A two-phase study evaluating the relationship between Thimerosal-containing vaccine administration and the risk for an autism spectrum disorder diagnosis in the United States

Background:Autism spectrum disorder(ASD)is defined by standardized criteria of qualitative impairments in social interaction,qualitative impairments in communication,and restricted and stereotyped patterns of behavior,interests,and activities.A significant number of children diagnosed with ASD suffer a loss of previously-acquired skills,which is suggestive of neurodegeneration or a type of progressive encephalopathy with an etiological pathogenic basis occurring after birth.To date,the etiology of ASD remains under debate,however,many studies suggest toxicity,especially from mercury(Hg),in individuals diagnosed with an ASD.The present study evaluated concerns about the toxic effects of organic-Hg exposure from Thimerosal(49.55%Hg by weight)in childhood vaccines by conducting a two-phased(hypothesis generating/hypothesis testing)study with documented exposure to varying levels of Thimerosal from vaccinations.Methods:A hypothesis generating cohort study was undertaken to evaluate the relationship between exposure to organic-Hg from a Thimerosal-containing Diphtheria-Tetanus-acellular-Pertussis(DTaP)vaccine in comparison to a Thimerosal-free DTaP vaccine administered,from 1998 through 2000,for the risk of ASD as reported in the Vaccine Adverse Event Reporting System(VAERS)database(phase I).A hypothesis testing case–control study was undertaken to evaluate the relationship between organic-Hg exposure from Thimerosal-containing hepatitis B vaccines administered at specific intervals in the first six months of life among cases diagnosed with an ASD and controls born between 1991 through 1999 in the Vaccine Safety Datalink(VSD)database(phase II).Results:In phase I,it was observed that there was a significantly increased risk ratio for the incidence of ASD reported following the Thimerosal-containing DTaP vaccine in comparison to the Thimerosal-free DTaP vaccine.In phase II,it was observed that cases diagnosed with an ASD were significantly more likely than controls to receive increased organic-Hg from Thimerosal-containing hepatitis B vaccine administered within the first,second,and sixth month of life.Conclusions:Routine childhood vaccination is an important public health tool to reduce the morbidity and mortality associated with infectious diseases,but the present study provides new epidemiological evidence supporting an association between increasing organic-Hg exposure from Thimerosal-containing childhood vaccines and the subsequent risk of an ASD diagnosis.

The Role of Medical Literature, Clinical Trials and Experimental Research in Drug Product-Injury Litigation: A Primer with Two Examples

When any type of product has been ordered to be removed from the marketplace by a governmental regulatory body, that action is a powerful indicator that the product has been determined to be unsafe for further use, thereby branding the product as defective and opening up the possibility of product liability litigation. When the product is a drug or medical device, it is especially serious since the possibility of personal injury (acute and/or chronic) or death may occur. Needless to say, in these situations, product injury litigation will almost surely follow. We review the definition and requisite claims needed to establish drug product liability, and the role that the medical literature, clinical trial data, and even experimental research data can play in product (drug)-injury litigation. We show how each of these resources played a significant role in two well-known cases: Fen-Phen and thimerosal. The ultimate goal of such knowledge is to make better informed decisions about drug safety.

Difference of the Pain during the DPT (Diphtheria-Pertussis-Tetanus) Vaccination

Background: The objective of this study is to determine whether analyze of the infant’s pain associated with diphtheria-pertussis-tetanus (DPT) immunization is useful for vaccination in children. It is not known whether the immunization pain can be prevented with the adequate choice of DPT vaccines among several manufacturers in Japan. Further, it is not clear whether the difference of the reaction during vaccination between gender and age. Design: Three manufacturer’s Japanese DPT vaccines were used in this study. The parents assessed their infant’s pain on a modified visual analogue scale (MVAS), the start of the crying and total crying time during the immunization. Results: The A manufacturer’s DPT vaccine was significantly lower on the proportion of crying, the duration of crying and MVAS score than the other two manufacturer’s DPT vaccines. The proportion of crying, the duration of crying and MVAS score was lower in the boy than in the girl. On the other hand, it had not found the difference of their reactions with age. Conclusions: Our studies have found that the adequate choice of DPT vaccine decreased vaccination pain. The studies also indicate that some tendencies with vaccinations were shown in children. To consider these tendencies was useful in performing less painful vaccination.