Interesting NY Times Article

[Guest guest]

Thought it might be of interest to the group. ~ Dani

interesting NY Times article

October 3, 2006 ©New York Times

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.

[Guest guest]

Good info on GF restaurants and their menus.

http://tinyurl.com/36766u