Fish oil article in New York Times

[Guest guest]

This is the most emailed article in the Times today, and it makes me

wonder, has anyone thought of using the presription fish oil

supplement Omacor off-label for apraxia?

October 3, 2006

In Europe It's Fish Oil After Heart Attacks, but Not in U.S.

By ELISABETH ROSENTHAL

ROME — 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, or omega-3 fatty acids.

" It is clearly recommended in international guidelines, " said Dr.

Massimo Santini, the hospital's chief of cardiology, who added that

it would be considered tantamount to malpractice in Italy to omit

the drug.

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 on 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, heart attack victims are not generally

given omega-3 fatty acids, even as they are routinely offered more

expensive and invasive treatments, like pills to lower cholesterol

or implantable defibrillators. Prescription fish oil, sold under the

brand name Omacor, is not even approved by the Food and Drug

Administration for use in heart patients.

" Most cardiologists here are not giving omega-3's even though the

data supports it — there's a real disconnect, " said Dr. Terry

son, 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 highlights the central role

that drug companies play in disseminating medical information,

experts said.

Because prescription fish oil is not licensed to prevent heart

disease in the United States, 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, " Dr. son said. " But pharmaceutical companies can't

drive this change. The fact that it's not licensed for this has

definitely kept doctors away. "

For example, on Solvay Pharmaceutical's Web site for Omacor,

www.solvay-omacor.com, the first question a user sees is, " Are you a

U.S. citizen? "

If the answer is yes, the user is sent to a page where heart attacks

are not mentioned. (In the United States, Omacor is licensed only to

treat the small number of people with extremely high blood

triglyceride levels.)

So community doctors do not learn how to use the drug. Lack of

F.D.A. approval also means that insurers will not pay for treatment

with Omacor. Approval from the agency for the use of the drug in

heart disease is not expected soon.

A study published last month in The Journal of the American Board of

Family Medicine found that only 17 percent of family doctors were

likely to prescribe fish oil to their patients, including patients

who had suffered a heart attack. There was a great need, the authors

concluded, to " improve awareness of this important advice. "

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. Franzosi, a

researcher at the Negri Institute in Milan. " In other

countries, uptake may be harder because doctors think of it as just

a dietary intervention. "

In the largest 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 one

gram of prescription fish oil a day after heart attacks. After three

years, the study found that the number of deaths was reduced by 20

percent and that the number of sudden deaths by 40 percent, compared

with a control group.

Later studies have continued to yield positive results, although

some scientists say there are still gaps in knowledge.

This summer, a critical review of existing research in BMJ, The

British Medical Journal, " cast doubt over the size of the effect of

these medications " for the general population, said Dr.

on, an author of the paper, " but still suggested that they

might benefit some people as a treatment. "

Dr. on said he believed that people should generally increase

their intake of omega-3 acids, best done by eating more fish.

Still, he acknowledged that it was difficult to eat foods containing

a gram of omega-3 acids each day. " If you ask me do I take omega-3

supplements every day, then, embarrassingly, the answer is yes, "

said Dr. on, 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, " he

said.

It seems natural for Italy to be at the forefront of the fish oil

trend and home to the largest clinical trials. Scientists have long

noted that Mediterranean diets are salubrious for the heart and

theorized that the high content of broiled and baked fish might be

partly responsible.

But the landmark Gissi-Prevenzione trial of fish oil had

methodological weaknesses: the patients treated with prescription

fish oil pills were compared with untreated patients, rather than

with patients given a dummy pill. This meant that, despite

impressive results, the trial did not meet the F.D.A.'s standards

for approval. Yet by 2004, regulators in almost all European

countries, including Spain, France and Britain, had approved Omacor

for use in heart attack patients.

lou Rowe, a spokeswoman for Reliant Pharmaceuticals, which owns

the license for the drug in the United States, said that further

trials of Omacor would be needed for it to be licensed for heart

attack patients in the United States. But she refused to discuss a

timetable.

The American College of Cardiology now advises patients with

coronary artery disease to increase their consumption of omega-3

acids to one gram a day, but it does not specify if this should be

achieved by eating fish or by taking capsules. But over-the-counter

preparations of fish oil 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, Dr. son of Emory gives the prescription

drug, " off label, " to cardiac patients, even though the F.D.A. has

not approved it for that use. " Then I know exactly what they're

getting, and there is no mercury, " he said.

He said he tells patients who cannot afford the prescription version

that they can take the over-the-counter supplements, although there

is uncertainty about the dose and they probably need three to four

pills a day.

In Europe, meanwhile, research on prescription fish oil, which is

now thought to act by stabilizing cell membranes, has gained

momentum. The Gissi Group is conducting two huge trials using fish

oil in patients with abnormal heart rhythms and in patients with

heart failure.