Dear FDA Commissioner, Show Empathy and Acknowledge Vax-Autism Link

Scott-Gottlieb.com

According to the FDA Commissioner Scott Gottlieb in his Senate confirmation hearing:

As early as 2002, there was a study in Denmark that looked at 540,000 children and found no correlation.

And in his defense, the study itself does claim:

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.

A Canadian statistician found otherwise. In his letter that was censored by the New England Journal of Medicine and subsequently published in an article that ran in the Journal of American Physicians and Surgeons:

Madsen et al. observed an adjusted rate ratio of autistic disorder after vaccination of 0.92 relative to no vaccination, when the crude rate ratio (my computation) was 1.45 (95% confidence interval 1.08-1.95). Moreover, the rate by time since vaccination increases to a high of 27.3 two years after vaccination (rate ratio 2.5) and decreases thereafter to 11.4 per 100,000 per year (Figure 1).

It is stated that adjustment for age eliminated these rate increases, but the corresponding data are unusual. Indeed, the rates of autistic disorder by age at vaccination, although not the age at follow-up, are 18.9, 14.8, 24.6, 26.9 and 12.0 per 100,000 per year respectively for ages <15, 15-19, 20-24, 25-35 and >35 months. These rates are all above the overall rate of 11.0 for the reference group of no vaccination, over all ages. It is then somewhat implausible for the adjusted rate ratio to fall below 1, unless the risk profile by age in the unvaccinated is vastly different than in the vaccinated (effect-modification). In this case, the adjustment for age could have been artificial. It would be useful then to present rates on subjects 24-29 months since vaccination and on the unvaccinated (crude rate ratio 2.5) stratified by age. Otherwise, one could be tempted to conclude that the figure is in fact suggestive of an association between MMR vaccination and the risk of autism.

Well Dr. Gottlieb, you did say you had empathy for autism families. Do you?

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