Life Extension Magazine
In 2019, the FDA sought the advice of an expert panel to review new data about a fish oil drug.
By a vote of 16-0, the panel recommended that the FDA allow broader claims about its ability to reduce cardiovascular risks.
In December 2019, the FDA acted on this recommendation by expanding the “approved use” of this fish oil drug to reducing risk of heart attack, stroke, and death in high-risk patients.
This decision was largely based on a study published in the New England Journal of Medicine showing remarkable benefits in people taking high doses of a fish oil drug that consisted of the EPA omega-3 fraction.
Compared with placebo, there was a 25% reduction in a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary stents/bypass surgeries, or unstable angina in the fish oil drug group.
The study observed several other benefits including:
- Cardiovascular death reduced by 20%
- Fatal or nonfatal heart attacks reduced by 31%
- Fatal or nonfatal stroke reduced by 28%
- Urgent or emergency coronary revascularization reduced by 35%
- Hospitalization for unstable angina reduced by 32%
This fish oil is marketed to doctors as a drug that lowers triglycerides without raising LDL cholesterol.
To the physician, this may sound appealing compared to a competitor fish oil drug that contains both EPA and DHA.
What troubles us, however, is that patients taking the EPA-only fish oil drug (Vascepa®) are unlikely to take other fish oil supplements. This ignores the critical role of the DHA component of the omega-3 family on life-sustaining processes, especially brain and eye health.
The estimated out-of-pocket cost, assuming no insurance coverage, is over $300 a month for this EPA-only fish oil drug. This is about seven times higher than what a comparable amount of EPA+DHA can be obtained for when using dietary supplements.
This editorial describes legal battles that took place over decades regarding fish oil, and introduces new data that corroborate the benefits of consuming higher omega-3 potencies.
Many of you may take for granted your ability to purchase affordable fish oil supplements, but it was not always this way.
On February 26, 1987, the FDA conducted an armed raid against Life Extension®.
The FDA seized our fish oil and brochures describing fish oil’s potential to reduce cardiovascular risk.
We fought a multi-year legal battle that resulted in the government dismissing all charges against Life Extension®, marking the first time in the FDA’s 88-year history that it has been forced to give up on a criminal prosecution.
Seven years later, Congress passed legislation that allowed consumers to access a variety of affordable dietary supplements.
This helped curb the FDA’s appetite for overly aggressive and frankly police-state-like enforcement actions. The FDA nonetheless continued to censor lifesaving data about fish oil and other healthy foods (such as walnuts and cherries).
This prompted another lawsuit filed in 1994 by Durk Pearson and Sandy Shaw that sought to force the FDA to allow the following health claim on fish oil supplement labels:
“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.”
The FDA rejected this one-sentence claim, and multi-year litigation ensued based on scientific and constitutional grounds.
The FDA contended this health claim was not adequately backed by scientific studies and that the agency had the legal authority to ban these kinds of health claims.
After seven years of extensive litigation, the FDA capitulated and said it would permit the following claim:
“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. FDA evaluated the data and determined that although there is scientific evidence supporting the claim, the evidence is not conclusive.”
Challenging FDA’s Restricted Health Claim
The FDA’s compromise claim that the evidence was “not conclusive” did not satisfy us. We viewed the scientific literature back then as providing evidence that consuming fish or fish oil could lower heart attack risk —the nation’s leading killer.
Life Extension® and Wellness Lifestyles, Inc. filed a health-claim petition against the FDA on June 23, 2003. The petition urged the FDA to allow the following revised claim:
“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.”
To substantiate this position, a document enumerating the scientific studies backing the benefits of omega-3 fatty acids was filed, along with arguments supporting the constitutional right to disseminate truthful, non-misleading information.
Everything I am describing has to do with what “words” the FDA allows to be on a fish oil label.
FDA Partially Capitulates
On September 8, 2004, the FDA decided to allow an expanded health claim on products containing the omega-3 fatty acids EPA and DHA as follows:
“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”10
The FDA went on to recommend that consumers not exceed more than 3,000 mg per day of EPA and DHA omega-3 fatty acids, with no more than 2,000 mg per day derived from dietary supplements.
Life Extension® argued that many studies show that higher amounts of EPA and DHA are often needed to obtain benefits, such as reduction of triglycerides.
Our position continues to be vindicated in studies showing benefits when higher potencies of omega-3s are consumed.
FDA Suffers Major Defeat in Federal Court
The FDA strictly regulates what drug makers are permitted to say about their products. Until recently, what could be said was limited to what the FDA allowed.
A major victory over FDA censorship occurred when a maker of prescription-drug fish oil sued the FDA to make a health claim about fish oil’s potential to reduce cardiovascular disease risk.
The FDA insisted it was illegal for the maker of this fish oil drug to state a coronary disease prevention claim until the FDA said so.
After years of costly litigation and thousands of pages of documents produced, a federal court ruled that a qualified health claim could be made for a fish oil drug called Vascepa®.
The court based this 2015 ruling on the facts that:
- The claim is truthful and non-misleading.
- FDA accepted this phrasing elsewhere in its regulatory labyrinth.
- The First Amendment to the U.S. Constitution allows it.
Here is the revised claim the federal court ruled could be made to doctors about this fish oil drug in 2015:
“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. Vascepa® should not be taken in place of a healthy diet and lifestyle or statin therapy.”
After years of protracted disagreement that led to full-blown litigation, the above statement is the primary outcome of this legal victory over FDA censorship.
In the ruling, the judge quoted from prior cases that:
“‘Securing First Amendment rights is in the public interest’” and “‘the government does not have an interest’ in the unconstitutional enforcement of a law.
Battling the Medical Mainstream
The fish oil controversy did not end with the FDA.
Defenders of conventional medicine like the American Medical Association and American Heart Association issued contradictory proclamations about fish oil’s benefits or purported lack thereof.
The back-and-forth was based largely on studies with huge variations in EPA/DHA potencies and/or unrealistic expectations of fish oil monotherapy.
Studies using higher omega-3 doses generally demonstrated fish oil efficacy, whereas lower -dose studies were often disappointing and resulted in mainstream medicine questioning fish oil’s value.
The media parroted conventional medicine’s vacillating positions, running tabloid-like headlines touting fish oil’s cardioprotective benefits or attacking it as worthless, depending on the study released that day.
There were some contradictions, such as a study showing low-dose fish oil (1,000 mg a day of EPA/DHA) markedly reducing fatal heart attack risk while other studies showed little value using this low dose.
Overlooked in much of this were dietary patterns in countries that had higher omega-3 intake in foods, and thereby needed less supplemental fish oil. These population groups might have benefited from a low-dose EPA/DHA supplement whereas dietary omega-3 consumption in much of the United States is woefully insufficient.
The American Heart Association confused matters more in 2017 by recommending fish oil to heart failure patients, but not to the general population. This ignores the importance of heart attack prevention.
Life Extension® published a rebuttal in February 2018 titled “An Illogical Position of the American Medical Association” to describe the absurdity of recommending people wait to develop heart failure before ensuring optimal omega-3 intake
Is A Consensus Being Reached?
Results from recent, large studies continue to validate the need for higher-dose omega-3 intake.
As mentioned in the introduction of this article, and in the November 2019 edition of Life Extension® magazine, robust benefits were found when a high dose (4,000 mg/day) of an EPA-only fish oil drug (Vascepa®) was used. The study found a 25% reduction across a broad spectrum of cardiovascular disorders.
In this same issue, we described why 1,000 mg a day of an EPA/DHA supplement (and only 2,000 IU/day of vitamin D) failed in its primary endpoint, but did yield meaningful risk reduction in several subgroups including:
- 25% reduction in cancer deaths in the vitamin D group when the first two years of follow-up were excluded,
- 28% reduction in heart attack risk, and 50% reduction in fatal heart attack risk, in the fish oil group, and
- 22% reduction in angioplasty procedures (opening a narrowed coronary blood vessel, often with a stent) in the fish oil group.
At the American Heart Association annual meeting in November 2019, a presentation on a study that administered about 3,300 mg of an EPA/DHA fish oil drug called Lovaza® revealed striking improvements in cognitive functions in older individuals.
What made this study so compelling is that blood levels of EPA/DHA were carefully measured. The cognitive benefits occurred in those with an omega-3 index over 4%. Here is the conclusion from this presentation made at the American Heart Association meeting:
“High dose EPA and DHA prevented cognitive decline in cognitively healthy coronary artery disease subjects, with younger subjects, nondiabetic subjects, and those achieving an omega-3 fatty acid index 4% having greatest benefit. These findings are especially important for coronary artery disease patients as coronary artery disease is a risk factor for dementia.”
What I continue to observe in the published data is consensus that higher-dose omega-3 intake is what induces meaningful risk-reduction benefits.
Overlooked Role of Dietary Omega-3s
No one argues with the idea that eating two to three cold-water fish meals a week reduces cardiovascular and other disease risks. This is nearly universally agreed upon and accepted, including in the medical profession and among researchers.
Yet missing from virtually all research on fish oil supplements is each study subject’s dietary intake of EPA/DHA-rich foods.
To put this into perspective, a 4-ounce can of wild salmon contains about 2,000 mg of total omega-3s providing about 1,800 mg of EPA/DHA.
So, a clinical trial using only 1,000 mg of supplemental EPA/DHA in people who regularly consume canned wild salmon might yield benefits because the total daily consumption of EPA+DHA is around 2,800 mg.
On the flip side, individuals consuming typical Western dietary patterns that are nearly devoid of omega-3s may require far higher amounts of supplemental EPA/DHA (3,300 mg to 4,000 mg) to achieve the same results.
The significance of these differences cannot be overstated, both from a public health standpoint and on huge savings on fish oil drugs and supplements.
People whose diets already provide ample quantities of EPA/DHA will likely require lower potencies of fish oil drugs or supplements.
Yet a one-size-fits-all approach is the current protocol. The FDA now allows certain high-risk patients to be prescribed a 4,000 mg/day potency of an expensive EPA-only drug — but advises against the same potencies of lower-cost fish oil supplements!
How This Impacts You
The importance of achieving optimal EPA/DHA status cannot be overstated. It impacts a person’s risk of multitudes of disorders, many that are life threatening.
Your blood ratio of omega-3 fats to omega-6 fats — which can be measured with the omega-3 index blood test is an important determinant of overall health status.
The good news is that pricing keeps dropping for the omega-3 index comprehensive fatty acid blood panel.
Results from this test can enable you to precisely determine how many fish oil capsules you need a day to achieve an optimal omega-3 index, which by most standards is over 8%.
The recent study presented at the American Heart Association conference found meaningful cognitive benefits when omega-3-index scores were over 4%.
I’ll describe soon how you can obtain low-cost omega-3/omega-6 blood tests that might enable you to reduce the number of fish oil capsules you take a day, saving you money over the long term.
Life Extension’s Position on Fish Oil Dosing
For many decades, we’ve suggested most of our readers supplement with about 2,400 mg of EPA + DHA each day from highly purified fish oil.
We know most of you consume omega-3s in your diet by eating cold-water fish meals and/or via plant sources like walnuts, flax, and other foods.
So, our typical reader may, on average, obtain over 3,000 mg-4,000 mg each day of EPA/DHA from their fish oil supplement plus omega-3-rich dietary components.
We caution, however, that not all people, and perhaps very few, convert plant-based omega-3s to EPA/DHA. This is what makes fish oil so important but presents a dilemma for vegans.
People with stubbornly high triglyceride levels are advised to increase their fish oil intake to target a triglyceride blood level below 100 mg/dL.
Based on published studies showing benefits with higher intake of EPA/DHA, more doctors are prescribing expensive fish oil drugs, often without considering an individual patient’s dietary intake of the omega-3s.
Supplementation with quality fish oil can cost about $300 a year whereas fish oil drugs can cost over $3,600 a year.
The Omega-3 Index Complete blood test includes the following measures:
- Omega-3 Index Percent (it should ideally be over 8%)
- Trans Fat Index
- Omega-6:Omega-3 ratio
- Arachidonic acid:EPA ratio
- Full fatty acid profile
Results from this blood test provide a guideline for dietary changes and fish oil supplementation for each person’s individual biochemistry.
Those who obtain few dietary omega-3s in their diet may want to boost their supplemental fish oil intake over 3,000 mg a day, whereas those who eat lots of cold-water fish may reduce their supplemental dose below 2,400 mg a day.
While these common-sense approaches are obvious to me and Life Extension’s scientific staff, many hurried physicians are likely to stick with the labeled high doses of FDA-approved fish oil drugs, i.e. the one-size-fits-all approach.
In This Month’s Issue…
Most people don’t know that after one suffers a heart attack, their risk of stroke is exponentially higher. A drug used to treat gout (colchicine) demonstrated a 74% reduction in post-heart-attack stroke risk.
Learn what to ask your cardiologist regarding colchicine on page 73 of this month’s issue.
The buildup of senescent cells continues to be recognized as a causative factor in degenerative aging. As you’ll read on page 26 a plant flavonoid (apigenin) can reduce the toxic secretions that emanate from senescent cells.
Sulforaphane from broccoli has demonstrated powerful anti-cancer properties. Page 54 describes the best ways of transporting sulforaphane from the digestive tract into the blood.
Too Many Needless Heart Attacks
Growing consensus about fish oil, along with the new claims allowed by the FDA, will help enable more Americans to benefit from higher consumption of omega-3 fatty acids.
The tragedy is that it took so long for the benefits of omega-3s to be widely recognized.
Cardiovascular disease remains the leading cause of disability and death in the United States, especially in elderly population groups.
Armed raids by the FDA against those who recognized fish oil’s benefits in the 1980s resulted in countless numbers of cardiovascular events and astronomical medical costs for bypass procedures, stents and prescription drugs.
We look forward to science prevailing over the kinds of actions one might expect in an authoritarian, police state.
This happened when doctors in Wuhan, China warned of a pneumonia epidemic in December 2019, but were silenced with threats of arrests for “spreading false rumors.”
This governmental censorship led to the deaths of hundreds of thousands of people worldwide from COVID-19 disease.
FDA censorship of fish oil dating back to the 1980s may have led to similar tragedies.
Turn the page for information on popular Male and Female Blood Test Panels and how you can obtain an omega-3 index at the lowest price ever.
For longer life,