Industry stakeholders say call for separate adverse event system for military is misguided

The editorial appeared last week in the Military Times​​​, a site maintained by the Department of Defense.  The editorial was written by a team led by Dr Melissa Givens, MD, who is the executive director of the Consortium for Health and Military Performance at the Uniformed Services University.

The editorial follows on the heels of a survey of adverse events among supplement users in the military.​​  That survey reported that as many as 18% of users had suffered an adverse event.  The methodology of that report was questioned by Rick Kingston, PharmD, who is the head of scientific and regulatory affairs at Safety Call International, a firm that helps supplement manufacturers and pharmaceutical firms manage adverse event reporting and product recalls.  Kingston is also a professor at the University of Minnesota’s School of Pharmacy.

Authors: Supplements can contain unsafe ingredients

In the Military Times​ editorial, the authors questioned whether supplement use could  compromise service readiness.

“Many of these supplements contain ingredients that could make them dangerous to the very service members we depend on to keep our nation safe,” ​they wrote.

The article asserts that supplement use among the military is higher than among the general population.  The categories that active service members go for the most are also those listed as areas of special concern by the US Food and Drug Administration: bodybuilding, energy or pre-workout and weight loss supplements. These are high on soliders’ lists because of the demands their profession makes on their bodies, the authors said.  But they also attributed the popularity of these categories to “predatory marketing.”​

The authors note that the most recent defense spending bill that became law at the end of 2021, "For the first time includes reporting language from both the Senate and House committees urging the Department of Defense to address the gap in reporting of dietary supplement-related adverse events.”​

"Adverse event reporting on dietary supplements in the Department of Defense would inform both the military health system and the FDA about potential health risks, which would have a beneficial impact on patient care, public safety, and mission readiness,”​ the authors argue.

Robust AER system already exists

The issue, from Kingston’s standpoint and that of Steve Mister, president and CEO of the Council for Responsible Nutrition, is that such a system already exists and functions well.  Dietary supplement manufacturers are required by law to collect adverse event reports and forward the serious ones on to FDA.  It’s unclear how a parallel DoD system would improve that picture.

“Ensuring that supplement adverse events involving military personnel are reported to the FDA is a noble cause.  The question is whether or not creating a new system just for military personnel would help or hinder FDA’s existing safety surveillance system.  Currently, FDA already maintains a robust AER system which includes reports of AEs made directly to the Agency as well as AEs reported to manufacturers,”​ Kingston said.

Serious AEs are generally described as those that require some sort of medical attention, ranging up to serious injuries and death.  Supplement manufacturers are required to investigate all of the AERs they receive to determine if they rise to that level and to forward the serious ones on to FDA within 15 business days.

“The current federal adverse event reporting system (AER) administered by FDA works. Creating additional federal bureaucracy to duplicate this effort inside the military is counterproductive and wasteful,”​ Mister noted.

“​Duplication of the effort by having the military maintain their own separate database would likely fracture versus enhance the existing system of post market surveillance.  It would also leave out the manufacturer who is in the best position to evaluate AEs and take action if their product poses a risk to consumers,”​ Kingston argued.

How can AER system be improved?

“​That said, there may be ways to enhance AE reporting not only for military personnel but for all consumers.  One option is a mandatory product listing for supplements which would make it easier to track specific products and also identify misbranded and/or adulterated products.  This option is strongly supported by a number of supplement trade associations,”​ Kingston noted.

One of those is CRN.  

“CRN supports ​mandatory product listing​, which will allow FDA to see all supplement labels and identify potential problems. Our members share our commitment to transparency and are required to submit information on all the products they manufacture and market in the ​Supplement OWL​.  Adding a redundant regulatory mechanism likely won’t address the underlying problem of spiked products, and would be a disservice to our military,”​ Mister said.

Response from authors of Military Times article

By: Melissa Givens, Andrea T. Lindsey, Allison Ivie, S. Bryn Austin, Patricia A. Deuster

Mr. Schultz is correct in noting in the recent article dated 13 Feb 2022 that a separate adverse event reporting system for dietary supplements within the military should not be separate from what now exists. As authors of the article, we did not state that there should be a separate system. Rather the intent is to have an easily accessible way for medical providers in Department of Defense (DoD) to report adverse events associated with dietary supplements in their normal workflow, i.e., the electronic health record (EHR). Then, that information could be sent directly to the already existing Food and Drug Administration reporting system or later exported to that system for comprehensive pooling of data.

Why does the DoD need a centralized reporting system in the military for adverse events caused by dietary supplements? First, research shows that the majority of military providers have seen an adverse event in association with dietary supplements, yet less than 2% are currently reported to the FDA and most go unreported. Reporting takes time and having it part of the regular workflow in the EHR will be the easiest way to capture the information. Being able to regularly review reports would allow the DoD to more quickly identify risky products and avert other avoidable negative consequences in Service Members. The current EHR does have the appropriate structure to easily report, review, or track adverse events. The language from both committees of the National Defense Authorization Act (NDAA) of 2022, signed into law by President Biden December 27, 2021 brought this issue to the forefront and the Military Health System and the Operation Supplement Safety Team are collaborating with our federal stakeholders for a common solution.

OPSS is a program under the Consortium for Health and Military Performance at the Uniformed Services University of the Health Sciences.