For decades, the pharmaceutical industry has sought to limit competition by trying to get the FDA to regulate high-potency supplements as drugs. It was only because of intense consumer backlash that Congress passed legislation that protected the free sale of most supplements in the United States.

For those who have battled to protect health freedom, the introduction of an overpriced prescription fish oil drug provides absolute proof that every letter to Congress was well worth sending. I am enormously gratified that Americans were perceptive enough to not let the drug industry (and federal government) trample our liberties under the guise of "protecting" us against "unproven" products.

Prescription Fish Oil

The scientific evidence documenting the effects of fish oil in the body is overwhelming.1-3 One of the substantiated benefits of fish oil supplementation is lowering elevated triglycerides in the blood.4-6

An enterprising company used the scientific findings about fish oil and conducted a study on humans with extremely high triglycerides (over 500 mg/dL).7 As would be expected, compared to placebo, the triglyceride levels of the patients who received the fish oil were reduced by 51.6%. This company then applied to the FDA to have its fish oil approved as a new drug. The FDA granted the approval based on the company-sponsored clinical study showing that fish oil does exactly what it had previously been shown to do that is, lower triglyceride levels.

With prescription drug status, this company is now free to make specific health claims about fish oil and aggressively sell it through cardiologists. If this company's marketing efforts are successful, it stands to earn an enormous amount of money from unwitting patients who do not realize that they can obtain fish oil supplements for a fraction of the price of this prescription fish oil drug.

Would You Ever Buy Your Fish Oil by Prescription?

When we saw the marketing materials for this new prescription fish oil product, we knew it would be more expensive than what dietary supplement companies charge. We almost fell off our chairs, however, when we called the largest pharmacy in the United States to find out the actual price.

A bottle containing 180 1000-milligram capsules costs a whopping $236.89! That is about nine times more expensive than what this amount of fish oil sells for in a health food store.

The company selling this prescription fish oil drug knew that some consumers might question why they should pay such a high price. In their marketing materials, the company tries to differentiate their fish oil drug from what is available in health food stores by stating the following:

"The US 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." 8

Those who feel more comfortable using FDA-approved products can choose to pay the outlandish price of $236.89 for each bottle of this prescription-only fish oil drug. Even people with health insurance may find that their co-pay for this fish oil drug is still higher than what they could freely pay for fish oil supplements at a health food store. That is to say nothing of how much health insurance premiums could increase if too many patients are deceived into using this overpriced fish oil drug.

Greater Concentration of EPA/DHA in Prescription Fish Oil

To be objective, I want to point out that this expensive fish oil drug provides more EPA and DHA in each capsule than do most fish oil products sold by supplement companies. What this means is that five or six ordinary fish oil capsules might be needed to get the same amount of EPA/DHA contained in four capsules of this prescription-only version.

Despite the greater concentration of EPA/DHA in the fish oil drug, on a cost-per-milligram basis, the price for the prescription fish oil is still 797% higher than what Life Extension members pay for a fish oil concentrate that also provides sesame lignans and olive fruit extract. The addition of sesame lignans has been shown to increase the effectiveness of fish oil, 9-14 while olive oil/olive fruit extract has shown additional cardiovascular and antioxidant benefits.15-30

What Other New Prescription Fish Oil Drugs Might the FDA Approve?

As you will read in this issue of Life Extension magazine, fish oil has been shown to prevent or alleviate a wide variety of ailments, including depression,31-41 osteoporosis,42-45 arthritis,46-50 stroke,51-53 heart attack,54-66 Alzheimer's disease, 67-76 and some forms of cancer.77-83

Might there be future prescription fish oil products approved by the FDA as anti-depressant drugs, as bone-protecting prescription drugs, as anti-arthritis prescription drugs, and even as cancer-preventive prescription drugs?

If so, some drug companies stand to make a lot of money. Elderly patients who are unaware of lower-cost fish oil supplements might have to do without some basic necessities in order to afford their fish oil prescriptions. This is unfortunate, as these high-priced fish oil drugs provide the same omega-3 fatty acids that health-conscious Americans have been supplementing with for the past 35 years.

How We Protect Your Pocketbook and Your Health

Members pay $75 a year to support the Life Extension Foundation. While we are best known for our forward-thinking scientific research, we have also been on the front lines protecting individual health freedom rights.

It is only because of organizations like the Life Extension Foundation that Americans have a choice between purchasing fish oil as a prescription drug or as a dietary supplement. If the drug industry had its way, fish oil would be available only by prescription. This would be bad news for consumers who would have to pay extortionary prices for fish oil they might need to help relieve inflammatory pain, alleviate mental depression, and possibly sustain their very lives.

For longer life,

William Faloon

P.S. Life Extension members will be pleased to learn in this issue that even more synergistic ingredients have been added to a popular fish oil supplement now called Super Omega-3 with Sesame Lignans and Olive Fruit Extract.

References

1. Guesnet P, Alessandri JM, Vancassel S, Zamaria N. Analysis of the 2nd symposium "Anomalies of fatty acids, ageing and degenerating pathologies." Reprod Nutr Dev. 2004 May-Jun;44(3):263-71.

2. Horrocks LA, Yeo YK. Health benefits of docosahexaenoic acid (DHA). Pharmacol Res. 1999 Sep;40(3):211-25.

3. Roland I, De Leval X, Evrard B, Pirotte B, Dogne JM, Delattre L. Modulation of the arachidonic cascade with omega3 fatty acids or analogues: potential therapeutic benefits. Mini Rev Med Chem. 2004 Aug;4(6):659-68.

4. Available at: http://www.ahrq.gov/news/press/pr2004/omega3pr.htm. Accessed June 29, 2006.

5. Bruckner G. Microcirculation, vitamin E and omega 3 fatty acids: an overview. Adv Exp Med Biol. 1997; 415:195-208.

6. Mori TA, Vandongen R, Beilin LJ, Burke V, Morris J, Ritchie J. Effects of varying dietary fat, fish, and fish oils on blood lipids in a randomized controlled trial in men at risk of heart disease. Am J Clin Nutr. 1994 May;59(5):1060-8.

7. Harris WS, Ginsberg HN, Arunakul N, et al. Safety and efficacy of Omacor in severe hypertriglyceridemia. J Cardiovasc Risk. 1997 Oct-Dec;4(5-6):385-91.

8. Available at: http://www.omacorrx.com/About_OMACOR/What_to_Expect_on_OMACOR.html. Accessed June 29, 2006.

9. Chavali SR, Zhong WW, Forse AA. Dietary alpha-linolenic acid increases TNF-alpha, and decreases IL-6, IL-10 in response to LPS: effects of sesamin on the delta-5 desaturation of omega6 and omega3 fatty acids in mice. Prostaglandins Leukot Essent Fatty Acids. 1998 Mar;58(3):185-91.

10. el Tahir KE, Hamad EA, Ageel AM, Abu Nasif MA, Gadkarim EA. Effects of sesame and cod liver oils on prostacyclin synthesis by the rat thoracic aorta. Arch Int Pharmacodyn Ther. 1988 Mar-Apr;292:182-8.

11. Kang MH, Naito M, Sakai K, Uchida K, Osawa T. Mode of action of sesame lignans in protecting LDL against oxidative damage in vitro. Life Sci. 2000; 66(2):161-7.

12. Ikeda S, Kagaya M, Kobayashi K, et al. Dietary sesame lignans decrease lipid peroxidation in rats fed docosahexenoic acid. J Nutr Sci Vitaminol (Tokyo). 2003 Aug;49(4):270-6.

13. Arachchige PG, Takahashi Y, Ide T. Dietary sesamin and docosahexaenoic and eicosapentaenoic acids synergistically increase the gene expression of enzymes involved in hepatic peroxisomal fatty acid oxidation in rats. Metabolism. 2006 Mar;55(3):381-90.

14. Ide T, Hong DD, Ranasinghe P, Takahashi Y, Kushiro M, Sugano M. Interaction of dietary fat types and sesamin on hepatic fatty acid oxidation in rats. Biochim Biophys Acta. 2004 Jun 1;1682(1-3):80-91.

15. Kris-Etherton PM, Hecker KD, Bonanome A, et al. Bioactive compounds in foods: their role in the prevention of cardiovascular disease and cancer. Am J Med. 2002 Dec 30;113 Suppl 9B:71S-88S.

16. Visioli F, Bogani P, Grande S, Galli C. Mediterranean food and health: building human evidence. J Physiol Pharmacol. 2005 Mar;56 Suppl 1:37-49.

17. O'Dowd Y, Driss F, Dang PM, et al. Antioxidant effect of hydroxytyrosol, a polyphenol from olive oil: scavenging of hydrogen peroxide but not superoxide anion produced by human neutrophils. Biochem Pharmacol. 2004 Nov 15;68(10):2003-8.

18. Masella R, Vari R, D'Archivio M, et al. Extra virgin olive oil biophenols inhibit cell-mediated oxidation of LDL by increasing the mRNA transcription of glutathione-related enzymes. J Nutr. 2004 Apr;134(4):785-91.

19. Weinbrenner T, Fito M, de la Torre R, et al. Olive oils high in phenolic compounds modulate oxidative/antioxidative status in men. J Nutr. 2004 Sep;134(9):2314-21.

20. Marrugat J, Covas MI, Fito M, et al. Effects of differing phenolic content in dietary olive oils on lipids and LDL oxidation a randomized controlled trial. Eur J Nutr. 2004 Jun;43(3):140-7.

21. Wiseman SA, Tijburg LB, van de Put FH. Olive oil phenolics protect LDL and spare vitamin E in the hamster. Lipids. 2002 Nov;37(11):1053-7.

22. Lavelli V. Comparison of the antioxidant activities of extra virgin olive oils. J Agric Food Chem. 2002 Dec 18;50(26):7704-8.

23. Fito M, Gimeno E, Covas MI, et al. Postprandial and short-term effects of dietary virgin olive oil on oxidant/antioxidant status. Lipids. 2002 Mar;37(3):245-51.

24. Gimeno E, Fito M, Lamuela-Raventos RM, et al. Effect of ingestion of virgin olive oil on human low-density lipoprotein composition. Eur J Clin Nutr. 2002 Feb;56(2):114-20.

25. de la Puerta R, Martinez Dominguez ME, Ruiz-Gutierrez V, Flavill JA, Hoult JR. Effects of virgin olive oil phenolics on scavenging of reactive nitrogen species and upon nitrergic neurotransmission. Life Sci. 2001 Jul 27;69(10):1213-22.

26. Masella R, Giovannini C, Vari R, et al. Effects of dietary virgin olive oil phenols on low density lipoprotein oxidation in hyperlipidemic patients. Lipids. 2001 Nov;36(11):1195-202.

27. Tuck KL, Freeman MP, Hayball PJ, Stretch GL, Stupans I. The in vivo fate of hydroxytyrosol and tyrosol, antioxidant phenolic constituents of olive oil, after intravenous and oral dosing of labeled compounds to rats. J Nutr. 2001 Jul;131(7):1993-6.

28. Owen RW, Giacosa A, Hull WE, Haubner R, Spiegelhalder B, Bartsch H. The antioxidant/anticancer potential of phenolic compounds isolated from olive oil. Eur J Cancer. 2000 Jun;36(10):1235-47.

29. Covas MI, Fito M, Lamuela-Raventos RM, Sebastia N, de la Torre-Boronat C, Marrugat J. Virgin olive oil phenolic compounds: binding to human low density lipoprotein (LDL) and effect on LDL oxidation. Int J Clin Pharmacol Res. 2000;20(3-4):49-54.

30. Visioli F, Bellomo G, Galli C. Free radical-scavenging properties of olive oil polyphenols. Biochem Biophys Res Commun. 1998 Jun 9;247(1):60-4.

31. Visioli F, Galli C. Oleuropein protects low density lipoprotein from oxidation. Life Sci. 1994;55(24):1965-71.

32. Tiemeier H, Van Tuijl HR, Hofman A, Kiliaan AJ, Breteler MM. Plasma fatty acid composition and depression are associated in the elderly: the Rotterdam Study. Am J Clin Nutr. 2003 Jul;78(1):40-6.

33. Su KP, Huang SY, Chiu CC, Shen WW. Omega-3 fatty acids in major depressive disorder. A preliminary double-blind, placebo- controlled trial . Eur Neuropsychopharmacol. 2003 Aug;13(4):267-71.

34. Nemets B, Stahl Z, Belmaker RH. Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder. Am J Psychiatry. 2002 Mar;159(3):477-9.

35. Peet M, Horrobin DF. A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs. Arch Gen Psychiatry. 2002 Oct;59(10):913-9.

36. Edwards R, Peet M, Shay J, Horrobin D. Omega-3 polyunsaturated fatty acid levels in the diet and in red blood cell membranes of depressed patients. J Affect Discord. 1998 Mar;48(2-3):149-55.

37. Peet M, Murphy B, Shay J, Horrobin D. Depletion of omega-3 fatty acid levels in red blood cell membranes of depressive patients. Biol Psychiatry. 1998 Mar 1;43(5):315-9.

38. Maes M, Christophe A, Delanghe J, Altamura C, Neels H, Meltzer HY. Lowered omega-3 polyunsaturated fatty acids in serum phospholipids and cholesteryl esters of depressed patients. Psychiatry Res. 1999 Mar 22;85(3):275-91.

39. Stoll AL, Severus WE, Freeman MP, et al. Omega-3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-contolled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12.

40. Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213.

41. Maes M, Smith R, Christophe A, et al. Fatty acid composition in major depression: decreased omega 3 fractions in cholesteryl esters and increased C20: 4 omega 6/C20:5 omega 3 ratio in cholesteryl esters and phospholipids. J Affect Disord. 1996; 38:35"“46.

42. Kruger MC, Coetzer H, de Winter R, Gericke G, van Papendorp DH. Calcium, gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA) supplementation in senile osteoporosis. Aging (Milano). 1998 Oct;10(5):385-94.

43. van Papendorp DH, Coetzer H, Kruger MC. Biochemical profile of osteoporotic patients on essential fatty acid supplementation. Nutr Res. 1995;15(3):325-34.

44. Bhattacharya A, Rahman M, Banu J, et al. Inhibition of osteoporosis in autoimmune disease prone MRL/Mpj-Fas(lpr) mice by N-3 fatty acids. J Am Coll Nutr. 2005 Jun; 24(3):200-9.

45. Kesavalu L, Vasudevan B, Raghu B, et al. Omega-3 fatty acid effect on alveolar bone loss in rats. J Dent Res. 2006 Jul;85(7):648-52.

46. Berbert AA, Kondo CR, Almendra CL, Matsuo T, Dichi I. Supplementation of fish oil and olive oil in patients with rheumatoid arthritis. Nutrition. 2005 Feb;21(2):131-6.

47. de la Puerta R, Martinez-Dominguez E, Ruiz-Gutierrez V. Effect of minor components of virgin olive oil on topical antiinflammatory assays. Z Naturforsch [C]. 2000 Sep-Oct;55(9-10):814-9.

48. Alexander JW. Immunonutrition: the role of omega-3 fatty acids. Nutr. 1998 Jul-Aug;14(7-8):627-33.

49. Ariza-Ariza R, Mestanza-Peralta M, Cardiel MH. Omega-3 fatty acid in rheumatoid arthritis: an overview. Semin Arthritis Rheum. 1998 Jun;27(6):366-70.

50. Kremer JM, Lawrence DA, Petrillow GF, et al. Effects of highdose fish oil on rheumatoid arthritis after stopping nonsteroidal antiinflammatory drugs. Arthritis Rheum. 1995 Aug;38(8):1107-14.

51. Serhan CN. Novel eicosanoid and docosanoid mediators: resolvins, docosatrienes, and neuroprotectins. Curr Opin Clin Nutr Metab Care. 2005 Mar;8(2):115-21.

52. Li H, Ruan XZ, Powis SH, et al. EPA and DHA reduce LPS-induced inflammation responses in HK-2 cells: evidence for a PPAR-gamma-dependent mechanism. Kidney Int. 2005 Mar;67(3):867-74.

53. Iso H, Rexrode KM, Stampfer MJ, et al. Intake of fish and omega-3 fatty acids and risk of stroke in women. JAMA. 2001 Jan 17;285(3):304-12.

54. Thorngren M, Gustafson A. Effects of 11-week increases in dietary eicosapentaenoic acid on bleeding time, lipids, and platelet aggregation. Lancet. 1981 Nov 28;2(8257):1190-3.

55. Hjerkinn EM, Seljeflot I, Ellingsen I, et al. Influence of long-term intervention with dietary counseling, long-chain n-3 fatty acid supplements, or both on circulating markers of endothelial activation in men with long-standing hyperlipidemia. Am J Clin Nutr. 2005 Mar;81(3):583-9.

56. Trichopoulou A, Bania C, Trichopoulou D. Mediterranean diet and survival among patients with coronary heart disease in Greece. Arch Intern Med. 2005 Apr 25;165(8):929-35.

57. Mori TA, Beilin LJ. Omega-3 fatty acids and inflammation. Curr Atheroscler Rep. 2004 Nov;6(6):461-7.

58. Calder PC. n-3 fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clin Sci (Lond). 2004 Jul;107(1):1-11.

59. Yam D, Bott-Kanner G, Genin I, Shinitzky M, Klainman E. The effect of omega-3 fatty acids on risk factors for cardiovascular diseases. Harefuah. 2001 Dec;140(12):1156-8, 1230.

60. Connor WE. n-3 Fatty acids from fish and fish oil: panacea or nostrum? Am J Clin Nutr. 2001 Oct;74(4):415-6.

61. Dewailly E, Blanchet C, Lemieux S et al. n-3 Fatty Acids and cardiovascular disease risk factors among the Inuit of Nunavik. Am J Clin Nutr. 2001 Oct;74(4):464-73.

62. Marchioli1 R. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Lancet. 1999 Aug 7;354(9177):447-55.

63. von Schacky C, Angerer P, Kothny W, Theisen K, Mudra H. The effect of dietary omega-3 fatty acids on coronary atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1999 Apr 6;130(7):554-62.

64. Singh RB, Niaz MA, Sharma JP, Kumar R, Rastogi V, Moshiri M. Randomized, double-blind, placebo-controlled trial of fish oil and mustard oil in patients with suspected acute myocardial infarction: the Indian experiment of infarct survival-4. Cardiovasc Drugs Ther. 1997 Jul;11(3):485-91.

65. Das UN. Essential fatty acid metabolism in patients with essential hypertension, diabetes mellitus and coronary heart disease. Prostaglandins Leukot Essent Fatty Acids. 1995 Jun;52(6):387-91.

66. Garcia-Closas R, Serra-Majem L, Segura R. Fish consumption, omega-3 fatty acids and the Mediterranean diet. Eur J Clin Nutr. 1993 Sep;47 Suppl 1:S85-90.

67. Lukiw WJ, Cui JG, Marcheselli VL, et al. A role for docosahexaenoic acid-derived neuroprotectin D1 in neural cell survival and Alzheimer disease. J Clin Invest. 2005 Oct;115(10):2774-83.

68. Bourre JM. Omega-3 fatty acids in psychiatry. Med Sci (Paris). 2005 Feb;21(2):216-21.

69. Bourre JM. Dietary omega-3 fatty acids and psychiatry: mood, behaviour, stress, depression, dementia and aging. J Nutr Health Aging. 2005 9(1):31-8.

70. Bourre JM. [The role of nutritional factors on the structure and function of the brain: an update on dietary requirements]. Rev Neurol (Paris). 2004 Sep;160(8-9):767-92.

71. Favreliere S, Perault MC, Huguet F, et al. DHA-enriched phospholipid diets modulate age-related alterations in rat hippocampus. Neurobiol Aging. 2003 Mar-Apr;24(2):233-43.

72. Martin DS, Lonergan PE, Boland B, et al. Apoptotic changes in the aged brain are triggered by interleukin-1beta-induced activation of p38 and reversed by treatment with eicosapentaenoic acid. J Biol Chem. 2002 Sep 13;277(37):34239-46.

73. Youdim KA, Martin A, Joseph JA. Essential fatty acids and the brain: possible health implications. Int J Dev Neurosci. 2000 Jul-Aug;18(4-5):383-99.

74. Conquer JA, Tierney MC, Zecevic J, Bettger WJ, Fisher RH. Fatty acid analysis of blood plasma of patients with Alzheimer's disease, other types of dementia, and cognitive impairment. Lipids. 2000 Dec;35(12):1305-12.

75. Morris MC, Evans DA, Bienias JL, et al. Consumption of fish and n-3 fatty acids and risk of incident Alzheimer disease. Arch Neurol. 2003 Jul;60(7):940-6.

76. Kyle DJ, Schaefer E, Patton G, Beiser A. Low serum docosahexaenoic acid is a significant risk factor for Alzheimer's dementia. Lipids. 1999;34 Suppl:S245.

77. Hardman WE. n-3 fatty acids and cancer therapy. J Nutr. 2004 Dec;134(12 Suppl):3427S-430S.

78. Burns CP, Halabi S, Clamon GH, et al. Phase I clinical study of fish oil fatty acid capsules for patients with cancer cachexia: cancer and leukemia group B study 9473. Clin Cancer Res. 1999 Dec; 5(12):3942"“7.

79. Tsuda H, Iwahori Y, Asamoto M, et al. Demonstration of organotropic effects of chemopreventive agents in multiorgan carcinogenesis models. IARC Sci Publ. 1996 (139):143-50.

80. Lai PB, Ross JA, Fearon KC, Anderson JD, Carter DC. Cell cycle arrest and induction of apoptosis in pancreatic cancer cells exposed to eicosapentaenoic acid in vitro. Br J Cancer. 1996 Nov;74(9):1375-83.

81. Gonzalez MJ. Fish oil, lipid peroxidation and mammary tumor growth. J Am Coll Nutr. 1995 Aug;14(4):325-35.

82. Zhu ZR, Agren J, Mannisto S, et al. Fatty acid composition of breast adipose tissue in breast cancer patients and patients with benign breast disease. Nutr Cancer. 1995;24(2):151-60.

83. O'Connor TP, Roebuck BD, Peterson F, Campbell TC. Effect of dietary intake of fish oil and fish protein on the development of L-azaserine-induced preneoplastic lesions in the rat pancreas. J Natl Cancer Inst. 1985 Nov;75(5):959-62.

2016 StopFDA.org