HAEMOPHILUS INFLUENZAE-B VACCINATION PROGRAMS HIGHLY EFFECTIVE, BUT HOW SAFE?

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HAEMOPHILUS INFLUENZAE-B VACCINATION PROGRAMS HIGHLY EFFECTIVE, BUT HOW SAFE?

http://www.vaccination.org.uk/vaccines/hib1.html

HAEMOPHILUS INFLUENZAE-B VACCINATION PROGRAMS HIGHLY EFFECTIVE, BUT HOW SAFE?

By Bob Greenfield, grandfather of an autistic child.

When invited to write an article on Haemophilus

influenzae-b (Hib) vaccines, I thought this would

be straight forward considering the huge amount

of material available on this topic. However, I

am not competent to discuss most of this

material, so I have described my efforts to

establish the increased risk of contracting Hib

disease soon after Hib vaccination. First a personal experience.

Mid October 1992 we became aware that our two and

a quarter year old grand-daughter had

become unresponsive to her family. From being a

very easy child to manage, she became

increasingly difficult, losing all understanding

and speech, and a year later was given a

diagnosis of Childhood Disintegrative Disorder

(CDD). CDD is at the severe end of the autistic

spectrum, the " mild " end being Attention Deficit

Hyperactive Disorder (ADHD). About mid 1993 we

realised that our grand-daughter's regression

began just after her Hib vaccination of October

1, 1992. Then, reviewing our home video record,

we found no autistic behaviours in clips taken before this date.

Because CDD is a rare disorder and vaccination at

's age is uncommon, it seemed unlikely that

such a coincidence could be due to chance alone.

We learned of another Australian child, ,

who also developed CDD after a Hib vaccination in

May 1992. His grandmother went overseas in April

of that year but, when she returned in July, she

was immediately aware that her grandson had

changed. was three years old, even more

removed from the common age of 18 months for

acquired autism. Parents of and tell

their stories in " When Autism Strikes " , by

Catalano, MD (Plenum Publishing Corporation, New York ISBN 0-36-45789-X90000).

In 1992, Australia and the UK introduced programs

to vaccinate against Hib disease. In Australia

there was a strong media push for the program,

emphasising a high risk of Hib meningitis in

children under five. My wife and I remember being

surprised that we had never heard of this disease

that was apparently the most common brain damaging illness in young children.

The package insert for the vaccine used on our

grand-daughter carried the warning:

" Physicians should be aware that recipients of

Haemophilus-b vaccines may develop Hib disease in

the week after vaccination, prior to the onset of

the protective effects of the vaccine. "

Did this mean that the vaccine could cause Hib

disease or just that the vaccine was ineffective

until after a week? We had no obvious way of

knowing, we found that the monitoring needed to

answer this question was either not done or the

data was unavailable. Australia has a Freedom of

Information Act, but a Confidentiality of

Epidemiological Information Act just predates it.

The equivalent UK arrangement would be the

Committee for the Safety of Medicines whose Proceedings are confidential.

Sir Graham , in the introduction to his

book " The Hazards of Immunisation " (1967),

commentson the secrecy surrounding accidents of vaccination:

" The late Dr J R Hutchinson of the Ministry of

the Ministry of Health collected records of fatal

immunological accidents during the war years, and

was kind enough to show them to me. I was frankly

surprised, when I saw them, to learn of the large

number of persons in the civil and military

population that had died apparently as the result

of attempted immunisation against some disease or

other. Yet very few of these were referred to in the medical journals. "

Thus direct evidence relating to vaccine damage

is unlikely to be reported or published and would

be hard to access. However, in 1985, when the US

introduced a Hib vaccination program, efficacy

studies indicated that, in the week following

vaccination, children had an increased risk of

contracting Hib disease. The program used an

unconjugated (PRP) vaccine, which was suitable

for children over two years old only.

" Early-onset " Hib disease occurring within a week

of PRP Hib vaccination became eligible for

compensation under the US Vaccine Damage Payments Scheme.

Hib vaccines should be very safe because no live

biological material was involved. What could be

going on? In chapter 25 of " The Hazards of

Immunisation " , on " Provocation Disease " , Sir Graham writes:

" It seems clear that any latent infection,

particularly when accompanied by transient

bacteraemia or viraemia, may be wakened into

activity by the disturbing effect on the tissue

resistance of various factors, among which

vaccines and certain medicaments are prominent.

Ideally, vaccination against any disease should

be preceded by a survey of the patient's medical

history and a simple physical examination to

detect signs of any obvious infection. Mass

vaccination, in which this is impossible, is

bound to be a hazardous procedure and is bound to

be followed by undesirable consequences of one sort or another. "

Reviewing Sir Graham's book in the British

Medical Journal, (18 November 1967, p 407), A Melvin Ramsay comments:

" He (Sir Graham) strongly condemns mass

immunisation with its inevitable masking of much

latent infection ... This is a work of outstanding merit. "

It seems that, although Hib vaccines may not

directly cause Hib disease, individuals exposed

to Hib disease could more easily develop serious

Hib illness soon after Hib vaccination.

In 1987 the US introduced a more effective

Hib vaccine, diphtheria conjugated vaccine

(PRP-D), which was suitable for 18 month and

older children. It was this vaccine that

Australia licensed in 1992, also for 18 month and

older children. Did this vaccine also carry an

increased risk of early-onset Hib disease?

The possible increased risk of Hib disease

soon after Hib vaccination prompted immunological

studies into several Hib vaccines. Animals more

easily developed meningitis soon after Hib

vaccination. 18 month old children with natural

Hib antibody experienced a fall in antibody two

days after vaccination before protection

developed. The studies indicated that PRP-D was

the most potent vaccine, but this vaccine

produced most early-onset meningitis and most

bacteraemia and the biggest fall in natural

antibody at day two. The most effective vaccine

appeared to involve the greatest risk.

The concentration of serum Hib antibody

needed for protection is believed to be at least

0.15 but possibly 1.0 micro-grams per millilitre.

In 18 month old children PRP-D vaccination caused

natural Hib antibody to fall typically from 0.18

to 0.04 micrograms per millilitre at day two

before rising to 7.20 micrograms permillilitre at day seven.

In 1994 the prestigious US Institute of

Medicine (IOM) published a major report " Adverse

Events Associated with Childhood Vaccines,

Evidence Bearing on Causality " . This report

acknowledged the increased risk of early-onset

hib disease with unconjugated vaccine but not

with conjugate vaccines. The immunological

evidence would seem to require careful monitoring

of the use of hib vaccines but the IOM report can

produce only a few very small epidemiological

studies. In concluding that there is no increased

risk of early-onset Hib disease with Rib

conjugate vaccines is the IOM report wrong?

The report's conclusions are based on four cases

of early-onset Rib disease in a meta analysis of

19 small studies. (A meta analysis attempts to

combine results from small studies to give

greater certainty). Addressing the general

question of whether an increased risk of

early-onset Hib disease occurs with conjugate Rib

vaccines, the report can answer " no " .

But we are specifically concerned about a

possible increased risk of early onset hib

disease with PRP-D conjugate vaccine in 18 month

and older children. Just three studies qualify to

answer this question, the answer being " yes " ,

with a Relative Risk of 2.88. A vaccinated child

was 2.88 times more likely than an unvaccinated

child to contract Rib disease in the following

week, or the odds of the vaccine being

responsible for a particular case is 1.88 to 1.

Three of the four cases of the IOM report's

early-onset disease occur for PRP-D in 18 month and older children.

Two reports in the American Journal of Diseases

in Children (AJDC, March 1990 and December 1991)

analyse the incidence of hib disease in

vaccinated children to demonstrate the greater

efficacy of PRP-D conjugate vaccine in 18 month

and older children over that of unconjugated hib

vaccine. Both reports compare failure rates of

PRP and PRP-D vaccines but also assume that

early-onset hib disease is the same for both PRP

and PRP-D. The data came from the Centres for

Disease Control (CDC) and Food and Drugs

Administration (FDA) data, but the AJDC

reports.were not considered in the IOM report.

Both data show a large fall in the incidence of

hib disease starting a week after vaccination, as

would be expected for a vaccine that takes a week

for protective antibodies to develop. However,

the falls are much greater than could be due to

vaccine efficacy. The only possible explanation

for these data is that there is more than the

" background " rate of early-onset hib disease

after PRP-D vaccination in children older than 18 months.

If there were no increased risk, early-onset hib

disease would be the same as the background rate

in unvaccinated children, which can be calculated

from the known vaccine failure rate and vaccine

efficacy. Comparison of actual and calculated

background rates of early-onset hib disease

indicate the relative risk to be in the range of 2 to10.

Do the calculations give the right answer? We can

check the method using the data for unconjugated

hib vaccine which are also provided in the AJDC

reports. For unconjugated hib vaccine, the method

gives a relative risk of early-onset hib disease

of 2.7, a good agreement with the 2.62 quoted in the IOM report.

Are UK families affected? The UK used a tetanus

conjugate vaccine for babies and HbOC conjugate

vaccine for children older than one year. The

fourth case of early-onset hib disease in the IOM

meta analysis occurs in the study for 15 to 18

month old children vaccinated with HbOC, the

relative risk being 1.5. On its own, a single

case would be insufficient to draw conclusions,

but the IOM report also compares nine cases of

early-onset Hib disease after HbOC, with one

after PRP-D, occurring between November 1990 and

July 1992, this being assumed to reflect the

greater use of HbOC during this period.

In Vol 5, No 10 of the UK monthly " What Doctors

Don't Tell You " , an acupuncturist reported that a

child she was treating had been hospitalised for

asthma, become hyperactive and running around

like a madman. She discovered that the child had

just had a " meningitis " vaccination, observing

that such incidents go unreported because " no

connection is made between such episodes " . The

first symptom 's grandmother noticed was

that she " ran aimlessly to and fro across the room " .

Although until recently the most common brain

damaging illness in children, hib meningitis has

been associated with just two cases of autism,

one child becoming autistic after having been

diagnosed with hib epiglottis (inflammation of the windpipe).

The Medical Journal of Australia of March 6, 1995

published data on the effect of Rib vaccination

in the Sydney region, demonstrating the potency

of the hib vaccination program, but also

revealing other features. For almost the first

year of the program, when vaccination was offered

to 18 month and older children only, hib disease

fell fastest in younger unvaccinated children.

Excess early-onset hib disease in vaccinated

children could explain this effect but the

case-by-case investigation needed to confirm this was not done.

The Sydney experience is not unique. On first use

of conjugate hib vaccines in the US and UK,

comparable falls in hib disease occurred in

unvaccinated and vaccinated children, which was

noted but not explained. Published information

contains insufficient detail for analysis.

Hib disease in young children has greatly

decreased following the introduction of hib

vaccination programs, also reducing the actual,

(but not relative), risk of vaccine provoked hib

disease. But questions about the safety of hib

vaccination programs need to be answered.

· Is meningitis always recognised?

· Do hib vaccines " mask " the symptoms of serious infections?

· Do parents mistake a serious brain damaging

illness for a normal vaccine reaction?

· Australian and UK vaccine adverse reaction

surveillance systems ought to have detected

noticeable post vaccination " early-onset " and

vaccine failure hib disease. Whey wasn't this detected?

· Did Australian and UK Governments fail to

exercise a proper " duty of care " for hib

vaccinees in failing to educate parents about

symptoms requiring urgent medical attention?

A paradox. Hib disease was the most common brain

damaging illness in young children, but little

detail on outcomes are described. Autistic

disorders are among the most common outcomes of

childhood brain damage, yet a cause is rarely identified. Why?

Bob Greenfield, Oct.1998

Recommended reading: " Hidden Truths " by

s, in the 23 May 1998 " New Scientist "

describing methods used by " Data Sleuths " to

identify consistencies in published data and to

extract meaning from limited or incomplete data.

Source: Informed Parent

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Washington State, USA

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