Lovaza: A Wolf in Sheep's Clothing?Originally posted April 2010
July 7, 2010
Nutrition Business Journal takes a close look at Lovaza, a prescription-only omega-3 fatty acid manufactured by Pronova Biopharma in Norway and marketed in the United States by GlaxoSmithKline (GSK), in our upcoming issue on the state of the nutrition industry. According to market research firm IMS Health, global sales of Lovaza topped $1 billion in 2009, with $758 million of those sales originating in the U.S.
The new fuss over Lovaza is more about marketing than innovation, as the drug received approval from the Food and Drug Administration (FDA) back in 2004, one year before Reliant Pharmaceuticals brought its predecessor, Omacor, to market. Supplement manufacturers are wary of the heavy ad campaign behind a pharmaceutical competing with one of industry�s star performers, but many view the exposure as a win-win.
�Overall, I think it�s very positive,� said Monique Wellise, professional sales manager for Nordic Naturals. �It validates the use of omega 3s in a clinical application.� Kyle Bliffert, president of Pure Encapsulations, agreed. �If GSK wants to spend millions of dollars advertising the health benefits of fish oil on TV, it can do nothing but benefit all of us. I�m in.�
NBJ bottom line: The news is not all rosy, however. If patients continue to bite for Lovaza in a big way, this could draw economic attention from big pharma toward OTC supplements already available to an educated consumer. The weight of a doctor�s opinion, and that�s doctor�s faith in a more heavily regulated and tested pharmaceutical, could spell trouble for supplements that reach blockbuster status. Already, pharmaceutical companies have rolled out prescription versions of Niacin (Niaspan has been around since 1997), and vitamin D2 (which many contend is actually inferior to over-the-counter D3). Future candidates for supplement-based drugs might include: plant sterols, coenzyme Q10, and glucosamine/chondroitin.
For the full story behind Lovaza, and comprehensive coverage of the current supplement industry, don�t miss NBJ�s 2010 Nutrition Industry Overview issue, available later this month through our website.
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Our pharmaceutical grade Super EPA(300 mg)DHA (200 mg), Fish oil 1000 mg /capsule - $22/60 capsules. A one month supply. CONTACT US FOR ORDERING INSTRUCTIONS.
Surprised? Probably not if you've followed us over the years or attended any of our educational programs.
We’ve been saying that pharmaceutical grade omega-3 fish oil can protect your heart for decades. Now Big PhRMA wants to scalp you and your checkbook too.
Consider this price: 120 capsules, $191.00, one reason why PhRMA/INS collusion artificially inflates health care costs.
And for that price, I'm sure you are considering just what might cost about $1.60 a piece.
This just happens to be an example of GSK's new prescription fish oil capsule.
The TV ad even stresses “you can't buy this in a health food store.”
The question then becomes, once getting the facts, why would you want to get it as an over priced prescription...
Currently each LOVAZA® (omega-3-acid ethyl esters) 1 gram capsule contains contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).
The daily dose of LOVAZA is 4 grams per day (4 capsules).
Drug interaction studies with several statin drugs were limited to 14 days. The effects of LOVAZA 4 grams per day were assessed in 2 randomized,placebo-controlled, double-blind, parallel-group studies of 84 adult patients.
The FDA has approved omega-3 fish oil as a heart-protecting drug. Big PhRMA is spending millions to market omega-3 fish oil. Why?, overwhelming that purified, concentrated omega-3 fish oil protects your heart from the risks of heart disease, stroke, and heart attack. The best part is that along with a healthy food plan and exercise it will lower deadly triglyceride levels.
What Big PhRMA isn't telling you: Prescription strength omega-3 fish oil is available without a prescription You’ll pay up to 6x more for prescription omega-3 fish oil Pharmaceutical grade EPA-DHA gives your heart EXACTLY THE SAME benefits as prescription omega-3 fish oil.
Lovaza capsules also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of soybean oil), and gelatin, glycerol, and purified water (components of the capsule shell).
Lovaza, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of Lovaza contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).
Inform your doctor of any other medical conditions, including blood clotting problems, liver problems, pancreas problems, obesity, thyroid problems, diabetes, consuming large amounts of alcohol, allergies (including fish, fish oil, or soy),
Cautions - DO NOT TAKE LOVAZA 1gm if you have had an allergic reaction to it or to any ingredient in this product, including soy.
Our note: Caution: Burping may be indicative of your inability to properly digest and absorb fat, convert EPA to DHA, or that the fish oil may be rancid.
Centrum Cardio contains GMO soy and canola oil. Look for our several articles using the search box.
And from the Journal of Nutrition -
Omega-3s Show Heart Benefits for Non-Fish Eaters
A new study from The Netherlands says that increased intakes of omega-3 fatty acids appear to decrease the risk of heart disease and heart attack in people with low fish intakes.
Findings published in the Journal of Nutrition reported that daily intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) of about 240 mg was associated with a 50% reduction in the risk of coronary heart disease (CHD), compared with intakes of about 40 mg.
Furthermore, the highest average intake of DHA and EPA was associated with a 38% reduction in heart attacks, said researchers from Wageningen University following a study including more than 21,000 people with low fish intakes.
The heart-health benefits of consuming oily fish, and the omega-3 fatty acids they contain, are well documented. To date, the polyunsaturated fatty acids (PUFAs) have been linked to improvements in blood lipid levels, a reduced tendency of thrombosis, blood pressure and heart rate improvements, and improved vascular function.
Intakes of EPA, DHA, and fish were assessed in 21,342 people aged between 20 and 65. Fish intakes ranged from 1.1 to 17.3 grams per day. Over the course of an average of 11.3 years, the researchers documented 547 deaths, of which 82 were linked to CHD, with 64 of these being heart attack.
According to the results, the highest average intake of EPA plus DHA (234 mg per day) was associated with a 51% reduction in the risk of fatal CHD, compared to the lowest average intake (40 mg per day).
"In conclusion, in populations with a low fish consumption, EPA+DHA and fish may lower fatal CHD and [heart attack] risk in a dose-responsive manner," wrote the researchers.
Journal of Nutrition Published online ahead of print, April 2010.
Lovaza vs fish oil supplements?
By Dr. William Davis, Jan 26, 10
Lovaza is the FDA-approved form of fish oil that is available only by prescription. It contains 842 mg of the omega-3 fatty acids, EPA and DHA, per capsule.
The FDA application for Lovaza is viewable here on the FDA website. Interestingly, while there is plenty of the usual regulatory gobbledy-gook about toxicology, dose escalation, and efficacy in the extensive documentation, there is little said about the issue of contamination.
In other words, critics of nutritional supplement fish oil harp on the possibility of contamination with mercury and pesticide residues, like dioxin and PCBs (polychlorinated biphenyls). Yet there is virtually nothing about these same issues in the FDA application for Lovaza.