Fish Oils Approved by FDA for Reducing Triglycerides—Prescription Required
Climate change is allowing subordinate males on a remote Scottish island a chance to mate. Higher temperatures and lower rainfall mean that female grey seals forage over a wider range, making it more difficult for the top male to keep an eye on them all.— Nature, December 28, 2006, p. 982
Scientific discovery consists in the interpretation for our own convenience of a system of existence which has been made with no eye to our convenience at all.— Norbert Wiener, The Human Use of Human Beings (1950)
In 2000, the U.S. Food and Drug Administration (FDA) required novel antibiotics to demonstrate cure rates that were not lower by 10% or more (“noninferior to”) than that of a designated existing antibiotic (the earlier standard was 10–20%). Then in July 2005, unbeknown to industry, FDA again changed its position, requiring placebo-controlled trials rather than noninferiority trials for certain infections.— Nature Biotechnology, editorial, December 2006
Comment: Requiring placebos (rather than evidence of noninferiority) when a treatment is available is a crime against humanity, a virtual replication of the “Tuskegee experiments,” where elderly black men with syphilis were deliberately not treated with penicillin even though it was known to be effective.All silencing of discussion is an assumption of infallibility.— John Stuart Mill, On Liberty (1859)
Prescription fish oils are now available, approved by the FDA for reducing high levels of triglycerides. The September 2006 Life Extension magazine reports that a bottle containing 180 1000-milligram capsules costs a “whopping” $236.89, about nine times as expensive as what this amount of fish oil sells for in a health food store. Moreover, the article goes on, the FDA permits the following statement to be made in package materials accompanying the prescription fish oils: “The U.S. Food and Drug Administration (FDA) has not approved nonprescription, dietary supplement omega-3s for the treatment of any specific disease or medical condition, like very high triglyceride levels.* Dietary supplement omega-3, or so-called fish oil, is not a substitute for prescription (fish oil) because they are not bioequivalent.”† [Emphasis as in original statement reprinted in article]
*By the FDA’s very narrow (and incorrect, in our opinion) interpretation of the Congressional statute permitting health claims, the FDA will not permit a “treatment claim” (such as: substance X may lower triglycerides) for any dietary supplement, no matter how much evidence exists demonstrating that the supplement is effective as a treatment. Thus, the fact that non-FDA-approved fish oils do not have FDA’s approval for use as a treatment for high triglyceride levels is meaningless, since the FDA will not give such approval. This company obviously hopes consumers will think that the FDA’s approval for their “prescription fish oils” means there is something special about their product (or, at least, special enough to be worth all that extra money).
†The article points out that there is more EPA and DHA in each prescription fish oil capsule than in most dietary supplement capsules of fish oils; however, all this means is that you might need to take 5 or 6 capsules of dietary supplement fish oils to get the same amount of EPA and DHA as in 4 capsules of the prescription version. The end result, according to the article, is that the prescription fish oil is still 797% higher than the nonprescription version sold by Life Extension. Moreover, nonprescription authentic fish oils are entirely bioequivalent to the prescription version (that is, their biological and biochemical properties are identical). This is a deadly fraud against the public by the FDA and opportunistic drug companies.
Comment: This company, relying upon the government’s guns to keep competitors’ speech from the market, implies that only FDA-approved fish oils can reduce triglycerides. While this is a lie, it is unfortunately true that most government (i.e., taxpayer-funded) “health care” programs and most insurance policies will only pay for FDA-approved treatments, and hence these contemptible, murderous creeps may actually profit from their lies.