Case Report: Encephalomyelitis caused by Hepatitis B vaccination
Nino Gulua MD.
Sanzona 4a building, flat #28
0191 Tbilisi, Republic of Georgia
Telephone: 995 32 603715; Cell Phone 995 77 792099.
Email: ngulua@hotmail.com Website: www.hapihealth.com
I want to tell the story of an accident that changed radically my son George Kobalia’s life as well as our family’s.
On March 18, 2002 the Hepatitis B vaccination was administered to my son George Qobalia in the polyclinic. At that time, George was 12¼-years-old. This particular vaccine was manufactured by Green Cross Vaccine Corporation in Korea and was imported in Georgia by the UN Children Fund - UNICEF humanitarian mission.
Three days following vaccination, the child suffered acute headache, general weakness, a loss of coordination that was followed by diminished mental capacity and he lapsed into a coma. An ambulance from Center of Catastrophic Medicine rushed the child to Kutaisi, and then to intensive care at Children’s Republican Hospital in Tbilisi, under the care of Dr. David Pulariani who initiated the child’s connection to an artificial respirator. These circumstances were the basis for the Georgian press and television broadcast that “12-year-old George Kobalia was struggling with death”.
It is hard to describe the pain and suffering George has undergone, including the suffering of our family and relatives. George was one of the best pupils and dancers of the Tsalenjikha Lyceum. It is difficult for his parents to comprehend that today George is incapable of doing any of the previous activities he engaged in. Such kind of post-vaccination complications are described in the foreign medical literature: 1 in 600,000 cases. That one case appeared to be crucial for George.
On July 11, 2002, the child was brought to the abovementioned clinic on the basis of an agreement laid down by the Ministry of Health of Georgia and the administration of Salzburg Neurological Clinic where he had undergone a medical treatment and testing. According to that agreement, the Ministry of Labor, Health and Social Affairs had to pay the clinic 10 thousand Euro. Due to some unknown reason, the transfer of the money did not happened, so the parents were forced to find a sponsor through their own efforts and sponsor took George to Germany—more specifically, to the Staffelstein Rehabilitation Center, where he was treated for 8 months. Our family will never forget the warmth and sympathy the German people showed toward George. Especially the medical personnel of the clinic and its chairman who covered the expenses of George’s treatment and rehabilitation.
The post-vaccination encephalomyelitis was diagnosed in Germany. This rare and at the same time serious adverse reaction was repeatedly covered by local press and television.
Now George’s mind is clear; he likes mathematics, knows English and computers, but his condition is still extremely serious. He has a tracheal tube because of diaphragmatic nerve paresis and this is also why his hand reflex is weak. Due to these conditions, George is incapable to do tasks on his own and always requires a nurse to assist him; costly medical treatment and rehabilitation are necessary for George, and our (Doctor’s) family does not have the needed financial resources.
We initiated legal action from the Tbilisi regional court against the Ministry of Labor, Health and Social Affairs, National Center of Statistics and Disease Control, Korean pharmaceutical firm “Green Cross Vaccine Corporation” and UN Children’s Fund-UNICEF.
Lawsuit took a very long time. In about 3 months, the respondents were:
1. Ministry of Labor, Health and Social Affairs;
2. National Center of Statistics and Disease Control;
3. Georgian lawyer hired by Korean pharmaceutical firm;
4. UN Children’s Fund - UNICEF that imported Korean vaccine to Georgia by humanitarian mission and now totally ignores the fact and is not interested in the child’s fate.
The litigation took place on 17th of December. Television and press existing in Georgia got actively involved in lawsuit and would observe how objectively the lawsuit ran. In our claim there was pointed out that George permanently requires a nurse and requires treatment and rehabilitation courses 3 months per year at the European Rehabilitation Center of demyelinization illness. Rehabilitation cost is 17,000 Euros per month.
Yet in Georgia it would cost US $1,600 including treatment, rehabilitation and education. Noted sum was counted for 50 years and according to this scheme it amounted to over US $3 million. (Rehabilitation cost is based on rates established in 2002. By today’s situation rehabilitation cost is 680 Euros per day or 21,080 Euros per month).
The Korean party mainly relies on the conclusion drawn by World Healthcare Organization expert, Mr. Stiven Vasilak, who arrived in Georgia with a scheduled visit and monitor the child. He arrived in Georgia on a poliomyelitis-planned visit and had not planned to study George’s case. It is notable that in our conversation he mentioned that he is not qualified in this case and left many unanswered questions posed by colleagues.
His examination did not go beyond conversation with doctors and general history; he was not even interested in seeing the child who had been in the worst state – connected to the artificial respirator. Representatives of World Healthcare Organization tried hard not to mention post-vaccine complications and this is natural because the World Health Organization had issued the quality certificate for that vaccine.
Their conclusion stated that there is no causative link between vaccine and disease because only a short period of 72 hours passed from vaccination to development of disease. However, they emphasize the fact that it is practically impossible to exclude thoroughly encephalomyelitis following vaccination.
The court made a biased ruling – George will get US $10,000 for moral damage and monthly aid in total of US $500. The National Center of Disease Control and Healthcare Ministry was obligated to pay. The court freed from responsibility and left inviolable Korean pharmaceutical firm which most of all must be held responsible for the damage caused by the vaccine produced by them. In the vaccine literature there was no mention of the complications that appeared to be applicable in George’s case. American literature indicates that the Hepatitis B vaccine may cause disseminated sclerosis, encephalitis and serious damage of the nervous system. But in the Korean literature for the vaccine, there is no mention concerning any such types of complications. It is beyond belief that the Korean pharmaceutical firm was free from any responsibility. All this creates doubts and question: who lobbies for the Korean pharmaceutical firm? Moreover, the lawyer of the Ministry of Health and Social Affairs announced with a menacing tone at the lawsuit that if the parents did not keep quite, they could fire them. It is inconceivable to me why I, the parent, should be silent? Who else is going to defend the rights of my son?
I want to resort to everybody and ask you to help me up in establishing the justice to protect my son’s rights and take care of his future. Can we disregard everything; close eyes to pain and suffering that George and our family bears.
Our case has now been referred to the Supreme Court in an attempt to obtain an objective decision and enable us to conduct the course of rehabilitation at the leading European clinics. In case the Supreme Court decision provides no relief, the last hope will be with the International Court of Justice which guarantees to protect the rights of children and patients.
Herroelen L, et al. Central-nervous-system demyelination after immunisation with recombinant hepatitis B vaccine. Lancet. 1991 Nov 9;338(8776):1174-5.
This article reports on two cases of central-nervous-system demyelinating disease occurring six weeks after administration of recombinant hepatitis B vaccine. One patient had a history of multiple sclerosis while the other had no history of neurological disease.
Hepatitis B vaccine and central nervous system demyelinating diseases. Viral Hepatitis Prevention Board. Pediatr Infect Dis J. 1999 Jan;18(1):23-4. Review.
Multiple sclerosis and hepatitis B vaccination. Nadler JP. Clin Infect Dis. 1993 Nov;17(5):928-9
Multiple sclerosis and hepatitis B vaccine? Hall A, et al. Vaccine. 1999 Jun 4;17(20-21):2473-5.
Vaccination against hepatitis B and multiple sclerosis. Diego Nunez MA, et al. An Esp Pediatr. 1999 Jan;50(1):97. Spanish.
Meningeal reaction after vaccination against hepatitis B.Marsaudon E, et al. Presse Med. 1996 Oct 26;25(32):1561-2. French.
Acute aseptic meningitis after hepatitis B vaccination. Heinzlef O, et al. Presse Med. 1997 Mar 8;26(7):328. French.
Leukoencephalitis after recombinant hepatitis B vaccine Manna R, et al. J Hepatol. 1996 Jun;24(6):764-5.
Acute myelitis after immunization against hepatitis B with recombinant vaccine.
Senejoux A, et al. Gastroenterol Clin Biol. 1996;20(4):401-2. French.
Transverse myelitis following hepatitis B vaccination.
Trevisani F, et al. J Hepatol. 1993 Sep;19(2):317-8.
Acute myelitis after vaccination against hepatitis B.
Mahassin F, et al. Presse Med 1993 Dec 18;22(40):1997-8 French.
This article discusses the case of a 56-year-old man hospitalized for acute myelitis after receiving hepatitis B vaccination.
Acute Myelitis after hepatitis B vaccination.
Song HK, et al J Korean Med Sci. 1997 Jun;12(3):249-51.
Deisenhammer F, et al. Acute cerebellar ataxia after immunisation with recombinant hepatitis B vaccine.
Acta Neurol Scand. 1994 Jun;89(6):462-3.
This article reports on the case of a woman who developed acute cerebellar ataxia 10 days after the second vaccination with recombinant hepatitis B vaccine. Mental nerve neuropathy as a result of hepatitis B vaccination. Maillefert JF, et al. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997 Jun;83(6):663-4 This article discusses the case of a 20-year-old woman who developed polyarthralgia and sensory neuropathy after hepatitis B vaccination.
Report of the working group on the possible relationship between hepatitis B vaccination and the chronic fatigue syndrome.
CMAJ. 1993 Aug 1;149(3):314-9
The possible relation between hepatitis B vaccination and chronic fatigue syndrome.
Delage G, et al. Union Med Can. 1993 Jul-Aug;122(4):278-9. French
Probable post-hepatitis A vaccination encephalopathy.
Hughes PJ, et al. Lancet. 1993 Jul 31;342(8866):302.
COMPLICATIONS AFFECTING THE JOINTS
Hepatitis B immunisation and reactive arthritis.
Birley HD, et al. BMJ 1994 Dec 3;309(6967):1514
The development of rheumatoid arthritis after recombinant hepatitis B
vaccination. Pope JE, et al. J Rheumatol 1998 Sep;25(9):1687-93
This article reports on 11 individuals who developed rheumatoid arthritis after receiving recombinant hepatitis B vaccination. In all cases the arthritis persisted for more than six months.
Polyarthritis associated with hepatitis B vaccination.
Bracci M, et al Br J Rheumatol. 1997 Feb;36(2):300-1.
Arthritis, hypercalcemia, and lytic bone lesions after hepatitis B
vaccination. Cathebras P, et al. J Rheumatol. 1996 Mar;23(3):558-60.
Reactive arthritis after hepatitis B vaccination.
Hachulla E, et al. J Rheumatol. 1990 Sep;17(9):1250-1.
Hepatitis B vaccine associated with erythema nodosum and polyarthritis.
Rogerson SJ, et al. BMJ. 1990 Aug 11;301(6747):345.
Reiter's syndrome and reactive arthritis in health care workers after
vaccination. Hassan W, et al. BMJ 1994 Jul 9;309(6947):94
Reiter's syndrome attributed to hepatitis B immunization.
Fraser PA, et al. BMJ 1994 Dec 3;309(6967):1513
Acute sero-positive rheumatoid arthritis occurring after hepatitis
vaccination. Vautier G, et al. Br J Rheumatol 1994 Oct;33(10):991
Arthritis after hepatitis B vaccination. Report of three cases.
Gross K, Combe C, Kruger K, Schattenkirchner M Scand J Rheumatol
1995;24(1):50-2
Exacerbation of chronic juvenile arthritis induced by hepatitis B
vaccination. Sebag O, et al.Arch Pediatr. 1998 Sep;5(9):1046. French.
COMPLICATIONS AFFECTING THE BLOOD
Cryoglobulinemia after hepatitis B vaccination.
Mathieu E, Fain O, Krivitzky A N Engl J Med 1996 Aug 1;335(5):355
Thrombocytopenia reported in association with hepatitis B and A vaccines.
Meyboom RH, et al. Lancet. 1995 Jun 24;345(8965):1638.
Thrombocytopenic purpura after recombinant hepatitis B vaccine.
Poullin P, et al. Lancet. 1994 Nov 5;344(8932):1293.
Thrombocytopenic purpura as adverse reaction to recombinant hepatitis B
vaccine. Ronchi F, et al. Arch Dis Child. 1998 Mar;78(3):273-4.
This article discusses three cases of immune thrombocytopenic purpura, a bleeding disorder, occurring in infants under 6 months of age after they received the first dose of recombinant hepatitis B vaccine. Immune thrombocytopenic purpura after recombinant hepatitis B vaccine: retrospective study of seven cases. Neau D, et al. Scand J Infect Dis. 1998;30(2):115-8.
This article discusses the cases of seven children (average age--12 years) who developed thrombocytopenia, a bleeding disorder, following vaccination with recombinant hepatitis B vaccine.
COMPLICATIONS AFFECTING THE EYES
Visual loss and eosinophilia after recombinant hepatitis B vaccine. Brezin A, et al. Lancet. 1993 Aug 28;342(8870):563-4.
Bilateral neuro-papillitis after hepatitis B vaccination. Berkman N, et al. Presse Med. 1996 Sep 28;25(28):1301. French.
Occlusion of central retinal vein after hepatitis B vaccination. Devin F, et al. Lancet. 1996 Jun 8;347(9015):1626.
Occlusion of the central retinal vein after vaccination against viral hepatitis B with recombinant vaccines. 4 cases. Granel B, et al. Presse Med. 1997 Feb 1;26(2):62-5. French.
Multiple evanescent white dot syndrome after hepatitis B vaccine. Baglivo E, et al. Am J Ophthalmol. 1996 Sep;122(3):431-2.
Ophthalmic complications of vaccines against hepatitis B virus. Arya SC. Int Ophthalmol. 1997;21(3):177-8.
OTHER COMPLICATIONS OF HEPATITIS B VACCINE
Lupus erythematosus disseminatus and vaccination against hepatitis B virus. Mamoux V, et al. Arch Pediatr. 1994 Mar;1(3):307-8. French.
Systemic lupus erythematosus following hepatitis B vaccine. Guiserix J. Nephron. 1996;74(2):441.
Myasthenia gravis after general anesthesia and hepatitis B vaccine. Biron P, et al. Arch Intern Med. 1988 Dec;148(12):2685.
Benign acute pericarditis after vaccination against hepatitis B. Bensaid J, et al. Presse Med. 1993 Feb 20;22(6):269. French.
Acute pericarditis after vaccination against hepatitis B: a rare effect to be known.
Peyriere H, et al. Rev Med Interne. 1997;18(8):675-6. French.
Severe acute hepatitis B infection after vaccination. Ballinger AB, et al. Lancet. 1994 Nov 5;344(8932):1292.
Acute hepatitis B infection after vaccination. McIntyre PG. Lancet. 1995 Jan 28;345(8944):261.
Acute hepatitis B infection after vaccination. Waugh MA. Lancet. 1995 Jan 28;345(8944):262; discussion 262-3.
Liver dysfunction and DNA antibodies after hepatitis B vaccination.Lilic D, et al. Lancet. 1994 Nov 5;344(8932):1292-3.
Liver inflammation and acute respiratory distress syndrome in a patient receiving hepatitis B vaccine: a possible relationship? Ranieri VM, et al.Intensive Care Med 1997 Jan;23(1):119-21
This article reports on the case of a man who developed liver and lung dysfunction after receiving the second dose of recombinant hepatitis B vaccine.
A case of Churg-Strauss vasculitis after hepatitis B vaccination.
Vanoli M, et al. Ann Rheum Dis. 1998 Apr;57(4):256-7
Nephrotic syndrome after recombinant hepatitis B vaccine.
Macario F, et al. Clin Nephrol. 1995 May;43(5):349.
The diabetes epidemic and the hepatitis B vaccines.
Classen JB N Z Med J 1996 Sep 27;109(1030):366
Asthma and urticaria after hepatitis B vaccination.
Lohiya G. West J Med. 1987 Sep;147(3):341.
Hair loss after routine immunizations.
Wise RP, Kiminyo KP, Salive ME JAMA 1997 Oct 8;278(14):1176-8
This paper describes 46 cases of alopecia (hair loss) reported to the
Vaccine Adverse Effects Reporting System after hepatitis B vaccination.
Major adverse reactions to yeast-derived hepatitis B vaccines--a review. Grotto I, et al. Vaccine 1998 Feb;16(4):329-34
This article discusses some of the adverse reactions that have been reported following hepatitis B vaccination. These include anaphylaxis (severe allergic response), lupus, and kidney, blood, eye, and nervous system problems.
Serious hepatitis B vaccine adverse reactions: are they immune-mediated?
Carmeli Y, De-Medina T Vaccine 1993 Oct;11(13):1358-9
Hepatitis B vaccine side-effect.
Carmeli Y, Oren R Lancet 1993 Jan 23;341(8839):250-1
On Autoimmunity and the Blood-Brain Barrier
I am responding to the post of 9/23 about autoimmunity and the connection with a faulty blood-brain barrier. The blood-brain barrier is not intact in infants until at least 6 weeks of life. This is why a newborn with a fever must be subjected to a spinal tap to rule out meningitis. Any virus or bacteria that a newborn is exposed to can go directly to the nervous system. This is why the Hepatitis B vaccine at birth is so dangerous. Between 1991 and 1999, when the shot contained thimerisol, giving it at birth would have resulted in mercury crossing into the brain since the blood-brain barrier was not yet intact. As a nurse, I'm concerned that this information about the normal timing of a blood-brain barrier forming is not more readily known. I think this normal delay in the forming of a blood-brain barrier is an important piece of the puzzle and one of the reasons for the surge of autism in the 90's.
Mary Barbera RN, MSN
Vital C, Vital A, Gbikpi-Benissan G, Longy-Boursier M, Climas MT, Castaing Y, Canron MH, Le Bras M, Petry K.
Neuropathology Department, Victor Segalen University, Bordeaux, France.
claude.vital@neuropath.u-bordeaux2.fr
Autoimmune inflammatory polyneuropathy (PN) can be triggered by vaccination. We report 3 such cases. A 36-year-old female nurse presented 15 days after a hepatitis B vaccination (HBV) with acute sensory disturbances in the lower limbs. She had severe ataxia but no weakness. Cerebrospinal fluid (CSF) protein level was 84 mg/100 mL, with 3 lymphocytes. A 66-year-old man presented 21 days after HBV with severe motor and sensory PN involving all 4 limbs. A 66-year-old man presented 15 days after a yellow fever vaccination with progressive motor and sensory PN involving all 4 limbs and bilateral facial paralysis. CSF protein level was 300 mg/100 mL, with 5 lymphocytes. Six weeks later, a tracheostomy was performed. In these 3 patients, the nerve deficits lasted for months. In each case, peripheral nerve biopsy showed KP1-positive histiocytes but no T-lymphocytes in the endoneurium. On ultrastructural examination, there was axonal degeneration in the first 2 cases; in case 2, a few myelinated fibers exhibited an intra-axonal macrophage but the myelin sheath was preserved. There was only 1 example of macrophage-associated demyelination in case 2, but these were numerous in case 3. It is likely that in the first 2 cases, an autoimmune reaction against some axonal or neuronal components was triggered by HBV. It induced an acute sensory ataxic PN in case 1 and an acute motor and sensory axonal neuropathy (AMSAN) in case 2. The third patient had a chronic inflammatory demyelinating PN, likely triggered by yellow fever vaccination.
To the Subcommittee on Criminal Justice, Drug Policy, and Human Resources
of the Committee on Government Reform
U.S. House of Representatives
RE: HEPATITIS B VACCINE HEARINGS
SCHOOL NURSE PERSPECTIVE
Submitted by Patti White, RN
May 17, 1999
Mr. Chairman and Members of the Subcommittee:
This is a school nursing perspective for the congressional hearings to be held on May 18, 1999 regarding the safety of the hepatitis B vaccine that is being mandated for newborns and now older children in America. We ask you to please consider the following information and submit it into the congressional testimony. As nurses we continually see more and more damaged children entering our schools, and we are very concerned that a major portion of that damage may be due to the hepatitis B vaccine's assault on the newborn neurological and immune system.
My name is Patti White, R.N. I am a registered professional nurse and the district health services coordinator for a multi-school district. I am writing on behalf of the school nurses in our district. We have very grave concerns about the hepatitis B vaccine.
For the past three or four years our school district has noted a significant increase in the number of children entering school with developmental disorders, learning disabilities, attention deficit disorders and/or serious chronic illness such as diabetes, asthma and seizure disorders. Each of the past four years has been worse than the year before. There is only one common thread we have been able to identify in these children: they are the children who received the first trial hepatitis B injections as newborns in the early 1990s.
As the hepatitis B compliance rate in newborns has gone up in our community, so has the percentage of damaged children. This is very alarming. Because of having so many damaged children we have tried to find the long-term clinical trials that ruled this vaccine "safe and effective". We discovered through an exhaustive Medline search that the FDA based its decision to approve hepatitis B vaccine for administration in the first hours of a newborn baby's life upon clinical trials and upon post-marketing surveillance studies in which patients and their doctors were asked to report any adverse effects they noticed within 4-5 days after each injection [4 days for SmithKline and 5 days for Merck].
The problems being reported in increasing numbers as occurring after hepatitis B vaccination appear to be autoimmune and neurological in origin. Such problems take weeks to months to produce noticeable symptoms, and cannot be spotted in a 4-5 day observation period. These are the only clinical studies that have been done by Merck or SmithKline. There is not one long-term study that we could find.
The CDC and FDA have no idea what the long-term effects will be on the newly developing neurological and immune systems of the infants who are injected with this vaccine. They seem to only be concerned with denying the connection between these damaged children and the hepatitis B shot they received within a few hours of birth. The CDC even admits the lack of study and states they do not even know how long the vaccine will be effective. We found this amazing since the vaccine was developed for a population at risk for hepatitis B: IV drug users, high-risk medical professionals and those who are involved in high risk sexual practices.
In 1950 (before mass immunizations began), the USA had the third lowest infant mortality rate in the world. By 1986, the USA dropped to 17th place. In 1995 the USA dropped to 23rd and now the USA has dropped to the appalling position of 24th in the health of its children. But the USA is now first in vaccine compliance through government mandates.
The elementary grades are overwhelmed with children who have symptoms of neurological and/or immune system damage: epilepsy, seizure disorders, various kinds of palsies, autism, mental retardation, learning disabilities, juvenile-onset diabetes, asthma, vision /hearing loss, and a multitude of new conduct/behavior disorders.
We have come to believe the hepatitis B vaccine is an assault on a newborns developing neurological and immune system. Vaccines are supposed to be making us healthier, however, in twenty-five years of nursing I have never seen so many damaged, sick kids. Something very, very wrong is happening to our children. The census of ill children treated in our health rooms each day has increased by 300% in only four years.
In our last school nurse meeting we discussed whether the combination of so many vaccines/viruses at one time (hepatitis B vaccine at the same time of the DPT, OPV or MMR) is causing the infant's immune system to be overwhelmed and unable to mount a sufficient defense response. We are advocating clinical studies to determine: Is the combination of all these viruses at one time an assault on an infant's immune and neurological system that increases the chances for adverse reaction AND what are the long-term neurological and immune system responses to these vaccines. We are all continuing to research this issue and will be happy to share the many resources we have found with you. I hope you will do the same as you open up this issue.
We have talked many times about the possible cause(s) of the continuing increase in pervasive developmental disorders (PDD), such as autism. From the literature we have found, we should expect a rate for PDD of about 2-5 in 10,000. In our community the rate in 1st and 2nd grade is about 1 in 150 and in kindergarten, 1 in 100.
As school nurses, we have had many parents calling and asking how they can exempt their children from the hepatitis B vaccination (HPB). Many of them have spent long hours in study and research perplexed over this issue. For the past six months we have been studying documents, books and research articles published by internationally respected doctors and scientists that cause us grave concern. You must understand that we began this study to reassure our parents and show them the truth about how safe vaccines are.
Unfortunately, our sincere, honest, dedicated study has caused a complete reversal of our once strongly held beliefs. Instead of being able to reassure the parents, we have found ourselves being drawn deeper and deeper into this unbelievable controversy over vaccines that is raging among physicians, scientists, researchers, parents, and the government. We pray you will have the courage to shine the light on this controversy through these hepatitis B hearings.
My daughter's own experience with the hepatitis B vaccine made me much more open-minded to the information we have been receiving from parents, teachers and other nurses in our community. I personally have had to research this on my own to determine if I have been enforcing a policy that is actually harming more children than it will ever help. I have spent countless hours reading books, vaccine-hearing testimony, research papers, medical journal articles and Internet web-sites from around the world. I did not come to my decision easily or lightly, I assure you. Twenty-five years of total belief in something does not shake that easily.
I have repeated the well-rehearsed refrain "Be Wise; Immunize" thousands of times during those years and reassured countless parents that they were doing the right thing by vaccinating their precious children . . . even the ones who came to me with serious doubts and reservations. I will now have to live with that.
We are all now faced with a moral dilemma: will we protect the "sacred cow of conventional vaccine philosophy" or will we stand up and speak out for the "health and well being of innocent children"? We choose children. We wonder, which will our government choose?
Because the hepatitis B vaccine was developed for those at risk of disease, including IV drug users and sexually promiscuous individuals, efforts to require administration of the vaccine to most, if not all of the U.S. population is very controversial. The increasing number of adverse reaction reports connected with this vaccine exacerbates the controversy. The controversy stems to a great extent from our lack of understanding of the mechanisms of the immune response to the hepatitis B surface antigen and lack of long term follow-up of individuals who have received the vaccine. In a January 27, 1999 press release, the National Vaccine Information Center (NVIC) released figures which show that the number of hepatitis B vaccine-associated serious adverse event and death reports in American children under the age of 14 outnumber the reported cases of hepatitis B disease.
During our research we discovered a copy of the grant proposal submitted recently to the National Institute of Health by Dr. B. S. Dunbar, who has worked in autoimmunity and vaccine development for over twenty years and was honored two years ago by the National Institute of Health. Dr. Dunbar is working with a team of veteran vaccine researchers from all over the world. Their grant is requested for the purpose of studying the hypothesis that: hepatitis B recombinant vaccine does cause adverse autoimmune reactions in genetically susceptible individuals. This study will also provide new insights into the predictability of determining adverse side effects of the hepatitis B vaccine in individuals at risk as related to their histocompatability subtypes. Their study of auto-immune diseases/symptoms caused by the hepatitis B vaccine include: lupus erythematosus, rheumatoid arthritis, vascular disorders, Guillain Barre syndrome, demyelinating disorders such as optic neuritis (blindness), Bell's palsy, demyelinating neuropathy (multiple developmental disorders), multiple sclerosis, diabetes mellitus and chronic fatigue syndrome to mention the most common.
This group of internationally respected vaccine researchers headed up by Dr. Dunbar also point out that, "The studies (for the approval of HPB) were not designed to assess serious, rare adverse events; the total number of recipients were too small; and the follow-up was too short to detect rare or delayed, serious, adverse reactions." Finally they point out that "overall the number of examples of adverse neurologic outcomes following receipt of hepatitis B vaccine are of concern, particularly those resulting in demyelinating neurologic disease."
They continue, "In view of these observations. . . it is medically crucial to evaluate the nature of the autoimmune reactions (i.e. risks) associated with the hepatitis B vaccine and to determine if individuals who will have these adverse reactions can be identified in advance of receiving the vaccine". There are critical questions that must be addressed to establish the risk/benefit of the current hepatitis B vaccines in the United States. These questions are particularly important in view of recent mandates to vaccinate all children including newborn infants."
Many groups have called for a moratorium on hepatitis B vaccination until some of these questions can be answered adequately. The NVIC reported "Newborn babies are dying shortly after their shots and their deaths are being written off as sudden infant death syndrome. Parents should have the right to give their informed consent to vaccination and Congress should give emergency, priority funding to independent scientists, who can take an unbiased look at this vaccine, instead of leaving the search for truth in the hands of government officials who have already decided to force every child to get the vaccine". We agree completely. The NVIC can be contacted at http://www.909shot.com for further information.
Our own school district's confidential health statistics show at least 20% of our children (K-3) have significant neurological damage and/or chronic illness. The last three years have shown an acceleration in the numbers of children who are entering our schools with these "developmental disorders". (Could these be the same infants who received the first trial doses of hepatitis B as only a few hour-old newborns?) As school nurses, working with these damaged children on a daily basis, we pray this is not true. If it is, the ramification to this generation of children is unthinkable!
Should we not pause, call for a moratorium on these poorly tested, rapidly approved vaccines, and allow independent American physicians and researchers to study them before blindly injecting an experimental vaccine into an entire generation? (We have found the only ones declaring the vaccine's safety are the ones who are making millions of dollars from its sales, whose employment depends on it or the ones being supported by the drug companies vast number of grants and fundings. The independent researchers seem to be coming up with an entirely different report.)
Vaccine producers have nothing to lose since our U.S. Congress has made them immune from responsibility or liability for injuries caused from their vaccines. The push is on for them to create more and more vaccines. There are huge amounts of money being made by these people who no longer worry about the consequences of their inadequate clinical trials. The United States government has had to pay out nearly a billion dollars in damages to families who can prove their children have been damaged or killed by vaccines, and there are thousands more cases pending.
We believe, as medical professionals, that we are doing a great disservice to our country by forcing government mandated vaccines on all children. Please research this and we pray you have the courage to speak out and tell the nation what you find.
(The views expressed are my personal beliefs and observations and do not necessarily reflect those of the school district.)
Patti White, RN
From Pediatric News
Little, if Any, Risk Of Alopecia After HBV Vaccination [Pediatric News
32(4):13, 1998. C 1998 International Medical News Group.]
ATLANTA -- The next hepatitis B immunization statement from the CDC will mention a possible link between the vaccine and alopecia, although the risk--if it exists--is quite small. Preliminary results from a study, begun after a case in San Francisco received media attention, found that there were no more than 8.2 cases of alopecia per 100,000 hepatitis B vaccine (HBV) recipients, which is not statistically significant, Dr. Steven Black said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
In the San Francisco case, a 12-month-old girl began to lose scalp hair 10 days after her second dose of HBV. Over the next 3 months, she became completely bald, but her hair grew back in by 18 months of age. Her hair began to fall out again about 1 week after her third HBV dose; she progressed to total baldness but had a full head of hair again by age 2. This report prompted a retrospective review of several vaccine adverse events databases. Since 1984, there have been 60 evaluable reports of alopecia after immunizations, 46 of which involved HBV.
Notable in that study, conducted by Dr. Robert P. Wise and his associates at the Food and Drug Administration, were four cases with positive rechallenges: The hair fell out, grew back, then fell out again
with another vaccine dose. The findings "provide evidence consistent with a causal relationship," Dr. Wise and his associates concluded (JAMA 278[14]:1176-78, 1997). However, Dr. Black and his associates did not find a significantly elevated risk of alopecia within 60 days after HBV administration among children enrolled in two California HMOs. Larger studies involving more individuals are planned, said Dr. Black, director of quality assessment at Kaiser Permanente of Northern California in Oakland. Miriam E. Tucker
MERCK PACKAGE INSERT FOR HEP B COMVAX VACCINE
Michael Belkin wrote:
This is the from the Merck package insert for their new COMVAX vaccine. Comvax is combination HIB/Hep B. Recombivax is hep B only. Last part is observed adverse reactions from marketing Recombivax. I'm sure it's a big relief to everyone that "these serious events were judged not to be related to vaccination with COMVAX by the investigator." Notice in the testing the control group gets another vaccine -- not a
true placebo. Total junk science. http://www.merck.com/product/usa/comvax/pi.html#adverse
COMVAX (TM) [haemophilus b conjugate (meningococcal protein conjugate)
and Hepatitis B (recombinant) vaccine]
... Among 856 infants from combined clinical trials who were monitored for both serious and non-serious adverse experiences, the following serious events were reported to occur in 13 infants during a 14-day period following vaccination with COMVAX (usually coadministered with other pediatric vaccines). These adverse experiences are grouped by case: viral infection; febrile seizure; asthma; diarrhea, vomiting, acidosis, dehydration, hypoglycemia, and seizure disorder; bacterial infection; bronchiolitis and reflux esophagitis; dehydration and fever; asthma, respiratory congestion, and tachypnea; asthma and upper respiratory infection; urinary tract infection and vomiting; pneumonia and asthma; apnea and reflux esophagitis; and vitreous hemorrhage. A causal relationship to the vaccine is unknown; however, these serious adverse events were judged not to be related to vaccination with COMVAX by the investigator.
Among 1756 infants who received COMVAX concomitantly with either an investigational pneumococcal polysaccharide protein conjugate vaccine or an investigational preparation of diphtheria, tetanus, pertussis, and inactivated poliovirus vaccine, the following serious events were reported to occur in 9 infants during a 14-day period following vaccination with COMVAX. These adverse experiences are grouped by case: respiratory syncytial virus; respiratory distress and otitis media; bronchiolitis in two vaccinees; viral gastroenteritis; skull fracture; bronchiolitis, respiratory syncytial virus, and pneumonia; respiratory syncytial virus and bronchiolitis; and upper respiratory infection, viral (see CLINICAL PHARMACOLOGY ). A causal relationship to the vaccine is unknown; however, these serious events were judged not to be related to vaccination with COMVAX by the investigator.
In a group of infants (n=126) given a three-dose course of COMVAX after previously receiving a dose of Hepatitis B Vaccine (Recombinant) at or shortly after birth, the type, frequency, and severity of adverse
experiences did not appear to be greater or different from those observed in infants given only COMVAX.
As with any vaccine, there is the possibility that broad use of COMVAX could reveal adverse experiences not observed in clinical trials. Potential Adverse Effects :In addition, a variety of adverse effects have been reported with marketed use of either PedvaxHIB or RECOMBIVAX HB in infants and children through 71 months of age. These adverse effects are listed
below.
PedvaxHIB
Hypersensitivity
Rarely, angioedema
Hematologic/Lymphatic
Lymphadenopathy
Nervous System
Febrile seizures
Skin
Sterile injection-site abscess; pain at the injection site
RECOMBIVAX HB
Hypersensitivity
Anaphylaxis and symptoms of hypersensitivity including reports of rash, pruritus, urticaria, edema, angioedema, arthralgia, dyspnea, hypotension, erythema multiforme, and ecchymoses
Cardiovascular System
Tachycardia; syncope
Digestive System
Elevation of liver enzymes
Hematologic
Increased erythrocyte sedimentation rate; thrombocytopenia
Musculoskeletal System
Arthritis
Nervous System
Bell's Palsy; Guillain-Barré Syndrome
Psychiatric/Behavioral
Agitation; somnolence; irritability
Skin
Stevens-Johnson Syndrome; alopecia
Special Senses
Conjunctivitis; visual disturbances
http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list
_uids=12365564&dopt=Abstract
J Peripher Nerv Syst 2002 Sep;7(3):163-7
Postvaccinal inflammatory neuropathy: peripheral nerve biopsy in 3 cases.
Vital C, Vital A, Gbikpi-Benissan G, Longy-Boursier M, Climas MT, Castaing Y, Canron MH, Le Bras M, Petry K.
Neuropathology Department, Victor Segalen University,Bordeaux, France.Claude.vital@neuropath.u-bordeaux2.fr
Autoimmune inflammatory polyneuropathy (PN) can be triggered by vaccination. We report 3 such cases. A 36-year-old female nurse presented 15 days after a hepatitis B vaccination (HBV) with acute sensory disturbances in the lower limbs. She had severe ataxia but no weakness. Cerebrospinal fluid (CSF) protein level was 84 mg/100 mL, with 3 lymphocytes. A 66-year-old man presented 21 days after HBV with severe motor and sensory PN involving all 4 limbs. A 66-year-old man presented 15 days after a yellow fever vaccination with progressive motor and sensory PN involving all 4 limbs and bilateral facial paralysis. CSF protein level was 300 mg/100 mL, with 5 lymphocytes. Six weeks later, a tracheostomy was performed. In these 3 patients, the nerve deficits lasted for months. In each case, peripheral nerve biopsy showed KP1-positive histiocytes but no T-lymphocytes in the endoneurium. On ultrastructural examination, there was axonal degeneration in the first 2 cases; in case 2, a few myelinated fibers exhibited an intra-axonal macrophage but the myelin sheath was preserved. There was only 1 example of macrophage-associated demyelination in case 2, but these were numerous in case 3. It is likely that in the first 2 cases, an autoimmune reaction against some axonal or neuronal components was triggered by HBV. It induced an acute sensory ataxic PN in case 1 and an acute motor and sensory axonal neuropathy (AMSAN) in case 2. The third patient had a chronic inflammatory demyelinating PN, likely triggered by yellow fever
vaccination.
A one year followup of chronic arthritis following rubella and hepatitis B vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database.
Geier DA, Geier MR.
Clin Exp Rheumatol 2002 Nov-Dec;20(6):767-71
MedCon, Inc., Silver Spring, Maryland, USA. mgeier@erols.com
OBJECTIVES: This analysis examined the incidence rate of chronic arthritis adverse reactions reported following adult rubella and hepatitis B vaccinations. In this analysis, etiologic mechanisms for chronic arthritis following adult rubella and hepatitis B vaccines were also explored. METHODS: The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for the incidence rate of reported cases of chronic arthritis in comparison to Tetanus-diphtheria (Td) and tetanus toxoid adult vaccine control groups. RESULTS: Chronic arthritis adverse reactions following adult rubella vaccination were primarily reported in females (female/male ratio = 3.0), at about 45 years-old, and at a mean onset time of 10-11 days following vaccination. Chronic arthritis adverse reactions following adult hepatitis B vaccination were also primarily reported in females(female/male ratio = 3.5), at about 33 years-old, and with a mean onset time of 16 days following vaccination. The incidence rates of chronic arthritis following adult rubella and adult hepatitis B vaccinations were statistically significantly increased, by chi 2 analysis, in comparison to the adult vaccine control groups. The attributable risk of chronic arthritis following adult rubella vaccine ranged from 32 to 53 and from 5.1 to 9.0 following adult hepatitis B vaccine in comparison to the adult vaccine control groups. CONCLUSION: This study revealed that adult rubella and adult hepatitis B vaccines were statistically associated with chronic arthritis which persisted for at least one year. The etiology for these adverse reactions may involve autoimmune mechanisms. Furthermore, potential biases in the reporting rates of adverse reactions to VAERS were not observed.
PMID: 12508767 [PubMed - in process]
http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=12532044&dopt=Abstract
J Dermatol 2002 Dec;29(12):781-5
Childhood bullous pemphigoid following hepatitis B immunization.
Erbagci Z.
Gaziantep University Medical Faculty, Department of Dermatology, Gaziantep, Turkey.
Bullous pemphigoid (BP) is an acquired autoimmune bullous disorder which predominantly affects the elderly. It is very rare in children. There are approximately 50 reported cases of childhood BP. Although the cause of childhood BP is unknown, drug intake and vaccination have been incriminated in some cases. A total of 13 patients with BP (10 adults and 3 infants) have been described to be related to various vaccines and tetanus toxoid booster. However, no case related to hepatitis B vaccination has previously been reported. Our case of childhood BP developed one week after hepatitis B immunization in a Turkish caucasian child. This case suggests that the hepatitis B surface antigen can function as the triggering factor for BP by inducing a nonspecific immune reactivation which unmasks subclinical BP or by stimulating a specific antibody production that may cross-react with BP antigens.
http://www.house.gov/reform/cj/hearings/99.5.18/Kirschner.htm
Subcommittee on Criminal Justice, Drug Policy and Human Resources Committee on Government Reform
HOME MEMBERS JURISDICTION SCHEDULE PRESS RELEASES HEARINGS ADDITIONAL RESOURCES
Testimony of Marilyn & Lindsay Kirschner
On the Hepatitis B Vaccine
May 18, 1999
I am here today with my daughter, Lindsay, maintaining a commitment to pave the way so that other parents can make an informed choice in regards to the Hepatitis B vaccine. Lindsay is representative of all the children who fall under the mandate. Six months before the vaccine we had an idyllic life, reveling in the joy of Lindsay's Bat Mitzvah, perfect in every way. Lindsay received the Hepatitis B vaccine two days before entering High School. The next day she seemed flu-like, the day after that so dizzy she couldn't stand-up without holding the walls. The following day she passed out. So our life goes, since August 1997. Lindsay has had syncopal & pre-syncopal episodes, her ability to stand was compromised for almost six months due to unremitting dizziness. Following our Drs. advice, unknown the vaccine was the culprit, Lindsay had the series of three. It was on the third shot Lindsay became so violently ill within two hours, that I knew the vaccine was the catalyst of her illness.
At 16, Lindsay should be having fun with friends, dating, & driving. Instead her days are filled with Dr. visits (15 specialists), MRI?S, CAT SCANS, SPINAL TAPS, ER VISITS, & Hospital admissions. Lindsay is plagued on a daily basis with HEADACHES (of a severe kind), JOINT PAIN, SEIZURES, NAUSEA, HAIR LOSS, DIZZINESS, GASTROESOPHOGAL REFLUX, & Extreme Fatigue. She has been diagnosed with an acquired Dysautonomia & is unable to hold food down with frequent retching, & vomiting. She takes a minimum of 10 doses of medication daily.
We have traveled to specialists in four States, and will be travelling to two more States before July.
Unfortunately, Lindsay is not isolated in her journey. After WPLG(MIAMI) HEALTH REPORTER, Kristi Krueger, broke Lindsay's story (the 1st one to air in the country), I heard from droves of people who have been or have family members affected by this vaccine. (video) Family life as we knew it has been destroyed. This illness is an emotional & extreme financial drain, as I am hardly able to work, depending on my family to support us, and often feeling like a beggar for our survival.
As a single parent this vaccine has ripped a part of our lives that can't be replaced. Lindsay, my former National Junior Honor Society President in 8th grade, is now on a 504 Disability Plan. missing 70 days of 9th grade, and pushing beyond that in this her 10th grade year. What about her future? College? A Career? Will my son David ever forgive me for being so unavailable last year when he was a senior, now that he's 3,000 miles away in LA. The joy of his scholarship offers, & prom departure all took a backseat to Lindsay's illness. Or the fact that he's spending his birthday on a plane so we could be at this hearing just after returning Sunday from his 1st year at USC. What about Lindsay's puppy Frisbee, who is boarded almost as much as he's at home? What about our shattered lives, barely a fragment left of what use to be? Tragedy is not supposed to be the American way. Lindsay, nor anyone should ever have to live like this because of the greed of the manufacturer.
By Geoff Metcalf
© 2000 WorldNetDaily.com
Michael Belkin was a financial forecaster and statistician uninvolved in medical policy -- that is, until his infant daughter died after receiving a hepatitis B vaccine. Since then, Belkin has devoted himself to battling mandated immunizations and the powerful forces involved. Belkin has testified before Congress in opposition to forced hepatitis B vaccinations. WorldNetDaily writer and talk show host Geoff Metcalf recently interviewed Belkin about his work in combating government-mandated vaccines. Metcalf's daily streaming radio show can be heard on TalkNetDaily weekdays from 7 p.m. to 10 p.m. Eastern time.
Question: How did you first get involved in the issue of mandated hepatitis B vaccines?
Answer: I learned about it the hard way. My daughter died about 15 hours after getting the second hepatitis B shot at the age of five weeks. I did an investigation and the first thing I found out was that hepatitis B is a disease of basically intravenous drug users and promiscuous homosexuals and heterosexuals. It is a blood-transmitted, sexually-transmitted disease. And they are giving it to babies.
Q: Children are not at risk but they are required to get this shot?
A: Yes. And therein lies a huge story. The way that vaccines are licensed and regulated and marketed in this country is a major scandal. Under the Freedom of Information Act, I got the adverse reaction report from the FDA. It turned out that as of two years ago, there were 25,000 adverse reactions reported to the FDA, including 440 deaths. The median onset was one day. I'm trained in statistics. I'm a graduate of U.C. Berkeley and am a former strategist at Solomon Brothers. I work with data -- I work with statistics. I provide econometric and financial market forecasts for some of the largest financial institutions in the world.
When I saw this data and started going through this, over and over I found the same thing that happened to my daughter. In the middle of the night, she became extremely agitated -- having tremors and making funny sounds -- and then she just went out like a light. That was it. She couldn't be resuscitated.
They found a swollen brain in the autopsy report. My wife's brother is a doctor in the UK studying neurology and we talked to him right away. He said, "Swollen brain -- that's a vaccine!"
Q: How often is this happening?
A: This obscure panel under the Centers for Disease Control decided in 1991 that they were going to give the hepatitis B vaccine to everybody. If you get an acute case of hepatitis B, you may end up in the hospital, but you will survive. In 90-95 percent of the cases, you get permanent immunity just like you would with the flu or anything else. In 5 percent of the cases, you will wind up with liver problems, probably decades later.
Q: So what are they trying to do with this vaccine?
A: They are trying to eliminate some rare form of liver problems that comes from risky behavior by giving this vaccine to everyone.
Q: Perhaps it's the cynic in me, but this sounds like a classic case of the drug companies pimping a product for profit.
A: Absolutely. In the United States, you have to get a product licensed by the FDA. You do a phase-one, phase-two and phase- three trial. Then, if they like the results, you get it licensed. The next step is to go to the Centers for Disease Control. In the case of vaccines, they have this particular panel called the ACIP [Advisory Committee on Immunization Practices]. I've sat through their meetings and know pretty much what goes on there. Basically, they rubber-stamp whatever the drug companies put in front of them.
But this committee comes up with language saying, such and such a person should get this vaccine at such and such a date. Then the drug company lobbyists take that recommendation from the ACIP and they go around to all the state legislatures and state health departments saying, "Did you see what the CDC says to
do?" And the American Academy of Pediatrics, of course, jumps in. There are huge donations flowing back and forth between all these people. It's a huge conflict of interest.
Q: How many states mandate this? In California, at least for now, you still have the opportunity to say, "No, I don't want that vaccine."
A: It's a state-by-state situation. There are philosophical exemptions, medical exemptions and religious exemptions, depending on the state you live in.
Q: We just told our doctor no, and he shrugged it off as no big deal.
A: You can still get investigated by state social services departments. For instance, if you don't vaccinate your child, they will exclude him from school. You really have to know what you're doing. You have to know the law, and you have to come back at them and use the law in your favor. You might have to get a lawyer if you want to send your kid to public school these days.
What you're up against is basically the drug companies and the Centers for Disease Control. It's for the profit of Smith-Cline -- that's who makes this vaccine. They are using the government as their marketing department.
Q: You can call them a marketing department. Some would call them a pimp.
A: Yes. They're saying you have to take this vaccine, inject it into your body and pay us for it. And if you die or develop adverse reactions that are reported to the FDA, tough luck.
Q: What recourse do you have to negative or the most negative consequences of taking this drug?
A: They have ring-shielded themselves with a government compensation program. By the way, after I started doing my research, I started being contacted by all kinds of people. I am constantly being contacted by parents whose children had convulsions, became autistic, had brain damage or died, as well as adults who developed progressive neurological disease. You start out with joint pains and it eventually develops into demyelination of the brain -- things resembling multiple sclerosis. But if this happens to you, first of all, they tell you it's a coincidence -- you're just dreaming. It's like eating Cheerios and getting in a car accident and blaming it on the cheerios.
Q: This sounds like what they told the guys with Agent Orange, the Gulf War Syndrome victims and guys who had problems with the anthrax vaccine. There is a common thread here.
A: Right. It is really a militarization of the U.S. culture, because those were all soldiers, and I have sympathy for them. But generally, you are not considered to be in the Army and have to take these toxic substances with no choice in the matter if you're a civilian. It turns out the Centers for Disease Control is basically a military organization. If you look at them, they wear uniforms. They dress up in uniforms and march around their compound one day a week. They take great pride in being a paramilitary organization.
Q: I didn't know that.
A: It is very strange. They look like Col. Klink of "Hogan's Heroes" to me. It would be funny if that were all they were. But what they are doing is more like a vaccine Gestapo, and it's not funny. By the time you get around to going to your pediatrician or going to school, they tell you that you have to have this toxic substance for a sexually transmitted disease -- either as one of the first things in life or as the cost of admission to school. It's ridiculous. They have completely usurped liberty in this country.
Q: There is a gaggle of websites with information. Where should we direct readers?
A: There are many groups springing up across the country. It's almost like citizens' resistance to the Vietnam war. In many states, there are local organizations that are trying to get the word out about vaccine choice and the risks of taking vaccines, because the doctors are not telling you about it at all. They tend to say, oh, it's perfectly safe -- a magic bullet. Then they disown you if you get an adverse reaction or your kid dies or something. I can't even get our medical records out of the pediatrician.
Q: Why? Your daughter died.
A: I requested it by registered mail. The doctor is just refusing. I'm not unique. This is pretty standard when it happens to parents. The doctors are brainwashed by the drug companies. The drug companies buy them lunch all day long.
Q: Are the doctors afraid of malpractice suits?
A: They are in denial. It's almost like a huge psychological brainwashing. They think that they are preventing disease, that they are like God's angels banishing disease and that they can't do any wrong. Then they refuse to admit it. This is very standard.
Q: I found one website that I want to direct our readers to. You participated in those congressional hearings back in May of 1999.
A: Yes.
Q: Whatever became of them?
A: It seemed nothing at the time. I was the first witness on the first victims' panel in the first hearing into hepatitis B vaccine. Hearings were conducted by Congressman Dan Burton of Indiana, who is chairman of the Government Reform Committee. Basically, it was a very strange experience. I went down there and I was attacked by the Democrats. They attacked the victim. [Rep. Henry] Waxman and his ilk tried to denigrate me. They said, "You don't know what you're talking about. It's all just an accident." In other words, the Democrats are talking the mainstream health department-drug company policy line. The Republicans are the ones who are digging to get at the truth. It was completely turned upside down from the way I thought it would be.
In answer to your question, it seemed like it was an exercise in futility. But two months after those hearings, there was a flurry of action. Thimerosal, which is a mercury-containing preservative in all vaccines -- mercury is the second most toxic metal there is -- is being removed from all vaccines because they realize they are giving so many vaccines that it is way over the permissible level.
Q: And this stuff is cumulative too, right?
A: Yes. And mercury is one of the things that crosses the blood-brain barrier, so it might be responsible for some of these adverse reactions. It's probably not the only thing.
Q: So what are they doing?
A: Do you think they are withdrawing all the vaccines that are out there on the market? No way! That would cost money.
Q: So are they using them up?
A: Yes. So when you go into a doctor and he gives you a vaccine, it probably still has thimerosal in it because they are working through the inventory. It is not cost-effective to remove a harmful product from the market.
Q: Even if it's killing people?
A: Yeah. Now Dan Burton has just issued a request to Health and Human Services, Donna Shalala, who is the one who is on top of CDC and everything, requesting that they immediately remove all thymerasol-containing vaccines in the United States. But she is not even answering his letters.
Q: Barbara Fisher, the co-founder and president of the National Vaccine Information Center, filed a couple of requests under the Freedom Of Information Act. Has she ever had any response to those?
A: No. I work with the National Vaccine Information Center, that's the website you referenced. I'm a volunteer on the hepatitis B program with them. I went down there and testified at the ACIP and we submitted a FOIA [Freedom Of Information Act] request a year or two ago.
Q: Basically asking federal health agencies to release public copies of peer-reviewed scientific studies?
A: Right. The data they used to show that the hepatitis B vaccine was safe to give to newborn infants and to everyone else. Science is supposed to work like this: You're supposed to do a study, it's supposed to be peer-reviewed, published in a peer-reviewed journal, and then it's legitimate science.
Q: Public record -- anybody should be able to get it.
A: Yes. The CDC hardly ever does that. But I managed to ambush the chairman of the ACIP -- he was chairman in 1991 -- I ambushed him a short time ago in New York at the New York Cornell Medical School when he was giving a lecture on vaccines in the new millennium. I asked him -- and I have a tape of it -- "What published peer-reviewed study did you use in 1991, when you were chairman, to give this vaccine, the hepatitis B vaccine, to newborn infants?" There was never any vaccine given to newborn infants before this one.
Q: And what was his answer?
A: His answer was: "You are quite right. There was no published peer-reviewed study."
I just gave a talk on this issue and the title of the talk was "Shoot first and ask questions later." That's what they are doing. They are giving these vaccines without knowing if they are safe. And then when the adverse reactions come in, they just go into a drawer at the FDA and nothing is done.
Q: This lack of informed consent -- it has sparked fear and distrust of all vaccines. Haven't they reached the point of diminishing return where it would be in their best interest, if they still want to peddle this stuff, to release the peer-reviewed data so people can see it is safe?
A: The study wasn't done! That's the problem. They have nothing to release. That is what I got him to admit.
Q: Well then, it should be a no-brainer. You simply withdraw the drug.
A: This is total scientific fraud. And you get these leaders of the CDC and people going up there saying, "Well, parents don't know what they are talking about. They are making unscientific judgments." To these guys, it is only true science if the government says it's true. And they don't have to have any evidence. They don't have to publish anything. They just say, "If we say it's true, it's true, and if we say it's not true, it's not true."
Q: Like global warming?
A: Yeah, but this is really despotic, intrusive. It reaches way down into your veins. This is not just some rule you have to follow -- this is going into your body.
Q: I found somewhere a piece that revealed the hepatitis B vaccine reaction reports actually outnumber the disease reports.
A: Yes, in newborns. This is a rare disease. You're not liable to contract it. There are 10,000 cases reported to CDC a year -- about 50 in the 0 to 1 age group. Now I went through the data, and there are 20 times more adverse reactions reports to the FDA after vaccination -- convulsions, liver damage, brain damage.
Q: They should withdraw the drug and do the studies they didn't do in the first place.
A: Listen, I'm in business. I have nothing against the free market. I mean this is what I do. I predict and give financial market forecasts. I came from the Austrian school before this -- where the free market always gets everything right. But this is a case when you have these monopolistic pharmaceutical manufacturers ramming unsafe products down -- without even testing them -- and then using the government to mandate that you have to take them. There is something seriously wrong with the way that vaccines are regulated.
Q: Hepatitis B is not widely contagious. That makes it different from some of these other diseases they push vaccines for, doesn't it?
A: It is contagious with blood or anal sex. That is how most of the people getting this disease contract it. It's not something you are going to get by breathing in the air. You really have to share bodily fluids.
Q: Statistically, the prospect of an infant getting it is pretty remote.
A: There are four million babies born every year in the U.S., but only 50-something cases of hepatitis B. That's a .001 percent incidence. And the babies that got it probably got it because their mother had the virus. That's the bottom line. In newborns, it's basically a crime against humanity to give them this vaccine.
Q: How does the CDC defend the indefensible in this regard?
A: They lie. I'm very sensitive to this because, on Wall Street where I work, you can't just make up numbers.
Q: If you do, you go to jail.
A: I mean you can do it, but eventually you'll get caught.
The Centers for Disease Control -- their own statistics show approximately 10,000 cases of hepatitis B a year in the U.S.
Q: So what do they say is their reason for having to take the hepatitis B vaccine?
A: They say there are 350,000 cases a year. So you go to them and ask, "How did you get that number of cases when in your own table it says 10,000? You claim there are 250 to 350,000." They waffle and say, "We did an unpublished study that 'suggested' that
that was the figure."
When you start investigating the CDC and what they are saying about vaccines, nothing checks out.
Q: Who is responsible for the oversight of the CDC? Is it Congress?
A: Health and Human Services Secretary Donna Shalala.
Q: Donna Shalala. So ultimately, culpability in this mess has to fall on her desk?
A: Are you kidding? Just pass the buck. If you think that Ford-Firestone is a big scandal -- and I don't want to belittle it, my sympathies go to those victims of that mess -- but there were 100 deaths linked to the tires. There are something like 500 deaths reported to the FDA from hep B vaccines. The former FDA Commissioner Kessler has said vaccine adverse reactions are underreported by a factor of 10. We're talking hundreds of thousands of adverse reactions.
Q: Hepatitis B apparently is not the killer many of us thought it was -- or were led to believe it was. It's a bad thing to get but, frankly, it is not as lethal as suggested.
A: Exactly. Ninety-some percent of the cases will pass.
Q: Also, the U.S. and Western Europe traditionally have always had the lowest rates of hepatitis B in the world.
A: Right. It's more endemic in Asia and Africa. By the way, the reason hepatitis B is endemic in those areas is because of another vaccination program gone bad -- the polio vaccine.
These polio viruses are cultured in monkey kidneys, and they didn't realize there was this cancer-causing virus in it -- which we're all carrying around -- and they are finding in cancers now. But that's another story.
When they did these polio vaccine programs in the past in places like Taiwan and China, guess what? It's not cost-effective for everyone to have his or her own needle. But everyone has to take the vaccine and you only have one needle. Guess how a rare blood disease like hepatitis B got spread around? The World Health Organization admits this. They have data that show that places where hepatitis B is endemic are areas where previous vaccine programs shared needles and transmitted a rare blood disease.
Q: So who is responsible for spreading the disease?
A: It's medicine. The whole idea of universal immunization, to me, is a crock. They take credit for eliminating all these diseases. In fact, the incidence of these diseases declined before the introduction of most vaccines due to the improvements in sanitation and nutrition.
Q: Where is all this heading?
A: This is heading to a universal AIDS vaccine. It's going to be universally mandated. That's what they are working towards.
Q: How do the recommendations of some government bureaucrat turn into state law that mandates immunization?
A: The drug companies have co-opted the system -- the regulatory and the legal system. There's a doctor in upstate New York who thinks he's saving humanity by not letting kids go to school unless they get this vaccine.
Q: He refuses to give up the federal money he will get for complying with the mandate.
A: Partly, he is being bribed. But you know who's behind that? Hillary Clinton. Vaccines for children. This is the one part of their health program that actually went into business. They got a bunch of government money devoted to mass immunization programs and they have instituted these intrusive mandates at the state level. But it is really the drug company lobbyists who are doing it. They are very skilled. They set up these bogus organizations where it looks like there are parents lobbying for the vaccine. And usually the effort is funded and set up by the drug company.
Q: Business and government together in partnership sounds not unlike fascism to some folks.
A: I'm afraid so. You know, the Nazis were big on forced vaccinations too.
Q: I also discovered that federal health officials actually give state health officials money to force these hepatitis B vaccinations. What is that all about?
A: Yes, there are billions of dollars in this. This gets so intrusive. There is really a "Mark of the Beast" angle to this whole thing. Revelation talks about how you can't do anything without the mark. I'm not saying the vaccine is the whole story, but it is one area where there is this sinister force injecting noxious poisons into your veins -- into your children's veins.
There are ways to escape. I'm not saying we are in a total police state yet. It depends on which state you live in. You need to know how the laws work and you need to take the exemptions. And if you have a doctor who doesn't know the kind of things I'm talking about, or they say vaccines are perfectly safe and there is no such thing as a vaccine adverse reaction, or that the adverse reactions are very rare events and much less common than the disease, in the case of hepatitis B they are wrong, and you should get another doctor. If you're a doctor reading this and you believe that, you had better educate yourself.
HEPATITIS B VACCINATION AND CHRONIC FATIGUE SYNDROME (CFS)
Dr. Byron Hyde (testimony before the Quebec College of Physicians Medical Board)
Dr. Hyde, a medical doctor. after listing his credentials, is recognized as an expert in the field of chronic fatigue syndrome (CFS).
Dr. Hyde begins his testimony by recalling his twelve years of research into CFS and brain dysfunctions as well as his work as Chairman of the non-profit Nightingale Research Foundation. The latter generates awareness and disseminates information on little known diseases as such as post-polio, fibromyalgia and CFS. He tells the Committee that he got involved in this research after his daughter fell ill with a disease process which was only subsequently recognized as being infectious and which became known as CFS. His search for answers, he adds, has taken him around the world.
He defines CFS as an epidemic illness, one which occurs primarily in the late summer and fall. It is typified by an acute onset of symptoms which vary from malaise to severe non-stop headaches and body pains now known in the US as fibromyalgia or myalgias. It is also accompanied by muscle weakness which develop alongside the pain symptoms and changes in brain function. The change in brain function is in several areas with one, a measurable decrease in the expected IQ, and, two, major cognitive losses that is, loss of sensory abilities to define one’s environment. which is very traumatic for the patients. Physicians have found very few physical modalities of the disease to help them to further diagnose the disease.
The disease process, he adds, very much resembles poliomyelitis in its incubation period. Prior to 1962, before polio immunization became generalized. epidemics of CFS like disease occurred concurrently with polio epidemics. A lot of people at that time felt that there may be a type of poliomyelitis-type injury without the paralytic dysfunction.
"My supposed expertise with hep B immunisation. And I say "supposed" because we know almost nothing….We know very little about hep B disease. We have no statistics in Canada, serious statistics. We don’t know, for instance, how many children in Canada die of it every year. There are no statistics. We don’t know who the people who fall ill with hep B are. Are they Haitian immigrants? Are they people who have just arrived from China? There are no government statistics on this information….
Why are we, in a time of major economic, medical and financial difficulty, spending literally a billion dollars, because that is what it would cost to immunise everybody in Canada against hepatitis B, for something in which we have the lowest risk in the world, for which we have no statistics, and for which there is no serious investigation on the side effects?
I would not for a minute say not to take hep B immunisation if you work in a hospital dealing with blood products….We have to know what we are doing in medicine before we go and immunise tens of thousands, hundreds of thousands of children…Because if they develop brain dysfunction after hep B immunisation when they’re in kindergarten, who in the world will know the reason if they fail grades one, two, three and four? Was it because they were stupid, not motivated, not intellectually able, or on drugs? Who is going to know if it is that or if they were brain dysfunctions due to immunisations that, we know, occur to minor degrees in many types of immunisations?
I did have a chance to spend a couple of evenings with the man in charge of getting the American soldiers ready for the Gulf (in Baton Rouge). He was in charge of anti-chemical, anti-germ warfare. He told me that many of the Gulf War Syndrom people were hospitalised immediately after massive immunisations and never got to the Gulf. I have never seen that written up. It is very interesting to note that hep B immunisation was only given to those people sent to the Gulf who were mediacl personnel, because they did not feel there was a risk for the regular soldier. Now, if the American government did not feel it was a risk to people in combat, it makes us wonder why we are giving it to our children today.
We looked at hep B immunisation in Quebec province because one nurse phoned us saying she had CFS after having hep B immunization.....About a month later the same nurse called again, she now had 5 other nurses in the area who had fallen ill with CFS-like symptoms after the vaccine, all were unable to return to work. I told her to phone the maker, Merck. She told me she did and they said the 6 nurses were the only persons in the whole world that had ever had a serious side effect and therefore there couldn't possibly be a link. And, they told her that she was the only person who had ever phoned....she said that when her doctor phoned, he too was told he was the only person in the world that had ever called, and when each of the doctors of the other nurses called in, each was told the same thing.
I also called Merck...and they said.."Oh Dr Hyde, you are the only doctor in all of Canada that has ever contacted us with such a complaint." This same nurse....(had) amassed 20 or 30 names of individuals, all post hep B immunisation cases...We received close to 120 calls from nurses and health care workers in the Quebec area with problems...many were severely disabled." Dr Hyde.
Dr Hyde mentioned that the investigation into the hep B vaccine raised after his efforts was funded, organised and run by a pharmaceutical company. He was not invited. "Nor was Dr. Phaneuf who has over 100 cases of post-hepatitis B immunisation in Quebec…Nobody who had ever published a paper on post-hepatitis immunisation adverse reaction was invited (to the Toronto conference on hepatitis B). So it was a very one sided meeting."
All paid for by Merck. When he asked the government for a copy of the research they said they had completed using the list of hepatitis B "victims" he had provided, he was told that it had been destroyed for lack of space!
Reproduced with permission of Here’s The Key Inc, CP309, Waterloo, Qc JOE 2NO, Canada. Tel: 001 450 297 2533. Fax: 001 450 297 4140
Selected extracts taken from The Trial of the Medical Mafia by Jochim Schafer ISBN 2921783029.
Available from: Whale Books, UK. Tel: 01981 240 125.
To reach Guylaine Lanctot, M.D. Tel: 001 514 297 4128. Fax: 001 514 297 4140
Wanted to send this report showing what vaccines can do at 19 years of age, yet they give to newborns hours old.
VAERS ID 179698 Vaccination Date: 2001-11-26
Age 15.0 Date filed: 2002-01-04
Sex M Where Administered: PUB
State NC Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: TPR, BP 109/61
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE
Vaccinations Manufacturer Lot Dose Route Site
1 HEP SMITHKLINE BEECH 5205A2 0 IM
2 MMR MERCK & CO. INC. 0154L 0 SC
Onset Date: 2001-11-26 Number of Days: 0
Symptoms: CONFUS PALLOR SOMNOLENCE SYNCOPE TREMOR TWITCH
The client had an unwitnessed fall to the floor as exiting the building. An employee saw the pt on the floor with feet raised, body shaking all over with tremors and his head hitting the floor repetitively. The body shaking lasted approx. 3-4 minutes. He was placed in a chair. When the nurse/MD were on the scene, the pt was placed supine. After ice pack to small raised area on crown, skin intact, color pale, lethargic, slow to answer questions and stated his age was 19. He did not know the day of week.
Presented at the 2nd International Symposium on Hyperbaric Oxygenation for Cerebral Palsy and the Brain-Injured Child Boca Raton, Florida July 25-28, 2001
Campbell AW, MD**, Anyanwu E, MS, PhD**, High W, MD, PhD**, Vojdani A. MT, PhD* **
Center for Immune, Environmental & Toxic Disorders 25010 Oakhurst, Suite 200, Spring, Texas 77386; Tel: 281-364-1013 Fax: 281-364-0492.
*Immunosciences Lab, Incorporated, Beverly Hills, California. Center for Immune, Environmental & Toxic Disorders 25010 Oakhurst, Suite 200, Spring, Texas 77386;
Tel: 281-364-1013 Fax: 281-364-0492.
Abstract Purpose: The causal involvement of adverse hepatitis B vaccines in cerebral palsy and epilepsy, remains controversial. In this study, we report a case report of a 21 month-old white female patient who presented with recurrent seizures and manifested all characteristic features of cerebral palsy as a result of hepatitis B vaccines.
Methods: neuroimmunologic techniques, family history, and previous medical records were used to evaluate, correlate and ascertain whether cerebral palsy and epilepsy were a consequence of hepatitis B vaccines adverse effects.
Results: Abnormal EEG showed bilateral cerebral hemispheric disturbances with abnormal rhythmic and irregular delta wave activity was present suggesting an underlying cortical rhythms, less evident in the area of involvement. Furthermore, there was 4 Hz, paroxysmal bilaterally synchronous generalized focal theta activity suggesting damage to a non-specific thalmo-cortical region. Also, multiple theta wave discharges were seen independently arising from different regions of the hemispheres suggesting several potentially epileptogenic foci. The immunologic evaluation showed multiple antibody abnormalities including T helper/suppressor ratio and immune complexe! s. Certain abnormal antibodies found in epilepsy (IgG, IgA) were present in all the patients. There was an elevation of Mg2+ ions receptor function probably, as a result of autoimmune dysfunction.
Conclusions: Since there were no known family history of individuals with developmental problems, mental retardation, or seizure disorders, it then meant that her health condition was related to after birth events. Hence, those abnormalities that are associated with neurological dysfunctions, and characteristics that are found in cerebral palsy and epilepsy, are most likely associated with hepatitis B vaccines adverse effects.
http://www.biospace.com/b2/Articles/111199_print.cfm
First Posted 11/11/99
Miracle or Murder?
The Hepatitis B Vaccine Controversy
Few US public health initiative seem as successful as our mandatory vaccination programs. But a growing number of people believe that one vaccine--that for the hepatitis B virus--is both dangerous and largely unnecessary. Emotions run high in a debate that involves pharmaceutical and biotech companies, US health agencies, Congress, and the parents of children now dead or disabled from what they believe is a vaccine about
which too little is known.
By B.J. Spalding
About a year ago, Michael Belkin's five-week-old daughter, Lyla Rose, got her third and final shot of the hepatitis B vaccine. She'd never been sick before getting that shot, but she was agitated and fussy at her final feeding that evening,. "And then she fell asleep and didn't wake up," says Belkin, president of Belkin Limited (New York), which provides statistical economic forecasts and financial forecasts to international mutual funds
and investment banks.
About five years ago, Bohn Dunbar, who at the time was healthy and athletic, got his first shot of the hepatitis B vaccine. Within 24 hours, he came down with a fever and severe fatigue, symptoms that lasted around a week, and roughly two weeks after that, he developed chronic joint pain and muscle pain, as well as fatigue and symptoms similar to multiple sclerosis. Today, Dunbar is rated permanently and totally impaired at greater than 90%. His health care has already cost Texas--where he got the vaccination--over $500,000 through its worker's compensation program, a figure that will only grow given the severity of his illness. "His problems have been attributed to the hepatitis B vaccine by over a dozen different specialists of unquestionable medical expertise," states his sister, Bonnie Dunbar, a professor of molecular biology and cell biology in the department of cell biology--the largest such department in the US--at Baylor College
of Medicine (Houston, TX).
Indeed, Lyla Rose Belkin's death and Bohn Dunbar's debilitating injuries are just two of the tens of thousands of adverse reactions attributed to the hepatitis B vaccine, which debuted in 1986 as the first recombinant vaccine to reach the US market. The safety of the controversial vaccine--as well as numerous other aspects of its commercialization--has come up at four recent Congressional hearings, though no legislation has yet been drafted regarding the product. Two of the hearings were held by the House subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, which is chaired by Congressman John Mica (R-FL). One of those hearings was devoted solely to investigating reports of hepatitis B vaccine injuries and deaths. The other two hearings were held by the Committee on Government Reform, which is chaired by Congressman Dan Burton (R-IN).
Burton, who has two grandchildren, said at the hearings that his granddaughter was hospitalized within hours of receiving the hepatitis B vaccine, while his grandson became autistic after getting shots of the vaccine. "You can call that a coincidence, but I think it's more," says Burton, adding that "we're going to be beating on this issue as long as I'm chairman of this committee." States Baylor's Dunbar, "Just about every time I talk to someone, they know someone who got sick after getting the vaccine. A lot of times, though, that person just didn't put the two
together, the getting sick and the taking of the vaccine."
Developed by Chiron (Emeryville, CA), the hepatitis B vaccine--which racked up over $2 billion in worldwide sales last year--was licensed to Merck (Whitehouse Station, NJ), which subsequently licensed it to SmithKline Beecham (SKB, Philadelphia, PA). Biogen (Cambridge, MA) also played a role in developing the product and still receives royalties on its sales from both Merck and SKB, as does Chiron.
"One of the main reasons we formed Chiron was to continue development of the hepatitis B vaccine," explains Bill Rutter, chairman emeritus of the firm. Along with his colleagues, Rutter began working on the vaccine in the late 1970s at the University of California at San Francisco. When his team moved to Chiron in 1981, the work continued under contract to Merck, with Chiron responsible for developing the vaccine and Merck responsible for manufacturing and marketing it. "It was beautiful and mysterious and complex. It turned out that in yeast over 100 different peptides self-aggregated to form a true mimic of the hepatitis B surface antigen. It was the first time such a major structure had been formed in such a novel system," exclaims Rutter. "Forming the particle was both a major milestone in molecular biology and vaccinology, as well as one of the major success stories of the 20th century in disease prevention."
Naturally, the merits of any achievement depend on a person's point of view. Says Michael Belkin, "It will only be just when, in their afterlives, all of the people responsible for that vaccine meet my daughter, Lyla Rose. When they meet all those babies whose lives were stolen, who never got a chance." Therein--in the irreconcilable and unresolvable contentions of the vaccine's detractors and supporters--lies the story of the hepatitis B vaccine, a story of contradiction and conflict, some of which is well-intended and some of which isn't.
Irreconcilable Differences
One contention, one that would seem simple to solve, is the number of people in the US infected with the hepatitis B virus. Generally transmitted through infected body fluids, mainly through infected blood, the virus is most prevalent in such high-risk populations as intravenous drug users and sexually promiscuous adults, and in lower-risk populations such as babies born to virus-infected mothers. Symptoms of the disease include fatigue, fever, and yellowing of the skin. About 95% of patients suffer an acute form of the disease, in which they clear the virus from their blood within six months. Approximately 5% of patients suffer from chronic infections, meaning that they never clear the virus and that they always remain infectious.
Up until the latter half of 1991, the Centers for Disease Control and Prevention (CDC, Atlanta, GA), along with most other medical authorities, stated that the US had one of the lowest rates of hepatitis B in the world, with only 0.1% to 0.5% of the population infected. This compares to countries in the Far East and Africa, where the disease affects 5% to 20% or more of the population. Indeed, early in 1991, the CDC reported only 18,003 cases of hepatitis B in a total US population of 248 million.
Yet late in 1991, the CDC did an about face. It was then that its Advisory Committee on Immunization Practices (ACIP) recommended that all infants be injected with the first of three doses of hepatitis B vaccine at birth, before being sent home from the hospital. And almost immediately, the CDC generated disease statistics to support this recommendation, stating that the US had an "estimated" 1 million to 1.25 million people with chronic hepatitis B infections and that each year about 4,000 to 5,000 of these people die from chronic liver diseases. It added that from 1980 to 1991, roughly 200,000 to 300,000 new hepatitis B infections occurred annually.
"I guess the drug companies wanted a big increase in US sales of the hepatitis B vaccine, because all of a sudden the CDC started hyping the disease as a huge health threat. And it generated disease statistics, which had no anchor in documented fact, to support this threat," says Barbara Loe Fisher, the president of the National Vaccine Information Center (NVIC, Vienna, VA). Fisher, in fact, has filed a request under the Freedom of Information Act (FOIA) with the CDC, asking the agency to release copies of the "medical and laboratory criteria used by the CDC to estimate the total number of American adults and children chronically infected with hepatitis
B disease."
Furthermore, Michael Belkin, who earns his livelihood working with statistics, states that the CDC is passing off "estimated, hypothetical numbers as actual cases. This is statistical fraud. In the financial world, such misrepresentation would lead to criminal charges. The whole exercise is designed to increase public hysteria about the risk of a low-risk disease, so the CDC can extend its pervasive influence, and so Merck and SKB can increase their annual vaccine revenues."
For its part, the CDC defends its 1991 change of the number of hepatitis B cases in the US. The first set of numbers that it reported--18,003 cases--were "acute, symptomatic" cases of the disease that doctors were seeing and reporting to their state health departments, which then sent these numbers on to the CDC, says Rob Lyerla, an epidemiologist in the agency's hepatitis branch. "But the CDC wanted to get a better idea about what was really happening in the states, because we knew we were just seeing the tip of the iceberg, the numbers for the symptomatic cases."
So the agency came up with the second set of numbers, including the 1million to 1.25 million chronic cases of the disease. These numbers are actually estimates derived from a blood survey that took place over a four-year cycle and that was made up of hundreds of thousands of tests on blood drawn from randomly selected people who comprised a cross sectional survey of the US population, according to Lyerla. The survey picked up both symptomatic and asymptomatic cases of the disease, both acute and chronic cases. It showed that there had been a vast underreporting of the disease, that doctors had only been reporting acute, symptomatic cases. "So we projected from the survey the number of, not only acute cases of hepatitis B, but acute and chronic cases of hepatitis B that we would expect to find in the entire US. We estimated from the survey, based on statistical
science, the actual number of US disease cases," Lyerla explains.
Both Merck and SKB stand by the CDC estimates. In fact, the CDC estimates have become facts. Somehow, they have evolved into the gold standard, cited unquestioningly by just about every mainstream medical organization on the globe, including the World Health Organization (Geneva), the American Medical Association (Chicago), and the American Academy of Pediatrics (Chicago), to name just a few such organizations. "They're the primary numbers. The CDC only reports primary data," says a Merck spokesperson, Isabelle Claxton. Adds an SKB spokesperson, Brian Jones, "These numbers are the rationale for our vaccinating for hepatitis B. They tell us that hepatitis B is a serious and life-threatening disease."
Is it safe?
Another contention between the victims and the supporters of the hepatitis B vaccine--aside from the true number of virus-infected Americans--is the safety of the vaccine, particularly its safety in babies and children. Following the 1991 ACIP recommendation to begin vaccinating babies for hepatitis B at birth, roughly 40 states mandate that children show proof that they have received three doses of the hepatitis B vaccine before entering daycare or school, with many states beginning the vaccination process near birth. "This, despite the fact that almost nothing is known about the health and integrity of an individual baby's immune system and neurological system at birth," states NVIC's Fisher. Her FOIA to the CDC, in fact, also requests copies of the "peer-reviewed, scientific studies" used to support the safety of the ACIP's 1991 recommendation.
"I would challenge any clinician or researcher to claim that we have a basic understanding of the human newborn immune system," says Baylor's Dunbar. "It's well-established in studies in animal models that the newborn immune system is very distinct from the adolescent or adult. In view of this lack of scientific and medical information of neonatal immunology, it's remarkable to me that newborn infants are being administered multiple injections of this vaccine, especially since there have been few, if any, clinical trials to adequately evaluate the potential long-term effects of neonatal immunization."
Michael Belkin has generated numbers that support these safety concerns for infants. He states that in 1996 doctors reported only 54 cases of hepatitis B to the CDC in babies between the ages of hours and one year. Yet that same year, the Vaccine Adverse Event Reporting System (VAERS)--a system jointly managed by the CDC and the Food and Drug Administration (FDA, Rockville, MD)--received a total of 1,080 reports of adverse reactions to the hepatitis B vaccine in babies from hours to one-year old, including 47 deaths. Exclaims Belkin, "So total VAERS hepatitis B reports for the 0 to 1 age group outnumber reported cases of hepatitis B by 20 to 1."
Overall, VAERS has received a total of 17,497 reports of adverse reactions to the hepatitis B vaccine, reactions that occurred after people received the vaccine alone, rather than in combination with other vaccines, during the period between July 1, 1990 and October 21, 1998. Moreover, fully 5,983 of these reports chronicled such serious events as hospitalizations, while 146 of them told of deaths. VAERS, furthermore, is a passive system, not a mandatory one. This suggests that only a fraction of adverse events are actually reported, a fraction estimated by FDA officials to be as low as 1% to 10%.
The CDC puts little stock in VAERS, since "case reports of adverse events following vaccination rarely provide a convincing link between the event and vaccination," claims Harold Margolis, chief of the CDC's hepatitis branch. VAERS case reports of adverse events may be "temporally linked, but causally unrelated. By chance alone, some patients who develop symptoms of illness will do so within several days of receiving a vaccine. Or a vaccine may lead to the earlier recognition of an illness, without increasing the overall risk of that illness occurring," Margolis states.
Interestingly, Merck, like the CDC before it, has come up with its own hepatitis B numbers, though Merck's figures deal with vaccine-related adverse reactions. These numbers, according to spokesperson Claxton, focus on Indiana, the home state of Congressman Burton, who chaired two of the hearings in which the safety and other aspects of the hepatitis B vaccine was raised. "If you immunized all of the people in the three biggest cities in Indiana with our hepatitis B vaccine, only one person would be at risk of suffering an adverse reaction. The risk of a serious adverse event would be over 1 in 10 million," says Claxton, though she didn't say how Merck
generated these numbers.
Baylor's Dunbar, for her part, found the VAERS reports at least partially useful. "What was obvious from the information I obtained from the VAERS reports was that there are thousands of reports listing such conditions as neurological damage, arthritis symptoms, and other serious immunological disorders. These are the same types of medical conditions that, in my extensively detailed investigation of the literature, have been published in dozens of medical journals that cite the correlation of this vaccine and severe immunological reactions."
Dunbar, in fact, has put together a table entitled "Reports of adverse reactions to hepatitis B vaccine" that lists 110 references from medical journals including the New England Journal of Medicine, the Journal of the American Medical Association, and the Archives of Internal Medicine, as well as numerous overseas publications, including the Lancet and the British Journal of Rheumatology. All of these references detail the diagnosis of adverse reactions to the hepatitis B vaccine, including lupus, arthritis, vascular disorders, demyelinating disorders, and chronic fatigue, among other diseases. A minority of these references, however, report on the original plasma-derived hepatitis B vaccine, which predated the recombinant form of the vaccine. "Patients are reacting to a protein in the vaccine," says Dunbar. "The source of the protein doesn't matter. It's still the same protein, whether it's plasma-derived or recombinant."
Molecular Mimicry: A Possible Culprit
Despite the weight of the evidence to the contrary, supporters of the hepatitis B vaccine deny that it causes any more adverse reactions than expected, as all vaccines cause at least some bad reactions. "No causal link has been scientifically proven between the vaccine and an unexpectedly high number of adverse events," says SKB's Jones. CDC's Margolis states, "Both pre-licensure and post-licensure reviews have shown that the hepatitis B vaccine is among the safest vaccines we have." And Chiron's Rutter adds, "The data show that the benefits of the vaccine far outweigh its risks, if it has any risks at all."
Dunbar, along with other researchers, believes that the risks of the hepatitis B vaccine are great, particularly to specific genetic populations. These researchers postulate that the hepatitis B protein used in the vaccine can cause autoimmune diseases in these subpopulations through several potential mechanisms. One is through a process called molecular mimicry. This process occurs when a person's immune system commits a colossal mistake, confusing a foreign protein for one of the body's own proteins. Consequently, when the immune system attacks the foreign protein, it also attacks its own protein, one of the very proteins that the immune system exists to protect. Such foreign proteins are contained by pathogens like viruses or, more specifically, viral antigens. The hepatitis B vaccine, for its part, is practically an exact replica of a protein antigen on the surface of the hepatitis B virus.
When the body encounters a virus, for instance, certain immune cells literally engulf the virus and chop it up into thousands of protein fragments, known as peptides, each of which is made up of 10 to 15 amino acids. A few of these peptides are carried to the immune-cell surface and placed in a sort of pocket atop what is called a major histocompatability complex (MHC). This signals the immune system to destroy all cells containing that peptide. Yet the immune system destroys not only virus-infected cells containing the peptide, but also cells in the body that contain similar peptides. "The process can set into motion a cascade of self destruction. And certain people end up developing autoimmune disorders," says Dunbar.
The reason for this is an individual's MHC genes, as well as potentially other genes involved in regulating the immune system. An individual's specific genetic makeup determines which of the thousands of peptides that the immune cell chops the virus into is eventually placed in the pocket of the MHC.
In the case of the association of the hepatitis B vaccine and demyelinating disorders, a number of phenomena appear to occur, Dunbar states. One involves a subpopulation of people, most probably of Caucasian origin, who share similar MHC genes or other genes regulating the immune system. A second involves the MHC genes, which seem to code for the selection of a peptide to be placed in the MHC pocket that is similar in structure to a peptide that is associated with myelin, a substance containing numerous peptides that insulate the nerves of the central nervous system. The third involves the hepatitis B vaccine, which must contain one or more similar peptides that have similar amino acid sequences or similar structures to the myelin-associated peptides.
"Molecular mimicry can then occur, as has been shown in numerous animal-model studies," states Dunbar. She adds that the National Institutes of Health (Bethesda, MD) has twice refused to fund a research proposal in which she and her colleagues would, among other aims, have attempted to "test our hypothesis that subsets of patients having adverse reactions to the hepatitis B vaccine have similar and predictable MHC gene sequences."
In near-absolute agreement with Dunbar is Burton Waisbren, a doctor in Milwaukee, WI, who presently is focusing on neurological disorders and who is a founding member of the Infectious Disease Society of America (Alexandria, VA). Says he, "The literally thousands of individuals who've been reported to VAERS and pharmaceutical companies, who claim to have suffered demyelination and autoimmunity from the hepatitis B vaccine, should be followed up to determine their MHC gene sequences to ascertain if host factors are partially causative of the complication." And he states that the hepatitis B vaccine should be "tested for the extent of its polypeptide homology with human tissue. If significant homology is shown, the offending polypeptides could be removed from the vaccine, or a synthetic vaccine could be produced without them.
Indeed, aside from hotly criticizing the CDC's recommendation to immunize all children with the hepatitis B vaccine, NVIC's Fisher cites a recent NVIC poll of 1,000 registered voters, in which 68% of Americans support a parent's right to choose whether or not their children should receive certain vaccines that could potentially hurt them. States Michael Belkin, "If the hepatitis B vaccine was recommended in 1991 without scientific proof that it was safe in a broad sample of racially and genetically diverse babies less than 48 hours old, then the CDC has been experimenting on babies like guinea pigs, and the universal immunization policy should be suspended." Both Fisher and Belkin believe that the US should do what France has already done. Late last year, France became the first country to end its hepatitis B vaccination requirements for schoolchildren, after reports of adverse reactions associated with the vaccine simply overwhelmed the country's Health Minister.
CHICAGO SUN TIMES
Roadblocks frustrate Little Al
July 23, 1999
BY HERB GOULD STAFF REPORTER
BROOKLYN, Mich.--To say racing has been unkind to Al Unser Jr. the last few years is putting it mildly. The second-winningest driver in Championship Auto Racing Teams history, Unser hasn't won a race since 1995. And with his Marlboro Penske team committed to questionable tires and a dubious chassis, his prospects of adding to his 31 CART victories soon are not bright.
As rugged as life has been on the track, though, getting behind the wheel of his race car provides relief from the twin agonies of a divorce from Shelly, his wife of nearly 20 years, and the paralysis of Cody, his 12-year-old daughter. "Getting in the car is definitely a way to get away from everybody," Unser, 37, said Thursday. "I'm getting stabbed in the back from a lot of people. I'm getting hit from all sides--and most of it is coming from Shelly's attorneys."
Shelly initially filed for divorce in 1996. After a legal separation, they reconciled and their fourth child was born. But the marriage deteriorated again. Late last year, the lawyers went to work in earnest. In February, Cody, the second of the Unsers' four children, was diagnosed with transverse myelitis, an illness apparently caused by an allergic reaction to a vaccine for hepatitis. She is paralyzed from the chest down.
"[Doctors] feel with some intense therapy, they can [restore] her back muscles and stomach muscles," Unser said. "But as far as her legs, they're not happy with the results of the testing." His family often used to travel with Unser, who drives a motor home from race to race. Now, they're back home in Albuquerque. "With the divorce going on, Shelly doesn't let me see my children at this point, even Cody," Unser said. "I have to go home to see my children. And when I go home, I run into Shelly. That makes it very difficult right now."
While outsiders wonder if Unser's days of championship driving are in the rear-view mirror, Unser draws strength from his daughter, who refuses to give in to her heartbreaking illness. "Her attitude, and the courage she has, has definitely inspired me to keep going," Unser said. "Unsers are not people to give up. She's helped me maintain the fight to try and go out there and do good." The troubles on the homefront certainly are more important. But Unser's frustrations on the racetrack also have been wrenching. On the first lap of this season's opening race at Miami, he fractured his right ankle in a crash with rookie Naoki Hattori and missed the next two races.
After switching to a Lola chassis in early June because the team's Penske creation wasn't working, Unser thought he had a chance for victory at Cleveland on June 27. "I'm running fifth and Bell Helmets decides to try a trick shield on my helmet. It didn't work. I couldn't see," he said. "For the first time in my career, driving any race car, I had to make a pit stop to change my shield. I felt Bell Helmet cost me the victory in Cleveland. I'm getting hit from all sides. It never ends."
Still, Unser goes into Sunday's U.S. 500 (12:30 p.m., Ch. 7) thinking he can win for the first time in 53 races. "You betcha. We had some real good tests here," Unser said. The two-time Indianapolis 500 winner insists that he remains excited about this season, and scoffs at those who say he's over the hill. "It's been a very tough year. But racing is my life. If racing was to be taken away from me, that would hurt a lot," Unser said, dismissing speculation that he's getting too old to win open-wheel races. "I'm as strong as I've ever been," Unser said, an opinion that was seconded by all-time CART champion Michael Andretti.
"I've heard a lot of talk that Al's washed up, but he's just in a difficult situation," Andretti said. "You put him in my car and give him a few laps to get his confidence back up and he'll be winning races again. People want to jump on the age right away, but its not Al's age at all." Bolstered by his daughter's strength, Unser remains positive. "I am frustrated, but I never go into a race thinking I don't have a shot at winning," he said. "You never know what's going to happen in a race. If you can make the race, you can win it."
Dr. Bonnie Dunbar – Excerpt from her speech given at the Second International Public Conference on Vaccination held in Arlington, Virginia, September 2000
Dr. Bonnie Dunbar, Ph.D. is a Professor of Molecular and Cell Biology at Baylor Medical College in Houston, Texas, an international authority on reproductive biology, molecular endocrinology, and a vaccine developer. Thrust into the vaccine debate when two people in her research laboratory suffered permanent health injuries as a result of being forced to take the hepatitis B vaccine, Dr. Dunbar described the events that alerted her to the kinds of devastating injuries that are linked to this vaccine.
“Both of these individuals were extremely brilliant, healthy and very athletic before this vaccine and have had severe, debilitating autoimmune side effects from this vaccine. I know the complete history of one, Dr. Bohn Dunbar, who is my brother who had serious rashes, joint pain, chronic fatigue, multiple sclerosis like symptoms, and now, affirmatively diagnosed with POTS (an autoimmune cardiovascular neurological problem). His problems have been attributed to the Hepatitis B vaccine by 5 different specialists of unquestionable medical expertise (including MD/PhD’s in major medical schools).”
The other individual was a young medical student working in her laboratory who came in one day feeling unwell and couldn’t see out of one eye. She had just been given a hepatitis B shot. She was diagnosed with optic neuritis. Dr. Dunbar found references in the medical literature linking optic neuritis to the vaccine, and informed her medical student of her findings who took the information to her own doctor and was told that “this is the safest vaccine ever developed.” She was also told she wouldn’t be able to continue in medical school without the hepatitis B vaccine. She was given the third shot and within two weeks she was hospitalized and completely lost her eyesight in that eye.
“The first thing that threw me off when I started reading the literature and drug company information was that ‘This is the safest vaccine ever developed because it is a genetically engineered vaccine’. Now for those of us who work with proteins in immunology, and I tell my medical students when we’re teaching immunology, is that the immune system doesn’t care where a peptide comes from as long as it has to process that peptide. So to say that a vaccine is safe simply because it’s a recombinant vaccine is so naïve as to be really startling - that they would promote it this way. And it’s amazing how many physicians I talk to say - ‘Oh but this is the safest vaccine because it’s recombinant’. Well I develop recombinant vaccines, and it still has to do with the nature of the vaccine, not just because it’s recombinant.”
Referring to dozens of published references on hepatitis B, she said “The second thing that I started looking at when going into the literature is the fact that the pathologies that are common to hepatitis B virus infections are the same types of symptoms that are associated with both the plasma derived (old vaccine) and the new yeast derived recombinant hepatitis B vaccine. These include rheumatoid arthritis type symptoms, optic neuritis, multiples sclerosis like symptoms, demyelinating disorders and a variety of vascular disorders and chronic fatigue syndrome.”
She was most surprised when going through the information in the product inserts and the PDR to find out that Merck said “No serious adverse reactions attributable to the vaccine have been reported in the course of the clinical trials” and that they were monitored for only 5 days after each dose. “How can you
evaluate a vaccine reaction if you only monitor it for 5 days after each dose? We also don’t know how many doses. And with the Smith Kline vaccine, they only monitored for 4 days following vaccination. So knowing what we know about the problems with the plasma derived vaccine and the autoimmune reactions, they still only monitored these trials for these number of days.” Dr. Dunbar empasized that in her work in autoimmunity and vaccine experiments, monitoring is done for many weeks, not just a few days.
A major problem is that individual researchers working in their labs and concentrating on one vaccine are not aware of the number of vaccines that are being administered simultaneously, without proper or adequate testing in many cases.
“In the absence of a lot of doctors who want to get involved with any type of adverse reactions to vaccines, we’ve been trying to set up a number of assays to start evaluating what’s going on with these patients, and so we’ve tried to categorize according to basic categories - and we’re inding there are 3 basic categories. When you look at the published reports in the literature we have a majority of neurological type of symptoms, rheumatic/rheumatology, autoimmune types of symptoms and a variety of others – vascular, etc.”
“In France, they’ve started a criminal investigation to evaluate why this vaccine was put out with false information. What the French physicians are seeing are the same types of patterns, the neurological, rheumatological, autoimmune types of reactions – again a totally different country, but the same kinds of reactions to this vaccine. In the absence of funding from the government, we’ve been trying to do as much as we can – thanks to the help of the NVIC who has been helping with questionnaires – getting us some information so we can construct a data base. We’ve been looking at patient cohorts – collecting blood samples, immortalizing blood cells, T cells, and also getting our serum bank and as we get our reagents ready and get more funding, we’ll be poised and ready to go.”
“In our first group that we have complete information on with the medical diagnoses correlating with this vaccine, we have 55 adults, and again we have a lot more people that we’ve talked to and have some information on. We see that of the numbers we have, 87% of the adults, and 93% of the children that have been reported have some type of neurological symptoms, including seizures, numbness, short term memory loss (very common in adults), visual and hearing problems, and many of these have autoantibodies to myelin basic protein. A lot of these have hair loss (alopecia), skin rashes, and lesions.” (top) <http://www.vran.org/vaccines/hepatitis/dunbar.htm#top> “A lot of these people have overlapping symptoms, and this is where it’s been very difficult to get a single symptom because these patients have so many of these different types of symptoms. Twenty five percent have all of these autoimmune types of symptoms. So it makes it very difficult to treat and certainly very difficult to diagnose which is complicating a lot of this. In a lot of these people where fatigue is common, often they have abnormal liver function - and we don’t have a clue with what’s going on with this. So given this cohort of patients, one of the things that we noticed is the high number of caucasians that are having these reactions And it has been shown for many years that the reactions to the hepatitis B virus itself is associated with the HLA gene. Likewise, it’s known that in a lot of people who get the vaccine and who don’t make antibodies, and this has been correlated with HLA subtypes.”
“The vast majority of adverse reactions reported are in the caucasian population. Most hepatitis B carriers are non-caucasian. Most of the long term studies were done in Asia, where you have a high percentage of carriers and a also high population of non-responders. No studies have been done as to whether the vaccine is effective in non-responders, and there are a lot of people who are non-responsive. (non-responders refers to people who do not develop any detectable antibodies after vaccination) Dunbar said that many of patients were nurses were non-responders. “They kept getting sick, and were told - ‘but you don’t have antibodies – if you want to be a nurse you have to take this shot.’ Some of these women were given 10 or 12 shots and still they weren’t making antibodies and were getting sicker and sicker.”
Dr. Dunbar posed some of the questions that need to be addressed concerning the hepatitis B vaccine. “We have to find out what nationalities are at risk for autoimmune diseases or adverse reactions. What nationalities are at risk for having no response to the vaccine. If they’re not making protective antibodies in different populations, are we truly protecting them? We don’t know. How many people are in these categories? What are the mechanisms causing these reactions? And how can these reactions be treated? Until we understand some of these mechanisms it’s more difficult to develop effective therapies. So we really have no way of knowing how effective this vaccine is in different populations because no studies have been done.”
Dr. Dunbar referred to a DNA sequence data base that is being developed and feels it will be important. They’ve seen a trend in the HLA class A gene so far and hope that with larger numbers of people and family cohorts to get a closer answer on this in the future. Another area of genetic study involves the MHC gene complexes and the way that recombinant hepatitis B protein alters the class 1 or class t MHC gene responses.
Molecular mimicry is a key phrase used by scientists like Dr.Dunbar to describe a particular mechanism of autoimmunity. “We know now that in molecular mimicry that different molecules and viruses have different epitopes that are similar if not identical to human proteins and these can induce autoimmunity………. not just to the molecule being mimicked to begin with, but to other molecules within that tissue.”
In 1996, in a presentation before the Institute of Medicine Vaccine Safety Forum, Dr. Waisbren, MD, a cell biologist and infectious diseases specialist, warned that “genetically engineered hepatitis B vaccines contain polypeptide sequences that are present in human neurologic tissues such as myelin, and
that by a mechanism called molecular mimicry, these polypeptides can act as autoantigens which can induce autoimmune demyelinating diseases of the brain such as multiple sclerosis.” ( NVIC special report – Hepatitis B Vaccine: The Untold Story” – Sept/98)
“And so finally, what has been amazing to me in these last two years, is the problem of scientists who want to study these reactions. Clinical adverse reaction data are not accessible. Patient information from the FDA adverse reaction reports are not accessible to any of us doing these studies. We can get some basic information, but no real information even though there are over 25,000 adverse reaction reports to this vaccine that have not been evaluated in great detail. Complete lack of government funding for these types of issues, and the total denial by pharmaceutical companies that there are any problems.”
Following Dr. Dunbar’s presentation, conference presenter and immunologist, Dr.Vijendra Singh observed that - “I don’t see any safety data available anywhere for any vaccines, and that to me as a scientist is one of the most puzzling problems that I encounter. As a scientist, you do not make vaccines, or any drug for that matter which is going to produce toxicity.” With liver toxicity being quite high in many of Dr. Dunbar’s patients, he said - “Do you know that when drug companies test their products for toxicity that one of the most important things in testing is liver toxicity. How can you have a product on the market where you do not provide proper liver toxicity data?”
Nino Gulua MD.
Sanzona 4a building, flat #28
0191 Tbilisi, Republic of Georgia
Telephone: 995 32 603715; Cell Phone 995 77 792099.
Email: ngulua@hotmail.com Website: www.hapihealth.com
I want to tell the story of an accident that changed radically my son George Kobalia’s life as well as our family’s.
On March 18, 2002 the Hepatitis B vaccination was administered to my son George Qobalia in the polyclinic. At that time, George was 12¼-years-old. This particular vaccine was manufactured by Green Cross Vaccine Corporation in Korea and was imported in Georgia by the UN Children Fund - UNICEF humanitarian mission.
Three days following vaccination, the child suffered acute headache, general weakness, a loss of coordination that was followed by diminished mental capacity and he lapsed into a coma. An ambulance from Center of Catastrophic Medicine rushed the child to Kutaisi, and then to intensive care at Children’s Republican Hospital in Tbilisi, under the care of Dr. David Pulariani who initiated the child’s connection to an artificial respirator. These circumstances were the basis for the Georgian press and television broadcast that “12-year-old George Kobalia was struggling with death”.
It is hard to describe the pain and suffering George has undergone, including the suffering of our family and relatives. George was one of the best pupils and dancers of the Tsalenjikha Lyceum. It is difficult for his parents to comprehend that today George is incapable of doing any of the previous activities he engaged in. Such kind of post-vaccination complications are described in the foreign medical literature: 1 in 600,000 cases. That one case appeared to be crucial for George.
On July 11, 2002, the child was brought to the abovementioned clinic on the basis of an agreement laid down by the Ministry of Health of Georgia and the administration of Salzburg Neurological Clinic where he had undergone a medical treatment and testing. According to that agreement, the Ministry of Labor, Health and Social Affairs had to pay the clinic 10 thousand Euro. Due to some unknown reason, the transfer of the money did not happened, so the parents were forced to find a sponsor through their own efforts and sponsor took George to Germany—more specifically, to the Staffelstein Rehabilitation Center, where he was treated for 8 months. Our family will never forget the warmth and sympathy the German people showed toward George. Especially the medical personnel of the clinic and its chairman who covered the expenses of George’s treatment and rehabilitation.
The post-vaccination encephalomyelitis was diagnosed in Germany. This rare and at the same time serious adverse reaction was repeatedly covered by local press and television.
Now George’s mind is clear; he likes mathematics, knows English and computers, but his condition is still extremely serious. He has a tracheal tube because of diaphragmatic nerve paresis and this is also why his hand reflex is weak. Due to these conditions, George is incapable to do tasks on his own and always requires a nurse to assist him; costly medical treatment and rehabilitation are necessary for George, and our (Doctor’s) family does not have the needed financial resources.
We initiated legal action from the Tbilisi regional court against the Ministry of Labor, Health and Social Affairs, National Center of Statistics and Disease Control, Korean pharmaceutical firm “Green Cross Vaccine Corporation” and UN Children’s Fund-UNICEF.
Lawsuit took a very long time. In about 3 months, the respondents were:
1. Ministry of Labor, Health and Social Affairs;
2. National Center of Statistics and Disease Control;
3. Georgian lawyer hired by Korean pharmaceutical firm;
4. UN Children’s Fund - UNICEF that imported Korean vaccine to Georgia by humanitarian mission and now totally ignores the fact and is not interested in the child’s fate.
The litigation took place on 17th of December. Television and press existing in Georgia got actively involved in lawsuit and would observe how objectively the lawsuit ran. In our claim there was pointed out that George permanently requires a nurse and requires treatment and rehabilitation courses 3 months per year at the European Rehabilitation Center of demyelinization illness. Rehabilitation cost is 17,000 Euros per month.
Yet in Georgia it would cost US $1,600 including treatment, rehabilitation and education. Noted sum was counted for 50 years and according to this scheme it amounted to over US $3 million. (Rehabilitation cost is based on rates established in 2002. By today’s situation rehabilitation cost is 680 Euros per day or 21,080 Euros per month).
The Korean party mainly relies on the conclusion drawn by World Healthcare Organization expert, Mr. Stiven Vasilak, who arrived in Georgia with a scheduled visit and monitor the child. He arrived in Georgia on a poliomyelitis-planned visit and had not planned to study George’s case. It is notable that in our conversation he mentioned that he is not qualified in this case and left many unanswered questions posed by colleagues.
His examination did not go beyond conversation with doctors and general history; he was not even interested in seeing the child who had been in the worst state – connected to the artificial respirator. Representatives of World Healthcare Organization tried hard not to mention post-vaccine complications and this is natural because the World Health Organization had issued the quality certificate for that vaccine.
Their conclusion stated that there is no causative link between vaccine and disease because only a short period of 72 hours passed from vaccination to development of disease. However, they emphasize the fact that it is practically impossible to exclude thoroughly encephalomyelitis following vaccination.
The court made a biased ruling – George will get US $10,000 for moral damage and monthly aid in total of US $500. The National Center of Disease Control and Healthcare Ministry was obligated to pay. The court freed from responsibility and left inviolable Korean pharmaceutical firm which most of all must be held responsible for the damage caused by the vaccine produced by them. In the vaccine literature there was no mention of the complications that appeared to be applicable in George’s case. American literature indicates that the Hepatitis B vaccine may cause disseminated sclerosis, encephalitis and serious damage of the nervous system. But in the Korean literature for the vaccine, there is no mention concerning any such types of complications. It is beyond belief that the Korean pharmaceutical firm was free from any responsibility. All this creates doubts and question: who lobbies for the Korean pharmaceutical firm? Moreover, the lawyer of the Ministry of Health and Social Affairs announced with a menacing tone at the lawsuit that if the parents did not keep quite, they could fire them. It is inconceivable to me why I, the parent, should be silent? Who else is going to defend the rights of my son?
I want to resort to everybody and ask you to help me up in establishing the justice to protect my son’s rights and take care of his future. Can we disregard everything; close eyes to pain and suffering that George and our family bears.
Our case has now been referred to the Supreme Court in an attempt to obtain an objective decision and enable us to conduct the course of rehabilitation at the leading European clinics. In case the Supreme Court decision provides no relief, the last hope will be with the International Court of Justice which guarantees to protect the rights of children and patients.
Herroelen L, et al. Central-nervous-system demyelination after immunisation with recombinant hepatitis B vaccine. Lancet. 1991 Nov 9;338(8776):1174-5.
This article reports on two cases of central-nervous-system demyelinating disease occurring six weeks after administration of recombinant hepatitis B vaccine. One patient had a history of multiple sclerosis while the other had no history of neurological disease.
Hepatitis B vaccine and central nervous system demyelinating diseases. Viral Hepatitis Prevention Board. Pediatr Infect Dis J. 1999 Jan;18(1):23-4. Review.
Multiple sclerosis and hepatitis B vaccination. Nadler JP. Clin Infect Dis. 1993 Nov;17(5):928-9
Multiple sclerosis and hepatitis B vaccine? Hall A, et al. Vaccine. 1999 Jun 4;17(20-21):2473-5.
Vaccination against hepatitis B and multiple sclerosis. Diego Nunez MA, et al. An Esp Pediatr. 1999 Jan;50(1):97. Spanish.
Meningeal reaction after vaccination against hepatitis B.Marsaudon E, et al. Presse Med. 1996 Oct 26;25(32):1561-2. French.
Acute aseptic meningitis after hepatitis B vaccination. Heinzlef O, et al. Presse Med. 1997 Mar 8;26(7):328. French.
Leukoencephalitis after recombinant hepatitis B vaccine Manna R, et al. J Hepatol. 1996 Jun;24(6):764-5.
Acute myelitis after immunization against hepatitis B with recombinant vaccine.
Senejoux A, et al. Gastroenterol Clin Biol. 1996;20(4):401-2. French.
Transverse myelitis following hepatitis B vaccination.
Trevisani F, et al. J Hepatol. 1993 Sep;19(2):317-8.
Acute myelitis after vaccination against hepatitis B.
Mahassin F, et al. Presse Med 1993 Dec 18;22(40):1997-8 French.
This article discusses the case of a 56-year-old man hospitalized for acute myelitis after receiving hepatitis B vaccination.
Acute Myelitis after hepatitis B vaccination.
Song HK, et al J Korean Med Sci. 1997 Jun;12(3):249-51.
Deisenhammer F, et al. Acute cerebellar ataxia after immunisation with recombinant hepatitis B vaccine.
Acta Neurol Scand. 1994 Jun;89(6):462-3.
This article reports on the case of a woman who developed acute cerebellar ataxia 10 days after the second vaccination with recombinant hepatitis B vaccine. Mental nerve neuropathy as a result of hepatitis B vaccination. Maillefert JF, et al. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997 Jun;83(6):663-4 This article discusses the case of a 20-year-old woman who developed polyarthralgia and sensory neuropathy after hepatitis B vaccination.
Report of the working group on the possible relationship between hepatitis B vaccination and the chronic fatigue syndrome.
CMAJ. 1993 Aug 1;149(3):314-9
The possible relation between hepatitis B vaccination and chronic fatigue syndrome.
Delage G, et al. Union Med Can. 1993 Jul-Aug;122(4):278-9. French
Probable post-hepatitis A vaccination encephalopathy.
Hughes PJ, et al. Lancet. 1993 Jul 31;342(8866):302.
COMPLICATIONS AFFECTING THE JOINTS
Hepatitis B immunisation and reactive arthritis.
Birley HD, et al. BMJ 1994 Dec 3;309(6967):1514
The development of rheumatoid arthritis after recombinant hepatitis B
vaccination. Pope JE, et al. J Rheumatol 1998 Sep;25(9):1687-93
This article reports on 11 individuals who developed rheumatoid arthritis after receiving recombinant hepatitis B vaccination. In all cases the arthritis persisted for more than six months.
Polyarthritis associated with hepatitis B vaccination.
Bracci M, et al Br J Rheumatol. 1997 Feb;36(2):300-1.
Arthritis, hypercalcemia, and lytic bone lesions after hepatitis B
vaccination. Cathebras P, et al. J Rheumatol. 1996 Mar;23(3):558-60.
Reactive arthritis after hepatitis B vaccination.
Hachulla E, et al. J Rheumatol. 1990 Sep;17(9):1250-1.
Hepatitis B vaccine associated with erythema nodosum and polyarthritis.
Rogerson SJ, et al. BMJ. 1990 Aug 11;301(6747):345.
Reiter's syndrome and reactive arthritis in health care workers after
vaccination. Hassan W, et al. BMJ 1994 Jul 9;309(6947):94
Reiter's syndrome attributed to hepatitis B immunization.
Fraser PA, et al. BMJ 1994 Dec 3;309(6967):1513
Acute sero-positive rheumatoid arthritis occurring after hepatitis
vaccination. Vautier G, et al. Br J Rheumatol 1994 Oct;33(10):991
Arthritis after hepatitis B vaccination. Report of three cases.
Gross K, Combe C, Kruger K, Schattenkirchner M Scand J Rheumatol
1995;24(1):50-2
Exacerbation of chronic juvenile arthritis induced by hepatitis B
vaccination. Sebag O, et al.Arch Pediatr. 1998 Sep;5(9):1046. French.
COMPLICATIONS AFFECTING THE BLOOD
Cryoglobulinemia after hepatitis B vaccination.
Mathieu E, Fain O, Krivitzky A N Engl J Med 1996 Aug 1;335(5):355
Thrombocytopenia reported in association with hepatitis B and A vaccines.
Meyboom RH, et al. Lancet. 1995 Jun 24;345(8965):1638.
Thrombocytopenic purpura after recombinant hepatitis B vaccine.
Poullin P, et al. Lancet. 1994 Nov 5;344(8932):1293.
Thrombocytopenic purpura as adverse reaction to recombinant hepatitis B
vaccine. Ronchi F, et al. Arch Dis Child. 1998 Mar;78(3):273-4.
This article discusses three cases of immune thrombocytopenic purpura, a bleeding disorder, occurring in infants under 6 months of age after they received the first dose of recombinant hepatitis B vaccine. Immune thrombocytopenic purpura after recombinant hepatitis B vaccine: retrospective study of seven cases. Neau D, et al. Scand J Infect Dis. 1998;30(2):115-8.
This article discusses the cases of seven children (average age--12 years) who developed thrombocytopenia, a bleeding disorder, following vaccination with recombinant hepatitis B vaccine.
COMPLICATIONS AFFECTING THE EYES
Visual loss and eosinophilia after recombinant hepatitis B vaccine. Brezin A, et al. Lancet. 1993 Aug 28;342(8870):563-4.
Bilateral neuro-papillitis after hepatitis B vaccination. Berkman N, et al. Presse Med. 1996 Sep 28;25(28):1301. French.
Occlusion of central retinal vein after hepatitis B vaccination. Devin F, et al. Lancet. 1996 Jun 8;347(9015):1626.
Occlusion of the central retinal vein after vaccination against viral hepatitis B with recombinant vaccines. 4 cases. Granel B, et al. Presse Med. 1997 Feb 1;26(2):62-5. French.
Multiple evanescent white dot syndrome after hepatitis B vaccine. Baglivo E, et al. Am J Ophthalmol. 1996 Sep;122(3):431-2.
Ophthalmic complications of vaccines against hepatitis B virus. Arya SC. Int Ophthalmol. 1997;21(3):177-8.
OTHER COMPLICATIONS OF HEPATITIS B VACCINE
Lupus erythematosus disseminatus and vaccination against hepatitis B virus. Mamoux V, et al. Arch Pediatr. 1994 Mar;1(3):307-8. French.
Systemic lupus erythematosus following hepatitis B vaccine. Guiserix J. Nephron. 1996;74(2):441.
Myasthenia gravis after general anesthesia and hepatitis B vaccine. Biron P, et al. Arch Intern Med. 1988 Dec;148(12):2685.
Benign acute pericarditis after vaccination against hepatitis B. Bensaid J, et al. Presse Med. 1993 Feb 20;22(6):269. French.
Acute pericarditis after vaccination against hepatitis B: a rare effect to be known.
Peyriere H, et al. Rev Med Interne. 1997;18(8):675-6. French.
Severe acute hepatitis B infection after vaccination. Ballinger AB, et al. Lancet. 1994 Nov 5;344(8932):1292.
Acute hepatitis B infection after vaccination. McIntyre PG. Lancet. 1995 Jan 28;345(8944):261.
Acute hepatitis B infection after vaccination. Waugh MA. Lancet. 1995 Jan 28;345(8944):262; discussion 262-3.
Liver dysfunction and DNA antibodies after hepatitis B vaccination.Lilic D, et al. Lancet. 1994 Nov 5;344(8932):1292-3.
Liver inflammation and acute respiratory distress syndrome in a patient receiving hepatitis B vaccine: a possible relationship? Ranieri VM, et al.Intensive Care Med 1997 Jan;23(1):119-21
This article reports on the case of a man who developed liver and lung dysfunction after receiving the second dose of recombinant hepatitis B vaccine.
A case of Churg-Strauss vasculitis after hepatitis B vaccination.
Vanoli M, et al. Ann Rheum Dis. 1998 Apr;57(4):256-7
Nephrotic syndrome after recombinant hepatitis B vaccine.
Macario F, et al. Clin Nephrol. 1995 May;43(5):349.
The diabetes epidemic and the hepatitis B vaccines.
Classen JB N Z Med J 1996 Sep 27;109(1030):366
Asthma and urticaria after hepatitis B vaccination.
Lohiya G. West J Med. 1987 Sep;147(3):341.
Hair loss after routine immunizations.
Wise RP, Kiminyo KP, Salive ME JAMA 1997 Oct 8;278(14):1176-8
This paper describes 46 cases of alopecia (hair loss) reported to the
Vaccine Adverse Effects Reporting System after hepatitis B vaccination.
Major adverse reactions to yeast-derived hepatitis B vaccines--a review. Grotto I, et al. Vaccine 1998 Feb;16(4):329-34
This article discusses some of the adverse reactions that have been reported following hepatitis B vaccination. These include anaphylaxis (severe allergic response), lupus, and kidney, blood, eye, and nervous system problems.
Serious hepatitis B vaccine adverse reactions: are they immune-mediated?
Carmeli Y, De-Medina T Vaccine 1993 Oct;11(13):1358-9
Hepatitis B vaccine side-effect.
Carmeli Y, Oren R Lancet 1993 Jan 23;341(8839):250-1
On Autoimmunity and the Blood-Brain Barrier
I am responding to the post of 9/23 about autoimmunity and the connection with a faulty blood-brain barrier. The blood-brain barrier is not intact in infants until at least 6 weeks of life. This is why a newborn with a fever must be subjected to a spinal tap to rule out meningitis. Any virus or bacteria that a newborn is exposed to can go directly to the nervous system. This is why the Hepatitis B vaccine at birth is so dangerous. Between 1991 and 1999, when the shot contained thimerisol, giving it at birth would have resulted in mercury crossing into the brain since the blood-brain barrier was not yet intact. As a nurse, I'm concerned that this information about the normal timing of a blood-brain barrier forming is not more readily known. I think this normal delay in the forming of a blood-brain barrier is an important piece of the puzzle and one of the reasons for the surge of autism in the 90's.
Mary Barbera RN, MSN
Vital C, Vital A, Gbikpi-Benissan G, Longy-Boursier M, Climas MT, Castaing Y, Canron MH, Le Bras M, Petry K.
Neuropathology Department, Victor Segalen University, Bordeaux, France.
claude.vital@neuropath.u-bordeaux2.fr
Autoimmune inflammatory polyneuropathy (PN) can be triggered by vaccination. We report 3 such cases. A 36-year-old female nurse presented 15 days after a hepatitis B vaccination (HBV) with acute sensory disturbances in the lower limbs. She had severe ataxia but no weakness. Cerebrospinal fluid (CSF) protein level was 84 mg/100 mL, with 3 lymphocytes. A 66-year-old man presented 21 days after HBV with severe motor and sensory PN involving all 4 limbs. A 66-year-old man presented 15 days after a yellow fever vaccination with progressive motor and sensory PN involving all 4 limbs and bilateral facial paralysis. CSF protein level was 300 mg/100 mL, with 5 lymphocytes. Six weeks later, a tracheostomy was performed. In these 3 patients, the nerve deficits lasted for months. In each case, peripheral nerve biopsy showed KP1-positive histiocytes but no T-lymphocytes in the endoneurium. On ultrastructural examination, there was axonal degeneration in the first 2 cases; in case 2, a few myelinated fibers exhibited an intra-axonal macrophage but the myelin sheath was preserved. There was only 1 example of macrophage-associated demyelination in case 2, but these were numerous in case 3. It is likely that in the first 2 cases, an autoimmune reaction against some axonal or neuronal components was triggered by HBV. It induced an acute sensory ataxic PN in case 1 and an acute motor and sensory axonal neuropathy (AMSAN) in case 2. The third patient had a chronic inflammatory demyelinating PN, likely triggered by yellow fever vaccination.
To the Subcommittee on Criminal Justice, Drug Policy, and Human Resources
of the Committee on Government Reform
U.S. House of Representatives
RE: HEPATITIS B VACCINE HEARINGS
SCHOOL NURSE PERSPECTIVE
Submitted by Patti White, RN
May 17, 1999
Mr. Chairman and Members of the Subcommittee:
This is a school nursing perspective for the congressional hearings to be held on May 18, 1999 regarding the safety of the hepatitis B vaccine that is being mandated for newborns and now older children in America. We ask you to please consider the following information and submit it into the congressional testimony. As nurses we continually see more and more damaged children entering our schools, and we are very concerned that a major portion of that damage may be due to the hepatitis B vaccine's assault on the newborn neurological and immune system.
My name is Patti White, R.N. I am a registered professional nurse and the district health services coordinator for a multi-school district. I am writing on behalf of the school nurses in our district. We have very grave concerns about the hepatitis B vaccine.
For the past three or four years our school district has noted a significant increase in the number of children entering school with developmental disorders, learning disabilities, attention deficit disorders and/or serious chronic illness such as diabetes, asthma and seizure disorders. Each of the past four years has been worse than the year before. There is only one common thread we have been able to identify in these children: they are the children who received the first trial hepatitis B injections as newborns in the early 1990s.
As the hepatitis B compliance rate in newborns has gone up in our community, so has the percentage of damaged children. This is very alarming. Because of having so many damaged children we have tried to find the long-term clinical trials that ruled this vaccine "safe and effective". We discovered through an exhaustive Medline search that the FDA based its decision to approve hepatitis B vaccine for administration in the first hours of a newborn baby's life upon clinical trials and upon post-marketing surveillance studies in which patients and their doctors were asked to report any adverse effects they noticed within 4-5 days after each injection [4 days for SmithKline and 5 days for Merck].
The problems being reported in increasing numbers as occurring after hepatitis B vaccination appear to be autoimmune and neurological in origin. Such problems take weeks to months to produce noticeable symptoms, and cannot be spotted in a 4-5 day observation period. These are the only clinical studies that have been done by Merck or SmithKline. There is not one long-term study that we could find.
The CDC and FDA have no idea what the long-term effects will be on the newly developing neurological and immune systems of the infants who are injected with this vaccine. They seem to only be concerned with denying the connection between these damaged children and the hepatitis B shot they received within a few hours of birth. The CDC even admits the lack of study and states they do not even know how long the vaccine will be effective. We found this amazing since the vaccine was developed for a population at risk for hepatitis B: IV drug users, high-risk medical professionals and those who are involved in high risk sexual practices.
In 1950 (before mass immunizations began), the USA had the third lowest infant mortality rate in the world. By 1986, the USA dropped to 17th place. In 1995 the USA dropped to 23rd and now the USA has dropped to the appalling position of 24th in the health of its children. But the USA is now first in vaccine compliance through government mandates.
The elementary grades are overwhelmed with children who have symptoms of neurological and/or immune system damage: epilepsy, seizure disorders, various kinds of palsies, autism, mental retardation, learning disabilities, juvenile-onset diabetes, asthma, vision /hearing loss, and a multitude of new conduct/behavior disorders.
We have come to believe the hepatitis B vaccine is an assault on a newborns developing neurological and immune system. Vaccines are supposed to be making us healthier, however, in twenty-five years of nursing I have never seen so many damaged, sick kids. Something very, very wrong is happening to our children. The census of ill children treated in our health rooms each day has increased by 300% in only four years.
In our last school nurse meeting we discussed whether the combination of so many vaccines/viruses at one time (hepatitis B vaccine at the same time of the DPT, OPV or MMR) is causing the infant's immune system to be overwhelmed and unable to mount a sufficient defense response. We are advocating clinical studies to determine: Is the combination of all these viruses at one time an assault on an infant's immune and neurological system that increases the chances for adverse reaction AND what are the long-term neurological and immune system responses to these vaccines. We are all continuing to research this issue and will be happy to share the many resources we have found with you. I hope you will do the same as you open up this issue.
We have talked many times about the possible cause(s) of the continuing increase in pervasive developmental disorders (PDD), such as autism. From the literature we have found, we should expect a rate for PDD of about 2-5 in 10,000. In our community the rate in 1st and 2nd grade is about 1 in 150 and in kindergarten, 1 in 100.
As school nurses, we have had many parents calling and asking how they can exempt their children from the hepatitis B vaccination (HPB). Many of them have spent long hours in study and research perplexed over this issue. For the past six months we have been studying documents, books and research articles published by internationally respected doctors and scientists that cause us grave concern. You must understand that we began this study to reassure our parents and show them the truth about how safe vaccines are.
Unfortunately, our sincere, honest, dedicated study has caused a complete reversal of our once strongly held beliefs. Instead of being able to reassure the parents, we have found ourselves being drawn deeper and deeper into this unbelievable controversy over vaccines that is raging among physicians, scientists, researchers, parents, and the government. We pray you will have the courage to shine the light on this controversy through these hepatitis B hearings.
My daughter's own experience with the hepatitis B vaccine made me much more open-minded to the information we have been receiving from parents, teachers and other nurses in our community. I personally have had to research this on my own to determine if I have been enforcing a policy that is actually harming more children than it will ever help. I have spent countless hours reading books, vaccine-hearing testimony, research papers, medical journal articles and Internet web-sites from around the world. I did not come to my decision easily or lightly, I assure you. Twenty-five years of total belief in something does not shake that easily.
I have repeated the well-rehearsed refrain "Be Wise; Immunize" thousands of times during those years and reassured countless parents that they were doing the right thing by vaccinating their precious children . . . even the ones who came to me with serious doubts and reservations. I will now have to live with that.
We are all now faced with a moral dilemma: will we protect the "sacred cow of conventional vaccine philosophy" or will we stand up and speak out for the "health and well being of innocent children"? We choose children. We wonder, which will our government choose?
Because the hepatitis B vaccine was developed for those at risk of disease, including IV drug users and sexually promiscuous individuals, efforts to require administration of the vaccine to most, if not all of the U.S. population is very controversial. The increasing number of adverse reaction reports connected with this vaccine exacerbates the controversy. The controversy stems to a great extent from our lack of understanding of the mechanisms of the immune response to the hepatitis B surface antigen and lack of long term follow-up of individuals who have received the vaccine. In a January 27, 1999 press release, the National Vaccine Information Center (NVIC) released figures which show that the number of hepatitis B vaccine-associated serious adverse event and death reports in American children under the age of 14 outnumber the reported cases of hepatitis B disease.
During our research we discovered a copy of the grant proposal submitted recently to the National Institute of Health by Dr. B. S. Dunbar, who has worked in autoimmunity and vaccine development for over twenty years and was honored two years ago by the National Institute of Health. Dr. Dunbar is working with a team of veteran vaccine researchers from all over the world. Their grant is requested for the purpose of studying the hypothesis that: hepatitis B recombinant vaccine does cause adverse autoimmune reactions in genetically susceptible individuals. This study will also provide new insights into the predictability of determining adverse side effects of the hepatitis B vaccine in individuals at risk as related to their histocompatability subtypes. Their study of auto-immune diseases/symptoms caused by the hepatitis B vaccine include: lupus erythematosus, rheumatoid arthritis, vascular disorders, Guillain Barre syndrome, demyelinating disorders such as optic neuritis (blindness), Bell's palsy, demyelinating neuropathy (multiple developmental disorders), multiple sclerosis, diabetes mellitus and chronic fatigue syndrome to mention the most common.
This group of internationally respected vaccine researchers headed up by Dr. Dunbar also point out that, "The studies (for the approval of HPB) were not designed to assess serious, rare adverse events; the total number of recipients were too small; and the follow-up was too short to detect rare or delayed, serious, adverse reactions." Finally they point out that "overall the number of examples of adverse neurologic outcomes following receipt of hepatitis B vaccine are of concern, particularly those resulting in demyelinating neurologic disease."
They continue, "In view of these observations. . . it is medically crucial to evaluate the nature of the autoimmune reactions (i.e. risks) associated with the hepatitis B vaccine and to determine if individuals who will have these adverse reactions can be identified in advance of receiving the vaccine". There are critical questions that must be addressed to establish the risk/benefit of the current hepatitis B vaccines in the United States. These questions are particularly important in view of recent mandates to vaccinate all children including newborn infants."
Many groups have called for a moratorium on hepatitis B vaccination until some of these questions can be answered adequately. The NVIC reported "Newborn babies are dying shortly after their shots and their deaths are being written off as sudden infant death syndrome. Parents should have the right to give their informed consent to vaccination and Congress should give emergency, priority funding to independent scientists, who can take an unbiased look at this vaccine, instead of leaving the search for truth in the hands of government officials who have already decided to force every child to get the vaccine". We agree completely. The NVIC can be contacted at http://www.909shot.com for further information.
Our own school district's confidential health statistics show at least 20% of our children (K-3) have significant neurological damage and/or chronic illness. The last three years have shown an acceleration in the numbers of children who are entering our schools with these "developmental disorders". (Could these be the same infants who received the first trial doses of hepatitis B as only a few hour-old newborns?) As school nurses, working with these damaged children on a daily basis, we pray this is not true. If it is, the ramification to this generation of children is unthinkable!
Should we not pause, call for a moratorium on these poorly tested, rapidly approved vaccines, and allow independent American physicians and researchers to study them before blindly injecting an experimental vaccine into an entire generation? (We have found the only ones declaring the vaccine's safety are the ones who are making millions of dollars from its sales, whose employment depends on it or the ones being supported by the drug companies vast number of grants and fundings. The independent researchers seem to be coming up with an entirely different report.)
Vaccine producers have nothing to lose since our U.S. Congress has made them immune from responsibility or liability for injuries caused from their vaccines. The push is on for them to create more and more vaccines. There are huge amounts of money being made by these people who no longer worry about the consequences of their inadequate clinical trials. The United States government has had to pay out nearly a billion dollars in damages to families who can prove their children have been damaged or killed by vaccines, and there are thousands more cases pending.
We believe, as medical professionals, that we are doing a great disservice to our country by forcing government mandated vaccines on all children. Please research this and we pray you have the courage to speak out and tell the nation what you find.
(The views expressed are my personal beliefs and observations and do not necessarily reflect those of the school district.)
Patti White, RN
From Pediatric News
Little, if Any, Risk Of Alopecia After HBV Vaccination [Pediatric News
32(4):13, 1998. C 1998 International Medical News Group.]
ATLANTA -- The next hepatitis B immunization statement from the CDC will mention a possible link between the vaccine and alopecia, although the risk--if it exists--is quite small. Preliminary results from a study, begun after a case in San Francisco received media attention, found that there were no more than 8.2 cases of alopecia per 100,000 hepatitis B vaccine (HBV) recipients, which is not statistically significant, Dr. Steven Black said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
In the San Francisco case, a 12-month-old girl began to lose scalp hair 10 days after her second dose of HBV. Over the next 3 months, she became completely bald, but her hair grew back in by 18 months of age. Her hair began to fall out again about 1 week after her third HBV dose; she progressed to total baldness but had a full head of hair again by age 2. This report prompted a retrospective review of several vaccine adverse events databases. Since 1984, there have been 60 evaluable reports of alopecia after immunizations, 46 of which involved HBV.
Notable in that study, conducted by Dr. Robert P. Wise and his associates at the Food and Drug Administration, were four cases with positive rechallenges: The hair fell out, grew back, then fell out again
with another vaccine dose. The findings "provide evidence consistent with a causal relationship," Dr. Wise and his associates concluded (JAMA 278[14]:1176-78, 1997). However, Dr. Black and his associates did not find a significantly elevated risk of alopecia within 60 days after HBV administration among children enrolled in two California HMOs. Larger studies involving more individuals are planned, said Dr. Black, director of quality assessment at Kaiser Permanente of Northern California in Oakland. Miriam E. Tucker
MERCK PACKAGE INSERT FOR HEP B COMVAX VACCINE
Michael Belkin wrote:
This is the from the Merck package insert for their new COMVAX vaccine. Comvax is combination HIB/Hep B. Recombivax is hep B only. Last part is observed adverse reactions from marketing Recombivax. I'm sure it's a big relief to everyone that "these serious events were judged not to be related to vaccination with COMVAX by the investigator." Notice in the testing the control group gets another vaccine -- not a
true placebo. Total junk science. http://www.merck.com/product/usa/comvax/pi.html#adverse
COMVAX (TM) [haemophilus b conjugate (meningococcal protein conjugate)
and Hepatitis B (recombinant) vaccine]
... Among 856 infants from combined clinical trials who were monitored for both serious and non-serious adverse experiences, the following serious events were reported to occur in 13 infants during a 14-day period following vaccination with COMVAX (usually coadministered with other pediatric vaccines). These adverse experiences are grouped by case: viral infection; febrile seizure; asthma; diarrhea, vomiting, acidosis, dehydration, hypoglycemia, and seizure disorder; bacterial infection; bronchiolitis and reflux esophagitis; dehydration and fever; asthma, respiratory congestion, and tachypnea; asthma and upper respiratory infection; urinary tract infection and vomiting; pneumonia and asthma; apnea and reflux esophagitis; and vitreous hemorrhage. A causal relationship to the vaccine is unknown; however, these serious adverse events were judged not to be related to vaccination with COMVAX by the investigator.
Among 1756 infants who received COMVAX concomitantly with either an investigational pneumococcal polysaccharide protein conjugate vaccine or an investigational preparation of diphtheria, tetanus, pertussis, and inactivated poliovirus vaccine, the following serious events were reported to occur in 9 infants during a 14-day period following vaccination with COMVAX. These adverse experiences are grouped by case: respiratory syncytial virus; respiratory distress and otitis media; bronchiolitis in two vaccinees; viral gastroenteritis; skull fracture; bronchiolitis, respiratory syncytial virus, and pneumonia; respiratory syncytial virus and bronchiolitis; and upper respiratory infection, viral (see CLINICAL PHARMACOLOGY ). A causal relationship to the vaccine is unknown; however, these serious events were judged not to be related to vaccination with COMVAX by the investigator.
In a group of infants (n=126) given a three-dose course of COMVAX after previously receiving a dose of Hepatitis B Vaccine (Recombinant) at or shortly after birth, the type, frequency, and severity of adverse
experiences did not appear to be greater or different from those observed in infants given only COMVAX.
As with any vaccine, there is the possibility that broad use of COMVAX could reveal adverse experiences not observed in clinical trials. Potential Adverse Effects :In addition, a variety of adverse effects have been reported with marketed use of either PedvaxHIB or RECOMBIVAX HB in infants and children through 71 months of age. These adverse effects are listed
below.
PedvaxHIB
Hypersensitivity
Rarely, angioedema
Hematologic/Lymphatic
Lymphadenopathy
Nervous System
Febrile seizures
Skin
Sterile injection-site abscess; pain at the injection site
RECOMBIVAX HB
Hypersensitivity
Anaphylaxis and symptoms of hypersensitivity including reports of rash, pruritus, urticaria, edema, angioedema, arthralgia, dyspnea, hypotension, erythema multiforme, and ecchymoses
Cardiovascular System
Tachycardia; syncope
Digestive System
Elevation of liver enzymes
Hematologic
Increased erythrocyte sedimentation rate; thrombocytopenia
Musculoskeletal System
Arthritis
Nervous System
Bell's Palsy; Guillain-Barré Syndrome
Psychiatric/Behavioral
Agitation; somnolence; irritability
Skin
Stevens-Johnson Syndrome; alopecia
Special Senses
Conjunctivitis; visual disturbances
http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list
_uids=12365564&dopt=Abstract
J Peripher Nerv Syst 2002 Sep;7(3):163-7
Postvaccinal inflammatory neuropathy: peripheral nerve biopsy in 3 cases.
Vital C, Vital A, Gbikpi-Benissan G, Longy-Boursier M, Climas MT, Castaing Y, Canron MH, Le Bras M, Petry K.
Neuropathology Department, Victor Segalen University,Bordeaux, France.Claude.vital@neuropath.u-bordeaux2.fr
Autoimmune inflammatory polyneuropathy (PN) can be triggered by vaccination. We report 3 such cases. A 36-year-old female nurse presented 15 days after a hepatitis B vaccination (HBV) with acute sensory disturbances in the lower limbs. She had severe ataxia but no weakness. Cerebrospinal fluid (CSF) protein level was 84 mg/100 mL, with 3 lymphocytes. A 66-year-old man presented 21 days after HBV with severe motor and sensory PN involving all 4 limbs. A 66-year-old man presented 15 days after a yellow fever vaccination with progressive motor and sensory PN involving all 4 limbs and bilateral facial paralysis. CSF protein level was 300 mg/100 mL, with 5 lymphocytes. Six weeks later, a tracheostomy was performed. In these 3 patients, the nerve deficits lasted for months. In each case, peripheral nerve biopsy showed KP1-positive histiocytes but no T-lymphocytes in the endoneurium. On ultrastructural examination, there was axonal degeneration in the first 2 cases; in case 2, a few myelinated fibers exhibited an intra-axonal macrophage but the myelin sheath was preserved. There was only 1 example of macrophage-associated demyelination in case 2, but these were numerous in case 3. It is likely that in the first 2 cases, an autoimmune reaction against some axonal or neuronal components was triggered by HBV. It induced an acute sensory ataxic PN in case 1 and an acute motor and sensory axonal neuropathy (AMSAN) in case 2. The third patient had a chronic inflammatory demyelinating PN, likely triggered by yellow fever
vaccination.
A one year followup of chronic arthritis following rubella and hepatitis B vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database.
Geier DA, Geier MR.
Clin Exp Rheumatol 2002 Nov-Dec;20(6):767-71
MedCon, Inc., Silver Spring, Maryland, USA. mgeier@erols.com
OBJECTIVES: This analysis examined the incidence rate of chronic arthritis adverse reactions reported following adult rubella and hepatitis B vaccinations. In this analysis, etiologic mechanisms for chronic arthritis following adult rubella and hepatitis B vaccines were also explored. METHODS: The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for the incidence rate of reported cases of chronic arthritis in comparison to Tetanus-diphtheria (Td) and tetanus toxoid adult vaccine control groups. RESULTS: Chronic arthritis adverse reactions following adult rubella vaccination were primarily reported in females (female/male ratio = 3.0), at about 45 years-old, and at a mean onset time of 10-11 days following vaccination. Chronic arthritis adverse reactions following adult hepatitis B vaccination were also primarily reported in females(female/male ratio = 3.5), at about 33 years-old, and with a mean onset time of 16 days following vaccination. The incidence rates of chronic arthritis following adult rubella and adult hepatitis B vaccinations were statistically significantly increased, by chi 2 analysis, in comparison to the adult vaccine control groups. The attributable risk of chronic arthritis following adult rubella vaccine ranged from 32 to 53 and from 5.1 to 9.0 following adult hepatitis B vaccine in comparison to the adult vaccine control groups. CONCLUSION: This study revealed that adult rubella and adult hepatitis B vaccines were statistically associated with chronic arthritis which persisted for at least one year. The etiology for these adverse reactions may involve autoimmune mechanisms. Furthermore, potential biases in the reporting rates of adverse reactions to VAERS were not observed.
PMID: 12508767 [PubMed - in process]
http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=12532044&dopt=Abstract
J Dermatol 2002 Dec;29(12):781-5
Childhood bullous pemphigoid following hepatitis B immunization.
Erbagci Z.
Gaziantep University Medical Faculty, Department of Dermatology, Gaziantep, Turkey.
Bullous pemphigoid (BP) is an acquired autoimmune bullous disorder which predominantly affects the elderly. It is very rare in children. There are approximately 50 reported cases of childhood BP. Although the cause of childhood BP is unknown, drug intake and vaccination have been incriminated in some cases. A total of 13 patients with BP (10 adults and 3 infants) have been described to be related to various vaccines and tetanus toxoid booster. However, no case related to hepatitis B vaccination has previously been reported. Our case of childhood BP developed one week after hepatitis B immunization in a Turkish caucasian child. This case suggests that the hepatitis B surface antigen can function as the triggering factor for BP by inducing a nonspecific immune reactivation which unmasks subclinical BP or by stimulating a specific antibody production that may cross-react with BP antigens.
http://www.house.gov/reform/cj/hearings/99.5.18/Kirschner.htm
Subcommittee on Criminal Justice, Drug Policy and Human Resources Committee on Government Reform
HOME MEMBERS JURISDICTION SCHEDULE PRESS RELEASES HEARINGS ADDITIONAL RESOURCES
Testimony of Marilyn & Lindsay Kirschner
On the Hepatitis B Vaccine
May 18, 1999
I am here today with my daughter, Lindsay, maintaining a commitment to pave the way so that other parents can make an informed choice in regards to the Hepatitis B vaccine. Lindsay is representative of all the children who fall under the mandate. Six months before the vaccine we had an idyllic life, reveling in the joy of Lindsay's Bat Mitzvah, perfect in every way. Lindsay received the Hepatitis B vaccine two days before entering High School. The next day she seemed flu-like, the day after that so dizzy she couldn't stand-up without holding the walls. The following day she passed out. So our life goes, since August 1997. Lindsay has had syncopal & pre-syncopal episodes, her ability to stand was compromised for almost six months due to unremitting dizziness. Following our Drs. advice, unknown the vaccine was the culprit, Lindsay had the series of three. It was on the third shot Lindsay became so violently ill within two hours, that I knew the vaccine was the catalyst of her illness.
At 16, Lindsay should be having fun with friends, dating, & driving. Instead her days are filled with Dr. visits (15 specialists), MRI?S, CAT SCANS, SPINAL TAPS, ER VISITS, & Hospital admissions. Lindsay is plagued on a daily basis with HEADACHES (of a severe kind), JOINT PAIN, SEIZURES, NAUSEA, HAIR LOSS, DIZZINESS, GASTROESOPHOGAL REFLUX, & Extreme Fatigue. She has been diagnosed with an acquired Dysautonomia & is unable to hold food down with frequent retching, & vomiting. She takes a minimum of 10 doses of medication daily.
We have traveled to specialists in four States, and will be travelling to two more States before July.
Unfortunately, Lindsay is not isolated in her journey. After WPLG(MIAMI) HEALTH REPORTER, Kristi Krueger, broke Lindsay's story (the 1st one to air in the country), I heard from droves of people who have been or have family members affected by this vaccine. (video) Family life as we knew it has been destroyed. This illness is an emotional & extreme financial drain, as I am hardly able to work, depending on my family to support us, and often feeling like a beggar for our survival.
As a single parent this vaccine has ripped a part of our lives that can't be replaced. Lindsay, my former National Junior Honor Society President in 8th grade, is now on a 504 Disability Plan. missing 70 days of 9th grade, and pushing beyond that in this her 10th grade year. What about her future? College? A Career? Will my son David ever forgive me for being so unavailable last year when he was a senior, now that he's 3,000 miles away in LA. The joy of his scholarship offers, & prom departure all took a backseat to Lindsay's illness. Or the fact that he's spending his birthday on a plane so we could be at this hearing just after returning Sunday from his 1st year at USC. What about Lindsay's puppy Frisbee, who is boarded almost as much as he's at home? What about our shattered lives, barely a fragment left of what use to be? Tragedy is not supposed to be the American way. Lindsay, nor anyone should ever have to live like this because of the greed of the manufacturer.
By Geoff Metcalf
© 2000 WorldNetDaily.com
Michael Belkin was a financial forecaster and statistician uninvolved in medical policy -- that is, until his infant daughter died after receiving a hepatitis B vaccine. Since then, Belkin has devoted himself to battling mandated immunizations and the powerful forces involved. Belkin has testified before Congress in opposition to forced hepatitis B vaccinations. WorldNetDaily writer and talk show host Geoff Metcalf recently interviewed Belkin about his work in combating government-mandated vaccines. Metcalf's daily streaming radio show can be heard on TalkNetDaily weekdays from 7 p.m. to 10 p.m. Eastern time.
Question: How did you first get involved in the issue of mandated hepatitis B vaccines?
Answer: I learned about it the hard way. My daughter died about 15 hours after getting the second hepatitis B shot at the age of five weeks. I did an investigation and the first thing I found out was that hepatitis B is a disease of basically intravenous drug users and promiscuous homosexuals and heterosexuals. It is a blood-transmitted, sexually-transmitted disease. And they are giving it to babies.
Q: Children are not at risk but they are required to get this shot?
A: Yes. And therein lies a huge story. The way that vaccines are licensed and regulated and marketed in this country is a major scandal. Under the Freedom of Information Act, I got the adverse reaction report from the FDA. It turned out that as of two years ago, there were 25,000 adverse reactions reported to the FDA, including 440 deaths. The median onset was one day. I'm trained in statistics. I'm a graduate of U.C. Berkeley and am a former strategist at Solomon Brothers. I work with data -- I work with statistics. I provide econometric and financial market forecasts for some of the largest financial institutions in the world.
When I saw this data and started going through this, over and over I found the same thing that happened to my daughter. In the middle of the night, she became extremely agitated -- having tremors and making funny sounds -- and then she just went out like a light. That was it. She couldn't be resuscitated.
They found a swollen brain in the autopsy report. My wife's brother is a doctor in the UK studying neurology and we talked to him right away. He said, "Swollen brain -- that's a vaccine!"
Q: How often is this happening?
A: This obscure panel under the Centers for Disease Control decided in 1991 that they were going to give the hepatitis B vaccine to everybody. If you get an acute case of hepatitis B, you may end up in the hospital, but you will survive. In 90-95 percent of the cases, you get permanent immunity just like you would with the flu or anything else. In 5 percent of the cases, you will wind up with liver problems, probably decades later.
Q: So what are they trying to do with this vaccine?
A: They are trying to eliminate some rare form of liver problems that comes from risky behavior by giving this vaccine to everyone.
Q: Perhaps it's the cynic in me, but this sounds like a classic case of the drug companies pimping a product for profit.
A: Absolutely. In the United States, you have to get a product licensed by the FDA. You do a phase-one, phase-two and phase- three trial. Then, if they like the results, you get it licensed. The next step is to go to the Centers for Disease Control. In the case of vaccines, they have this particular panel called the ACIP [Advisory Committee on Immunization Practices]. I've sat through their meetings and know pretty much what goes on there. Basically, they rubber-stamp whatever the drug companies put in front of them.
But this committee comes up with language saying, such and such a person should get this vaccine at such and such a date. Then the drug company lobbyists take that recommendation from the ACIP and they go around to all the state legislatures and state health departments saying, "Did you see what the CDC says to
do?" And the American Academy of Pediatrics, of course, jumps in. There are huge donations flowing back and forth between all these people. It's a huge conflict of interest.
Q: How many states mandate this? In California, at least for now, you still have the opportunity to say, "No, I don't want that vaccine."
A: It's a state-by-state situation. There are philosophical exemptions, medical exemptions and religious exemptions, depending on the state you live in.
Q: We just told our doctor no, and he shrugged it off as no big deal.
A: You can still get investigated by state social services departments. For instance, if you don't vaccinate your child, they will exclude him from school. You really have to know what you're doing. You have to know the law, and you have to come back at them and use the law in your favor. You might have to get a lawyer if you want to send your kid to public school these days.
What you're up against is basically the drug companies and the Centers for Disease Control. It's for the profit of Smith-Cline -- that's who makes this vaccine. They are using the government as their marketing department.
Q: You can call them a marketing department. Some would call them a pimp.
A: Yes. They're saying you have to take this vaccine, inject it into your body and pay us for it. And if you die or develop adverse reactions that are reported to the FDA, tough luck.
Q: What recourse do you have to negative or the most negative consequences of taking this drug?
A: They have ring-shielded themselves with a government compensation program. By the way, after I started doing my research, I started being contacted by all kinds of people. I am constantly being contacted by parents whose children had convulsions, became autistic, had brain damage or died, as well as adults who developed progressive neurological disease. You start out with joint pains and it eventually develops into demyelination of the brain -- things resembling multiple sclerosis. But if this happens to you, first of all, they tell you it's a coincidence -- you're just dreaming. It's like eating Cheerios and getting in a car accident and blaming it on the cheerios.
Q: This sounds like what they told the guys with Agent Orange, the Gulf War Syndrome victims and guys who had problems with the anthrax vaccine. There is a common thread here.
A: Right. It is really a militarization of the U.S. culture, because those were all soldiers, and I have sympathy for them. But generally, you are not considered to be in the Army and have to take these toxic substances with no choice in the matter if you're a civilian. It turns out the Centers for Disease Control is basically a military organization. If you look at them, they wear uniforms. They dress up in uniforms and march around their compound one day a week. They take great pride in being a paramilitary organization.
Q: I didn't know that.
A: It is very strange. They look like Col. Klink of "Hogan's Heroes" to me. It would be funny if that were all they were. But what they are doing is more like a vaccine Gestapo, and it's not funny. By the time you get around to going to your pediatrician or going to school, they tell you that you have to have this toxic substance for a sexually transmitted disease -- either as one of the first things in life or as the cost of admission to school. It's ridiculous. They have completely usurped liberty in this country.
Q: There is a gaggle of websites with information. Where should we direct readers?
A: There are many groups springing up across the country. It's almost like citizens' resistance to the Vietnam war. In many states, there are local organizations that are trying to get the word out about vaccine choice and the risks of taking vaccines, because the doctors are not telling you about it at all. They tend to say, oh, it's perfectly safe -- a magic bullet. Then they disown you if you get an adverse reaction or your kid dies or something. I can't even get our medical records out of the pediatrician.
Q: Why? Your daughter died.
A: I requested it by registered mail. The doctor is just refusing. I'm not unique. This is pretty standard when it happens to parents. The doctors are brainwashed by the drug companies. The drug companies buy them lunch all day long.
Q: Are the doctors afraid of malpractice suits?
A: They are in denial. It's almost like a huge psychological brainwashing. They think that they are preventing disease, that they are like God's angels banishing disease and that they can't do any wrong. Then they refuse to admit it. This is very standard.
Q: I found one website that I want to direct our readers to. You participated in those congressional hearings back in May of 1999.
A: Yes.
Q: Whatever became of them?
A: It seemed nothing at the time. I was the first witness on the first victims' panel in the first hearing into hepatitis B vaccine. Hearings were conducted by Congressman Dan Burton of Indiana, who is chairman of the Government Reform Committee. Basically, it was a very strange experience. I went down there and I was attacked by the Democrats. They attacked the victim. [Rep. Henry] Waxman and his ilk tried to denigrate me. They said, "You don't know what you're talking about. It's all just an accident." In other words, the Democrats are talking the mainstream health department-drug company policy line. The Republicans are the ones who are digging to get at the truth. It was completely turned upside down from the way I thought it would be.
In answer to your question, it seemed like it was an exercise in futility. But two months after those hearings, there was a flurry of action. Thimerosal, which is a mercury-containing preservative in all vaccines -- mercury is the second most toxic metal there is -- is being removed from all vaccines because they realize they are giving so many vaccines that it is way over the permissible level.
Q: And this stuff is cumulative too, right?
A: Yes. And mercury is one of the things that crosses the blood-brain barrier, so it might be responsible for some of these adverse reactions. It's probably not the only thing.
Q: So what are they doing?
A: Do you think they are withdrawing all the vaccines that are out there on the market? No way! That would cost money.
Q: So are they using them up?
A: Yes. So when you go into a doctor and he gives you a vaccine, it probably still has thimerosal in it because they are working through the inventory. It is not cost-effective to remove a harmful product from the market.
Q: Even if it's killing people?
A: Yeah. Now Dan Burton has just issued a request to Health and Human Services, Donna Shalala, who is the one who is on top of CDC and everything, requesting that they immediately remove all thymerasol-containing vaccines in the United States. But she is not even answering his letters.
Q: Barbara Fisher, the co-founder and president of the National Vaccine Information Center, filed a couple of requests under the Freedom Of Information Act. Has she ever had any response to those?
A: No. I work with the National Vaccine Information Center, that's the website you referenced. I'm a volunteer on the hepatitis B program with them. I went down there and testified at the ACIP and we submitted a FOIA [Freedom Of Information Act] request a year or two ago.
Q: Basically asking federal health agencies to release public copies of peer-reviewed scientific studies?
A: Right. The data they used to show that the hepatitis B vaccine was safe to give to newborn infants and to everyone else. Science is supposed to work like this: You're supposed to do a study, it's supposed to be peer-reviewed, published in a peer-reviewed journal, and then it's legitimate science.
Q: Public record -- anybody should be able to get it.
A: Yes. The CDC hardly ever does that. But I managed to ambush the chairman of the ACIP -- he was chairman in 1991 -- I ambushed him a short time ago in New York at the New York Cornell Medical School when he was giving a lecture on vaccines in the new millennium. I asked him -- and I have a tape of it -- "What published peer-reviewed study did you use in 1991, when you were chairman, to give this vaccine, the hepatitis B vaccine, to newborn infants?" There was never any vaccine given to newborn infants before this one.
Q: And what was his answer?
A: His answer was: "You are quite right. There was no published peer-reviewed study."
I just gave a talk on this issue and the title of the talk was "Shoot first and ask questions later." That's what they are doing. They are giving these vaccines without knowing if they are safe. And then when the adverse reactions come in, they just go into a drawer at the FDA and nothing is done.
Q: This lack of informed consent -- it has sparked fear and distrust of all vaccines. Haven't they reached the point of diminishing return where it would be in their best interest, if they still want to peddle this stuff, to release the peer-reviewed data so people can see it is safe?
A: The study wasn't done! That's the problem. They have nothing to release. That is what I got him to admit.
Q: Well then, it should be a no-brainer. You simply withdraw the drug.
A: This is total scientific fraud. And you get these leaders of the CDC and people going up there saying, "Well, parents don't know what they are talking about. They are making unscientific judgments." To these guys, it is only true science if the government says it's true. And they don't have to have any evidence. They don't have to publish anything. They just say, "If we say it's true, it's true, and if we say it's not true, it's not true."
Q: Like global warming?
A: Yeah, but this is really despotic, intrusive. It reaches way down into your veins. This is not just some rule you have to follow -- this is going into your body.
Q: I found somewhere a piece that revealed the hepatitis B vaccine reaction reports actually outnumber the disease reports.
A: Yes, in newborns. This is a rare disease. You're not liable to contract it. There are 10,000 cases reported to CDC a year -- about 50 in the 0 to 1 age group. Now I went through the data, and there are 20 times more adverse reactions reports to the FDA after vaccination -- convulsions, liver damage, brain damage.
Q: They should withdraw the drug and do the studies they didn't do in the first place.
A: Listen, I'm in business. I have nothing against the free market. I mean this is what I do. I predict and give financial market forecasts. I came from the Austrian school before this -- where the free market always gets everything right. But this is a case when you have these monopolistic pharmaceutical manufacturers ramming unsafe products down -- without even testing them -- and then using the government to mandate that you have to take them. There is something seriously wrong with the way that vaccines are regulated.
Q: Hepatitis B is not widely contagious. That makes it different from some of these other diseases they push vaccines for, doesn't it?
A: It is contagious with blood or anal sex. That is how most of the people getting this disease contract it. It's not something you are going to get by breathing in the air. You really have to share bodily fluids.
Q: Statistically, the prospect of an infant getting it is pretty remote.
A: There are four million babies born every year in the U.S., but only 50-something cases of hepatitis B. That's a .001 percent incidence. And the babies that got it probably got it because their mother had the virus. That's the bottom line. In newborns, it's basically a crime against humanity to give them this vaccine.
Q: How does the CDC defend the indefensible in this regard?
A: They lie. I'm very sensitive to this because, on Wall Street where I work, you can't just make up numbers.
Q: If you do, you go to jail.
A: I mean you can do it, but eventually you'll get caught.
The Centers for Disease Control -- their own statistics show approximately 10,000 cases of hepatitis B a year in the U.S.
Q: So what do they say is their reason for having to take the hepatitis B vaccine?
A: They say there are 350,000 cases a year. So you go to them and ask, "How did you get that number of cases when in your own table it says 10,000? You claim there are 250 to 350,000." They waffle and say, "We did an unpublished study that 'suggested' that
that was the figure."
When you start investigating the CDC and what they are saying about vaccines, nothing checks out.
Q: Who is responsible for the oversight of the CDC? Is it Congress?
A: Health and Human Services Secretary Donna Shalala.
Q: Donna Shalala. So ultimately, culpability in this mess has to fall on her desk?
A: Are you kidding? Just pass the buck. If you think that Ford-Firestone is a big scandal -- and I don't want to belittle it, my sympathies go to those victims of that mess -- but there were 100 deaths linked to the tires. There are something like 500 deaths reported to the FDA from hep B vaccines. The former FDA Commissioner Kessler has said vaccine adverse reactions are underreported by a factor of 10. We're talking hundreds of thousands of adverse reactions.
Q: Hepatitis B apparently is not the killer many of us thought it was -- or were led to believe it was. It's a bad thing to get but, frankly, it is not as lethal as suggested.
A: Exactly. Ninety-some percent of the cases will pass.
Q: Also, the U.S. and Western Europe traditionally have always had the lowest rates of hepatitis B in the world.
A: Right. It's more endemic in Asia and Africa. By the way, the reason hepatitis B is endemic in those areas is because of another vaccination program gone bad -- the polio vaccine.
These polio viruses are cultured in monkey kidneys, and they didn't realize there was this cancer-causing virus in it -- which we're all carrying around -- and they are finding in cancers now. But that's another story.
When they did these polio vaccine programs in the past in places like Taiwan and China, guess what? It's not cost-effective for everyone to have his or her own needle. But everyone has to take the vaccine and you only have one needle. Guess how a rare blood disease like hepatitis B got spread around? The World Health Organization admits this. They have data that show that places where hepatitis B is endemic are areas where previous vaccine programs shared needles and transmitted a rare blood disease.
Q: So who is responsible for spreading the disease?
A: It's medicine. The whole idea of universal immunization, to me, is a crock. They take credit for eliminating all these diseases. In fact, the incidence of these diseases declined before the introduction of most vaccines due to the improvements in sanitation and nutrition.
Q: Where is all this heading?
A: This is heading to a universal AIDS vaccine. It's going to be universally mandated. That's what they are working towards.
Q: How do the recommendations of some government bureaucrat turn into state law that mandates immunization?
A: The drug companies have co-opted the system -- the regulatory and the legal system. There's a doctor in upstate New York who thinks he's saving humanity by not letting kids go to school unless they get this vaccine.
Q: He refuses to give up the federal money he will get for complying with the mandate.
A: Partly, he is being bribed. But you know who's behind that? Hillary Clinton. Vaccines for children. This is the one part of their health program that actually went into business. They got a bunch of government money devoted to mass immunization programs and they have instituted these intrusive mandates at the state level. But it is really the drug company lobbyists who are doing it. They are very skilled. They set up these bogus organizations where it looks like there are parents lobbying for the vaccine. And usually the effort is funded and set up by the drug company.
Q: Business and government together in partnership sounds not unlike fascism to some folks.
A: I'm afraid so. You know, the Nazis were big on forced vaccinations too.
Q: I also discovered that federal health officials actually give state health officials money to force these hepatitis B vaccinations. What is that all about?
A: Yes, there are billions of dollars in this. This gets so intrusive. There is really a "Mark of the Beast" angle to this whole thing. Revelation talks about how you can't do anything without the mark. I'm not saying the vaccine is the whole story, but it is one area where there is this sinister force injecting noxious poisons into your veins -- into your children's veins.
There are ways to escape. I'm not saying we are in a total police state yet. It depends on which state you live in. You need to know how the laws work and you need to take the exemptions. And if you have a doctor who doesn't know the kind of things I'm talking about, or they say vaccines are perfectly safe and there is no such thing as a vaccine adverse reaction, or that the adverse reactions are very rare events and much less common than the disease, in the case of hepatitis B they are wrong, and you should get another doctor. If you're a doctor reading this and you believe that, you had better educate yourself.
HEPATITIS B VACCINATION AND CHRONIC FATIGUE SYNDROME (CFS)
Dr. Byron Hyde (testimony before the Quebec College of Physicians Medical Board)
Dr. Hyde, a medical doctor. after listing his credentials, is recognized as an expert in the field of chronic fatigue syndrome (CFS).
Dr. Hyde begins his testimony by recalling his twelve years of research into CFS and brain dysfunctions as well as his work as Chairman of the non-profit Nightingale Research Foundation. The latter generates awareness and disseminates information on little known diseases as such as post-polio, fibromyalgia and CFS. He tells the Committee that he got involved in this research after his daughter fell ill with a disease process which was only subsequently recognized as being infectious and which became known as CFS. His search for answers, he adds, has taken him around the world.
He defines CFS as an epidemic illness, one which occurs primarily in the late summer and fall. It is typified by an acute onset of symptoms which vary from malaise to severe non-stop headaches and body pains now known in the US as fibromyalgia or myalgias. It is also accompanied by muscle weakness which develop alongside the pain symptoms and changes in brain function. The change in brain function is in several areas with one, a measurable decrease in the expected IQ, and, two, major cognitive losses that is, loss of sensory abilities to define one’s environment. which is very traumatic for the patients. Physicians have found very few physical modalities of the disease to help them to further diagnose the disease.
The disease process, he adds, very much resembles poliomyelitis in its incubation period. Prior to 1962, before polio immunization became generalized. epidemics of CFS like disease occurred concurrently with polio epidemics. A lot of people at that time felt that there may be a type of poliomyelitis-type injury without the paralytic dysfunction.
"My supposed expertise with hep B immunisation. And I say "supposed" because we know almost nothing….We know very little about hep B disease. We have no statistics in Canada, serious statistics. We don’t know, for instance, how many children in Canada die of it every year. There are no statistics. We don’t know who the people who fall ill with hep B are. Are they Haitian immigrants? Are they people who have just arrived from China? There are no government statistics on this information….
Why are we, in a time of major economic, medical and financial difficulty, spending literally a billion dollars, because that is what it would cost to immunise everybody in Canada against hepatitis B, for something in which we have the lowest risk in the world, for which we have no statistics, and for which there is no serious investigation on the side effects?
I would not for a minute say not to take hep B immunisation if you work in a hospital dealing with blood products….We have to know what we are doing in medicine before we go and immunise tens of thousands, hundreds of thousands of children…Because if they develop brain dysfunction after hep B immunisation when they’re in kindergarten, who in the world will know the reason if they fail grades one, two, three and four? Was it because they were stupid, not motivated, not intellectually able, or on drugs? Who is going to know if it is that or if they were brain dysfunctions due to immunisations that, we know, occur to minor degrees in many types of immunisations?
I did have a chance to spend a couple of evenings with the man in charge of getting the American soldiers ready for the Gulf (in Baton Rouge). He was in charge of anti-chemical, anti-germ warfare. He told me that many of the Gulf War Syndrom people were hospitalised immediately after massive immunisations and never got to the Gulf. I have never seen that written up. It is very interesting to note that hep B immunisation was only given to those people sent to the Gulf who were mediacl personnel, because they did not feel there was a risk for the regular soldier. Now, if the American government did not feel it was a risk to people in combat, it makes us wonder why we are giving it to our children today.
We looked at hep B immunisation in Quebec province because one nurse phoned us saying she had CFS after having hep B immunization.....About a month later the same nurse called again, she now had 5 other nurses in the area who had fallen ill with CFS-like symptoms after the vaccine, all were unable to return to work. I told her to phone the maker, Merck. She told me she did and they said the 6 nurses were the only persons in the whole world that had ever had a serious side effect and therefore there couldn't possibly be a link. And, they told her that she was the only person who had ever phoned....she said that when her doctor phoned, he too was told he was the only person in the world that had ever called, and when each of the doctors of the other nurses called in, each was told the same thing.
I also called Merck...and they said.."Oh Dr Hyde, you are the only doctor in all of Canada that has ever contacted us with such a complaint." This same nurse....(had) amassed 20 or 30 names of individuals, all post hep B immunisation cases...We received close to 120 calls from nurses and health care workers in the Quebec area with problems...many were severely disabled." Dr Hyde.
Dr Hyde mentioned that the investigation into the hep B vaccine raised after his efforts was funded, organised and run by a pharmaceutical company. He was not invited. "Nor was Dr. Phaneuf who has over 100 cases of post-hepatitis B immunisation in Quebec…Nobody who had ever published a paper on post-hepatitis immunisation adverse reaction was invited (to the Toronto conference on hepatitis B). So it was a very one sided meeting."
All paid for by Merck. When he asked the government for a copy of the research they said they had completed using the list of hepatitis B "victims" he had provided, he was told that it had been destroyed for lack of space!
Reproduced with permission of Here’s The Key Inc, CP309, Waterloo, Qc JOE 2NO, Canada. Tel: 001 450 297 2533. Fax: 001 450 297 4140
Selected extracts taken from The Trial of the Medical Mafia by Jochim Schafer ISBN 2921783029.
Available from: Whale Books, UK. Tel: 01981 240 125.
To reach Guylaine Lanctot, M.D. Tel: 001 514 297 4128. Fax: 001 514 297 4140
Wanted to send this report showing what vaccines can do at 19 years of age, yet they give to newborns hours old.
VAERS ID 179698 Vaccination Date: 2001-11-26
Age 15.0 Date filed: 2002-01-04
Sex M Where Administered: PUB
State NC Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: TPR, BP 109/61
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE
Vaccinations Manufacturer Lot Dose Route Site
1 HEP SMITHKLINE BEECH 5205A2 0 IM
2 MMR MERCK & CO. INC. 0154L 0 SC
Onset Date: 2001-11-26 Number of Days: 0
Symptoms: CONFUS PALLOR SOMNOLENCE SYNCOPE TREMOR TWITCH
The client had an unwitnessed fall to the floor as exiting the building. An employee saw the pt on the floor with feet raised, body shaking all over with tremors and his head hitting the floor repetitively. The body shaking lasted approx. 3-4 minutes. He was placed in a chair. When the nurse/MD were on the scene, the pt was placed supine. After ice pack to small raised area on crown, skin intact, color pale, lethargic, slow to answer questions and stated his age was 19. He did not know the day of week.
Presented at the 2nd International Symposium on Hyperbaric Oxygenation for Cerebral Palsy and the Brain-Injured Child Boca Raton, Florida July 25-28, 2001
Campbell AW, MD**, Anyanwu E, MS, PhD**, High W, MD, PhD**, Vojdani A. MT, PhD* **
Center for Immune, Environmental & Toxic Disorders 25010 Oakhurst, Suite 200, Spring, Texas 77386; Tel: 281-364-1013 Fax: 281-364-0492.
*Immunosciences Lab, Incorporated, Beverly Hills, California. Center for Immune, Environmental & Toxic Disorders 25010 Oakhurst, Suite 200, Spring, Texas 77386;
Tel: 281-364-1013 Fax: 281-364-0492.
Abstract Purpose: The causal involvement of adverse hepatitis B vaccines in cerebral palsy and epilepsy, remains controversial. In this study, we report a case report of a 21 month-old white female patient who presented with recurrent seizures and manifested all characteristic features of cerebral palsy as a result of hepatitis B vaccines.
Methods: neuroimmunologic techniques, family history, and previous medical records were used to evaluate, correlate and ascertain whether cerebral palsy and epilepsy were a consequence of hepatitis B vaccines adverse effects.
Results: Abnormal EEG showed bilateral cerebral hemispheric disturbances with abnormal rhythmic and irregular delta wave activity was present suggesting an underlying cortical rhythms, less evident in the area of involvement. Furthermore, there was 4 Hz, paroxysmal bilaterally synchronous generalized focal theta activity suggesting damage to a non-specific thalmo-cortical region. Also, multiple theta wave discharges were seen independently arising from different regions of the hemispheres suggesting several potentially epileptogenic foci. The immunologic evaluation showed multiple antibody abnormalities including T helper/suppressor ratio and immune complexe! s. Certain abnormal antibodies found in epilepsy (IgG, IgA) were present in all the patients. There was an elevation of Mg2+ ions receptor function probably, as a result of autoimmune dysfunction.
Conclusions: Since there were no known family history of individuals with developmental problems, mental retardation, or seizure disorders, it then meant that her health condition was related to after birth events. Hence, those abnormalities that are associated with neurological dysfunctions, and characteristics that are found in cerebral palsy and epilepsy, are most likely associated with hepatitis B vaccines adverse effects.
http://www.biospace.com/b2/Articles/111199_print.cfm
First Posted 11/11/99
Miracle or Murder?
The Hepatitis B Vaccine Controversy
Few US public health initiative seem as successful as our mandatory vaccination programs. But a growing number of people believe that one vaccine--that for the hepatitis B virus--is both dangerous and largely unnecessary. Emotions run high in a debate that involves pharmaceutical and biotech companies, US health agencies, Congress, and the parents of children now dead or disabled from what they believe is a vaccine about
which too little is known.
By B.J. Spalding
About a year ago, Michael Belkin's five-week-old daughter, Lyla Rose, got her third and final shot of the hepatitis B vaccine. She'd never been sick before getting that shot, but she was agitated and fussy at her final feeding that evening,. "And then she fell asleep and didn't wake up," says Belkin, president of Belkin Limited (New York), which provides statistical economic forecasts and financial forecasts to international mutual funds
and investment banks.
About five years ago, Bohn Dunbar, who at the time was healthy and athletic, got his first shot of the hepatitis B vaccine. Within 24 hours, he came down with a fever and severe fatigue, symptoms that lasted around a week, and roughly two weeks after that, he developed chronic joint pain and muscle pain, as well as fatigue and symptoms similar to multiple sclerosis. Today, Dunbar is rated permanently and totally impaired at greater than 90%. His health care has already cost Texas--where he got the vaccination--over $500,000 through its worker's compensation program, a figure that will only grow given the severity of his illness. "His problems have been attributed to the hepatitis B vaccine by over a dozen different specialists of unquestionable medical expertise," states his sister, Bonnie Dunbar, a professor of molecular biology and cell biology in the department of cell biology--the largest such department in the US--at Baylor College
of Medicine (Houston, TX).
Indeed, Lyla Rose Belkin's death and Bohn Dunbar's debilitating injuries are just two of the tens of thousands of adverse reactions attributed to the hepatitis B vaccine, which debuted in 1986 as the first recombinant vaccine to reach the US market. The safety of the controversial vaccine--as well as numerous other aspects of its commercialization--has come up at four recent Congressional hearings, though no legislation has yet been drafted regarding the product. Two of the hearings were held by the House subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, which is chaired by Congressman John Mica (R-FL). One of those hearings was devoted solely to investigating reports of hepatitis B vaccine injuries and deaths. The other two hearings were held by the Committee on Government Reform, which is chaired by Congressman Dan Burton (R-IN).
Burton, who has two grandchildren, said at the hearings that his granddaughter was hospitalized within hours of receiving the hepatitis B vaccine, while his grandson became autistic after getting shots of the vaccine. "You can call that a coincidence, but I think it's more," says Burton, adding that "we're going to be beating on this issue as long as I'm chairman of this committee." States Baylor's Dunbar, "Just about every time I talk to someone, they know someone who got sick after getting the vaccine. A lot of times, though, that person just didn't put the two
together, the getting sick and the taking of the vaccine."
Developed by Chiron (Emeryville, CA), the hepatitis B vaccine--which racked up over $2 billion in worldwide sales last year--was licensed to Merck (Whitehouse Station, NJ), which subsequently licensed it to SmithKline Beecham (SKB, Philadelphia, PA). Biogen (Cambridge, MA) also played a role in developing the product and still receives royalties on its sales from both Merck and SKB, as does Chiron.
"One of the main reasons we formed Chiron was to continue development of the hepatitis B vaccine," explains Bill Rutter, chairman emeritus of the firm. Along with his colleagues, Rutter began working on the vaccine in the late 1970s at the University of California at San Francisco. When his team moved to Chiron in 1981, the work continued under contract to Merck, with Chiron responsible for developing the vaccine and Merck responsible for manufacturing and marketing it. "It was beautiful and mysterious and complex. It turned out that in yeast over 100 different peptides self-aggregated to form a true mimic of the hepatitis B surface antigen. It was the first time such a major structure had been formed in such a novel system," exclaims Rutter. "Forming the particle was both a major milestone in molecular biology and vaccinology, as well as one of the major success stories of the 20th century in disease prevention."
Naturally, the merits of any achievement depend on a person's point of view. Says Michael Belkin, "It will only be just when, in their afterlives, all of the people responsible for that vaccine meet my daughter, Lyla Rose. When they meet all those babies whose lives were stolen, who never got a chance." Therein--in the irreconcilable and unresolvable contentions of the vaccine's detractors and supporters--lies the story of the hepatitis B vaccine, a story of contradiction and conflict, some of which is well-intended and some of which isn't.
Irreconcilable Differences
One contention, one that would seem simple to solve, is the number of people in the US infected with the hepatitis B virus. Generally transmitted through infected body fluids, mainly through infected blood, the virus is most prevalent in such high-risk populations as intravenous drug users and sexually promiscuous adults, and in lower-risk populations such as babies born to virus-infected mothers. Symptoms of the disease include fatigue, fever, and yellowing of the skin. About 95% of patients suffer an acute form of the disease, in which they clear the virus from their blood within six months. Approximately 5% of patients suffer from chronic infections, meaning that they never clear the virus and that they always remain infectious.
Up until the latter half of 1991, the Centers for Disease Control and Prevention (CDC, Atlanta, GA), along with most other medical authorities, stated that the US had one of the lowest rates of hepatitis B in the world, with only 0.1% to 0.5% of the population infected. This compares to countries in the Far East and Africa, where the disease affects 5% to 20% or more of the population. Indeed, early in 1991, the CDC reported only 18,003 cases of hepatitis B in a total US population of 248 million.
Yet late in 1991, the CDC did an about face. It was then that its Advisory Committee on Immunization Practices (ACIP) recommended that all infants be injected with the first of three doses of hepatitis B vaccine at birth, before being sent home from the hospital. And almost immediately, the CDC generated disease statistics to support this recommendation, stating that the US had an "estimated" 1 million to 1.25 million people with chronic hepatitis B infections and that each year about 4,000 to 5,000 of these people die from chronic liver diseases. It added that from 1980 to 1991, roughly 200,000 to 300,000 new hepatitis B infections occurred annually.
"I guess the drug companies wanted a big increase in US sales of the hepatitis B vaccine, because all of a sudden the CDC started hyping the disease as a huge health threat. And it generated disease statistics, which had no anchor in documented fact, to support this threat," says Barbara Loe Fisher, the president of the National Vaccine Information Center (NVIC, Vienna, VA). Fisher, in fact, has filed a request under the Freedom of Information Act (FOIA) with the CDC, asking the agency to release copies of the "medical and laboratory criteria used by the CDC to estimate the total number of American adults and children chronically infected with hepatitis
B disease."
Furthermore, Michael Belkin, who earns his livelihood working with statistics, states that the CDC is passing off "estimated, hypothetical numbers as actual cases. This is statistical fraud. In the financial world, such misrepresentation would lead to criminal charges. The whole exercise is designed to increase public hysteria about the risk of a low-risk disease, so the CDC can extend its pervasive influence, and so Merck and SKB can increase their annual vaccine revenues."
For its part, the CDC defends its 1991 change of the number of hepatitis B cases in the US. The first set of numbers that it reported--18,003 cases--were "acute, symptomatic" cases of the disease that doctors were seeing and reporting to their state health departments, which then sent these numbers on to the CDC, says Rob Lyerla, an epidemiologist in the agency's hepatitis branch. "But the CDC wanted to get a better idea about what was really happening in the states, because we knew we were just seeing the tip of the iceberg, the numbers for the symptomatic cases."
So the agency came up with the second set of numbers, including the 1million to 1.25 million chronic cases of the disease. These numbers are actually estimates derived from a blood survey that took place over a four-year cycle and that was made up of hundreds of thousands of tests on blood drawn from randomly selected people who comprised a cross sectional survey of the US population, according to Lyerla. The survey picked up both symptomatic and asymptomatic cases of the disease, both acute and chronic cases. It showed that there had been a vast underreporting of the disease, that doctors had only been reporting acute, symptomatic cases. "So we projected from the survey the number of, not only acute cases of hepatitis B, but acute and chronic cases of hepatitis B that we would expect to find in the entire US. We estimated from the survey, based on statistical
science, the actual number of US disease cases," Lyerla explains.
Both Merck and SKB stand by the CDC estimates. In fact, the CDC estimates have become facts. Somehow, they have evolved into the gold standard, cited unquestioningly by just about every mainstream medical organization on the globe, including the World Health Organization (Geneva), the American Medical Association (Chicago), and the American Academy of Pediatrics (Chicago), to name just a few such organizations. "They're the primary numbers. The CDC only reports primary data," says a Merck spokesperson, Isabelle Claxton. Adds an SKB spokesperson, Brian Jones, "These numbers are the rationale for our vaccinating for hepatitis B. They tell us that hepatitis B is a serious and life-threatening disease."
Is it safe?
Another contention between the victims and the supporters of the hepatitis B vaccine--aside from the true number of virus-infected Americans--is the safety of the vaccine, particularly its safety in babies and children. Following the 1991 ACIP recommendation to begin vaccinating babies for hepatitis B at birth, roughly 40 states mandate that children show proof that they have received three doses of the hepatitis B vaccine before entering daycare or school, with many states beginning the vaccination process near birth. "This, despite the fact that almost nothing is known about the health and integrity of an individual baby's immune system and neurological system at birth," states NVIC's Fisher. Her FOIA to the CDC, in fact, also requests copies of the "peer-reviewed, scientific studies" used to support the safety of the ACIP's 1991 recommendation.
"I would challenge any clinician or researcher to claim that we have a basic understanding of the human newborn immune system," says Baylor's Dunbar. "It's well-established in studies in animal models that the newborn immune system is very distinct from the adolescent or adult. In view of this lack of scientific and medical information of neonatal immunology, it's remarkable to me that newborn infants are being administered multiple injections of this vaccine, especially since there have been few, if any, clinical trials to adequately evaluate the potential long-term effects of neonatal immunization."
Michael Belkin has generated numbers that support these safety concerns for infants. He states that in 1996 doctors reported only 54 cases of hepatitis B to the CDC in babies between the ages of hours and one year. Yet that same year, the Vaccine Adverse Event Reporting System (VAERS)--a system jointly managed by the CDC and the Food and Drug Administration (FDA, Rockville, MD)--received a total of 1,080 reports of adverse reactions to the hepatitis B vaccine in babies from hours to one-year old, including 47 deaths. Exclaims Belkin, "So total VAERS hepatitis B reports for the 0 to 1 age group outnumber reported cases of hepatitis B by 20 to 1."
Overall, VAERS has received a total of 17,497 reports of adverse reactions to the hepatitis B vaccine, reactions that occurred after people received the vaccine alone, rather than in combination with other vaccines, during the period between July 1, 1990 and October 21, 1998. Moreover, fully 5,983 of these reports chronicled such serious events as hospitalizations, while 146 of them told of deaths. VAERS, furthermore, is a passive system, not a mandatory one. This suggests that only a fraction of adverse events are actually reported, a fraction estimated by FDA officials to be as low as 1% to 10%.
The CDC puts little stock in VAERS, since "case reports of adverse events following vaccination rarely provide a convincing link between the event and vaccination," claims Harold Margolis, chief of the CDC's hepatitis branch. VAERS case reports of adverse events may be "temporally linked, but causally unrelated. By chance alone, some patients who develop symptoms of illness will do so within several days of receiving a vaccine. Or a vaccine may lead to the earlier recognition of an illness, without increasing the overall risk of that illness occurring," Margolis states.
Interestingly, Merck, like the CDC before it, has come up with its own hepatitis B numbers, though Merck's figures deal with vaccine-related adverse reactions. These numbers, according to spokesperson Claxton, focus on Indiana, the home state of Congressman Burton, who chaired two of the hearings in which the safety and other aspects of the hepatitis B vaccine was raised. "If you immunized all of the people in the three biggest cities in Indiana with our hepatitis B vaccine, only one person would be at risk of suffering an adverse reaction. The risk of a serious adverse event would be over 1 in 10 million," says Claxton, though she didn't say how Merck
generated these numbers.
Baylor's Dunbar, for her part, found the VAERS reports at least partially useful. "What was obvious from the information I obtained from the VAERS reports was that there are thousands of reports listing such conditions as neurological damage, arthritis symptoms, and other serious immunological disorders. These are the same types of medical conditions that, in my extensively detailed investigation of the literature, have been published in dozens of medical journals that cite the correlation of this vaccine and severe immunological reactions."
Dunbar, in fact, has put together a table entitled "Reports of adverse reactions to hepatitis B vaccine" that lists 110 references from medical journals including the New England Journal of Medicine, the Journal of the American Medical Association, and the Archives of Internal Medicine, as well as numerous overseas publications, including the Lancet and the British Journal of Rheumatology. All of these references detail the diagnosis of adverse reactions to the hepatitis B vaccine, including lupus, arthritis, vascular disorders, demyelinating disorders, and chronic fatigue, among other diseases. A minority of these references, however, report on the original plasma-derived hepatitis B vaccine, which predated the recombinant form of the vaccine. "Patients are reacting to a protein in the vaccine," says Dunbar. "The source of the protein doesn't matter. It's still the same protein, whether it's plasma-derived or recombinant."
Molecular Mimicry: A Possible Culprit
Despite the weight of the evidence to the contrary, supporters of the hepatitis B vaccine deny that it causes any more adverse reactions than expected, as all vaccines cause at least some bad reactions. "No causal link has been scientifically proven between the vaccine and an unexpectedly high number of adverse events," says SKB's Jones. CDC's Margolis states, "Both pre-licensure and post-licensure reviews have shown that the hepatitis B vaccine is among the safest vaccines we have." And Chiron's Rutter adds, "The data show that the benefits of the vaccine far outweigh its risks, if it has any risks at all."
Dunbar, along with other researchers, believes that the risks of the hepatitis B vaccine are great, particularly to specific genetic populations. These researchers postulate that the hepatitis B protein used in the vaccine can cause autoimmune diseases in these subpopulations through several potential mechanisms. One is through a process called molecular mimicry. This process occurs when a person's immune system commits a colossal mistake, confusing a foreign protein for one of the body's own proteins. Consequently, when the immune system attacks the foreign protein, it also attacks its own protein, one of the very proteins that the immune system exists to protect. Such foreign proteins are contained by pathogens like viruses or, more specifically, viral antigens. The hepatitis B vaccine, for its part, is practically an exact replica of a protein antigen on the surface of the hepatitis B virus.
When the body encounters a virus, for instance, certain immune cells literally engulf the virus and chop it up into thousands of protein fragments, known as peptides, each of which is made up of 10 to 15 amino acids. A few of these peptides are carried to the immune-cell surface and placed in a sort of pocket atop what is called a major histocompatability complex (MHC). This signals the immune system to destroy all cells containing that peptide. Yet the immune system destroys not only virus-infected cells containing the peptide, but also cells in the body that contain similar peptides. "The process can set into motion a cascade of self destruction. And certain people end up developing autoimmune disorders," says Dunbar.
The reason for this is an individual's MHC genes, as well as potentially other genes involved in regulating the immune system. An individual's specific genetic makeup determines which of the thousands of peptides that the immune cell chops the virus into is eventually placed in the pocket of the MHC.
In the case of the association of the hepatitis B vaccine and demyelinating disorders, a number of phenomena appear to occur, Dunbar states. One involves a subpopulation of people, most probably of Caucasian origin, who share similar MHC genes or other genes regulating the immune system. A second involves the MHC genes, which seem to code for the selection of a peptide to be placed in the MHC pocket that is similar in structure to a peptide that is associated with myelin, a substance containing numerous peptides that insulate the nerves of the central nervous system. The third involves the hepatitis B vaccine, which must contain one or more similar peptides that have similar amino acid sequences or similar structures to the myelin-associated peptides.
"Molecular mimicry can then occur, as has been shown in numerous animal-model studies," states Dunbar. She adds that the National Institutes of Health (Bethesda, MD) has twice refused to fund a research proposal in which she and her colleagues would, among other aims, have attempted to "test our hypothesis that subsets of patients having adverse reactions to the hepatitis B vaccine have similar and predictable MHC gene sequences."
In near-absolute agreement with Dunbar is Burton Waisbren, a doctor in Milwaukee, WI, who presently is focusing on neurological disorders and who is a founding member of the Infectious Disease Society of America (Alexandria, VA). Says he, "The literally thousands of individuals who've been reported to VAERS and pharmaceutical companies, who claim to have suffered demyelination and autoimmunity from the hepatitis B vaccine, should be followed up to determine their MHC gene sequences to ascertain if host factors are partially causative of the complication." And he states that the hepatitis B vaccine should be "tested for the extent of its polypeptide homology with human tissue. If significant homology is shown, the offending polypeptides could be removed from the vaccine, or a synthetic vaccine could be produced without them.
Indeed, aside from hotly criticizing the CDC's recommendation to immunize all children with the hepatitis B vaccine, NVIC's Fisher cites a recent NVIC poll of 1,000 registered voters, in which 68% of Americans support a parent's right to choose whether or not their children should receive certain vaccines that could potentially hurt them. States Michael Belkin, "If the hepatitis B vaccine was recommended in 1991 without scientific proof that it was safe in a broad sample of racially and genetically diverse babies less than 48 hours old, then the CDC has been experimenting on babies like guinea pigs, and the universal immunization policy should be suspended." Both Fisher and Belkin believe that the US should do what France has already done. Late last year, France became the first country to end its hepatitis B vaccination requirements for schoolchildren, after reports of adverse reactions associated with the vaccine simply overwhelmed the country's Health Minister.
CHICAGO SUN TIMES
Roadblocks frustrate Little Al
July 23, 1999
BY HERB GOULD STAFF REPORTER
BROOKLYN, Mich.--To say racing has been unkind to Al Unser Jr. the last few years is putting it mildly. The second-winningest driver in Championship Auto Racing Teams history, Unser hasn't won a race since 1995. And with his Marlboro Penske team committed to questionable tires and a dubious chassis, his prospects of adding to his 31 CART victories soon are not bright.
As rugged as life has been on the track, though, getting behind the wheel of his race car provides relief from the twin agonies of a divorce from Shelly, his wife of nearly 20 years, and the paralysis of Cody, his 12-year-old daughter. "Getting in the car is definitely a way to get away from everybody," Unser, 37, said Thursday. "I'm getting stabbed in the back from a lot of people. I'm getting hit from all sides--and most of it is coming from Shelly's attorneys."
Shelly initially filed for divorce in 1996. After a legal separation, they reconciled and their fourth child was born. But the marriage deteriorated again. Late last year, the lawyers went to work in earnest. In February, Cody, the second of the Unsers' four children, was diagnosed with transverse myelitis, an illness apparently caused by an allergic reaction to a vaccine for hepatitis. She is paralyzed from the chest down.
"[Doctors] feel with some intense therapy, they can [restore] her back muscles and stomach muscles," Unser said. "But as far as her legs, they're not happy with the results of the testing." His family often used to travel with Unser, who drives a motor home from race to race. Now, they're back home in Albuquerque. "With the divorce going on, Shelly doesn't let me see my children at this point, even Cody," Unser said. "I have to go home to see my children. And when I go home, I run into Shelly. That makes it very difficult right now."
While outsiders wonder if Unser's days of championship driving are in the rear-view mirror, Unser draws strength from his daughter, who refuses to give in to her heartbreaking illness. "Her attitude, and the courage she has, has definitely inspired me to keep going," Unser said. "Unsers are not people to give up. She's helped me maintain the fight to try and go out there and do good." The troubles on the homefront certainly are more important. But Unser's frustrations on the racetrack also have been wrenching. On the first lap of this season's opening race at Miami, he fractured his right ankle in a crash with rookie Naoki Hattori and missed the next two races.
After switching to a Lola chassis in early June because the team's Penske creation wasn't working, Unser thought he had a chance for victory at Cleveland on June 27. "I'm running fifth and Bell Helmets decides to try a trick shield on my helmet. It didn't work. I couldn't see," he said. "For the first time in my career, driving any race car, I had to make a pit stop to change my shield. I felt Bell Helmet cost me the victory in Cleveland. I'm getting hit from all sides. It never ends."
Still, Unser goes into Sunday's U.S. 500 (12:30 p.m., Ch. 7) thinking he can win for the first time in 53 races. "You betcha. We had some real good tests here," Unser said. The two-time Indianapolis 500 winner insists that he remains excited about this season, and scoffs at those who say he's over the hill. "It's been a very tough year. But racing is my life. If racing was to be taken away from me, that would hurt a lot," Unser said, dismissing speculation that he's getting too old to win open-wheel races. "I'm as strong as I've ever been," Unser said, an opinion that was seconded by all-time CART champion Michael Andretti.
"I've heard a lot of talk that Al's washed up, but he's just in a difficult situation," Andretti said. "You put him in my car and give him a few laps to get his confidence back up and he'll be winning races again. People want to jump on the age right away, but its not Al's age at all." Bolstered by his daughter's strength, Unser remains positive. "I am frustrated, but I never go into a race thinking I don't have a shot at winning," he said. "You never know what's going to happen in a race. If you can make the race, you can win it."
Dr. Bonnie Dunbar – Excerpt from her speech given at the Second International Public Conference on Vaccination held in Arlington, Virginia, September 2000
Dr. Bonnie Dunbar, Ph.D. is a Professor of Molecular and Cell Biology at Baylor Medical College in Houston, Texas, an international authority on reproductive biology, molecular endocrinology, and a vaccine developer. Thrust into the vaccine debate when two people in her research laboratory suffered permanent health injuries as a result of being forced to take the hepatitis B vaccine, Dr. Dunbar described the events that alerted her to the kinds of devastating injuries that are linked to this vaccine.
“Both of these individuals were extremely brilliant, healthy and very athletic before this vaccine and have had severe, debilitating autoimmune side effects from this vaccine. I know the complete history of one, Dr. Bohn Dunbar, who is my brother who had serious rashes, joint pain, chronic fatigue, multiple sclerosis like symptoms, and now, affirmatively diagnosed with POTS (an autoimmune cardiovascular neurological problem). His problems have been attributed to the Hepatitis B vaccine by 5 different specialists of unquestionable medical expertise (including MD/PhD’s in major medical schools).”
The other individual was a young medical student working in her laboratory who came in one day feeling unwell and couldn’t see out of one eye. She had just been given a hepatitis B shot. She was diagnosed with optic neuritis. Dr. Dunbar found references in the medical literature linking optic neuritis to the vaccine, and informed her medical student of her findings who took the information to her own doctor and was told that “this is the safest vaccine ever developed.” She was also told she wouldn’t be able to continue in medical school without the hepatitis B vaccine. She was given the third shot and within two weeks she was hospitalized and completely lost her eyesight in that eye.
“The first thing that threw me off when I started reading the literature and drug company information was that ‘This is the safest vaccine ever developed because it is a genetically engineered vaccine’. Now for those of us who work with proteins in immunology, and I tell my medical students when we’re teaching immunology, is that the immune system doesn’t care where a peptide comes from as long as it has to process that peptide. So to say that a vaccine is safe simply because it’s a recombinant vaccine is so naïve as to be really startling - that they would promote it this way. And it’s amazing how many physicians I talk to say - ‘Oh but this is the safest vaccine because it’s recombinant’. Well I develop recombinant vaccines, and it still has to do with the nature of the vaccine, not just because it’s recombinant.”
Referring to dozens of published references on hepatitis B, she said “The second thing that I started looking at when going into the literature is the fact that the pathologies that are common to hepatitis B virus infections are the same types of symptoms that are associated with both the plasma derived (old vaccine) and the new yeast derived recombinant hepatitis B vaccine. These include rheumatoid arthritis type symptoms, optic neuritis, multiples sclerosis like symptoms, demyelinating disorders and a variety of vascular disorders and chronic fatigue syndrome.”
She was most surprised when going through the information in the product inserts and the PDR to find out that Merck said “No serious adverse reactions attributable to the vaccine have been reported in the course of the clinical trials” and that they were monitored for only 5 days after each dose. “How can you
evaluate a vaccine reaction if you only monitor it for 5 days after each dose? We also don’t know how many doses. And with the Smith Kline vaccine, they only monitored for 4 days following vaccination. So knowing what we know about the problems with the plasma derived vaccine and the autoimmune reactions, they still only monitored these trials for these number of days.” Dr. Dunbar empasized that in her work in autoimmunity and vaccine experiments, monitoring is done for many weeks, not just a few days.
A major problem is that individual researchers working in their labs and concentrating on one vaccine are not aware of the number of vaccines that are being administered simultaneously, without proper or adequate testing in many cases.
“In the absence of a lot of doctors who want to get involved with any type of adverse reactions to vaccines, we’ve been trying to set up a number of assays to start evaluating what’s going on with these patients, and so we’ve tried to categorize according to basic categories - and we’re inding there are 3 basic categories. When you look at the published reports in the literature we have a majority of neurological type of symptoms, rheumatic/rheumatology, autoimmune types of symptoms and a variety of others – vascular, etc.”
“In France, they’ve started a criminal investigation to evaluate why this vaccine was put out with false information. What the French physicians are seeing are the same types of patterns, the neurological, rheumatological, autoimmune types of reactions – again a totally different country, but the same kinds of reactions to this vaccine. In the absence of funding from the government, we’ve been trying to do as much as we can – thanks to the help of the NVIC who has been helping with questionnaires – getting us some information so we can construct a data base. We’ve been looking at patient cohorts – collecting blood samples, immortalizing blood cells, T cells, and also getting our serum bank and as we get our reagents ready and get more funding, we’ll be poised and ready to go.”
“In our first group that we have complete information on with the medical diagnoses correlating with this vaccine, we have 55 adults, and again we have a lot more people that we’ve talked to and have some information on. We see that of the numbers we have, 87% of the adults, and 93% of the children that have been reported have some type of neurological symptoms, including seizures, numbness, short term memory loss (very common in adults), visual and hearing problems, and many of these have autoantibodies to myelin basic protein. A lot of these have hair loss (alopecia), skin rashes, and lesions.” (top) <http://www.vran.org/vaccines/hepatitis/dunbar.htm#top> “A lot of these people have overlapping symptoms, and this is where it’s been very difficult to get a single symptom because these patients have so many of these different types of symptoms. Twenty five percent have all of these autoimmune types of symptoms. So it makes it very difficult to treat and certainly very difficult to diagnose which is complicating a lot of this. In a lot of these people where fatigue is common, often they have abnormal liver function - and we don’t have a clue with what’s going on with this. So given this cohort of patients, one of the things that we noticed is the high number of caucasians that are having these reactions And it has been shown for many years that the reactions to the hepatitis B virus itself is associated with the HLA gene. Likewise, it’s known that in a lot of people who get the vaccine and who don’t make antibodies, and this has been correlated with HLA subtypes.”
“The vast majority of adverse reactions reported are in the caucasian population. Most hepatitis B carriers are non-caucasian. Most of the long term studies were done in Asia, where you have a high percentage of carriers and a also high population of non-responders. No studies have been done as to whether the vaccine is effective in non-responders, and there are a lot of people who are non-responsive. (non-responders refers to people who do not develop any detectable antibodies after vaccination) Dunbar said that many of patients were nurses were non-responders. “They kept getting sick, and were told - ‘but you don’t have antibodies – if you want to be a nurse you have to take this shot.’ Some of these women were given 10 or 12 shots and still they weren’t making antibodies and were getting sicker and sicker.”
Dr. Dunbar posed some of the questions that need to be addressed concerning the hepatitis B vaccine. “We have to find out what nationalities are at risk for autoimmune diseases or adverse reactions. What nationalities are at risk for having no response to the vaccine. If they’re not making protective antibodies in different populations, are we truly protecting them? We don’t know. How many people are in these categories? What are the mechanisms causing these reactions? And how can these reactions be treated? Until we understand some of these mechanisms it’s more difficult to develop effective therapies. So we really have no way of knowing how effective this vaccine is in different populations because no studies have been done.”
Dr. Dunbar referred to a DNA sequence data base that is being developed and feels it will be important. They’ve seen a trend in the HLA class A gene so far and hope that with larger numbers of people and family cohorts to get a closer answer on this in the future. Another area of genetic study involves the MHC gene complexes and the way that recombinant hepatitis B protein alters the class 1 or class t MHC gene responses.
Molecular mimicry is a key phrase used by scientists like Dr.Dunbar to describe a particular mechanism of autoimmunity. “We know now that in molecular mimicry that different molecules and viruses have different epitopes that are similar if not identical to human proteins and these can induce autoimmunity………. not just to the molecule being mimicked to begin with, but to other molecules within that tissue.”
In 1996, in a presentation before the Institute of Medicine Vaccine Safety Forum, Dr. Waisbren, MD, a cell biologist and infectious diseases specialist, warned that “genetically engineered hepatitis B vaccines contain polypeptide sequences that are present in human neurologic tissues such as myelin, and
that by a mechanism called molecular mimicry, these polypeptides can act as autoantigens which can induce autoimmune demyelinating diseases of the brain such as multiple sclerosis.” ( NVIC special report – Hepatitis B Vaccine: The Untold Story” – Sept/98)
“And so finally, what has been amazing to me in these last two years, is the problem of scientists who want to study these reactions. Clinical adverse reaction data are not accessible. Patient information from the FDA adverse reaction reports are not accessible to any of us doing these studies. We can get some basic information, but no real information even though there are over 25,000 adverse reaction reports to this vaccine that have not been evaluated in great detail. Complete lack of government funding for these types of issues, and the total denial by pharmaceutical companies that there are any problems.”
Following Dr. Dunbar’s presentation, conference presenter and immunologist, Dr.Vijendra Singh observed that - “I don’t see any safety data available anywhere for any vaccines, and that to me as a scientist is one of the most puzzling problems that I encounter. As a scientist, you do not make vaccines, or any drug for that matter which is going to produce toxicity.” With liver toxicity being quite high in many of Dr. Dunbar’s patients, he said - “Do you know that when drug companies test their products for toxicity that one of the most important things in testing is liver toxicity. How can you have a product on the market where you do not provide proper liver toxicity data?”