FoundMyFitness · 2021-12-07 · Rhonda Patrick (host), Bill Harris
Dr. Bill Harris on the Omega-3 Index: Increasing Omega-3 to Promote Longevity & Transform Health
74 research-tied claims examined: 3 contradicted 1 overstated 4 context 61 supported 5 unverified
3 Contradicted by research
FDA package inserts for prescription omega-3s Lovaza and Vascepa state they do not cause clinically significant bleeding.
"even the FDA in their package insert for Lovaza and all the omega-3s, for Vascepa, they say does not cause clinically significant bleeding." (said at 0:12:54)
The speaker claimed that FDA package inserts for Lovaza, Vascepa, and all omega-3s state they do not cause clinically significant bleeding. This assertion is contradicted. While older FDA labeling for Lovaza (omega-3-acid ethyl esters) stated that trial prolongation of bleeding time did not exceed normal limits or cause clinically significant bleeding episodes (while still cautioning co-administration with anticoagulants), the FDA package insert for Vascepa (icosapent ethyl) carries an explicit 'Warnings and Precautions' section for 'Risk of Bleeding'. This warning is based on the REDUCE-IT phase 3 clinical trial, which demonstrated an increased incidence of bleeding events (and a numerical excess of serious bleeding events) in patients treated with icosapent ethyl compared to placebo.
The average intake of EPA and DHA in the United States is 100 to 150 mg per day, with a median intake of zero.
"The average intake of EPA and DHA in America is something 100 to 150 milligrams a day. The median intake is zero, okay? The average, because some people eat a lot and a whole lot of people eat none. Wow. You know, so the median is zero, at least to two decimal places. And, but the average intake is 100, say 120 milligrams a day." (said at 0:54:51)
Nationally representative dietary surveillance data from the US National Health and Nutrition Examination Survey (NHANES) shows that the average daily intake of combined EPA and DHA from foods and supplements in US adults is approximately 113 mg/day (41 mg/day EPA and 72 mg/day DHA), which aligns with the speaker's estimate of 100 to 150 mg/day. However, the assertion that the median intake is zero is contradicted by usual intake modeling. In NHANES 2003–2008, median usual intake from food alone was 18 mg/day for EPA and 50 mg/day for DHA (totaling ~68 mg/day), and median total long-chain omega-3 intake across the population was approximately 110 mg/day. While many individuals do not consume fish on any single 24-hour recall day, their modeled usual median intake is non-zero.
- contradicts: U.S. adults are not meeting recommended levels for fish and omega-3 fatty acid intake: res… (Nutrition journal 2014) · cited 239x in the literature
"Intake from foods alone for ALA, EPA and DHA was 1.5 ± 0.01 g/d, 23 ± 7 mg/d and 63 ± 2 mg/d, respectively. ALA, EPA and DHA from food only median intakes were 1.4 g/d, 18 mg/d and 50 mg/d, respectively. Intake of ALA, EPA and DHA from foods and dietary supplements was 1.6 ± 0.04 g/d, 41 ± 4 mg/d and 72 ± 4 mg/d, respectively." (abstract, results, passage verified)
pubmedfull study (doi) - contradicts: Total Long-Chain n-3 Fatty Acid Intake and Food Sources in the United States Compared to R… (Lipids 2017) · cited 61x in the literature
"More than 90% consumed less than the recommended 0.5 g/day from food sources (median = 0.11 g/day; mean = 0.17 g/day)." (abstract, results, passage verified)
pubmedfull study (doi)
Vascepa is the only omega-3 formulation approved by the FDA for reducing cardiovascular event risk, whereas Lovaza has never been tested in a cardiovascular outcome trial.
"Only Vascepa is indicated for people for reducing risk for cardiovascular events because it's the only one that's been shown to do that. Lovaza has never been tested for lowering cardiovascular events." (said at 1:06:26)
The spoken statement combines two distinct assertions. The first part is correct: Vascepa (icosapent ethyl / purified EPA) is currently the only omega-3 formulation approved by the FDA with an indication to reduce cardiovascular event risk based on the REDUCE-IT trial. However, the second part—stating that Lovaza has never been tested in cardiovascular outcome trials—is contradicted by published clinical trial literature. Lovaza (prescription omega-3-acid ethyl esters, also marketed internationally as Omacor) has been evaluated in multiple major randomized cardiovascular outcome trials, including the GISSI-Prevenzione trial (11,324 post-myocardial infarction patients) and the GISSI-HF trial (6,975 heart failure patients), as well as subsequent trials of EPA/DHA combinations such as OMEMI.
- contradicts: Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardia… (Lancet (London, England) 1999) · cited 2065x in the literature
"From October, 1993, to September, 1995, 11,324 patients surviving recent (<= 3 months) myocardial infarction were randomly assigned supplements of n-3 PUFA (1 g daily, n=2836), vitamin E (300 mg daily, n=2830), both (n=2830), or none (control, n=2828) for 3.5 years. The primary combined efficacy endpoint was death, non-fatal myocardial infarction, and stroke... Treatment with n-3 PUFA, but not vitamin E, significantly lowered the risk of the primary endpoint (relative-risk decrease 10% [95% CI 1-18] by two-way analysis, 15% [2-26] by four-way analysis)." (abstract, methods and results)
pubmed - contradicts: Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISS… (Lancet (London, England) 2008) · cited 1355x in the literature
"We enrolled patients with chronic heart failure of New York Heart Association class II-IV, irrespective of cause and left ventricular ejection fraction, and randomly assigned them to n-3 PUFA 1 g daily (n=3494) or placebo (n=3481)... 1981 (57%) patients in the n-3 PUFA group and 2053 (59%) in the placebo group died or were admitted to hospital for cardiovascular reasons (adjusted HR 0.92 [99% CI 0.849-0.999], p=0.009)." (abstract, methods and results, passage verified)
pubmedfull study (doi) - context: A Fishy Topic: VITAL, REDUCE-IT, STRENGTH, and Beyond: Putting Omega-3 Fatty Acids into Pr… (Current cardiology reports 2021) · cited 15x in the literature
"Several trials that tested purified EPA (JELIS, REDUCE-IT, EVAPORATE) were associated with reduced CVD risk and regression of low attenuation coronary plaque volume, whereas studies that employed the combination EPA/DHA (VITAL, OMEMI, STRENGTH) failed to derive clinical benefit." (abstract, results, passage verified)
pubmedfull study (doi)
Unverified means no publication matching the claim was located; it does not prove the claim false. Spotted an error? See the corrections policy - disputes from the people quoted are prioritized.