Preston Mason, PhD, is still a believer in omega-3 fatty acids’ potential to reduce the risk of cardiovascular events, despite a recent meta-analysis published in JAMA Cardiology that concluded omega-3 supplements demonstrate no such benefit.
In fact, the meta-analysis is “a poster child” for the difficulties of proving the worth of legitimate products, Mason said. Nearly half the products included in the analysis are categorized as dietary supplements, meaning they have less strict regulatory standards. In addition, dosing of omega-3 fatty acids ranged from 226 to 1,800 milligrams per day, below the two to four grams Mason believes are necessary to achieve any therapeutic benefit.
“These companies that sell these prescription products, it’s just the bane of their existence,” said Mason, a biochemist affiliated with Brigham and Women’s Hospital and Harvard Medical School in Boston. “What a challenge to be working in this field when the products out there are just all over the map, and hence the studies that involve these products can have such highly variable results.”
Mason is eagerly awaiting the results of two ongoing trials—REDUCE-IT and STRENGTH—which are evaluating more potent omega-3 compounds for treating high triglycerides with the goal of preventing long-term cardiovascular events.
REDUCE-IT is testing a pure eicosapentaenoic acid (EPA) formulation in combination with a statin and is expected to report results in the third quarter of this year. STRENGTH is testing a compound of EPA and docosahexaenoic acid (DHA), also in combination with a statin, and is estimated to conclude in October 2019. Both trials will include daily doses of up to 4 grams of the key omega-3s.
In the meantime, Mason is attempting to debunk the theory that dietary supplements hailing their omega-3 content are equal to more rigorously tested products—a task that may be more daunting than it initially sounds.
In his presentation on omega-3 supplements at the 2017 American Heart Association (AHA) Scientific Sessions, Mason shared a 2013 poll which showed about 85 percent of pharmacists and physicians who recommended fish oil supplements mistakenly believed they were FDA approved as over-the-counter products. Further, 30 percent of pharmacists and 22 percent of MDs in that study believed prescription and supplement omega-3s were similar in terms of strength and content.
But because dietary supplements are classified as “food,” they don’t require clinical trials and FDA preapproval that even over-the-counter products must meet before becoming available for sale.
“The FDA has watered down these products to avoid oversight. They have very powerful friends in Congress, so they’re classified as a food,” Mason said. “Basically, until you get poisoned, they’re not going to do anything about these products—like any food.”
Mason made it clear that he’s not against all dietary supplements. He takes magnesium and Vitamin C, for example; he just doesn’t believe in unregulated omega-3 products.
His reasons are outlined in the AHA presentation, which he also shared with Cardiovascular Business. Through slick packaging and even outright misinformation, omega-3 supplement manufacturers have managed to make millions of dollars by tricking consumers—and even doctors and pharmacists—into thinking they are getting a quality, prescription-strength product, Mason said.
In a 2017 study, Mason and a colleague looked at the specific components in the capsules of top-selling omega-3 supplements. One pill in particular had 21 percent EPA, 9 percent DHA and 19 percent of one type of saturated fat.
“Saturated fat is not a good idea to be consuming if you have cardiovascular disease,” Mason said.
There is additional proof of misinformation. According to a study out of New Zealand published in 2015, only three of 32 fish oil supplements analyzed contained amounts of EPA and DHA that were equal to or higher than the amount suggested on the label.
Another problem, according to Mason, is dietary omega-3 supplements may contain oxidized or rancid fish oil which actually increase a person’s cholesterol and triglyceride levels, whereas pure omega-3 products at appropriate doses have demonstrated the potential to lower those levels.
The bottom line, he said, is fish oil supplements shouldn’t be considered a safe and effective substitute for omega-3 products that have undergone strict clinical testing and FDA oversight. Likewise, professional medical organizations shouldn’t equate the two groups when making recommendations.
Mason has a different takeaway for consumers.
“If you’re healthy and you’re fine, then it’s probably not going to hurt you,” he said. “But if you’re sick and you really need it, then I have a problem. You should not be taking this. Some people are just throwing away their money. The other people might actually be hurting themselves if they have heart disease.”