Statins - benefits versus risks

[ShottleBop 515]

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.

 

It's not weird if they were never included in the peer-review process. There are several people who, having independently reviewed the report of a study and the underlying data, have come to the same conclusions regarding its deficiencies. Why is that arrogant? If I can get six people to agree with me, that means that my conclusions are written in stone and beyond question--regardless of who paid for my study and what issues can readily be seen from reviewing the data (for example: the vast difference in perception that can be created simply by stating risk reduction as a relative risk reduction--or noting that total mortality numbers are not provided, so that it becomes impossible to evaluate certain aspects of a report's conclusions), and regardless of how many other studies, paid for by the same folks who paid for my study, will never see the light of day because the results were not as favorable as the ones in my study? Why is it "arrogant" to point out that the authors of a study such as HPS have refused to make portions of the data available for review?

 

"One person"? In the face of a group including, among those already named (Uffe Ravnskov, Malcolm Kendrick, Beatrice Golomb, J Abramson, Joel Kauffman, Anthony Colpo, Jay Cohen, Kevin Groves), as well as the many others who comprise the 83 members of THINCS.org--how many people is it necessary to invoke before your dismissive reference to "one person" can be seen as the empty rhetorical device that it is?

 

It's time, Grant, that you stopped the ad hominem attacks on these folks, and addressed the points that they make.

[ShottleBop 515]

That should be Barry Groves, not "Kevin" Groves, in my last post.

[NewdestinyX 10]

It's not weird if they were never included in the peer-review process. There are several people who, having independently reviewed the report of a study and the underlying data, have come to the same conclusions regarding its deficiencies. Why is that arrogant?

Because the 'alleged deficiencies' are their 'OPINION' -- no more FACT than the people who were in teh peer review and found no 'deficiency'.

If I can get six people to agree with me, that means that my conclusions are written in stone and beyond question--regardless of who paid for my study

Uh.... YES?! Unless you believe the 'crank' notion that all in a peer review are 'bought off'.

and what issues can readily be seen from reviewing the data

WHO readily sees it? You? Me? Or this 'standalone' doc/mini group of docs without having been part of the original peer review.

(for example: the vast difference in perception that can be created simply by stating risk reduction as a relative risk reduction--or noting that total mortality numbers are not provided, so that it becomes impossible to evaluate certain aspects of a report's conclusions),

Then it would have been equally impossible for the original peer review to have made any conclusions too.... ?? Why does 'your group of docs' have greater clout than the docs in the original peer review? That's what I don't get. Why do you trust them MORE than the original peer review? That's what seems arrogant to me among 'your group of docs' you list. Who the heck are they? Why are they the 'higher' and more inherently trustworthy voices?

and regardless of how many other studies, paid for by the same folks who paid for my study, will never see the light of day because the results were not as favorable as the ones in my study?

Favorable to what? It's not about 'buyable' conclusions.. It's about OBVIOUS and PLAIN outcome data from the study.

Why is it "arrogant" to point out that the authors of a study such as HPS have refused to make portions of the data available for review?

That's not the arrogant part. In fact that's PART of peer review -- to require ALL data. If that's NOT being done -- it SHOULD be pointed out. And it begs the question -- WHY is data being supressed. I'm with you there. But if data is NOT being supressed in actuality then it's the stuff of cranks. And who's to say that data is being supressed and how is that found out? AND VERIFIED?

"One person"? In the face of a group including, among those already named (Uffe Ravnskov, Malcolm Kendrick, Beatrice Golomb, J Abramson, Joel Kauffman, Anthony Colpo, Jay Cohen, Kevin Groves),

Shottle -- what makes this group of people so special? What gives them greater clout then any other name in a peer review? These are just 'other' docs with, at most, equal clout.

As well as the many others who comprise the 83 members of THINCS.org--how many people is it necessary to invoke before your dismissive reference to "one person" can be seen as the empty rhetorical device that it is?

It's not a rhetorical device - it's the fact that they speak 'in isolation' - apart from the peer review process which allows rebuttals and explanations to be given in response to challenges. These people take pot shots at the original study and conclusions without the original researchers being able to respond. That is why I call them 'opinion pieces'. Peer review is a two way evaluation process.

It's time, Grant, that you stopped the ad hominem attacks on these folks, and addressed the points that they make.

Ok - agreed - to a point -- but I am not trained (and neither are you) to evaluate the validity of their comments, Shottle -- that's the whole point of my filter process in this thread (that I fear is doomed). You are not trained to find the flaws in their medical reasoning. Again -- peer review is the way to protect yourself from 'isolated' crank and agenda-driven voices - And even ones who make up a 'group' like THINCS.org may have their own agenda if they, as a group, don't submit their findings/concerns to the peer review process with peers OUTSIDE of THINC. --- BUT --- it is time to see how much 'corroboration' of their data that exists.. I will keep reading -- every word and make a few comments. I want to try and keep an open mind. But I wonder how you'd react if I cited the American Heart Association or the ADA as 'my group' of critics -- how quickly you'd want to shoot them down.... Why do I fear there could be a double standard here sometimes? But interacting with the findings themselves is something we have to do. I agree.

[ramon 693]

Found this on the BBC

 

 

 

 

Another 'bad' cholesterol linked to heart disease found

 

Home testing kits can check for high cholesterol, but not Lp(a) specifically

Scientists say they have found proof that another "bad" type of cholesterol contributes to heart disease.

 

Unlike the well-known LDL cholesterol, lipoprotein(a) or Lp(a) cannot be controlled by cutting down on dietary fats or taking a statin drug.

 

But researchers say high levels do not carry the same risk as LDL.

 

And other drugs might work to minimise its effects, they told the New England Journal of Medicine.

 

LDL is considered the aggressive tiger of the cholesterol world, furring the arteries and greatly increasing heart risk. Scientist believe Lp(a), which is inherited, is more of a pussycat, although it does appear to upset blood clotting.

 

Inherent risk

 

The researchers used gene-chip technology to scan DNA that they knew from previous studies were potential "hotspots" for heart disease risk. This analysis revealed the two genetic culprits.

 

Professor Martin Farrall, lead author of the study carried out at Oxford University, said one in six people carries one or more of the genes for Lp(a).

 

The hope now is that by targeting both we could get even better risk reduction

 

Lead researcher Professor Martin Farrall

He said: "The increase in risk to people from high Lp(a) levels is significantly less severe than the risk from high LDL cholesterol levels.

 

"So Lp(a) doesn't trump LDL, which has a larger impact and which we can already control pretty effectively.

 

"The hope now is that by targeting both we could get even better risk reduction."

 

Some existing drugs, such as Niacin, and others coming on to the market, such as CETP-inhibitors, lower Lp(a) as well as LDL cholesterol.

 

Professor Peter Weissberg of the British Heart Foundation, which funded the study, said the findings were useful but urged people not to be alarmed by them.

 

"They highlight the importance of trying to lower Lp(a), which will spark new efforts to design a medicine to achieve this effectively.

 

"And they reveal clues that open a new avenue for research to decipher how heart disease develops.

 

"But LDL is still the type of cholesterol to be more concerned about."

 

Fats from food are turned into cholesterol by the liver. There are different types but some, such as LDL, are known as "bad" cholesterol. They can lead to a build-up in the body's cells.

 

Prof Weissberg said everyone could reduce their risk of heart disease by eating a healthy balanced diet, being physically active and avoiding smoking.

[bunbury 10]

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 Sunday Times, a UK newspaper broke the Thalidomide story. Journalists can be a reliable source, just as scientists can be unreliable.

 

Originally Posted by dgrilli

I have never been convinced that Cholesterol is bad?

 

Statins good for my portfolio bad for my health imho

 

NewdestinyX Then I guess you didn't read the first article I posted. The 'benefits' are clear. Whether they outweigh the 'risks' -- well that's what we're discussing here. But the 'benefits', from my reading', to higher risk patients are well documented.o

 

According to the Lancet 85% of people taking statins for raised cholesterol are overweight. This exposes them to a range of increased health risks such as CVD and Diabetes. For many/most of them this brought about by lifestyle choices such as diet and lack of exercise.

 

So:

 

1) By taking statins they are treating one symptom of an unhealthy lifestyle while doing nothing to address the underlying problem with its attendant risks such as CVD and diabetes.

2) There are known health risks associated with statin use. How many is open to debate, but if you read the label you will find the ones the drug companies admit to.

3) The role of raised Cholesterol as a health hazard is in doubt.

 

So, I'm with dgrilli. For a lot of statin users the drugs deliver little or no benefit beyond their stock portfolios, while exposing them to real health risks either as a direct consequence of taking the drugs, or indirectly by making them think a pill can make their lifestyle sustainable.

 

There may well be some people out there for for whom the benefits outweigh the risks. I wasn't one of them and stopped taking them when I sorted out my life style. If 85% of users are overweight (Lancet) then I suggest that for a very large number of statins users the benefits are imaginary and the risks are real.

[CALynn 10]

Maybe when we're done with this thread we'll start another one: "How many points did your LDL drop when you took statins?"

 

Ten points for me. Big deal. In exchange it created havoc with my liver and caused myalgia and myositis, which led to my inability to walk more than about 500' per day.....which caused me to gain more weight.......

 

Bottom line is that if the liver is compromised [and not all the statins are metabolized in the liver, true] then statins are not necessarily a good bet.

 

And as others have pointed out, if people take a statin and think it's a license to eat all the cholesterol they want, then why bother?

[bunbury 10]

And as others have pointed out, if people take a statin and think it's a license to eat all the cholesterol they want, then why bother?

 

 

The dietary culprit is not cholesterol.

 

Diet and Serum Cholesterol in Man

 

Lack of Effect of Dietary Cholesterol1,2,

 

Ancel Keys, J. T. Anderson, Olaf Mickelsen3, Sadye F. Adelson and Flaminio Fidanza4

Laboratory of Physiological Hygiene, University of Minnesota, Minneapolis, the Agricultural Research Service, U. S. Department of Agriculture, and the Metabolism Unit, Hastings State Hospital, Hastings, Minnesota

 

1. Two cross sectional surveys in Minnesota on young men and 4 on older men showed no relationship between dietary cholesterol and the total serum cholesterol concentration over most of the ordinary intake range characteristic of American diets.

2. Two surveys on the Island of Sardinia failed to show any difference in the serum cholesterol concentrations of men of the same age, physical activity, relative body weight and general dietary pattern but differing markedly in cholesterol intake.

3. Careful study during 4 years of 33 men whose diets were consistently very low in cholesterol showed that their serum values did not differ from 35 men of the same age and economic status whose diets were very high in cholesterol.

4. Comparisons made of 23 men before and after they had voluntarily doubled their cholesterol intakes and of 41 men who halved theirs failed to show any response in the serum cholesterol level in 4 to 12 months while the rest of the diet was more or less constant.

5. A detailed study of the complete dietary intakes of 119 Minnesota businessmen failed to show any significant increase of serum cholesterol with increasing dietary cholesterol intake.

6. In 4 completely controlled experiments on men the addition to or removal from the diet of 500 to 600 mg of cholesterol daily had no effect on the serum cholesterol fall produced by a rice-fruit diet or on the rise in changing from a rice-fruit diet to an ordinary American diet.

7. In a completely controlled experiment on 5 physically healthy men the change from a rice-fruit diet containing 500 mg of cholesterol daily to the same diet devoid of cholesterol had no effect on the serum level.

8. In a similar experiment with 13 men receiving 66 gm of fat daily there was no significant effect in changing from a cholesterol intake of 374 mg/day to one of 1369 mg/day. In another 12 men the reverse change was likewise without effect on the blood serum.

9. It is concluded that in adult men the serum cholesterol level is essentially independent of the cholesterol intake over the whole range of natural human diets. It is probable that infants, children and women are similar.

[yannah 10]

The dietary culprit is not cholesterol.

 

this is true for me. low carb and moderate-high fat and cholesterol is what got my cholesterol in range without a statin.

 

other factors could be weight loss, bs control or getting off one of the many drugs I didn't need but was taking. I don't know about that. my chol, went down , down , down hdl went up up up, over a year and boom I was in range. the year started with low carbing.

[fgummett 15]

In case you missed the authors just above Ancel Keys (listed first just above, by Bunbury) is considered to be the "father" of the lipid hypothesis -- which linked dietary fats and cholesterol with heart disease -- even he is now stating that

...in adult men the serum cholesterol level is essentially independent of the cholesterol intake over the whole range of natural human diets. It is probable that infants, children and women are similar.

[fgummett 15]

Peer review is a two way evaluation process.

Since when?

An article is published (if accepted by any journals) and other scientists (usually those who read the same journals) are free to review them and respond, or even try the same study for themselves (if they can get funding).

 

---

 

As for rhetoric... look to your use of the word "critique" above in response to where others are using the word "review". A "critique" clearly carries negative connotation which a "review" does not. Critique is by definition "critical" where a review can be balanced.

 

I would also ask that you stick to facts and not make attacks on persons... instead provide counter-arguments to their points/arguments. I think that would make for a more substantial and less emotive thread. Perhaps a bias on part -- I am only human -- but when I see an ad hominem attack I lean towards thinking that the attacker must have a pretty weak argument to resort to this...it becomes even harder for me to take anything they say as trustworthy.

[MrsMia 1,608]

Just to help sort out any confusion of the meaning of 'peer reviewed' and perhaps how much weight should be given to it maybe this will help:

 

The Importance and limitations of Peer Review:

 

Complete article can be read here:

 

Science-Based Medicine The Importance and Limitations of Peer-Review

 

From the article:

 

 

Overview

 

When the statement is made that research is “peer-reviewed” this is usually meant to refer to the fact that it has been published in a peer-reviewed journal. Different scientific disciplines have different mechanisms for determining which journals are legitimately peer-reviewed. In medicine the National Library of Medicine (NLM) has rules for peer-review and they decide on a case by case basis which journals get their stamp of approval. Such journals are then listed as peer-reviewed.

 

The basic criterion is that there is a formalized process of peer-review prior to publication – so this presents a barrier to publication that acts as a quality control filter. Typically, the journal editor will give a submitted paper to a small number of qualified peers – recognized experts in the relevant field. The reviewers will then submit detailed criticism of the paper along with a recommendation to reject, accept with major revisions, accept with minor revisions, or accept as is. It is rare to get an acceptance as is on the first round.

 

The editor also reviews the paper, and may break a tie among the reviewers or add their own comments. The process, although at times painful, is quite useful in not only checking the quality of submitted work, but improving the quality. A reviewer, for example, may point out prior research the authors did not comment on, or may point our errors in the paper which can be fixed.

 

It is typical for authors to submit a paper to a prestigious journal first, and then if they get rejected to work their way down the food chain until they find a journal that will accept it. This does not always mean that the paper was of poorer quality – the most prestigious journals have tons of submissions and can pick and choose the most relevant or important studies. But sometimes it does mean the paper is mediocre or even poor.

 

The limitations of Peer-Review

 

It is important to realize that not all peer-reviewed journals are created equal. Small or obscure journals may follow the rules and gain recognized peer-reviewed status, but be desperate for submissions and have a low bar for acceptance. They also have a harder time getting world-class experts to review their submissions, and have to find reviewers that are also farther down the food chain. The bottom line is that when a study is touted as “peer-reviewed” you have to consider where it was reviewed and published.

 

Even at the best journals, the process is only as good as the editors and reviewers, who are people who make mistakes. A busy reviewer may give a cursory read through a paper that superficially looks good, but miss subtle mistakes. Or they may not take the time to chase down every reference, or check all the statistics. The process generally works, and is certainly better than having no quality control filter, but it is also no guarantee of correctness, or even the avoidance of mistakes.

 

Peer-reviewers also have biases. They may be prejudiced against studies that contradict their own research or their preferred beliefs. They may therefore bias the published studies in their favored direction, and may be loath to give a pass to a submission that would directly contradict something they have published. For this reasons editors often allow authors to request or recommend reviewers, or to request that certain people not be asked to be reviewers. Each journal has their own policy. Sometimes an editor will specifically use a reviewer that the authors request not be used, thinking they may be trying to avoid legitimate criticism.

 

The process can be quite messy, and full of politics. But in the end it more or less works. If an author thinks they were treated unfairly by one journal, they can always go to another or they can talk directly to the editor to appeal a decision and try to make their case.

 

Perhaps the biggest weakness of peer-review, however, is when an entire discipline of peers is lacking in some fundamental way. For example, there are now many journals dedicated to so-called “alternative medicine” (CAM). The editors of such journals tend to have a pro-CAM bias, and they find reviewers with a pro-CAM bias. So pretty much any pro-CAM article can get published. Some have enough ideological friends at the NLM that they can get approved as peer-reviewed, despite glaring biases in their editorial policy.

 

Hopes this helps clear up what it means to be peer reviewed if anybody isn't sure and how it should be approached (at least that is what is said in the article). If there are other explanations different than this one about the meaning of 'peer review' and it's importance and limitations then it would be good to post them also.

[ShottleBop 515]

Journal of the Royal Society of Medicine: "Conflicts of interest: how money clouds objectivity", by Richard Smith* Excerpts:

I want to begin this article with a fantasy, one that has a powerful hold in the minds of many. Doctors treat patients using simply the best evidence and their experience. They are not influenced by money or self interest. Similarly, researchers try to answer the important questions in medicine; specialist societies are concerned only with what is best for a population of patients; and editors of journals publish only what is true and important for medicine. Unlike people who work in the venal worlds of commerce, politics, or journalism we in healthcare are untainted by money and `the pursuit', in the words of Sigmund Freud, `... of fame and the love of beautiful women (or perhaps men)'.

 

This is, of course, nonsense. Those who work in healthcare are human beings and just as prone as any other humans to acting in their own interest; responding to economic incentives, and stumbling into frank fraud and corruption. Anybody who has knocked around in the world and read Dante, Juvenal, Balzac and Dickens knows that this is how human beings behave. Yet somehow in medicine we have fallen prey to the fantasy that we are superhuman. We are not. We are exposed to conflicts of interest, like everybody else. Our response should not be to pretend that they do not exist, but rather to acknowledge and disclose them always—and sometimes to accept that they are so extreme that the doctor should not treat a particular patient or an author write an editorial in a medical journal.

 

. . .

 

THE EFFECTS OF CONFLICT OF INTEREST

 

Several studies have shown that financial benefit will make doctors more likely to refer patients for tests, operations, or hospital admission,9-11 or to ask that drugs be stocked by a hospital pharmacy.12 Caesarean section rates vary dramatically across the world and are higher when women are cared for by private practitioners who are paid for the operation.13,14 Doctors in Britain performed screening examinations on older people when paid to do so—even though most argued that there was no evidence to support such screening. Dentists in Britain carry out many unnecessary fillings because they are paid much more to fill teeth than to simply clean them. Doctors, in other words, do respond to financial incentives, and it would be surprising if they did not.

 

The JAMA review found 11 studies that compared the outcome of studies sponsored by industry and those not so sponsored.1 In every study those that were sponsored were more likely to have a finding favourable to industry. When the results were pooled the sponsored studies were almost four times more likely to find results favourable to industry. When we remember that industry sponsors about three quarters of the randomized trials in the major weekly journals,15 then we can see that there is substantial room for bias.

 

The study I have already quoted on calcium channel antagonists classified 70 articles from major journals as critical of the drugs (23), supportive (30), or neutral (17). Almost all supportive authors (96%) had financial relationships with manufacturers, compared with 60% of neutral authors and 37% of critical authors.5

 

An important study from JAMA looked at what characteristics determined the conclusions of review articles on passive smoking.16 The authors identified 106 reviews, with 37% concluding that passive smoking was not harmful and the rest that it was. They then considered all the factors that might mean that authors of reviews reached different conclusions. One was the quality of the review. Perhaps better done reviews reached one conclusion and poorly done ones another. Another factor they considered was whether a journal was peer reviewed. It might be that journals that had peer review system would publish better reviews that reached the same conclusion. Or could it be the year of publication? Perhaps recent studies had changed the direction of the evidence. The authors of the JAMA study expected to find that the quality of the review would be the most important determinant of whether or not authors of reviews found that passive smoking was harmful.

 

In fact, the only factor associated with the review's conclusion was whether the author was affiliated with the tobacco industry. Three-quarters of the articles concluding that passive smoking was not harmful were written by tobacco industry affiliates. The study authors suggest that `...the tobacco industry may be attempting to influence scientific opinion by flooding the scientific literature with large numbers of review articles supporting its position that passive smoking is not harmful to health'. Again, only a minority of the articles (23%) disclosed the sources of funding for research. The authors had to use their own database of researchers linked with the tobacco industry to determine whether authors had such links.17

 

This is a disturbing finding. It suggests that, far from conflict of interest being unimportant in the objective and pure world of science where method and the quality of data is everything, it is the main factor determining the result of studies.

 

Grant, please, please recognize that, when you say that peer-reviewed articles must carry more weight than analysis by those critics (and mischaracterize their comments as mere "opinion"), you are committing the fallacy of "appeal to authority," which pretty much sums up the basis of your argument.

 

_______________

*Richard Smith was editor of the BMJ and chief executive of the BMJ Publishing Group for 13 years. In his last year at the journal he retreated to a 15th century palazzo in Venice to write a book. This is a much shortened chapter from the author's book provisionally entitled The Trouble With Medical Journals that the RSM Press will publish in the autumn [http://www.rsmpress.co.uk], and this is the third in a series of extracts that will be published in the JRSM

[notme 2,915]

This thread has veered severely off topic and has run its course. It is now locked.