Guest guest Posted March 28, 2008 Report Share Posted March 28, 2008 Autism would come under encephalopathy Many of the diseases can cause Encephalopathy All the vaccines can cause Encephalopathy Sheri MMR & Encephalopathy (en·ceph·a·lop·a·thy (e(n-se(f'?-lo(p'?-the-) pronunciation n., pl. -thies. Any of various diseases of the brain.) http://www.909shot.com/Diseases/mmr.htm excerpt MMR VACCINE The most frequent reactions reported to occur following MMR vaccine include brief burning and stinging at the injection site; fatigue, sore throat, cough, runny nose, headache, dizziness, fever, rash, nausea, vomiting or diarrhea, and sore lymph glands. Other reported reactions include anaphylaxis, convulsions, encephalopathy, otitis media, conjunctivitis, nerve deafness, thrombocytopenia purpura, optic neuritis, retinitis, arthritis, Guillain-Barre syndrome, and subacute sclerosing panencephalitis. In 1981, the British National Childhood Encephalopathy Study concluded that there was a statistically significant association between measles vaccination and the onset of a serious neurological disorder within 14 days of receiving measles vaccine. The risk for previously normal children was estimated to be 1 in 87,000 measles vaccinations. In 1991, the Institute of Medicine concluded that there is compelling scientific evidence that the rubella vaccine portion of the MMR shot can cause acute arthritis, with the highest incidence occurring in adult women who receive rubella vaccine (up to 15 percent) and that some individuals go on to develop chronic arthritis. Because either no studies or too few scientific studies have ever been conducted to investigate rubella vaccine reactions, a determination could not be made as to whether rubella vaccine causes other serious health problems which have been reported following rubella vaccination including thrombocytopenia purpura, radiculoneuritis (spinal nerve pain) or other neuropathies such as carpal tunnel syndrome. In 1994, the Institute of Medicine concluded that there is compelling scientific evidence that the measles vaccine can cause anaphylaxis that can end in death and that the MMR vaccine can cause thrombocytopenia (a decrease in the number of platelets, the cells involved in blood clotting) that can end in death. The incidence of thrombocytopenia was estimated to be 1 case per 30,000 to 40,000 vaccinated children. The IOM also concluded that the measles vaccine portion of the MMR vaccine can cause vaccine-strain measles virus infection that can end in death. Because either no studies or too few studies have ever been conducted to investigate MMR vaccine reactions, a determination could not be made as to whether measles or mumps vaccine causes encephalitis or encephalopathy (brain disease); sensorineural deafness, or insulin dependent diabetes mellitus; whether the mumps vaccine causes aseptic meningitis, orchitis (inflammation of the testis) or sterility; or whether the measles vaccine causes subacute sclerosing panencephalitis, residual seizure disorders, optic neuritis, transverse myelitis, or Guillain-Barre syndrome. In 1995, a British study concluded that adults who were vaccinated with measles vaccine as children were at much higher risk of developing inflammatory bowel disease such as Crohn's disease and ulcerative colitis, as adults. Several researchers are looking into the possible link between inflammatory bowel disease and measles vaccine as well as other vaccines. The vaccine manufacturer's product insert for MMR vaccine states " It is also not known whether [the vaccine] can cause fetal harm when administered to pregnant women or can affect reproduction capacity " and " it is not known whether measles or mumps vaccine virus is secreted in human milk. Recent studies have shown that lactating postpartum women immunized with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. " An MMR vaccine manufacturer states that in a study of 279 children 11 months to 7 years of age, MMR vaccine was shown to be 95 to 99 percent effective. Protection is estimated to persist for up to 11 years. In a measles outbreak in the U.S. in the late 1980's and early 1990's, it was found that there were a significant number of vaccine failures in older children, teenagers and adults, when the disease can be more severe. The government proceeded to recommend that a second MMR shot be given to boost immunity either before entrance to kindergarten or before entrance to junior high school. In the national outbreak of measles during the late 1980's and early 1990's, it also became apparent that children who had been vaccinated before 15 months of age were also at risk for vaccine failure, especially if their mothers had recovered naturally from measles disease as children. An MMR vaccine manufacturer states " Infants who are less than 15 months of age may fail to respond to the measles component of the vaccine due to presence in the circulation of residual measles antibody of maternal origin, the younger the infant, the lower the likelihood of seroconversion. " The manufacturer goes on to advise that infants vaccinated at less than 12 months of age will have to be revaccinated after 15 months of age even though " there is some evidence to suggest that infants immunized at less than one year of age may not develop sustained antibody levels when later immunized. " The measles outbreaks in the late 1980's and early 1990's in the U.S. also demonstrated that babies, whose young vaccinated mothers had never naturally recovered from measles infection as children, were vulnerable to measles infection from birth. The young vaccinated mothers did not have natural maternal antibodies to transfer to their newborns to protect them from measles in the first year of life. In the 1989-91 measles outbreak in the U.S., the largest increase in measles cases was in infants under one year old. In 1995, there were 309 cases of measles reported in the U.S. Out of 219 cases where vaccination status was known, 123 (56 percent) had been vaccinated with at least one dose. Of 285 measles cases where age was known, 38 percent were under 5 years old and 39% were more than 20 years old. In the mid-1990's, reports of an association between autism and vaccination (specifically suggesting a possible link with MMR vaccine) were published. Although the U.S. Institute of Medicine (IOM) acknowledged the hypothesis was biologically plausible, IOM concluded there was not enough evidence establishing a causal relationship. Nevertheless, in light of persistent reports by parents that their children are regressing into autism after MMR vaccination, there is an on-going scientific investigation by independent scientific researchers, such as British gastroenterologist Wakefield, M.D., into clinical and laboratory evidence that MMR vaccination may cause autism in biologically vulnerable children. Information on Autism and MMR can be found on this website. ************ VIEW at webpage for charts and graphs PDF file http://www.phac-aspc.gc.ca/cnic-ccni/2004/ pres/_pdf-tue-mar/4_LE_SAUX_NICOLE_Tuesday_210ae.pdf Encephalopathy/ Encephalitis 5 to 30 days Following Measles, Mumps, Rubella Vaccine, 1992 to 2003 N. Le Saux*, D. Scheifele*, S. Halperin*, T. Tam # , M. Mozel*, W. Wallop # and IMPACT* Investigators *Immunization Program, Active (IMPACT)# Immunization and Respiratory Infections Division, Center for Infectious Diseases Prevention and Control, Health Canada Conclusions 1. Encephalopathy post measles vaccine is a rare event in Canada. 2. Clinicians should continue to assiduously investigate all causes of encephalopathy. 3. Active surveillance for serious neurological sequelae is vital and should continue to maintain confidence in measles vaccine. ***************** http://pediatrics.aappublications.org/cgi/content/full/101/3/383 PEDIATRICS Vol. 101 No. 3 March 1998, pp. 383-387 Acute Encephalopathy Followed by Permanent Brain Injury or Death Associated With Further Attenuated Measles Vaccines: A Review of Claims Submitted to the National Vaccine Injury Compensation Program E. Weibel*, Vito Caserta*, E. BenorDagger , and Geoffrey * From the * Division of Vaccine Injury Compensation, National Vaccine Injury Compensation Program, Health Resources and Services Administration, Public Health Service, Rockville, land; and the Dagger Office of the General Counsel, United States Department of Health and Human Services, Rockville, land. ABSTRACT Top Abstract Introduction Methods Results Discussion References Objective. To determine if there is evidence for a causal relationship between acute encephalopathy followed by permanent brain injury or death associated with the administration of further attenuated measles vaccines (Attenuvax or Lirugen, Hoechst n Roussel, Kansas City, MO), mumps vaccine (Mumpsvax, Merck and Co, Inc, West Point, PA), or rubella vaccines (Meruvax or Meruvax II, Merck and Co, Inc, West Point, PA), combined measles and rubella vaccine (M-R-Vax or M-R-Vax II, Merck and Co, Inc, West Point, PA), or combined measles, mumps, and rubella vaccine (M-M-R or M-M-R II, Merck and Co, Inc, West Point, PA), the lead author reviewed claims submitted to the National Vaccine Injury Compensation Program. Methods. The medical records of children who met the inclusion criteria of receiving the first dose of these vaccines between 1970 and 1993 and who developed such an encephalopathy with no determined cause within 15 days were identified and analyzed. Results. A total of 48 children, ages 10 to 49 months, met the inclusion criteria after receiving measles vaccine, alone or in combination. Eight children died, and the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders. The onset of neurologic signs or symptoms occurred with a nonrandom, statistically significant distribution of cases on days 8 and 9. No cases were identified after the administration of monovalent mumps or rubella vaccine. Conclusions. This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization. Key words: measles vaccine, encephalopathy, encephalitis. INTRODUCTION Top Abstract Introduction Methods Results Discussion References Live attenuated measles vaccines used in the United States have almost eliminated natural measles and its complications.1 The Edmonston B strain of live attenuated measles virus vaccine induced fever >103°F in approximately one third and a measles-like rash in approximately one half of vaccine recipients.2 This vaccine, first licensed for general use in the United States on March 21, 1963, was simultaneously administered with 0.02 mL/kg of human immunoglobulin that greatly reduced the occurrence of fever and rash. Further, or more attenuated, Edmonston-Enders measles vaccines were developed to eliminate the use of immunoglobulin. The Schwarz strain (Lirugen) was licensed on February 2, 1965, and used until 1976. Edmonston-Enders strain (Attenuvax), licensed on November 26, 1968, was combined with rubella vaccine (MR) or mumps and rubella (MMR) and licensed on April 22, 1971. MMR soon became the preferred immunization, and by 1976, Attenuvax became the only measles strain distributed in the United States. On September 15, 1978, United States licensure of RA27/3 strain of MR replaced the HPV-77 (duck embryo) strain licensed on June 9, 1969, and II was added to the trade names. Postinfectious encephalopathy complicates approximately 1 in 1000 cases of natural measles and results in a mortality rate of 10% to 20% and permanent central nervous system impairment in the majority of survivors.3-6 Encephalopathy, in this report, is defined as any significant acquired abnormality of, injury to, or impairment of function of the brain, with or without an inflammatory response (ie, encephalitis, encephalomyelitis). The onset of encephalopathy usually occurs 2 to 7 days after the rash. Pleocytosis is reported in approximately 20% of these patients. The cause of this acute monophasic encephalopathy that occurs in the absence of a detectable virus in the brain is obscure, but may be suggestive of an autoimmune encephalopathy. This disease is distinct from progressive subacute sclerosing panencephalitis or subacute inclusion-body encephalitis in immunodeficient patients caused by a persistent measles virus infection.7,8 Case reports and reviews suggest that similar neurologic complications can, less frequently, follow the administration of live attenuated measles vaccine.9-11 In 1973, Landrigan and Witte11 reviewed 84 patients with the onset of neurologic disorders within 30 days after a live measles vaccination who were reported to the Centers for Disease Control and Prevention from 1963 to 1971. Encephalopathy (used interchangeably with encephalitis) of undetermined cause occurred 1 to 25 days after vaccination in 59 patients, and of these, 45 patients had an onset 6 to 15 days after vaccination. Long-term follow-up of 50 of the 59 patients revealed that 5 died, 19 had persistent encephalopathy, and 26 had recovered fully. In a study of the incidence of encephalitis in Olmsted County, Minnesota, from 1950 to 1981 by Beghi et al,12 78% of the patients recovered completely. In the National Childhood Encephalopathy Study of the United Kingdom from July 1, 1976 to June 30, 1979, Alderslade et al13 reported convulsions or acute encephalopathy, without separating the two conditions, in 17 children 7 to 14 days after receiving the Schwarz strain measles vaccine, and in 10 unvaccinated age-matched controls from the local community. This study, designed to assess serious neurologic disorders associated with whole-cell pertussis vaccine, reported the onset of encephalopathy <7 days after the administration of whole-cell pertussis. The purpose of this study of claims submitted to the National Vaccine Injury Compensation Program is to determine whether or not there is evidence for a causal relationship between the first dose of a currently used attenuated measles vaccine, MR, MMR, mumps, or rubella vaccine and encephalopathy of undetermined cause with permanent brain injury or death that occurred within 15 days after administration. STATUTORY FRAMEWORK The National Childhood Vaccine Injury Act of 1986 established the compensation program, a federal no-fault system that became effective on October 1, 1988, to provide compensation for individuals who were injured or who died as a result of specified immunizations.14 Claims of encephalopathy, seizure disorder, or death after the administration of covered vaccines, including measles, mumps, or rubella, can be submitted to the program and awarded compensation, if the condition meets certain medical and legal qualifications. For an individual who received a measles, mumps, or rubella vaccine, the act grants, in the Vaccine Injury Table, the presumption of vaccine causation if the first manifestation of encephalopathy occurs, in the absence of an alternate cause, 15 days or less after receiving any of these vaccines. The injury or its residual effects, except when death occurs, must persist for >6 months. The standard of proof is a preponderance of the medical evidence (ie, >50%, or more likely than not). In addition, a vaccine cause may be demonstrated in the absence of a Vaccine Table Injury, but legally, this is a more difficult process for the person seeking compensation. Effective March 10, 1995, the program changed the time period of a Vaccine Table Injury for these vaccines and the onset of encephalopathy from <15 days to 5 to 15 days.15 In 1994, an Institute of Medicine Committee published a scientific review of clinical studies and case series and reports of encephalopathy after the administration of measles, MR, MMR, and mumps vaccine.9 Their review identified no conclusive evidence of the occurrence of encephalopathy or encephalitis after the administration of measles or mumps vaccine. Nevertheless, the Institute of Medicine Committee acknowledged biologic plausibility that measles vaccine might cause encephalopathy. The lack of controlled studies that distinguish background rates of encephalopathy of undetermined cause in unvaccinated populations makes a determination of causation difficult. METHODS Top Abstract Introduction Methods Results Discussion References The medical records and affidavits in each petition are reviewed by physicians in the compensation program to determine, if possible, the cause of the injury and to classify the findings. The program's finding as to the onset of neurologic signs or symptoms is based only on the medical records. The diagnosis in each case is based on the preponderance of the medical evidence and the assessments of the treating physicians. When deemed necessary, a medical expert is obtained to review the case and provide an expert opinion. All of the cases of encephalopathy discussed in this article have been reviewed in a consistent manner by the first author. Children with appropriate development who acquired an acute encephalopathy of undetermined cause within 15 days after the administration of the first dose of measles, MR, MMR, mumps, or rubella vaccine between April 1970 and March 1993 followed by chronic encephalopathy or death were selected for further analysis. The neurologic criteria used for the diagnosis of acute encephalopathy of undetermined cause were an abrupt onset of neurologic symptoms and/or signs with significant brain impairment including behavior changes with a depressed level of consciousness, ataxia, or seizures. Children selected for this study had an acute encephalopathic illness followed by chronic encephalopathy including mental retardation, seizure disorders, movement disorders, or motor or sensory disorders. Cases of encephalopathy were excluded if an infectious, toxic, traumatic, or metabolic cause or a recent exposure to natural measles, mumps, or rubella was identified or full recovery occurred within 6 months. Seizures with mental dysfunction attributed to the postictal state or medication were not considered to be encephalopathy. All children at the time of the vaccination were considered by the authors to be susceptible to the vaccines administered and >95% would be expected to develop an immune response to the vaccines. The evaluation of these children reflects the standards and technical advancements for diagnoses at the time of the injury. In a few instances, attempts to isolate virus from cerebral tissue and cerebrospinal fluid were unsuccessful. Viral isolation and antibody studies for arboviruses, enteroviruses, and herpesvirus were negative on all children evaluated. Identified patients were categorized with the variables of sex, vaccine or vaccines administered, age at vaccination, postvaccination day of onset, neurologic symptom at onset, level of consciousness or behavior changes during the day of onset, fever, measles-like rash, cerebrospinal fluid analysis, developmental regression during or after the acute illness, hospitalization, antibody studies, and manifestations of permanent brain injury or death. RESULTS Top Abstract Introduction Methods Results Discussion References A total of 403 claims of encephalopathy and/or seizure disorder after measles, MR, MMR, mumps, or rubella vaccination were identified during this 23-year period. Of these claims, 48 (25 males and 23 females) met the inclusion criteria and acquired an acute encephalopathy of undetermined cause 2 to 15 days after receiving measles vaccine, MR, or MMR. This acute encephalopathy was followed by permanent brain impairment or death. The patients ranged in age from 10 months to 49 months, with a median age of 15 months and a mean age of 17.5 months. No case of encephalopathy of undetermined cause within 15 days after the administration of monovalent mumps or rubella vaccine was identified. Either Attenuvax or Lirugen was administered to 4 children between 1970 and 1974, and Attenuvax was administered to 4 children between 1977 and 1982. One child received MR, and 30 children received MMR. Of the remaining 9 children, 2 received MMR and diphtheria, tetanus, pertussis vaccine (DTP), 2 received MMR and Haemophilus influenzae type b vaccine (Hib), 4 received MMR, DTP, and oral poliovirus vaccine (OPV), and 1 received MMR, DTP, OPV, and Hib. The onset of these 48 cases of encephalopathy (Fig 1) occurred 2 to 15 days after the administration of a measles-containing vaccine. All patients were apparently well during the first 48 hours after the vaccination (postimmunization days 0 and 1). The clustering and peak onset of encephalopathy occurred in 17 patients on days 8 and 9. Of the 12 cases of encephalopathy that occurred within 7 days after vaccination, 10 received only MMR; 1 with an onset on day 4 received MMR and Hib; and 1 with an onset on day 5 received MMR and DTP. View larger version (73K): [in this window] [in a new window] Fig. 1. Onset of encephalopathy by day after the administration of the first dose of MMR, MR, or further attenuated measles vaccine in 48 children (1970-1993). The clinical features of acute and chronic encephalopathy or death in these 48 patients (Table 1) were classified into three groups based on the initial finding of ataxia in 6, behavior changes in 8, and seizures in 34. The onset of neurologic findings varied in severity from ataxia or behavior changes to prolonged seizures or coma. Fever preceded the onset of acute encephalopathy by several hours to several days in 43 of 48 children. A measles-like rash with a postvaccination onset from day 6 to 15 occurred in 13 children. View this table: [in this window] [in a new window] TABLE 1 Clinical Findings of Acute Encephalopathy Among 48 Patients 2-15 Days After the First Dose of a Further Attentuated Measles Vaccine, MR, or MMR, 1970-1993, and Sequelae All children with acute ataxia had significant behavior changes, and 3 of the 6 were hospitalized. Neurologic sequelae in the ataxia group included mental retardation in 3, seizure disorder in 1, chronic ataxia in 4, and sensorineural hearing loss in 1. A case example of this group is a normal 16-month-old female who received MMR, and 9 days later, she had a fever, a measles-like rash, and ataxia. Neurologic examinations revealed unsteadiness and truncal titubation, nystagmus, dysmetria, developmental regression, and pleocytosis with 41 monocytes, and a normal brain scan with magnetic resonance imaging. She was diagnosed as having brainstem encephalitis. At age 10 years, she had global developmental delay and cerebellar dysfunction. The 8 children with initial behavior changes rapidly progressed to coma. Two died during the acute illness with autopsy findings of massive cerebral edema and herniation. Of the 6 survivors, 6 had mental retardation, 5 spastic paresis, 1 seizure disorder, 1 choreoathetosis, and 1 died 6 years after the acute illness. A case example of this group is a normal 29-month-old male who received MMR and Hib, and 14 days later, he developed fever, emesis, and progressive lethargy. The following day, he was hospitalized in coma with pleocytosis (246 monocytes, 54 lymphocytes), an elevated cerebrospinal fluid (CSF) protein (49), negative CSF bacterial and viral cultures, and an electroencephalogram (EEG) with diffuse cerebral slowing. He became rigid and opisthotonic. Magnetic resonance imaging of the brain revealed leukodystrophy. At age 5 years, he had hyperactivity and aggressive behavior. In the 34 children with an onset of generalized or focal seizures, coma and behavior changes could not be attributed to a postictal state or medication. These seizures, associated with fever in 32 and a measles-like rash in 9, rapidly progressed to coma in 29 and depressed or changed consciousness in 5. Two apparently normal healthy children received MMR vaccine and died 2 and 12 days later. Autopsy findings revealed cerebral edema and uncal gyral herniation in one, and viral encephalitis with hemorrhagic infarctions of the thalamus and pons in the other. All survivors had chronic encephalopathy with mental retardation in 31, seizure disorder in 23, and spastic paresis in 10. Three deaths occurred 3 months to 4 years later. A case example of this group is a normal 16-month-old female who received measles vaccine, and 7 days later, she developed a fever and a measles-like rash. Ten days after the vaccination, she was hospitalized with status epilepticus, a temperature of 106°F, and a normal CSF analysis. The following day, she had intermittent seizures on anticonvulsant therapy, coma, and left hemiparesis. An EEG showed totally disorganized activity, epileptiform discharges, and right hemisphere suppression. At age 10 years, she had spastic left hemiparesis and cognitive difficulties. CSF analyses performed on 40 of the 48 children were abnormal in 16. Pleocytosis, mainly mononuclear cells, ranged from 7 to 246 cells in 11 patients, with an elevated protein of 49 mg to 101 mg in 4 of these 11. Four patients had only an elevated CSF protein of 117 to 172 mg/dL and 1 had an elevated CSF pressure of 320 mm H2O without further CSF analyses recorded. The 48 patients (Table 2) are divided into three time periods based on an onset day of 1 to 5, 6 to 10, and 11 to 15. The onset of ataxia, behavior changes, seizures, and CSF pleocytosis occurred in each time period, with approximately one half of the cases in the 6 to 10 day time period. The acute illness was associated with fever in all but 5 patients; 3 of the afebrile children were in the 1 to 5 day time period. View this table: [in this window] [in a new window] TABLE 2 Clinical Findings in 48 Patients Through Postvaccination Day 15 by Type of Neurologic Onset in 5-Day Period Groups The distribution of encephalopathy by month of onset (Fig 2) is random throughout the year with a variation of 10 to 13 cases by season. By year of onset, the number of cases ranged from 0 to 4 each year with a total of 15 in the 1970s, 1 to 5 with a total of 21 in the 1980s, and 1 to 6 with a total of 12 in the 1990s with a peak in 1989 and 1990 and no trend in the pattern throughout the years. The medical evaluations reflected the standards of each time period. Prevaccination clinical records revealed no evidence of hypersensitivity. View larger version (75K): [in this window] [in a new window] Fig. 2. Onset of encephalopathy by month after the administration of the first dose of MMR, MR, or further attenuated measles vaccine in 48 children (1970-1993). Statistical Analysis A statistical analysis was performed on the distribution of the 48 cases that met the inclusion criteria. A random distribution would show the onset of 3.0 cases/day (48 div 16). The denominator of 16 is used because the inclusion criterion within 15 days includes 16 periods of 24 hours when the day of immunization is counted as day 0. A comparison of the observed number to the expected number per day was performed based on the use of a standardized morbidity ratio. The distribution was nonrandom with clustering and 2 statistically significant increases (0.01 < P < ..05) of 9 and 8 cases on postvaccination days 8 and 9, respectively.16 Our analysis found no significant difference between the onset of encephalopathy and age or sex. In the absence of any obvious bias and confounding, this finding is evidence for a causal relationship between further attenuated measles vaccine, alone or in combination, and acute encephalopathy of undetermined cause followed by permanent brain impairment or death. DISCUSSION Top Abstract Introduction Methods Results Discussion References Manifestations of acute encephalopathy including loss of consciousness, ataxia, seizures, and pleocytosis among these 48 children is similar to the clinical features of acute encephalopathy described after natural measles and other live measles vaccines.1,2,4,8,10 The earlier onset of these cases of encephalopathy after the injection of live attenuated measles vaccine as compared with the onset after natural respiratory exposure to wild-type measles virus may be related to the route of entry, as is the earlier onset of measles-like symptoms and immune responses.17 Whether the onset of encephalopathy within 5 days after a measles vaccination can be caused by vaccine virus replication and immune responses is not clear. Encephalopathy after natural measles is known to occur in young children, and in some, there is full recovery. Among children in England and Wales, et al6 reported 389 cases of encephalitis after natural measles with 11% of these cases at age 1 to 2 years and 13% at 3 to 4 years. It is biologically plausible that encephalopathy with variable outcomes could occur after measles vaccine administered to children of the same age. A comparison of these cases to claims seeking compensation could be biased, but there is no evidence for bias in the recording of the onset of acute encephalopathy in the medical records or the selection of cases analyzed. Study of this issue is hampered by a lack of background encephalopathic rates in unvaccinated children. A review of similar cases reported to other systems could be helpful. Claims with an onset of acute encephalopathy of undetermined cause within 15 days after a measles, MR, MMR, mumps, or rubella vaccination between 1970 and 1993 followed by permanent brain injury or death have an equal likelihood of being recommended for compensation by the program physicians regardless of whether the injury began on day 0 or day 15. If the null hypothesis is true and the measles, mumps, or rubella vaccine has no causal relationship to the acute encephalopathy, the number of cases with an onset of neurologic findings of encephalopathy each day during this period would be expected to have a random distribution with essentially equal numbers of cases on each day. Our results of a statistically significant cluster on days 8 and 9 after measles immunization indicates this may be an effect of measles vaccine, MR, and MMR. From 1970 to 1993 in the United States, approximately 75 000 000 children received measles vaccine by age 4 years based on 83 000 000 births and an immunization rate of 90%. The 48 cases of encephalopathy probably represent underreporting to this passive system, which does not require individuals to file for compensation and requires medical documentation. However, given the generous compensation offered in this program, it is reasonable to conclude that most serious cases temporally related to a vaccination have been captured. In the absence of a specific test to determine vaccine causation, these 48 cases may include some nonvaccine cases representing background rates. Nevertheless, with a denominator of 75 000 000 vaccinees throughout 23 years, the incidence of acute encephalopathy caused by measles vaccine in this cohort can reasonably be described as very low. FOOTNOTES Received for publication Jul 30, 1997; accepted Sep 23, 1997. Reprint requests to (R.E.W.) National Vaccine Injury Compensation Program, Health Resources and Services Administration, Parklawn Building, Room 8A-46, 5600 Fishers Lane, Rockville, MD 20857. ACKNOWLEDGMENTS We thank the program staff and the Centers for Disease Control and Prevention, National Immunization Program, especially on, BS, and Chen, MD. ABBREVIATIONS MR, measles-rubella vaccine. MMR, measles-mumps-rubella vaccine. DTP, diphtheria, tetanus, pertussis vaccine. Hib, Haemophilus influenzae type b vaccine. OPV, oral poliovirus vaccine. CSF, cerebrospinal fluid. REFERENCES Top Abstract Introduction Methods Results Discussion References 1. Centers for Disease Control and Prevention Measles---United States, 1996, and the interruption of indigenous transmission. MMWR 1997; 46:242-246 [Medline] 2. Markowitz LE, Katz SL. Measles vaccine. In: Plotkin SA, Mortimer EA, eds. Vaccines. Philadelphia, PA: WB Saunders Co; 1994:229-276 3. Babbott FL Jr, Gordon JE Modern measles. Am J Med Sci. 1954; 228:334-361 4. RT, DE, Hirsch RL, Measles encephalomyelitis---clinical and immunologic studies. N Engl J Med 1984; 310:137-141 [Abstract] 5. DL Frequency of complications of measles, 1963. Br Med J. 1964; 2:75-78 6. HG, Stanton JB, Gibbons JL Para-infectious encephalomyelitis and related syndromes. Q J Med. 1956; 25:427-505 7. Roos RP, Graves MC, Wollman RL, Chilcote RR, Nixon J Immunologic and virologic studies of measles inclusion body encephalitis in an immunocompromised host: the relationship to subacute sclerosing panencephalitis. Neurology. 1981; 31:1263-1270 [Abstract] 8. Chen RE, Ramsay DA, deVeber LL, Assiss LJ, Levin SD Immunosuppressive measles encephalitis. Pediatr Neurol 1994; 10:325-327 [CrossRef][Medline] 9. Institute of Medicine. Adverse Events Associated with Childhood Vaccines---Evidence Bearing on Causality. Washington, DC: National Academy Press; 1994 10. Nadar PR, Warren RJ Reported neurologic disorders following live measles vaccine. Pediatrics 1968; 41:997-1001 [Medline] 11. Landrigan PJ, Witte JJ Neurologic disorders following live measles-virus vaccination. JAMA 1973; 223:1459-1462 [CrossRef][Medline] 12. Beghi E, Nicolosi A, Kurland LT, Mulder DW, Hauser WA, Shuster L Encephalitis and aseptic meningitis, Olmsted County, Minnesota, 1950-1981: I. Ann Neurol 1984; 16:283-294 [Medline] 13. Alderslade R, Bellman MH, Rawson NS, Ross EM, DL. The National Childhood Encephalopathy Study: A Report on 1000 Cases of Serious Neurological Disorders in Infants and Young Children From the NCES Research Team. London, England: Her Majesty's Stationery Office; 1981:79-154 14. National Childhood Vaccine Injury Act of 1986, codified as §2111, et seq. of the Public Health Service Act [42 USC 300aa-11 et seq.] 15. National Vaccine Injury Compensation Program; Revision of the Vaccine Injury Table. Federal Register. February 8, 1995;60:7678-7695 16. Bailar JC, Edemer, F Significance factors for the ratio of a Poisson variable to its expectation. Biometrics 1964; 20:639-643 17. Bellanti JA, Sanga RL, Klutinis B, Brandt B, Artenstein MS Antibody responses in serum and nasal secretions of children immunized with inactivated and attenuated measles-virus vaccines. N Engl J Med 1969; 280:628-633 [Medline] Pediatrics (ISSN 0031 4005). Copyright ©1998 by the American Academy of Pediatrics ************* http://www.whale.to/vaccine/testimonies4.html *********** http://www.vaccine-info.com/articles/latent_period/index.htm The Controversy of the Latent Period Following Immunizations Harold E Buttram, MD September 21, 2001 Introduction: In 1986 the U.S. Congress passed the National Childhood Vaccine Injury Act, which set up a system whereby the families of vaccine-injured children could be compensated for such injuries. Based on personal experience and observation, there has been much criticism of this system and question whether not it is serving its intended purpose. (1) One of the major areas of controversy surrounding the act involves its limitations in the latent periods, whereby certain defined reactions following vaccines must be identified within a certain time period to qualify for compensation by the childhood vaccine injury act. For the complication of encephalitis, the time limitation for the DTP or DTaP vaccine is 3 days; for the measles-mumps-rubella (MMR) vaccine it is 5 to 15 days. The limitations in latent periods following vaccines have been generally accepted by our medical-legal system as guidelines in other areas as well. Prominent among these is the " shaken baby syndrome " (SBS) in which a parent or caretaker is accused of injuring or murdering an infant by violent shaking and causing a triad of findings now commonly accepted as diagnostic of SBS: retinal hemorrhages, subdural hematomas, and diffuse axonal injury. (2-5) However, it has been observed that many cases attributed to the SBS have occurred in a time-related fashion following routine childhood vaccines, especially in compromised children that had been born from medically complicated pregnancies. (6) Consequently there are valid reasons for questioning whether or not some or many cases that have been accused of SBS were not the result of mistaken diagnoses, the true causes of death or injury of the child having been vaccines. Since questions surrounding the latent period play a prominent role in many of these cases, it is timely and appropriate to review the background of this issue. Are Current Guidelines in the Latent Period Artifactual? (A) The DTP (diphtheria-tetanus-pertussis) Vaccine: If we think in terms of a vaccine-induced encephalitis, most of the earlier literature deals with the pertussis vaccine. Flexner (1930) noted a strong tendency for the nervous system manifestations to declare themselves between the 10th and 13th days. (7) In a review of 108 cases recorded before 1929 by Gorter (1933) , the onset of encephalitis was " strikingly constant, " usually observed between the 10th and 12th days following vaccination, commonly with a febrile period on the 7th and 8th days, followed by recovery until onset of the encephalitis. (8) In 1929 an editorial in the Journal of the American Medical Association reported on an increase in severe neurological complications following infections and inoculations occurring on about the 11th day after vaccines. (9) Over 50 years later Munoz, (1984) in a mice study of experimental encephalomyelitis elicited by injection of pertussigen, found the same latent period of 11 to 13 days. (10) In contrast, some of the literature since the 1970s has reported an entirely different pattern, with the onset of encephalopathy largely falling within a 3-day period following vaccines. (11-13) We can only speculate as to the reasons for this changing pattern. Perhaps it can be attributed to the fact that, in those early years, children were given very limited numbers of vaccines in comparison with more recent years during which they have routinely received the hepatitis B, H influenza, and polio vaccines in addition to the DTP, all given at the same time. The hepatitis B vaccine has been implicated in neurological disorders, autoimmune disorders, various forms of vasculitis and cutaneous reactions, as well as hemorrhagic complications. (See below, page 6) Both the pertussis and H influenza vaccines have been shown to have unusually high hyper-sensitizing properties. (14) In many vaccines thimerosal, which contains ethyl mercury, has been added as a preservative. (In some vaccines its use dates back to the 1930s.) Thimerosal has also been found to have sensitizing properties. (15) Consequently there are valid reasons for believing that the pertussis and H influenza vaccines, some of which contain mercury, may be acting in a three-way synergy in causing hypersensitivity reactions. In the text, Vaccinations and Behavioral Disorders, by Greg , the author made the following comment in regards to the latent period: " Today the latent period is rarely mentioned in connection with neurological complications of immunization. Contemporary studies on the pertussis vaccine select an arbitrary time limit in which reactions have to occur to be considered as vaccine related. This time limit is usually 3 to 7 days. " Perhaps the only study which explores the dynamics of post DPT reactions is an independent Australian study by Karlsson and Scheibner which, with a monitor which followed breathing volumes, found particular times of stress-induced breathing following DPT injections. " (16) " Of special importance (for stress) are days 2,5,6, and 8,11,13-16 and 18-21. (17) By way of explanation, the above study involved the use of a Cotwatch breathing monitor controlled by a micro-processor and designed to provoke alarms with breathing delays (apnea of hypopnea with 5% or less of normal breathing patterns) following DTP immunizations. It was found in the study that these periods of stressed breathing occurred in clusters of 15 minutes at a time on the post-vaccine days listed above, varying greatly from child to child. From our point of view, the important feature of the study is not so much the specific post-vaccine days on which the stressed breathing occurred but the fact that the clusters continued for 21 days following the vaccines, (18) which would tend to discredit the current medical-legal limitation for DPT reactions to 3 days. Dr. Scheibner's findings do have some support in a study which showed a fairly high incidence of cardio-respiratory complications in premature infants following vaccinations. (19) Unfortunately, this study was of limited duration. Another study throwing light on the latent period is one coming from Japan, from which it was found that increased histamine sensitivity in mice, brought about by the pertussis vaccine, showed two peaks, one on the 4th day following vaccination, and a second on the 12th day. (20) In the same vein, in a letter to the British Medical Journal, Rosemary Fox, secretary of Parents of Vaccine Damaged Children, made the following comments: " Two years ago we started to collect details from parents of serious reactions suffered by their children to immunizations of all kinds. In 65% of the cases referred to us, reactions followed the triple vaccine (diphtheria-pertussis-tetanus). The children in this group total 182 to date; all are severely brain damaged, some are also paralyzed, and 5 have died. Approximately 60% of reactions…occurred within 24 hours of vaccination, 80% within 3 days, and all within 12 days. " (21) It is important to point out in the above-survey that 20% of reactions occurred beyond the current 3 day medical-legal limitation for the DPT vaccine. Another important study throwing light on the latent period involves an unpublished series of 25 cases with accusations or convictions of parents or caretakers for the shaken baby syndrome, a series collected by attorney Toni Blake of San Diego, California (personal communication, 2000) which have the following features: 1) All occurred in fragile infants born from complicated pregnancies. Problems included prematurity, low birth weights, drug/alcohol problems, diabetic mothers, or other maternal complications. 2) All infants were 6 months age or less. 3) Onset of signs and symptoms occurred at about 2,4, or 6 months of age,WITHIN 12 DAYS OF VACCINES, 4) All infants had subdural hematomas. 5) Some had multiple fractures. In addition to the work of Dr Viera Scheibner and attorney Toni Blake, another enlightening area of study for the latent period is the federal Vaccine Adverse Events Reporting System (VAERS). In her book, What Your Doctor May Not Tell You About Children's Vaccinations, (22) Dr. Cave makes the following observations about VAERS: " It is common knowledge that less than 10% of all adverse events following vaccinations are reported to VAERS, which means that instead of the 12,000 to 14,000 reports of hospitalizations, injuries, and deaths made every year, there may be as many as 120,000 to 140,000. " Even a cursory examination of the VAERS database for DTP/DTaP vaccines will reveal that the latent periods for many vaccine reactions extend into the 7 to 13 day periods, some extending beyond 14 days. (23) No review of the latent period would be complete without pointing out an almost insuperable difficulty in getting dependable data on these reactions due to the extreme reluctance of doctors to report on vaccine reactions, a pattern which has existed since the earliest days of childhood vaccines. There are a number of reasons for this. From their earliest years of training, medical doctors have been taught to look upon vaccines as one of the greatest achievements in medical science, and any question about the vaccines is often looked upon as disloyalty to the profession. In addressing this issue in the classic text, Shot in the Dark, by Coulter and Fisher, the authors quoted an attorney specializing in vaccine-damaged children. In commenting on the deficiency in doctors' reporting of vaccine reactions, the attorney commented, " As is the case with many pertussis-vaccine-injured children, none of the treating physicians would commit themselves to a final etiological diagnosis. It is strange that parents of pertussis-vaccine-damaged children often can only get an etiological diagnosis by hiring an attorney and seeing one of the few recognized experts in the U.S. on post-pertussis vaccine encephalopathy. " (25) As a result of this physician-reluctance to report vaccine reactions, large numbers of reactions may be taking place beyond the currently established time limits of the latent period, unrecognized as to their true nature. ( The Hemophilus influenza (HiB) vaccine: In one of the largest, if not the largest randomized epidemiological trial ever conducted, the effect of the Hemophilus vaccine on the development of insulin dependent diabetes mellitus (IDDM) was studied in Finland. (26) All children born in Finland between October 1st, 1985 and August 31st, 1987, approximately 116,000, were randomized to receive 4 doses of the HiB vaccine (PPR-D, Connaught) starting at 3 months of life or one dose starting at 24 months of life. An intent to treat method was used to calculate the incidence of IDDM in both treatment groups until age 10. The incidence of IDDM was also calculated in a control group of 128,500 children which did not receive the HiB vaccine. (27) The results demonstrated a rise in IDDM which was specific for the vaccinated cohort. (28) However, the important point for our purposes was that there was a consistent delay of 3.5 years between vaccination and onset of IDDM. (It should be pointed out that IDDM is considered an autoimmune disease.) At a presentation this past spring in Nashville, Tennessee sponsored by the American College for the Advancement of Medicine, (29) Dr. Classen reviewed 32 publications in the medical literature showing a similar increases in diabetes mellitus in a number of countries with the MMR and hepatitis B as well as the HiB vaccine, again with latent periods up to three years or more, according to graphs that were provided. (Copies of references will be provided on request). Rather than being specific to any one vaccine, Dr. Classen offered his opinion that the general immune stimulation from the vaccines was the cause of a rise in autoimmunity. As an interesting sidelight, Dr. Classen mentioned that personnel in the U.S. navy are more heavily immunized than their European counterparts, and that the U.S. navy personnel have five times more diabetes than their European counterparts. © The MMR (measles-mumps-rubella) vaccine: Whereas DTP and Hib vaccine-related encephalopathy may be the result of interactions between endotoxin and mercury, (the latter in the form of the additive, thimerosal), the primary mechanism of viral vaccines in causing encephalopathy may be related to the propensity of viruses (and viral vaccines) in bringing about autoimmune reactions. (30) In order to provide an overview of the latent period, there are two basic classes of immune systems, the humoral or antibody producing system, which tends to produce immediate-type reactions, and cellular immunity, in which reactions are delayed. Either class is capable of producing autoimmunity. (31) Obviously, the usual 15 day limitation for the MMR vaccine excludes a recognition of the delayed-type autoimmune reactions and, by inference, even denies their existence. In an article by Cohen and Shoenfeld dealing with questions of vaccine-induced autoimmunity, the authors pointed out that it is a subject about which relatively little is known, due to the paucity of clinical and laboratory studies. (32) In point of fact a more recent review on this subject cites a temporal relationship of 2 to 3 months between vaccines and autoimmune reactions. (33) Recently the subject of the latent periods for the MMR vaccine came sharply into focus in an article published in Adverse Drug Reaction & Toxicology Review, (34) in which researchers Wakefield and Montgomery, who have been investigating a possible causal relationship between the MMR vaccine and the autism-enterocolitis syndrome, carefully reviewed deficiencies in the early pre-licensing trials of the MMR vaccine. In the article they pointed out that follow up periods following the vaccine were a maximum of 28 days and in some studies even shorter periods. They stressed that such short periods of observations following the vaccine were totally inadequate to detect delayed reactions, including pervasive developmental delay (autism), immune deficiencies, and inflammatory bowel disease, which are known from earlier published reports to occur following both the natural measles infection and the measles vaccine. The most interesting feature of the Wakefield/Montgomery article was that it was reviewed by four leading British authorities, all of whom had previously held positions in the regulation and licensing of medicines in the United Kingdom. (35) Taken as a whole, the reviewers were supportive of the article, three highly so. Fletcher, formerly a senior professional medical officer for the Department of Health wrote, " being extremely generous, evidence of safety (of the MMR vaccine) was very thin. " Noting that single vaccines for measles, mumps, and rubella already existed, he argued, " caution should have ruled the day " granting of a product license was definitely premature. " Professor Duncan Vere, former member of the Committee on the Safety of Medicines, agreed that the periods for tests were too short. " In almost every case, " he wrote, " observation periods were too short to include the onset of delayed neurological or other adverse events. " (D) The Hepatitis B vaccine: Other than the references provided by Classen, M.D. on the findings of increased diabetes from the hepatitis B vaccine with a latent period of 3 years, I am not aware of additional information bearing on the latent periods between hepatitis B vaccine and other forms of reactions, which reflects the sheer lack of data on the subject. However, many reactions to hepatitis B vaccine may be taking place unrecognized, for two reasons: Reason one, I have in my possession a list of 109 references of published articles reporting on complications from the hepatitis B vaccine including autoimmune disorders, neurological disorders, vasculitis and cutaneous reactions. This list will be provided on request. For reason two, in 1994 a special committee of the national Academy of Sciences (Institute of Medicine) published a comprehensive review of the safety of the hepatitis B vaccine. When the committee, which carries the responsibility for determining the safety of vaccines by Congressional mandate, investigated five possible and plausible adverse effects, they were unable to come to conclusion for four of them because they found that relevant safety research had not been done. Furthermore, they found that serious " gaps and limitations " exist in both the knowledge and infrastructure needed to study vaccine adverse events. Among the 76 types of vaccine adverse events reviewed by the IOM, the basic scientific evidence was inadequate to assess definitive vaccine causality for 50 (66%). The IOM also noted that " if research(is) not improved, future reviews of vaccine safety will be similarly handicapped " . (36) For this reason, the published reports of hepatitis B vaccine reactions may only be a small portion of those actually taking place, with large numbers of delayed reactions taking place unrecognized. Conclusion: Based on published evidence that many vaccine reactions take place beyond current medical-legal time limits that have been established for vaccines, and on overwhelming evidence that large numbers of delayed vaccine reactions may be taking place unrecognized, there are grounds for believing that these time limitations may be unrealistic and artifactual. References: (1) Buttram HE, The National Vaccine Childhood Injury Act - a Critique, Townsend Letter for Doctors & Patients, October, 1998:66-68. (2) TJ, Shaken baby (shaken impact) syndrome; non-accidental head injury in infancy, Royal Soc Med, Nov., 1999; 99:556-561. (3) Weston IT, The pathology of child abuse, in:Heifer RE, Kempe CH, editors, The Battered Child, University of Chicago Press, 1968:77-100. (4) Caffey J, On the theory and practice of shaking infants; its potential residual effects of permanent brain damage and mental retardation, Am J Dis Child, 1972; 124:161-169. (5) Guthkelch AN, Infantile subdural hematoma and its relationship to whiplash injury, Brit Med J, 1971; 11:430-431. (6) Buttram HE, Shaken baby syndrome or vaccine-induced encephalitis?, Medical Sentinel, Fall, 2001; 6(3):83-89. (7) Flexner S, Postvaccinal encephalitis and allied conditions, JAMA, 1930; 94(5):305-311. (8) Gorter E, Postvaccinal encephalitis, JAMA, 1933; 101(24):1871-1874. (9) JAMA (editorial), Postinfectious encephalitis, a problem of increasing importance, May, 1929; 92(18):1523-1524. (10) Munoz JJ et al, Elicitation of experimental encephalomyelitis in mice with the aid of pertussigen, Cellular Immunology, 1984; 83(1):92-100. (11) Menkes JH & Kinsbourne M, Workshop on neurologic complications of pertussis and pertussis vaccination, Neuropediatrics, 1990; 21:171-176. (12) Menkes JH, Neurologic complications of pertussis vaccination, Ann Neurology, 1990; 28:428. (13) Cody CL et al, Nature and rates of adverse reactions associated with DTP and DT immunization in infants and children, Pediatrics, Nov., 1981; 68(5):650-660. (14) Terpstra OK et al, Comparison of vaccination of mice and rats with Hemophilus influenza and Bordetella pertussis as models, Clin Exp Pharmacol Physiol, March-April, 1979; 6(2):139-149. (15) Patrizi A et al, Sensitization to thimerosal in atopic children, Contact Dermatitis, Feb., 1999; 40(2):94-97. (16) Vaccination and Behavioral Disorders, a Review of the Controversy, Greg , Tuntable Creek Publishing, PO Box 1448, Lismore NSW 2480, Australia, 2000, pages 48-49. (17) Karlsson L & Scheibner V, Association between non-specific stress syndrome, DPT injections and cot death, paper presented to the 2nd immunization conference, Canberra, May 27-29, 1991. (18) Vaccination: 100 Years of Orthodox Research Shows that Vaccines Represent a Medical Assault on the Immune System, Viera Scheibner, Ph.D., Australian Print Group, borough, , Australia, 1993, pages 230-235. (19) Pourcyrous M et al, Interleukin-6, C-reactive protein, and abnormal cardiorespiratory responses to immunization in premature infants, Pediatrics, March, 1998; 101(3):461. (20) Horiuchi S et al, Two different histamine-sensitizing activities of pertussis vaccine observed in mice on the 4th and 12th days of sensitization, Japan J Med Sci Biol, 1993; 46:17-27. (21) Fox R, letter, British Med J, Feb. 21, 1976. (22) What Your Doctor May Not Tell You About Children's Vaccinations, Cave, M.D., F.A.A.F.P., Warner Books, An AOL Time Warner Company, 2001, page xvi. (23) VAERS Databases: www.vaers.org, www.fda.gov/cber, or www.fedbuzz.com/vaccine/vacmain.htm (24) Reisinger RC, A final mechanism of cardiac and respiratory failure, SIDS, 1974, Proc of Camps Intern Symp on SID in Infancy; also Congressional Record S. 1745, September 20, 1973. (25) A Shot in the Dark, L Coulter & Barbara Loe Fisher, Avery Publishing Group, Inc., Garden City Park, New York, 1991, Page 47. (26) Classen JB, Classen DC, Association between type I diabetes and Hib vaccine, causal relation likely, British Med J, 1999; 319:1133. (27) Tuomilehto J, Virtala E, Karvonen M et al, Increase in incidence of insulin-dependent diabetes mellitus among children in Finland, Intern J Epidemiology, 1995; 24:984-992. (28) Tuomilehto J, Karonen M, Pitkaniemi J et al, Record high incidence of type 1 (insulin dependent) diabetes mellitus in Finnish children, Diabetologia, 1999; 42:655-660. (29) American College for the Advancement of Medicine, 23121 Verdugo Dr., Ste. 204, Laguna Hills, CA 92653, phone 949-583-7666, fax 949-455-0679. (30) Singh V & V Yang, Serological association of measles virus and human herpes virus-6 with brain autoantibodies in autism, Clin Immunol and Immunopath, 1998; 88(1):105-108. (31) Immunobiology, A Janeway et al, fourth Edition, Current Biology Publications, New York, 1999, page 495. (32) Cohen DC & Shoenfeld Y, Vaccine-induced autoimmunity, J Autoimmunity, 1996; 9:699-703. (33) Shoenfeld Y & A Aron-Maor, Vaccination and autoimmunity-'vaccinosis:' a dangerous laison?, J Autoimmunity, Feb., 2000; 14(1):1-10. (34) Wakefield AJ & S Montgomery, Measles, mumps, rubella vaccine: through a glass darkly, Adv Drug React Toxicol Rev, Jan., 2001; 19(3):1-19. (35) Hurley DR, DW Vere, AP Fletcher, Referee 1, 2, 3, & 4, Adverse Drug React Toxicol Rev, 2001; 19(4): 1-2. (36) Stratton KR, CJ Howe and RB ston, Jr., Editors, Adverse Events Associated with Childhood Vaccines; Evidence Bearing on Causality, Institute of Medicine, National Academy Press, Washington D.C., 1994, pp 211-236. Quote Link to comment Share on other sites More sharing options...
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