Guest guest Posted November 1, 2003 Report Share Posted November 1, 2003 http://www.redflagsweekly.com/yazbak/2003_nov01_5.html REGRESSIVE AUTISM AND MMR VACCINATION By RFD Columnist, F. Edward Yazbak, MD, FAAP. TL Autism Research Falmouth, Massachusetts E-mail: tlautstudy Part Four here The Yazbak comments (November 2002) It is more than likely that the CDC would not have supported a study in Denmark without being assured, in advance, that the results provided evidence against an MMR-Autism association. My disagreement with the Madsen study was based on the fact, that whatever it proved in Denmark, was not relevant to the situation in the United States. The MMR story in Denmark Based on a Medline search. (27) § Before the MMR was introduced in Denmark (The Campaign), 98% of Danish children aged 9 were immune to measles. § Within two years from the beginning of the campaign, the Health Authorities were concerned about acceptance already. § Almost HALF of the physicians questioned were neither certain about nor comfortable with the MMR vaccine’s efficacy. § Parents were concerned about the adverse effects and efficacy of the MMR § “All practices expressed a positive attitude towards the usefulness of MMR vaccination, but only 56% of the respondents expressed a whole-hearted positive attitude. The average vaccination rate in practices with unreservedly positive attitudes was 85%, compared with 69% in practices with more guarded attitudes.” Note: According to the authors of the study themselves, 18% of children born between 1991 and 1998 did not receive the MMR vaccine. This is quite high. Only 3% of the children in the study had not received the HIB vaccine. Vaccination Practices: USA & Denmark (1991-1998) The Hepatitis B vaccine was not administered routinely to infants in Denmark during the study period. In the USA, the first dose is often administered a few hours after birth; the second at age 1 to 2 months and the third at age 6 to 12 months. Each dose of Hepatitis B vaccine, at the time, contained 12.5ug of ethyl mercury. DTP (or DTAP) and HIB contained each 25ug of ethyl mercury per dose During the period in question, infants in the USA potentially received 12 vaccines in the first six months of life: DTP (DTaP) x3, HIB x3, Polio x3, Hepatitis B x3. [More vaccines are administered now and even more are planned.] Infants in Denmark received 6 vaccines by age 6 months: DTP (DtaP) x2, HIB x2, Polio x2 [The third series was administered at age 12 months] The Potential Ethyl Mercury Load (ug.) Age USA Denmark (1992) 1 day 12.5 0 1 month 12.5 0 2 months 50 0 3 months 0 0 4 months 50 0 5 months 0 0 6 months 62.5 0 The adult “safe” amount of mercury is 0.1µg/kg/day according to the Environmental Protection Agency (EPA). In the United States, a 2-month old infant (4-5 kg) who received the second dose of hepatitis B vaccine with DTP and HIB would be getting 62.5 ug of ethyl mercury or 12-15 ug/kg that day. An infant receiving 187 ug of ethyl mercury through vaccines over 6 months has had an average daily exposure in excess of the EPA adult safe amount. MMR Vaccination The MMR vaccine was almost always administered alone, at age 15 months, in Denmark. In the U.S., the MMR was administered at age 12 months, frequently with the chicken pox vaccine and the last dose of HIB and Hepatitis B vaccines. Again, both Professor Spitzer and I based our critiques (above) of the study from Denmark only on information and data published by the authors in the NEJM in November 7, 2002. The Danish investigators reviewed information on a group of children born between January 1991 and December 1998, and who would be therefore 5 to 12 year old now. They stated: “ Results Of the 537,303 children in the cohort (representing 2,129,864 person-years), 440,655 (82.0%) had received the MMR vaccine. We identified 316 children with a diagnosis of autistic disorder and 422 with a diagnosis of other autistic-spectrum disorders. After adjustment for potential confounders, the relative risk of autistic disorder in the group of vaccinated children, as compared with the unvaccinated group, was 0.92 (95 percent confidence interval, 0.68 to 1.24) and the relative risk of another autistic-spectrum disorder was 0.83 (95 percent confidence interval, 0.65 to 1.07). There was no association between the age at the time of vaccination, the time since vaccination, or the date of vaccination and the development of autistic disorder. Conclusion This study provides strong evidence against the hypothesis that MMR vaccination causes autism”. The vaccine authorities widely publicized the results of the research and reassured everyone that the “Danish Study” had proved that the MMR vaccine did not cause autism, not only in Denmark but elsewhere also. Feeling that they had won that battle and considering the subject closed, the researchers from Denmark turned their attention to Thimerosal in vaccines and published a study on the subject. They were immediately confronted by an informed group of parents who found serious problems with their data. While preparing this presentation, I decided to review any available autism statistics from Denmark. The following important analysis is lengthy and detailed; it is intended for parents as well as professionals. To the best of my knowledge, this information has not been published to date. Examination of the autism data from the Danish Psychiatric Central Register reveals that there has been a serious increase in autism in children under 14 in the last few years. (Graph II). Graph II Incidence of Autism in Denmark by Age Group Source The Danish Psychiatric Central Register. The MMR vaccine was introduced in Denmark in 1987. It has been estimated that only 70% of the 15-month old children received the MMR vaccine in 1987-1988. The percentage of vaccinated toddlers then reached and remained at 80 to 88% for several years. It is estimated that in the last two to three years, about 95% of the 15-month old children in Denmark received the MMR vaccine. The present rise in autism in Denmark appears to have started 4 to 5 years after the introduction of the MMR vaccine. It also appears to correspond with the percentage of children who received the MMR. The mean age at the time of diagnosis in Denmark is probably around 4.7 years (“The mean age at diagnosis for autism was 4 years, 3 months, and for autistic spectrum disorders 5 years, 3 months. " ) This would be compatible with the following analysis. Looking at the mean value of autism incidence for 2002-2003, there are approximately 70 cases per 100000 among 5 to 9 age group 41 cases per 100000 among 0 to 4 age group 35 cases per 100000 among 10 to 14 age group 16 cases per 100000 among 15 to 19 age group If all 4 age groups under the age of 20 are combined, there are 162 [70+41+35+16] individuals with autism per 100000. By computing the percentage contribution of each age group we find that: 43% of cases of autism are diagnosed in the 5 to 9 age group 25% of cases are diagnosed in to 0 to 4 age group 22% of cases are diagnosed in the 10 to 14 age group 10% of cases are diagnosed in the 15 to 19 age group When one looks for further validation at the percentages in 1998 (the last year examined by Dr. Madsen), similar findings are noted: 39% among 5 to 9 age group 26% among 0 to 4 age group 19% among 10 to 14 age group 17% among 15 to 19 age group In summary, using the 2002-2003 mean values (1st set of percentages above) we find that about 25% (1/4) of autism cases in Denmark are reported under the age of 5 and the remainder 75% (3/4) of affected children are reported when they are 5 to 19 years old. The 2,129,864 person-years reported in the Madsen study divided by the number of children 537,303 indicates that the average age of the children in the study is less than 4 years (range 1 to 7 years). Those children would be 5 to 12 years old in 2003. Because the mean age at diagnosis is 4.7 years in Denmark, the Madsen study could NOT have detected many of the cases of autism that were subsequently diagnosed when these children were older, thereby missing the connection between MMR vaccination and autism. The 0-4 year old group of children (Graph II, black) remains the lowest from 1980 to 1991, because autism was/is rarely diagnosed under the age of 4 in Denmark. The prevalence of autism in that age group starts climbing after 1991, 4 years after the introduction of the MMR vaccine, to become the second highest by 1993 but it always remains distinctly lower than in the 5 to 9 year old group. The 5-9 age group is the earliest cohort to first receive the MMR vaccine after coverage has improved and is also old enough to be diagnosed. That group (red) is the largest all along and the spread between it and the next older age group increases with the passing years. The 10-14 age group (dark green) represents the earlier cohort that first received the MMR vaccine, but at lower coverage rates. . Those affected children aged 10 to 14 in 2003 were aged 1 to 5 in 1994. They reflect the startup of the autism increase associated with the startup and progression of the MMR vaccination program. The 15-19 age group (light green) were aged 1 to 5 in 1989; their number increases but at a much slower rate than in the younger age groups. Lastly, the 20-24 age group (brown) shows only a slight increase starting in 1994 possibly because few if any of this cohort received the MMR vaccine at a vulnerable age. Looking at data similar to that used in the Danish study, but with five additional years added, appears to invalidate the conclusions of the Madsen group and to support the hypothesis, that increases in autism in Denmark, may be correlated with increases in percentage coverage and number of children receiving MMR vaccination. It is likely that in Graph II, the 0-4 year group of affected children represents those who were not generally diagnosed earlier, that the 5-9 age group represents the highest increase which occurred after wide-spread coverage of the MMR vaccine and that the 10-14 age group represents the earlier cohort that first received the MMR vaccine, but at a low coverage rate. It is possible that the rate of autism will now level off at the higher rate since children receiving MMR immunization have now saturated the age groups and replaced individuals in the age groups that were previously unvaccinated. Around 65,000 babies are born every year in Denmark. Graph II shows the early slow ramp-up period due to low vaccination rates as my literature review had suggested. (28). When MMR vaccination coverage improved beyond a certain level, from 1993 to 2001, there was a steady and increasing trend in autism yearly. That gradual rise leveled out after the entire cohort aged <10 was almost completely vaccinated (vaccine coverage at >95%). One must keep in mind that many of the children of the most affected 5 to 9 group, could have started with symptoms as early as the second year of life. The prevalence rate of autism in Danish children under the age of 14 has increased by 729% from 17.67 per 100,000 Population in 1980 to 146.42 in 2002. (Graph III) Graph III Children with Autism under Age 14 In Denmark per 100,000 Population. Source The Danish Psychiatric Central Register. The prevalence of autism in children and teens under the age of 14 in Denmark, which was 131.42/100000 in the 7 years before the MMR vaccine, increased by 542% to 843.73/100000 in the last 7 years. Indeed, the prevalence of autism in that group was 11% higher (146.42/131.42) in 2002 alone than in the combined 7 years before the introduction of the MMR vaccine. Two doses of MMR are administered in Denmark, one at age 15 months, and one at age 12 years. (29) The data suggest that the main concern is the vaccination given at age 15 months. The prevalence of autism in Denmark in the 0 to 14 year-olds leveled off in the last 3 years, when toddler MMR coverage reached the 95-98% level. The reason why this did not take place in the United States in the 90’s (Graph I) may have been because pediatric vaccines in the US contained Thimerosal, further supporting the argument that countries with strikingly different vaccination practices should not be compared. In summary: I: The Madsen study, as designed, could NOT have detected an increase in Autism in Denmark after MMR vaccination. II: Autism HAS INCREASED in Denmark after the introduction of the MMR vaccine. The rate ratio (incidence of autism after vs. before MMR vaccine) is 8.8 (95% C.I., 6.3 to 12.1) among 5 to 9 year olds. III. Honest, accurate and unbiased clinical studies are needed. Parents must be interviewed and children must be examined and thoroughly evaluated. Looking at databases is not the answer. Questions and Parting Thoughts There are two questions for Dr. Madsen Why did an autism study involve an age group that was so young, when it was well known that the majority of cases were diagnosed at a later age? If the MMR vaccine is not responsible for the more than 700% increased prevalence in pediatric autism in Denmark after 1992 then what is? There is only one question for the CDC Director: “When will the CDC sponsor and support clinical studies of autism? * * * The health authorities in Denmark should take a close look at the autism situation. If autism is due to an autoimmune problem and if indeed a brain-gut relationship exists, then delaying the diagnosis to age 4 or later is unacceptable. Early strict diet management and intensive ABA have been clearly associated over the years with improved outcomes. It is clear that there are many problems with several anti-Wakefield studies. It is unfortunate that so much faith was put in their conclusions. The Wakefield hypothesis remains valid and ongoing results and replications are encouraging. The blind acceptance of the anti-Wakefield studies has resulted in a dangerous situation. The health authorities and the research community, by accepting their conclusions at face value, are essentially saying that a vaccine-autism connection does not exist and that scientists should stop looking. If the authorities are wrong in their assumption and if Dr. Wakefield is correct, even greater harm to our children may be occurring. In the UK, believing these same flawed studies that deny an MMR-Autism link has just resulted in the cancellation of legal aid funds necessary for a class action suit. The research that would have been revealed in Court has thus been snuffed. Only £10m ($15m US) more was needed to see the parents’ legal case through to conclusion; this amount represents the approximate cost for lifetime care for only four children suffering from severe autism. The UK Government has been spending considerably more money on a propaganda campaign to defend the MMR vaccine than it has on autism research. In January 2002 funds were promised for autism research as long as it did not involve the MMR vaccine. To date, not a single study has been launched. At his annual report on July 3, 2003, Sir Liam Donaldson, the UK Chief Medical Officer, did not even mention autism His five priorities at present were the health risks of second-hand smoke, West Nile virus, obesity, poor clinical performance by physicians and the safe administration of intrathecal chemotherapy. This year, the CDC has spent immensely more time discussing SARS in China than it has looking at the causes of this true epidemic of autism. 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