The report was issued recently by the National Association of Boards of Pharmacy. Its title: “Risky Dietary Supplements: How Pharmacists Can Help Protect Patients” is a clear signal of the tone of document.
Report puts bad actors under magnifying glass
The report openly focuses on the bad actors in the dietary supplement industry. No one can say with certainty how big a percentage of the overall industry falls into this group, but most experts agree that it is a very small number.
Nevertheless, the board report informs pharmacists that these products can pose an outsized risk.
“Misbranded and adulterated dietary supplements put patients at risk. For example, a cancer patient may forego medically necessary treatment when presented with a supplement that is marketed as a chemotherapy alternative. An adulterated supplement may contain dangerous substances that result in serious adverse health effects. These risks are not merely theoretical. According to researchers, herbal and dietary supplement-induced liver injury now accounts for 20% of hepatotoxicity cases in the United States,” the report notes.
The report contains a brief overview of federal regulation of dietary supplements, then delves into a discussion of several products categories of concern and common illegal and/or adulterated ingredients that can be found within them. The product categories are sexual enhancement, sports performance, weight loss, muscle building and cognitive enhancement. The report highlights some illegal ingredients that can be found in such products including erectile dysfunction APIs, sildenafil (a former weight loss drug), DMAA and others.
CRN: More education could broaden pharmacists’ views
Steve Mister, president and CEO of the Council for Responsible Nutrition, said the report takes a narrow view of the supplement industry
“The report is a little bit alarmist in that it focuses on some very narrow problems, at the expense of not looking at the benefits that supplements supply to a lot of people,” Mister told NutraIngredients-USA.
Mister said the industry has more work to do to educate pharmacists on the wide array of compliant products on the market that are made to high quality standards. While the horror stories do exist, and bad products could be found if a consumer digs hard enough, such items are not sold in pharmacies.
Mister said for a number of years now CRN has been involved in reaching out to pharmacy groups to offer education on the risks and benefits of dietary supplements. Mister noted that the NABP has observer status in the Dietary Supplements Quality Collaborative (DSQC), as does the Purdue University School of Pharmacy.
Pharmacist: Risk is low for products purchased from above board channels
Pharmacist Alex Berce, owner of Good Value Pharmacy, a six-location chain of independent stores in southeastern Wisconsin, said he relies on the quality of the brands of supplements he has stocked in his stores for years. There is little risk to patients when buying products in this way, he said. Out in the real world, the issue can look different, he said.
“We have certain brands that we trust that don’t make those kinds of risky products. We trust their manufacturing procedures,” he said.
“I think if you are buying from non traditional sources there certainly could be a risk. I think the Internet is a bad place to search for and buy products unless you really know what you are looking for,” Berce added.
Kingston: Focusing on illegal products unfairly impugns industry
Rick Kingston, PharmD, is an authority on how pharmacists are educated about dietary supplements. Kingston, who is a professor at the University of Minnesota School of Pharmacy, said the course he teaches on the pharmacology of natural ingredients is one of the few taught at any school in the United States. And, what’s even rarer, it’s about the only one that focuses on these substances as potentially beneficial in and of themselves rather than as a source of new drug ingredients.
Kingston is also president of scientific and regulatory affairs at SafetyCall International, a firm that helps manage adverse event reporting and product recalls for dietary supplement and drug manufacturers. As such, he’s well versed in the true risk that supplements present, or, more accurately, the relative lack thereof.
“Really the name of the report should have been how pharmacists can safeguard patients from illegal dietary supplements. We need to change the narrative,” he said.
“What’s missing in this analysis is context. What is being described as risks associated with dietary supplements is simply a description of criminal activity that results in adulterated and illegal supplements getting into the hands of consumers. They could just as easily be discussing the risks associated with counterfeit and adulterated drugs which we know is also a huge issue. Yet, when that issue is discussed, it does not include an admonishment against all properly manufactured drugs that are not affected,” Kingston said.
Discredited ER visits study makes another appearance
Kingston especially took issue with the mention in the report of the number of and rising tide of emergency room visits associated with the use of dietary supplements. The NABP report cited a paper that was published in the New England Journal of Medicine in 2015 that many in the dietary supplement field believe to have been thoroughly refuted. Just citing alarmist numbers, such as 23,000 ER visits linked to dietary supplements, without a proper statistical framework is tantamount to fear mongering, Kingston said.
“I also don’t think the citing of the ER study utilizing NEISS data to support their assessment of risks associated with dietary supplements as a whole holds any water. First, the incredibly low number of ER visits compared to the national consumption of supplements is noteworthy. Secondly, in that study there was no analysis of any supplements to determine if adulterated products put into the market illegally were the cause of any adverse effects resulting in a consumer seeking care in an ER. Lastly, the study provided no medical outcome for the ER visits that occurred,” Kingston said.
“A large number of those involved accidental exposure by children that did not result in adverse effects, and only warranted evaluation and observation as a precaution,” he added.