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The end of cholesterol…

Posted by medconsumers on August 15, 2011

It’s somewhat like observing the first signs of spring. Lipitor, the last of the block-buster cholesterol-lowering statin drugs, is about to go off patent, so you look around for signs that the affected drug companies have found a way to keep revenues up. Lovaza, a prescription-only capsule of omega-3 fatty acid may well fit the bill. It’s time to scare us about another blood lipid — triglycerides. After all, the statin drugmakers have gone about as far as they can go with the dangers of high cholesterol.

“Very high triglycerides [TG], or too much fat in the blood, are a “very serious medical condition,” say the Lovaza ads. Then comes the scary but vague, “having too many triglycerides in your blood may lead to future health problems.” And here’s the best part: “Lavaza has not been shown to prevent heart attack or stroke.” (Occasionally, the FDA requires drug ads to be honest.)

Are high TG really dangerous to health? “Not particularly is the short answer,” responded cardiologist Vikas Saini, MD, president of the Lown Cardiovascular Research Foundation,  which is affiliated with the unique second-opinion consultation center near Boston. In a telephone interview, Dr. Saini explained that when you pool the results of observational studies, there may be a little extra risk to having very high TG, but no one knows whether lowering TG will reduce the risk of cardiac events. Usually, elevated TG comes with high blood sugar and low HDL (good) cholesterol, so it’s hard to tease out the independent effect of TG alone. “I view high TG as a signal that that a patient’s energy balance is out of whack. In the vast majority, high TG is due to inactivity, weight gain, and a diet too high in carbs, specifically simple sugars and sweets.”

The statin drugmakers have always given lip service to lifestyle changes, knowing full well that many of us would prefer to pop a pill. The statin companies already made a bundle successfully marketing a drug that benefits only a tiny minority who take it (click here) and are unlikely to walk away from the goldmine without finding some way it can be reworked into another goldmine. One company has already tried—and failed—to get the FDA to allow the sale of its statin over-the-counter. (The FDA sees this as too risky without doctor supervision, but it could come around as pressure to reduce drug costs intensify.)

GlaxoSmithKline (GSK), maker of Lovaza, seems to have another plan. First, it can rightfully claim to be the only producer of fish oil capsules to have tested its product against a placebo to the FDA’s satisfaction. And as of four years ago GSK bought the right to make a generic version of the statin Mevacor after it lost patent protection.

GSK is positioning itself to produce a combination statin/fish oil drug and has already passed the FDA-required tests. (Agency standards aren’t all that rigorous; approval was based on two trials that went no longer than 16 weeks and showed TG went down and LDL cholesterol improved.) Once the combination drug becomes available, all GSK has to do now is make us think that purchasing its costly fish oil plus a statin in one pill is more convenient than taking them separately.  And perhaps an insurance company or two will pay a portion of the tab. This wouldn’t be the first time an off-patent statin was reworked into an expensive combination drug.  Remember Vytorin?   (See “Why is anyone taking Zetia or Vytorin?”)

“Fish oil is good,” says Dr. Saini, “but as a prescription drug [Lovaza] is likely to be more expensive than the over-the-counter fish oil capsules and/or eating fish high in omega-3 fatty acid [blue fish, mackerel, lake trout, anchovies, etc.], but then again I haven’t done any price comparison.”

Yes, but.   As with all dietary supplements, fish oil supplements do not have to meet any quality standards. The companies that make fish oil supplements are not required to conduct clinical trials to prove safety, effectiveness, or even that the product actually contains fish oil.  We can thank GSK for its tests which showed that the adverse effects like belching, indigestion and taste perversion, occurred in 3% more of the people on Lovaza, compared with those on the placebo. And the FDA-required label for Lovaza warns of fish oil’s potential effect on prolonged bleeding, advising physicians to monitor people taking anticoagulants or other drugs affecting coagulation (e.g., aspirin, NSAIDs, warfarin, Coumadin).

If you want to take a fish oil supplement, see which products were found to be the most trustworthy, according to the independent testing of ConsumerLab.Com (subscription fee is required).

Maryann Napoli, Center for Medical Consumers©

One Response to “The end of cholesterol…”

  1. [...] maker of the new prescription-strength fish oil medication, sold under the name Lovaza, has a new combination statin-fish oil drug in the works, which has reportedly already passed the required FDA [...]

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