Recently, Harvard researchers conducted a study involving dietary supplements, later published in the Journal of Adolescent Health, to review adverse event reports from January 2004 to April 2015 using data from the FDA Adverse Event Reporting System (FAERS). The FAERS is a database that contains line listings of select fields of data from Adverse Event (AE) reports contained in the FDA database. These listings do not contain analyzed data or a determination of causation related to the products in each report and a substantial amount of data from the original reports are omitted.
During the study, Harvard found 977 single-supplement AE reports that affected people ages 0 to 25. In total, there were 166 reports involving hospitalization, 39 with life threatening events, and 22 that reported a fatality. Based on their review the authors concluded that the highest risk supplement categories were for weight loss, muscle building, and energy.
There was substantial coverage of the article including stories from media outlets such as NBC, MedScape, and Cosmos which all ran articles that warned of the supposed dangers of these dietary supplements specifically among children and teenagers.
In response, experts and scientists in the field took a critical view of the paper and various related statements. One of the AER professionals who commented on the study was SafetyCall International’s President, Regulatory and Scientific Affairs /Senior Clinical Toxicologist, and Clinical Professor of Pharmacy, University of Minnesota, Dr. Rick Kingston.
Dr. Kingston explained that these adverse events are typically spontaneously reported incidents direct from consumers and frequently have very little if any corroboration by medical professionals. He also emphasized that for the data that was analyzed in the study, significant elements of the original reports were not included as part of the analysis. Key details such as case narratives, quantity of exposure, and existing medical conditions were among the data fields not accessed as part of the data analysis. Additionally, none of the reported incidents included any assessment by FDA officials as to the accuracy, completeness or significance of the reported events.
Other experts in the field weighed in on the analysis with general agreement regarding the study limitations and how it was conducted. When comparing the number of incidents to the volume of supplements used, adverse reactions make up a very small number. The call by the study authors to further regulate the category was simply not supported by the data.
The data that was cited in the study is best described as beneficial for high level signal detection, not determining or confirming causal links. Dr. Kingston summarized it well stating, “You don’t apply statistical data to hearsay, it looks really high-tech but means nothing”.
To read more of Dr. Kingston’s and other health professional’s statements regarding the topic follow this link: https://www.nutraingredients-usa.com/Article/2019/06/06/You-don-t-apply-statistical-analysis-to-hearsay-AER-expert-slams-new-Harvard-analysis
Source: Daniells, Stephen. ‘You don’t apply statistical analysis to hearsay’ AER expert slams new Harvard analysis. Nutra ingredients-usa.com[Internet]. William Reed. 2019, Jun 6 [cited 2019 Jun 13] Available from: https://www.nutraingredients-usa.com/Article/2019/06/06/You-don-t-apply-statistical-analysis-to-hearsay-AER-expert-slams-new-Harvard-analysis