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

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


    New York Times
    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 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 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. Jacobson 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, Omacor, 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. 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 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. Roger Harrison, an author of the paper, “but still suggested that they might benefit some people as a treatment.”

    Dr. Harrison 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. 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,” 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.

    Marylou 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. Jacobson 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.

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    Interesting.

    I wonder if fish oil's blood thinning properties come into efect here?
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    Quote Originally Posted by yeahright
    New York Times
    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 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 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. Jacobson 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, Omacor, 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. 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 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. Roger Harrison, an author of the paper, “but still suggested that they might benefit some people as a treatment.”

    Dr. Harrison 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. 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,” 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.

    Marylou 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. Jacobson 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.

    Maybe, if the fishoil industry would pay the FDA some "research" or kickback money, they would approve fish oil for its fat stabilizing effects. That's the procedure that the "statin drug" manufactures followed and it worked like a charm. The FDA is now "officially"(as of last week) rididled with corruption, to the point of "criminal" incompetence(vioxx) in certain cases. The rats are looking for scapegoats(insurance companies?) until they can get an exit strategy. It would be hard to imagine that anyone who can read (a lab report) would ever believe anything the FDA spouts!

    Fishoil = GOOD, criminal negligence for profit= BAD
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    Quote Originally Posted by NO HYPE
    Interesting.

    I wonder if fish oil's blood thinning properties come into efect here?
    So many medical conditions are turning out to have an inflamation component that it wouldn't surprise me.
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    3-4 caps i saw mentioned
    but how does all this correlate into what we take.for example i take NOW softgells they are a gram of fish oil each

    how do we know and breakdown how many mgs of the epa/dha and/or overal fishoil grammage to correlate to this study?

    ive been struggling with a wihle to idealize my omega3/fish oil consumption.some say 12 one gram softgels a day,some 4-6 some only 1-2 per day.

    whats the general consensus here on ideal intake?

    how potent are those script fishy pills?
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    As a general rule, you need to look at how much EPA/DHA are in the fish oil capsules. Some capsules may contain a gram of oil but only half a gram of that are the Omedga-3 fatty acids.

    Here is a link with medically verfied dosages for various conditions:

    Omega-3 fatty acids, fish oil, alpha-linolenic acid - MayoClinic.com

    Here is a link on the prescription fish oil mentioned in this article:

    Omega-3-acid ethyl esters (Systemic) - MayoClinic.com
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    good links thanks
    for the script page..it has this listed for sides?ive never heard of such things for fish oils wtf?
    also maybe i missed it but i couldnt find an actual epa/dha amt per script capsule.anyone know?

    More common

    Arm, back or jaw pain; chest pain or discomfort; chest tightness or heaviness; difficult or labored breathing; fast or irregular heartbeat; nausea; shortness of breath; sweating; tightness in chest; wheezing.

    Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

    Less common

    Back pain; bad unusual or unpleasant (after)taste; belching; bloated full feeling; change in taste; chills; cough; diarrhea; excess air or gas in stomach; fever; general feeling of discomfort or illness; headache; hoarseness; joint pain; loss of appetite; lower back or side pain; muscle aches and pains; pain; painful or difficult urination; rash; runny nose; shivering; sore throat; sweating; trouble sleeping; unusual tiredness or weakness; vomiting.

    Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
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    (containing 850-1800mg of EPA + DHA) reduces the risk of non-fatal heart attac

    when it states things like that...is this meaning combined total of epa/dhl together?
    say i wanted to take the higher end of this and ingest 1800mg of epa/dha per day as it says
    i have now brand softgels which have per two capsules
    360mg epa
    240mg dha
    other omega 80mg

    so thats 600mg epa/dha per two softgels correct?thats how i read that?so i would need to take 6 softgels per day to get 1800mg epa/dha per day?

    i was also wondering if these need to be spaced out thruought the day or if they can all be taken in one shot and if so,what would ideal timing be?
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    Quote Originally Posted by juggernaut333
    (containing 850-1800mg of EPA + DHA) reduces the risk of non-fatal heart attac

    when it states things like that...is this meaning combined total of epa/dhl together?
    say i wanted to take the higher end of this and ingest 1800mg of epa/dha per day as it says
    i have now brand softgels which have per two capsules
    360mg epa
    240mg dha
    other omega 80mg

    so thats 600mg epa/dha per two softgels correct?thats how i read that?so i would need to take 6 softgels per day to get 1800mg epa/dha per day?

    i was also wondering if these need to be spaced out thruought the day or if they can all be taken in one shot and if so,what would ideal timing be?
    Ummmmm, if my math is right, you would need THREE (not six) 600mg capsules to equal 1800mg.

    Yes, I space mine out throughout the day. I try and take one with breakfast, lunch and dinner (none on snack meals).
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    too much control


    [QUOTE=yeahright]New York Times
    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 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 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. Jacobson 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, Omacor, 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. 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 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. Roger Harrison, an author of the paper, “but still suggested that they might benefit some people as a treatment.”

    Dr. Harrison 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. 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,” 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.

    Marylou 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. Jacobson 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.[/QUOTEY Yeah right, i noticed your article kept referring to fishoil as a drug, even if it is a drug (all suplements probably are) it could be dangerous to look at them like that. Im saying that we dont need the pharmaceutical companies controling supplements, i'm sure they would like too.
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    Juggs,
    Bobo had said he thought 3-4 grams of the standared fish oil caps were fine per day (300 mgs total EPA+DHA per cap).
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    Quote Originally Posted by yeahright
    New York Times
    October 3, 2006

    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.
    I love this kind of stuff. NYT hilites the "central role" drug companies havve in this apparent problem. Meanwhile the drug companies would be happy to sell the stuff, but if they did sell it/recommend its prescription under these specific label claims the FDA would pounce on them like a panther on a rabbit. But it's the drug companies that are the problem.

    Plus I need to know, is this really still news to people that fish oil is good for cardiac health? I mean in all honesty what ****-nut needs a doctor to tell him this?
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    Yes, there are a lot of people who just dont read or get out much. And the doctors know what is good for them, they (doctors) either don't care, can't recomend anything not approved by the FDA for a specific ailment or are too concerned about generic (specific) protocol for treating whatever problem the person has so they they can hurry through their patients too make more money. You would think a doctor would take the time to make up a sheet for patients containing as much information for them as possible and links to other info just incase they missed something. I for one believe it is not easy to find a good doctor, at least in my area.
    And I know we live in a sue happy country, which is sad because it reflects that people dont have enough money, yeah i know some can never have enough and will stop a nothing to obtain 1 more dollar, this even goes for the little man, we all know about the wonderful BIG guy.
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    Quote Originally Posted by yeahright
    Ummmmm, if my math is right, you would need THREE (not six) 600mg capsules to equal 1800mg.

    Yes, I space mine out throughout the day. I try and take one with breakfast, lunch and dinner (none on snack meals).
    that dose is per two caps bro.i also think in general spacing supps out and timing is important.its just always nicer if one can wack it all in the am and forget it for the rest of the day.im gonna start dosing 2 three times a day spaced out evenly now.
    anyone aware of any studies that would be relevent to this as far as timing,and what/how it works with the meal taken with,such as slin sensitivity props,nute partitioning props,cellular misc..etc etc?
    sorry if that wasnt to clear
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    Quote Originally Posted by jmh80
    Juggs,
    Bobo had said he thought 3-4 grams of the standared fish oil caps were fine per day (300 mgs total EPA+DHA per cap).
    but for what purpose/s?fat burning and/or musclebuilding or for overall IDEAL health effects or all of the above?as sometimes those will differe know what i mean?

    i believe im feeling comfortable and gonna stick with 2 1g caps three times a day w/ bfast,lunch,dinner
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    I think that was for general health, Juggs.
  

  
 

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