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Fish oil: A heart drug in Europe but not U.S.

By Elisabeth Rosenthal

International Herald Tribune

Oct. 4, 2006

 

Fish oil routinely used to treat heart patients in Europe, but not U.S.

 

Cardiologists across Italy and in a few other parts of Europe would consider it malpractice not to give heart attack patients a prescription for purified fish oil, whose active ingredients are two Omega-3 fatty acids. But in the United States - and, to a lesser degree, in Britain - heart attack victims do not generally get Omega-3 fatty acids from their doctors, even as they are routinely offered more expensive and invasive treatments.

 

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Every patient in the cardiac care unit at the San Filippo Neri Hospital who survives a heart attack goes home with a prescription for purified fish oil, said Dr. Marco Tubaro, the unit's director, surrounded by a sea of the latest pumps and monitors.

 

Cardiologists across Italy and in a few other parts of Europe would consider it malpractice to omit the drug, whose active ingredients are two Omega-3 fatty acids. "It is clearly recommended in international guidelines," said Dr. Massimo Santini, chief of cardiology at San Filippo Neri.

 

In a large number of studies, prescription fish oil has been shown to improve survival after heart attacks and to reduce fatal heart rhythms. The American College of Cardiology recently strengthened its position concerning the medical benefit of fish oil, although some critics say that studies have not defined the magnitude of the effect.

 

But in the United States, and, to a lesser degree, in Britain, heart attack victims do not generally get Omega-3 fatty acids from their doctors, even as they are routinely offered more expensive and invasive treatments, such as pills to lower cholesterol or implantable defibrillators. Prescription fish oil, sold under the brand name Omacor, is not even approved by the U.S. Food and Drug Administration for use in heart patients.

 

"Most cardiologists here are not giving Omega-3s even though the data supports it - there's a real disconnect," said Dr. Terry Jacobson, a preventive cardiologist at Emory University in Atlanta. "They have been very slow to incorporate the therapy."

 

The fact that heart patients receive such different treatments in sophisticated hospitals around the world illustrates that medicine, like everything else, has its fashions. It also highlights the central role that drug companies play in disseminating medical information, experts said.

 

Since prescription fish oil is not licensed in the United States to prevent heart disease, drug companies may not legally promote it for that purpose at conferences, in doctors' offices, to patients, or even on the Internet.

 

"If people paid more attention to guidelines, more people would be on the drug," Jacobson said. "But pharmaceutical companies can't drive this change. The fact that it's not licensed for this has definitely kept doctors away."

 

The first question on the Omacor Web site, www.solvay-omacor.com, is "Are you a U.S. citizen?" If the answer is "yes," the user is redirected to a page where heart attacks are not mentioned. (In the United States, Omacor is only licensed to treat the small number of people with extremely high blood- triglyceride levels.)

 

The fact that fish oil is also sold as a nutritional supplement has made it harder for some doctors to regard it as a powerful drug, experts said.

 

"Using this medicine is very popular here in Italy, I think partly because so many cardiologists in this country participated in the studies and were aware of the results," said Dr. Maria Franzosi, a researcher at the Mario Negri Institute in Milan. "In other countries, uptake may be harder because doctors think of it as just a dietary intervention."

 

In the largest, seminal study of fish oil - conducted more than a decade ago - Italian researchers from the GISSI group (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto) gave 11,000 patients each 1 gram of prescription fish oil a day after heart attacks. After three years, the number of deaths among those receiving the fish oil was reduced by 20 percent, compared with a control group.

 

Subsequent studies have continued to yield positive results, although some scientists say there are still gaps in knowledge. For example: can eating more fish - or taking over-the-counter supplements - provide the same benefits as the more expensive prescription medicine? There is less regulation of the nonprescription variant, so it is harder to ensure the proper dose and to make sure that there is no mercury contamination, doctors said.

 

This summer, a critical review of existing research in the British Medical Journal "cast doubt over the size of the effect of these medications" for the general population, "but still suggested that they might benefit some people as a treatment," said Dr. Roger Harrison, a co-author of the paper.

 

Harrison, who is currently conducting a trial on using Omega-3 acids to control abnormal heart rhythms, believes that people generally should increase their intake. But, he says, that is best done by eating more fish.

 

Still, he acknowledges that it is difficult to eat 1 gram of Omega-3 acids a day, as is recommended in guidelines. "If you ask me do I take Omega-3 supplements every day, then embarrassingly the answer is yes," said Harrison, a professor at Bolton Primary Care Trust of the University of Manchester in England. "I, too, am caught up in this hectic world where I have little time to shop and prepare the healthy foods I know I should be eating."

 

It is natural that Italy would be at the forefront of the fish oil trend, and home to the largest clinical trials. Scientists have long noted that Mediterranean diets were healthy for the heart and theorized that the high content of broiled and baked fish might be partially responsible.

 

But the landmark GISSI-Prevenzione trial of fish oil, conducted in Italy, was not a placebo-controlled blinded trial, meaning that patients treated with prescription fish oil pills were compared to untreated patients, rather than patients given a "dummy" pill. So, despite the impressive results, the trial did not meet U.S. Food and Drug Administrations standards for approval.

 

British regulators approved the pill, Omacor, at the end of 2003, for heart attack victims and most other countries in the European Union added it to their national formularies in 2004. But prescription of the drug is still highly spotty. Harrison said treatment with Omega-3 fatty acids was "not widely used" after heart attacks in Britain.

 

Further trials of Omacor would be needed for it to be licensed in the United States for heart attack patients, said Marylou Rowe, a spokeswoman for Reliant Pharmaceuticals, which has owned the U.S. license for the drug since late 2004.

 

In Europe, as in the United States, over-the-counter preparations of fish oil are sold in health food stores, but these have much less rigorous quality control and are often blends of the two fish oils know to be beneficial in heart disease, with other less useful fatty acids.

 

For that reason, Jacobson of Emory University gives the prescription drug, "off label" to cardiac patients even though it is not approved for that use. He says patients may take the over-the- counter pills, although there is uncertainty about the dose and they probably need three to four pills a day.

 

In Europe, the GISSI group is now conducting huge trials using fish oil to control abnormal heart rhythms, as well as in patients with heart failure.

 

In a pilot study here in Rome at San Filipo Neri Hospital, patients undergoing bypass surgery who were pretreated with Omega-3 fatty acids had a lower incidence of arrhythmia and needed one less day in intensive care, "which is traumatic for the patient and expensive," Santini said.


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