quote from journal article

Discussion in 'Health and medical' started by Kathy, Jan 25, 2004.

  1. Kathy

    Kathy Guest

    "At the present time, the value of treating hyperlipidemia in patients greater than 80 years of age
    is unknown, and therapy in this age group must be individualized. (c)1999 by CVRR, Inc."

    Is this a joke or what? How can you individualize therapy if the value is unknown?
     
    Tags:


  2. Nigel

    Nigel Guest

    [email protected] (Kathy) wrote in news:b98653c0.0401250033.1379a550
    @posting.google.com:

    > "At the present time, the value of treating hyperlipidemia in patients greater than 80 years of
    > age is unknown, and therapy in this age group must be individualized. (c)1999 by CVRR, Inc."
    >
    > Is this a joke or what? How can you individualize therapy if the value is unknown?
    >

    Not a joke, the vocabulary of science.

    Therapy must be individualized to attain the clinical end point; a change of blood cholesterol
    levels as measured in the lab.

    Of unknown value because in this group, there is no evidence of a change in morbidity or mortality.
     
  3. Badant

    Badant Guest

    Nigel <I.don'[email protected]> wrote in message news:<[email protected]>...
    > [email protected] (Kathy) wrote in news:b98653c0.0401250033.1379a550 @posting.google.com:
    >
    > > "At the present time, the value of treating hyperlipidemia in patients greater than 80 years of
    > > age is unknown, and therapy in this age group must be individualized. (c)1999 by CVRR, Inc."
    > >
    > > Is this a joke or what? How can you individualize therapy if the value is unknown?
    > >
    >
    > Not a joke, the vocabulary of science.
    >
    > Therapy must be individualized to attain the clinical end point; a change of blood cholesterol
    > levels as measured in the lab.
    >
    > Of unknown value because in this group, there is no evidence of a change in morbidity or
    > mortality.

    Benefit? Little to none in ANY group. Rather, debilitating adverse effect. B'adant

    Unclogging the heart debate: Do cholesterol pills help or harm?

    By PAUL TAYLOR Saturday, January 24, 2004 - Page F4

    For the past three years, Melvyn Mould has been taking a medication to keep his cholesterol under
    control. The 62-year-old retired carpenter never liked the idea of being on a drug. So he also
    adhered to a strict low-fat diet and exercised regularly, hoping to reduce his dependence on the
    daily pill. And now Mr. Mould's efforts appear to be paying off.

    After recently doubling his exercise routine -- to six days a week from three -- his LDL, or so-
    called bad cholesterol, has been cut by almost half. If his LDL remains low at his next medical
    checkup, Mr. Mould's doctor may decide to reduce or eliminate the drug entirely.

    "I am really looking forward to my next appointment," says Mr. Mould, who lives in Toronto.

    Mr. Mould would be bucking a trend if he is taken off medication. More patients are going on these
    powerful drugs all the time. From 1998 to 2003, the number of prescriptions filled in Canada for
    cholesterol medications skyrocketed to 16 million from seven million, IMS Health Canada reports.
    The dollar value of those drug sales soared to $1.4-billion from $675-million.

    A panel of Canadian heart specialists recently issued new guidelines to help family physicians
    decide which of their patients should be taking cholesterol medications based on a variety of risk
    factors for cardiovascular disease. The guidelines, published in the Canadian Medical Association
    Journal, could increase the number of patients considered at high risk of a heart attack -- and
    deemed in need of immediate drug treatment.

    But some doctors are worried about the increasing reliance on medications. "My concern is that
    people may rush [to drug treatment] without actually seeing whether lifestyle changes can make
    a difference," said Dr. David Jenkins, director of a treatment clinic at St. Michael's Hospital
    in Toronto.

    Ms. Michael Evans, an assistant professor at the University of Toronto, shares those concerns. "As a
    family doctor, I would prefer if patients got increased exercise and developed better eating
    habits and therefore lost weight because they would have less chance of developing
    osteoarthritis and diabetes -- and it can even improve their sleep."

    Mt. Jim Wright, a professor at University of British Columbia, has touched off a fierce debate in
    the medical community by suggesting that some patients might actually be harmed by the over-
    prescription of these drugs.

    He points out that taking medication carries the risk of some side effects such as liver function
    problems, muscle aches and pains, and possible nerve damage. For patients who truly are at an
    elevated chance of suffering a debilitating or even lethal heart attack, those risks are clearly
    worth it. But the benefit is not so clear-cut in patients who are at far lower probability of having
    an attack, he argues.

    Mu. Wright recently reviewed the data from several major international trials of the leading cholesterol-
    lowering drugs, known as statins, to determine their effects on lower-risk patients. He found
    that the drugs produced a drop of 1 to 2 per cent in total heart attacks and strokes over a three-to-five-
    year period. But these benefits seemed to be washed away by other unexplained adverse events
    which weren't specified in the studies. The patients on the drugs ended up in hospital with "life-
    threatening events" just as many times as people popping the placebos.

    "There is good reason to not be taking the drugs unless you are pretty confident that you are in a
    group that is going to stand to benefit,"
    Mv. Wright said.

    He also takes issue with the new cholesterol guidelines, insisting that there is not enough
    scientific evidence to back them up.

    Mw. Ruth McPherson, one of the authors of the guidelines and a professor at the University of
    Ottawa, defends her work. "I don't think it's true that we are treating people who don't require
    treatment."

    The debate has become so heated, in part, because much is still unknown about cardiovascular
    disease. Studies have not yet demonstrated the ideal level for cholesterol.

    What has been clearly established is that lowering cholesterol in a person who has already had one
    heart attack greatly reduces the chances of a second attack. Treating these patients is known as
    secondary prevention, and all the experts agree that it makes sense to focus medical efforts on
    people with proven heart disease.

    But doctors also want to help people before they've had their first heart attack, a treatment
    strategy known as primary prevention. And this is where the guesswork begins. Medical experts have
    tried to put together a list of risk factors, such as cholesterol, blood pressure and smoking
    habits, which may predispose people to atherosclerosis.

    However, the known risks account for only about half of all cases of heart disease. To complicate
    matters further, the medical view of heart disease is rapidly changing with advances in research.

    Experts used to think heart disease was caused by the simple accumulation of fatty deposits inside
    blood vessels. Now, they see it as the end result of a far more complex inflammatory process. It
    starts when certain fats and other highly reactive substances float through the bloodstream
    gradually damaging the inside lining of the blood vessels. This leads to the buildup of plaque -- a
    form of scar tissue -- which is filled with various fats and cellular debris. At first, the growing
    plaque doesn't impede blood flow. But in time, the plaque can rupture and form a clot -- triggering
    a heart attack or stroke.

    If doctors had an easy way to peer inside blood vessels, they would have a better idea of which
    patients are at greatest risk of heart disease. Dr. David Spence believes he has developed just such
    a test. The professor at the Robarts Research Institute in London, Ont., has been using ultrasound
    to create two-dimensional images of plaque deposits in the arteries.

    His tests have focused on the carotid arteries just under the surface of the neck. Dr. Spence
    says these images of the carotid arteries provide a window of what's happening in blood vessels
    in the heart.

    In a five-year study, he found that patients with the highest plaque deposits in their carotid
    arteries were 3.5 times more likely to suffer a heart attack, stroke or death than those with the
    lowest deposits.

    "The benefit of doing these plaque measurements is that it sorts out who is at risk and who isn't --
    and I believe it will make therapy much more cost effective, he said. "Some version of this is how
    people are going to be treating the arteries in the next ten years," he predicts. If he's correct,
    it may go a long way to settling the current debate.

    Paul Taylor is a Globe and Mail assistant national editor, responsible for health and
    science coverage.
     
  4. Jg

    Jg Guest

    "Badant" <[email protected]> wrote...
    > Nigel <I.don'[email protected]> wrote>...
    > > [email protected] (Kathy) wrote in news:b98653c0.0401250033.1379a550 @posting.google.com:
    > >
    > > > "At the present time, the value of treating hyperlipidemia in patients greater than 80 years
    > > > of age is unknown, and therapy in this age group must be individualized. (c)1999 by CVRR,
    > > > Inc."
    > > >
    > > > Is this a joke or what? How can you individualize therapy if the value is unknown?
    > > >
    > >
    > > Not a joke, the vocabulary of science.
    > >
    > > Therapy must be individualized to attain the clinical end point; a
    change
    > > of blood cholesterol levels as measured in the lab.
    > >
    > > Of unknown value because in this group, there is no evidence of a change
    in
    > > morbidity or mortality.
    >
    >
    > Benefit? Little to none in ANY group. Rather, debilitating adverse effect.

    ANY group? In the studies that I've seen, statins have decreased CV mortality by 40% or more and all-
    cause mortality by around one-third.

    > Unclogging the heart debate: Do cholesterol pills help or harm?
    >
    > By PAUL TAYLOR Saturday, January 24, 2004 - Page F4
    >
    > For the past three years, Melvyn Mould has been taking a medication to keep his cholesterol under
    > control. The 62-year-old retired carpenter never liked the idea of being on a drug. So he also
    > adhered to a strict low-fat diet and exercised regularly, hoping to reduce his dependence on the
    > daily pill. And now Mr. Mould's efforts appear to be paying off.
    >
    > After recently doubling his exercise routine -- to six days a week from three -- his LDL, or so-
    > called bad cholesterol, has been cut by almost half. If his LDL remains low at his next medical
    > checkup, Mr. Mould's doctor may decide to reduce or eliminate the drug entirely.
    >
    > "I am really looking forward to my next appointment," says Mr. Mould, who lives in Toronto.
    >
    > Mr. Mould would be bucking a trend if he is taken off medication. More patients are going on these
    > powerful drugs all the time. From 1998 to 2003, the number of prescriptions filled in Canada
    > for cholesterol medications skyrocketed to 16 million from seven million, IMS Health Canada
    > reports. The dollar value of those drug sales soared to $1.4-billion from $675-million.
    >
    > A panel of Canadian heart specialists recently issued new guidelines to help family physicians
    > decide which of their patients should be taking cholesterol medications based on a variety of risk
    > factors for cardiovascular disease. The guidelines, published in the Canadian Medical Association
    > Journal, could increase the number of patients considered at high risk of a heart attack -- and
    > deemed in need of immediate drug treatment.
    >
    > But some doctors are worried about the increasing reliance on medications. "My concern is that
    > people may rush [to drug treatment] without actually seeing whether lifestyle changes can make a
    > difference," said Dr. David Jenkins, director of a treatment clinic at St. Michael's Hospital in
    > Toronto.
    >
    > Dr. Michael Evans, an assistant professor at the University of Toronto, shares those concerns. "As
    > a family doctor, I would prefer if patients got increased exercise and developed better eating
    > habits and therefore lost weight because they would have less chance of developing
    > osteoarthritis and diabetes -- and it can even improve their sleep."
    >
    > Dr. Jim Wright, a professor at University of British Columbia, has touched off a fierce debate in
    > the medical community by suggesting that some patients might actually be harmed by the over-
    > prescription of these drugs.
    >
    > He points out that taking medication carries the risk of some side effects such as liver function
    > problems, muscle aches and pains, and possible nerve damage. For patients who truly are at an
    > elevated chance of suffering a debilitating or even lethal heart attack, those risks are clearly
    > worth it. But the benefit is not so clear-cut in patients who are at far lower probability of
    > having an attack, he argues.
    >
    > Dr. Wright recently reviewed the data from several major international trials of the leading cholesterol-
    > lowering drugs, known as statins, to determine their effects on lower-risk patients. He found
    > that the drugs produced a drop of 1 to 2 per cent in total heart attacks and strokes over a
    > three-to-five-year period. But these benefits seemed to be washed away by other unexplained
    > adverse events which weren't specified in the studies. The patients on the drugs ended up in
    > hospital with "life-threatening events" just as many times as people popping the placebos.
    >
    > "There is good reason to not be taking the drugs unless you are pretty confident that you are in a
    > group that is going to stand to benefit,"
    > Dr. Wright said.
    >
    > He also takes issue with the new cholesterol guidelines, insisting that there is not enough
    > scientific evidence to back them up.
    >
    > Dr. Ruth McPherson, one of the authors of the guidelines and a professor at the University of
    > Ottawa, defends her work. "I don't think it's true that we are treating people who don't
    > require treatment."
    >
    > The debate has become so heated, in part, because much is still unknown about cardiovascular
    > disease. Studies have not yet demonstrated the ideal level for cholesterol.
    >
    > What has been clearly established is that lowering cholesterol in a person who has already had one
    > heart attack greatly reduces the chances of a second attack. Treating these patients is known as
    > secondary prevention, and all the experts agree that it makes sense to focus medical efforts on
    > people with proven heart disease.
    >
    > But doctors also want to help people before they've had their first heart attack, a treatment
    > strategy known as primary prevention. And this is where the guesswork begins. Medical experts have
    > tried to put together a list of risk factors, such as cholesterol, blood pressure and smoking
    > habits, which may predispose people to atherosclerosis.
    >
    > However, the known risks account for only about half of all cases of heart disease. To complicate
    > matters further, the medical view of heart disease is rapidly changing with advances in research.
    >
    > Experts used to think heart disease was caused by the simple accumulation of fatty deposits inside
    > blood vessels. Now, they see it as the end result of a far more complex inflammatory process. It
    > starts when certain fats and other highly reactive substances float through the bloodstream
    > gradually damaging the inside lining of the blood vessels. This leads to the buildup of plaque --
    > a form of scar tissue -- which is filled with various fats and cellular debris. At first, the
    > growing plaque doesn't impede blood flow. But in time, the plaque can rupture and form a clot --
    > triggering a heart attack or stroke.
    >
    > If doctors had an easy way to peer inside blood vessels, they would have a better idea of which
    > patients are at greatest risk of heart disease. Dr. David Spence believes he has developed just
    > such a test. The professor at the Robarts Research Institute in London, Ont., has been using
    > ultrasound to create two-dimensional images of plaque deposits in the arteries.
    >
    > His tests have focused on the carotid arteries just under the surface of the neck. Dr. Spence
    > says these images of the carotid arteries provide a window of what's happening in blood vessels
    > in the heart.
    >
    > In a five-year study, he found that patients with the highest plaque deposits in their carotid
    > arteries were 3.5 times more likely to suffer a heart attack, stroke or death than those with the
    > lowest deposits.
    >
    > "The benefit of doing these plaque measurements is that it sorts out who is at risk and who isn't
    > -- and I believe it will make therapy much more cost effective, he said. "Some version of this is
    > how people are going to be treating the arteries in the next ten years," he predicts. If he's
    > correct, it may go a long way to settling the current debate.
    >
    > Paul Taylor is a Globe and Mail assistant national editor, responsible for health and science
    > coverage.
     
  5. Al. Lohse

    Al. Lohse Guest

    JG wrote:
    >
    > "Badant" <[email protected]> wrote...
    > > Nigel <I.don'[email protected]> wrote>...
    > > > [email protected] (Kathy) wrote in news:b98653c0.0401250033.1379a550 @posting.google.com:
    > > >
    > > > > "At the present time, the value of treating hyperlipidemia in patients greater than 80 years
    > > > > of age is unknown, and therapy in this age group must be individualized. (c)1999 by CVRR,
    > > > > Inc."
    > > > >
    > > > > Is this a joke or what? How can you individualize therapy if the value is unknown?
    > > > >
    > > >
    > > > Not a joke, the vocabulary of science.
    > > >
    > > > Therapy must be individualized to attain the clinical end point; a
    > change
    > > > of blood cholesterol levels as measured in the lab.
    > > >
    > > > Of unknown value because in this group, there is no evidence of a change
    > in
    > > > morbidity or mortality.
    > >
    > >
    > > Benefit? Little to none in ANY group. Rather, debilitating adverse effect.
    >
    > ANY group? In the studies that I've seen, statins have decreased CV mortality by 40% or more and
    > all-cause mortality by around one-third.
    >

    Please, JG, direct us to such studies. Simply post some URL's.

    Thanks,

    A.L.
     
  6. Jg

    Jg Guest

    "Al. Lohse" <[email protected]> wrote ...
    > JG wrote:
    > > "Badant" <[email protected]> wrote...
    > > > Nigel <I.don'[email protected]> wrote>...
    > > > > [email protected] (Kathy) wrote :
    > > > >
    > > > > > "At the present time, the value of treating hyperlipidemia in patients greater than 80
    > > > > > years of age is unknown, and therapy in this age group must be individualized. (c)1999 by
    > > > > > CVRR, Inc."
    > > > > >
    > > > > > Is this a joke or what? How can you individualize therapy if the value is unknown?
    > > > > >
    > > > >
    > > > > Not a joke, the vocabulary of science.
    > > > >
    > > > > Therapy must be individualized to attain the clinical end point; a
    > > change
    > > > > of blood cholesterol levels as measured in the lab.
    > > > >
    > > > > Of unknown value because in this group, there is no evidence of a
    change
    > > in
    > > > > morbidity or mortality.
    > > >
    > > >
    > > > Benefit? Little to none in ANY group. Rather, debilitating adverse effect.
    > >
    > > ANY group? In the studies that I've seen, statins have decreased CV mortality by 40% or more and
    > > all-cause mortality by around one-third.
    > >
    >
    > Please, JG, direct us to such studies. Simply post some URL's.

    Here are just a few cites; the abstracts are available on Medline.
    http://www.ncbi.nlm.nih.gov/PubMed/ Note this is not to say that statins are effective in ALL
    populations (their efficacy in primary prevention is questionable); but the previous poster's
    assertion that they were of little or no benefit in ANY group is pretty clearly false.

    Pedersen TR. Coronary artery disease: the Scandinavian Simvastatin Survival Study experience. Am J
    Cardiol. 82(10B):53T-56, 1998.

    Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin
    in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas
    Coronary Atherosclerosis Prevention Study. JAMA. 279(20):1615-1622, 1998.

    Hebert PR, Gaziano JM, Chan KS, Hennekens CH. Cholesterol lowering with statin drugs, risk of
    stroke, and total mortality. An overview of randomized trials. JAMA. 278(4):313-321, 1997.

    Vrecer M, Turk S, Drinovec J, Mrhar A. Use of statins in primary and secondary prevention of
    coronary heart disease and ischemic stroke. Meta-analysis of randomized trials. Int J Clin Pharmacol
    Ther. 2003 Dec;
    41(12): 567-77.
     
  7. Al. Lohse

    Al. Lohse Guest

    JG wrote:
    >
    > "Al. Lohse" <[email protected]> wrote ...
    > > JG wrote:
    > > > "Badant" <[email protected]> wrote...
    > > > > Nigel <I.don'[email protected]> wrote>...
    > > > > > [email protected] (Kathy) wrote :
    > > > > >
    > > > > > > "At the present time, the value of treating hyperlipidemia in patients greater than 80
    > > > > > > years of age is unknown, and therapy in this age group must be individualized. (c)1999
    > > > > > > by CVRR, Inc."
    > > > > > >
    > > > > > > Is this a joke or what? How can you individualize therapy if the value is unknown?
    > > > > > >
    > > > > >
    > > > > > Not a joke, the vocabulary of science.
    > > > > >
    > > > > > Therapy must be individualized to attain the clinical end point; a
    > > > change
    > > > > > of blood cholesterol levels as measured in the lab.
    > > > > >
    > > > > > Of unknown value because in this group, there is no evidence of a
    > change
    > > > in
    > > > > > morbidity or mortality.
    > > > >
    > > > >
    > > > > Benefit? Little to none in ANY group. Rather, debilitating adverse effect.
    > > >
    > > > ANY group? In the studies that I've seen, statins have decreased CV mortality by 40% or more
    > > > and all-cause mortality by around one-third.
    > > >
    > >
    > > Please, JG, direct us to such studies. Simply post some URL's.
    >

    Thank you very much on your reply. Allow me to clarify, to illuminate.

    > Here are just a few cites; the abstracts are available on Medline.
    > http://www.ncbi.nlm.nih.gov/PubMed/ Note this is not to say that statins are effective in ALL
    > populations (their efficacy in primary prevention is questionable); but the previous poster's
    > assertion that they were of little or no benefit in ANY group is pretty clearly false.
    >
    > Pedersen TR. Coronary artery disease: the Scandinavian Simvastatin Survival Study experience. Am J
    > Cardiol. 82(10B):53T-56, 1998.

    4S is anomalous in the benefits it discovered. The authors of the original study told us the
    sponsor had an insider in on the trial. The authors did not tell us the insider had no access to
    the raw data.

    >
    > Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin
    > in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas
    > Coronary Atherosclerosis Prevention Study. JAMA. 279(20):1615-1622, 1998.

    AFCAPS, though statistically insignificant, showed slightly greater mortality in the treated group
    than in the untreated group. Not something I would count amongst the successes, certainly no 33% on
    all cause mortality.

    >
    > Hebert PR, Gaziano JM, Chan KS, Hennekens CH. Cholesterol lowering with statin drugs, risk of
    > stroke, and total mortality. An overview of randomized trials. JAMA. 278(4):313-321, 1997.

    AN "overview" can only be considered to be valid if ALL the information from ALL the trials is
    available. We have learned recently that sponsors can close trials that are not showing favourable
    results without publishing those results. You have to agree that an "overview" of *selected* trials
    lacks generality.

    >
    > Vrecer M, Turk S, Drinovec J, Mrhar A. Use of statins in primary and secondary prevention of
    > coronary heart disease and ischemic stroke. Meta-analysis of randomized trials. Int J Clin
    > Pharmacol Ther. 2003 Dec;
    > 41(12): 567-77.

    "Meta-analysis," like "overview," is only valid if ALL the information is available, especially that
    from abandoned trials. Unless we are certain all the information is available to the authors, "meta-
    analyses" and "overviews" cannot help but yield overly optimistic results.

    Also, I think most of us would agree, the most reliable information comes from the publications of
    the original studies. Write-ups based on those studies can be "ghost" written and can emphasize
    positives while ignoring or de-emphasizing negatives. Ghost written articles are marketing tools.

    So, your statement: "In the studies that I've seen, statins have decreased CV mortality by 40% or
    more and all-cause mortality by around one-third." is not entirely correct. It is quite possible
    that marketing interests only wanted you to see reports or write-ups of those studies.

    I think, what is really needed, is to determine how people fare on those drugs in the real world.
    Comparing a population on those drugs with a similar population not on the drugs would go a long way
    to proving whether the beneficial results of *reported* clinical trials can be obtained in the
    public at large.

    Regards,

    A.L.
     
  8. Jg

    Jg Guest

    "Al. Lohse" <[email protected]> wrote...
    > JG wrote:
    > > "Al. Lohse" <[email protected]> wrote ...
    > > > JG wrote:
    > > > > "Badant" <[email protected]> wrote...
    > > > > > Nigel <I.don'[email protected]> wrote>...
    > > > > > > [email protected] (Kathy) wrote :
    > > > > > >
    > > > > > > > "At the present time, the value of treating hyperlipidemia in
    > > > > > > > patients greater than 80 years of age is unknown, and therapy
    > > > > > > > in this age group must be individualized. (c)1999 by CVRR,
    Inc."
    > > > > > > >
    > > > > > > > Is this a joke or what? How can you individualize therapy if the value is unknown?
    > > > > > >
    > > > > > > Not a joke, the vocabulary of science.
    > > > > > >
    > > > > > > Therapy must be individualized to attain the clinical end point;
    a
    > > > > change
    > > > > > > of blood cholesterol levels as measured in the lab.
    > > > > > >
    > > > > > > Of unknown value because in this group, there is no evidence of
    a
    > > change
    > > > > in
    > > > > > > morbidity or mortality.
    > > > > >
    > > > > >
    > > > > > Benefit? Little to none in ANY group. Rather, debilitating adverse effect.
    > > > >
    > > > > ANY group? In the studies that I've seen, statins have decreased CV mortality by 40% or more
    > > > > and all-cause mortality by around
    one-third.
    > > > >
    > > >
    > > > Please, JG, direct us to such studies. Simply post some URL's.
    > >
    >
    > Thank you very much on your reply. Allow me to clarify, to illuminate.
    >
    >
    > > Here are just a few cites; the abstracts are available on Medline.
    > > http://www.ncbi.nlm.nih.gov/PubMed/ Note this is not to say that statins are effective in ALL
    > > populations
    (their
    > > efficacy in primary prevention is questionable); but the previous
    poster's
    > > assertion that they were of little or no benefit in ANY group is pretty clearly false.
    > >
    > > Pedersen TR. Coronary artery disease: the Scandinavian Simvastatin
    Survival
    > > Study experience. Am J Cardiol. 82(10B):53T-56, 1998.
    >
    > 4S is anomalous in the benefits it discovered. The authors of the original study told us the
    > sponsor had an insider in on the trial. The authors did not tell us the insider had no access to
    > the raw data.

    It's impossible to answer such a allegation--You're essentially implying falsification of data. It's
    possible, but some proof is required.

    > > Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute
    coronary
    > > events with lovastatin in men and women with average cholesterol levels: results of
    > > AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 279(20):1615-
    > > 1622, 1998.
    >
    > AFCAPS, though statistically insignificant, showed slightly greater mortality in the treated group
    > than in the untreated group. Not something I would count amongst the successes, certainly no 33%
    > on all cause mortality.

    But this was in patients without clinically evident atherosclerotic cardiovascular disease (and
    normal total cholesterol and LDL); as I said, the benefit in this group is still debatable. And
    lovastatin did *significantly* reduce the incidence of first acute major coronary event (P <.001),
    myocardial infarction (P =.002), unstable angina (P = .02), coronary revascularization procedures (P
    =.001), coronary events (P =.006), and cardiovascular events (P = .003).

    > > Hebert PR, Gaziano JM, Chan KS, Hennekens CH. Cholesterol lowering with statin drugs, risk of
    > > stroke, and total mortality. An overview of
    randomized
    > > trials. JAMA. 278(4):313-321, 1997.
    >
    > AN "overview" can only be considered to be valid if ALL the information from ALL the trials is
    > available. We have learned recently that sponsors can close trials that are not showing favourable
    > results without publishing those results. You have to agree that an "overview" of *selected*
    > trials lacks generality.

    Again, you seem to be implying that falsification or trimming of data was involved in some studies.
    It's possible, but I'd want proof.

    > > Vrecer M, Turk S, Drinovec J, Mrhar A. Use of statins in primary and secondary prevention of
    > > coronary heart disease and ischemic stroke. Meta-analysis of randomized trials. Int J Clin
    > > Pharmacol Ther. 2003 Dec;
    > > 41(12): 567-77.
    >
    > "Meta-analysis," like "overview," is only valid if ALL the information is available, especially
    > that from abandoned trials. Unless we are certain all the information is available to the authors,
    > "meta-analyses" and "overviews" cannot help but yield overly optimistic results.
    >
    > Also, I think most of us would agree, the most reliable information comes from the publications of
    > the original studies. Write-ups based on those studies can be "ghost" written and can emphasize
    > positives while ignoring or de-emphasizing negatives. Ghost written articles are marketing tools.

    Actually, many of the primary research articles reporting on clinical trials are written by "ghost
    writers." A review article may well be written by a ghost writer; but I've never seen a meta-
    analysis so written, and it seems unlikely because of the nature of such articles.

    The question of ghost writers was discussed here recently; I'll repeat what I posted:

    Many articles appearing in the medical journals are indeed written by professional writers whose
    name does not appear as an author. So what? The data used for the article are from actual
    clinical trials conducted by medical research scientists, usually the ones whose names do appear
    on the article.

    If those studies are for a new drug application, the protocols have been approved by the FDA as well
    as the review boards at the hospital or university where they are conducted (and paid for by the
    drug company that is evaluating the drug). Or, if it's a review article, it's based on a review of
    publications appearing in peer-reviewed journals. In all cases, those listed as authors read and
    approve the article before submission. They can and usually do make any changes that they wish. In
    fact, such articles usually go through a much more extensive review process than articles written by
    researchers themselves. And I know because I've been through both processes many times.

    Far from being a "deception," this practice just facilitates the communication of important findings
    by leaving the writing to a professional who knows how to present them clearly.

    Articles *not* involving ghost writers (i.e., written entirely by academic researchers) also
    commonly include authors who have had little to do with the research or writing of the article.
    They are listed as authors because they are head of the lab or section or even for reasons of
    internal politics.

    > So, your statement: "In the studies that I've seen, statins have decreased CV mortality by 40% or
    > more and all-cause mortality by around one-third." is not entirely correct. It is quite possible
    > that marketing interests only wanted you to see reports or write-ups of those studies.
    >
    > I think, what is really needed, is to determine how people fare on those drugs in the real world.
    > Comparing a population on those drugs with a similar population not on the drugs would go a long
    > way to proving whether the beneficial results of *reported* clinical trials can be obtained in the
    > public at large.

    > Regards,
    >
    > A.L.
     
  9. 1833418809

    1833418809 Guest

    > "At the present time, the value of treating hyperlipidemia in patients greater than 80 years of
    > age is unknown, and therapy in this age group must be individualized. (c)1999 by CVRR, Inc."
    >
    > Is this a joke or what? How can you individualize therapy if the value is unknown?

    "individualized" refers to the heterogeneity of the condition.
     
  10. David Rind

    David Rind Guest

    Kathy wrote:
    > "At the present time, the value of treating hyperlipidemia in patients greater than 80 years of
    > age is unknown, and therapy in this age group must be individualized. (c)1999 by CVRR, Inc."
    >
    > Is this a joke or what? How can you individualize therapy if the value is unknown?

    Ignoring that this is from a 1999 article apparently, you could have individualized at the time by
    extrapolating from existing data in younger people, and only treating those who had a number of
    cardiac risk factors but were otherwise in good enough health that they were expected to live five
    or ten years. The article is presumably pointing out that treating high cholesterol levels in
    someone who is debilitated or has a rapidly fatal illness is not likely to be of much benefit.

    --
    David Rind [email protected]
     
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