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Re: Research into cot deaths
 

Jonathan Gornall’s paper on sudden infant deaths raises important issues about redefining cot deaths as well as the direction of research into SIDS1. With the availability of paediatric pathology services and advances in various diagnostic facilities, the number of sudden unexpected infant deaths attributed to SIDS has been steadily narrowed down.

At the North Cheshire Hospital, taking a five year cohort of cot deaths, there was a yearly average of 15.5 babies classed as to have died of SIDS between1970-4 compared with 8.6 between 1985-9. Despite the Back to Sleep campaign the yearly average has remained relatively unchanged in the last fifteen years (Table 1).

Table 1: Yearly average of cot deaths seen at North Cheshire Hospital

1970-4 (15.5); 1975-9 (11.4); 1980-4 (8.2); 1985-9 (8.6); 1990-4 (3.4); 1995-9 (3.8); 2000-4 (4.1)

Redefining cot deaths as SUDI has expanded the remit of investigation into the cause/association of these tragic infant deaths; the proportion of unascertained cases, currently around 25 % of cot deaths, is likely to increase. Use of multi-agency protocol for management of SUDI is helping to identify other important contributing factors. Parental smoking has been identified to be one of the major associations and recently parental alcohol intake with bed sharing or sleeping in parents’ arms or on a sofa have been identified as other risk factors/triggers2,3. Apparent life threatening events are common in these infants before the fatal event and parental smoking and formula feeding and important risk factors4.

Decades of research has helped us to identify at-risk communities, various triggers and the pattern of cot deaths. Should the focus of research and investigation also be directed towards looking at various strategies in reducing the cot death among the at-risk geographically defined populations?

References:

1.Gornall J. Does Cot Death still exist? BMJ 2008:336;302-304

2.Mir NA. Alcohol as an important risk factor for Sudden Unexplained Deaths in Infancy. Arch Dis Child (2007):adc.bmj.com/cgi/eletters/92/2/195

3.Mitchell EA, Milerad J. Smoking and sudden infant death syndrome. In: Tobacco Free Initiative. International consultation on environmental tobacco smoke (ETS) and child health. Geneva: World Health Organisation, 1999:105-29.

4.Mir NA, Hussen N. Apparent Life threatening event in infancy. Paper Europaediatrics Prague 19-22 2003.

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Re: Inappropriate parenting, inadequate investigation and cot death causality.
 

Annie Groves, chief deputy coroner in Vanderburgh County, Indiana, does not believe in SIDS deaths. “If you do a complete investigation, you will find a cause of death,” she says. This degree of certainty will no doubt be of great comfort to the parents of Christopher Blum who died suddenly in his cot in June 1987.

Guardian journalist Audrey Gillan reported,

“Christopher Blum was four months old when he died. His father found him in his bedroom, rigid and cold in his Babygro, his hands bunched up beside his face, a tear of blood dried around his nose. The pathologist told the parents that their son had died of cot death. They didn't believe it, and they still don't. Hours before his death, Christopher had been given a triple vaccination. That was in June 1987. Since then, his body has been lying in a London mortuary, his tiny frame kept at -8C, wrapped in a package at the back of an adult-sized drawer that is rarely opened by staff, and marked "Baby Blum: Deceased."” [1]

http://www.guardian.co.uk/frontpage/story/0,,2001042,00.html

“And there Christopher will stay until he is either buried or cremated. There is no sign of either. His parents refuse to register the death which would allow the funeral to take place. The Blums simply do not wish their son's death certificate to carry the words "sudden infant death syndrome".

Mr Blum “has demanded that an inquest be opened into the death. However, Dr Bill Dolman, the North London coroner, told the Guardian that will not happen. "I was not the coroner at the time of this infant's death. I am just very distressed that this poor man has been living with strong feelings and worries which all the investigations and postmortems have not resolved. I do hope that things can be resolved, I just wonder if he just can't face the tragic truth of the matter.” Mr Blum does not see how the case will be resolved. "I hope it won't go on forever," he said. "Of course I want to have him buried. If they release him now I'll bury him, but I am not going to sign the register if it says cot death."

Of course, since Christopher died, “a lot has been learnt about the major modifiable risk factors and the role of parenting in cot death”, says journalist Jonathan Gornall. He even reports that maternal smoking during pregnancy has now met the criteria for causality of such deaths. Good news for the Blums: it is now almost certain that that an alternative cause of death can be ascertained and Christopher Blum can be buried along with the inappropriate diagnosis of SIDS.

[1] Frozen in time. Christopher has lain in a mortuary for 20 years. His family will not bury him. Audrey Gillan. The Guardian. Monday 29.01.07

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Re: Re: Inappropriate parenting, inadequate investigation and cot death causality.
 

How many "cot deaths" have been associated with a baby or infant being put to sleep with a soft pillow? Surely no pillows are necessary and are inadvisable?

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Re: SIDS and VACCINES
 

Editor,

“It continually surprises me that so many published debates, particularly in the media where one expects at least a modicum of investigative ability, fail to entertain or acknowledge the highly probable links between SIDS and childhood vaccinations. Granted there may be other causes, from the chemical constituents of bedding to the way the child lies in sleep or to parental smoking and other household pollutants, but the case for a proportion of SIDS being caused by vaccinations seems irrefutable,” said John Heptonstall in 1999 {BMJ Rapid Response 24th November}. He was responding to the article by Green and Limerick ‘Time to put ‘cot death’ to bed.[1]

The failure “to entertain or acknowledge the highly probable links between SIDS and childhood vaccinations” is what has sent some innocent parents to prison. Perhaps an Investigative Journalist could heed John Heptonstall's excellent advice and submit the result to the Editor of the BMJ.

Michael Innis

Reference:

1.Green MA, Limeridk S. Time to put ‘cot death’ to bed? BMJ 1999;607 -700

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Re: Include vaccine damage in differential diagnosis for cot death
 

Mark Struthers reminds us of the tragic case of baby Blum in 1987 reported in The Guardian, "Hours before his death, Christopher had been given a triple vaccination"

20 years later Neville Hodgkinson reminds us that Sally Clark's child was given a triple vaccination "with a known history of adverse reactions" 5 hours before his death. (1)

The Minutes of meetings of the Adverse Reactions to Vaccination commercial groups in the UK; VAERS in the USA; the Brighton Collaboration and the Yellow card scheme all provide evidence of baby deaths following vaccination.

The day that is admitted and included in the differential diagnosis, is the day we can stop using SIDS and cot death terminology.

1. What killed Sally Clark’s child? | The Spectator 16 May 2007 www.spectator.co.uk/archive/features/30630/what-killed-sally-clarks- child.thtml

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Re: Re: Include vaccine damage in differential diagnosis for cot death
 

Just to recall a key paragraph from Neville Hodgkinson's article:

"An examination of related legal and other correspondence has now made clear the reason for this extraordinary omission. It is that child health experts, following public loss of confidence in vaccination when the risks of brain damage were first publicised, were trying to maintain a united front in preventing further debate. Even paediatricians who gave testimony on Mrs Clark’s behalf told defence lawyers that if vaccination were mentioned as a possible cause of Harry’s death, they would dispute it. Not wanting to confuse the jury, and with judges having a history of bowing to dominant medical opinion, the defence decided to stay silent on the issue.

Neville Hodgkinson, 'What killed Sally Clark's child', http://www.spectator.co.uk/the-magazine/cartoons/30630/what-killed-sally- clarks-child.thtml

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Re: SIDS is not a disease entity
 

Jonathon Gornall’s excellent article is very important.

SIDS is not a disease entity. It is a description of an outcome. It is a term used to acknowledge a failure to make a diagnosis. The value of the term is that it informs us that no blame is apportioned to the carer. The weakness is that it implies that we understand more than we do. The new term SUDI or Sudden Unexpected Death in Infancy is unfortunate in that it would have been better if the 'U' stood for 'unexplained' rather than 'unexpected'. Our vital function is to explain this process and by doing so eliminate it

It is important to understand that while parents are usually blameless for the death, they may still be partly responsible. For instance, a whole generation of parents laid their babies face down in the cot, believing that they were doing the best. If the parents have contributed to the cause of death we do them a disservice by not saying so.

We know the major risk factors that predispose to cot deaths. These do not strictly cause the death but make it more probable. We still need to understand the triggers and the mode of death.

We could do more to understand these triggers and the mode of death. A cot death is almost never observed and that suggests that, had appropriate action been taken, the death would have been avoided. From time to time paediatricians see babies who appear to be on the point of death. Some have respiratory infections. They perk up with oxygen, and then appear only to have minor illnesses. It seems that the hypoxia causes a vicious cycle of under breathing. We see similar recoveries in some babies with gastroenteritis when given intravenous fluids. If these babies had been unobserved at night and had died, I doubt that the pathologist would have recognised the severity of illness that these seemingly minor infections had induced. One could envisage similar outcomes with arrhythmias, with hypoglycaemia or with fits. Babies who sleep close to their mothers may be protected by the early recognition of these illnesses.

The Care of the Next Infant scheme could devise a comprehensive surveillance of infants at risk that included loop video recording, heart rate monitoring, perhaps other monitoring and an alarm that would both alert the parent and also provide a record of the event so that we might both avoid the death and better understand the process.

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Re: A timely debate
 

It sometimes takes an outsider to point out that the emperor has no clothes. Jonathan Gornall has performed this salutary function in his article - though in this case it’s not that the emperor is naked, rather that his clothes have worn so thin they’re no longer respectable.

One item of nomenclature first needs to be clarified. Gornall uses the term “cot death” as synonymous with “Sudden Infant Death Syndrome” (SIDS). Many people make a distinction between the two, describing as a cot death any sudden and unexpected death of a baby for which no cause is immediately apparent, while using SIDS in its more restricted definition of a sudden and unexpected death that remains unexplained after thorough investigation. Although SIDS is a category of exclusion and not a positive diagnosis, it’s acceptable as a “cause” of death for the purposes of registration. Cot death in the generic sense certainly does still exist and probably always will, and there’ll always be a need to determine the cause of each death and to support the parents. However, in the light of recent advances it does indeed seem timely to question whether there’s still a place for the term SIDS.

After the term was introduced in 1969, SIDS soon became the largest category of deaths in infancy outside the neonatal period. A great deal of money and effort was expended all over the world to try and discover its causes. As Gornall points out, the outcome of this research has been mostly disappointing. Each new theory has been enthusiastically hailed as the holy grail, only to prove, in time, to be either unfounded or relevant to a very small proportion of deaths. The main reason for the poor progress was the early focus on pathology rather than epidemiology. This focus was determined partly by the higher status and greater glamour of clinical and laboratory work as compared with epidemiology and health education, and partly by the understandable need of bereaved parents for an answer that didn’t leave them feeling responsible. It’s less painful to think that your baby died from a heart disorder nobody knew about than because you smoked in pregnancy.

Pathology has made some helpful contributions, the most notable being the demonstration that a small number of unexpected deaths result from inborn errors of metabolism. A far greater reduction in deaths, however, has resulted from detailed epidemiological studies that have identified the major risk factors. But the mechanisms by which these factors operate remain largely unknown - perhaps this is a productive area for future laboratory research. Meanwhile there’s a growing debate as to whether deaths associated with well-known and avoidable risk factors, such as co- sleeping on a sofa, should be attributed to SIDS, to accident or to negligence.

Thus in recent years the number of unexplained deaths that can be properly classified as SIDS has been steadily eroded, on one side by identification of causative disease, on the other by recognition of risk factors. Now only a rump of truly unexplained deaths remains, so that, as Gornall suggests, it’s debatable whether the term SIDS still has a useful role. Some would argue that it’s positively unhelpful, because it may take the edge off the quest for an underlying cause of death. Those who work in the SIDS arena, rather than regretting that their subject is dwindling before their eyes, can be glad that their success, though late in coming, has now almost done them out of a job.

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Re: Alarmist and misleading
 

Mark Struthers, Michael Innis, Lisa Blakemore-Brown and John Stone all appear to support the view expressed by John Heptonstall in 1999, and quoted here by Innis, that the link between SIDS and childhood vaccinations is “highly probable”. But where was Heptonstall’s evidence - and where is their evidence?

Such alarmist and misleading conspiracy theories make interesting reading, but should not be confused with fact.

The Centers for Disease Control and Prevention rebuts this dangerous old chestnut on its website: “From 2 to 4 months old, babies begin their primary course of vaccinations. This is also the peak age for sudden infant death syndrome (SIDS). The timing of these two events has led some people to believe they might be related. However, studies have concluded that vaccinations are not a risk factor for SIDS.” [1]

Blakemore-Brown and Stone also invoke Neville Hodgkinson’s May 2007 Spectator article, “What killed Sally Clark’s child?”. In the article, Hodgkinson stated that “the most likely cause of Harry’s death” was an adverse reaction to vaccines, although he appeared to have no evidence for the claim.

He further suggested that the vaccine defence was not raised at Sally Clark’s trial because “child health experts, following public loss of confidence in vaccination when the risks of brain damage were first publicised, were trying to maintain a united front in preventing further debate”.

I wonder what Sally Clark’s legal team made of the implied suggestion that they preferred to see their client go to jail for a crime she did not commit rather than upset the public-health status quo?

Hodgkinson was dealt with in a letter written in response to his article by Dr David Elliman, Dr Helen Bedford and Dr Patricia Hamilton, President of the Royal College of Paediatrics and Child Health, and published in full on the Great Ormond Street Hospital website. [2] Although no doubt regarded by some as yet further evidence of a sinister conspiracy, it is worth quoting here at length:

“Neville Hodgkinson argues that there is a strong possibility that the death of one of the [Clark] boys was due to the DTP (diphtheria/tetanus/whooping cough) vaccine he had recently received. Vaccines are one of the most researched aspects of modern medicine and this suggestion is not supported by the evidence. A major US review, in 2003, of the proposed role of vaccines in cot death concluded that the evidence ‘favors rejection of a causal relationship between DTwP vaccine and SIDS’. There is no credible research that contradicts this conclusion.

“Neville Hodgkinson refers to an unpublished report, produced by Professor Gordon Stewart, showing the whooping cough vaccine was ineffective. Professor Stewart’s views on the vaccine are well-known and are not supported by the facts. There is considerable evidence that the vaccine in use in UK was highly effective, as is the new one. Similarly Neville Hodgkinson suggests that there is a strong case that autism is caused by vaccines. There is now a large body of evidence showing this is not the case, for any vaccine, including MMR.

“We ask that journalists check credible scientific evidence before making misleading statements that could have serious consequences.”

[1] www.cdc.gov/od/science/iso/concerns/sids_faq.htm

[2] www.ich.ucl.ac.uk/pressoffice/pressrelease_00524

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Re: cot death is a syndrome
 

Sir

The journalist Jonathan Gornall asks, does ' cot death' still exist? (feature BMJ 9 February P302) and goes on to claim that work over the past two decades makes it possible to attribute most cases to parental neglect or incompetence - citing figures which suggest that the association with maternal smoking during pregnancy is causal.

'Cot death ' (SID) is of course, not a diagnosis, but a category comprising babies found dead in their cots without the cause being apparent. While we hope in the long run to be able to assign an immediate cause in the vast majority of cases, this is not the state of affairs at present - though a number of associations have been established and there is accumulating evidence that amongst them may be rare inborn errors, accidental or intentional suffocation and possibly allergy and overwhelming infection.

Smoking in pregnancy is obviously not directly causal and it is not understood how its effects on intrauterine development predispose to mortality after birth.

The journalistic approach taken to the subject by Johathan Gornall does not do justice to the complexity of the phenomenon.

Yours faithfully

John A Davis

(One time Chairman of the Research Committee of the FSID but not speaking for that body)

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Re: Whose fault was it exactly?
 

"A whole generation of parents laid their babies face down in the cot, believing that they were doing the best."

Yes, that is because they were acting on the advice of health professionals - so, "if the parents have contributed to the cause of death" that was due to advice they were being given by "experts".

According to Dr Ruth Gilbert, of the Institute of Child Health, University College London (1), by 1970 there was significant evidence from clinical research that putting babies to sleep on their front increased the risk of cot death, compared with putting the babies on their backs. By 1986 it could have been shown that sleeping on the front was more harmful than any other position.

“The safest position, on the back, was not consistently recommended until 1995. The ‘Back to Sleep’ campaign had a dramatic effect on sudden infant death, but was not launched until November 1991.”

Dr Gilbert says that advice to put infants to sleep on the front for nearly a half century was “contrary to evidence available from 1970 that this was likely to be harmful”. A systematic review of preventable risk factors for SIDS from 1970 would have led to earlier recognition of the harms of sleeping on the front and might have prevented over 10,000 infant deaths in the UK and at least 50,000 in Europe, the USA, and Australasia.

These findings show that wrong advice can cost lives.

So, whose fault was it anyway?

1. http://www.ich.ucl.ac.uk/pressoffice/pressrelease_00334

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Re: Curiouser and curiouser
 

In his statement of evidence for the vanishing diagnosis of SIDS, Jonathan Gornall stated that,

“... Britain’s leading SIDS research team concluded that maternal smoking during pregnancy—already a recognised factor in 90% of cot death cases—met the criteria for causality and was directly responsible for 60% of such deaths”.

However, it would appear that a near temporal association of vaccination can be safely ignored while maternal smoking in pregnancy can find itself promoted from significant risk factor to a certifiable cause of death in an infant who dies unexpectedly. This is curious.

Of course, any curiosity in the matter is immediately satisfied when one understands that a diagnosis of murder by maternal smothering was preferred over one of SIDS in an infant who had died five hours after his first vaccination. [1]

[1] What killed Sally Clark’s child? Neville Hodgkinson, Wednesday, 16th May 2007. http://www.spectator.co.uk/archive/features/30630/what-killed-sally-clarks -child.thtml

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Re: Re: Alarmist and misleading
 

Jonathan Gornall claims myself and others have no evidence that deaths (and other reactions) have followed vaccines. In my response I referred to VAERS, to the Brighton Collaboration,the Yellow Card scheme and to the commercial meetings of the ARVI - Adverse Reactions to Vaccinations and Immunisations which Mr Gornall appears to have ignored.

I quote from the July 1987 ARVI meeting, as just one example: " The paper on anaphylaxis including Yellow Card reports to the CSM, protocols for treatment of anaphylaxis, dosage regimens and training, was prescribed. It was felt that reassurance could be derived from the small number of deaths (3) from 212 reports of anaphylaxis, anaphylactoid reactions and allergy. The Chairman suggested that an advisory group should convene to provide advice on anaphylaxis with Professor Hull as Chairman and Professor Breckenridge, Dr McGuinness and Dr Salisbury as members" (1)

Neville Hodgkinson referred to the Sally Clark case and to the evidence that one of the infants had received vaccines hours before they died. This cannot be ignored.

1) Adverse Reactions to Vaccinations and Immunisations (ARVI) meeting. Minutes 6th July 1987 10.30 am . Room 1611/12 Market Towers . http://www.dh.gov.uk/assetRoot/04/13/53/12/04135312.pdf

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Re: Re: Alarmist and misleading
 

Jonathan Gornall fails to note my reply to Drs Elliman, Bedford and Hamilton in the Spectator [1]. In point of fact Prof Stewart's views about the ineffectiveness of pertussis vaccine were corroborated by a recent Medical Research Council Study supported study published in BMJ [2]. The study concluded:

"For school age children presenting to primary care with a cough lasting two weeks or more, a diagnosis of whooping cough should be considered even if the child has been immunised. Making a secure diagnosis of whooping cough may prevent inappropriate investigations and treatment." [2]

I recall myself having a whooping cough like illness as a child, despite being immunised - about the lack of safety I can also give testimony.

The other point is that the confidence of Drs Elliman, Bedford and Hamilton that Harry Clark was not adversely affected by receiving five vaccines hours before death is not evidence based. Gornall complains that correspondents do not have evidence, but actually the investigations were never carried out by the appropriate parties. If this happens every time there is an issue of adverse events with vaccine, what is the evidence base? For Harry and Sally Clark, not even a yellow card, apparently.

[1] John Stone, Letter: 'Vaccination Risks', Spectator 2 June 2007, http://findarticles.com/p/articles/mi_qa3724/is_20070602/ai_n19287980

[2] Harnden et al, 'Whooping cough in school age children with persistent cough: prospective cohort study in primary care', 22 July 2006. http://www.bmj.com/cgi/content/full/333/7560/174

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Re: Re: Curiouser and curiouser
 

Editor,

"Of course, any curiosity in the matter is immediately satisfied when one understands that a diagnosis of murder by maternal smothering was preferred over one of SIDS in an infant who had died five hours after his first vaccination" says Mark Struthers.

To prevent death following vaccination Alan Clemetson's opinion is;

"There are very rare instances of severe reactions or even death following the usual infant inoculations. Although such events are rare, we need to do all we can to prevent them.

Animal observations have shown that the blood histamine concentration is increased following the injection of vaccines or toxoids and this is most likely responsible for the problems.

Vitamin C supplementation is now known to reduce the blood histamine levels; it also reduces the mortality rates following inoculations, both in animals and in man.

It is suggested that inoculations should not be given to severely debilitated infants and that supplementary vitamin C should be given in orange juice, before inoculation, to any infant with coryza, and also to any infant or adult who is to receive an unduly large number of inoculations at one time.

Moreover, vitamin C should be given by injection whenever convulsions or other untoward events occur within a day or two after vaccination or inoculation."[1]

Why not try Clemetson's suggestions - out of curiosity?

Michael Innis

Reference:

1. C. Alan B. Clemetson, M.D. Vaccinations, Inoculations and Ascorbic Acid The Journal of Orthomolecular Medicine Vol. 14, 3rd Quarter 1999

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Re: Res ipse loquitur
 

A recent review of reports submitted to the Vaccine Adverse Events Reporting System (VAERS) may be relevant to this discussion. [1]

Part of the review was focused on pediatric vaccinations administered between January 10 and October 8, 2007, and specifically on reports related to three vaccines that are usually administered in the U.S. at 2, 4 and 6 months of age: A 5 in 1 vaccine (DTaP + HepB + IPV), a HIB conjugate vaccine and a 7-valent pediatric pneumococcal vaccine.

The search was limited to infants 6-month old or younger thus excluding adverse events that followed late vaccinations. Filings that were delayed for any reason and the many reports that were never filed were obviously not considered.

There were thirty seven (37) reported infant deaths during the selected 279 day-period with an average of one death a week. Thirty-six (36) infants had received the three vaccines; one had not received the pneumococcal vaccine. Twenty-five (25) infants had also received the new rotavirus vaccine. [2]

At least 8 of the 37 infants (22%) died within hours of vaccination; 21 infants (64%) died by the end of the following day; 31 infants (84%) died within a week. The cause of death was listed as SIDS, or sudden death or sudden infant death syndrome in 12 reports in spite of the fact that some infants had cerebral edema, cerebral ischemia, a coagulopathy, encephalopathy, and cardiac and pulmonary abnormalities. [3]

Many physicians would like to believe that a diagnosis of SIDS — even when the infant died shortly after vaccination — will somehow guarantee the continued success of our very intense vaccination programs. These well -meaning people are clearly not aware of a 1998 research publication by Ridgway [4] where he reviewed all 786 claim-disputes from the start of the U.S. National Vaccine Injury Compensation Program (VICP) in 1988 through June 1996.

One hundred and seven (107) of the 786 claims were DTP-related death claims. The Special Masters of the U.S. Court of Claims, who heard the cases, awarded compensation in 73 (68%) of the 107 cases - after deciding that the deaths were vaccination-related.

In fifty (68.5%) of the 73 compensated claims, the originally-stated diagnosis was SIDS.

References:

1. Yazbak FE, Multiple Vaccinations and the Shaken Baby Syndrome. http://nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm  

2. http://tinyurl.com/39p3c9  

3. http://tinyurl.com/3x7wc7  

4. Ridgway D. Disputed Claims for Pertussis Vaccine Injuries Under the National Vaccine Injury Compensation Program. J Investig Med 1998; 46: 168–74.

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Re: Cot deaths
 

This correspondence recalls your earlier reports about the conviction of Sally Clark for murder in trials for the sudden deaths of her two infants, and about her own death after the conviction had been annulled. I am writing about this because on 18th August 1999 I was approached by solicitors in Manchester who were defending Mrs Clark against the charge of having murdered her two infant sons, Christopher in 1996 and Harry in 1998. They asked me to read and advise them on reports on these deaths by paediatricians, pathologists and other experts beginning with the autopsies performed by Dr Williams, the Coroner’s pathologist at Macclesfield, Cheshire.

I found, as Dr Williams did, that the two deaths were different and that for this and other reasons, the reports sent to me were confusing, contradictory and inconclusive. None of them offered a conclusion fulfilling the requirement that a verdict of unnatural death had to be beyond reasonable doubt, so I wrote back to the defending solicitors to say that a charge of murder was unjustified. The same opinion was given by one of the experts, Professor John Emery, a leading authority in the UK on Sudden Unexplained Infant Deaths (SUID). Christopher had been cremated but Professor Emery had conducted a second autopsy on Harry in the presence of another expert witness. He was unable, under the circumstances, to give a definite opinion about the cause of death but he did exclude, as I did, unnatural death due to murder. We agreed that the deaths were different and noted that Harry had received an injection of triple vaccine about 4 hours before his death which could have occurred after admission to hospital. I had already asked the solicitors for more details, and was awaiting a reply from them to enable me to write a fuller report.

I was therefore astonished to read some months later in The Times that Sally Clark had been tried at Chester Crown Court and found guilty of murdering her two infant sons. I wrote immediately (on 24th April, 2000) to the solicitors questioning this verdict. They did not reply but I learned that neither Professor Emery’s report nor mine had been quoted in Court, and that conviction by the jury had apparently been based on the Judge’s acceptance of the opinion of Sir Roy Meadow that the chance of the second death (of Harry) being natural in the circumstances was one in 73 million. I regarded this as an absurd and unproven statistic, and was surprised also that the Defence had failed to refer to Emery’s report and mine which were favourable to their client.

The solicitors in Manchester did not reply to a second letter but I then received a call from a new solicitor (JB) who wanted to consult me about the verdict, and his instruction by Sally, her husband and father to appeal against it. They were consulting me because Dr W H (Bill) Inman, former Principal Medical Officer at the Ministry of Health and Chief Medical adviser to the Committee on the Safety of Medicines had recommended that they should do so because of my experience with vaccines. We arranged a meeting at my home and he came there with Sally’s father (FL) and more evidence. We discussed the case and the reasons for appeal for several hours, and arranged a further meeting, at Sally’s father’s residence in Salisbury where he had been Superintendent of Police until his retirement, A long sequence of telephone calls, correspondence and a further meeting followed, and led to the Appeal, which was rejected by three Judges who sidelined the one in 73 million statistic. Additional evidence was available from a professor of paediatric neurology and a professor of epidemiology, both from centres of excellence respectively in USA and UK. Their opinion was that the injection of pertussis vaccine given along with other vaccines was more likely than not to have been the cause of Harry’s death, and that Christopher’s death was different.

All of this and much more clinical and forensic detail about the two deaths is available in the transcripts, correspondence and especially in the book Stolen Innocence by John Batt, all of which contain additional reasons for questioning the conviction. For instance, it was revealed that the medics who transported Harry alive to the hospital in Macclesfield and the three doctors – a casualty officer, a registrar and a consultant paediatrician - who examined and tried unsuccessfully to revive him were not called to give evidence. There is no proof anywhere that the vaccines used (DTP/Hib/Polio) cause death but the pertussis component was the whole cell preparation are known to be associated with apnoea, shock, encephalopathy, and very occasionally with deaths, which led Sir Graham Wilson, former and first Director of the PHLS, to say in his book on Hazards of Immunization that life-spoiling and threatening reacticns, especially after pertussis vaccine and in the context of incomplete or non -protection were too frequent to justify mass vaccination. These features, widely-recognized internationally, led some countries in the 1960’s and others later to omit pertussis from childhood programmes and to replacement of the whole-cell vaccine with an acellular replacement. In the UK, this did not happen until 2006. It should be noted also that the three main manufacturers of pertussis vaccine in the UK and 10/13 in the USA withdrew their products between 1978 and 1986. These facts are important because vaccination is compulsory in most States of the USA and some in the EC. This removes the safeguard of parental option, respect for contraindications and medical discretion.

This information was understandably lacking in Clare Dyer’s short article. Sally Clark was acquitted after five years in prison only because bacteriological reports about a questionable staphylococcal infection had been with-held by Dr Williams and others from the previous hearings. The success of Dr Williams’s appeal ensures that expert witnesses can overlook or with-hold essential evidence without fear of the penalty that can be imposed legally on criminal defendants, of whom Sally is just one.

Gordon T. Stewart, MD, FFPH/RCP. Emeritus Professor of Public Health, University of Glasgow, UK.

Dyer C. Pathologist in Sally Clark case wins appeal against removal from government register BMJ 2007; 335: 466.

Batt, John. Stolen Innocence. London, Ebury Press, 2004.

Wilson GS Hazards of Immunization. London: Athlone Press, 1962.(pp195 -201;221; 281-290.

Stewart GT. Vaccination against whooping cough: efficacy versus risks. Lancet 1977; 1; 234- 7. See also: Whooping cough and pertussis vaccine: a comparison of risks and benefits in Britain during the period 1968-83, Dev biol Standard 1985; 61; 395-405. Geneva 1985, Karger-Basel for W.H.O.

Fox, Rosemary. Helen's story. London, 2006: John Blake.

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Re: Does cot death still exist
 

The culimnation of rapid responses to Gornall's feature highlight these inescapable facts:

(1) The grave dangers and indeed injustice initiated by those who rely on but the evidence 'offered in court'. Which as Professor Gordon Stewart so graphically describes can be but part of the story.

(2) That the Criminal Court, relying as it does on the adversarial system, is really the last place to decide how a baby died.

(3) That the 'expert witness' system has more to do with who is the best 'witness' on their feet, which may be more to do with theatre than with clinical expertise.

(4) Similarly who has the best lawyer which is also more about theatre than good law or practice.

(5) That in the end of the day no-one really knows. Whatever number of doctors can be assembled to swear on oath an equal number can always be found to swear the opposite.

(6) That the most outrageous things, once said or written, can later be recycled as 'in the literature' in an attempt to verify ill conceived theory.

Arising from these (and doubtless other idiosyncracies I have not thought of) journalists like Gornall can pontificate to kingdom come but it does little or nothing other than provide copy. And of course, perpetuate the agony of innocent victims desperately trying to find closure. Sometimes ending in tragedy.

I am not really in a position to judge whether it does anything for clinical debate but I do know that over the past 10 years we are no further forward.

C Frank Lockyer

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Re: Risk and benefit
 

As the father of Sally Clark, Frank Lockyer has a great deal more invested in this debate than the rest of the correspondents here, but it saddens me to learn that he considers my article to have amounted to little more than pontification. The issue of the Clark case has been introduced not by me but by those keen to hijack the tragedy in service of their anti-vaccination agenda.

It is my understanding of the Clark case that the defence team did not raise the issue of SIDS as a possible cause of the deaths, though until the last minute it may have given the impression that it would. Indeed, I believe it was expectation of this that led the prosecution to introduce the one in 73 million “chance of SIDS” figure into the trial. Another example, perhaps, of the Clark defence team shooting itself in the foot, at great cost to its client.

The purpose of my article was solely to focus attention on the reality that the majority of the remaining so-called SIDS deaths result from recognised deviations from best parenting practice and that to pretend otherwise, out of understandable but ultimately misguided compassion for individual parents, is to condemn other babies to avoidable deaths and other parents to avoidable grief.

As for the vaccination debate, one is spoiled for choice when it comes to evidence that demonstrates that, for society as a whole, vaccination is safer than non-vaccination, but a cautionary tale told on the website of the Children’s Hospital of Philadelphia (in a set of “frequently asked questions” about vaccination, referred to as an approved source of information by the Centers for Disease Control) sheds a useful light.

It is especially relevant because Gordon T Stewart recalls that the pertussis component of the vaccination received by Harry Clark shortly before his death was the whole-cell preparation, “known to be associated with apnoea, shock, encephalopathy, and very occasionally with deaths”.

This, says Stewart, had led Sir Graham Wilson, former and first director of the Public Health Laboratory Service, to say that “life-spoiling and threatening reactions, especially after pertussis vaccine and in the context of incomplete or non–protection, were too frequent to justify mass vaccination”.

This contrasts with the following cautionary tale about the disastrous Japanese experience, offered by Philadelphia in answer to the question “Was the old pertussis vaccine safe?”. It won’t, of course, dent the certainty of the sceptics, but it does demonstrate the importance of understanding properly the relationship between risk and benefit in a public-health context:

“The old pertussis vaccine was called the ‘whole-cell’ vaccine and had a high rate of severe side effects. Persistent, inconsolable crying occurred in one of every 100 doses, fever greater than 105 degrees occurred in one of every 330 doses, and seizures with fever occurred in one of every 1,750 doses. Due to negative publicity about this vaccine, the use of pertussis vaccine decreased in many areas of the world.

"For example, the Japanese Ministry of Health decided to stop using the pertussis vaccine in 1975. In the three years before the vaccine was discontinued, there were 400 cases of pertussis and 10 deaths from pertussis in Japan. In the three years after the pertussis vaccine was discontinued, there were 13,000 cases of pertussis and 113 deaths. It should be noted that although the side effects of the pertussis vaccine were high, children didn’t die from pertussis vaccine, they died from pertussis infection.

"The Japanese Ministry of Health, realizing how costly their error had been, soon reinstituted the use of pertussis vaccine. The children of Japan proved that the benefits of the old pertussis vaccine clearly outweighed the risks. In 1996 a new (“acellular”) pertussis vaccine was available for use in the United States. The new vaccine had a much lower risk of severe side effects than the old vaccine. Therefore, the new pertussis vaccine is safer than the old pertussis vaccine. But because the benefits of the old pertussis vaccine outweighed its risks, it too was safe.”

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Re: Re: Risk and benefit
 

With thanks to Jonathan Gornall:

“inconsolable crying occurred in one of every 100 doses, fever greater than 105 degrees occurred in one of every 330 doses"

We didn't have the seizures. I am ever so grateful for the benefits bestowed on my son. At the time we were advised that this was normal, and not so much as a mention was made in his notes.

Perhaps Gornall can cite the long term follow up studies which showed how infants that suffered these reactions fared in later life. I would also point out to him that we did in fact have our children vaccinated then, whatever sloganising he indulges in now.

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Re: Re: Risk and benefit
 

Gornall says the purpose of his article "was solely to focus attention on the reality that the majority of the remaining so-called SIDS deaths result from recognized deviations from best parenting practice and that to pretend otherwise, out of understandable but ultimately misguided compassion for individual parents, is to condemn other babies to avoidable deaths and other parents to avoidable grief. “

He presumes to know the cause of “the majority of the remaining so- called SID deaths.” Where did he acquire that knowledge and what medical qualification does he have? <

Michael Innis

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Re: Does Cot Death Still Exist? Jonathan Gornall. BMJ 2008;336:302-304 - A Reply
 

Mr. Gornall, a freelance journalist in London, argues that it is time to do away with “cot death” (SIDS in the United States) as a cause of sudden infant death given the view of some that modifiable infant care practices, such as prone sleep position and maternal smoking, now meet the criteria for causality. He quotes a chief deputy coroner in Indiana who does not “believe in SIDS deaths” and asserts that a cause of death will be found in cases of sudden infant death if a complete investigation is undertaken. Gornall also notes that the UK’s only forensic pediatric pathologist never uses the term. In his argument that this is a time for reassessment, he notes that it is illogical to continue to classify cases as SIDS in which a clear cause has been identified, and it no longer makes sense to continue investing limited research funds in the search for a cause. Nevertheless, he acknowledges, if not supports, perhaps unknowingly, the triple-risk hypothesis for SIDS proposed nearly 15 years ago by Filiano and Kinney1 when he notes that babies may be born with “unidentified weaknesses” or “susceptibilities” to risk factors that predispose them to sudden death.

Despite his provocative question, is it appropriate to eliminate SIDS as a diagnosis? I think not. To begin with, the UK forensic pediatric pathologist quoted by Gornall acknowledges that there are still cases that “absolutely fulfill all the international criteria” for SIDS. And, iIt is certainly naïve to suggest that complete investigations will identify a cause of death in every case of sudden infant death. That has not been my experience during the last 30 years nor that of the international panel who authored the “San Diego” SIDS definition had similar experiences, they not only stratified the general SIDS definition into categories based on certainty of a SIDS diagnosis, they also created a category of “Unexpected Sudden Infant Death (USID) for those cases that postmortem investigations still failed to identify a cause of death.2 That said, one must acknowledge that death scene investigation and evaluation of the circumstances of death still vary widely in every country including in the UK and US. This sad situation could be considerably mitigated by adoption and use of the CDC’s SUIDI Reporting Form (www.cdc.gov/SIDS/SUID.htm) and standardized autopsy protocols.3

Gornall’s statement that it no longer makes sense to classify cases as SIDS in which a clear cause has been identified is oxymoronic. By its very definition, SIDS is a default diagnosis when another cause is specifically not found.2

Finally, his allegation that Fleming and Blair concluded that maternal smoking during pregnancy “met the criteria for causality and was directly responsible for 60% of such deaths” overstates what they actually said: “Exposure may lead to a complex range of effects upon normal physiological and anatomical development in fetal and postnatal life that places infants at greatly increased risk (italics mine) of SIDS.”4 One must remember that risk factors are identified from analyses of large numbers of babies; at the same time, our current understanding does not allow identification of the specific role of a particular risk factor, such as maternal smoking, in the death of a single baby.

In conclusion, the triple-risk hypothesis for SIDS is still a valid model for our current understanding of SIDS.1 It states that SIDS is the cataclysmic and lethal outcome of a vulnerable infant (e.g. medullary serotonin network deficiency5) exposed to an environmental risk factor (e.g. prone sleep position or maternal cigarette smoke exposure) during a critical age of development (1-6 months of age). As long as infants continue to die supine in pristine sleep environments without prior exposure to risk factors, SIDS will continue to serve a useful function for medical examiners, vital statisticians, researchers, and importantly, survivors. After all, SIDS acknowledges that the cause of death is “undetermined” or “unascertained” and at the same time acknowledges as well a constellation of circumstances and findings that simply do not apply to an “undetermined” cause of death in an adult!

References

1. Filiano JJ, Kinney HC. A perspective on neuropathologic findings in victims of the sudden infant death syndrome: the triple-risk model. Biol Neonate. 1994;65:194-197.

2. Krous HF, Beckwith JB, Byard RW, et al. Sudden infant death syndrome and unclassified sudden infant deaths: a definitional and diagnostic approach. Pediatrics. 2004;114:234-238.

3. Krous HF, Byard RW. International standardized autopsy protocol for sudden unexpected infant death. Appendix I. In: Byard RW, Krous HF, eds. Sudden Infant Death Syndrome: Problems, Progress and Possibilities. London: Arnold; 2001:319-333.

4. Fleming P, Blair PS. Sudden Infant Death Syndrome and parental smoking. Early Hum Dev. 2007;83:721-725.

5. Kinney HC. Abnormalities of the brainstem serotonergic system in the sudden infant death syndrome: a review. Pediatr Dev Pathol. 2005;8:507- 524.

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Re: Re: Does Cot Death Still Exist? Jonathan Gornall. BMJ 2008;336:302-304 - A Reply
 

Editor,

Dr Krous implies the adoption and use of the CDC’s SUIDI Reporting Form (www.cdc.gov/SIDS/SUID.htm) and standardized autopsy protocols would assist, but not necessarily identify a cause of death in every case of sudden infant death/sudden unexpected infant death.

However the SUIDI Reporting form to which he refers while requiring information on the Pregnancy history, information on Metabolic Disorders, Birth Defects, Dietary history and Incident Scene Investigation makes no mention of Adverse Vaccine Reactions.

Ignoring the role of Adverse Vaccine Reactions as a cause of SIDS/SUID is what sent Sally Clark to prison and is keeping the infant Christopher Blum in a London mortuary 21 years after his death.

With regard to the Dietary history attention should be drawn specifically to the possibility of Vitamin C , D and K deficiencies all of which have at one time or another been mistaken for Sudden Unexplained Infant Death.

Until these defects are rectified the CDC’s SUIDI Reporting Form is little more than worthless - and the Judicial system wanting.

Michael Innis