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Showing posts with label British Heart Foundation. Show all posts
Showing posts with label British Heart Foundation. Show all posts

Friday, July 4, 2014

How do statin proponents deal with debate? They stifle it - Briffa

How do statin proponents deal with debate? They stifle it.

Last month, one of my blog posts featured a letter written by a group of doctors, expressing their concerns about the mooted expansion of statin therapy. The letter detailed six major objections to the plan, including the mass-medicalization of millions of healthy individuals, the unreliability of the evidence regarding the adverse effects of statins, and the facts that almost all the evidence is industry-funded and that multiple conflicts of interest exist on the ‘expert committee’ that is adjudicating on the statin issue. The letter received widespread coverage in the press and other media, and I think it did much to stoke the flaming debate that some have described as the ‘statin wars’.

Those strongly supportive of the plans to widen statin prescriptions are hardly going to go away without a fight, though. And this week six professors convened a press briefing at the Science Media Centre to put forward their arguments. The briefing was reported in the British Medical Journal this week [1].

Two of the ‘usual suspects’ were Professor Sir Rory Collins (head of the Cholesterol Treatment Trialists collaboration) and Professor Peter Weissberg (medical director of the British Heart Foundation).

One of Professor Collins’ gripes was, apparently, that “misrepresenting the evidence” will have a negative impact on people who are at high risk of cardiac events. He is quoted as saying: “It’s perfectly reasonable to debate whether patients at lower risk should get statins or not, but it’s inappropriate to misrepresent the evidence.”

He redoubled his assertion that rates of ‘myopathy’ are much lower than some people state. However, he is referring to the incidence of muscle problems where the threshold of ‘abnormal’ is when levels of the enzyme used to assess muscle damage (creatinine kinase) is at least 10 times the upper limit of normal. Professor Sir Rory Collins is apparently disinterested unless muscles are in near-meltdown. We can, I suppose, just ignore those poor unfortunates with less biochemical aberrations even though their symptoms are real and often debilitating. I think it’s clearly business as usual for Rory Collins, who makes claims that some are misleading the public while I think he, ahem, continues to mislead the public.

Professor Weissberg tells us that the “…the critics are wrong. They’ve retracted, they’re wrong.” Except, that the only thing that has been retracted were the misleading representations of statin side-effects as reported in one piece of research. All the major objections detailed in the original letter stand until someone properly disputes them.

With regard to these, Professor Weissberg calms any concerns about industry involvement in the evidence base, because drug companies only paid people to do the studies, rather than the drug companies doing the studies themselves. So, nothing to concern ourselves with here.

He adds that: “The biggest threat to good medicine is prejudice and anecdote.” I have some sympathy for this view, but boy would I like to see Professor Weissberg stay away from prejudice and anecdote myself. It was not so long ago that he made claims to support statins using data that did not support the use of statins at all.

And perhaps the most telling thing of all are the comments that come from Fiona Fox, director of the Science Media Centre. Apparently, only pro-statin experts were invited to the briefing. In defence of this tactic, Ms Fox tells us that the “vast majority” of cardiac and statin experts believed that the evidence was overwhelming, and that it was not the centre’s job to provide a platform to a minority who did not and thereby project a false image that the debate was in equipoise (when it was not).
First of all, I wouldn’t be too sure that the evidence is overwhelming or that the pro-statin camp is in the great majority.  And even if there things were true, is that a reason to stifle debate and allow no right of reply?

Do these tactics suggest that Professors Collins and Weissberg and the rest of their merry band of men have true confidence in their position? I personally doubt it, and believe that their attempt to shut down debate suggests they may be desperate not to have the weakness of the data and their arguments revealed in front of their very own eyes.

References:
1. Hawkes N, et al. Six professors back NICE guidance on extending use of statins. BMJ 2014;349:g4380
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Read the complete article here.

Friday, August 9, 2013

British Heart Foundation does not want to engage with the troubling science on sterols - Briffa

The medical director of the British Heart Foundation does not want to engage with the troubling science on sterols

Last month, I wrote a blog post about how there was no evidence that cholesterol-lowering ‘stanols’ and ‘sterols’ (found in some margarines and other ‘functional foods’) have benefits for health. In fact, the National Institute for Health and Care Excellence explicitly states that they should not be used. Yet, the British Heart Foundation (BHF) recommends the use of stanols and sterols, though I wondered if this might have something to do with the fact that one of its corporate partners is Flora pro.activ (a brand of sterol-enriched foods made by Unilever).

On the 17th July, I emailed the BHF about this. Here’s my email to them:

The National Institute for Health and Care Excellence has this to say about dietary stanols and sterols: “People should not routinely be recommended to take plant sterols and stanols for the primary prevention of [cardiovascular disease].”
We are also advised by NICE that: “There is a need for trials to test both efficacy and effectiveness of plant sterols and stanols in people who are at high risk of a first CVD event.

 These trials should test whether plant sterols or stanols change lipid profiles and reduce CVD events under best possible conditions. Randomised controlled trials are needed to test the effectiveness of advising people who are at high risk of experiencing a first CVD event to include food items containing plant sterols or stanols in a low-fat diet. The trial should last for at least 2 years and should consider appropriate outcomes.”

Yet, I notice that the BHF advocates stanols and sterols. Can someone explain the discrepancy, and whether the BHF believes the fact that Flora pro-avtiv is a corporate partner of represents a financial conflict of interest?
 
On the 30th July, I got a reply from Professor Peter Weissberg, the medical director of the BHF. Here are the highlights from his email:
  • They are not suggesting that plant sterols/stanols can prevent a heart attack
  • They do help to reduce LDL cholesterol, which is a risk factor for heart disease
  • Their information reflects this and has not been altered by their fundraising partnership with Flora pro.activ.
  • The BHF  has a very clear set of principles on the basis of which they work with commercial organisations.
  • The amount of money they take from Flora pro.activ is a tiny percentage of their overall budget.
The same day, I emailed Professor Weissberg again, this time questioning the presumed benefit of LDL-cholesterol reduction, but also to draw his attention, should he not be aware of it already, of the considerable body of evidence which suggests sterols have the potential for harm. Here’s my email:
 
Dear Professor Weissberg
Thank you for getting back to me.

As you allude to, sterols/stanols have never been demonstrated to have clinical benefit, and it appears your support of them rests on their ability to reduce LDL-cholesterol levels (which you say is a risk factor for heart disease). Unfortunately, as I’m sure you’ll know, reduction of LDL-cholesterol most certainly does not assure clinical benefit. Ezetimibe – which has a similar mechanism of action to sterols/stanols – is a case in point.

Also, if arsenic and cyanide were found to be effective LDL-cholesterol reducing agents, it still would not make sense to recommend them for people for the reduction of cardiovascular disease risk, right?

The reason that I use this example is because, as you may know, there is a considerable body of evidence which suggests that sterols/stanols may have adverse effects on health. These are very well summarized in a paper published in the European Heart Journal in 2009 [Weingartner O, et al Controversial role of plant sterol esters in the management of hypercholesterolaemia. Europlean Heart Journal 2009;30:404-409]. If you have not already read it, I urge you to.

In this paper, the authors cite evidence linking the presence of sterols in the blood with an increased risk of cardiovascular disease. For example:

…there is evidence that elevated levels of plant sterols are associated with an increased cardiovascular risk. Glueck et al [Relationships of serum plant sterols (phytosterols) and cholesterol in 595 hypercholesterolemic subjects, and familial aggregation of phytosterols, cholesterol, and premature coronary heart disease in hyperphytosterolemic probands and their first-degree relatives. Metabolism 1991;40:842–848] were the first to report that elevated plant sterols might be a risk factor for coronary heart disease. In a study with 595 hypercholesterolaemic patients, they found that slightly elevated plasma levels of plant sterols were a heritable marker for an increased cardiovascular risk.

Rajaratnam et al [Independent association of serum squalene and noncholesterol sterols with coronary artery disease in postmenopausal women. J Am Coll Cardiol 2000;35:1185–1191]…found that in postmenopausal women, plant sterols were independently associated with coronary heart disease in a multivariate analysis. These findings were confirmed by Sutherland and his team in a study involving both sexes over all age groups [Association of plasma noncholesterol sterol levels with severity of coronary heart disease. Nutr Metab Cardiovasc Dis 1998;8:386–391].

The Scandinavian Simvastatin Survey Study (4S study) also identified a subpopulation of coronary artery disease patients with low endogenous synthesis of cholesterol and high absorption of cholesterol and plant sterols. The subjects of this subpopulation had the highest levels of plant sterols and the highest risk of recurrent coronary events despite lower levels of serum cholesterol due to simvastatin ingestion [Baseline serum cholestanol as predictor of recurrent coronary events in subgroup of Scandinavian simvastatin survival study. Finnish 4S Investigators. BMJ 1998;316:1127–1130]

Larger epidemiological studies reported similar data. Results of the PROCAM-study showed that patients afflicted with myocardial infarction or sudden cardiac death had increased plant sterol concentrations [Plasma sitosterol elevations are associated with an increased incidence of coronary events in men: results of a nested case-control analysis of the Prospective Cardiovascular Munster (PROCAM) study. Nutr Metab Cardiovasc Dis 2006;16:13–21]. Upper normal levels of plant sterols were associated with a three-fold increase of risk for coronary events among men in the highest tertile of coronary risk according to the PROCAM-algorithm.

Similar data are available for the plant sterol campesterol from the MONICA/KORA-study. In this prospective study, campesterol correlated directly with the incidence of acute myocardial infarction [Abstract 4099: elevated campesterol serum levels–a significant predictor of incident myocardial infarction: results of the population-based MONICA/KORA follow-up study 1994–2005. Circulation 2006;114:II_884].

This is all epidemiological evidence, of course, but it supported by several animal, in vitro and clinical experiments that, I think, give us genuine cause for concern. Again, from the European Heart Journal paper [Weingartner O, et al Controversial role of plant sterol esters in the management of hypercholesterolaemia. Europlean Heart Journal 2009;30:404-409]:

Current experimental findings from our own research group show that a diet supplementation with plant sterol esters that is equivalent to a commercially available spread induces endothelial dysfunction and leads to an increase of ischaemic stroke size in wild-type mice [Vascular effects of diet supplementation with plant sterols. J Am Coll Cardiol 2008;51:1553–1561].

…in a clinical study, we demonstrated that patients who were consuming plant sterol ester enriched margarine had increased concentrations of plant sterols in cardiovascular tissue [Vascular effects of diet supplementation with plant sterols. J Am Coll Cardiol 2008;51:1553–1561].

Further mechanistic data suggest that vascular deposits of sterols, when compared with cholesterol, result in increased oxidation and release of oxygen radicals [Oxidized plant sterols in human serum and lipid infusions as measured by combined gas-liquid chromatography-mass spectrometry. J Lipid Res 2001;42:2030–2038].

…the induction of apoptosis is not limited to tumour cells, but extends also to vascular cells. Recent in vitro experiments demonstrated that the plant sterol sitosterol exerts a strong cytotoxic propensity inducing apoptosis in human endothelial cells, revealing detrimental effects on the vasculature [Beneficial or harmful influence of phytosterols on human cells? Br J Nutr 2008;100:1183–1191].
In fact, the first experimental study reporting negative cardiovascular effects dates back to the year 2000. Ratnayake et al.  [Vegetable oils high in phytosterols make erythrocytes less deformable and shorten the life span of stroke-prone spontaneously hypertensive rats. J Nutr 2000;130:1166–1178 reported that increased serum levels of plant sterols increase rigidity of erythrocytes and shorten the life span of stroke-prone spontaneously hypertensive (SHRSP) rats.

These findings were the reason for Health Canada, the federal department responsible for helping Canadians maintain and improve their health, to raise significant safety issues and not to allow functional foods enriched with plant sterol esters to be sold in Canada.

I am sure you must be very busy, but please take some time to consider this evidence. From what I can see from the research, we have no evidence at all that sterols/stanols improve clinical outcomes, and considerable evidence linking them with potential for harm. Until we have positive evidence regarding outcomes, wouldn’t the most prudent and safety-conscious thing be to not recommend sterols/stanols (as NICE does)?

Thank you for your explanation regarding your corporate partners. If the funds derived from this relationship are so low, why not sever the link and have no conflict of interest at all, here?
I look forward to hearing from you.
Kind regards
John Briffa
 
On the 6th August, I got this response from Professor Weissberg:
Dear Dr Briffa
Thank you for your further email on this subject. I am aware of a large number of publications, of varying quality and validity, on the subject of plant stanols and sterols and their potential benefits and harms. I would prefer not to enter into a debate on any one of them since they all have their strengths and weaknesses.

So, as with so much in science, interpretation of the data is not as straightforward as is sometimes presented. Nevertheless, we are agreed that, ideally, one would like to see appropriately designed outcome trials to test their role in protection against cardiovascular events. In the absence of such data (and I doubt they will ever be produced), it is a matter of judgement as to whether or not plant stanols should be included as part of a wider strategy to reduce cardiovascular risk, and different national bodies have come to different conclusions.

In drawing this correspondence to a close I would conclude by saying that the BHF only enters into partnerships after careful consideration of all the pros and cons of so doing. As discussed previously, the main objective of the partnership with Unilever is to utilise their considerable reach to help us highlight the risk of CVD to women.

I thank you for your interest in this project and assure you we take seriously all feedback we receive.
Yours
 
Notice here how Professor Weissberg makes no comment at all on the specifics of the studies, nor puts up one scrap of evidence to refute the concerns raised. And what are we to glean from his writing: “In drawing this correspondence to a close…” To me, that gives the impression Professor Weissberg wants to hear no more from me (or perhaps anyone else) on the matter. Case closed!
I think we deserve better to be honest. I genuinely believe that, based on the evidence, there is a case to answer regarding the health effects of sterols, and it’s simply not good enough for Professor Weissberg to dismiss the evidence based on rhetoric to do with, supposedly, the evidence being of ‘varying quality and validity’. This is true of all science, so is Professor Weissberg suggesting we just go back to the dark ages and believe what suits us?

How many people do you imagine look to the BHF as being a reliable and credible organisation dedicated to our heart health? Lots, I would imagine. How do you think they would feel to know that when legitimate concerns are raised about products they recommend (some of which are made by a company the BHF partners with), their medical director just flatly refuses to engage with the science?
There is absolutely no evidence that sterols benefit health, but it seems the BHF is going to recommend them anyway, even in light of significant evidence suggesting they have the potential for harm.

Professor Weissberg seems to claim that the BHF’s relationship with Unilever does not compromise them. In fact, Unilever is helping them raise awareness about the risk of cardiovascular disease in women! I wonder how many of these women will be concerned enough to put their faith in utterly bogus food products enriched with sterols?
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Read the complete article here.

Friday, December 28, 2012

More Misinformation from the British Press - Smith


More Misinformation from the British Press



Yesterday, an article was published on the front page of a national newspaper in the UK, claiming “proof that statins save millions” and “wonder pill halves heart attack deaths”.

The article was published in the Daily Express newspaper on 27 December 2012, written by Giles Sheldrick. I have formally complained to the editor about the gross inaccuracies the article contains.
The article is based on data published in a recent report from the British Heart Foundation (BHF). The title of this report is Coronary Heart Disease Statistics 2012.

The article in the Daily Express claims that the reduction in heart disease deaths / heart attacks is mostly due to cholesterol lowering statins.

The recent BHF publication (available here) does clearly show that deaths from heart disease have continued to fall, however, nowhere in this publication is there any data to support the claim that statins have played a significant part.

The BHF publication references only one study; a 2004 study referenced on pages 14 and 15 of the publication. This referenced study is freely available here:
http://circ.ahajournals.org/content/109/9/1101.long

It is absolutely clear from this study that the vast majority of the reduction in heart disease deaths was from the reduction in the number of people smoking and improvements in emergency treatments. It had very little to do with statin medications. In fact, if you look at Table 1 of this study, we can see that statins, at best, contributed less than one percent to the reduction in deaths.

The first line of the Daily Express article reads “THE use of statins has halved the number of deaths from heart attacks”. There is no data to support this statement anywhere in the BHF publication or the 2004 study referenced by the BHF.

There are a number of additional points to consider.

The graph below is from another publication from the British Heart Foundation (Coronary Heart Disease Statistics 2008, available here) . If we look at figure 1.4 from page 25, we can see that heart disease deaths have been reducing since the 1970s, but there is no significant change in the graph around 1995. This is important because statin medications first started to be widely prescribed in 1995. If statins were having a significant impact, we would of course expect to see a more dramatic reduction around 1995, but we do not. In fact, some age groups have seen a slowing down of the reduction since the widespread introduction of statins in 1995.

It is important to note that even if statins do very slightly reduce the risk of suffering a heart attack (typically less than one percent reduction in risk), at the same time, these medications increase the risk of dying from other serious diseases. This is particularly the case when statins are used for 'prevention'. All of the clinical trials, where statins have been used for 'prevention' have failed to show any increase in life expectancy. The potential very slight reduction in heart attack risk has always been off-set by an increase in deaths from other causes due to the statin.

Not to mention the fact that around 20 percent of people who take statins experience considerable adverse effects, which in many cases have ruined peoples' lives.
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Read the complete article here.

Tuesday, November 9, 2010

More Misleading Information and Propaganda from the British Heart Foundation

Good new article by Justin Smith author of "$29 billion reasons to lie about cholesterol"
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More Misleading Information and Propaganda from the British Heart Foundation

Tuesday, November 9, 2010 at 11:30AM


Here is the latest headline from the British Heart Foundation (BHF):

“Research by BHF-funded scientists has shown that when it comes to cholesterol, ‘lower seems to be better’ for protecting us against heart attacks... The researchers looked at the effects of increasing the dosage of statins, a medicine that reduces cholesterol. They showed that a bigger drop in cholesterol – from more intensive treatment with statins – cut risks even more.”

This refers to a study just released in the Lancet. This study, and the media hype that the BHF have created about it, is nothing more than an attempt to confuse and mislead people.

If you read the headlines and the summary report you could certainly be forgiven for thinking that statins are wonder drugs and cholesterol really is humanity’s nemesis. This study did indeed find a reduction in heart attacks associated with more intensive use of statin drugs. However, there are at least four major reasons why the results are misleading.

The first reason is that the reduction in risk quoted in the interpretation of the study refers to a reduction in LDL cholesterol that is not normally seen in real life. This exaggerates the perceived benefits.

The interpretation refers to reductions in LDL levels of 2-3 mmol/l. The authors state that this reduction in LDL cholesterol would reduce the risk of a vascular event (such as a heart attack) by 40-50 percent.

Well, LDL cholesterol is typically around 2-3 mmol/l anyway, so the suggestion that it could be reduced by 2-3 mmol/l is nonsense – most people would have to be clinically dead to achieve this drastic reduction. So, the suggested risk reduction is completely academic and for most people could never happen.

The second reason is that, as usual, relative percentages are used instead of absolute percentages. This problem is ubiquitous in statin clinical trials and I have commented on it many times before. The risk reductions of 40-50 percent are relative percentages, which can only mislead people. In real terms, the percentages come down to single digits or less.

The third reason is that, as usual, the issue of deaths from all causes is not addressed. Statins can reduce the risk of suffering a heart attack or other cardiovascular event, but at the same time, these drugs can also increase the risk of dying from other causes, and overall, there is usually no net benefit.

There is not much point in taking an expensive medication if the risk for one disease is reduced at the cost of increasing the risk for another disease within the same time period.

I called the BHF today and asked them for the data concerning deaths from all causes. The press office said they didn't know, but they did kindly send me the full report for the study.

In this trial, the risk of dying from any cause was reduced from 2.3 percent to 2.1 percent. So, in real terms, the benefit of more intensive statin use equates to a risk reduction of just 0.2 percent.

But even this meagre 0.2 percent risk reduction may not be experienced by real people who take statins. This issue relates to the fourth problem with this study.

The forth reason why the results are misleading is that the analysis did not distinguish between people at a lower risk for a heart attack and people at a higher risk.

Around 7 million people are taking statins in England alone, and in America it is estimated that more than 20 million people may be taking them. The vast majority of these people are taking statins for primary prevention. This means that they do not have cardiovascular disease but are given the medications in the hope of preventing future disease.

To date, there is no convincing evidence that statins provide any net benefit to people when they are taken for primary prevention - they do not reduce the overall death rate. This was the conclusion of the latest analysis in the Archives of Internal Medicine.

The analysis that the BHF are supporting includes data from higher risk groups - the results do not represent the majority of people who currently take a statin.