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The Controversy of the Latent Period Following Immunizations
by Harold E Buttram, MD
Introduction
In 1986 the U.S. Congress passed the National Childhood Vaccine Injury Act,
which set up a system whereby the families of vaccine-injured children could be
compensated for such injuries. Based on personal experience and observation,
there has been much criticism of this system and question whether not it is
serving its intended purpose.
(1) One of the major areas of controversy surrounding the act involves its
limitations in the latent periods, whereby certain defined reactions following
vaccines must be identified within a certain time period to qualify for
compensation by the childhood vaccine injury act. For the complication of
encephalitis, the time limitation for the DTP or DTaP vaccine is 3 days; for the
measles-mumps-rubella (MMR) vaccine it is 5 to 15 days.
The limitations in latent periods following vaccines have been generally
accepted by our medical-legal system as guidelines in other areas as well.
Prominent among these is the "shaken baby syndrome" (SBS) in which a parent or
caretaker is accused of injuring or murdering an infant by violent shaking and
causing a triad of findings now commonly accepted as diagnostic of SBS: retinal
hemorrhages, subdural hematomas, and diffuse axonal injury. (2-5)
However, it has been observed that many cases attributed to the SBS have
occurred in a time-related fashion following routine childhood vaccines,
especially in compromised children that had been born from medically complicated
pregnancies. (6) Consequently there are valid reasons for questioning whether or
not some or many cases that have been accused of SBS were not the result of
mistaken diagnoses, the true causes of death or injury of the child having been
vaccines.
Since questions surrounding the latent period play a prominent role in many of
these cases, it is timely and appropriate to review the background of this
issue.
Are Current Guidelines in the Latent Period Artifactual?
(A) The DTP (diphtheria-tetanus-pertussis) Vaccine:
If we think in terms of a vaccine-induced encephalitis, most of the earlier
literature deals with the pertussis vaccine. Flexner (1930) noted a strong
tendency for the nervous system manifestations to declare themselves between the
10th and 13th days. (7)
In a review of 108 cases recorded before 1929 by Gorter (1933) , the onset of
encephalitis was "strikingly constant," usually observed between the 10th and
12th days following vaccination, commonly with a febrile period on the 7th and
8th days, followed by recovery until onset of the encephalitis. (8)
In 1929 an editorial in the Journal of the American Medical Association reported
on an increase in severe neurological complications following infections and
inoculations occurring on about the 11th day after vaccines. (9) Over 50 years
later Munoz, (1984) in a mice study of experimental encephalomyelitis elicited
by injection of pertussigen, found the same latent period of 11 to 13 days. (10)
In contrast, some of the literature since the 1970s has reported an entirely
different pattern, with the onset of encephalopathy largely falling within a
3-day period following vaccines. (11-13) We can only speculate as to the reasons
for this changing pattern.
Perhaps it can be attributed to the fact that, in those early years, children
were given very limited numbers of vaccines in comparison with more recent years
during which they have routinely received the hepatitis B, H influenza, and
polio vaccines in addition to the DTP, all given at the same time.
The hepatitis B vaccine has been implicated in neurological disorders,
autoimmune disorders, various forms of vasculitis and cutaneous reactions, as
well as hemorrhagic complications. (See below, page 6) Both the pertussis and H
influenza vaccines have been shown to have unusually high hyper-sensitizing
properties. (14) In many vaccines thimerosal, which contains ethyl mercury, has
been added as a preservative. (In some vaccines its use dates back to the
1930s.)
Thimerosal has also been found to have sensitizing properties. (15) Consequently
there are valid reasons for believing that the pertussis and H influenza
vaccines, some of which contain mercury, may be acting in a three-way synergy in
causing hypersensitivity reactions.
In the text, Vaccinations and Behavioral Disorders, by Greg Wilson, the author
made the following comment in regards to the latent period:
"Today the latent period is rarely mentioned in connection with neurological
complications of immunization…Contemporary studies on the pertussis vaccine
select an arbitrary time limit in which reactions have to occur to be considered
as vaccine related. This time limit is usually 3 to 7 days.
"Perhaps the only study which explores the dynamics of post DPT reactions is an
independent Australian study by Karlsson and Scheibner which, with a monitor
which followed breathing volumes, found particular times of stress-induced
breathing following DPT injections." (16) "Of special importance (for stress)
are days 2,5,6, and 8,11,13-16 and 18-21. (17)
By way of explanation, the above study involved the use of a Cotwatch breathing
monitor controlled by a micro-processor and designed to provoke alarms with
breathing delays (apnea of hypopnea with 5% or less of normal breathing
patterns) following DTP immunizations. It was found in the study that these
periods of stressed breathing occurred in clusters of 15 minutes at a time on
the post-vaccine days listed above, varying greatly from child to child.
From our point of view, the important feature of the study is not so much the
specific post-vaccine days on which the stressed breathing occurred but the fact
that the clusters continued for 21 days following the vaccines, (18) which would
tend to discredit the current medical-legal limitation for DPT reactions to 3
days.
Dr. Scheibner's findings do have some support in a study which showed a fairly
high incidence of cardio-respiratory complications in premature infants
following vaccinations. (19) Unfortunately, this study was of limited duration.
Another study throwing light on the latent period is one coming from Japan, from
which it was found that increased histamine sensitivity in mice, brought about
by the pertussis vaccine, showed two peaks, one on the 4th day following
vaccination, and a second on the 12th day. (20) In the same vein, in a letter to
the British Medical Journal, Rosemary Fox, secretary of Parents of Vaccine
Damaged Children, made the following comments:
"Two years ago we started to collect details from parents of serious reactions
suffered by their children to immunizations of all kinds. In 65% of the cases
referred to us, reactions followed the triple vaccine (diphtheria-pertussis-tetanus).
The children in this group total 182 to date; all are severely brain damaged,
some are also paralyzed, and 5 have died. Approximately 60% of
reactions…occurred within 24 hours of vaccination, 80% within 3 days, and all
within 12 days." (21)
It is important to point out in the above-survey that 20% of reactions occurred
beyond the current 3 day medical-legal limitation for the DPT vaccine.
Another important study throwing light on the latent period involves an
unpublished series of 25 cases with accusations or convictions of parents or
caretakers for the shaken baby syndrome, a series collected by attorney Toni
Blake of San Diego, California (personal communication, 2000) which have the
following features: 1) All occurred in fragile infants born from complicated
pregnancies.
Problems included prematurity, low birth weights, drug/alcohol problems,
diabetic mothers, or other maternal complications. 2) All infants were 6 months
age or less. 3) Onset of signs and symptoms occurred at about 2,4, or 6 months
of age, WITHIN 12 DAYS OF VACCINES, 4) All infants had subdural hematomas. 5)
Some had multiple fractures.
In addition to the work of Dr Viera Scheibner and attorney Toni Blake, another
enlightening area of study for the latent period is the federal Vaccine Adverse
Events Reporting System (VAERS). In her book, What Your Doctor May Not Tell You
About Children's Vaccinations, (22) Dr. Stephanie Cave makes the following
observations about VAERS:
"It is common knowledge that less than 10% of all adverse events following
vaccinations are reported to VAERS, which means that instead of the 12,000 to
14,000 reports of hospitalizations, injuries, and deaths made every year, there
may be as many as 120,000 to 140,000."
Even a cursory examination of the VAERS database for DTP/DTaP vaccines will
reveal that the latent periods for many vaccine reactions extend into the 7 to
13 day periods, some extending beyond 14 days. (23)
No review of the latent period would be complete without pointing out an almost
insuperable difficulty in getting dependable data on these reactions due to the
extreme reluctance of doctors to report on vaccine reactions, a pattern which
has existed since the earliest days of childhood vaccines. There are a number of
reasons for this.
From their earliest years of training, medical doctors have been taught to look
upon vaccines as one of the greatest achievements in medical science, and any
question about the vaccines is often looked upon as disloyalty to the
profession. In addressing this issue in the classic text, Shot in the Dark, by
Coulter and Fisher, the authors quoted an attorney specializing in
vaccine-damaged children.
In commenting on the deficiency in doctors' reporting of vaccine reactions, the
attorney commented, "As is the case with many pertussis-vaccine-injured
children, none of the treating physicians would commit themselves to a final
etiological diagnosis. It is strange that parents of pertussis-vaccine-damaged
children often can only get an etiological diagnosis by hiring an attorney and
seeing one of the few recognized experts in the US on post-pertussis vaccine
encephalopathy." (25)
As a result of this physician-reluctance to report vaccine reactions, large
numbers of reactions may be taking place beyond the currently established time
limits of the latent period, unrecognized as to their true nature.
(B) The Hemophilus influenza (HiB) vaccine:
In one of the largest, if not the largest randomized epidemiological trial ever
conducted, the effect of the Hemophilus vaccine on the development of insulin
dependent diabetes mellitus (IDDM) was studied in Finland. (26) All children
born in Finland between October 1st, 1985 and August 31st, 1987, approximately
116,000, were randomized to receive 4 doses of the HiB vaccine (PPR-D, Connaught)
starting at 3 months of life or one dose starting at 24 months of life.
An intent to treat method was used to calculate the incidence of IDDM in both
treatment groups until age 10. The incidence of IDDM was also calculated in a
control group of 128,500 children which did not receive the HiB vaccine. (27)
The results demonstrated a rise in IDDM which was specific for the vaccinated
cohort. (28)
However, the important point for our purposes was that there was a consistent
delay of 3.5 years between vaccination and onset of IDDM. (It should be pointed
out that IDDM is considered an autoimmune disease.)
At a presentation this past spring in Nashville, Tennessee sponsored by the
American College for the Advancement of Medicine, (29) Dr. John Classen reviewed
32 publications in the medical literature showing a similar increases in
diabetes mellitus in a number of countries with the MMR and hepatitis B as well
as the HiB vaccine, again with latent periods up to three years or more,
according to graphs that were provided. (Copies of references will be provided
on request).
Rather than being specific to any one vaccine, Dr. Classen offered his opinion
that the general immune stimulation from the vaccines was the cause of a rise in
autoimmunity. As an interesting sidelight, Dr. Classen mentioned that personnel
in the US navy are more heavily immunized than their European counterparts, and
that the US navy personnel have five times more diabetes than their European
counterparts.
(C) The MMR (measles-mumps-rubella) vaccine:
Whereas DTP and Hib vaccine-related encephalopathy may be the result of
interactions between endotoxin and mercury, (the latter in the form of the
additive, thimerosal), the primary mechanism of viral vaccines in causing
encephalopathy may be related to the propensity of viruses (and viral vaccines)
in bringing about autoimmune reactions. (30)
In order to provide an overview of the latent period, there are two basic
classes of immune systems, the humoral or antibody producing system, which tends
to produce immediate-type reactions, and cellular immunity, in which reactions
are delayed. Either class is capable of producing autoimmunity. (31) Obviously,
the usual 15 day limitation for the MMR vaccine excludes a recognition of the
delayed-type autoimmune reactions and, by inference, even denies their
existence.
In an article by Cohen and Shoenfeld dealing with questions of vaccine-induced
autoimmunity, the authors pointed out that it is a subject about which
relatively little is known, due to the paucity of clinical and laboratory
studies. (32) In point of fact a more recent review on this subject cites a
temporal relationship of 2 to 3 months between vaccines and autoimmune
reactions. (33)
Recently the subject of the latent periods for the MMR vaccine came sharply into
focus in an article published in Adverse Drug Reaction & Toxicology Review, (34)
in which researchers Andrew Wakefield and Scott Montgomery, who have been
investigating a possible causal relationship between the MMR vaccine and the
autism-enterocolitis syndrome, carefully reviewed deficiencies in the early
pre-licensing trials of the MMR vaccine.
In the article they pointed out that follow up periods following the vaccine
were a maximum of 28 days and in some studies even shorter periods. They
stressed that such short periods of observations following the vaccine were
totally inadequate to detect delayed reactions, including pervasive
developmental delay (autism), immune deficiencies, and inflammatory bowel
disease, which are known from earlier published reports to occur following both
the natural measles infection and the measles vaccine.
The most interesting feature of the Wakefield/Montgomery article was that it was
reviewed by four leading British authorities, all of whom had previously held
positions in the regulation and licensing of medicines in the United Kingdom.
(35) Taken as a whole, the reviewers were supportive of the article, three
highly so.
Peter Fletcher, formerly a senior professional medical officer for the
Department of Health wrote, "being extremely generous, evidence of safety (of
the MMR vaccine) was very thin." Noting that single vaccines for measles, mumps,
and rubella already existed, he argued, "caution should have ruled the
day…granting of a product license was definitely premature."
Professor Duncan Vere, former member of the Committee on the Safety of
Medicines, agreed that the periods for tests were too short. "In almost every
case," he wrote, "observation periods were too short to include the onset of
delayed neurological or other adverse events."
(D) The Hepatitis B vaccine:
Other than the references provided by John Classen, M.D. on the findings of
increased diabetes from the hepatitis B vaccine with a latent period of 3 years,
I am not aware of additional information bearing on the latent periods between
hepatitis B vaccine and other forms of reactions, which reflects the sheer lack
of data on the subject.
However, many reactions to hepatitis B vaccine may be taking place unrecognized,
for two reasons: Reason one, I have in my possession a list of 109 references of
published articles reporting on complications from the hepatitis B vaccine
including autoimmune disorders, neurological disorders, vasculitis and cutaneous
reactions. This list will be provided on request.
For reason two, in 1994 a special committee of the national Academy of Sciences
(Institute of Medicine) published a comprehensive review of the safety of the
hepatitis B vaccine. When the committee, which carries the responsibility for
determining the safety of vaccines by Congressional mandate, investigated five
possible and plausible adverse effects, they were unable to come to conclusion
for four of them because they found that relevant safety research had not been
done.
Furthermore, they found that serious "gaps and limitations" exist in both the
knowledge and infrastructure needed to study vaccine adverse events. Among the
76 types of vaccine adverse events reviewed by the IOM, the basic scientific
evidence was inadequate to assess definitive vaccine causality for 50 (66%). The
IOM also noted that "if research…(is) not improved, future reviews of vaccine
safety will be similarly handicapped. (36)
For this reason, the published reports of hepatitis B vaccine reactions may only
be a small portion of those actually taking place, with large numbers of delayed
reactions taking place unrecognized.
Conclusion
Based on published evidence that many vaccine reactions take place beyond
current medical-legal time limits that have been established for vaccines, and
on overwhelming evidence that large numbers of delayed vaccine reactions may be
taking place unrecognized, there are grounds for believing that these time
limitations may be unrealistic and artifactual.
--------------------------------------------------------------------------------
References:
(1) Buttram HE, The National Vaccine Childhood Injury Act - a Critique, Townsend
Letter for Doctors & Patients, October, 1998:66-68.
(2) David TJ, Shaken baby (shaken impact) syndrome; non-accidental head injury
in infancy, Royal Soc Med, Nov., 1999; 99:556-561.
(3) Weston IT, The pathology of child abuse, in: Heifer RE, Kempe CH, editors,
The Battered Child, University of Chicago Press, 1968:77-100.
(4) Caffey J, On the theory and practice of shaking infants; its potential
residual effects of permanent brain damage and mental retardation, Am J Dis
Child, 1972; 124:161-169.
(5) Guthkelch AN, Infantile subdural hematoma and its relationship to whiplash
injury, Brit Med J, 1971; 11:430-431.
(6) Buttram HE, Shaken baby syndrome or vaccine-induced encephalitis?, Medical
Sentinel, Fall, 2001; 6(3):83-89.
(7) Flexner S, Postvaccinal encephalitis and allied conditions, JAMA, 1930;
94(5):305-311.
(8) Gorter E, Postvaccinal encephalitis, JAMA, 1933; 101(24):1871-1874.
(9) JAMA (editorial), Postinfectious encephalitis, a problem of increasing
importance, May, 1929; 92(18):1523-1524.
(10) Munoz JJ et al, Elicitation of experimental encephalomyelitis in mice with
the aid of pertussigen, Cellular Immunology, 1984; 83(1):92-100.
(11) Menkes JH & Kinsbourne M, Workshop on neurologic complications of pertussis
and pertussis vaccination, Neuropediatrics, 1990; 21:171-176.
(12) Menkes JH, Neurologic complications of pertussis vaccination, Ann
Neurology, 1990; 28:428.
(13) Cody CL et al, Nature and rates of adverse reactions associated with DTP
and DT immunization in infants and children, Pediatrics, Nov., 1981;
68(5):650-660.
(14) Terpstra OK et al, Comparison of vaccination of mice and rats with
Hemophilus influenza and Bordetella pertussis as models, Clin Exp Pharmacol
Physiol, March-April, 1979; 6(2):139-149.
(15) Patrizi A et al, Sensitization to thimerosal in atopic children, Contact
Dermatitis, Feb., 1999; 40(2):94-97.
(16) Vaccination and Behavioral Disorders, a Review of the Controversy, Greg
Wilson, Tuntable Creek Publishing, PO Box 1448, Lismore NSW 2480, Australia,
2000, pages 48-49.
(17) Karlsson L & Scheibner V, Association between non-specific stress syndrome,
DPT injections and cot death, paper presented to the 2nd immunization
conference, Canberra, May 27-29, 1991.
(18) Vaccination: 100 Years of Orthodox Research Shows that Vaccines Represent a
Medical Assault on the Immune System, Viera Scheibner, Ph.D., Australian Print
Group, Maryborough, Victoria, Australia, 1993, pages 230-235.
(19) Pourcyrous M et al, Interleukin-6, C-reactive protein, and abnormal
cardiorespiratory responses to immunization in premature infants, Pediatrics,
March, 1998; 101(3):461.
(20) Horiuchi S et al, Two different histamine-sensitizing activities of
pertussis vaccine observed in mice on the 4th and 12th days of sensitization,
Japan J Med Sci Biol, 1993; 46:17-27.
(21) Fox R, letter, British Med J, Feb. 21, 1976.
(22) What Your Doctor May Not Tell You About Children's Vaccinations, Stephanie
Cave, M.D., F.A.A.F.P., Warner Books, An AOL Time Warner Company, 2001, page
xvi.
(23) VAERS Databases: www.vaers.org, www.fda.gov/cber, orwww.fedbuzz.com/vaccine/vacmain.htm
(24) Reisinger RC, A final mechanism of cardiac and respiratory failure, SIDS,
1974, Proc of Camps Intern Symp on SID in Infancy; also Congressional Record S.
1745, September 20, 1973.
(25) A Shot in the Dark, Harris L Coulter & Barbara Loe Fisher, Avery Publishing
Group, Inc., Garden City Park, New York, 1991, Page 47.
(26) Classen JB, Classen DC, Association between type I diabetes and Hib
vaccine, causal relation likely, British Med J, 1999; 319:1133.
(27) Tuomilehto J, Virtala E, Karvonen M et al, Increase in incidence of
insulin-dependent diabetes mellitus among children in Finland, Intern J
Epidemiology, 1995; 24:984-992.
(28) Tuomilehto J, Karonen M, Pitkaniemi J et al, Record high incidence of type
1 (insulin dependent) diabetes mellitus in Finnish children, Diabetologia, 1999;
42:655-660.
(29) American College for the Advancement of Medicine, 23121 Verdugo Dr., Ste.
204, Laguna Hills, CA 92653, phone 949-583-7666, fax 949-455-0679.
(30) Singh V & V Yang, Serological association of measles virus and human herpes
virus-6 with brain autoantibodies in autism, Clin Immunol and Immunopath, 1998;
88(1):105-108.
(31) Immunobiology, Charles A Janeway et al, fourth Edition, Current Biology
Publications, New York, 1999, page 495.
(32) Cohen DC & Shoenfeld Y, Vaccine-induced autoimmunity, J Autoimmunity, 1996;
9:699-703.
(33) Shoenfeld Y & A Aron-Maor, Vaccination and autoimmunity-'vaccinosis:' a
dangerous laison?, J Autoimmunity, Feb., 2000; 14(1):1-10.
(34) Wakefield AJ & S Montgomery, Measles, mumps, rubella vaccine: through a
glass darkly, Adv Drug React Toxicol Rev, Jan., 2001; 19(3):1-19.
(35) Hurley DR, DW Vere, AP Fletcher, Referee 1, 2, 3, & 4, Adverse Drug React
Toxicol Rev, 2001; 19(4): 1-2.
(36) Stratton KR, CJ Howe and RB Johnston, Jr., Editors, Adverse Events
Associated with Childhood Vaccines; Evidence Bearing on Causality, Institute of
Medicine, National Academy Press, Washington D.C., 1994, pp 211-236.

Childhood Immunizations and Abrupt-Onset Apnea: An Unresolved Issue in Shaken
Baby Syndrome
Harold E Buttram, MD & Alan R Yurko
Introduction
Based on personal experiences of the authors in reviewing many cases
diagnosed as shaken baby syndrome (SBS), there has been a common pattern of
unexpected and sudden onset of apnea with respiratory collapse (cessation of
breathing) in a time-related fashion following routine childhood
immunizations. For the most part these collapses have occurred during the
first 6 or 7 months of life during the time period of routine 2, 4, and
6-month immunizations. It is the purpose of this article to review existing
medical evidence and literature indicating that it is both possible and
plausible that there is a direct causal relation between immunizations and
the abrupt onset of apnea seen in many SBS cases. Part of this evidence comes
from disclosures from ongoing US Congressional hearings on issues of vaccine
safety sponsored by the Congressional Committee for Government Reform, which
have revealed fundamental deficiencies in scientific infrastructure and
safety testing of vaccines; and that as a result of these deficiencies many
adverse vaccine reactions are taking place unrecognized. Part comes from
scientific publications by primary researchers in the field of biomechanics
indicating that shaking alone cannot generate sufficient force to cause brain
damage or brain hemorrhages in infants, and that some of the fundamental
doctrines of shaken baby syndrome are based on assumptions not supported by
scientific evidence. Part comes from limited but specific medical
literature indicating vaccines as a potential cause of apnea. Based on these
different lines of evidence, it is both possible and plausible that many SBS
cases are being misdiagnosed. Each of these areas will be addressed in the
following:
Deficiencies in Scientific Safety
Infrastructure of Childhood Vaccines
As reviewed in current
Physician's Desk
References, potentially toxic and/or sensitizing substances found
in childhood vaccines may include aluminum phosphate, mercury, formaldehyde,
phenols, alcohols, mineral oils, antibiotics, animal serums, animal DNA, and
aborted fetal tissue. In addition, the Hepatitis B vaccine, which is cloned
in yeast cells, runs the risk of causing sensitivity reactions in infants who
may be sensitive to yeast. Based on this list alone, one would think that
safety considerations in the combinations and scheduling of vaccines would be
considered of preeminent importance, but has this actually taken place?
Since 1999 there have been ongoing hearings in the U.S. Congress concerning
growing concerns about vaccine safety. Primarily these hearings have dealt
with concerns about a possible link between the MMR vaccine and growing
epidemic of childhood autism in the USA. From these hearings there is now an
emerging background pattern of deficiencies in basic science in vaccine
safety testing. (1)
As a result of these deficiencies it is reasonable to assume that many
vaccine reactions are taking place unrecognized as to their true nature,
especially those of a delayed nature. Based on these hearings, scientific
evidence does not support the safety of immunizations in that safety studies
have been limited to short periods only: several days to several weeks. There
are no long-term (months or years) safety studies on any childhood vaccine in
use today.
There have been no systematic before-and-after studies on the effects of
vaccines on the immune, hematologic, brain, and neurologic systems of babies,
studies which should be considered indispensable for any ongoing medical
intervention. As an example of this type of before-and-after testing, as
reported in the
New England
Journal of Medicine in 1984, 11 healthy adults had tests
involving T-lymphocyte subpopulations (white blood cells) showing a
significant though temporary drop in T–helper lymphocytes.(2)
Special concern rests in the fact that in 4 of the subjects the T-helper
lymphocytes dropped to levels found in active AIDS patients. If this was the
case with healthy adults, it is sobering to think of the immune consequences
of the multiple vaccines given to infants with their immature and vulnerable
immune systems, and yet this test has never been repeated as far as can be
determined by surveys of the literature.
There as been inadequate consideration to the additive or synergistic adverse
effects of multiple simultaneous vaccines, although in cases of toxic
chemicals, two chemicals together may be 10 times as toxic as either
separately, or 3 chemicals 100 times more toxic. (3-4)
Medical-Legal Issues
As reviewed in “the amicus brief for SBS,” and provided through the courtesy
of Toni Blake, (5)
one of the current beliefs on which SBS accusations and convictions are based
is that
shaking alone in an otherwise healthy child can cause a subdural hematoma,
there are a number of publications which lead to the conclusion
that this syndrome is an assumption which is not supported by scientific
evidence. Foremost among these is an article by Mark Donohoe (2003,
American Journal
of Forensic medicine and Pathology) in which he stated that half
of articles about SBS were published before 1999 and half after 1999. Given
that 1998/1999 is regarded as a turning point in acceptance of the tenets and
practice of
evidence-based medicine, it seemed reasonable to the author to
assess the quality of evidence before 1999 and to compare it with the quality
of evidence on the same subject since that time. Qualities of evidence were
placed in IV broad categories, with level I or level II evidence showing
compelling evidence from consistent findings in 2 or more well-constructed,
controlled trials or population-based epidemiologic studies. In contrast,
clinical practice guidelines with level IV evidence represent consensus
statements of the expert panel according to clinical experience and limited
scientific data. Following a review of articles on SBS published before 1999,
Donohoe found that the majority of evidence showed a level of IV, “opinions
that shed no new light upon SBS and did not add to knowledge about SBS.” None
were found that exceeded a level III-2. (6)
In the fall issue of
The Warrior,
Journal of the
Trial Lawyers College,
2003, Attorney Elaine Whitfield Sharp wrote a comprehensive article reviewing
the history of SBS. (7)
Beginning in 1966 and 1968 Ayub K Ommaya, MD, a Pakistani-born and
Oxford-educated neurosurgeon, set out to determine the amount of force it
takes to cause certain types of brain injuries and hemorrhages from rear-end
car crashes. In experiments with Rhesus monkeys (experiments now prohibited),
Ommaya used the monkeys to mimic car accidents by accelerating them on chairs
fixed to a track and decelerating them
without impact to
their heads. Ommaya's experiments showed that it took between
35,000 to 40,000 radians per second (squared) of angular or rotational
acceleration to cause brain hemorrhages in the monkeys. Transposing the size
of monkey brains to that of human brains, Ommaya calculated that the amount
of force required to cause brain hemorrhages in humans would be 6,000 to
7,000 radians. According to the review by Sharp, other notable names in the
field of SBS transposed Ommaya's findings to the field of SBS. It was on this
basis that the current tenets of SBS were formed.
It was not until
1987 that a bio-mechanician and a group of neurosurgeons set out to prove
that subdural hemorrhages in babies were not caused by shaking but by impact.
The bio-mechanician was Lawrence E Thibault who, with team members made a
surrogate baby model and attached an accelerometer to its neck. First they
asked some burley football players to shake the model as hard as they could.
The most force they were able to generate was a mean of 1,138 radians, far
below the 6,000 to 7,000 radians required to cause human brain hemorrhages. (8)
Other publications since that time tend to confirm tather than falsify these
findings, one example being a report by Prange, Coats, Duhaime, and Margulies
which concluded that “there are no data showing that the maximum change in
angular velocity… .during shaking and inflicted impact against unencased foam
is sufficient to cause subdural hemorrhages or primary traumatic axonal
(nerve) injury in an infant.” (9)
Increased Hazards of Vaccines in Premature
Infants (10)
As reviewed in a previous article in
Townsend Letter,
(11)
a series unpublished cases of SBS collected by Toni Blake, jury counselor of
San Diego, found a striking pattern of subdural (brain) hemorrhages occurring
in “fragile infants” in a time-related fashion following routine
immunizations given during the first 6 months of life. Risk factors included
prematurity, low birth weight, maternal drug or alcohol problems, maternal
diabetes, or toxemia of pregnancy. Among these risk factors, the best
information to date connecting vaccines to apnea is to be found in studies of
premature infants. Because of their importance, five of these will be
reviewed below.
The authors of many well-documented studies have concluded that the risk and
benefit of vaccination in preterm infants should be evaluated prior to
administering the vaccines. They also emphasized that preterm infants who
have received vaccines should be monitored. The following are descriptions of
several selected studies conducted in the USA and other countries to
illustrate these points.
-
Case histories
of 45 preterm babies who were vaccinated with DPT/Hib (diphtheria, tetanus
toxoids, and pertussis (Haemophilus influenzae type B conjugate) in the
neonatal intensive care unit of the Royal Gwent Hospital, Newport, UK
between January 1993 and December 1998 were studied retrospectively. (12)
Apparent adverse events were noted in 17 of 45 (37.8%) babies; 9 (20%) had
major events, i.e. apnea, bradycardia or desaturations, and 8 (17.8% had
minor events; i.e. increased oxygen requirements, temperature instability,
poor handling and feed intolerance. Age at 70 days or less was
significantly associated with increased risk (p<0.01). Of 27 babies
vaccinated at 70 days or less, 9 (33.3%) developed major events compared
with none when vaccinated over 70 days. The authors concluded that
vaccine-related cardiorespiratory events are relatively common in preterm
babies. Problems were much more common if vaccine is administered at or
before 70 days. Therefore babies should therefore be monitored
post-vaccination.
-
After observing
the occurrence of apnea (a respiratory pause of 20 seconds or longer,
usually associated with bradycardia, heart rate less than 80 beats/min) in
two preterm infants following immunization with DTP and HibC, Sanchez et al
conducted a prospective surveillance of 97 (50 girls and 47 boys) preterm
infants younger than 37 weeks of gestation who were immunized with DTP (94
also received HibC at the same time) in the neonatal intensive care unit in
Texas USA to assess the frequency of adverse reactions, and in particular
the occurrence of apnea. For each infant data were recorded for a 3-day
period before and after receipt of the immunizations. (13)
Their study showed that apneic episodes occurred in 34 infants (34%) after
immunizations. Twelve infants (12%) experienced a recurrence of apnea, and
11 (11%) had at least a 50% increase in the number of apneic and
bradycardia episodes in the 72 hours after immunization. This occurred
primarily among smaller preterm infants who were immunized at a lower
weight (p=0.01, had espereinced more severe apnea of prematurity (p=0.01),
and had chronic lung disease (p=0.03). some of these infants required new
medical intervention for the increased apneic/bradycardiac episodes. (23)
-
Bothan et al
conducted a prospective study of 98 preterm infants (53 males and 45
females) of gestational age 24-31 weeks who were immunizated at
approximately 2 months postnatal age with diphtheria-tetanus-whole cell
pertussis vaccine (DTPw) in the neonatal intensive care unit (NICU) at King
George V Hospital in Sydney, Australia. Half the infants also received
Haemophilus influenzae type b conjugate vaccine (Hib) simultaneously. All
infants were monitored for apnea and bradycardia in the 24 hour periods
pre-and post immunization. Their study showed only one infant had apnea
and/or bradycardia pre-immunization compared with 17 post-immunization. For
12 infants these events were brief, self-limiting and not associated with
desaturations (oxygen saturation <90%). However, for five infants (30%)
these events were associated with oxygen desaturation, and two of these
infants required supplemental oxygen. When considering immunization for
preterm infants, the benefits of early immunization must be balanced
against the risk of apnea and bradycardia. (14)
-
Slack et al.,
(1999) from the United Kingdom stated that four premature infants
develop0ed apneas severe enough to warrant resuscitation after immunization
with diphtheria, pertussis, and tetanus (DPT) and Haemophilus influenzae B
(Hib). One required intubation and ventilation. They also reported that,
although apneas after immunization are recognized, they are not well
documented. They concluded that it is time for further research to
elucidate the best time to immunize such infants. (15)
-
Botham et al
conducted a prospective study in ninety-seven preterm infants who were
immunized with diptheria-tetanus-pertussis to document respiratory and
cardiac events. (16)
The mean gestational age at birth was 28.1 weeks (range 24 to 34) and the
mean age at immunization was 80.6 days (range 44-257). They found that
nineteen (20%) infants developed apnea or bradycardia within 24 hours of
immunization. The infants who developed apnea and/or bradycardia had a
younger gestational age at birth than those who did not (p=0.03), were
artificially ventilated for longer (p=0.01), and were more likely to have a
diagnosis of chronic lung disease (p=0.006). Two infants who developed
concurrent upper respiratory tract infections required additional oxygen,
and one of them was treated with oral theophylline. They stated that
cardiorespiratory function should be monitored after immunization in very
preterm infants who had prolonged ventilatory support and/or chronic lung
disease.
In Nelson
Textbook of Pediatrics, 16 th Edition, there are precautions in
the use of potentially toxic medications in premature infants because of
diminished renal clearances for almost all substances excreted in the urine (17)
The text also cautions about drugs that are detoxified in or conjugated by
the liver in premature infants. Should not vaccines be included in the
category of potentially toxic medications? The five references cited above
show unmistakable evidence that there is a significant increase in apneic
episodes following immunizations, to which preterm/premature are
exceptionally vulnerable.
Diphtheria-Pertussis-Tetanus (DPT) Vaccines
and Infant Apnea in Sudden Infant Death Syndrome (SIDS)
According to a report by WC Torch of
Reno,
Nevada, over 150 DPT-postvaccinal deaths have been reported in the literature
by 37 authors in 12 countries. (18)
Although 90% of reactions occurred with one week of DPT, the remainder as
long as 20 months following protracted reactions. About one-half were sudden
infant death-like (SIDS) or anaphylactic; about one-half followed neurotoxic
or systemic symptoms (
apnea
(emphasis mine), dyspnea, apnea, seizures, shock, irritability, lethargy,
apathy, coma, decerebrate-decorticate rigidity, spasticity, hypotonia, or
paralysis). In deaths within 3 hours of DPT the brain was normal; between 6
and 72 hours,
varying degrees of brain edema, vascular congestion, petechia or (brain)
hemorrhage, monocytic infiltrates, and neuronal degeneration were
seen. In some later deaths demyelination, gliosis, or atrophy was seen. The
author and others maintained a causal relationship between DPT vaccine and
yet-to-be determined SIDS fraction.
Vaccines, Vitamin C Depletion and Apnea
In the next 25 years or so, when there is greater knowledge about the adverse
reactions and aftermath from current childhood vaccine programs, physicians
and scientists, as well as the lay public, may look back on these programs
with embarrassment if not worse. This is not to say that vaccines do not have
a proper role in preventive health, which they do, but not with neglect in
safety considerations.
The rationale for these statements is based largely on the work of Dr.
Archivedes Kalokerinos, who worked as a medical officer among the Australian
aborigines in the “outback” in the 1960s and 1970s. Being troubled by very
high infant mortality, in some areas approaching 50%, he began to investigate
possible causes. Having noticed signs of scurvy in some of the infants, and
observing that the children often died following immunizations, especially if
they had colds or minor respiratory infections, the thought occurred to him
that there might be a connection between vitamin C deficiency and deaths
following vaccines. With improved nutrition, routine oral vitamin C
supplementation of children and infants,
avoidance of
immunizations during minor illnesses, even if just a runny nose,
and large doses of injectable vitamin C during crises, infant mortality was
virtually abolished. Although Kalokerinos was awarded the Australian Medal of
Merit in 1978 for his work, it has never been acknowledged by mainstream
medicine. What is worse, it has never been subjected to systematic,
meaningful scientific studies.
In contrast to classical scurvy of earlier times in the days of
wooden sailing ships, when scurvy was characterized by a total lack of
Vitamin C, what we may be seeing today is something quite different. As
described by Dr. Kalokerinos (19)
and Alan Clemetson, MD (20)
subclinical scurvy is a condition in which apparently healthy infants with
marginally low but adequate levels of Vitamin C in unstressed conditions may
be suddenly thrown into states of critical Vitamin C depletion by
combinations of stresses from common infections and toxins, including the
toxins found in vaccines. As one example of marginal Vitamin C deficiency
on the modern scene, in a study of people attending an HMO (Health
Maintenance Organization Clinic) in Tempe, Arizona in 1998, 30% were found to
be depleted with plasma Vitamin C levels between 0.2 and 0.5 mgs/100 ml and
to be deficient in 6% with levels below 0.2%. (21)
In regards to infants, it is true that infant formulas have been mandated to
include Vitamin C at levels providing the required 30 mgs per day. However,
this is a maintenance level and makes no allowances for additional stresses
which may bring about many-fold increases in need for Vitamin C. Common
colds, for instance, have been shown to reduce Vitamin C levels up to 50%. (22)
No one knows the effects of vaccines on Vitamin C levels in infants, because
before-and-after studies of this type have never been done, but Vitamin C is
known to neutralize the toxins of diphtheria, (23-26)
tetanus, (27)
typhoid endotoxin, (28)
and four varieties of gas gangrene. (29)
As will be described below, in the process of neutralizing these toxins,
Vitamin C is necessarily used up and depleted.
If the reader will consult with these references, which were extracted from
an article by A Clemetson, (30)
it will be found that most of these studies are quite old and some published
in foreign languages. To us that is the pity of it, as our own scientific &
medical system has never recognized their importance or followed through with
further investigation.
Returning to the importance of vitamin C in relation to vaccines, one of the
prime roles of Vitamin C in the body is its action as an antioxidant in
donating electrons to quench free-radical inflammatory damage from infections
and/or toxins, with our consideration here being vaccine toxins. However, in
the process of donating electrons, Vitamin C necessarily becomes depleted.
Once the level of Vitamin C is reduced to the point that it can no longer
protect the brain, which is unduly susceptible to toxic and infectious
damage, it (the brain) may become subject to free-radical damage. By
definition a “free-radical” consists of a molecular fragment with one or more
unpaired electrons in its outer orbital ring, causing it to be highly
oxidative, unstable, and to react instantaneously with other substances in
its vicinity. Within a few millionths of a second, free radicals have the
potential to react with and damage nearby molecules and cell membranes with a
chain reaction of damage. (31-33)
When uncontrolled, these can be very destructive to the body, such as may
take place when exposed to harmful radiation. Vitamin C is critically
important in protecting against free-radical proliferation because, in
donating electrons, it neutralizes the unpaired electrons in the
“free-radical” molecular fragments. Of all the organs of the body, the brain
appears to be most vulnerable to this type of damage because of its
relatively high fat content.
For these reasons, combinations of vaccines given to fragile infants may be
an invitation to disaster with the brain being potentially subjected to a
firestorm of free-radical inflammatory damage. Once this pattern has been set
in motion, there is a variable latent period with gradual progression of
inflammatory brain edema (swelling). The breathing center, located at the
base of the brain, appears to be uniquely vulnerable to the process. This in
turn may result in respiratory paralysis and collapse. In other instances
there may be seizures. Among the cases of SBS that we have reviewed, this as
been a common pattern, too frequent to be coincidental.
As described in his autobiography, Dr. Kalokerinos describes the mechanisms
involved in the production of brain edema with retinal and brain hemorrhages
in much the same fashion: (18)
“1. Endotoxin (endogenous and/or from vaccines) damages the endothelial
linings of the brain's blood vessels.
2. endotoxin then ‘leaks' through to the surrounding brain tissue. This
includes the retina that is an extension of the brain.
3. The brain tissue is damaged.
4. The blood supply to the portions of the brain involved is reduced.
5. Insufficient oxygen, glucose, and Vitamin C follows.
6. Parts of the brain are ‘rich' in ‘bound' (controlled) iron. This is
released.
7. Violent free radical reactions result, and these cannot be controlled
because of a lack of immediately available Vitamin C and other antioxidants.
8. So further, and rapid, brain tissue damage results, with more free radical
reactions.
9. Hemorrhages occur in the area/areas involved.
10. After a variable period (depending on a host of factors) some of the red
blood cells in the hemorrhages break down and release their stores of iron
and copper.
11. This results in a further cascade of free radical reactions and tissue
destruction.
12. Cerebral edema (brain swelling) occurs.”
By way of comparison, in
Vienna
in the 1840s, long before recognition of the importance of sanitation and the
role of microbes in causing disease, a doctor named Ignaz Semmelweis was
assigned to an obstetrical post at a birthing center which was notorious for
its high maternal mortality rates. Based on simple observation, Semmelweis
deduced that doctors and nurses were carrying infections from one patient to
another and subsequently required that they wash their hands between
patients. As a result, the mortality rate among maternity patients under his
care was reduced from nearly 30% in other wings of the hospital to less than
2% for patients under his care or supervision.
Was Semmelweis honored by his peers for this discovery? No, at least not at
that time. Instead he was dismissed from the hospital staff because his
procedures did not conform with the medical thinking of the time. In the
cases of Drs. Archivedes Kalokerinos and CA Clemetson, could history be
repeating itself?
Inverse Relations between Plasma Ascorbic
Levels and Whole Blood Histamine; Elevated Histamine the True Cause of
Capillary Fragility in Scurvy
In 1980 A Clemetson reported that the whole blood histamine levels of human
subjects are inversely proportional to their plasma vitamin C levels, (34)
in that 34 percent of people who had subnormal but not deficient ascorbic
acid levels were found to have significantly increased blood histamine
concentrations. The 2 percent of subjects who were markedly vitamin C
depleted (<0.2 mg/100 ml) had a four-to-five-fold increase in their blood
histamine concentrations. Frank scurvy does not occur until blood histamine
is increased more than ten-fold. Nevertheless, the blood histamine
concentration returns to normal very rapidly following the oral
administration of ascorbic acid.
Indications that elevated blood histamine is the true cause of capillary
fragility in scurvy comes from electron-microscopic studies by Gore et al in
guinea pigs with scurvy, in which widening of the intercellular junction gaps
were demonstrated in the vascular endothelium. (35)
Moreover, Majno and Palade have observed similar widening of the endothelial
junction gaps and leakage of tracer particles through endothelial gaps in
rats following the injection of histamine. (36)
Consequently it seems that histaminemia is the crucial factor causing
bleeding in scurvy and may be responsible for the fragility of the bridging
veins and venules between the brain and the dura mater, as well as the
retinal petechiae.
As a matter of opinion, Clemetson's work in elucidating the inverse
relationship between vitamin C and blood histamine levels, with elevated
histamine being the primary cause of capillary fragility, (34)
is of critical importance in shaken baby syndrome, so that there should be
mandatory requirements for obtaining blood plasma levels of vitamin C and
whole blood histamine in hospital emergency rooms before bringing charges of
SBS.
An Hypothetical Analysis of the
Vaccine/Apnea Connection and its Pathogenesis in Causing Brain and Retinal
Hemorrhages
Current theories surrounding shaken baby syndrome maintain that subdural
and/or retinal hemorrhages are diagnostic of shaken baby syndrome in absence
of known accidental trauma. In opposition to this assumption, Jennian Geddes,
Neuropathologist at Royal London Hospital, and colleagues have shown evidence
that many of these cases are the result of injuries to the respiratory center
located at the base of the brain, injuries
not necessarily involving either violence
or impact. (37-38)
Once respiratory collapse takes place, brain swelling rapidly ensues as a
result of hypoxia according to Geddes. Locked as it is inside a rigid skull,
the brain then becomes its own tourniquet, quite effectively blocking off
venous blood outflow from the brain. As a result there is an increase in
central venous pressure, the true cause of subdural and retinal hemorrhages,
as well as the primary cause of apneic episodes in these infants. (39-41)
Assuming next that vaccines can and do bring about respiratory collapse in
infants, what would be the mechanism? Based on evidence provided here, it is
almost certain in these cases that there is smoldering brain inflammation
with gradual swelling of the brain. This may reach the point where the
respiratory center at the base of the brain becomes constricted from the
brain swelling, or possibly herniated into the spinal canal. In the absence
of brain edema, it may be the effects of the vaccine toxins.
Conclusion
In summary, based on our own reviews of shaken baby syndrome cases there has
been a common pattern of sudden and unexpected onset of apnea (cessation of
breathing) in a time-related fashion following vaccines. Many times the
parent or caretaker in attendance of the baby, being untrained in
resuscitation, have shaken the baby in sheer panic attempting to restore
breathing. Later admitting this to the police, parents or caretakers have
been accused of inflicting injury on the baby by SBS. In our opinion this is
a superficial analysis of what has taken place, the real question being what
caused of the respiratory collapse which preceded the shaking. If this
issue receives the meaningful and objective investigation that it deserves,
we predict it will be found that many innocent parents and caretakers have
been falsely accused and convicted of SBS.
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