The omega-3 industry will continue its efforts to overcome unfairly negative messaging about omega-3 ingredients and to highlight positive findings.
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Upswings and downswings are not unusual for popular nutritional ingredients, especially one as high profile as omega-3 fatty acids. Omega-3s, a mainstream success story, are as beloved by many as they are fiercely criticized by those who underline clinical trials with negative or null results as point-blank evidence that omega-3 supplementation does not yield health benefits. The story, of course, is never that simple. Unfortunately, newly published omega-3 clinical studies are often the subject of splashy black-and-white media headlines that often fail to delve into gray area or the intricacies of any positive findings around omega-3 supplementation. Thus the story will continue in 2019, with the industry’s biggest omega-3 advocate, the Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City, UT), continuing to fight to overcome any unfairly negative messaging about omega-3 ingredients and, often, to help the public read between the lines and understand a study’s less-publicized takeaways.
Omega-3s actually had a lot to celebrate last year, with long-awaited results finally coming in from REDUCE-IT1 (Reduction of Cardiovascular Events with EPA Intervention Trial). This trial, on Amarin Pharma’s omega-3 EPA drug, Vascepa, was a large-scale, 8179-subject, five-year clinical trial that looked at any omega-3-based effects on reducing long-term cardiovascular events in dyslipidemia patients on statins. Researchers saw statistically significant 25% risk reduction in major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction (heart attack), and nonfatal stroke. This big study, showing big effects, was celebrated by health practitioners, media, and the omega-3 industry alike.
Two other primary, large-scale omega-3 studies showed some benefits from omega-3, but garnered mixed headlines. One of those was the VITAL study2 (Vitamin D and Omega-3 Trial), a 25,871-subject, five-year study on the effects of lipid-regulating EPA+DHA omega-3 drug Omacor plus vitamin D on reducing the risk of major cardiovascular disease (CVD) events. The study did not show statistically significant effects related to the primary outcome of reducing major CVD events, nor did it show benefits for another study objective, the prevention of cancer. While media coverage of VITAL was mixed, GOED pointed to some important, statistically significant positive takeaways, including: a 28% risk reduction in myocardial infarction and a 17% risk reduction in coronary heart disease, with greatest reduction seen in African American subjects and those with low dietary fish intake. While some media outlets called the study results “disappointing,” GOED actually called the results “better than expected,” considering the study’s extremely high bar, including the prevention of cancer.
Another study out last year, the ASCEND study3 (A Study of Cardiovascular Events in Diabetes), also saw mixed media coverage. The 15,480-patient, seven-year study examined whether omega-3 fatty acids helped prevent serious vascular events in diabetes patients. The study found no statistically significant differences in the risk of serious vascular events between the supplementation and the placebo group; however, GOED pointed out that there was an 18% statistically significant reduction in risk of vascular death in the omega-3 group compared to the placebo group.
These three, large-scale trials commanded attention last year, even as there were other publications, positive and negative, that yielded headlines of their own. These included a negative-and controversial-Cochrane Review4, which GOED and many in the omega-3 industry criticized on many fronts; a positive Cochrane Review5 showing that prenatal omega-3s reduce the risk of premature birth; a new, largely negative book on fish oil, The Omega Principle, by environmental author Paul Greenberg; and a balanced, objective review6 of omega-3 research and design issues, issues that the industry and GOED have pointed out limit the results of many large-scale omega-3 clinical trials.
Any positive findings from recent studies, even less-publicized ones, add to what we know about omega-3 fatty acids, points out Chris Gearheart, GOED’s director of member communications and engagement: “What’s important is that the three above studies together”-REDUCE-IT, VITAL, and ASCEND-”strengthened the body of evidence supporting omega-3s’ effect on cardiovascular outcomes, particularly myocardial infarction and coronary heart disease.”
Harry Rice, PhD, GOED’s vice president of regulatory and scientific affairs, says: “First, while there are a whopping 4,000-plus published clinical trials on using omega-3s as a treatment, the reality is that we are still learning a great deal with each study that is published. Each year, our knowledge base grows. Many of the studies not reporting positive results were designed many years ago, before we had the advantage of our current understanding. I think our most recent learning, which we’ve suspected for a number of years, is that dose really matters and that if you don’t provide enough EPA/DHA, you aren’t going to move the needle and demonstrate a positive effect on the intended outcome(s) of interest. Second, because of shrinking research budgets, corners on experimental design have been cut, which has resulted in insufficiently powered (i.e., too few subjects) clinical trials.”
Many consumers and healthcare providers find themselves pushed/pulled by the controversial media coverage on omega-3s when trying to decide if omega-3 supplementation is beneficial. This is where GOED’s new education campaign comes in. Last year, the association announced a new website and series of campaigns geared at teaching health practitioners-including nurse practitioners, physician’s assistants, and pharmacists-about the myriad health benefits of omega-3s. The association also continues to maintain its www.AlwaysOmega3s.com consumer education website.
GOED will continue to try to provide a balancing voice in the media. “It’s unfortunate that we are forced to fight the messaging war in the media, as dissecting the science does not easily fit into media headlines or Twitter posts,” Gearheart says. “GOED’s plan is to continue to highlight positive studies and parse out the nuances of seemingly neutral studies. We share this information with our network of reporters and consumer influencers in the nutrition space in hopes that consumers will at least see a balanced story in all of the coverage.”
In addition to anticipating new research-and new headlines-on omega-3s in 2019, Rice says GOED continues to keep its eye on potential regulatory developments that would be important to the industry, including: 1) an FDA decision regarding a GOED petition for a qualified health claim linking omega-3s to blood pressure management, 2) a possible review of omega-3 supplementation by the U.S. Dietary Guidelines Advisory Committee, and 3) a proposal in Egypt to adopt the Codex Standard for Fish Oils as its own. Keep all these potential developments on your radar in 2019.
As for further industry developments in 2019, Gearheart says: “The market potential for omega-3s varies considerably on a global basis, with the largest growth coming from the Asia region. In the U.S., concentrates will continue to grow, primarily at the expense of 18:12 oils. The success of REDUCE-IT and VITAL should help spur ongoing interest in omega-3s overall. The availability of additional algae offerings will also aid growth of the category for vegetarians or those with fish intolerances.”
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