Drug makers lured by fish oil’s heart benefit
But results on effectiveness in lowering cholesterol elusive
Bloomberg News
Fish oil has been touted as useful for everything from growing hair to treating clinical depression. Now drug makers are stepping up their promotion of its benefits for treating heart disease.
AstraZeneca, Amarin and GlaxoSmithKline are betting the market for prescription fish-oil pills will follow the success of cholesterol-lowering drugs including Lipitor, once the world’s best-selling medicine with revenue of $13 billion a year.
Heart disease remains the world’s biggest killer, accounting for 30 percent of global deaths, even as statins and other treatments have become more widely used. Now that Lipitor and many other statins have cheaper, generic competitors, drugmakers are looking for new ways to tackle the array of conditions that can lead to heart disease, including coupling triglyceride treatments with existing cholesterol-lowering pills for a one-two punch.
“The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes,” AstraZeneca chief executive officer Pascal Soriot said when he bought fish-oil pill maker Omthera Pharmaceuticals Inc. for $443 million last month. “There is a clear need for effective and convenient alternatives to some of the existing treatments.”
Unlike capsules that can be bought in healthfood stores, the drugmakers’ products are available only with a prescription, are highly concentrated and undergo a severalstep purification process approved by the U.S. Food and Drug Administration.
There’s a hitch, however. Statins have been proven in studies to cut heart risk. The benefits of fish- oil pills are less certain. Though they target triglycerides, fatty substances in the blood that have been linked to a higher risk of heart attacks, little evidence exists that the pills prevent heart attacks.
“It’s very unclear what role fatty acids play for cardiac patients,” Mark Urman, a member of the American College of Cardiology Prevention Committee and practicing cardiologist at Cedars-Sinai Heart Institute, said in an interview. “The lab tests look better, but has it done the patient any good?”
Study results have been mixed. Japanese research on almost 19,000 people who took fish oil with a statin had a 19 percent lower risk of heart attacks, sudden cardiac death and other Studies remain mixed on whether fatty acids from fish, like this salmon, provide health benefits. major coronary events, compared with those who took a statin alone.
A late-stage trial of Vascepa sponsored by Amarin found that it cut triglyceride levels by almost 22 percent at a 4-gram dose and 10 percent at a 2-gram dose without raising cholesterol levels in patients taking statins.
Other t rials have shown little or no benefit. A study of more than 12,500 patients showed that a 1-gram daily dose of omega-3 fatty acids didn’t prevent death or other cardiovascular events compared with placebo, according to an article in the New England Journal of Medicine in June 2012. And a review of data from 68,000 patients who took fish oil supplements over 24 years showed no reduction in risk of heart attack, stroke and death, the Journal of the American Medical Association said in September.
Without much evidence to support the claim that the pills cut heart risk, health- care purchasers remain skeptical of the benefits. Britain’s medical spending watchdog, the National Institute for Health and Care Excellence, this month said it no longer recommends that heart attack survivors take fish-oil pills to prevent further heart attacks, citing their “minimal” benefit.