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Posted: 27 February 2015 06:58 AM   [ Ignore ]   [ # 31 ]
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In regards to your comments about The acknowledgements. Several points

You asked if other articles supplied information on any conflicts of interest and I showed you that they did

Secondly the article you provided has no outside influence simply because its not a study. Its a simple review and reviews cost virtually nothing to perform. Studies on the other hand are extremely expensive and need to be financed some how. Contributors to the study may provide cash but in many cases they are simply providing unbranded samples of their drug to be used in a placebo controlled trial. The people who do these studies are not characters from a conspiracy in some dime store novel. Most are hard working health care professionals who have devoted their life to advancing medicine. In addition academic institutions which conduct these studies have strict rules and oversight to limit the influence of pharma in the outcome of studies. All studies also pass through peer review which is a rigorous process for the more prestigious journals

Finally while there are a number of contributors on the list who may have a vested interest in a particular outcome to the study there are also others who’s sole interest is a well done study such as the National heart and Lung institute and the NCI. Although we would prefer of course to have no bias influence in such studies the realities are that studies are expensive. We can either be cynical and throw the baby out with the bath water (ie. turning away from the science and going back to the dark ages of anecdotes) or we can try to manage outside influences and accept outside funding. The other alternative would be public funding of all studies. Do you think that you and the rest of society are willing to pay perhaps an extra $1,000/yr or more in taxes to finance a completely public research effort?

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Posted: 27 February 2015 07:06 AM   [ Ignore ]   [ # 32 ]
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kkwan - 26 February 2015 07:05 PM

CVD is preventable:

It is estimated that 90% of CVD is preventable. Prevention of atherosclerosis is by decreasing risk factors through: healthy eating, exercise, avoidance of tobacco smoke and limiting alcohol intake. Treating high blood pressure and diabetes is also beneficial. Treating people who have strep throat with antibiotics can decrease the risk of RHD.

Right. You can stick your head in the sand and think all we need to do is get everybody to follow this advice. Unfortunately we live in the real world. Physicians advise their patients on lifestyle changes every day (in fact we invented them) but when these efforts fail as they do in most cases we can either stick our heads in the sand and let them have a heart attack or we can use the other tools ( statins, BP meds, Diabetic medications, sometimes aspirin) at our disposal to prevent them. The head in the sand approach doesn’t work well for me.

As a matter of point this…“Treating people who have strep throat with antibiotics can decrease the risk of RHD” has nothing to do with the subject we’re discussing. RHD is an entirely different and unrelated condition.

[ Edited: 27 February 2015 07:10 AM by macgyver ]
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Posted: 27 February 2015 08:37 AM   [ Ignore ]   [ # 33 ]
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macgyver - 26 February 2015 08:55 PM

While there was an option of using the 20% criteria that does not really represent how physicians practiced in this country. While it was one of the criteria used prior to Nov 2013 the actual recommendations were to use statins EITHER when the calculated risk was greater than 20% OR if the patent met one of the following criteria

1) Was a diabetic or had a history of CAD and an LDL of greater than 100
2) Had two or more risk factors and an LDL of 130 or greater
3) No risk factors but an LDL of 160 or greater

For practical reasons nearly all physicians used these 3 guidelines rather than the cardiac risk calculation because the calculation takes too long to do on every patient. Collecting the necessary data from the patients chart and going through the calculation takes about 5 minutes which doesn’t sound like much but it can add as much as 45 minutes to a doctors day so its not routinely done for most patients. Even now I only occasionally calculate a patients cardiac risk. Usually I do it when the LDL isn’t terrible but my gut tells me that the cardiac risk is high ( ie. an obese 50 yr old white male who smoked or had borderline blood sugar). More often than not I have used the calculator to see if we can stop someone’s statin ie. they were started on a statin in the past because of an LDL of 160 but they turn out to have a calculated risk of only 2%.

The emphasis on keeping LDL low (below 130 or 160) is questionable.

So, in 3) even with no risk factors, statins would be prescribed.

Is it necessary to have low LDL for a proven therapeutic effect or is it just because statins can do that?

In regards to your second post an anecdotal report really doesn’t mean much so while its interesting it doesn’t really have a place in this discussion.

Being “anecdotal” does not mean it can be dismissed.

From the same article cited in post 29:

I am a vascular surgeon. Before founding a private clinic in Dorset 11 years ago, specialising in varicose veins, I worked in the NHS for 13 years. Back then, I didn’t question medical guidance on cholesterol, and thought statins were a wonder drug. And so they probably are, for men who have heart disease — not necessarily because they lower cholesterol, but because they may cut other risks such as the inflammation-marker CRP.

He is not just a layman.

And at the end of the article:

GPs are, by definition, generalists. They don’t have time to read and analyse data from every paper on every medical condition. Even so, in a recent survey by Pulse magazine, six in 10 GPs opposed the draft proposal to lower the risk level at which patients are prescribed statins. And 55 per cent said they would not take statins themselves or recommend them to a relative, based on the proposed new guidelines.

Why are these doctors so recalcitrant?

The best advice is to eat a well balanced diet that limits saturated and trans fats as well as simple carbs. Everything in moderation is generally good advice unless there is solid evidence that a diet of extremes ( ie . very low carbs and high fats) is beneficial.

And red wine (in moderation)?

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Posted: 27 February 2015 09:12 AM   [ Ignore ]   [ # 34 ]
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macgyver - 27 February 2015 06:58 AM

Secondly the article you provided has no outside influence simply because its not a study. Its a simple review and reviews cost virtually nothing to perform. Studies on the other hand are extremely expensive and need to be financed some how. Contributors to the study may provide cash but in many cases they are simply providing unbranded samples of their drug to be used in a placebo controlled trial. The people who do these studies are not characters from a conspiracy in some dime store novel. Most are hard working health care professionals who have devoted their life to advancing medicine. In addition academic institutions which conduct these studies have strict rules and oversight to limit the influence of pharma in the outcome of studies. All studies also pass through peer review which is a rigorous process for the more prestigious journals

Finally while there are a number of contributors on the list who may have a vested interest in a particular outcome to the study there are also others who’s sole interest is a well done study such as the National heart and Lung institute and the NCI. Although we would prefer of course to have no bias influence in such studies the realities are that studies are expensive. We can either be cynical and throw the baby out with the bath water (ie. turning away from the science and going back to the dark ages of anecdotes) or we can try to manage outside influences and accept outside funding. The other alternative would be public funding of all studies. Do you think that you and the rest of society are willing to pay perhaps an extra $1,000/yr or more in taxes to finance a completely public research effort?

Why was there no declaration on conflict of interest?

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Posted: 27 February 2015 09:23 AM   [ Ignore ]   [ # 35 ]
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Like all of these issues, the relationship between alcohol and cardiovascular disease risk is complex and uncertain. Some evidence does suggest that light-to-moderate alcohol consumption reduces overall CVD risk(1), and that some types of alcohol (including red wine but also beer) may be more beneficial than others (2). However, not all studies or interpretations of the evidence agree. A recent paper (3), for example, found a significant problem with how “drinkers” and “non-drinkers” were defined in earlier studies. When people who used to drink but stopped because of substance abuse or health problems are included as “non-drinkers” at the time of a study, they tend to make the non-drinking group look less healthy. When people with light to moderate consumption are compared only to people who have never drunk at all, excluding these former drinkers, then the health differences between the light drinkers and the non-drinkers mostly go away. So there is some reason to think at least some of the “benefits” of alcohol consumption may be a function of selection bias in the research.

In any case, as MacGyver keeps pointing out, there is a difference between the theoretical benefits of behavioral changes to reduce CVD risk and the real-life impact of recommending these. If, for example, light-to-moderate drinking really does lower CVD risk, should doctors recommend people drink this way? How many people would end up drinking to excess and being harmed by alcohol abuse, car accidents, and other negative health effects of alcohol unintentionally? Would this outweigh the number of people who benefitted from including some alcohol in their diet as a strategy for reducing CVD risk? Even lifestyle modifications have risks, just like medications, and often these risks are harder to identify and quantify because there is less data and more complexity involved than in the analysis of medication side effects. A good general rule of medicine is that if something, anything, has a benefit, it also has risks.

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Posted: 27 February 2015 09:36 AM   [ Ignore ]   [ # 36 ]
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macgyver - 27 February 2015 07:06 AM

Right. You can stick your head in the sand and think all we need to do is get everybody to follow this advice. Unfortunately we live in the real world. Physicians advise their patients on lifestyle changes every day (in fact we invented them) but when these efforts fail as they do in most cases we can either stick our heads in the sand and let them have a heart attack or we can use the other tools ( statins, BP meds, Diabetic medications, sometimes aspirin) at our disposal to prevent them. The head in the sand approach doesn’t work well for me.

Nobody advocates the “head in the sand approach”.

I can understand your dilemma as a physician, but do statins prevent heart attacks or strokes?

I know friends and relatives who religiously took statins for many years but they still got them.

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Posted: 27 February 2015 10:07 AM   [ Ignore ]   [ # 37 ]
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mckenzievmd - 27 February 2015 09:23 AM

Like all of these issues, the relationship between alcohol and cardiovascular disease risk is complex and uncertain. Some evidence does suggest that light-to-moderate alcohol consumption reduces overall CVD risk(1), and that some types of alcohol (including red wine but also beer) may be more beneficial than others (2). However, not all studies or interpretations of the evidence agree. A recent paper (3), for example, found a significant problem with how “drinkers” and “non-drinkers” were defined in earlier studies. When people who used to drink but stopped because of substance abuse or health problems are included as “non-drinkers” at the time of a study, they tend to make the non-drinking group look less healthy. When people with light to moderate consumption are compared only to people who have never drunk at all, excluding these former drinkers, then the health differences between the light drinkers and the non-drinkers mostly go away. So there is some reason to think at least some of the “benefits” of alcohol consumption may be a function of selection bias in the research.

In any case, as MacGyver keeps pointing out, there is a difference between the theoretical benefits of behavioral changes to reduce CVD risk and the real-life impact of recommending these. If, for example, light-to-moderate drinking really does lower CVD risk, should doctors recommend people drink this way? How many people would end up drinking to excess and being harmed by alcohol abuse, car accidents, and other negative health effects of alcohol unintentionally? Would this outweigh the number of people who benefitted from including some alcohol in their diet as a strategy for reducing CVD risk? Even lifestyle modifications have risks, just like medications, and often these risks are harder to identify and quantify because there is less data and more complexity involved than in the analysis of medication side effects. A good general rule of medicine is that if something, anything, has a benefit, it also has risks.

From this article here

Wine only protects against CVD in people who exercise

Professor Taborsky said: “This is the first randomised trial comparing the effects of red and white wine on markers of atherosclerosis (1) in people at mild to moderate risk of CVD. We found that moderate wine drinking was only protective in people who exercised. Red and white wine produced the same results.”

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Posted: 27 February 2015 10:08 AM   [ Ignore ]   [ # 38 ]
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kkwan - 27 February 2015 09:36 AM
macgyver - 27 February 2015 07:06 AM

Right. You can stick your head in the sand and think all we need to do is get everybody to follow this advice. Unfortunately we live in the real world. Physicians advise their patients on lifestyle changes every day (in fact we invented them) but when these efforts fail as they do in most cases we can either stick our heads in the sand and let them have a heart attack or we can use the other tools ( statins, BP meds, Diabetic medications, sometimes aspirin) at our disposal to prevent them. The head in the sand approach doesn’t work well for me.

Nobody advocates the “head in the sand approach”.

I can understand your dilemma as a physician, but do statins prevent heart attacks or strokes?

I know friends and relatives who religiously took statins for many years but they still got them.

Once again, read the studies in my first post and you will find ample evidence for the sue of statins in primary prevention. Anecdotal reports are not helpful. The use of statins does not Guarantee you will never have a heart attack or stroke. It reduces the risk so of course there will be people on statins who have heart attacks and strokes especially since we tend to put the highest risk people on these drugs.  Some people who have gotten the measles vaccine (which is close to 99% effective after two doses) will on occasion get the measles. That doesnt mean taking the measles vaccine isn’t s good choice to make.

Smoking dramatically increases your risk of dying at an early age but it doesn’t guarantee it. Its still a good choice not to smoke even if someone comes up with an anecdotal report of an uncle who smoked three packs a day and lived until he was 95.
the whole idea is to manage risk. You can’t eliminate it.

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Posted: 27 February 2015 10:22 AM   [ Ignore ]   [ # 39 ]
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macgyver - 27 February 2015 10:08 AM

Once again, read the studies in my first post and you will find ample evidence for the sue of statins in primary prevention. Anecdotal reports are not helpful. The use of statins does not Guarantee you will never have a heart attack or stroke. It reduces the risk so of course there will be people on statins who have heart attacks and strokes especially since we tend to put the highest risk people on these drugs.  Some people who have gotten the measles vaccine (which is close to 99% effective after two doses) will on occasion get the measles. That doesnt mean taking the measles vaccine isn’t s good choice to make.

Where are the statistics for statins preventing heart attacks or strokes?

OTOH, we have close to 99% for the measles vaccine.

Smoking dramatically increases your risk of dying at an early age but it doesn’t guarantee it. Its still a good choice not to smoke even if someone comes up with an anecdotal report of an uncle who smoked three packs a day and lived until he was 95.
the whole idea is to manage risk. You can’t eliminate it.

Bertrand Russell lived to 98.

Nothing can eliminate risk.

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Posted: 27 February 2015 10:45 AM   [ Ignore ]   [ # 40 ]
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kkwan - 27 February 2015 09:12 AM

Why was there no declaration on conflict of interest?

I don’t really understand the need if they tell you which parties are providing assistance with the study. How would that help the reader? Obviously on some level yes there is a potential for a conflict of interest but as I already said they do their best to try and remove that as much as is humanly possible. Its left to the reader to factor this in to their interpretation of the data since there is no way anyone could ever quantify how much influence there might have been. To ask the authors to try an quantify it would be fruitless since they believe rightly or wrongly that they have eliminated this with their efforts. 

As I stated, what other option do you have. Either trust the system we have and always have some level of skepticism or find a better approach which no one has come up with yet. Relying on anecdotes and personal experience would be far worse. There are checks and balances. No study stands on its own. Other researchers are always trying to reproduce the results from any sufficiently important study such as these. If the results are reproducible then we have greater confidence in them. If not then we have to question them.

[ Edited: 27 February 2015 12:07 PM by macgyver ]
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Posted: 27 February 2015 11:07 AM   [ Ignore ]   [ # 41 ]
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kkwan - 27 February 2015 08:37 AM

The emphasis on keeping LDL low (below 130 or 160) is questionable.

So, in 3) even with no risk factors, statins would be prescribed.

Is it necessary to have low LDL for a proven therapeutic effect or is it just because statins can do that?

 

Treating to keep the LDL below 130 or 160 is questionable NOW because we have more information which is why the recommendations were changed. They were reasonable at the time the original recommendations were authored just as treating to keep your total below 200 was reasonable at one time and now we know better. Medicine like all of science evolves as knowledge is accumulated. Thats the way it has to be unless you are an omnipotent god who comes into the world knowing everything there is to know.

kkwan - 27 February 2015 08:37 AM

Being “anecdotal” does not mean it can be dismissed.

 

It can and should be dismissed when there is objective evidence that the conclusion being drawn is inaccurate.

kkwan - 27 February 2015 08:37 AM

From the same article cited in post 29:

I am a vascular surgeon. Before founding a private clinic in Dorset 11 years ago, specialising in varicose veins, I worked in the NHS for 13 years. Back then, I didn’t question medical guidance on cholesterol, and thought statins were a wonder drug. And so they probably are, for men who have heart disease — not necessarily because they lower cholesterol, but because they may cut other risks such as the inflammation-marker CRP.

He is not just a layman.

 

Of course not and he is not the originator of this idea. All he is dong is repeating current medical theory of atherosclerosis and the mechanism by which statins most likely work. If you read my first post you would see that I said exactly the same thing in there. This is the standard medical theory of atherogenesis and rationale behind statin use today.

kkwan - 27 February 2015 08:37 AM

GPs are, by definition, generalists. They don’t have time to read and analyse data from every paper on every medical condition. Even so, in a recent survey by Pulse magazine, six in 10 GPs opposed the draft proposal to lower the risk level at which patients are prescribed statins. And 55 per cent said they would not take statins themselves or recommend them to a relative, based on the proposed new guidelines.

Why are these doctors so recalcitrant?

Because most doctors just like most people have a difficult time changing their world view quickly. We have run into exactly the same issue with PSA’s and Mammograms. I was trained to do these test as part of a routine exam in the correct age groups. More recently studies have since shown that PSA’s do not decrease death rates or prolong life but we are having a very tough time convincing doctors to eliminate them from the standard blood work they do on men even though they have nothing to gain by doing them. Mammograms have similarly been shown not to reduce death rate in women under 50 but when suggestions were made to delay regular screening from the current standard of 40 to 50 years of age there was a tremendous outcry from not only the public but physicians as well…even among physicians who do not stand to make a profit from this practice. Several large studies have shown that home glucose monitors do nothing to improve outcomes for Type 2 diabetics who are not on insulin. I have been campaigning for years to eliminate the practice of home glucose testing in this group but have run into tremendous resistance from colleagues because their brain tells them it should be helpful and they have a difficult time believing the data. People don’t change easily.. even the smart ones.

Doctors are human and sometimes subject to the same foibles as the rest of humanity.

[ Edited: 27 February 2015 12:09 PM by macgyver ]
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Posted: 27 February 2015 10:10 PM   [ Ignore ]   [ # 42 ]
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macgyver - 27 February 2015 10:45 AM

I don’t really understand the need if they tell you which parties are providing assistance with the study. How would that help the reader? Obviously on some level yes there is a potential for a conflict of interest but as I already said they do their best to try and remove that as much as is humanly possible. Its left to the reader to factor this in to their interpretation of the data since there is no way anyone could ever quantify how much influence there might have been. To ask the authors to try an quantify it would be fruitless since they believe rightly or wrongly that they have eliminated this with their efforts.

A declaration of conflict of interest is important to show no bias in the study.

For instance, if pharmaceutical companies provided the majority of the funds, then the study is not independent and the findings are questionable and not credible.

OTOH, not to declare conflict of interest implies possible hidden agendas which cannot be disclosed.

As I stated, what other option do you have. Either trust the system we have and always have some level of skepticism or find a better approach which no one has come up with yet. Relying on anecdotes and personal experience would be far worse. There are checks and balances. No study stands on its own. Other researchers are always trying to reproduce the results from any sufficiently important study such as these. If the results are reproducible then we have greater confidence in them. If not then we have to question them.

From this article
here

A competing interest—often called a conflict of interest—exists when professional judgment concerning a primary interest (such as patients’ welfare or the validity of research) may be influenced by a secondary interest (such as financial gain or personal rivalry). It may arise for the authors of an article in The BMJ when they have a financial interest that may influence, probably without their knowing, their interpretation of their results or those of others.

We believe that, to make the best decision on how to deal with an article, we should know about any competing interests that authors may have, and that if we publish the article readers should know about them too. We are not aiming to eradicate such interests; they are almost inevitable. We will not reject your article simply because you have a conflict of interest, but we want you to make a declaration on whether or not you have competing interests. (We also ask our staff and reviewers to declare any competing interests.)

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Posted: 27 February 2015 10:41 PM   [ Ignore ]   [ # 43 ]
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macgyver - 27 February 2015 11:07 AM

Treating to keep the LDL below 130 or 160 is questionable NOW because we have more information which is why the recommendations were changed. They were reasonable at the time the original recommendations were authored just as treating to keep your total below 200 was reasonable at one time and now we know better. Medicine like all of science evolves as knowledge is accumulated. Thats the way it has to be unless you are an omnipotent god who comes into the world knowing everything there is to know.

If keeping the “LDL below 130 or 160 is questionable NOW”, then why should statins be prescribed at all for 3)?

It can and should be dismissed when there is objective evidence that the conclusion being drawn is inaccurate.

That should be determined on a case by case basis, not whole scale per se.

Of course not and he is not the originator of this idea. All he is dong is repeating current medical theory of atherosclerosis and the mechanism by which statins most likely work. If you read my first post you would see that I said exactly the same thing in there. This is the standard medical theory of atherogenesis and rationale behind statin use today.

Why did he stop taking statins? 

Because most doctors just like most people have a difficult time changing their world view quickly. We have run into exactly the same issue with PSA’s and Mammograms. I was trained to do these test as part of a routine exam in the correct age groups. More recently studies have since shown that PSA’s do not decrease death rates or prolong life but we are having a very tough time convincing doctors to eliminate them from the standard blood work they do on men even though they have nothing to gain by doing them. Mammograms have similarly been shown not to reduce death rate in women under 50 but when suggestions were made to delay regular screening from the current standard of 40 to 50 years of age there was a tremendous outcry from not only the public but physicians as well…even among physicians who do not stand to make a profit from this practice. Several large studies have shown that home glucose monitors do nothing to improve outcomes for Type 2 diabetics who are not on insulin. I have been campaigning for years to eliminate the practice of home glucose testing in this group but have run into tremendous resistance from colleagues because their brain tells them it should be helpful and they have a difficult time believing the data. People don’t change easily.. even the smart ones.

Doctors are human and sometimes subject to the same foibles as the rest of humanity.

Would you take statins or recommend them to your friends and relatives as in 3)?

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Posted: 28 February 2015 06:57 AM   [ Ignore ]   [ # 44 ]
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kkwan - 27 February 2015 10:10 PM

A declaration of conflict of interest is important to show no bias in the study.

For instance, if pharmaceutical companies provided the majority of the funds, then the study is not independent and the findings are questionable and not credible.

OTOH, not to declare conflict of interest implies possible hidden agendas which cannot be disclosed.

Nothing is hidden. They are telling you who sponsored the study. Its up to the reader to decide whether that may result in a conflict of interest. Asking the writer to make that decision is like asking someone accused of a crime if they are guilty. It makes no sense.

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Posted: 28 February 2015 07:15 AM   [ Ignore ]   [ # 45 ]
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kkwan - 27 February 2015 10:41 PM

If keeping the “LDL below 130 or 160 is questionable NOW”, then why should statins be prescribed at all for 3)?

I assume by “3)” you are referring to the current recommendation to treat people who have an LDL greater than 190? You seem to be misunderstanding things here. No one is saying that cholesterl levels aren’t important. What we are saying with the new recommendations is that if someone has an average risk based on other risk factors an LDL of 190 or above is in itself enough of a risk to justify statin use

kkwan - 27 February 2015 10:41 PM

It can and should be dismissed when there is objective evidence that the conclusion being drawn is inaccurate.

That should be determined on a case by case basis, not whole scale per se.

 

Anecdotal stories are generally used in arguments to undermine and misdirect the discussion.They provide very little objective evidence for anything. Anecdotal reports have only one real use. If there is a subject we have no data on they can raise a flag that something may deserve closer inspection. If on the other hand we have significant data anecdotal reports are just aberations like the 95 year old smoker. They serve no real purpose except to cause people to ignore the real data.

kkwan - 27 February 2015 10:41 PM

Of course not and he is not the originator of this idea. All he is dong is repeating current medical theory of atherosclerosis and the mechanism by which statins most likely work. If you read my first post you would see that I said exactly the same thing in there. This is the standard medical theory of atherogenesis and rationale behind statin use today.

Why did he stop taking statins? 

I have no idea. I don;t know the specifics of his case. Maybe he was only on statins because his LDL was 140 and under the new guidelines he doesn’t need to take them. I can’t get in side his head, but as I already stated even doctors make decisions sometimes that are not supported by the evidence. This isn’t about personal opinion. Its about the risk benefit analysis.

kkwan - 27 February 2015 10:41 PM

Would you take statins or recommend them to your friends and relatives as in 3)?

Yes

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