TO THE NUFFIELD COUNCIL ON BIOETHICS CONSULTATION ON "PUBLIC HEALTH: ETHICAL ISSUES"
SUBMITTED BY CLIFFORD G. MILLER
15th September 2006
revised & resubmitted 27th September 2006

Qualification
This response has to be prefaced with the remarks that any consultation by The Nuffield Council on Bioethics, especially one funded jointly by the Medical Research Council, the Nuffield Foundation and the Wellcome Trust is unlikely to be anything other than partial.

Further, in view of the facts stated below, one has to question whether it is at all possible that someone as personally and so closely involved with the matters described, with so close personal interests and direct responsibilities as some of the members of your Working Party are in previous roles in public health matters in this country, can in any way be considered otherwise.  That therefore casts a shadow over any findings.

Everything stated here can be verified independently for accuracy. As I only learnt of this "consultation" the day before the last day for submissions this paper lacks some of the references I would normally cite.  What is said here is firmly driven by the head and the known facts. 

Flawed Consultation
This Consultation is based on a flawed assumption.  Unless and until the following issues are answered fully, impartially and by wholly independent duly authoritative persons, no actions of the kind implied by the questions posed by this "Consultation" can be justified, clinically, economically or ethically.

To demonstrate this and as will be shown here, there is good evidence that our public health officials have been historically and continue to be responsible for overseeing the uncomfortable increases in allergies, asthma and the related mortality and morbidity that plague public health today.  There is also good evidence to show that the harm caused greatly outweighs the benefits claimed for interventions which have no adequate safety basis in any literature or in fact.

That evidence also suggests the facts set out below have been known for a very long time to a very select few who have chosen to ignore the merited concerns of the many and have failed to research basic safety issues.    These are not the only problems they have been overseeing and are responsible for.

The current position regarding the increases in allergies and asthma are documented in a very recent paper from "Thorax" (1st September).  It can be found here:-
Time trends in allergic disorders in the UK.  Thorax. Published Online First: 1 September 2006. doi:10.1136/thx.2004.038844

THE ASTHMA AND ALLERGY DISASTER
The Bigger Picture
The attached extract of Glaxo's 2004 Report & Accounts demonstrates why there is such reluctance on the part of vaccine manufacturers to broadcast to the public what causes their and their childrens' asthma and allergies.  It shows one third of Glaxo's sales turnover, £4.5 billion of a £17 billion total sales turnover comes from asthma medication and nearly another £1 billion comes from vaccine sales. 

What Causes Asthma and Allergies Is Long Known
There are some peer reviewed publications on this issue, but the literature is scant.  In no small part this is due to the abject failure of the Medical Research Council to fund ground-breaking research and to start asking the questions proper scientists should ask.  And it should be borne in mind that not only are the medical community not proper scientists, but their medical training trains them to think in a fashion that is the antithesis to science.  A true scientist has no truck with questioning the existence of the very ground by which his or her feet are supported. 

Excipients, adjuvants and preservatives (like thiomersal) in vaccines cause sensitisation.  This has been known for years to a select few (including Glaxo). The following item which I had published in the British Medical Journal responses has embedded links to factual reference material:-

Avoiding Adjuvants & Excipients Can Avoid Allergies Clifford G. Miller - 10 September 2006
Here is a 2005 paper which found unvaccinated children have less asthma and allergy than vaccinated:-
"The relationship between vaccine refusal and self-report of atopic disease in children." ( J Allergy Clin Immunol. 2005 Apr;115(4):737-44.)
As a side note which illustrates the current atmosphere relating to criticism of vaccination programmes, when I challenged the lead author over the final statement, she replied "at least they published".  The paper concludes:-
"Parents who refuse vaccinations reported less asthma and allergies in their unvaccinated children. ........ The known benefits of vaccination currently outweigh the unproved risk of allergic disease."
"Unproved" is revealing.  It is the more so when in the light of this:-
"Big rise in patients with deadly allergies  - Children are worst hit by rise in killer reactions"
The Observer - Sunday April 16, 2006 - Jamie Doward, home affairs editor"
This is a story I researched and placed with The Observer.  It is one I intend to publish a peer reviewed paper on.  Can the MRC be relied on to sponsor research of this kind?  That is to be doubted in view of the history of playing safe and keeping to the status quo.

The Human and Financial Cost of Asthma
Here is a summary of the statistics showing asthma beats measles and the costs of measles (source: Asthma UK - a charity funded by the pharmaceutical industry):- Asthma is a significant problem in the US also:
AAAAI  Media Resources: Media Kit - Asthma Statistics  Source: American Academy of Allergy, Asthma & Immunology asthma statistics

The American Academy of Allergy, Asthma & Immunology is the largest professional medical specialty organization in the United States, representing allergists, asthma specialists, clinical immunologists, allied health professionals, and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has nearly 6,300 members in the United States, Canada and 60 other countries.
 
Please bear in mind, asthma and allergies are just one area.  There is justified cause for concern in a many others which have increased significantly.  Obesity which this "Consultation" refers to has recently been linked to asthma.  That posits a link to the same causes.  There are extraordinary increases across the board in other areas also, including diabetes and cancers.   And yet when faced by the scale of evidence that exists those nominally responsible fail to carry out the safety studies which will demonstrate the interventions are unsafe and continue with them in the blind belief that the benefit outweighs the harm.  Regrettably, anyone with eyes to see knows that is a traverse of the reality.


SNAPSHOT OF MEASLES
Please see the attached .pdf graph from ONS mortality stats.  Measles vaccine was introduced in 1968.  However, by 1967 measles deaths had fallen to a ten year average of 86 pa for all ages.  And deaths had been dropping fast and were continuing to drop. 

 
10 Year Period to 10 Year Average
1939 2368
1949 568
1959 163
1967 86

All childhood diseases follow this identical pattern.  I can produce graphs for all the diseases from the offical statistics from ONS which I have in electronic form.

Please note that 21 children pa are now dying from asthma.  The Anaphylaxis Campaign estimates 20 deaths pa from anaphylaxis.  The current deaths are quickly balancing out any claimed savings particularly because measles mortality was still falling rapidly when the vaccine was introduced.

Morbidity must also be taken into account - the adverse effects of measles in the few children who perhaps may be left deaf or brain damaged. 

Two factors need to be considered on this.  As mortality fell, morbidity also fell.  Further, and we now know, measles is much easier to treat than previously thought and with simple treatments.  Peer reviewed studies show we can prevent the worst effects of measles with vitamin A supplementation.  This has the advantage over vaccination of providing broader disease protection and also poorer children will grow up overall healthier and stronger with less disease.  Had we been developing treatments over the past 30 years in addition to immunoglobulin and vitamin A we would have no issue on this at all now.  

Vitamin A supplementation has been shown to reduce the mortality rate due to measles dramatically.  In this randomised clinical trial only 2 deaths in the vitamin A treated group against 10 in the placebo group.  And it reduced morbidity by half:-
A randomized, controlled trial of vitamin A in children with severe measles. Hussey GD, Klein M. N Engl J Med. 1990 Jul 19;323(3):160-4
There are a number of peer reviewed publications documenting the effect of vitamin A on human disease resistance.  WHO have been busily scurrying around the world administering vitamin A to third world children and have even been looking at a genetically modified rice rich in vitamin A as a way of enhancing children's own disease resistance.

Without doubt the already low and falling mortality and morbidity from measles could have been eradicated by developing the treatments we already know of.  Whilst not so lucrative as vaccines for the pharmaceutical industry, the overall cost/benefit to the nation financially and in life quality would undoubtedly be a safer healthier nation with a substantially reduced burden on social, healthcare and education budgets.

Further, the effects of what we are doing to the sick and malnourished children of the third world have yet to be studied.  WHO produces only "estimates" to support an intervention which on the above figures it seems we may have difficulty justifying clinically, economically or ethically for our own first world children.

It is interesting in the light of the foregoing, that whilst the pharmaceutical industry has successfully lobbied at an EU level for stringent controls on vitamin, health food and food supplements, I am informed that they have also been busy buying up these competiting businesses.  And this perhaps is at a lower price had the new EU laws not been effected.

There is a temptation to say, "OK, let's have vaccines without excipients and adjuvants".  Will that be the solution?  "Solution" suggests there is a problem and careful study of the trends indicate that the "problem" is nothing like what we have been led to believe but of lesser significance regardless of our failures to develop effective treatments.  Further, even if there was a problem and even if a need was demonstrated, the safety would need to be established before any step could be taken.

I am quietly confident that any truly independent, impartial and careful analysis would indicate that overall cost/benefit for the individual, the nation and the third world is weighted heavily in favour of alternative interventions.

It is also my belief that in addition to there being scant safety information on long term acute and chronic illness caused by vaccination practices, our New Labour government will be unable to lay their hands on a single cost/benefit study either at all or one that survives any reasonable scrutiny.  I had, for example, requested under FOIA, a copy of the cost benefit analysis underpinning the proposals to introduce universal varicella vaccination.  What I was sent did not vaguely resemble any form of cost/benefit analysis.

THE AVALANCHE OF AUTISM
 
I have submitted a paper on 26th September for peer review in a medical journal which lays claim to demonstrating that the increase in pervasive development disorders/autistic disorders (DSM IV/ICD10) since the mid 1980s:- The conclusions are presented on the basis of three sets of data from four independent and diverse sources, and which data support the paper's conclusions.  One of the sets of data draws on the study Advancing Paternal Age and Autism [1] published Monday 4th September in the Archives of General Psychiatry in combination with the Baird paper published in July this year [2].

The Baird and Paternal Age papers indicate an increase in PDDs of up to 1200 percent between the mid 1980s and 1996, of which the minimum increase in autism is 300% on Baird's narrow definition and is otherwise 450% on Baird's figures based on DSM IV/ICD 10 criteria.  Previously this increase has been dismissed as "better diagnosis" and "greater awareness" as the government and others claim.   Baird in combination with the Paternal Age study permit an "apples for apples" comparison based on contemporary criteria applied to subjects born respectively in a two year period ending not later than 1996 and a six year period ending no later than 1988.

These two papers, in combination with other papers documenting PDD prevalences, confirm the problem is international and validates at least order of scale comparisons of prevalence across first world western economy boundaries.

It is of interest that a lawyer living in a village in Kent is publishing peer reviewed papers on these kinds of topics.  The MRC's investigations into the links between autism and immunisation omitted consideration of relevant material and predictably played safe by closely following the status quo.

However, apart from why it is that a lawyer is writing these kinds of papers when the MRC has not been, the questions people should be asking are:- These are questions I sincerely doubt this "Consultation" will either address or answer with any conviction or convincing answers.

Research for the MRC
Clearly, time is long overdue for proper studies comparing exposed populations to non exposed populations in careful independent and impartial studies.  Regrettably, there does not seem much chance of that happening.

As it is tacitly accepted by the authors of the Paternal Age paper and as appears to be the case from a review of the literature, that a study of jewish Israeli subjects born in Israel can be relevant to subjects born and living in other nations, there must therefore be good reason to study why autism appears to be almost unknown in the Amish.  The argument that the Amish might be genetically different is clearly an inappropriate diversion from appropriate action.  A further study of a population of Israeli citizens published in 2001 [3] concludes (and MRC take careful note):-
 
"The epidemiological characteristics found in the Haifa area are similar to those reported from non-Israeli communities. This finding supports an underlying biological mechanism for this disorder. These data can be used for future trend analyses in Israel."
 

A Review of the MRC's Approach To Autism Research

I quote with his express general permission, the following statements to me in a private communication from Paul Shattock, Director of the Autism Research Unit, University of Sunderland. 

"....... I know that some very eminent child psychistrists (Baird, Le-Couteur and others) submitted an excellent proposal for gluten free trials and autism but the MRC turned it down and funded studies that are of comparatively minor interest or usefulness. ............
 
The vast majority of their money appears to be spent on genetics or on brain imaging which may be of scientific interest but so far has given a completely nil return in terms of practical benefits to people with ASDs or their families. .......................

............. We are self funding a number of biggish projects right now. ................. Quite frankly, the only way one can conduct the research that actually needs doing is to get your own money. MRC funded research is so "safe" ....
 
......... the MRC has performed pathetically and betrayed people with ASDs and the politicians who should be able to leave such decisions to them. .......

 
I think the MRC actually believe that they are doing a good job in only funding studies that fit in with their own agendas - what we, as parents, think of as "so what?" research.
 
..... all the meaningful research has involved parental input. All the biomedical teams are either run by parents (such as ours; Rimland's studies) or have substantial parent input in terms of finance and moral support (Reichelt's in Norway, Waring's, Jill James (Arkansas) and, of course, Wakefield's).
 
....... I am not saying that the genetic, brainscanning type studies should not be done but they should be accompanied and balanced by areas which hold promise of useful interventions or prevention.........
 
I stress that I am not attacking physicians or researchers (geneticists or otherwise) who do get grants. These are the areas in which they are expert and in which they work. They could not pretend otherwise.
 
Fortunately, the American NIMH seem to have had a kick up the bottom and just this year are looking at projects that are of relevance. I would like to think that the MRC would take a leaf out of their book."
 
Conclusion
In the light of the foregoing, any conclusions of this "Consultation", which is funded and executed by those among whose number seem to be representatives of the vested and other interests responsible for overseeing what is the largest public health disaster in history, can happily be ignored in so far as any pretence is made as to their reliability as independent conclusions.  What they cannot be ignored as is their likely use as a political tool to continue the public health mayhem started in the 1980s without any safety studies of any note and continued to this day in the same fashion.

Publication of two peer reviewed papers, one currently in press and one in review to follow shortly.  Other papers in research.

Sincerely,       

Clifford G. Miller
CLIFFORD MILLER
50 Burnhill Road, Beckenham, Kent BR3 3LA, England

REFERENCES
[1] “Advancing Paternal Age and Autism” Abraham Reichenberg; Raz Gross; Mark Weiser; Michealine Bresnahan; Jeremy Silverman; Susan Harlap; Jonathan Rabinowitz; Cory Shulman; Dolores Malaspina; Gad Lubin; Haim Y. Knobler; Michael Davidson; Ezra SusserArch Gen Psychiatry 2006; 63: 1026-1032

[2] Prevalence of disorders of the autism spectrum in a population cohort of children in South Thames: the Special Needs and Autism Project (SNAP). Baird G, Simonoff E, Pickles A, Chandler S, Loucas T, Meldrum D, Charman T. Lancet. 2006 Jul 15;368(9531):210-5.

[3] Autism in the Haifa area--an epidemiological perspective. Michael Davidovitch, MD, Gabriela Holtzman, MD and Emanuel Tirosh, MD.IMAJ 2001: 3: March: 188-189