The Perilous Haemophilus or is it.....pneumonia - Hilary

[Guest guest]

The Perilous Haemophilus or is it.....pneumonia -

http://www.vaccination.org.uk/m/butler7.html

The Perilous Haemophilus

or is it.....pneumonia

By

July 1996

" CHILDREN SICKER AND LOTS MORE ATTENDING STARSHIP HOSPITAL "

So said the NZ Herald, 26 Dec 1995, A3. What has

that to do with the title of this article?

There appears to me a coincidence which is rather

remarkable, and I probably wouldn’t have twigged

to it, except that the NZ Herald, 15 April 1988,

A2, had this heading: " COT DEATH INCREASE

‘APPALLING’ " which discussed the " appalling "

increase in the number of cot deaths throughout

Auckland in 1987, especially in July, the worst

month on record. Shirley Tonkin was quoted as

saying: " We are just appalled by this increase,

and we do not know why it is happening. "

The cot deaths increase occurred THREE MONTHS

after the introduction of the nationwide blanket

administration of the first Hepatitis B vaccine immediately after birth.

Interesting too, that a Department of Health memo

dated 21 March 1988 circulated to all hospital

and Area Health Boards, detailed that the first

injection should be delayed until shortly before

discharge home in the case of babies of healthy

mothers because: " Minor side effects from the

first H-B-VAX injection in a newborn baby may be

confused with more serious ill health. "

In 1988 the IAS and I were run off our feet with

mothers who had distressed babies after this

vaccine ­ and those were only from that 1­5% of

the population who, according to the Health

Department, knew about our existence. I heard

from a nurse whose career was ruined by the

hepatitis B vaccine, and from Public Health

nurses who had had the vaccine and the following

winter had had health problems never previously experienced.

Even more interesting was the fact that shortly

after that memo, it was considered that the first

shot should be given at six weeks.

The telephone line between Dr Ralph (then

the Adverse Reactions doctor in Dunedin) and I

was hot for 18 months about complaints from the

toddler catch-up campaign and newborn babies.

It’s all fact ­ and mentioned inside one of the

fancy reports filed in obscurity somewhere in the Health Department.

What has that to do with the first heading about ‘Children sicker’ in Auckland?

There is a saying that those who don’t heed

history are destined to repeat past mistakes.…

When the 26/12/95 NZ Herald article appeared, I

read the fine print to find that from the

beginning of July 1994 to the end of October

1995, there was a 23% increase in youngsters

being brought into hospital and a 15% increase in

admissions. This occurred just over one year

after the introduction of TETRAMUNE in this

country and two years after the introduction of

ProHIBit (Hib vaccine for 18 month children and

older), and in the year when the Health

Department had flooded the media with reports of

how the cases of Hib had fallen to rock bottom.

We were told that this vaccine would ease the

total work load of the paediatric staff but here

we see more, sicker children than ever before.

BUT, I hear you say, there is no direct time

connection with the Hib vaccine as was alleged

with Hepatitis B. Read on! In the latest article:

" Doctors are noticing that the proportion of very

young children admitted is getting higher and

that generally, children seem to be sicker when they arrive. "

Interestingly they mentioned an increase in cases

of pneumonia, asthma, meningococcal disease,

fevers and bronchiolitis….that the reasons

weren’t clear, but " lack of money to pay doctor’s

bills could be a factor. " That was the same

reason they used in 1988 to explain the increase

in cot death. The article went on to state that

two Starship paediatricians are, meanwhile, probing the pneumonia increases.

What is the evidence linking pneumonia in the NZ

Herald article heading with the Haemophilus vaccine?

One of the most direct (yet dismissed) pieces of

research is in Paediatric Infectious Diseases

Journal, December 1993, Vol. 12, 981 ­ 5, where

there was an article looking at the safety of the

Haemophilus vaccine in Kaiser, USA, from 1

November 1990, to 26 July 1991. The initial

analysis of babies given TETRAMUNE (the one in

use in New Zealand) showed that these children

appeared to have a higher rate of hospitalisation

for pneumonia than children who were given Hib

and DPT in separate shots. (It’s a shame there

wasn’t a third more valid control ­ children who

had received no vaccines at all.) The article commented:

" This initial association was believed most

probably to be a result of chance alone. The

[Tetramune] vaccine offers the convenience of a

single combined vaccine... " (p. 981).

" In addition to having an effective vaccine it is

also important to administer the vaccine in a way

that encourages parental and physician acceptance

and minimises trauma to the infants receiving the vaccine. "

" ... The additional injections are associated

with additional administration costs at each

visit. Parents may also be reluctant to subject

their infants to multiple injections at the same

time. This either generates unnecessary return

visits or reduces compliance with recommended

vaccination schedules. " (pg. 982.)

So what did the trial authors do?

" In this study there was no significant

difference for rates of medical adverse events as

observed from emergency visits between the two

vaccine groups. However, a statistically

significant increased risk of pneumonia was seen

after Tetramune. To investigate this possible

association further analyses were

undertaken...Because of the known overlap between

the diagnoses of pneumonia and bronchiolitis in

clinical practice in this age group, the charts

of all children with these respiratory diagnoses

were reviewed by a single observer who was

blinded to the vaccine status of these children. " ­ pg. 985.

This analysis showed no significant difference in

the rates of pneumonia between the two groups. The article then said:

" It was concluded that...the single observed

association in the automated data of pneumonia

with receipt of Tetramune was most probably

caused by misclassification of the diagnoses in

the automated data set, or by chance alone.

Tetramune would appear to offer the convenience

of a single combined vaccine offering protection... "

The authors seemed very eager to talk about the

logistical and financial advantages of TETRAMUNE,

and I couldn’t help wondering if this was a case

of re-working the data to fit the desired

outcome. What would have happened if another

evaluation was done by a paediatrician opposed to the use of Hib?

I filed this article under my ‘think’ pile until

the December 1995 NZ Herald article, when I went

back to the pile to find out when Kaiser

introduced TETRAMUNE. 1989 was the first year

that TETRAMUNE, and other new Hib vaccines were

approved for use in children under 18 months and,

by the end of 1991, nearly 75% of children under

two years of age had received the Hib vaccine,

some separately and some together because they weren’t sure about it.

The time lapse between the introduction of

Tetramune and the increase in pneumonia in

Starship is the same as the time lapse had been

in the Kaiser study (and in Finland).

Is this a coincidence?

TETRAMUNE did what they said it would. It seemed

to knock out Hib. The Kaiser study (Arch Ped.

Adol. Med. Jan 1994 pg. 54) did admit that the

rates of Haemophilus had been falling in the two,

four and six month age group, previously

unvaccinated, for some time before its

introduction...yet it was amongst this very group

of babies that the study was done for the safety

of TETRAMUNE ­ the same vaccine we use in New Zealand.

Bells started ringing in my head. Some years ago,

the first Swedish study of the Japanese acellular

pertussis (whooping cough) vaccine was abruptly

stopped because a larger number of serious

infections and deaths were occurring in the

vaccinated group than the unvaccinated. The raw

data repeatedly came up with PNEUMONIA and MENINGOCOCCAL MENINGITIS.

But acellular pertussis is a DIFFERENT vaccine. True. So

what’s going on here? First, here is some easy

history you should know, and some other

" coincidental " pieces of the jigsaw that need to be placed...

CRASH COURSE IN HAEMOPHILUS HISTORY.

Have you ever wondered why the name Haemophilus

INFLUENZAE? A bit contradictory for a bacteria, don’t you think?

About 1888 Pfeiffer isolated the organism

from the sputum of patients with influenza and,

for the next 30 years, the medical community

assumed that Haemophilus caused the ’flu. It

wasn’t until the 1918 ­ 19 flu pandemic that it

became accepted that Haemophilus was a part of

the normal bacterial flora in the upper

respiratory tract and not necessarily the cause

of respiratory disease. (pg. 300, VACCINES (BOOK)

Harcourt Brace Jovanovich, 1988). The name

remains a testimony to the misconceptions of the past.

Another interesting historical question regarding

Haemophilus is: " Can we tell who will become sick

as a result of H. Influenzae infection? "

The answer to that is " yes and no " :

" The reports of genetic marker associations with

invasive Hib disease risk and responses to

vaccines support the view that genetic factors

may influence disease susceptibility. "

Trouble is that the immunologists haven’t figured

out enough to be able to say " you, you and you "

yet. We know that certain groups are more LIKELY

to get it but that also applies to meningitis

caused by other than Hib as well. People who have

immune system problems are more likely to get

bacterial meningitis but the groups that can

actually be pinpointed are few and far between.

" Academic " , say the researchers. Why waste more

money when a vaccine is now here to solve all clinical ills?

In February 1993 IAS newsletter readers were

alerted to a seeming connection between the use

of the Haemophilus vaccine and an increase in

Pneumococcal disease in an article entitled

DREAMERS AND THEIR APPRENTICES. To recap the

story until that time, this is what had happened:

The June 1992 issue of Newsletter from the

Journal of Paediatric Infectious Disease (JPID) stated:

" THE PERILOUS PNEUMOCOCCUS. We have great concern

for the increasing prevalence of relatively or

absolutely penicillin resistant pneumococci

coupled with the increased relative frequency of

pneumococcal diseases as a result of universal Haemophilus vaccination. "

" We need new agents that are active against these

strains, especially WHEN THEY CAUSE INFECTION OF

DIFFICULT TO TREAT SITES LIKE THE MENINGES OR HEART VALVES. "

After considerable discussion, on 27 July 1992,

Dr and I sent a letter to JPID:

" RELATIONSHIP BETWEEN PREVALENCE OF PNEUMOCOCCAL

MENINGITIS AND UNIVERSAL HAEMOPHILUS INFLUENZA VACCINATION "

To the Editors:

In the Paediatric Infectious Disease Journal

newsletter (1992;18:6) concern was expressed

" ...for the increasing prevalence of relatively

or absolutely penicillin resistant pneumococci

coupled with the increased relative frequency of

pneumococcal diseases as a result of universal

Haemophilus vaccination. For example, we recently

managed a nine month old infant with pneumococcal

meningitis who failed to respond adequately to ceftriaxone therapy. "

These sentences could be taken to mean that

concern was prompted by an increase in prevalence

of diseases including meningitis due to infection

with penicillin-resistant pneumococci and that

the increase resulted from universal Haemophilus

vaccination. How or why one circumstance resulted

in the other is not given in the quoted sentences

nor given elsewhere in the newsletter note. That

prior administration of Haemophilus vaccine might

increase on rare occasions susceptibility to

pneumococcus infection was not entertained.

The sentences might also mean that universal

Haemophilus vaccination resulted in a decrease in

Haemophilus diseases including meningitis and

that the void was filled by an increase in

pneumococcal diseases caused by antibiotic

resistant pneumococci. If this is the

explanation, then solution of one problem has

given rise to another and this new problem is

difficult to treat with available antibiotics

which gives rise to a new need: antibiotics that

are active against pneumococcal strains that

invade difficult to treat sites like the meninges and heart valves.

This apparent one step forward-one step backward

situation is reminiscent of similar problems that

accompanied early use in the 1960’s of

inactivated adenovirus vaccines to prevent

respiratory diseases caused by adenovirus types

3, 4 and 7. The vaccines were highly effective in

preventing disease caused by these types, but not

effective in preventing respiratory diseases

caused by the other 40 or more adenoviruses that

moved in to replace types 3, 4 and 7. Soon after

this situation was recognised, use of adenovirus

vaccines, except for use in military personnel,

was abandoned. It might be well when assessing

the overall value of the current program of

universal Haemophilus vaccination, to keep in

mind the earlier adenovirus vaccine experience.

J. , Ph.D. Bell of Atri, Inc.

IAS. "

On 29th July (quick response!) the reply came back, which said:

" We will have an item of clarification in the

September Newsletter concerning the potentially

confusing statement in The Perilous Pneumococcus item. "

Before the " clarification " came another item came

up ­ one which was already in press at the time of the above correspondence:

August 1992 JPID:

Kaiser study 130,000 children. " Only six

vaccinated children developed invasive

Haemophilus disease, five of whom had received

only one dose. In a Letter to the Editors in the

October issue, Leggiadro and colleagues will show

a substantial reduction in cases of invasive

Haemophilus disease admitted to LeBonheur

Children’s Hospital, Memphis, TN from 1982 ­

1991. OF CONCERN WAS A TWOFOLD INCREASE IN THE

RATE OF PNEUMOCOCCAL DISEASE IN 1991. " (emphasis mine)

Note the year ­ 1991, which was in the 12 ­ 24

month period after the introduction of this vaccine. Just like in Auckland.

Then came the ‘clarification’.

September 1992: JPID: " A CHOICE OF WORDS: Dr J.

asked what we meant by " increased

relative frequency of Pneumococcal disease as a

result of Haemophilus vaccination that appeared

in our item THE PERILOUS PNEUMOCOCCUS in the June

1992 newsletter; our statement reflects the

dramatic decline in the number of cases of

invasive Haemophilus disease we and many others

have experienced in the last 12 months or longer

as a result of vaccination. We did not mean to

imply that the absolute number of cases of

pneumococcal disease would increase: rather, the

frequency relative to Haemophilus disease would

become greater as fewer cases of the latter are encountered. "

On 10 April, after some interesting medical

articles, Dr fired off another letter

reminding Dr of our previous letter, including a copy of it, and adding:

" Knowledge of past events is of value if it is of

use in predicting future events. Thus in the 3

April issue of LANCET is a paper

" population-based study of Non-typable

Haemophilus Influenzae Invasive Disease in

children and Neonates " . It reports " Infections

due to (non-capsulated) H influenzae strains are,

after the implementation of Hib vaccines, likely

to persist and represent a substantial proportion

of the serious infections caused by this

species... Furthermore, the relative importance

of such organisms may increase because of the

general introduction of type b polysaccharide

vaccines, which will greatly diminish invasive

Hib disease, but not systemic infection caused by

NST of H influenzae of other capsular types.

" The episode in the 1990’s with Hib vaccine is

reminiscent of the experience in the 1960’s with

adenovirus vaccine. This is more so now than in July 1992.

" In light of the new information you might now

think that messages in the July 1992 letter will

be instructive for your readers. If so, permission for publication is granted. "

J.A.

After a slightly more sedate consideration than

last time, on 22 April 1993, the reply said:

" We are not inclined to publish your letter

because to date there are no data from the United

States and Finland that substantiate an increase

in Haemophilus disease caused by non-type b

strains after vaccination of the

population...Incidentally, we were fascinated by

your analogy with adenovirus infections after

vaccination. Is there documentation of the change

in adenovirus types after vaccination? We would

very much appreciate receiving the reference for this. "

Funny they weren’t " fascinated " the first time...

Dr educated them, and his final paragraph

in his reply (21 October 1993) reads:

" Information in the above quoted passages and in

the attached references provides a pathway to the

fascinating adenovirus vaccine story. That this

story is apparently unknown to the editors of

PIDJ is the basis for another fascinating story. "

In the meantime I had written to the then

Minister of Health on 23 March, and 1 May 1993,

detailing my concerns and asking key questions, one of which was:

" Will the incidence of other serious infections

(black wolves) rise as a result of the demise of HIB (white wolves)? "

In his reply on 3 June 1993, Mr Bill Birch

advised me that his advisers had advised him

that: " The short answer is that this is unlikely.

The papers that you included with your latest

letter show that the relative importance of other

forms of meningitis increase, but the INCIDENCE

remains the same. The only incidence that changes

is that of HIB meningitis. And this incidence

falls by 90% of its pre- vaccination rate in both

of your articles that show figures. So, other

causes of meningitis have not filled the gap left

by HIB. The white wolves have not been replaced

by black wolves to use your analogy. There are

just fewer cases of meningitis (wolves) overall,

and the reduction in cases is entirely due to a

reduction in meningitis due to HIB (white wolves). "

IF A VACCINE is being so useful and NOT affecting

any other disease statistics EXCEPT reducing one,

surely there should show a REDUCTION in the total

number of disease admissions to hospital ­ NOT

the increase noticed over the last few months?

Evidently at that time the advisors to Bill Birch

thought we were cruising just nicely.

Another article I came across in the Arch Ped

Adol Med Journal Jan 1994, pg. 49 discussed the

pre-vaccine Haemophilus decline in all groups but

being most dramatic in the unvaccinated under 18 month old group, this way:

" This is consistent with findings from other

reports, and it suggests that immunisation is not

responsible for all of the falling incidence of Hib disease. "

(Refs.: JAMA 1993;269:221 ­ 226/JAMA 1993;269:227

­ 231/JAMA 1993;269:246 ­ 248.)

But let us not nit-pick. ALL articles said how

wonderful the Hib vaccine was. It has been hailed

as one of the safest, state-of-the-art vaccines,

which is the bench-mark of medical ingenuity.

Let us be generous. Let us say that regardless of

the incompleteness of the epidemiological data

for America, that the recent claims of making the

world a Hib-free planet using a vaccine might even have some basis.

BUT AT WHAT COST?

Is the medical profession assuming that the

present increase in pneumonia is just part of

swings and roundabouts of disease increase and decrease?

I thought it could be ­ until I read an article

in The Lancet, 11 March 1995, Volume 345, p661,

from Finland, the first country to use the Hib vaccine in a widespread fashion.

" INCREASE IN BACTERAEMIC PNEUMOCOCCAL INFECTIONS IN CHILDREN " .

TEXT EXTRACTS:

" For comparison, the figure shows the declining

occurrence of bacteraemic Haemophilus influenzae

type B (Hib) infections in the coverage area of

the hospital. Hib vaccinations started in Finland

in 1986, and the last case of invasive disease in

our hospital was seen in 1991. Thus our results

suggest that following the disappearance of

invasive Hib disease in children bacteraemic

pneumococcal infections have increased. A

similar, although less striking increase has been reported in Philadelphia. "

" It is tempting to speculate that the increase in

invasive pneumococcal infections is causally

related to the disappearance of Hib disease. It

is known that Hib vaccinations have reduced the

carriage of H influenzae and pneumococci may have

found a new niche in colonising children. Even

though the reason for the increase in bacteraemic

pneumococcal infections remains unknown, the

increase is a clinical reality...an increase in

systemic pneumococcal infections emphasise the

need for effective pneumococcal vaccines for young children. "

Now we have a clear link between similar patterns

in Kaiser, Philadelphia, Finland and New Zealand.

New Zealand statistics show that there has been a

gradual increase in pneumococcus ISOLATES

(isolates = presence on swabs of pneumococcus ­

not necessarily disease) since 1990, as there

have been with several other nasties. Whether

that is because they are LOOKING for it more now

than before, or whether that reflects a real

increase in disease, is not stated. There had

been no media releases reflecting concern about

any overall increase in the incidence of CLINICAL

PNEUMOCOCCAL DISEASE (as opposed to isolates),

which predominantly affects the elderly whose

immune systems are weaker. The warning on 26

December 1995 only mentioned babies and young children.

Why is the difference between ISOLATES and DISEASE important?

The medical literature makes it quite clear, with

studies done on healthy people showing that:

" Other organisms will be found in throat swabs.

In general these have no relevance to clinical

illness, and the laboratory should not report

other organisms, including staphylococcus aureus,

Haemophilus influenzae, and the meningococcus. " (NEW ETHICALS JUNE 1994.)

An even better study in Acta Paediatr 1995;

84:566-4 found that when tracheal and laryngeal

aspiration were performed on healthy children it

was found the majority carry potentially

pathogenic bacteria, and: " we conclude that

aspirates from the larynx and the trachea are of

limited value in the diagnosis of bacterial PNEUMONIA in children. "

This would indicate that the carriage and

exposure rate of bacterial pneumonia in children

is as high as ever. The next logical questions are:

What has happened to make children, instead of

just carrying the bacteria, actually come down with the disease?

Two things:

1. Indiscriminate use of paracetemol (See volume 8, No. 3 pgs 3, 4 and 5)

2. On the basis of the above it is my

personal opinion that the introduction of the

vaccine TETRAMUNE is the prime suspect for the

increased number of sick children, either by

suppressing the immune system allowing carriage

of pneumococcal bacteria to become clinical

disease, or by providing a new niche for the

bacteria to increase its loading dose in

children, resulting in clinical disease. Either way, the result is undesirable.

IS THERE TALK OF A CHILDREN’S VACCINE FOR THIS DREADED NEW THREAT?

ASM News, Vol. 60, No. 1, 1994 sounds concerned

because the increase in the number of antibiotic

resistant pneumococcal cases is pressing

companies for vaccines. There are multivalent

vaccines for adults (with very variable

effectiveness rates!!!) but a current 23-valent

vaccine offers no protection to children less

than two years. Merck now has a conjugate vaccine

being tested to see if they can prevent otitis

media (earache) in children, but the reality is

that it is projected to be at least year 2000 before any vaccine is available.

Which brings us back to where we started ­ the

Herald article talking about sicker kids and more

of them, and an increase in pneumonia. The first

warning signs elsewhere in the world were there

to see for those who chose to read ­ BEFORE they

chose to introduce this vaccine to New Zealand.

If the Finland scenario of increasing

pneumococcal infections continues here, and

invasive pneumococcus disease (or even perhaps

other new-niche-seekers) skyrockets in this

country, not only will vaccinated children be at

risk from pneumococcus, so will unvaccinated children and their parents.

WHY?

Older people who have not had the vaccine are

usually immune to Haemophilus (and hopefully

pneumococcus) anyway. They developed immunity

prior to the age of five in most cases, and most

likely our unvaccinated older children have done the same.

If, by using the Hib vaccine, the result is that

everyone has to face a new threat in the form of

greater carriage of pneumococcal bacteria in

vaccinated children then what the medical

profession has done, as I stated in my letter to

Mr Birch, is SHOOT THE WHITE WOLVES (Hib) and

replace them WITH BLACK WOLVES. Pneumococcus is a

far more serious disease, and far more

untreatable, with more antibiotic resistance than

Hib ever had, and the vaccinated majority would

be responsible for passing this on to both the

unvaccinated minority and the older community. In

other words, this vaccine changes the whole

existing bacterial balance, and it could be THIS

change that has led to more severe sickness overall.

It is, as Dr maintains, repeating the

Adenovirus vaccine scenario all over again.

Except that the Adenovirus vaccine was removed

from use in children and the previous balance in

viral types was allowed to re-establish itself.

If the above scenario is true then we, as parents

of unvaccinated children, could have every reason

to resent the introduction of Hib vaccines.

Especially if the solution put forward by medical

people is likely to be a pneumococcal vaccine

sometime in the future, in addition to the Tetramune.

And if the introduction of a pneumococcal vaccine

leads to an increase in something else, what then?

Maybe its time to talk again to Dr D.

, Editor of THE PEDIATRIC INFECTIOUS

DISEASE JOURNAL...I’m sure he will be as enthusiastic as ever to hear from us.

POSTSCRIPT

This article was delayed to see if other

countries might voice concerns. The silence has

been resounding, which leads to three possible conclusions:

1. Silence is golden

2. It is no longer an issue to them

3. Since there is a pneumococcal vaccine on the

horizon, the benefits of the Hib vaccine still outweigh any risks.

I also wonder, on the New Zealand scene whether

they even realise or accept the reality of

vaccines changing bacterial flora in a community.