community is really ‘sleeping’ over the issue? It is more interesting to know whether John ‘understands’ the different types of ‘risks’ measured to assess the strength of an association in any epidemiologic studies, more so, their public health implications. ‘ADR’ reporting is not the sine qua none. There are better alternatives. Reason coupled with patience and time may be an answer to such alternatives. Vaccine-associated adverse events can be ‘effectively’ and ‘credibly’ detected through pharmacovigilance, for distinguishing ‘causal’ reactions from ‘coincidental’ reactions by pharmacoepidemiological or other studies, and for risk communication. (1.2.3) I repeat, without such a system, vaccine-safety concerns may snowball into societal tragedies when the media and the public confuse ‘ASSOCIATION’ with ‘CAUSALITY’ and shun immunisation. This painful history was shared by the UK (among others) over pertussis in the 1970s (4) after another similar case-series was widely publicised, (5) and is likely to be repeated all too easily over MMR. This would be tragic because ‘passion’ would then conquer ‘reason’ and the facts again not only in the UK but also in other developed nations.

A reminder of the well-known British statistician, Sir Bradford Hill, who cautioned: "All scientific work is incomplete- whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. This does not confer upon a freedom to ignore the knowledge we already have, or to postpone the action that it appears to demand at a given time. Who knows, asked Robert Browning, but that the world may end to-night? True, but on available evidence most of us make ready to commute on the 8.30 next day." (6)

Regards,

Zubair

References:

1. Howsen CP, Howe CJ, Fineberg HV, eds. Institute of Medicine. Adverse effects of pertussis and rubella vaccines: a report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. Washington DC: National Academy Press, 1991.

2. Stratton KR, Howe CJ, Johnstone RB, eds. Adverse events associated with childhood vaccines: evidence bearing causality. Washington DC: National Academy Press, 1994.

3. Chen RT. Special methodological issues in pharmacoepidemiology studies of vaccine safety. In: Strom BL, ed. Pharmacoepidemiology. Chichester: John Wiley, 1994: 581-94.

4. Gangarosa EJ, Galazaka AM, Wolfe CR, et al. Impact of the anti- vaccine movements on pertussis control: the untold story. Lancet 1998; 351: 356-61.

5. Kulenkampff M, Schwartzman JS, Wilson J. Neurological complications of pertussis inoculation. Arch Dis Child 1974; 49: 46-49.

6. Hill AB. The envioronment and disease: association or causation? Proc. R. Soc. Med. 1965; 58: 295.

Re: Cause-effect relationship: a scientific judgment or an old tired argument? 25 February 2001
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Alan Challoner,
Retired

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Re: Re: Cause-effect relationship: a scientific judgment or an old tired argument?

Zubair Kabir writes, "... vaccine-safety concerns may snowball into societal tragedies when the media and the public confuse ‘ASSOCIATION’ with ‘CAUSALITY’ and shun immunisation. This painful history was shared by the UK (among others) over pertussis in the 1970s (4) after another similar case-series was widely publicised, (5) and is likely to be repeated all too easily over MMR. This would be tragic because ‘passion’ would then conquer ‘reason’ and the facts again not only in the UK but also in other developed nations." I feel I must return to reiterate what I wrote earlier, parents are probably very well aware of the value to society of vaccination. However, until there are adequate safeguards to compensate for individual tragedies, they will not take heed of Zubair's "societal tragedies" for the obvious reason that they are further away from home. Zubair also seems to ride roughshod over the actual experiences of parents who have seen their child suffer the after-effects of vaccination - on the instant. Now that it has been satisfactorily refuted that such adverse events are 'infantile convulsions' coincidental to the vaccination, it will be interesting to know how the brain damage that such children suffer is explained in Zubair's actual experience. What facts and reasoning can he provide that will allow parents, who now have a life-long disabled person to care for, to believe that the vaccination had nothing to do with it? With one or two exceptions it seems that the medical professionals who believe there to be a connection, are those who have a family member affected.

Re: Cause-effect relationship: a scientific judgment or an old tired argument? 1 March 2001
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John P Heptonstall,
Director of The Morley Acupuncture Clinic and Complementary Therapy Centre
West Yorkshire

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Re: Re: Cause-effect relationship: a scientific judgment or an old tired argument?

Editor

Editor

In response to points made by Zubair: -

1. The Concise Oxford Dictionary (COD) says “Information” is “knowledge”.

2. One cannot restrict ‘science’ to a ‘proven scientific community’. Science is “a branch of knowledge conducted on objective principles involving the systematised observation of an experiment with phenomena, esp. concerned with material & functions of the physical universes” and is also defined as “archaic knowledge of any kind” (COD). It cannot be monopolised by any person or group.

3. Scientists cannot always agree on the way forward: “We consulted more than 50 infectious disease experts in epidemiology, government, medicine, nursing, obstetrics and gynaecology, paediatrics and surgery. In light of the disagreement regarding the implementation of standard, we used group discussions to reach a consensus…” (1) Krause PJ et al, 1994.

4. I think there are a number of archaeologists and palaeontologists who would disagree with the statement “well-conceived scientific research is never a collection of bones from different graveyards”.

5. I agree “well-conceived scientific research functions with the application of skills ‘objectively’ to the betterment of the whole of mankind”; unfortunately not all scientific research is well-conceived. Much has brought mankind to the brink of destruction, forging noxious swathes through a once healthy-giving environment and assuring the extinction of many species along the way. Hardly examples of ‘betterment’.

6. The politics of ‘science’ often precludes the ideal Zubair and I aspire to: “Without high quality research there can be no high quality evidence on which to base effective health care. But in Britain the infrastructure which generates that research has long been sick…. to make matters worse, the mechanisms for measuring research quality – and allocating research funds - is ‘misleading unscientific and unjust’…it has no means of capturing the clinical impact of research, as distinct from its academic influence; and even in its measurement of academic impact it is crude, relying on the flawed measure of journal impact factor. Nor has it any mechanism for recognising new areas of research.” (2) Goldbeck-Wood BMJ2000.

7. “Negative findings” in epidemiological studies can be important; it depends on whether the study was designed to answer the questions now asked. For example, Peltola et al (Finland MMR) and Gillberg et al (Sweden MMR) presumably did not design their studies to answer questions they are now alleged by government to answer about autism; they are not good examples of ‘negative findings’.

8. I think pharmacovigilence requires greater scientific maturity, as I noted in my last response, before it can provide a more reliable source of vaccine side- effect data from the masses than a properly administered ADR-reporting system. The immunotoxicity and immunopathogenesis of vaccines is poorly understood for an immune system that is exposed vaccine ‘assaults’ which cannot be adequately quantified by the scientists carrying them out. I would suggest that current best evidence is ‘the horses mouth’ – assuming that horse is still alive, retains sufficient cognitive ability and is old enough to respond; otherwise parents may be the best witnesses.

9. With respect to cause/association for measles/MS, I provide the following quotes. “Data regarding the immunological abnormalities to measles virus (MV) and the presence of neurological complications induced by MV infection suggest that MV may be a CAUSATIVE AGENT of the demyelisation observed in MS” (3) “To sum up, our results suggest an INVOLVEMENT OF MEASLES VIRUS in at least some of the MS patients considered” (4) “We believe that intra BBB IgG synthesis is CAUSED BY a persistent antigen, most likely a virus, possible measles” (5). “These findings support the view that there IS A DISTINCT MEASLES VIRUS SPECIFIC impairment in cell-mediated cytotoxicity in MS” (6).

10. I think that the historical reality of whether refusal of pertussis vaccine caused more harm than good is clouded with medico- political prose just like the MMR debate. One cannot ascertain clearly whether the increased morbidity and mortality associated with childhood epilepsy, diabetes, bacterial meningitis, IBD, cancers, MS, leukaemias, severe allergies (disorders one hardly heard of in the ‘50s and ‘60s) coincident with mass vaccination campaigns outweigh the dangers of outbreaks of wild viruses such as measles, mumps, pertussis or rubella. Most necessary databases currently available are inexcusably useless due to contamination with flawed material and inadequate reporting by physicians.

11. A concerned researcher made the following comments in 1977 which illustrate the futility of predicting effects of vaccine-science despite a position of assumed expertise: “Because the event causing MS is believed to occur before the age of 15 and MS begins on the average by age 30, a 15 years lag in the effect of measles vaccine on MS frequency is to be expected. Mass measles vaccination was begun in 1965 thus by 1980 a decline in MS frequency might be looked for as a test of the hypothesis… perhaps by then the Pan American Congress of Neurology shall be able to report that MS is disappearing” (7) Alter M, 1977. Alter was obviously over-optimistic, and reminded me of a conversation I had with a Canadian physician at an alt. med. conference in 1990; she had noticed ‘an alarming increase in young people in wheelchairs with MS and ME’ in the shopping precincts of her large city through the 1980’s, precincts which hardly ever saw such sufferers till then.

Although I appreciate the dedication shown by scientists like Zubair, one often feels that much research data is being accepted almost without question despite the terrible flaws in our national data collection and recording systems.

Regards

John H.

References

1. “Quality standard for assurance of measles immunity among health workers. The Infectious Diseases Society of America”, Krause PJ et al, Infect Control Hosp Epidemiol 1994 Mar; 15(3): 193-9

2. “Reviving academic medicine in Britain” Goldbeck-Wood, BMJ 2000; 320: 591-2 (4 March)

3. “Multiple sclerosis and measles virus”, Ohara Y, Jpn J Infect Dis 1999 Oct; 52(5): 198-200

4. “Serum and cerebrospinal fluid antibodies against measles virus in patients with MS”, Ferrante P et al, Arch Sci Med (Torino) 1982 Jan-Mar; 139

5. “The long march of the cerebrospinal fluid profile indicative of clinical definite multiple sclerosis; is still marching”, Tourtellotee WW et al, J Neuroimmunol 1988 Dec; 20(2-3): 217-27

6. “Virus specific cytotoxic T lymphocytes in MS: a normal mumps virus response adds support for a distinct impairment in the measles virus response”, Goodman AD et al, J Neuroimmunol 1989 May; 22(3): 201-9

7. “Is multiple sclerosis an age-dependent host response to measles?” Alter M, Neurol Neurocir Psiquiatr 1977: 18(2-3 Suppl): 341-55