How much longer will you live if you take a statin?

"Looking at the Heart Protection Study (HPS) done in the UK, we used a technique for analysing survival time called RMST (restricted mean survival time). I won’t go into the details. The HPS study lasted for five years, and we calculated that the average increase in survival time was 15.6 days. This was at the end of five years of treatment (with a confidence interval of 5 days either side). For 4S, the figure was 17 days."

"Framing this slightly differently, what this meant was that taking a statin for one year, in the highest risk group possible, would increase your life expectancy by around three days."

"However, more recently the BMJ did decided to publish another paper entitled: ‘The effect of statins on average survival in randomised trials, an analysis of end point postponement.’

Results: 6 studies for primary prevention and 5 for secondary prevention with a follow-up between 2.0 and 6.1 years were identified. Death was postponed between −5 and 19 days in primary prevention trials and between −10 and 27 days in secondary prevention trials. The median postponement of death for primary and secondary prevention trials were 3.2 and 4.1 days, respectively."

Conclusions: Statin treatment results in a surprisingly small average gain in overall survival within the trials’ running time. For patients whose life expectancy is limited or who have adverse effects of treatment, withholding statin therapy should be considered

Overall their findings were far less impressive, even, than ours. They calculated, approximately, a single day of increase in life expectancy for each year of taking a statin. Slightly more in secondary prevention, slightly less in primary (people who have not previously had a heart attack or a stroke).

The main take away message I believe, is the following. Statins do not prevent fatal heart attacks and strokes. They can only delay them. They delay them by about one or two days per year of treatment. For those who have read my books you will know that I have regularly suggested we get rid of the concept of ‘preventative medicine’. We need to replace it with the concept of ‘delayative medicine’.

Read Dr. Kendrick's complete article here.

Putting "Relative Risk" in perspective - Eades

Absolute risk versus relative risk: Why you need to know the difference

30. December 2013,

Six years ago, the airwaves were alive with Lipitor ads. Lipitor, a statin and the largest selling drug in the world at that time, was being challenged by other less expensive statins that had gone off patent, so Pfizer, the manufacturer, was blanketing the media in an effort to keep sales humming.

Pfizer had a series of ads featuring Dr. Robert Jarvik, one of the developers of the first artificial heart. These ads were a first in that a real doctor had never appeared in an ad touting a drug. As I posted at the time, Pfizer and Dr. Jarvik got into some trouble because they all played a little fast and loose with the truth about Dr. Jarvik’s credentials.



Aside from the misrepresentation by both Pfizer and Jarvik, one of the claims many of these ads made was that by taking Lipitor you could reduce your risk of heart disease by 36 percent. Sounds pretty good. I would like to reduce my risk of heart disease by 36 percent as did millions of people who went on the drug.

These ads weren’t technically misleading, but they didn’t tell the whole truth, because the 36 percent reduction in heart attack risk was what’s called a relative risk reduction.

Relative Risk
Relative risk is always stated as a percentage. Let’s say we do a study in which we randomize 200 subjects in two groups of 100. One group (the study group) takes a drug, and the other (the control group) takes a sugar pill. We keep the subjects in the two groups on their pill regimen and wait for, say, ten years to see what happens. After ten years, we find that 90 people in the group taking the sugar pill died while only 60 people taking the drug died.

We can then do the following calculation. 90 − 60 = 30. 30 divided by 90 = 0.33. Converting 0.33 to a percentage = 33 percent. Which is the relative risk. If this were an actual study, you could say people taking the drug reduced their risk of dying by 33 percent.

Would this be important? Absolutely. In this case as least. Why? Because 150 people out of 200 died. This means most of the people in the study died, so a 33 percent reduction in risk is huge. I would be all over this drug in a heartbeat.

So what’s the problem, then, with the 36 percent reduction in risk found in the Lipitor study? And why shouldn’t people be begging to go on Lipitor?

Because they need to know the absolute risk before the relative risk becomes important.

Absolute Risk
The absolute risk is simply the total risk for whatever is being studied. In our made up example above, the study end point we were looking for was death. In that example, 150 out of 200 died. So if you were a subject in that study, your absolute risk of dying would be 150 divided by 200 or 75 percent, which is very high.

If your absolute risk of crashing during a commercial airline flight were 75 percent, you would never fly. But if you absolutely had to fly, and one airline offered a 33 percent reduction in risk of crashing (relative risk), you would be stupid not to fly that airline.

To make sense out of relative risk, you’ve got to know the absolute risk.

Let’s go back to our Lipitor claim.

The 36 percent relative risk reduction figure came from a study published in Drugs titled Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial–Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial.

This study was a subset of a larger study in which about 20,000 subjects with high blood pressure and three other cardiovascular risk factors were randomized into two groups, the subjects in each of which got one of two blood pressure lowering medications. From this larger group, a little over 10,000 subjects were found who had cholesterol levels at or below 250 mg/dl (6.5 mmol/l). In addition to the blood pressure medications, half of this group got 10 mg of Lipitor (atorvastatin) per day while the other half got a placebo along with their blood pressure medication.

In the Lipitor/placebo arm of this study, the endpoint was defined as a non-fatal heart attack or death from heart disease.

After about 3.3 years, this arm of the study was discontinued because there were a significant number of either heart attacks of deaths from heart disease in the placebo group, and the researchers felt it was unethical to continue the study.

When the data were examined, it turned out that the group taking Lipitor experienced a 36 percent decrease in relative risk for heart disease. Thus the barrage of ads for Lipitor that followed.
Even websites aimed at doctors, using info from the Lipitor package insert, showed graphics designed to make any doctor grab for the Lipitor pre-printed prescription pad. This graph is 100 percent accurate, but, as we shall see, hugely misleading.


Figure 1 below is a graphic showing what that 36 percent relative risk looks like.

Figure 1. Relative risk of 36 percent with a large absolute risk.

 

Pretty impressive, isn’t it? Makes you wonder why anyone wouldn’t want to take Lipitor. Problem is, Figure 1, which I made up, shows a relative risk differential of 36 percent, but it also shows a large absolute risk.

Looking at Figure 2 below, which shows the actual absolute risk of experiencing a heart attack or dying from heart disease in this study, you can see that the 36 percent relative risk reduction is accurate. But does it really make you want to stampede to the pharmacy to pick up your Lipitor? Remember, these subjects all had high blood pressure and two other risk factors for heart disease, yet their absolute risk is pretty low. Would you want to take a medicine that could give you muscle aches and pains along with muscle wasting, short term memory loss and possibly fatal liver or kidney damage based on the absolute risk shown in Figure 2?

Figure 2.  Relative risk of 36 percent with actual absolute risk in the Lipitor study. 

 

If you compare Figure 1 to Figure 2 above, both of which have the same relative risk, you can readily see that the absolute risk is extremely important. If the absolute risk is high, as it is in Figure 1 at the top, then the relative risk becomes important.

If, as in Figure 2, the real Lipitor vs placebo graphic, the absolute risk is small, then not so much so. Both Figure 1 and Figure 2 show the same relative risk, but not anywhere close to the same absolute risk. Which is why you always want to know the absolute risk before you make a decision on anything based on relative risk. Because absolute risk is usually pretty low in drug studies, the pharmaceutical industry typically uses the relative risk number to sell their medicines.

In the case of statins, most people go on statins because what they really fear is dropping dead of a heart attack, and they feel the statins are protective.

What happened in this study? There were two more deaths in the placebo group than in the Lipitor group, but that number wasn’t statistically significant. Figure 3 below is a graphic showing the absolute risk of having a fatal heart attack in the Lipitor trial.

Figure 3. Relative and absolute risk of fatal heart attack in the Lipitor study.

 

Not a huge absolute risk.

Let’s look at another example that is much more dramatic than the Lipitor study above.

I pulled a paper from the New England Journal of Medicine (NEJM) looking at coronary artery calcification (CAC) scores and risk for having a heart attack.

Approximately 20 percent of the plaque in coronary arteries is composed of calcium, which shows up on X-rays. But since the heart is constantly in motion, it’s difficult to see the calcium in standard X-rays of the chest. Specialized CT machines, however, can take extremely fast photos of the heart and actually see the calcium in the coronary arteries. A computer program then converts this calcium into a score, which is simply a number. If you have a zero score, you have no calcium accumulation, which means you probably don’t have any plaque to speak of. You could have some soft plaque that hasn’t yet calcified, but a zero CAC score is definitely a good one.

The NEJM study looked at CAC scores of 6,722 subjects and broke them out into one of four groups. Zero, CAC score of 1-100, CAC score of 101-300, and CAC score of greater than 300. These groups were followed for about 4 years on average for the main endpoint of the study, which was a major coronary event, defined as a heart attack or death from coronary heart disease.

You can see the relative and absolute risk in the graphics below. Upper left is zero CAC score. Upper right, 1-100 CAC score. The lower left is 101-300 CAC score, and the lower right is greater than a 300 CAC score.

Figure 4. Relative and absolute risks for various CAC scores.  Zero upper left. 1-100 CAC upper right.

101-300 CAC lower left.  Greater than 300 lower right.

 

As you can see, the risk for a major coronary event is negligible with a CAC score of zero. And the risk increases as the CAC scores go up. The subjects in this study who had CAC scores above 300 experienced 19 times more major coronary events than did those with zero CAC scores. Which would mean a 300+ CAC score carries a relative risk of 1900 percent* as compared to a zero, which is humongous. But looking at the absolute risk tells a different story.

I’ve seen patients with 300+ CAC scores come unglued. Granted, it’s not a score you want to see, but it doesn’t mean you’re going to die the next day. A lot of people feel that way, though. Which is why knowing the absolute risk is important before you decompensate over a high relative risk for this or any condition.

If you would like to play around with these absolute and relative risk graphics, you can do so at this site.  Keep the site bookmarked, so the next time you come across a relative risk, look up the actual risk and graph it.  Only then will you know the true risk involved.

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*I used a relative risk score based on the raw data from the study.  If you look at the actual study (linked above), you see different relative risks than what I have.  The ones in the study are lower because the authors extrapolate the data out longer and take into account when the events happened.  So, if you happen to have a high CAC score, your risk is lower than what I show above, which was strictly for illustrative purposes.
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Read the complete article here.

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20140721 Added this link to good video on relative risk. Well worth the watch.

The controversial study that started the War on Cholesterol - Watson

The controversial study that started the War on Cholesterol…

      

Alan Watson | June 14, 2012   

Revisiting the Coronary Primary Prevention Trial (CPPT) – 1973 to 1984

Using "relative risk statistics" and changing the study's design, the CPPT researchers declared success and the War on Cholesterol began in earnest

 

Launched in 1973 by the National Institutes of Health, the Coronary Primary Prevention Trial (CPPT) set out to prove that lowering blood cholesterol with a drug and a low cholesterol, low saturated fat diet would reduce the risk of coronary heart disease and extend the lives of the study participants.

(As part of the study, twelve new Lipid Research Clinics were set up by the Heart Institute at large universities throughout the country including Baylor, Stanford, Johns Hopkins and the University of Washington in Seattle.)

The researchers were looking for middle-aged men with total cholesterol levels exceeding those of 95 percent of Americans. (Only men with the highest 0.8 percent total cholesterol qualified.) The CPPT researchers screened 480,000 applicants in order to select 3,806 high risk men between the ages of 35 and 59.

This meant that many of the participants had familial hypercholesterolemia, a rare genetic defect in cholesterol metabolism present in about 1 percent of the population. The trials chance of success was therefore greatly increased by focusing on this particular group of presumably vulnerable men.
In their preliminary report, CPPT researchers announced that they would study two separate outcomes:  (1) Nonfatal heart attacks and (2) fatal heart attacks or deaths from coronary heart disease. The CPPT directors emphasized that they would be satisfied with nothing less than the strongest statistical proof of their findings; they had to be “99 percent certain that the results were not due to chance.”

The researchers also announced their goal of reducing blood cholesterol in the treatment group by 25 percent and reducing the risk of heart disease in the treatment group by at least 50 percent.
Approximately half of the 3,806 men were provided low cholesterol, low saturated fat dietary advice and were treated with cholestyramine, a cholesterol-lowering bile acid resin (Questran).

(Cholestyramine lowers cholesterol by interfering with digestion. Statins such as Lipitor, Mevacor and Zocor were not available yet.)

The control group was provided the same dietary advice and an unpleasant tasting placebo – an indigestible mixture of sand, sugar and food coloring. Both trial groups suffered with moderate to severe gastrointestinal distress. There were eight gastrointestinal cancer deaths in the treatment group (out of 21 cases) and one in the placebo group (out of 11 cases).

(There were more deaths from cancer, intestinal disease, stroke, violence and suicide in the group taking the cholesterol-lowering drug, and overall mortality was essentially the same for both groups.)

Disappointing Results

In 1984, the disappointing results were tabulated. Cholesterol levels in the treatment group had decreased by no more than 7 percent. Cholestyramine and the low cholesterol, low saturated fat diet had failed to lower cholesterol enough to prove that lowering cholesterol would reduce the risk of heart disease and extend the lives in the treatment group.

The difference in nonfatal heart attacks was not statistically significant. In the treatment group, 130 participants (6.8 percent) had a heart attack versus 158 in the placebo group (8.3 percent). After 7 years, the fraction of the treatment group that had benefited was less than 2 percent.

                                       Nonfatal heart attacks               Fatal heart attacks/coronary deaths
1,900 Control Group:         158 or 8.3 percent                               38 or 2.0 percent
1,906 Treatment Group:     130 or 6.8 percent                              30 or 1.6 percent

The difference in fatal heart attacks was not significant either. In the treatment group, 30 participants (1.6 percent) suffered a fatal heart attack compared to 38 in the placebo group (2.0 percent) Again – after 7 years of taking an unpleasant drug (and following a low fat diet), the fraction of the treatment group that benefited was less than 1 percent.

However, by applying relative risk statistics (a percentage of a percentage), the CPPT researchers improved their results. They took the number of people who presumably didn’t have a heart attack because of taking the drug (28) and looked at it as a percentage of the people who did have heart attacks (158) but didn’t take the drug:

The less than 2 percent absolute difference in nonfatal heart attacks rose to a reported 19 percent reduction in risk of a heart attack!

 

In similar statistical fashion, the researchers announced a 24 percent reduction in the risk of dying from a heart attack. The 8 men or 1.6 percent out of 1,900 who presumably did not have a fatal heart attack because they took the drug became the same 24 percent who reduced their risk of mortality compared to those in the control group who did die (38) but did not take the drug.

Additional study design changes

To prop up their victory, the CPPT researchers decided to exclude  “uncertain” nonfatal heart attacks from the treatment group while including  “uncertain” fatal heart attacks in the placebo group. Also, using the original 99 percent standard, the small favorable trend in either group could only be explained by chance (as defined by the researchers themselves at the start of the trial.)
By applying the less stringent 95 percent standard and by combining the two groups into one (nonfatal and fatal heart attacks), the CPPT researchers improved their results – declared victory – while the press responded with unbridled enthusiasm.

In 1984, the press and medical journals portrayed CPPT as the long sought proof that animal fats were the cause of heart disease. It was widely reported that for the first time:

“It had been proven that lowering cholesterol would reduce the mortality from heart disease and lower the risk of having a heart attack.”

 

Much of what we hear today about diet and heart disease can be traced back to this notorious failed study. When other scientists voiced their objections to the trial’s design changes, the CPPT directors simply denied that they had ever embraced the original more stringent standards.

In January 1984, the Journal of the American Medical Association (JAMA) dutifully reported:

“The trial’s implications…could and should be extended to other age groups and women, and to others with more modest elevations of cholesterol levels. The benefits that could be expected from cholestyramine treatment are considerable.”

 

George Mann, M.D., professor in medicine and biochemistry at Vanderbilt University, severely criticized the CPPT directors and the trial’s unsupportable results:

“The managers at the National Institutes of Health have used Madison Avenue hype to sell this failed trial in the way the media people sell an underarm deodorant…”

 

 Giving cholestyramine for over seven years to 1,906 middle age men – many with a genetic predisposition to atherosclerosis – had only saved the lives of eight but the Heart Institute was now recommending that cholesterol-lowering drug treatment be extended to patient groups that had not been part of the trial.

Even without the solid evidence they sought, the medical elite in the American Heart Association and the National Institute of Health decided to push ahead with cholesterol-lowering drugs and the still unproven low cholesterol, low saturated fat diet:

 “Now we have proved that it is worthwhile to lower blood cholesterol; no more trials are necessary. Now is the time for treatment.”

 

 The long War on Cholesterol had begun
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Read the complete article here.

Statin Drugs Raise the Risk for Diabetes in Postmenopausal Women by 48%

Statin Drugs Raise the Risk for Diabetes in Postmenopausal Women by 48%

Older women using Statin Drugs like Lipitor may be at a 48% higher risk for becoming Type 2 Diabetics. This result was published in the Archives of Internal Medicine and reported by Medpage Today, January 9, 2012. The study didn’t specifically prove that statins cause Diabetes but rather proved that either the use of statins causes Diabetes or that statin use is somehow related to the incidence of Diabetes. Future studies will be needed to prove any cause/effect relationships.
This is yet another “shot across the bow” at the statin drug industry which has convinced many Americans that they have to take statins for their cardiovascular health. I stopped taking Lipitor months ago because I deemed the risk much greater than the benefit – and my physician went along with it because of my weight loss with a low carb diet. To acquaint you with the dark side of statins and why many are doing as I have, watch the following video by Dr. Diamond. He covers statins starting at 33:45 into the clip. His presentation is backed up by data and references from the University of South Florida.

In terms of the 48% higher risk figure, it is important to realize that this is called a Hazard Risk and is a ratio of a ratio, masking some important issues. You need to consider a simpler perspective of the data to meaningfully assess what this means. I don’t have the exact figures, but based on the published study data, the likelihood of all the women in the study becoming Diabetic was around 6.7%. The women on statins were (based on the study results) found to have a 48% higher risk of becoming diabetic. The rough estimate of the likelihood of women on statins to become diabetic was therefore 148% of 6.7%, or 9.9%. From this simpler perspective the numbers aren’t so frightening. In other words, for these women, going on a statin increased the likelihood of Diabetes by 3.2%, from 6.7% to 9.9%. It is still, however, a finding that is not good news for patients on statins.
Getting back to the new statin study: Yunsheng Ma, MD, PhD, of the University of Massachusetts School of Medicine, was intrigued by prior research that suggested a link between statins and Diabetes and established an estimate of a 9% higher risk of Diabetes for statin users. Based on this, Dr. Ma and his colleagues decided to investigate further with an analysis of the data from a large study called the Women’s Health Initiative. After that analysis, in short, they found a much higher risk for Diabetes, for postmenopausal women on statins.
The Women’s Health Initiative provided data on 153,840 women with an average age of 63, who didn’t have Diabetes when they entered the study in 1993. About 7% of the women were on statins at the beginning of the study. Analysis of the women on statins compared to women not on statins yielded a 48% greater risk of the onset of Type 2 Diabetes during the study, which was last analyzed in 2005. This result was obtained after analysis adjustments were made to make sure that issues like age, race, and weight weren’t contributing factors. The 48% higher risk was seen for all types of statins (for example Lipitor, Crestor, Zocor, and Mevacor).
Since the study didn’t conclusively find that statins cause Diabetes, the researchers were clear in recommending that patients consult with their doctors on this issue before changing their medications. They did suggest, however, that since there is a higher risk of Diabetes with statin users, patients should strongly consider lifestyle change (such as weight loss and exercise) to improve their health rather than think that they can, “without risk”, just take the easy approach with statins.
Some interesting things are going on with the TV News coverage. Yesterday NBC reported on the study mentioned here, using the 48% increased risk factor (Hazard Risk). On the Today Show today, however, NBC reported on the same story but chose to report the numbers from the “simpler perspective” with no mention of the Hazard Factor 48% number. They reported that the likelihood of women becoming Diabetic was 10% for women who were on statins but only 6.4% for women who weren’t. That doesn’t look so frightening does it? I wonder if the change from the Hazard Risk to the less frightening simple perspective had anything to do with the minute-long Lipitor commercial that NBC aired during the show!
It’s ironic that the supporters of statin drugs may have pulled the same trick (but in reverse) when they put together the original clinical study analysis that got us onto statins in the first place. See the video above from Dr. Diamond at around 37:30 into the clip. The detailed analysis results indicated that reducing cholesterol lowered the likelihood of death by Coronary Heart Disease from 2% to 1.6% (only 0.4%) – not very exciting. The statin supporters however proclaimed that it was a 24% reduction in risk (Hazard Risk)!
This post is featured on the Modern Paleo Blog.
From: http://cravingsugar.net/statin-drug-study-reveals-48-increased-risk-diabetes-women-lipitor.php

Bad Science Used To Push Cholesterol-Reducing Drugs

By Cholesterol Truth

I had a patient in my practice this week who was seeking advice about the prevention of heart disease. He’d been on a statin for several years, and then started to get what he felt might be side-effects.
 
He stopped the statin and the side-effects went away. As he rightly pointed out, the relief from his symptoms might have been entirely coincidental and nothing to do with the fact that he stopped his statin medication. However, he was disinclined to restart. My patient told me that he expects his doctor to be up in arms about this. He has, apparently, an unbridled enthusiasm for statins and believes ‘everyone should be taking them’.

As I pointed out to my patient, the reality is the vast majority of people who take statins are destined not to benefit from them. And then we have the problem, of course, of toxicity and side effects.
Not to mention the cost. What is it then, that causes doctors to be so enthusiastic about drugs that, on balance, have limited benefits and can cause serious harm?

Well, some of this has to do with the fact that doctors make money from cholesterol reduction. In private medicine, the cholesterol concept suddenly makes ‘patients’ out of essentially healthy people.
Here in the UK, national health general practitioners are remunerated for their cholesterol-reducing efforts with patients.

But a major part of the problem too, I think, has to do with how the ‘benefits’ of statins and other drugs are communicated to doctors by drug companies. As I’ve pointed out before, the emphasis is usually on reductions in the ‘relative risk’ of, say, heart disease. But if the overall risk is small, the real reduction in risk (known as the ‘absolute risk’ reduction) becomes vanishingly small.
 
Another problem is that data can be presented to doctors that gives a misleading account of a drug’s effects for the unwary. I spotted a prime example of this recently in the on-line version of the GP magazine Pulse here.

 

The title of this piece reads: Ezetimibe plus statin ‘halves death risk’. What the piece is really about is that some primary care trusts have banned GPs from prescribing ezetimibe (a cholesterol-reducing drug), supposedly on the basis of cost. Some doctors, it seems, are upset about this. The piece cites some evidence in which individuals taking ezetimibe plus the statin simvastatin were about half as likely to die compared to those taking simvastatin alone. In case you haven’t clicked through to the actual piece, here’s how the opening paragraph of the piece reads: ‘A cholesterol-lowering drug that has been blacklisted by some PCTs on financial grounds has been shown to reduce mortality in patients following a first acute myocardial infarction.’

One problem: the study that purportedly shows that ezetimibe saves lives actually does nothing of the sort. The study is ‘epidemiological’ in nature, and can only tell us that ezetimibe is associated with a reduced risk of death. You see, individuals who take ezetimibe may have a reduced risk of death that has nothing to do with ezetimibe. Maybe, for example, they’re particularly health conscious and in addition to pressing their doctors for more and stronger medication, they’re also active and eat good diets.

The fact that the study in question here is epidemiological means that the statement that ‘A cholesterol-lowering drug…has been shown to reduce mortality…’ is simply wrong and misleading.
To know if ezetimibe really does save lives, we need clinical ‘intervention’ studies. We now have several of these. And here’s what you and your doctor need to know: Not one of them has shown that ezetimibe benefits health or health markers. Some of the studies actually suggest the ezetimibe does more harm than good.

The Pulse piece ends with the following paragraph: ‘Dr Peter Fellowes, a GP in Lydney, Gloucestershire and a member of the GPC clinical and prescribing subcommittee, said: ‘I don't think it should be blacklisted. It is very useful in patients who are statin intolerant. The arguments against ezetimibe and the more potent statins are entirely cost based as I see it, and that is a sorry state of affairs.'’

I’ll tell you what’s a ‘sorry state of affairs’: When a doctor is advocating the use of an expensive and potentially toxic drug that has no proven benefits on health. And it doesn’t help that a magazine for GPs presents information on cholesterol-reducing drugs in a misleading and utterly imbalanced way, either.

To your good health,
Dr. John Briffa
for The Cholesterol truth
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Read the full article here.

Lies, damned lies, and statistics

A blog I follow View from the hill just had a good article titled Lies, damned lies, and statistics which has very good points some of which I've feebly discussed here in the past.

Here's a quote exerpting one small paragraph along with a couple of his summary statements of note.



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"There has been much publicity, about the trials of various drugs recently, highlighting the pro's and the con's (literally) of their worth. The use of statin's, for example, was initially believed to be a panacea for low risk (should that be no risk?) patients in the prevention, of future heart disease. But this has been clearly shown to be of little benefit, whilst at the same time as increasing risks for other diseases such as diabetes. The use of statin's in primary prevention is now pretty much a 'dead parrot', but will GP's stop prescribing them for the achievement of a highly dubious surrogate end point? Well, err, no, because they are paid to achieve them by the QOF (Quality Outcomes Framework). And let not the science, get in the way of a nice little earner!"

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"So, long suffering reader, I would urge scepticism in all data, that is presented to you as 'proof' of anything, especially a drug or treatment, that has been provided as a preventative measure by your 'hard pressed' GP."
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"Finally, be a sceptic, and believe only that, which is proven by real science, not Daily Mail headline drivel, or advocacy research, or perhaps worse, what your Doctor tells you (if it's QOF'ed)."


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Please read the complete article here

Researchers urge caution in prescribing statins to healthy people

Good Article By Dr  Briffa on statin use
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- Dr Briffa's Blog - http://www.drbriffa.com -
Researchers urge caution in prescribing statins to healthy people
Posted By John Briffa On 20 January 2011 @ 12:51 am In Cholesterol and Statins, Food and Medical Politics

My blog on Monday focused on a piece published in the American Journal of Public Health which detailed some of the tactics drug companies use to persuade doctors to prescribe their wares. The conclusion? The more aggressively a drug is marketed to doctors, the more suspicious of it we should be, basically. I ended the blog with the following remark: “Applying the inverse benefits law should, I think, cause us to be particularly wary of cholesterol reducing drugs. Let us not be too surprised, then, that the science shows statin drugs to be not-very-effective at saving lives, while at the same time putting those who take them at risk of sometimes severe adverse effects.”
What I didn’t know when I wrote this is that a review of statin treatment was about to be published by the researchers from the Cochrane Collaboration [1]. This international collective of researchers prides itself of conducting systematic, unbiased reviews of treatments. The point of this review, the researchers claimed, was to assess the risks and benefits of statin treatment in what is known as the ‘primary prevention’ setting.
Here’s some context on this from a previous blog post:
Statin therapy broadly divides into two main approaches:
Primary prevention – where statins are given to essentially healthy people with no known cardiovascular disease (i.e. there is no evidence of arterial disease and no history of a heart attack and/or stroke)

Secondary prevention – where statins are given to people with known arterial disease and/or a history of heart attack and/or stroke
This distinction is important because individuals in the secondary prevention category are at generally high risk of further problems, and stand to benefit most from statin therapy. On the other hand, individuals in the primary prevention category are at generally low risk of cardiovascular disease issues (such as heart attack and stroke), and may therefore not benefit much from a strategy or treatment intended to prevent cardiovascular disease. This primary prevention category is particularly important when one considers that the vast majority of people taking statins are in this category, and if the pharmaceutical industry and some of its hired hands in the scientific and medical community have their way, increasing numbers of people will be taking statins in the future.
In the recent Cochrane review, 14 trials were analysed. They reported, having amassed the evidence, that overall risk of death was reduced by 17 per cent, and overall risk of fatal and non-fatal cardiovascular events such as heart attacks and strokes were reduced by 30 per cent. On face value, these results look pretty good. However, the devil turns out to be in the detail.
To begin with, the researchers allowed studies in which up to 10 per cent of participants were in the secondary prevention category. What this basically means is that their assessment of the data was not really focused on the primary prevention setting. What’s required is an analysis of purely primary prevention data. The Cochrane researchers did not manage this, but other researchers have. A meta-analysis of data from individuals in the primary prevention category published just last year [2] (reported here [1]), no reduction in overall risk of death was found with statin therapy.
The Cochrane authors do mention this study, but it’s somewhat buried in the discussion. It is not mentioned at all in the introduction of their review in which they list more than one review, like theirs, that allowed secondary prevention data to corrupt the primary prevention data.
The Cochrane authors have also largely confined themselves to assessment of ‘relative risk’. However, it is well accepted that a more useful judge of the true effectiveness of a treatment is absolute risk reduction (if risk if low, relative reductions in risk translate to very small real reductions in risk) as well as ‘number need to treat’ (e.g. how many people need to be treated for one year to prevent one heart attack – generally, NNTs in primary prevention are high).
However, there are, I think, many good things about this Cochrane review. It highlights many of the deficiencies in the evidence-based regarding statin therapy. Here are a few highlights:
•Of the 14 studies reviewed, four of them were not double-blind in design (double-blind studies, where neither the researchers not the participants know whether they are taking the active drug or placebo are considered the ‘gold standard’ for good clinical research).

•11 of the 14 studies recruited individuals who, while perhaps not having a history of cardiovascular disease, nonetheless had what would traditionally be regarded as at least one major risk factor for cardiovascular disease such as raised blood fats, high blood pressure or diabetes.

•2 major trials were stopped prematurely. This is as cause for concern as may lead to “an over-estimation of treatment effects…”

•All but one of the studies was industry-funded. According to the authors, “It is now established that published pharmaceutical industry-sponsored trials are more likely than non-industry-funded trials to report results and conclusions that favour drug over placebo due to biased reporting and/or interpretation of trial results.”

•The study participants were ostensibly white, male and middle-aged (average age 57), and the authors of the Cochrane review question the appropriateness of this data in, say, older individuals and women.

•There was no evidence of significant adverse effects, though about half of the studies did not even report adverse effects. (For more on adverse effects, see the blog post I link to above).

•There was little or no significant evidence on the cost-effectiveness of statins in primary prevention.

•There was little or no significant evidence on the effects of statins on quality of life.
The authors conclude:
“This current systematic review highlights the shortcomings in the published trials and we recommend that caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.”
While I have my reservations about this review, I do think it is high commendable that some researchers (at least) have a mind to review the data on statins with a degree of objectivity. While statins are vigorously promoted by many doctors and researchers, it is good to see some academics urging caution. It’s good that they are presenting the other side to statins. It’s a story that is rarely heard, but one that needs to be heard if individuals are going to make truly informed choices about whether they take a statin or not.
UPDATE.
After writing this post yesterday I got to talk about some of the issues the research raises on Channel 4 News here in the UK. Here’s the video…
References:
1. Taylor F, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD004816. DOI: 10.1002/14651858.CD004816.pub4.
2. Ray KK, et al. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65 229 participants. Arch Intern Med. 2010;170(12):1024-1031
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7 Comments
7 Comments To "Researchers urge caution in prescribing statins to healthy people"
#1 Comment By Chris On 20 January 2011 @ 8:05 pm
Dr Briffa, well done, an excellent summation of the Cochrane report. Congratulations too for your contribution to the debate on CH4 news.
A PDF of the report can be found [2]
It’s an uphill struggle I know, but the report did receive reasonable media coverage. BBC radio news reported it as did the [3]. BBC Breakfast News (BBC1) covered it too and invited Dr Rosemary Leonard to pass comments. Dr Leonard largely defended the use of statins. To some in the know she would, no doubt, have looked pretty dumb.

Of the papers I noticed the http://www.drbriffa.com/
Damn those html tags!
#3 Comment By Chris On 20 January 2011 @ 8:14 pm
Of the papers I noticed the [4] were quick on the uptake
#4 Comment By Jo On 21 January 2011 @ 6:54 pm
Wow, you put your case very well Dr Briffa. C4 covered this better than the BBC reports I saw. The Beeb are clinging on to the idea that statins are still a wonder drug. Their resident doc seems to push the conventional wisdom, but I imagine that’s what a state run news broadcaster is expected to do so she has to tow the line. My doc prescribed statins to me despite my cholesterol being in the ‘green’ area (they think we’re so stupid we need a traffic light system to understand). Maybe we will be once the entire population is taking these pills. I experienced memory loss and stopped taking them.
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Dr Briffa’s Blog — Topsy.com On 21 January 2011 @ 9:11 pm
[...] This post was mentioned on Twitter by Jayne, H Padarin. H Padarin said: A step in the right direction… the real story of statins is finally starting to be acknowledged. Anyone on… [5] [...]
#6 Comment By gill oliver On 21 January 2011 @ 10:53 pm
I decided two months ago to stop taking statins, as i was aching all over and just didn’t feel right, i used to take anti- inflammatory tabs, plus co- codamol for my back pain, i now no longer need these and can get by on the occasional paracetamol and i feel much better in myself.
#7 Pingback By Check the links…
Pure Spontaneity On 21 January 2011 @ 11:38 pm
[...] Bad news for statins = good news. And more. [...]
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Article printed from Dr Briffa's Blog:
URL to article: http://www.drbriffa.com/2011/01/20/researchers-urge-caution-in-prescribing-statins-to-healthy-people/
URLs in this post:
[1] here: http://www.drbriffa.com/2010/06/30/do-statins-save-lives-in-essentially-healthy-people-no/
[2] : http://www.drbriffa.comwww.thecochranelibrary.com/details/file/985303/CD004816.html
[3] : http://www.bbc.co.uk/news/health-12224312
[4] : http://www.telegraph.co.uk/health/healthnews/8267570/Millions-taking-statins-needlessly.html
[5] : http://fb.me/SAQBLhUX
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Innumeracy. What's that!

Innumeracy, a term coined by cognitive scientist Douglas R Hofstadter in the early 1980’s, is a term meant to convey a person's inability to make sense of the numbers that run their lives.

Gerd Gigerenzer, in his book Calculated Risks: How to Know When the Numbers Deceive You clearly demonstrates that innumeracy is common among physicians, and is exploited by medical vendors. (Italic emphasis added by B Davis)

The book is reviewed in the Journal of American Physicians and Surgeons Volume 9 Number 1 Spring 2004. Exerpts follow with the whole review found at http://www.aapsonline.org/jpands/vol9no1/bookreviews.pdf.

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“The object of this book was to clear the mist from typically misleading, if not fraudulent, claims for the effectiveness of drugs and the accuracy of clinical assays. Gigerenzer’s focus is on deceptive presentation of data, usually in the form of relative risk (RR) rather than absolute risks or number needed to treat (NNT).

Gigerenzer points out with many examples that relative risk is always a larger number than absolute risk. One example is a 5-year study of pravastatin.the anticholesterol drug Pravachol.vs. placebo. All-cause death was said in the original paper to be reduced by 22% (RR=0.78). Would you prescribe it? The absolute change was 0.9%, or just 0.18% per year! Would you still prescribe it? It is also known that studies of drugs sponsored by their maker are biased, so even the 0.9% was probably exaggerated.”