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.
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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.
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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