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Watchdog Group Decries High-Dose Omega-3 Drug
4/27/2009
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Rationale for monopolistic omega-3 drug undermined by new concerns; WorstPills.org says Lovaza's cholesterol impacts undermine its benefits
by Craig Weatherby


Heart-health authorities worldwide recommend that healthy people consume 500 mg of omega-3s daily, and say that heart patients should take 1,000 mg (one gram) per day.

But the small minority of people with very high blood levels of triglycerides (fats) are urged to take the higher doses, ranging from 2 to 4 grams per day, needed to yield and sustain dramatic reductions.

If you have very high triglyceride levels that need lowering, the FDA and drug giant GlaxoSmithKline have a sucker's proposition for you.

Instead of a standard or high-dose fish oil supplement, you can take a high-dose prescription fish oil product called Lovaza®.

You may be able to take fewer capsules per day, but you will gain higher LDL cholesterol levels... with no guarantee of lowering your heart risks any more than with standard, lower-dose fish oil

Better yet for GlaxoSmithKline, you
or a willing insurance companywill pay $2,000 to 3,000 more than you'd spend for the same dose of the same omega-3s, delivered by a standard fish oil supplement.

A monopoly won by patent law and deep pockets... not invention
If a doctor wants to prescribe fish oil for a patient’s high triglyceride levels, only one omega-3 fish oil supplement enjoys the status of an FDA-approved drug, with the possibility of being reimbursed by health insurance.

The FDA allows only Lovaza® brand omega-3 fish oil to make a drug claim… with the consequent opportunity to make loads of money from patients with generous health insurance.

Key Points
  • Prescription fish oil costs 3 to 20 times more than fish oil supplements for the same dose of omega-3s.
  • The very high omega-3 doses in prescription fish oil (Lovaza®) lower high triglyceride levels far more than standard fish oils do.
  • High-dose fish oils are not proven to beat lower dose oils for reducing heart disease risk or heart-related death rates.
  • High-dose fish oil raises LDL cholesterol levels much more than standard fish oil does; the implications are uncertain but more likely negative.
This unique prescription omega-3 product
made by GlaxoSmithKline (GSK)is FDA-approved for the purpose of lowering very high (greater than 500 mg/dL) triglyceride levels in adults.

High triglyceride levels are associated with increased risk of cardiovascular disease and death, and can lead to dangerous liver disease.

Omega-3 fatty acids from fish oilespecially the omega-3 called DHAlower triglyceride levels by decreasing the production of triglycerides in the liver, and by boosting clearance of excess triglycerides from the blood.

High daily doses of omega-3s (2-4 grams) lower triglyceride levels the most, at least among people with very high triglyceride levels.

But large clinical trials show that people who consume smaller daily doses of omega-3s (1 to 2 grams) enjoy substantially lowered levels of triglycerides …plus a reduced risk of heart-related deaths (Schwellenbach LJ et al. 2006; Harris WS et al. 2007; Harris WS et al. 2008).

In fact, while the high omega-3 doses delivered by Lovaza® are clinically proven to reduce high triglyceride levels by about one-third, Lovaza® has not been tested or proven to prevent cardiovascular disease or reduce the risk of heart-related death.

And while high doses of omega-3s, such as those found in chemically concentrated fish oils like LovazaŇ, can lower triglyceride levels much more than smaller doses do, there is no evidence that extremely high doses of omega-3s reduce heart risks to any greater extent.

That picture may change as doctors accumulate records from people who take high dose fish oil over several decades.

For the moment, we know two things: The efficacy of high-dose fish oil becomes less pronounced after the first month… and following high-dose fish oil therapy with lower daily maintenance doses is even less able to sustain large initial drops in patients’ triglyceride levels.

And we seem to have just discovered another thing. As we’ll explain further below, high-dose fish oil drugs seem to raise LDL cholesterol levels substantially… far above the very slight rises sometimes seen with standard fish oil supplements.

Is prescription fish oil better for anyone but drug firms?
LovazaŇ is similar to standard non-prescription fish oils, except for the extremely high dose of omega-3s in each capsule.

Like standard fish oil supplementsbut unlike our whole, unrefined salmon oilLovazaŇ is refined using chemical processes called deodorization and molecular distillation, which involve flash exposure to high temperatures (400 degrees F).

These chemical procedures remove contaminants, but they also remove or reduce many of the fatty acids natural to fish oils.

In most cases, manufacturers use molecular distillation to produce fish oil supplements containing levels of omega-3s that are unnaturally high, but not extremely so.

Thus, except for its extraordinarily high omega-3 levels, Lovaza® is much like any another distilled fish oil.

However, those very high omega-3 levels and its approved-drug status make Lovaza® different in two important, undesirable ways.

Cardiologist decries the “Lovaza® rip-off”
As GlaxoSmithKline says, four capsules of Lovaza® provide the amount of omega-3s (EPA and DHA) found in about 18 capsules of a standard fish oil supplement.

But Lovaza® also costs many times more than standard fish oil supplements, in terms of the milligrams of omega-3s provided per dollar… even though it is not proven to produce better long-term health outcomes.

Last year David Williams, M.D., a cardiologist in Milwaukee, critiqued what he called the “Lovaza® rip-off” in his blog.

Astonishingly, any given dose of omega-3s (EPA + DHA) from Lovaza® costs from three to 20 times more than the same dose from a non-prescription fish oil supplement.

Is the minor convenience of taking fewer pills worth paying $2,000 to $3,000 per year for the privilege?

If public or private insurance picks up the prescription, the patient is spared but the cost gets spread around to all as higher taxes or premiums, respectively.

Except in serious cases, where no other alternative works, it seems not worth it… especially since a very high daily dose of omega-3s is neither proven to improve heart outcomes much more than lower doses do, nor very likely to do so.

It seems clear that most of the cardiac benefits associated with omega-3s stem from their roles in our cells membranes, from where they influence heart rhythms and inflammation.

At some point, the cell membranes become saturated with omega-3s and will accept no more.

Need a high dose fish oil? Consider over-the-counter
Lovaza® did not gain approval as a triglyceride-lowering drug because it is the only high-dose fish oil that would work, or the only one available to people with very high triglyceride levels.

Instead, Lovaza® gained FDA approval because only a deep-pocketed drug firm like GSK can afford the $250 million or so it takes to get through the costly process.

In fact, Lovaza®’s approval as a drug rests on the same kind of clinical evidence seen with non-prescription, high-dose fish oil.

Lovaza® is simply a high-potency omega-3 supplement with a specific - hence patentable - chemical profile, made by a big drug firm able to fund its own clinical trials.

Lovaza®’s potentially counterproductive cholesterol effects
What’s the possible second drawback to high-dose fish oils Lovaza® or its non-prescription counterparts?

The April 2009 newsletter from WorstPills.org criticizes Lovaza® for exerting undesirable effects on people’s cholesterol profiles (WorstPills.org is the Web site of the Ralph Nader spin-off group Worst Pills, Best Pills).

Like all fish oil supplements, Lovaza® raises blood levels of certain kinds of LDL cholesterol… a category that includes many sub-types of LDL, which are rather misleadingly lumped together as “bad” cholesterol.

But compared with other fish oils, Lovaza® raises LDL levels far higher… to an extent that could be harmful, especially in people with certain genetic profiles.

WorstPills.org was circumspect about the critique, given the complexity of cholesterol-related cardiovascular risk factors: “Elevated levels of LDL cholesterol are associated with a greater risk of heart disease, but it is unclear if the elevation in LDL levels seen with high-dose Lovaza® therapy is harmful” (WPBP 2009).

We must concur with their circumspection, given the broader effects of Lovaza® on cholesterol profiles, which may be beneficial, overall.

Lovaza® stands out among all fish oil products because it raises several kinds of LDL cholesterol so much more than standard, lower-dose fish oils do… including some LDL types that are regarded as especially risky.

Despite this drawback, Lovaza® lowers levels of all non-HDL cholesterol… and when it comes to people’s cholesterol profiles, this highly beneficial effect results from taking any fish oil.

Omega-3s do not “lower cholesterol” like statin drugs (e.g., Lipitor) are proven to do.

Instead, it’s thought that omega-3s reduce the risk of strokes, sudden cardiac death, and second heart attacks by doing four things:
  1. Lower blood triglyceride (fat) levels.

  2. Raise levels of “good” (HDL) cholesterol.

  3. Lower levels of all non-HDL cholesterol.

  4. Reduce risk of arrhythmias
In fact, supplemental omega-3s often raise levels of LDL cholesterol slightly… and not nearly enough to matter.

The mild LDL-raising effects of fish oil appear mostly in people with high triglyceride levels, and are not a cause for concern.

Instead, omega-3 fish oils lower blood levels of all non-HDL types of cholesterol… something that’s clinically proven more protective than lowering LDL cholesterol.

This effect of omega-3s is very significant, for three reasons (Bays H 2008; Bays HE et al. 2008):
  1. Having high blood levels of total non-HDL cholesterol predicts risk of arteriosclerosis better than having high LDL levels;

  2. Non-HDL cholesterol includes all of the cholesterol carried by oxidation-susceptible—hence, plaque-promoting—lipoproteins, not just LDL;

  3. After LDL-lowering treatment goals have been reached, reduction of total non-HDL cholesterol is a recommended secondary treatment target in patients with high blood triglyceride levels (200 mg/dl or more).
Bottom line: Lovaza® doesn’t deserve its exalted status or premium price
Even if Lovaza® is ultimately proven to present no real cholesterol-related risks, it still seems wrong that this super-costly fish oil supplement enjoys an exalted status that permits GSK shareholders to reap in largely undeserved profits.

Publicly funded university research showed that omega-3s lower triglycerides, and it was this public research that led GSK to pursue a patent for and gain drug approval for their high-potency but otherwise unremarkable supplement.

This all-too-typical outrage against taxpayers springs from the confluence of money and politics, nurtured by the revolving doors between Congress, regulatory agencies, and the drug industry.


Sources
  • Calabresi L, Villa B, Canavesi M, Sirtori CR, James RW, Bernini F, Franceschini G. An omega-3 polyunsaturated fatty acid concentrate increases plasma high-density lipoprotein 2 cholesterol and paraoxonase levels in patients with familial combined hyperlipidemia. Metabolism. 2004 Feb;53(2):153-8.
  • Calabresi L, Donati D, Pazzucconi F, Sirtori CR, Franceschini G. Omacor in familial combined hyperlipidemia: effects on lipids and low density lipoprotein subclasses. Atherosclerosis. 2000 Feb;148(2):387-96.
  • Davis W. Lovaza Rip-off. December 20, 2008. Accessed online at http://www.wellsphere.com/heart-health-article/lovaza-rip-off/534837
  • Harris WS, Miller M, Tighe AP, Davidson MH, Schaefer EJ. Omega-3 fatty acids and coronary heart disease risk: clinical and mechanistic perspectives. Atherosclerosis. 2008 Mar;197(1):12-24. Epub 2007 Dec 26. Review.
  • Harris WS, Kris-Etherton PM, Harris KA. Intakes of long-chain omega-3 fatty acid associated with reduced risk for death from coronary heart disease in healthy adults. Curr Atheroscler Rep. 2008 Dec;10(6):503-9. Review.
  • Lee JH, O'Keefe JH, Lavie CJ, Marchioli R, Harris WS. Omega-3 fatty acids for cardioprotection. Mayo Clin Proc. 2008 Mar;83(3):324-32. Review. Erratum in: Mayo Clin Proc. 2008 Jun;83(6):730.
  • McKenney JM, Sica D. Role of prescription omega-3 fatty acids in the treatment of hypertriglyceridemia. Pharmacotherapy. 2007 May;27(5):715-28. Review.
  • Montori VM, Farmer A, Wollan PC, Dinneen SF. Fish oil supplementation in type 2 diabetes: a quantitative systematic review. Diabetes Care. 2000 Sep;23(9):1407-15. Review.
  • Schwellenbach LJ, Olson KL, McConnell KJ, Stolcpart RS, Nash JD, Merenich JA; Clinical Pharmacy Cardiac Risk Service Study Group. The triglyceride-lowering effects of a modest dose of docosahexaenoic acid alone versus in combination with low dose eicosapentaenoic acid in patients with coronary artery disease and elevated triglycerides. J Am Coll Nutr. 2006 Dec;25(6):480-5.
  • Skulas-Ray AC, West SG, Davidson MH, Kris-Etherton PM. Omega-3 fatty acid concentrates in the treatment of moderate hypertriglyceridemia. Expert Opin Pharmacother. 2008 May;9(7):1237-48. Review.
  • Worst Pills Best Pills (WPBP). LOVAZA: Limited Use Drug for Lowering Trigylcerides. April, 2009. Accessed online at http://www.worstpills.org/member/newsletter.cfm?n_id=634

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