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  1. Jul 2018
    1. On 2016 Feb 16, Gary Goldman commented:

      In this second study published 8 months following the first, Moro et al. noted 121 spontaneous abortion (SAB) and 19 stillbirth (SB) reports or a total of 140 fetal-loss reports to VAERS during the first 5 months of the 2009/2010 influenza season. This equates to greater than 57 reports per million (>140/2,437,113) vaccinated pregnant women. The ratio of the 140 fetal-loss reports during the incomplete 2009/2010 season to the 1.21 reports/year representing the mean of the 19 prior seasons, yields a 116-fold (140/1.21) increase in fetal-loss reports (SAB and SB) in the VAERS database. Moro et al. attributed this dramatic increase, in part, to reporting bias, citing a "Weber-like effect." The Weber effect is a temporal reporting pattern whereby the number of reported adverse events (AEs) for a new drug increases during the first 2 years of marketing and then subsequently declines, presumably reflecting decreased enthusiasm for reporting as AEs become well known.

      Despite the statistically significant rate ratio (RR) of 29.4 (95% confidence interval (CI): 19.0–45.8) for 2009/2010 fetal-loss report rate (57 reports/1 million) to the mean rate of 1.9 reports/1 million (over the previous 19 influenza seasons), the second Moro et al. study concluded, "… H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes."

      That this large spike in fetal death case reports to VAERS during the 2009/2010 influenza season was unlikely a mere "Weber Effect" and indeed a concerning pattern among pregnant women is addressed in the Goldman GS study titled, Comparison of VAERS fetal-loss reports during three consecutive influenza seasons: Was there a synergistic fetal toxicity associated with the two-vaccine 2009/2010 season? Hum Exp Toxicol. 2013 May;32(5):464-75. doi: 10.1177/0960327112455067. Epub 2012 Sep 27. Goldman GS, 2013

      A study using a different methodology by Brown and Austin was published in Toxicological & Environmental Chemistry 2012 Sept;94(8):1610-27. Maternal transfer of mercury to the developing embryo/fetus: is there a safe level? DOI:10.1080/02772248.2012.724574 http://www.tandfonline.com/doi/abs/10.1080/02772248.2012.724574 It concluded: "It is, therefore, critical that regulatory advisories around maximum safe Hg exposures account for pregnant women and secondary exposure that children in utero experience. This study focused on standardized embryonic and fetal Hg exposures via primary exposure to the pregnant mother of two common Hg sources (dietary fish and parenteral vaccines). Data demonstrated that Hg exposures, particularly during the first trimester of pregnancy, at well-established dose/weight ratios produced severe damage to humans including death. In light of research suggestive of a mercuric risk factor for childhood conditions such as tic disorders, cerebral palsy, and autism, it is essential that Hg advisories account for secondary prenatal human exposures."


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    2. On 2016 Feb 16, Gary Goldman commented:

      None


      This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.

  2. Feb 2018
    1. On 2016 Feb 16, Gary Goldman commented:

      None


      This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.

    2. On 2016 Feb 16, Gary Goldman commented:

      In this second study published 8 months following the first, Moro et al. noted 121 spontaneous abortion (SAB) and 19 stillbirth (SB) reports or a total of 140 fetal-loss reports to VAERS during the first 5 months of the 2009/2010 influenza season. This equates to greater than 57 reports per million (>140/2,437,113) vaccinated pregnant women. The ratio of the 140 fetal-loss reports during the incomplete 2009/2010 season to the 1.21 reports/year representing the mean of the 19 prior seasons, yields a 116-fold (140/1.21) increase in fetal-loss reports (SAB and SB) in the VAERS database. Moro et al. attributed this dramatic increase, in part, to reporting bias, citing a "Weber-like effect." The Weber effect is a temporal reporting pattern whereby the number of reported adverse events (AEs) for a new drug increases during the first 2 years of marketing and then subsequently declines, presumably reflecting decreased enthusiasm for reporting as AEs become well known.

      Despite the statistically significant rate ratio (RR) of 29.4 (95% confidence interval (CI): 19.0–45.8) for 2009/2010 fetal-loss report rate (57 reports/1 million) to the mean rate of 1.9 reports/1 million (over the previous 19 influenza seasons), the second Moro et al. study concluded, "… H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes."

      That this large spike in fetal death case reports to VAERS during the 2009/2010 influenza season was unlikely a mere "Weber Effect" and indeed a concerning pattern among pregnant women is addressed in the Goldman GS study titled, Comparison of VAERS fetal-loss reports during three consecutive influenza seasons: Was there a synergistic fetal toxicity associated with the two-vaccine 2009/2010 season? Hum Exp Toxicol. 2013 May;32(5):464-75. doi: 10.1177/0960327112455067. Epub 2012 Sep 27. Goldman GS, 2013

      A study using a different methodology by Brown and Austin was published in Toxicological & Environmental Chemistry 2012 Sept;94(8):1610-27. Maternal transfer of mercury to the developing embryo/fetus: is there a safe level? DOI:10.1080/02772248.2012.724574 http://www.tandfonline.com/doi/abs/10.1080/02772248.2012.724574 It concluded: "It is, therefore, critical that regulatory advisories around maximum safe Hg exposures account for pregnant women and secondary exposure that children in utero experience. This study focused on standardized embryonic and fetal Hg exposures via primary exposure to the pregnant mother of two common Hg sources (dietary fish and parenteral vaccines). Data demonstrated that Hg exposures, particularly during the first trimester of pregnancy, at well-established dose/weight ratios produced severe damage to humans including death. In light of research suggestive of a mercuric risk factor for childhood conditions such as tic disorders, cerebral palsy, and autism, it is essential that Hg advisories account for secondary prenatal human exposures."


      This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.