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NewdestinyX

Statins - benefits versus risks

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NewdestinyX
If any criticism of the drug companies will always be seen by you as an attempt to address a motive, and therefore inappropriate, it will be impossible to have a full and fair discussion. In order to properly evaluate the peer-reviewed studies that have been funded by drug companies, it is imperative that we understand (i) whether abstracts and conclusions are truly supported by the raw data, and (ii) that the drug companies as a matter of proven fact do not report every study they do. Not a matter of conspiracy, a matter of fact. And that is what we are trying to determine here, no? How much of what we have heard about statins--pro and con--is factual?
What you propose here is that nothing we read in a study is reliable. I reject that notion, Shottle. That is the very definition of 'conspiracy theories'. And maybe you and I are working from two different definitions of 'peer review'. PEER REVIEW, by definition, precludes the possibility of people in the drug company's employ doing the 'reviewing'. That would indeed be too often tainted and we could come to 'no conclusions'. The peer review process is a process whereby the study parameters and conclusions are re-scrutinized by medical professionals from a different organization or a different individual -who often even recreate some of the study steps themselves and then corroborate or present opposition to the outcomes and conclusions of the original study.

 

All you have to do is Google the names of the docs in the peer list and you can find out if they're from the same organizations. It takes a little more work. But we must do our homework well. I do not accept the premise that all data that we would share here would be unreliable. I have created a very fair and protected way of determining whether data presented is something we can 'bank on' and 'stake our health' on.

peer-reviewed studies that have been funded by drug companies,

I am 'not' asking only for these. I offered one because it was peer reviewed by independent organizations. To imply that 'all studies funded by a drug company' could have tainted results is ONE thing.. But to imply that the 'peer review' process is also taint-able -- is to deny the definition and paradigm of a true 'peer review', a process that was designed to 'eliminate' potential tainting. That's why to adopt a definition of 'peer review' that allows for tainted conclusions is the stuff of 'conspiracy theorists' - who always change definitions to cast aspersions on verifiability of data.

 

So questioning the trustworthiness of the 'peer review' process itself -- is also off topic. Please.

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NewdestinyX

From WIKIPEDIA:

Peer review (also known as refereeing) is the process of subjecting an author's scholarly work, research, or ideas to the scrutiny of others who are experts in the same field. Peer review requires a community of experts in a given (and often narrowly defined) field, who are qualified and able to perform impartial review. Impartial review, especially of work in less narrowly defined or inter-disciplinary fields, may be difficult to accomplish; and the significance (good or bad) of an idea may never be widely appreciated among its contemporaries. Although generally considered essential to academic quality, peer review has been criticized as ineffective, slow, and misunderstood (see anonymous peer review and open peer review).

 

Pragmatically, peer review refers to the work done during the screening of submitted manuscripts and funding applications. This process encourages authors to meet the accepted standards of their discipline and prevents the dissemination of irrelevant findings, unwarranted claims, unacceptable interpretations, and personal views. Publications that have not undergone peer review are likely to be regarded with suspicion by scholars and professionals.

Yes, I do acknowledge Wiki's one caveat there too. Remember though -- Wiki is written by individuals.. But I thought it would be the perfect source to present since there's a always a little 'ambiguity' in Wiki stuff. - And note their definition says potential for 'ineffectiveness, slowness and misunderstanding -- but it does NOT say 'inaccuracy or untrustworthiness'. Peer reviews, true ones -- are 'trustworthy' in establishing truth you can bank on.

 

Let's put this to rest now - please. Back to the articles! If we all want to learn more about this -- enough to look our docs in the face and say 'yes, please', or 'no thank you' to a statin we have to do our homework. For this thread - we will be trusting the 'peer review process'. If you are the type to distrust that process then maybe a new thread can open debating that. Please, not here. The topic of this thread is the 'RISKS and BENEFITS' of STATINS in your experience and in the articles you've read.. And that would have to include talk about 'high cholesterol's' risks (or lack) as well.

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yannah

yes I can prove that drug companies will push a drug because the patent ran out on there big seller. and I can prove they will know its dangerous and they will cover it up. EI Lilly was sued by thousands in a class action for just this. the drug that gave me diabetes. Lilly lost.

 

Bitter Pill : Rolling Stone

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NewdestinyX
yes I can prove that drug companies will push a drug because the patent ran out on there big seller. and I can prove they will know its dangerous and they will cover it up. EI Lilly was sued by thousands in a class action for just this. the drug that gave me diabetes. Lilly lost.

 

Bitter Pill : Rolling Stone

:topic:

 

And forgive me, Yannah, but Rolling Stone magazine can hardly be considered a reliable source of verifiable data. Nor can any of us claim a drug company 'gave us' diabetes.

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ShottleBop
From WIKIPEDIA:

Yes, I do acknowledge Wiki's one caveat there too. Remember though -- Wiki is written by individuals.. But I thought it would be the perfect source to present since there's a always a little 'ambiguity' in Wiki stuff. - And note their definition says potential for 'ineffectiveness, slowness and misunderstanding -- but it does NOT say 'inaccuracy or untrustworthiness'. Peer reviews, true ones -- are 'trustworthy' in establishing truth you can bank on.

 

Let's put this to rest now - please. Back to the articles! If we all want to learn more about this -- enough to look our docs in the face and say 'yes, please', or 'no thank you' to a statin we have to do our homework. For this thread - we will be trusting the 'peer review process'. If you are the type to distrust that process then maybe a new thread can open debating that. Please, not here. The topic of this thread is the 'RISKS and BENEFITS' of STATINS in your experience and in the articles you've read.. And that would have to include talk about 'high cholesterol's' risks (or lack) as well.

 

For the reasons I have already pointed out, it is impossible to have a balanced discussion about the benefits and risks of statins if you confine all input to peer-reviewed studies. You either want those benefits and risks to be fully aired, or you don't. You cannot, merely be reasoning of writing the opening post, force the discussion into a format that will, almost by definition, result in only half the story being told.

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yannah
:topic:

 

And forgive me, Yannah, but Rolling Stone magazine can hardly be considered a reliable source of verifiable data. Nor can any of us claim a drug company 'gave us' diabetes.

 

the rolling stone is known for its journalism but I will post other things about this for you. give me 30 seconds.

 

I like that article, it is the easiest best read on the subject which I happen to be an expert on for obvious reasons.

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yannah

here it is in wikpedia if that is simple enough and reliable enough for you. I will be glad to give you many more or you can just google it.

 

the rolling stones article is much better. much more comprehensive.

 

Olanzapine - Wikipedia, the free encyclopedia

 

I was not off topic. you said we could not prove drug companies do this and they do.

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NewdestinyX
For the reasons I have already pointed out, it is impossible to have a balanced discussion about the benefits and risks of statins if you confine all input to peer-reviewed studies. You either want those benefits and risks to be fully aired, or you don't. You cannot, merely be reasoning of writing the opening post, force the discussion into a format that will, almost by definition, result in only half the story being told.
I'm sorry to not agree, Shottle. It will force the discussion to be free-"er" of non peer reviewed studies that 'should' carry less consideration in the minds of people 'desperate' to help themselves to be healthier for a longer time like we T2Ds. But I don't think it will be 1-sided. Several of your articles from the Zocor thread were peer-reviewed by at least one other professional and that's good enough for me here too. I DO want to see both sides of the issue for sure. What I want to 'filter' out are a single researcher's study with no peer review of any kind and one single (non-research) Drs' comments on another researcher. If it's posted here -- it needs to be 'vetted' by the peer review process -- either multiple drs/researchers in the review or any 'one' or more researcher(s) commenting/reviewing another researcher.

 

The internet, tragically, is full of opinion pieces by GP's and even specialists that have 'hunches'. They don't do their own research but spend time, like we do -- Googling. If they find even '1' article supporting their hunch they 'author' an article and occasionally even get their 'association's to sign on (Endoncrine specialists of "The World" ;)) -- But these opinion pieces based on the flimsiest of studies get published on blog sites on the internet and then the 'helpless' (us) latch onto them. Only the 'hurting' -- go looking for articles to back up their 'troubles' with a med, etc...

 

So in short -- I want us to have a lasar beam focus in this thread... And Peer Review will make us better informed to make such huge decisions like should I take a statin even if my doc has already prescribed it. These disease-based fora tend to gather folks that, for lack of a better term, are like the 'naturalists' who hate all meds.. It's SO easy to find 'some research' supporting what you're HUNCH is that leads to our fears about this or that med.

 

I would, however, myself, also visit a thread one may start called: "Statins and LDL -- the Story Behind the Story." Though I might question the reliability of everything I'd read there -- it would make for good reading. But here -- I'm hoping for the 'highest' standard of research and research commentary. Why? Because I will make my choice to start a statin or not based on our conclusions.

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NewdestinyX
infact again, wikpedia, has a great article on Lilly and medical ethics.

 

Eli Lilly controversies - Wikipedia, the free encyclopedia

Yannah. As I've mentioned this rabbit trail is off topic. So I simply won't respond anymore and ask that no one else respond too. I'd be happy to visit a thread you started on that topic though, as I'd love to know more of your story - which I don't at this point. My heart does go out to you, though, for whatever you've gone through.

 

Thanks!

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ShottleBop
The internet, tragically, is full of opinion pieces by GP's and even specialists that have 'hunches'. They don't do their own research but spend time, like we do -- Googling. If they find even '1' article supporting their hunch they 'author' an article and occasionally even get their 'association's to sign on (Endoncrine specialists of "The World" ;)) -- But these opinion pieces based on the flimsiest of studies get published on blog sites on the internet and then the 'helpless' (us) latch onto them. Only the 'hurting' -- go looking for articles to back up their 'troubles' with a med, etc...

 

This is not what I'm talking about at all. As was the letter I posted commenting on the HPS, I am talking about criticisms of the same peer-reviewed studies you want to see. Anthony Colpo, Uffe Ravnskov, Malcom Kendrick, Beatrice Golomb--none of them are acting on "hunches"; they are simply reviewing the extant literature.* They are informed critics, and their work is entirely germaine to the discussion. To denigrate them as nothing more than "googlers"--especially without buying, and reading, their books, would be unwarranted.

 

 

 

__________

* If you want to see an example of cherry-picking, check out Ancel Keys' Seven Countries Study--it has long since been pointed out that he had data regarding 22 countries, but left out any that didn't support the hypothesis he was interested in advancing.

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yannah

okay, then there isn't much to discuss IMO.

 

statin use is fine Grant. the benefits always outweigh the risks.

Pharma companies are only there to help us. anything stating otherwise is a conspiracy theory or a result of bad research, or just people googling.

 

what is the topic of this thread? Statin use, not much to think about?

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jenb

Grant, I mean this in the most respectful way.

 

Your insistent, officious gatekeeping has resulted in the very thing that you ostensibly wished to avoid: Your thread has devolved into an unfortunate conversation rife with demeaning comments (some of which you have made). I hope you will return to the original topic - a discussion of statins and their usefulness for the diabetic community. That is what is of interest here, at least in my humble opinion.

 

Thanks!

 

Jen

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yannah

the thing I like most in threads and get the most from, is the winding and thoughtfulness of so much thought and so much different experience. things I never would have thought of thinking about. people here are so informed and experienced. sometimes conversation travels and along the way, I learn more about so much I had not anticipated. also the same topics come up over and over with new people and new twists.

and so I know I will never be done learning at DF..

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ShottleBop

Table 1. Risk reduction (total mortality) in six clinical statin trials (all stated as percents)

 

4S2

-29 decrease in relative risk

-3.3 decrease in absolute risk

88.5 survival rate, untreated

91.8 survival rate, treated

 

WOSCOPS3

-21 decrease in relative risk

-0.9 decrease in absolute risk

95.9 survival rate, untreated

96.9 survival rate, treated

 

CARE4

-8 decrease in relative risk

-0.78 decrease in absolut risk

90.57 survival rate, untreated

91.35 survival rate, treated

 

AFCAPS/TexCAPS5

+3.9 increase in relative risk

+0.09 increase in absolute risk

97.7 survival rate, untreated

97.6 survival rate, treated

 

LIPID6

-21 decrease in relative risk

-3.0 decrease in absolute risk

85.9 survival rate, untreated

89 survival rate, treated

 

EXCEL7

+150 increase in relative risk

+0.3 increase in absolute risk

99.8 survival rate, untreated

99.5 survival rate, treated

 

Source. Accompanying commentary:

Letter to Archives of Internal Medicine, submitted on July 20, 2002

 

Exaggerated benefit of statin treatment in the elderly?

 

by

 

Uffe Ravnskov, MD, PhD (corresponding author), Magle Stora Kyrkogata 9, S-22350 Lund, Sweden. Tel/fax +46 46145022 (call before faxing) , e-mail: ravnskov+tele2.se (exchange + with @)

 

Joel M. Kauffman; PhD, Professor of Chemistry Emeritus, University of the Sciences in Philadelphia

 

Peter H. Langsjoen, M.D., F.A.C.C., 1107 Doctors Drive, Tyler, Texas

Kilmer S. McCully, M.D., Chief, Pathology & Laboratory Medicine Service, Boston Area Consolidated Laboratories, US Department of Veterans Affairs

Paul J. Rosch, Clinical Professor of Medicine and Psychiatry, New York Medical College; President, The American Institute of Stress

 

In his editorial about cholesterol lowering in the elderly Scott Grundy pleads for aggressive statin treatment with the argument that statins reduce the risk for major coronary events by at least one third.1 However, this end-point includes non-fatal myocardial infarction and instable angina, conditions that may heal with little discomfort or residual damage. Since what most patients care about is whether treatment will prolong life, a more appropriate end-point would be total mortality, which also has the advantage of being free of bias. Furthermore, to report treatment results in terms of relative risk reduction is misleading because it exaggerates the benefit for the individual patient. A more honest way to inform the patient is to calculate his/her chance of surviving with and without treatment. These odds, as well as the relative and the absolute reduction or increase of total mortality in the five trials2-6 that were used by Grundy as evidence and in the statin trial, EXCEL,7 that he ignored are shown in the following table.

 

As can be seen, the optimistic figures for relative risk reduction actually reflect unimpressive absolute risk reductions. These small benefits are also illustrated by the trivial differences between the survival rates with and without treatment. In two of the three trials that included healthy people only,5,7 the chance of surviving was even better without treatment.

 

According to Grundy the results from the Heart Protection Study (HPS)8 demonstrated that older persons achieved the same relative benefit from LDL-lowering therapy as did other subgroups. Unfortunately the data given by the HPS directors do not allow a calculation of the chance of surviving for the individual age groups, but as the results from HPS were only half as good as the results from the previous simvastatin trial,9 the increased chance of surviving for old people must have been even lower than given in the table.

 

That senior citizens with coronary heart disease, non-coronary atherosclerotic disease and diabetes deserve intensive LDL-lowering therapy, as suggested by Grundy, is questionable since recent studies have shown that a low, not a high cholesterol, is more predictive of coronary heart disease in the elderly.10,11 How is it possible to prevent CHD by cholesterol lowering if a low cholesterol predicts future CHD? The answer is that the cardioprotective benefits associated with statin therapy are obviously not the result of lipid-lowering but rather other advantageous effects, some of which Grundy referred to.

 

That cholesterol lowering has any effect by itself is also contradicted by the observation of a general lack of exposure-response in the statin trials. Exposure-response has often been claimed because the outcome of a trial was associated with the initial or pre-trial cholesterol level. However, true exposure-response demands that the outcome is associated with the degree of total or LDL-cholesterol lowering, whether outcome is expressed by clinical events or by degree of atherosclerosis growth, and such associations are rarely found. Thus, the p values for the relationships between the outcome, and the percentage or the absolute change in LDL cholesterol, as calculated in one of the trial reports, were 0.76 and 0.97, respectively;12 and with one exception. none of 18 cholesterol lowering angiographic trials found exposure-response for LDL, total cholesterol or any other lipid fraction.13

 

One may question whether statin treatment should be used at all because the small absolute risk reduction rewards may be outweighed by potential serious long-term side effects. One statin drug has already been withdrawn because of a large number of fatal cases of rhabdomyolysis and another serious side effect is peripheral neuropathy. In a recent case control study the relative risk of idiopathic polyneuropathy for patients treated with statins for two years or longer was 26.4 (7.8 to 45.4), and the risk was strongly associated with duration of treatment and cumulative dose.14 It was calculated that one new case of neuropathy could be expected for each 2200 patient years among those aged 50 years or older, a figure that by time easily may exceed the small number of lives saved in the statin trials, in particular in those that included healthy individuals.

 

Should properly informed patients still request statins, then the lowest effective dose should be prescribed rather than trying to reduce LDL to an arbitrary level as the end point.15

 

The letter was not published:

Sept. 25, 2002

 

Dear Dr. Ravnskov

 

Thank you for your recent letter to the editor. Unfortunately, because of the many submissions we receive and our space limitations in the letter section, we are unable to publish your letter in the Archives of Internal Medicine.

 

After considering the opionion of our editorial staff, we determined your letter did not receive a high enough priority rating for publication in THE ARCHIVES. We are able to publish only a small fraction of the many letters submitted to us each year, which means that published letters must have an extremely high rating. We appreciate your interest and thank you for the opportunity to review your letter

 

Sincerely

 

James E.Dalen, MD, MPH

Editor

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jenb

Thank you Shottlebop. Very interesting. One wonders how many letters to the editor in support of statin use have been published in THE ARCHIVES versus letters taking the position of the above named.

 

Jen

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fgummett

I think there is a direct parallel between the "establishment" view on statins/cholesterol and the "establishment" view on global climate change... this OP seems to be suggesting that the establishment view carries weight simply because it IS the establishment view... I do not think that science should be based on a popularity contest.

 

I chose "climate change" because the OP has himself mentioned Al Gore on more than one occasion, leaving me with the impression that he does not subscribe to the apparent "consensus" that "Humans are responsible for Global Warming/Climate Change".

 

I am [also] not convinced that we as a species are responsible for global climate change.

 

I am convinced by substantial evidence, that climate change is "standard operating procedure" on Earth... the climate has always been in flux.

 

I am also convinced that we as a species need to take responsible action for our misuse/overuse of natural resources and clean up our act; in terms of pollution... or face extinction.

 

I try to look at this issue in calm, impassionate, scientific terms. However this has become both a political and an emotional issue, with polarized views and little room for impartiality. Listen to the media, politicians and pretty much anyone you talk to and they will report a worldwide consensus of science that global warming is man-made. And yet there is NOT a consensus among all scientists. The science follows the money... researchers who rely on grants have to be careful what they study and what they report, in order to protect their bread and butter. Media outlets looking for sensation report only the scariest headlines. It becomes self-perpetuating... and anyone who tries to speak out, even to say "just a minute, maybe we should look at this again" is branded as a heretic, crank, conspirator or worse.

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Rekarb

I can't quote a peered review article, at least at this moment. The problem has been that so many interesting articles are blocked off from view, you just get the abstract, unless you have a university account or something similar.

 

At any rate, statins were supposedly about lowering LDL with the thought this would effect CVD. The point of this article was that LDL density is the most important feature and that statins do not effect this density.

 

It seems to me that statins have shown good effects for a certain class of middle age men but for no one else.

 

Mike

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ShottleBop

From "Future Lipidology," October 2007, Vol. 2, No. 5, Pages 481-483 , DOI 10.2217/17460875.2.5.481 (doi:10.2217/17460875.2.5.481), by Malcolm Kendrick

 

I believe that, currently, statins are overused. This is a view that places me in a distinct minority. Indeed, rather than leading a counter-revolution, I feel more like King Canute trying, without any discernible effect, to stop the tide from coming in.

 

For example, there have been recent calls to place all men over 50 years of age on statins [101]. And this would only be the start. A review of the latest European Society of Cardiology guidelines compiled in Norway, suggested that, were the guidelines to be followed, more than 50% of men aged 25 or over would require statins [1].

 

This move towards, what can only be described as mass medicalization, would be a grave error. Even today I think that the benefits of statins are heavily outweighed by the costs – financial, medical and societal – and the seemingly inexorable pressure for even greater prescribing of statins can only unbalance the equation even further towards the negative.

 

My main objections to statins are as follows:

 

 

 

 

 

Over-hyping of benefits

 

When I speak to patients, they have often heard that taking a statin will reduce their risk of a heart attack by up to 40%. The press release for the Heart Protection Study (HPS) claimed that 50,000 lives a year could be saved by increased prescribing of statins [102]. Information presented in this way sounds incredibly impressive, and leads to the view that statins are unparalleled life-saving drugs.

 

However, the question most people should ask – but do not – is this:

 

‘How much longer will I live, if I take a statin for, say, 30 years.’

 

The answer, if you are a women, is:

 

‘Not one day.’

 

And this is true for both primary and secondary prevention. Even in the HPS study, which is hailed as universally positive, there was no significant benefit on overall mortality in women [103].

 

And the same is true for men without existing heart disease, because the primary prevention trials in men have not demonstrated any benefit on overall mortality in this group either [2]. I have been told that the trials were not powered to demonstrate such a benefit. Possibly, but if a series of 5-year long, and longer, trials involving tens of thousands of patients are not big enough, or long enough, to demonstrate a benefit, then any such positive effect must be vanishingly small.

 

Other people have argued with me that preventing nonfatal strokes and myocardial infacrtions (MIs) has a major benefit on the quality of life, so I should look beyond overall mortality. However, in those trials that have reported such things, serious adverse events (SAEs) were the same in the placebo as the statin arm.

 

If a SAE in the statin was, for example, rhabodomyolysis with subsequent renal failure, then this would have a more impact on the quality of life than a nonfatal MI. I can only use a speculative example because the Cholesterol Treatment Trialists (CTT) collaborators have not, indeed will not, release the data on SAEs from the major statin trials, despite being asked repeatedly if they would do so [104].

 

Costs

 

The costs of prescribing statins are extraordinary, and rising. In the UK, where I work, statins cost the National Health Service (NHS) approximately $1.2 billion in 2005 [105]. But the drug cost is only a fraction of the total costs incurred in ancillary activities such taking extra blood tests, added consultations, prescribing fees, prescription charges, and so on.

 

Consider the area of consultations. On average, a patient on a statin will see a doctor for review twice a year. In the UK, around four million people take statins currently. So, there is a need for eight million consultations, which is the entire workload of 2000 general practitioners, costing $200,000/year to the NHS. A grand total of $4 billion/year.

 

This is a massive cost to a health service that is currently having trouble funding drugs for Alzheimer’s, leukemia and breast cancer. In fact, last year the NHS went into such severe debt that thousands of staff had to be made redundant. Every single one of them could have remained in work, using only a small percentage of the money spent on statins.

 

Side effects

 

It is generally stated that statins have very few side effects. In many trials, these have been reported as less than 1%, exactly the same as placebo. My personal experience is that a significant number of people suffer side effects, usually muscle weakness and pain, and often problems with cognition.

 

Unfortunately, these are frequently not mentioned by the patients, or if they are, they are downplayed or dismissed by their own doctors [3]. One problem, impotence, I believe is very common. The problem here is that cardiovascular disease is associated with impotence, as is diabetes. So the patients are often told that their impotence is a sign of underlying cardiovascular disease – or diabetes – which makes it even more important that they take their statin. I call this the ‘double-whammy’ effect.

 

Perhaps more worryingly, some of the side effects of the statins seem to be permanent, for example, peripheral neuropathy [4]. More worrying still is the fact that the WHO is picking up a high signal noise associated with statins and amyotrophic lateral sclerosis [5], which is just about as unpleasant and deadly a side effect as can be imagined.

 

Statins & cancer

 

There is no doubt that a lower cholesterol level is strongly associated with an increased risk of cancer [6]. Statins lower cholesterol levels. In animal studies, statins at doses comparable to those now used in humans, caused cancer [106].

 

A recent meta-analysis demonstrated a small, but significant, increased risk of cancer [7]. The only study performed in older people, the Pravastatin in Elderly Individuals at Risk of Vascular Disease (PROPER) study, found an increased risk of cancer [7], and the Japan Lipid Intervention Trial (J-LIT) performed in Japan warned that statin ‘hyper-responders’ had a greatly increased risk of dying of cancer [8].

 

So far the risk appears relatively small. However, it has been pointed out by some other cholesterol skeptics (yes there are others), that carcinogens, for instance those found in cigarette smoke, can take many years to produce a clear effect. My worry is that statins could cause cancer with long-term use. Yet there is no study in place (that I know of) to monitor this possibility.

 

Summary

 

I think that statins have been over-hyped and consequently over-used. This situation has occurred for a number of reasons, but the net effect has led to a massive over-prescribing of these drugs, something that seems likely to get worse.

 

I believe that statins do not provide significant overall health benefits – if you look outside pure cardiovascular disease prevention. I think they have many more side effects than is generally accepted. The costs are huge, and rising, and they may – in the long term – significantly increase the risk of cancer.

 

Financial & competing interests disclosure

 

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

 

No writing assistance was utilized in the production of this manuscript.

 

Footnotes are at the link; when I tried to include them, I went over the post limit.

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ShottleBop

Jay S. Cohen, MD, studied medicines and their side effects generally. He advocates the use of statins, at the lowest effective dosage, where indicated. This article from his website, MedicationSense addresses the use of statin:

The Crestor for C-Reactive Protein Study: Limited Benefits and Serious Risks

 

What are the implications as doctors place millions of patients on this powerful, cholesterol-lowering statin drug?

 

If you read a newspaper or watched television news on December 10, 2008, you would have thought that Crestor, a cholesterol-lowering statin medication, was a wonder drug.

 

Of course, a few years ago you would have thought the same thing after the heavy news coverage for another powerful statin, Lipitor. Yet, my analyses at MedicationSense (2005, 2006) revealed that the Lipitor studies demonstrated limited benefits and worrisome adverse effects.

 

The new Crestor study, which involved more than 17,000 subjects, examined the drug's effectiveness in reducing elevated blood levels of C-reactive protein (CRP), a marker for cardiovascular inflammation.1 It is currently believed that increased levels of inflammation are associated with a higher incidence of heart attacks and strokes (more on CRP below).

 

Crestor Study Results -- and What They Really Mean

 

The authors of the Crestor-CRP study reported that over the 1.9 years of the study, there was a 44% reduction in cardiac events (defined as heart attack, stroke, severe angina, or cardiac death) among the subjects taking Crestor versus those taking a placebo. A 44% reduction sounds very impressive, but it is misleading.

 

Here on the actual numbers from the study. Over 2 years, 1.36% of subjects in the placebo group experienced a cardiac event; 0.77% of subjects in the Crestor group experienced an event. The difference was 0.59%. That is, less than 1%, a tiny difference.

 

The difference was so tiny that it will require 120 individuals with elevated CRP to take Crestor every day for two years for just one person to obtain benefit.2 Meanwhile, the other 119 individuals taking and paying for Crestor for two years will obtain no protection from a cardiovascular event.[/b]

 

Why would the results of the Crestor-CRP study be proclaimed so loudly nationwide despite being so tiny? The Crestor-CRP study was underwritten by AstraZeneca, the manufacturer of Crestor. We have seen previously that the marketing departments of drug companies are masters at obtaining maximum media coverage for their studies even if the results are unimpressive. Wide exposure means increased sales and big profits.

 

One media outlet took a critical stance. ABCNEWS.com boldly offered a dissenting opinion. In "Doctor Urges Caution in Interpreting New Findings on Cholesterol Drug," Dr. Nortin Hadler wrote, "The benefit shown in this study is tiny, and if [the Crestor-CRP study] were repeated, there might be no benefit at all. I never leap to act on the basis of such small effects."3

 

Serious Side Effects Downplayed

 

In Crestor-CRP, the drug displayed many of the common adverse effects of other statin medications (Lipitor, Zocor, Pravachol, Mevacor, Lescol). Typical side effects include abdominal pain, muscle pain, serious muscle breakdown (rhabdomyolysis), renal disorders, and liver disorders. More subjects in the Crestor group experienced these side effects than subjects in the placebo group.

 

A far more serious adverse effect occurred with Crestor: 270 cases of newly diagnosed diabetes were reported among Crestor users, and 216 cases were reported among placebo users. The 54 more cases of diabetes in the Crestor group was a significant and worrisome finding. Diabetes is one of the most destructive, life-shortening disorders of our time. It also is a leading cause of heart attacks and strokes. Imagine, taking Crestor to prevent a heart attack and getting diabetes instead.

 

When the FDA decides whether to approve a new drug, it makes it decision based on whether the drug will produce significantly more benefit than risk. If Crestor were being evaluated today for approval by the FDA, I believe Crestor would not be approved because its use in the Crestor-CRP study was associated with many new cases of diabetes.

 

Should I Be Tested for Elevated CRP?

 

Half of all cardiac deaths occur in people with normal cholesterol levels, so other factors cleary are involved in the development of cardiovascular disease. New studies suggest that an elevated level of CRP may be as important an indicator of cardiac risk as cholesterol levels.4.5

 

"Forward-thinking cardiologists suspect that internal inflammation is the root cause of many diseases including those of the heart and blood vessels," states cardiologist Stephen Sinatra. "Studies have shown that people with elevated CRP run two times the risk of dying from a cardiovascular-related problem compared with those who have high cholesterol levels. Combine a cholesterol burden with a markedly elevated CRP and your risk of heart attack and stroke increases by a factor of nine."6

 

Despite this, experts still disagree on whether the entire population should be tested for elevated CRP. I believe that anyone who has cardiovascular disease or is at risk for it should be tested for elevated CRP. Furthermore, I also encourage anyone interested in prevention to have a CRP test.

 

A CRP level below 1 is low-risk; 1-3 moderate-risk; above 3 high-risk.

 

Should My Elevated CRP Be Treated?

 

If your CRP level is elevated, it should not be ignored. Yet this does not mean that your doctor should immediately prescribe you a statin. As Dr. James Ehrlich, a pioneer in cardiovascular disease screening, said, an elevated CRP "is a call for more information, not an invitation to take an automation-like approach to prescribing life-long statins."7

 

An elevated CRP indicates a higher than normal level of inflammation in the body. Many medical conditions can produce inflammation. Your doctor should examine you for signs of infection: teeth, sinuses, bladder, ovaries or prostate. A recent cold or bout of the flu can also elevate CRP. Inflammatory disorders such as rheumatoid arthritis may cause an elevated CRP.

 

If no other causes of infection are found, the elevated CRP likely reflects cardiovascular inflammation. Should it be treated? Experts differ on this, but in general I recommend treatment.

 

Is Crestor the Only Treatment for Elevated CRP?

 

No. There are many choices, pharmaceutical and natural. This section will discuss statin therapy.

 

We have known for a decade that the effects of all statins are similar. This means that all statins can reduce elevated CRP.

 

In the Crestor-CRP study, 20 mg of Crestor was used. This is a powerful dose, and because Crestor is only available as a brand-need drug, it is expensive. At a nationwide discount pharmacy, 100 pills of 20-mg Crestor costs $340. The cost over one year is approximately $1360. Over 20 years, the cost of Crestor 20 mg per day is approximately $27,000.8 An equally powerful dose, 80 mg, of Zocor is available as a generic (simvastatin), and it costs about 90% less.

 

Just because the Crestor-CRP study used a powerful dose of Crestor does not mean that only a powerful dose will reduce elevated CRP. Some experts believe that it is not necessary to use the same strong statin doses that doctors frequently prescribe to reduce cholesterol levels. Elevated levels of CRP may not require such strong treatment. According to Dr. Uve Ravnskov, "It may be wiser to search for the lowest effective dose instead of the dose with maximal effect on LDL-cholesterol."9

 

If you are prone to getting side effects with medications, or if you simply want to reduce your risk of side effects, ask your doctor about starting with the lowest dose of simvastatin. If this does not adequately reduce your elevated CRP level, ask your doctor to increase the dose gradually until you arrive at the amount that works. With Zocor (simvastatin), the lowest dose is 10 mg.

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ShottleBop

Continuation of last post:

 

Natural Approaches

 

Integrative doctors recommend a variety of natural approaches to reduce elevated CRP. Because smoking increases CRP, the first step for any smoker is to stop smoking. Being overweight increases CRP, so weight loss is also important. Healthy eating and exercise can also reduce CRP levels.

 

Women taking hormone replacement therapy should be aware that the therapy can increase CRP levels.10 Check with your doctor.

 

There are several natural supplements that have anti-inflammatory qualities. Alternative doctors often include one, such as curcumin or ginger, in their combination treatment for elevated CRP. Some alternative doctors include aspirin because of its proven anti-inflammatory effect.

 

Vitamin C might also be included in the treatment of elevated CRP. A study in the Journal of the American College of Nutrition demonstrated that 515 mg/day of vitamin C reduced CRP 24%.11 In comparison, in the Crestor-CRP study, Crestor reduced CRP levels by an average up 37%. Vitamin C plus other therapies mentioned in this section might rival or exceed this result.

 

Vitamin E, with its natural anti-inflammatory effects, might also help reduce elevated CRP.

 

Omega-3 fatty acids (fish oils) have proven anti-inflammatory effects. Studies have shown that daily intake of omega-3 fatty acids reduce the risk of cardiac death and also reduce the pain of rheumatoid arthritis.12,13 Fish oils should be a standard part of the treatment of elevated CRP. Because fish oils and aspirin taken together can increase the body's tendency for bleeding, check with your doctor before taking these therapies together.

 

A natural supplement with properties similar to prescription statins is red yeast rice. This fermentation product contains small amounts of several statin-like compounds. It works like a mild statin and, like prescription statins, reduces vascular inflammation and elevated CRP. Red yeast rice can also reduce cholesterol levels. Like prescription statins, red yeast rice can cause adverse effects, but the risk is low and, if side effects occur, they are usually milder than with prescription statins.

 

Jay S. Cohen M.D. is a nationally recognized expert on medications and side effects. He is an adjunct associate professor of preventive medicine and author of What You Need to Know about Statin Drugs and Their Natural Alternatives (Square One Publishers 2005). Dr. Cohen provides consultations to people across America who are interested in statin drugs or natural alternatives for reducing elevated CRP or cholesterol, or who are interested in cardiovascular health and methods of prevention.

 

References

 

1. Ridker PM, Danielson E, Fonseca FAH, et al (for the JUPITER Study Group). Rosuvastatin to prevent vascular events in men and women with elevated C?reactive protein. The New England Journal of Medicine, Nov. 20, 2008;359(21):2195?2207.

 

2. Hlatky MA. Expanding the Orbit of Primary Prevention ?? Moving beyond JUPITER. New England Journal of Medicine, Nov. 20, 2008;359 (21):2280?82.

 

3. Hadler NM. Crestor, by Jove... or Not. Doctor urges caution in interpreting new findings on cholesterol drug. ABC News, Nov. 10, 2008:ABCNews.com - Breaking news, politics, online news, world news, feature stories, celebrity interviews and more - ABC News.

 

4. Ridker, PM, Rifai, N, Rose, L, et al. R. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. New England Journal of Medicine 2002;347:1557-1565.

 

5. Albert, MA, Glynn, RJ, Ridker, PM. Plasma concentration of C-reactive protein and the calculated. Framingham Coronary Heart Disease Risk Score. Circulation 2003;108(2):161?5.

 

6. Sinatra, S. Statins: grossly overprescribed for cholesterol and underprescribed for internal inflammation. The Sinatra Health Report, Sept. 2002;8:1.

 

7. West A. JUPITER: separating the solid clinical matter from the hot gas. Holistic Primary Care, Winter 2008;9(4):1-2.

 

8. Crestor costs. Costco pharmacy, Dec. 20, 2008:Costco.com: Offering thousands of items you won?t find in your local Costco..

 

9. Ravnskov, U. Is atherosclerosis caused by high cholesterol? QJM (Quarterly Journal of Medicine) 2002;95:397-403.

 

10. Walsh, BW, Paul, S, Wild RA, et al. The Effects of Hormone Replacement Therapy and Raloxifene on C?Reactive Protein and Homocysteine in Healthy Postmenopausal Women: A Randomized, Controlled Trial. Journal of Clinical Endocrinology and Metabolism 2004;85:214?218.

 

11. Block, G, Jensen, C, Dietrich, M, et al. Plasma C-reactive protein concentrations in active and passive smokers: influence of antioxidant supplementation. Journal of the American College of Nutrition 2004;23:141-147.

 

12. Simopoulos, AP. Essential Fatty Acids in Health and Chronic Disease. American Journal of Clinical Nutrition 1999;70(suppl):560S-569S.

 

13. Simopoulos, AP. The Mediterranean diets: What is so special about the diet of Greece? Journal of Nutrition 2001;131:3065S-3073S.

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Harold

:topic:

 

Moved this thread, about time, from type 2 because it does not lower bg's to 'Other Medications' where it belongs. Since statins are drugs for related problems to diabetes it fits better here. The redirect is set for a week.

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NewdestinyX
This is not what I'm talking about at all. As was the letter I posted commenting on the HPS, I am talking about criticisms of the same peer-reviewed studies you want to see. Anthony Colpo, Uffe Ravnskov, Malcom Kendrick, Beatrice Golomb--none of them are acting on "hunches"; they are simply reviewing the extant literature.* They are informed critics, and their work is entirely germaine to the discussion. To denigrate them as nothing more than "googlers"--especially without buying, and reading, their books, would be unwarranted.
Well -- this response will seem 'too late' and 'after the fact' since I've been away all day - but what I was going to say is -- that I appreciate your input so much Shottle and I know you've already whittled down the 'pure crank' stuff to 'the more credible' so I was going to say 'let's give it a go' with some of these 'critiques'. Though I need to be on record as saying -- that the 'notion' of "critiquing" a 'peer review' is 'very weird' -- as if the 'critiquer' believes that 'they alone' are the 'almighty' evaluator capable of assessing the work of a 'team of other 'peers'???? That's a pretty arrogant notion to me. At best they can serve 'as 1' of a GROUP of peers. But if they alone are 'contra' a group of 6 peers - it is 'their' 'singular' input that lacks corroboration -- not the peer groups conclusions - and therefore it's less reliable as a place to hang our hats. This is where the 'cranks' with agendas come from -- from unpeer-reviewed 'single voice sources' -- as if they alone 'stand above' with the ability to 'critique' the peer group's findings. It's a shaky leg to stand on in my view.

 

But let's get the widest input possible.

 

But let me be on record as having stated that: I see no reason to consider these 'single' "pioneers" any inherently more credible or credentialed than any other practitioners 'venturing' their opinion. And I can't promise I won't be hard on these 'lone-ranger-critquers'. Why? 'Cause I don't trust 'lone ranger critics'. And you shouldn't either. You should trust the peer review process. But let's see where this takes us.

 

I was also going to ask that you quote less of the articles. Nancy (notme) once said that long citations in one post from scientific articles don't make for good 'forum thread flow' or 'easy reading'. It is better to link the article and then take the time to just highlight a few interesting sentences and your comments on those few sentences. And then summarize the context for people. People can 'context verify' your assertions/implications by reading the full article themselves.

 

Thanks for taking the time to repost some of the more compelling arguments in the "risks outweigh the benefits position", Shottle.

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NewdestinyX
Grant, I mean this in the most respectful way.

 

Your insistent, officious gatekeeping has resulted in the very thing that you ostensibly wished to avoid: Your thread has devolved into an unfortunate conversation rife with demeaning comments (some of which you have made). I hope you will return to the original topic - a discussion of statins and their usefulness for the diabetic community. That is what is of interest here, at least in my humble opinion.

 

Thanks!

 

Jen

I respect your input, Jen, but think you've overstated the case. There has been no 'demeaning' that I've read. You'd need to cite in a PM to me specific comments that you think are demeaning and we can discuss it there. I want to own anything 'demeaning' if I've been the culprit.

 

And sadly -- an OP on this forum does need to 'officiate' a thread to keep it focussed sometimes. When they don't stay focussed they end up getting closed or deleted. I'm trying to focus this thread to keep it open as long as possible and as free of 'even more controversial' things that will indeed derail it. I believe the OP has the right to try and get at the goals they were after in the thread they started.

 

Moving along...... I hope..

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