Egregious Errors in AER Monitoring

WASHINGTON--A new analysis reiterates there are errors and questionable data in the frequency and severity of adverse events related to dietary supplements reported in the Special Nutitional/Adverse Event Monitoring System (SN/AEMS) database (J Orthomol Med, 22, 1, 2007). After analyzing each case reported, Alexander G. Schauss, Ph.D., director of life sciences, American Institute for Biosocial and Medical Research Inc. (AIBMR), found the innaccurate and misleading errors a risk to public health policy. He listed 10 of the most serious in a report to the Food and Drug Administration (FDA) and National Institutes of Health (NIH). Schauss stated: In reviewing the data in SN/ AEMS, deaths were attributed to company products the companies in question did not manufacture or market. Other deaths reported were improbable and should not appear in the SN/AEMS unless there is good evidence of possible association. Deaths were attributed to vitamin C and E, never in my 30 years as a professional have I seen death due to either vitamin C or E, he said.

Another adverse event profile attibuted nine deaths to a variety of products from one company. The company had never heard of even one death related to any of their products. Multiple deaths were also reported for several individuals, one of whom, according to AEMS, died 11 times. Another error included lack of information. For nine cases of death attributed to a dietary supplement, no information is provided about the name of the manufacturer or the ingredients in the product, Schauss report stated.