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Statins
Posted: 23 February 2015 06:26 PM   [ Ignore ]   [ # 16 ]
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macgyver - 23 February 2015 05:19 AM

You did not post a link to “paper”/study or even a clinical review. You posted a link to layman’s story about the subject which contains no data, only opinion.

Did I not do so?

Again, from the article I cited:

Their critique of the exaggerated claims regarding statins’ ability to prevent strokes, heart attacks and heart disease-related deaths on a large scale has been published in the medical journal “Expert Review of Clinical Pharmacology” at http://informahealthcare.com/ .

The paper is available here

How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease

David M Diamond, Uffe Ravnskov
Expert Review of Clinical Pharmacology Mar 2015, Vol. 8, No. 2: 201–210.

It is not available if you are not a subscribing member of Informa Healthcare.

Whether this is a medical forum or not this IS a skeptical forum and if you are going to take a position here you will be challenged to provide evidence to support that position. Since other people read our comments, as a physician I see it as my responsibility to make sure there is a rational evidence based debate when controversial views are presented.

I am not taking a position and as such is not required to “provide evidence”.

I am merely informing CFI about the latest findings on statins.

Whoever read our posts are at liberty to decide what to believe or disbelieve.

In regards to the definition of a “drug”. There is no one authority on the definition and although foods may “generally” be excluded from this definition that does not mean they are not drugs. That is simply a convention just as we don’t conventionally refer to cigarettes as a drug delivery system even though they clearly are. It does not mean that foods and other substances are not drugs just because we don’t include them as a matter of convenience or convention. This is the same argument we have all the time about supplements and herbs. Just because we don’t cal them drugs does not mean they aren’t drugs.

If the motive for calling things drugs is to create a convenient method for us to distinguish between things which are potentially harmful and those which are not it fails completely. Every substance which is put in the body with resultant biochemical effects deserves respect and caution. However, rather than applying a blanket caution to all of these substance we need to examine each one for its risks and benefits. Oxygen and water can both be exceptionally toxic (poisonous) under the right circumstances and there are drugs that are completely harmless even when taken amounts that are ten times the approved dose. For this reason it is counterproductive to artificially define some bioactive substances as drugs and others as not drugs if the motive is to help the public decide which things they need to be wary of and which they don’t.

It is obvious to most people what a drug is and a statin is a drug, not a placebo.

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Posted: 25 February 2015 09:27 AM   [ Ignore ]   [ # 17 ]
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This 2013 open access paper is available here

The Ugly Side of Statins. Systemic Appraisal of the Contemporary Un-Known Unknowns

Sherif Sultan1,2#, Niamh Hynes1,2

Department of Vascular and Endovascular Surgery, Western Vascular Institute, University College Hospital Galway, Galway, Ireland

Department of Vascular and Endovascular Surgery, Galway Clinic, Galway, Ireland

From 3. Review of The Statin Saga:

What cholesterol is for:

Cholesterol is crucial for energy, immunity, fat metabolism, leptin, thyroid hormone activity, liver related synthesis, stress intolerance, adrenal function, sex hormone syntheses and brain function. When prescribing HMGCoA reductase inhibitors one needs to be cognisant of the fact that the body had increased its’ cholesterol as a compensatory mechanism and investigate accordingly.

The consequences of inhibiting the production of cholesterol by the liver with statins:

The statin industry, with all of its spin-off, is a 20-billion-a-year industry. We are observing the revealing of the utmost medical tragedy of all times. It is unprecedented that the healthcare industry has inadvertently induced life-threatening nutrient deficiency in millions of otherwise healthy people. What is even more disparaging is that not only has there been a failure to report on these negative side-effects of statins, there has actually been active discouragement to publish any negative studies on statins.

Bold added by me.

From the conclusions:

There is increased risk of Diabetes Mellitus, Cataract formation, and Erectile Dysfunction in young statin users, all of which are Alarming. Furthermore there is a significant increase in the risk of cancer and neurodegenerative disorders in the elderly plus an enhanced risk of a myriad of infectious diseases.

Have statins opened Pandora’s Box?

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Posted: 25 February 2015 12:28 PM   [ Ignore ]   [ # 18 ]
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The article you site is not a study. Its a review which is fine but I disagree with their conclusions and in fact most of the medical community would.

To address just a few points.

“There is a categorical lack of clinical evidence to support the use of statin therapy in primary prevention.” 
This is “categorically” wrong. If you read my original post in this thread I give a number of citations which provide evidence to the contrary

“Furthermore statins are associated with triple the risk of coronary artery and aortic artery calcification”
This is irrelevant. Unless you can show that it leads to an increase in disease it doesn’t matter

“Cardiovascular primary prevention and regeneration programmes, through life style changes and abstaining from tobacco use have enhanced clinical efficacy and quality of life over any pharmaceutical or other conventional intervention”
Physicians would be extremely happy if this were true but in the real world it just isn’t. Its not because these things don;t work but because people have a difficult time complying with these recommendations. I spend a good part of my day encouraging and educating y patients on lifestyle changes to improve everything from hypertension to diabetes and heart disease but the sad fact is that its difficult to change habits that have been developed over a lifetime and despite our best efforts most of us will fail. For the author to suggest that this is an alternative is an insult to the medical community. We all work to encourage our patients to improve their habits but when that doesn’t work we need other tools like medications.

It must be noted that many of the reports of side effects associated with statins are not well supported by the trials.

For example, muscle pain is the most common side effect attributed to statins and probably the most frequent reason the drug is stopped. It is rarely a serious side effect and usually resolves as soon as the medicine is discontinued. Of note though, some studies have shown no real difference between the rate of muscle complaints in patients on statins compared to those on placebo. Other studies have looked at patients on statins and compared them to patients not on statins but these studies are flawed by observer bias and the nocebo effect. Many patients have heard that Statins can cause muscle pain so if you put them on a statin they are more likely to notice pains they did not pay attention to previously.

Other studies linking things such as renal failure, diabetes, and erectile dysfinction to statin use need to be viewed with caution because patients with elevated cholesterol levels are at greater risk of these problems even if not treated with statins. Since most of these studies which look at NNH ( number needed to harm) are not randomized trials and are often post hoc analysis its difficult to know how reliable such data is.

Some of the data is highly suspect. One of the statements made is that one would expect 74 cases of liver failure in every 10,000 patients treated yet I have been in practice for over 24 years and easily treated 2,000 patients with statins yet never had a single case of liver failure.

Then there is the blatant “cherry picking” and complete lack of objectivity in the article. The authors state that statins have been associated with an increase in cancer but fail to point out that one of the articles they cite in support of this comment states that there were increases in some cancers but a decrease in others.

Quote “For haematological malignancies there was a significant reduced risk associated with any statin use…. Prolonged (more than 4 years) use of statins was associated with a significantly increased risk of colorectal cancer, bladder cancer “
“Exposure to Statins and Risk of Common Cancers: A Series of Nested Case-Control Studies,” BMC Cancer, Vol. 11, No. 1, 2011, p. 409. doi:10.1186/1471-2407-11-409

and again they fail to point out that these are not randomized control trials and as such the increase in cancer may have more to do with lifestyle factors that lead to the statin use (obesity, high fat diets, lack of exercise, insufficient fiber intake) in the first place and may not be attributable to the drug. We don’t know. These are associations. There is no evidence for causation.

There is also this comment which is biologically naive and of course self serving.

“When prescribing HMGCoA reductase inhibitors one needs to be cognisant of the fact that the body had increased its’ cholesterol as a compensatory mechanism and investigate accordingly”

Not every condition is a matter of beneficial compensation by the body. High blood sugar in diabetic patients is not due to compensation by our bodies endocrine system. Its due to failure of that system. We have no evidence that the spectrum of cholesterol levels we see throughout the population are a compensatory mechanism. more likely its a manifestation of our genetic variability which at its extremes may be harmful to the organism. A scientific article should not be making such unscientific statements as this one.

Given the wealth of data on this subject as well as my own experience which is in stark contrast to the claims of these authors I can’t help but come to the conclusion that they had a preconceived notion of what they wanted to find and say before they even started looking at the evidence. For a less biased opinion on this subject you may want to look at this statement from the Cochrane review.

http://www.cochrane.org/CD004816/VASC_statins-for-the-primary-prevention-of-cardiovascular-disease

[ Edited: 25 February 2015 12:32 PM by macgyver ]
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Posted: 25 February 2015 05:08 PM   [ Ignore ]   [ # 19 ]
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I’m happy to see that you guys are going at it.  And sad to say that I don’t have time to read all that is posted: must work!  So just a brief note to say that I do not mean by my scant comments that we should stop doing science, far from it, rather that we need more science.  We need more government funded and institutional science, to balance out Big Pharm.  We need to keep collecting as much Big Data as we can so that later on, when we figure out what questions we want to ask of that data, we have it.  We also need some way to ensure that pharmaceutical interests aren’t able to bury damning data, and that is tricky.  The FDA is supposed to require hard data to approve a drug, but they have no way of accessing any data not actually submitted, and therein lies the problem.  We don’t know what was in the studies that didn’t come to light, other than a guess that the data probably wouldn’t convince you to give a statin to your mother, hence the need to hide that data to protect sales.

The thing about cholesterol and cardiovascular disease that bugs me is the fact that the standards for acceptable cholesterol levels are arbitrary.  It’s just like the 40 years of governmental advice telling us not to eat bacon and eggs: when statins have long gone out the window, what will we argue about next?  Governments make mistakes.  Doctors make mistakes.  The trick is to be flexible enough in our thinking to admit it when we have made one, and to reverse course.  I am interested in ALTERNATIVES to statins for gaining and maintaining low cardiovascular risk.  There are many.  Drugs, foods, supplements, nutrients, herbs, whatever you want to use, there are many ways to skin this cat.  It is amusing to me to see how many people use red rice yeast thinking that they are avoiding the trouble with statins, when in fact they are taking a substance that works by the same mechanism and would have the same side effects if they were able to get the same dose.  It is hopeful to me that many conventional doctors are prescribing CoQ10 to their patients who are on statins.  Eventually we’ll arrive at some agreement about the best approach because the evidence will be overwhelming.  Until then, we fight against overwhelm.

Water can be lethal in the wrong dose.  =-]

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Posted: 25 February 2015 05:15 PM   [ Ignore ]   [ # 20 ]
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I like to look at many angles, to mull on associations and try to understand the big picture.  This is the process by which we determine what questions we want to ask of our Big Data collection.  Here’s one that raises some interesting questions.

ELEVATED NONFASTING REMNANT CHOLESTEROL ASSOCIATED WITH LOW VITAMIN D
http://circgenetics.ahajournals.org/content/early/2014/07/27/CIRCGENETICS.113.000416.abstract
Esther M. Ooi, Shoaib Afzal, and Børge G. Nordestgaard.
Elevated Remnant Cholesterol in 25-Hydroxyvitamin D Deficiency in the General Population: A Mendelian Randomization Study.
Circ Cardiovasc Genet. Originally published July 27, 2014. 

doi: 10.1161/CIRCGENETICS.113.000416

Genetically elevated nonfasting remnant cholesterol is associated with low 25(OH)D levels, while genetically reduced HDL cholesterol is not associated with low 25(OH)D levels.
These findings suggest that low 25(OH)D levels observationally is simply a marker for elevated atherogenic lipoproteins, and question a role for vitamin D supplementation in the prevention of cardiovascular disease.

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Posted: 25 February 2015 06:06 PM   [ Ignore ]   [ # 21 ]
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TG_ND - 25 February 2015 05:08 PM

I’m happy to see that you guys are going at it.  And sad to say that I don’t have time to read all that is posted: must work!  So just a brief note to say that I do not mean by my scant comments that we should stop doing science, far from it, rather that we need more science.  We need more government funded and institutional science, to balance out Big Pharm.  We need to keep collecting as much Big Data as we can so that later on, when we figure out what questions we want to ask of that data, we have it.  We also need some way to ensure that pharmaceutical interests aren’t able to bury damning data, and that is tricky.  The FDA is supposed to require hard data to approve a drug, but they have no way of accessing any data not actually submitted, and therein lies the problem.  We don’t know what was in the studies that didn’t come to light, other than a guess that the data probably wouldn’t convince you to give a statin to your mother, hence the need to hide that data to protect sales.

The thing about cholesterol and cardiovascular disease that bugs me is the fact that the standards for acceptable cholesterol levels are arbitrary.  It’s just like the 40 years of governmental advice telling us not to eat bacon and eggs: when statins have long gone out the window, what will we argue about next?  Governments make mistakes.  Doctors make mistakes.  The trick is to be flexible enough in our thinking to admit it when we have made one, and to reverse course.  I am interested in ALTERNATIVES to statins for gaining and maintaining low cardiovascular risk.  There are many.  Drugs, foods, supplements, nutrients, herbs, whatever you want to use, there are many ways to skin this cat.  It is amusing to me to see how many people use red rice yeast thinking that they are avoiding the trouble with statins, when in fact they are taking a substance that works by the same mechanism and would have the same side effects if they were able to get the same dose.  It is hopeful to me that many conventional doctors are prescribing CoQ10 to their patients who are on statins.  Eventually we’ll arrive at some agreement about the best approach because the evidence will be overwhelming.  Until then, we fight against overwhelm.

Water can be lethal in the wrong dose.  =-]

You started off well. I agree with your first paragraph. In fact if you want to help the effort to require pharma to publish all studies you may want to sign the petition at AllTrials (http://www.alltrials.net/).

I disagree with your comments in the second paragraph. The recommendations regarding statin use are not arbitrary. Its a risk benefit analysis based on the nest evidence we have. Its true that these things change but medicine and science are not religion. We don’t rely on dogma. As new data accumulates we need to be flexible enough to change our advice based on that data. The same goes for dietary guidelines. Changing our advice because of new data is not evidence that we don’t know what we are doing. An unwillingness to change advice is the best evidence that someone doesn’t know what they are doing.

In regards to herbs and supplements I’ve made the point often enough. They should be required to provide exactly the same level of evidence we require from all drugs because these substances are either totally inert or they are in fact a drug. They should not be treated any differently. The red yeast rice extract which you mentioned is a perfect example. Its not that this substance works “like” statins. This substance actually IS a statin. It contains varying amounts of Lovastatin commonly known as mevacor.Its absolutely wrong that this is marketed without any regulation and without a prescription. Its a drug just like any substance that is biologically active is a drug whether its over the counter, behind the counter, or in the herb and supplement isle.

Finally in regards to CoQ10. The logic behind “trying” this substance was reasonable but as often happens, something which seems like a good idea on a simple biochemical level often does not pan out when we try to translate that to the complexities of the human body. The studies that have been done do not show any benefit when CoQ10 is used to prevent statin induced myalgias. As I stated above. A good doctor/scientist has to be willing to discard ideas when the science doesn’t support it.

[ Edited: 25 February 2015 06:23 PM by macgyver ]
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Posted: 25 February 2015 06:10 PM   [ Ignore ]   [ # 22 ]
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TG_ND - 25 February 2015 05:15 PM

I like to look at many angles, to mull on associations and try to understand the big picture.  This is the process by which we determine what questions we want to ask of our Big Data collection.  Here’s one that raises some interesting questions.

ELEVATED NONFASTING REMNANT CHOLESTEROL ASSOCIATED WITH LOW VITAMIN D
http://circgenetics.ahajournals.org/content/early/2014/07/27/CIRCGENETICS.113.000416.abstract
Esther M. Ooi, Shoaib Afzal, and Børge G. Nordestgaard.
Elevated Remnant Cholesterol in 25-Hydroxyvitamin D Deficiency in the General Population: A Mendelian Randomization Study.
Circ Cardiovasc Genet. Originally published July 27, 2014. 

doi: 10.1161/CIRCGENETICS.113.000416

Genetically elevated nonfasting remnant cholesterol is associated with low 25(OH)D levels, while genetically reduced HDL cholesterol is not associated with low 25(OH)D levels.
These findings suggest that low 25(OH)D levels observationally is simply a marker for elevated atherogenic lipoproteins, and question a role for vitamin D supplementation in the prevention of cardiovascular disease.

Be careful not to fall into the trap everyone has these days when it comes to vitamin D. Lots of associative studies and very little evidence that vitamin D supplementation is safe and effective for treating anything but rickets. Its all interesting stuff but checking vitamin D levels and providing supplementation has no place in clinical medicine yet.

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Posted: 25 February 2015 06:53 PM   [ Ignore ]   [ # 23 ]
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TG_ND - 25 February 2015 05:08 PM

The thing about cholesterol and cardiovascular disease that bugs me is the fact that the standards for acceptable cholesterol levels are arbitrary.  It’s just like the 40 years of governmental advice telling us not to eat bacon and eggs: when statins have long gone out the window, what will we argue about next?  Governments make mistakes.  Doctors make mistakes.  The trick is to be flexible enough in our thinking to admit it when we have made one, and to reverse course.  I am interested in ALTERNATIVES to statins for gaining and maintaining low cardiovascular risk.  There are many.  Drugs, foods, supplements, nutrients, herbs, whatever you want to use, there are many ways to skin this cat.  It is amusing to me to see how many people use red rice yeast thinking that they are avoiding the trouble with statins, when in fact they are taking a substance that works by the same mechanism and would have the same side effects if they were able to get the same dose.  It is hopeful to me that many conventional doctors are prescribing CoQ10 to their patients who are on statins.  Eventually we’ll arrive at some agreement about the best approach because the evidence will be overwhelming.  Until then, we fight against overwhelm.

Exactly.

Here is a youtube video for your entertainment and information:

How Bad Science and Big Business Created the Obesity Epidemic

https://www.youtube.com/watch?v=3vr-c8GeT34

It is tragic to see many friends and relatives religiously taking statins for years, avoid “bad” cholesterol foods and oils BUT they still get heart attacks, strokes and even Parkinson’s disease.

So, eat, drink wine (in moderation) and be merry but avoid sugar and simple carbohydrates?

LOL

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Posted: 25 February 2015 07:24 PM   [ Ignore ]   [ # 24 ]
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macgyver - 25 February 2015 12:28 PM

The article you site is not a study. Its a review which is fine but I disagree with their conclusions and in fact most of the medical community would.

To address just a few points.

“There is a categorical lack of clinical evidence to support the use of statin therapy in primary prevention.” 
This is “categorically” wrong. If you read my original post in this thread I give a number of citations which provide evidence to the contrary

“Furthermore statins are associated with triple the risk of coronary artery and aortic artery calcification”
This is irrelevant. Unless you can show that it leads to an increase in disease it doesn’t matter

“Cardiovascular primary prevention and regeneration programmes, through life style changes and abstaining from tobacco use have enhanced clinical efficacy and quality of life over any pharmaceutical or other conventional intervention”
Physicians would be extremely happy if this were true but in the real world it just isn’t. Its not because these things don;t work but because people have a difficult time complying with these recommendations. I spend a good part of my day encouraging and educating y patients on lifestyle changes to improve everything from hypertension to diabetes and heart disease but the sad fact is that its difficult to change habits that have been developed over a lifetime and despite our best efforts most of us will fail. For the author to suggest that this is an alternative is an insult to the medical community. We all work to encourage our patients to improve their habits but when that doesn’t work we need other tools like medications.

It must be noted that many of the reports of side effects associated with statins are not well supported by the trials.

For example, muscle pain is the most common side effect attributed to statins and probably the most frequent reason the drug is stopped. It is rarely a serious side effect and usually resolves as soon as the medicine is discontinued. Of note though, some studies have shown no real difference between the rate of muscle complaints in patients on statins compared to those on placebo. Other studies have looked at patients on statins and compared them to patients not on statins but these studies are flawed by observer bias and the nocebo effect. Many patients have heard that Statins can cause muscle pain so if you put them on a statin they are more likely to notice pains they did not pay attention to previously.

Other studies linking things such as renal failure, diabetes, and erectile dysfinction to statin use need to be viewed with caution because patients with elevated cholesterol levels are at greater risk of these problems even if not treated with statins. Since most of these studies which look at NNH ( number needed to harm) are not randomized trials and are often post hoc analysis its difficult to know how reliable such data is.

Some of the data is highly suspect. One of the statements made is that one would expect 74 cases of liver failure in every 10,000 patients treated yet I have been in practice for over 24 years and easily treated 2,000 patients with statins yet never had a single case of liver failure.

Then there is the blatant “cherry picking” and complete lack of objectivity in the article. The authors state that statins have been associated with an increase in cancer but fail to point out that one of the articles they cite in support of this comment states that there were increases in some cancers but a decrease in others.

Quote “For haematological malignancies there was a significant reduced risk associated with any statin use…. Prolonged (more than 4 years) use of statins was associated with a significantly increased risk of colorectal cancer, bladder cancer “
“Exposure to Statins and Risk of Common Cancers: A Series of Nested Case-Control Studies,” BMC Cancer, Vol. 11, No. 1, 2011, p. 409. doi:10.1186/1471-2407-11-409

and again they fail to point out that these are not randomized control trials and as such the increase in cancer may have more to do with lifestyle factors that lead to the statin use (obesity, high fat diets, lack of exercise, insufficient fiber intake) in the first place and may not be attributable to the drug. We don’t know. These are associations. There is no evidence for causation.

There is also this comment which is biologically naive and of course self serving.

“When prescribing HMGCoA reductase inhibitors one needs to be cognisant of the fact that the body had increased its’ cholesterol as a compensatory mechanism and investigate accordingly”

Not every condition is a matter of beneficial compensation by the body. High blood sugar in diabetic patients is not due to compensation by our bodies endocrine system. Its due to failure of that system. We have no evidence that the spectrum of cholesterol levels we see throughout the population are a compensatory mechanism. more likely its a manifestation of our genetic variability which at its extremes may be harmful to the organism. A scientific article should not be making such unscientific statements as this one.

Given the wealth of data on this subject as well as my own experience which is in stark contrast to the claims of these authors I can’t help but come to the conclusion that they had a preconceived notion of what they wanted to find and say before they even started looking at the evidence. For a less biased opinion on this subject you may want to look at this statement from the Cochrane review.

http://www.cochrane.org/CD004816/VASC_statins-for-the-primary-prevention-of-cardiovascular-disease

Thank you for the “long lecture”, but no thanks for your prejudice, ignorance and closed mind.

Wrt Cochrane, from the paper I cited in post 17:

The finding in a Cochrane systemic review by Taylor et al. is alarming [3]. They reviewed the current concept of the use of statins in primary prevention and found evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. The authors cautioned about prescribing statins for primary prevention among people at low cardiovascular risk.

Bold added by me.

So, who is cherry picking?

And is there a declaration in these “studies” as in the notes of the paper I cited:

Neither author has any conflict of interest The authors declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work, no other relationships or activities that could appear to have influenced the submitted work.

BTW, is’nt blue a no no in CFI?

LOL

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Posted: 25 February 2015 08:26 PM   [ Ignore ]   [ # 25 ]
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kkwan - 25 February 2015 07:24 PM

Thank you for the “long lecture”, but no thanks for your prejudice, ignorance and closed mind.

I’m sorry if I taxed your attention span. I gave you a critical analysis of the single article you decided to post to support your viewpoint. If you don’t like your ideas being challenged I can’t help that

kkwan - 25 February 2015 07:24 PM

The authors cautioned about prescribing statins for primary prevention among people at low cardiovascular risk.

This is already standard practice. The current recommendations for statin use which were updated in Nov 2013 clearly lay out the groups in whom statin use should be considered. No doubt these recommendations will evolve over time as we learn more but they are sensible based on what we currently know.

kkwan - 25 February 2015 07:24 PM

Wrt Cochrane, from the paper I cited in post 17

Please provide the direct link again. I can not seem to find it in your prior post

kkwan - 25 February 2015 07:24 PM

And is there a declaration in these “studies” as in the notes of the paper I cited:

The “declaration” you refer to is known as an Acknowledgement and is standard practice for studies in all reputable journals for the past few decades. Authors are required to disclose any conflict of interest that may exist and they are required to disclose who funded the study. If you check the Jupiter study and others I referenced in post #1 you will find all of them have this near the end of the article. There is nothing unique about this. Just because there was no outside influence does not mean that the authors don’t have a personal bias. Its just my impression but there seemed to be a clear bias in the review as well as some naivete and errors in their understanding of human physiology.

One thing I need to point out. “BIg Pharma” is often bandied about like its a four letter word and in some ways its deserved but the fact is that statin use does not have to be a big expense for patients nor a cash cow for the phramceutical industry. Among my patients who are on statins the majority are on generic versions of these drugs and in particular most are on Lovastatin (Mevacor). If purchased at Walmart or Target with a prescription a 90 day supply costs only $10 (Thats not the copay. Thats the total cost for people paying cash). That’s $40/year. Its far less than what many people pay for useless herbs and vitamins from supplement companies which for some reason aren’t viewed with the same disdain even though they make billions every year from unproven and sometimes dangerous products. Go figure.

kkwan - 25 February 2015 07:24 PM

BTW, is’nt blue a no no in CFI?

Yes, my bad

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Posted: 26 February 2015 09:51 AM   [ Ignore ]   [ # 26 ]
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macgyver - 25 February 2015 08:26 PM

I’m sorry if I taxed your attention span. I gave you a critical analysis of the single article you decided to post to support your viewpoint. If you don’t like your ideas being challenged I can’t help that

It is not my ideas being challenged.

I have read your comments in full, but your “critical analysis” is neither convincing nor comprehensive.

Did you take the time and the effort to read and digest the whole paper?

This is already standard practice. The current recommendations for statin use which were updated in Nov 2013 clearly lay out the groups in whom statin use should be considered. No doubt these recommendations will evolve over time as we learn more but they are sensible based on what we currently know.

From your post 1:

3) All patients with a cardiac risk of 7.5% or higher.

Apparently, it was 20% before the 2013 recommendation. Why has this being reduced substantially and does that mean many more people will be given statins?

What is the rationale for this?

Please provide the direct link again. I can not seem to find it in your prior post

It was not in my post 24. It was in my post 17.

Anyway, the link is here

The finding in a Cochrane systemic review by Taylor et al. is alarming [3]. They reviewed the current concept of the use of statins in primary prevention and found evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. The authors cautioned about prescribing statins for primary prevention among people at low cardiovascular risk.

[3] refers to reference 3 at the end of the paper.

The “declaration” you refer to is known as an Acknowledgement and is standard practice for studies in all reputable journals for the past few decades. Authors are required to disclose any conflict of interest that may exist and they are required to disclose who funded the study. If you check the Jupiter study and others I referenced in post #1 you will find all of them have this near the end of the article. There is nothing unique about this. Just because there was no outside influence does not mean that the authors don’t have a personal bias. Its just my impression but there seemed to be a clear bias in the review as well as some naivete and errors in their understanding of human physiology.

Can you show me the declarations in all these studies?

One thing I need to point out. “BIg Pharma” is often bandied about like its a four letter word and in some ways its deserved but the fact is that statin use does not have to be a big expense for patients nor a cash cow for the phramceutical industry. Among my patients who are on statins the majority are on generic versions of these drugs and in particular most are on Lovastatin (Mevacor). If purchased at Walmart or Target with a prescription a 90 day supply costs only $10 (Thats not the copay. Thats the total cost for people paying cash). That’s $40/year. Its far less than what many people pay for useless herbs and vitamins from supplement companies which for some reason aren’t viewed with the same disdain even though they make billions every year from unproven and sometimes dangerous products. Go figure.

The problem is “Big Pharma” is profit driven and statins were big earners for more than 10 years.

For instance, from the wiki on atorvastatin here

From 1996 to 2012 under the trade name Lipitor, atorvastatin became the world’s best-selling drug of all time, with more than $125 billion in sales over approximately 14.5 years.

Since the patent on statins have expired, the generics are much cheaper and they are freely available. However, cost is not the issue.

How will “Big Pharma” maintain earnings from statins? Sell much more.

Is that the rationale for 7.5%?

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Posted: 26 February 2015 02:29 PM   [ Ignore ]   [ # 27 ]
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Its not correct that the previous recommendation was to only treat people with a risk of 20%.  The previous recommendations were to treat based on LDL depending on which risk category you fell into. IN fact under the prior recommendations even the lowest risk individuals were treated if their LDL was above 160. The new recommendations only advise treating low risk individuals if the LDL is greater than 190. Its unclear whether the new recommendations will results in more people being treated with statins or fewer. Some people who previously would not have been treated ( diabetics with normal cholesterol levels) may now be treated but even before the change the goal was to keep a diabetics LDL below 100 so this may not change much. On the other hand lots of patients who had been treated for an LDL of 140 or 160 may now come off. In fact I have removed statin treatment from a couple dozen patients based on the new guidelines.

Regarding the acknowledgments and declarations at the end of the studies I cited. I don’t have time to cut and paste all of them here but as an example in the JUPITER TRIAL (http://circoutcomes.ahajournals.org/content/2/3/279.full) if you scroll near the end you will find the following.

Acknowledgments

Disclosures

Dr Ridker has received investigator-initiated research grant support from the National Heart, Lung, and Blood Institute, the National Cancer Institute, the Donald W. Reynolds Foundation, the Leducq Foundation, Astra-Zeneca, Novartis, Merck, Abbott, Roche, and Sanofi-Aventis; consulting fees or lecture fees from Astra-Zeneca, Novartis, Merck, Merck-Schering Plough, Sanofi-Aventis, ISIS, Dade-Behring, and Vascular Biogenics; and is listed as a coinventor on patents held by the Brigham and Women’s Hospital that relate to the use of inflammatory biomarkers including CRP in cardiovascular disease. These patents comply with guidelines established by the Harvard Medical School and have been licensed to Seimens and Astra-Zeneca. The JUPITER trial was investigator initiated and funded by Astra-Zeneca.


I think its important to keep in mind that just because you can imagine a motive for misdeeds doesn’t prove that a misdeed has occurred. If that were the case then we would have to suspect everyone who runs any business or earn any income from their efforts. I am not saying pharma might not try to influence the recommendations but neither you nor I have any proof that they did or that they were successful if they did try. These recommendations aren’t made in a vacuum. Lots of experts around the world give feedback and critique them. If they were truly unsupported by the evidence there would be far more criticism than just a couple of irish authors writing one paper in an obscure journal. Just because pharma might benefit if they manipulated the recommendations does not prove that the recommendations have been manipulated by pharma.

[ Edited: 26 February 2015 02:45 PM by macgyver ]
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Posted: 26 February 2015 05:20 PM   [ Ignore ]   [ # 28 ]
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macgyver - 26 February 2015 02:29 PM

Its not correct that the previous recommendation was to only treat people with a risk of 20%.  The previous recommendations were to treat based on LDL depending on which risk category you fell into. IN fact under the prior recommendations even the lowest risk individuals were treated if their LDL was above 160. The new recommendations only advise treating low risk individuals if the LDL is greater than 190. Its unclear whether the new recommendations will results in more people being treated with statins or fewer. Some people who previously would not have been treated ( diabetics with normal cholesterol levels) may now be treated but even before the change the goal was to keep a diabetics LDL below 100 so this may not change much. On the other hand lots of patients who had been treated for an LDL of 140 or 160 may now come off. In fact I have removed statin treatment from a couple dozen patients based on the new guidelines.

From this 10 June 2014 BBC article here

Scrap plan to extend statin use, say doctors

The signatories include Royal College of Physicians president Sir Richard Thompson and former Royal College of GPs chairwoman Clare Gerada as well as cardiologists and leading academics.

Side-effects

Prof Simon Capewell, an expert in clinical epidemiology at Liverpool University and one of the signatories, said: “The recent statin recommendations are deeply worrying, effectively condemning all middle-aged adults to lifelong medications of questionable value.

Bold added by me.

20%:

Currently, doctors are meant to offer statin tablets to the estimated seven million people who have a 20% chance of developing cardiovascular disease over 10 years, based on risk factors such as their age, sex, whether they smoke and what they weigh.

The reduction to 7.5% from 20% in the 2013 recommendation implies much more people will be treated with statins, irrespective of their LDL levels.

Regarding the acknowledgments and declarations at the end of the studies I cited. I don’t have time to cut and paste all of them here but as an example in the JUPITER TRIAL (http://circoutcomes.ahajournals.org/content/2/3/279.full) if you scroll near the end you will find the following.

Acknowledgments

Disclosures

Dr Ridker has received investigator-initiated research grant support from the National Heart, Lung, and Blood Institute, the National Cancer Institute, the Donald W. Reynolds Foundation, the Leducq Foundation, Astra-Zeneca, Novartis, Merck, Abbott, Roche, and Sanofi-Aventis; consulting fees or lecture fees from Astra-Zeneca, Novartis, Merck, Merck-Schering Plough, Sanofi-Aventis, ISIS, Dade-Behring, and Vascular Biogenics; and is listed as a coinventor on patents held by the Brigham and Women’s Hospital that relate to the use of inflammatory biomarkers including CRP in cardiovascular disease. These patents comply with guidelines established by the Harvard Medical School and have been licensed to Seimens and Astra-Zeneca. The JUPITER trial was investigator initiated and funded by Astra-Zeneca.

Is the credibility and independence of the Jupiter Trial not questionable if grants and consulting/lecture fees came from so many pharmaceutical companies including those who sell statins?

This is a conflict of interest issue.

From the wiki on conflict of interest here

A conflict of interest (COI) is a situation in which a person or organization is involved in multiple interests (financial, emotional, or otherwise), one of which could possibly corrupt the motivation of the individual or organization.

As the saying goes, “he who pays the piper calls the tune”.

I think its important to keep in mind that just because you can imagine a motive for misdeeds doesn’t prove that a misdeed has occurred. If that were the case then we would have to suspect everyone who runs any business or earn any income from their efforts. I am not saying pharma might not try to influence the recommendations but neither you nor I have any proof that they did or that they were successful if they did try. These recommendations aren’t made in a vacuum. Lots of experts around the world give feedback and critique them. If they were truly unsupported by the evidence there would be far more criticism than just a couple of irish authors writing one paper in an obscure journal. Just because pharma might benefit if they manipulated the recommendations does not prove that the recommendations have been manipulated by pharma.

In the case of statins, it is glaringly obvious that “something is rotten in the state of Denmark”.

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Posted: 26 February 2015 07:05 PM   [ Ignore ]   [ # 29 ]
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From this article here

Why I’ve ditched statins for good

The only major changes I’d made to my lifestyle since coming off statins were eliminating sugar (including alcohol and starchy foods such as bread) and eating more animal fat. Many experts now believe that sugar is emerging as a true villain in the heart-disease story; while after decades of demonisation, saturated fat has been acquitted of causing heart disease by a recent “meta” analysis of 70 studies by Cambridge University.

Typically, I was eating red meat three or four times a week and enjoying butter, full-fat milk and plenty of eggs. You would have thought that after three months on a diet so high in saturated fat, my cholesterol would have shot back up to pre-statin levels — but no, it came down and has stayed down seven months on. Not only that, but my levels of LDL (so-called bad cholesterol) were also lower than when I’d been on statins, and my ratio of HDL (so-called good cholesterol) to LDL was under four for the first time, an excellent sign, according to medical wisdom.

So, is sugar and simple carbohydrates, not saturated fats or cholesterols per se, the actual cause of Cardiovascular disease (CVD)?

What is CVD?

From the wiki on CVD here

Cardiovascular disease (CVD) is a class of diseases that involve the heart or blood vessels. Common CVDs include: ischemic heart disease (IHD), stroke, hypertensive heart disease, rheumatic heart disease (RHD), aortic aneurysms, cardiomyopathy, atrial fibrillation, congenital heart disease, endocarditis, and peripheral artery disease (PAD), among others.

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.

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Posted: 26 February 2015 08:55 PM   [ Ignore ]   [ # 30 ]
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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%.

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.

Dietary recommendations are going through some change right now and thats fine. Diet studies are always difficult to do because its nearly impossible to do long term well controlled prospective studies on diet. Most of the data linking diet to CAD are the result of retrospective studies, population studies, and cohort studies with all the weaknesses and problems they present. The existing data linking saturated and transfats to CAD suffers from this weakness just as newer data linking high carb diets do. Its tempting to jump on the new trend and discard the guilt about eating high fat foods but that would be premature. 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.

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