The point of the cartoon above by Eric Allie holds true for the recently released Jupiter study: the reporting of the data by the media often overshadows the actual data.
Let’s first take a look at the reporting.
The lede from MSNBC:
People with low cholesterol and no big risk for heart disease dramatically lowered their chances of dying or having a heart attack if they took the cholesterol pill Crestor, a large study found.
The headline from Fox News:
Study: Cholesterol Drug Causes Risk of Heart Attack to Plummet
The New York Times headline and lede (on the front page, no less):
Cholesterol-Fighting Drugs Show Wider Benefit
A large new study suggests that millions more people could benefit from taking the cholesterol-lowering drugs known as statins, even if they have low cholesterol, because the drugs can significantly lower their risk of heart attacks, strokes and death.
The Wall Street Journal, usually a more measured source, effuses:
Cholesterol Drug Cuts Heart Risk in Healthy Patients
AstraZeneca PLC’s cholesterol drug Crestor sharply lowered risk of heart attacks among apparently healthy patients in a major study that challenges longstanding heart-disease prevention strategies. The findings could substantially broaden the market for statins, the world’s best-selling class of medicines.
I could go on, but you get the picture. I’m sure you’ve read all this in your own papers. But it’s not just the papers and media that are harping on this study – it s even the statinators themselves.
Here is the commentary from Steven Nissen, M.D., a Master Statinator if there ever was one:
The extent of reduction in death, heart attacks, and stroke is larger than we’ve seen in any trial I can remember. I don’t know how you get much bigger than that.
Says Dr. W. Douglas Weaver, president of the American College of Cardiology:
[The findings] really change what we are going to do in the future. This targets a patient group that normally would not be screened or treated to prevent cardiovascular disease.
And in a statement that I’m sure will prove true, Dr. Weaver follows up with:
This will become an important part of the armamentarium of the primary care doctor. I see this as being part of that panel of preventions that they will be applying in men over 50 and women over 60.
Dr. Tim Garder, president of the American Heart Association, opines without any evidence whatsoever that
This is likely to be a class effect, not a specific drug effect. This is a win for all statins, I would say.
The above is a sampling of the reporting and the blathering so far about the Jupiter study. The general impression that most people (and, sadly, most physicians) will take away is that statins will prevent heart disease even in those people who don’t have risk factors for heart disease. Any one of any sex at any age should queue up for a dose of statins to prevent heart disease.
That’s the reporting. Now for the data. What does the study actually show?
If you believe the data from this study (we’ll get to that later), it indicates that men over 50 and women over 60 with normal LDL-cholesterol levels AND elevated C-reactive protein levels who took the very expensive ($3.50 per day) statin drug rosuvastatin (Crestor) minimally reduced their risk of developing heart disease or dying of any cause as compared to those who took placebo.
That’s it, folks. And that’s only if you believe the data.
The study says nothing about men under 50 or women under 60. The study says nothing about other types of statin drugs reducing risk. And the study applies ONLY to those men over 50 and women over 60 who have fairly markedly elevated C-reactive protein levels. The study says nothing about anyone of an sex or any age who doesn’t have a markedly elevated C-reactive protein level.
So, what’s the big deal?
Well, the big deal is that there is finally a study that shows some benefit to statin drugs in terms of decreasing all-cause mortality. And, as I’ve posted before, those studies are few and far between.
There is so much excitement on the part of the statinators of renown because their coffers will soon be filled to overflowing with fees from AstroZeneca (and other statin manufacturers that want to piggyback onto this study) for speaking gigs promoting Crestor. (Here is a post on the payola to doctors promoting anti-depressant drugs. Drug company income from anti-depressant drugs is a drop in the bucket compared to the income from statins, so you can only imagine how lucrative it is to be a speaking statinator.) There is considerable excitement at AstroZeneca and the other statin makers because the physicians who are non-critical thinkers and non-study readers (sadly, the vast majority) will commence giving statins to just about everyone who walks through their office doors.
It appears to be another modern medical triumph – everyone profits but the patients. Looks like Erasmus was way ahead of his time when he wrote about Jupiter way back in the 14th century.
Jupiter, not wanting man’s life to be wholly gloomy and grim, has bestowed far more passion than reason /you could reckon the ration as twenty-four to one.
Passion to reason in the ratio of 24 to 1. That equation certainly applies to the media covering this study and the statinators feeding them their info.
Let’s take a look at what the study really shows. But before we do, let’s psychoanalyze the people putting the study together. What do you think they wanted out of this study.
Typically a study starts with an hypothesis, say, zinc cures the common cold. The study then involves giving people suffering from colds zinc or a placebo to see what happens. The researchers then say that the data confirms the hypothesis or refutes it. It’s not good to go into a study with a predetermined idea of what you want. You just need an hypothesis. Your hypothesis could be that zinc has no effect on the common cold. You wouldn’t go into a study with the idea that we’re by God going to prove zinc cures the common cold. It just doesn’t work that way.
But what about the Jupiter study? Know what Jupiter stands for? It stands for Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin. Which translates to by God we’re going to prove that statins prevent something. We certainly know the mindsets of the people running this study.
After a couple of critical reads of this paper (full text here), I can’t see a real problem with the data. But there are a few sort of fishy things going on with this study and three really fishy things. Before you read on, give a quick read through to a post I wrote a while back about relative risk so that you will be familiar with the kinds of statistics we’ll be talking about.
Although the relative risk numbers in this study appear to be correct, you’ve got to realize that these are small numbers we are talking about. Out of almost 18,000 subjects there is a difference of not quite 50 deaths between the two groups during the years over which the study took place. Which means, of course, that neither subjects in the placebo group nor subjects in the Crestor group were at great risk of dying. There is a difference, but in these small numbers (as explained in the post linked above) it is almost meaningless.
You can really see the difference when you look at this graph taken from the study.
Notice the bottom two curves. Those are the all-cause deaths from the placebo and Crestor groups. As you can see, the two curves are pretty much superimposed upon one another. That’s what it looks like when very small numbers are involved. The authors had to use a different scale to make it look like there was a major difference as they did in the two divergent curves at the top of this chart.
Let’s look at the sort of fishy aspects of this study. First, the patient population is most unusual. How many subjects are there out there who have both normal LDL-cholesterol levels (defined as 130 mg/dl or below) AND elevated C-reactive protein levels. Not very many. Especially if you eliminate anyone with any history of inflammatory disorders, which the researchers did.
Most people who have an inflammation arising from the metabolic syndrome, obesity or other common inflammatory disorders will have both elevated lipids AND elevated C-reactive protein levels. They are typically found together. The authors of this study had to use 1315 sites in 26 different countries to get the 17,802 subjects involved. Simple division tells us that there were an average of about 13 subjects per center. Not many. To paraphrase F. Scott Fitzgerald who said “the rich are different from you and me.” Well, these subjects are different from you and me. And what may work for them may not necessarily work for you and me.
Second, when you look at Table 1 showing the baseline characteristics of the participants, you can see that in virtually all respects the two groups of subjects look identical, which is as it should be in a randomized study.
But closer evaluation indicates they’re not identical in a couple of parameters. In the category Family History of Premature CHD (coronary heart disease) we see that there are 51 more subjects with a family history of premature CHD in the placebo group than in the Crestor group. Since a family history of premature CHD is probably the strongest risk factor for developing premature CHD, do you think a few more of the subjects in the placebo group may have developed it? And maybe died as a result?
Third, looking at this same table and checking the very next category, Metabolic Syndrome, we find that 71 more patients in the placebo group with metabolic syndrome than we do in the Crestor group. Since the metabolic syndrome is another strong risk factor for development of CHD, do you think some of that difference in deaths could have come from this disparity in the groups? As I say, not conclusive, but fishy.
The three real fishy things are more problematic. First, according to the paper
At the time the study was terminated, 75% of the participants were taking their study pills.
Which means, of course, that 25% weren’t taking their study pills. And we don’t really know how many of the deaths in the study group came from the 75% taking their meds or the 25% who weren’t because the data was evaluated using an intention-to-treat analysis.
The second fishy deal on this study is that both the placebo group and the Crestor group reported the same number of side effects. Say what? Crestor is a potent statin, known for causing side effects, and the group taking this drug reported no more side effects than those taking the placebo. That’s real fishy. When you look at the most common side effect of statin drugs – muscle pains – only 19 people out of 18,000 reported this symptom: 10 in the Crestor group and 9 in the placebo group. Something totally fishy is going on here.
Finally, the fishiest thing of all.
They stopped the study right in the middle of it. When studies are done that might put people at risk by giving them potentially dangerous drugs, it is typical for an outside group to take a peek at the data at certain milestones to make sure the study medication isn’t killing people. When this data is evaluated, and it is found that subjects on the experimental medicine are dying at unacceptably high rates, the study is often halted. I’ve never seen a study halted because the placebo group was dying at higher rates. That really makes me wonder.
One of the negative findings in this study was that the group on Crestor developed diabetes during the trial at a significantly higher rate than did those on placebo. I suspect that the outside group checked the progress of the study, found that the subjects on Crestor were at the time of the evaluation showing better results than those on placebo, so the decision was made to stop the study while it was looking good. Had it gone on for the full term, the deaths could have evened out, way more people could have developed diabetes, or who knows what might have occurred had the study continued. So, the powers that be decided to quit while ahead.
But, let’s assume I’m taking this study at its absolute worst. Let’s look at it in the best light possible. If we do, we find that a small group of unusual patients – those with low LDL-cholesterol AND high C-reactive protein – may slightly decrease their risk for all-cause mortality by taking a drug that costs them almost $1,300 per year and slightly increases their risk for developing diabetes. That’s the best spin possible given the data from this study. Compare that to the spin the media is giving it.
Excellent take, doc.
The Danish researcher, Børge Nordestgaard, who is part of the Jupiter Study Group, made headlines in the Danish newspapers lately as co-author of a Danish study that proved the relationship btw. high levels of C-Reactive Protein and heart disease. If you pubmed ‘Nordestgaard’, the Jupiter Study is the topmost and the CRP study is the second from top.
I would think that most of your readers here would like to get the Eadesian take on CRP, what is it, how does it become elevated, why does it do damage, how can we prevent it and so on. I know you have touched upon CRP widely throughout the blog in relation to posts on inflammation, but maybe the time has come for an exclusive post on CRP and maybe you could take of in the Zacho-Nordestgaard study.
Incidentally, you misspelled Statin in the paragraph where you explain what Jupiter stands for … deja vu from Malcolm Kendrick’s famously misspelled chapter header in The Great Cholesterol Con, eh?
kr
Michael Kvetny
You’re right, I should do a post on CRP, especially since it’s going to be getting so much play thanks to Jupiter.
Nice catch on the Statin misspelling. I went back and changed it.
Cheers–
MRE
Great, I misspelled ‘know’ as ‘now’ in my second paragraph. So much for my proof reading skills ;-))
Don’t worry. I fixed it on the fly when I read your comment. I guess my own proofreading skills are better when applied to someone else’s work.
Dr Mike, another excellent post, rich in detail and worthy of several reads – and bookmarking for future reference (the hallmark of quality work)!
This story was covered heavily in the UK press and as soon as I saw the words ‘statin’ and ‘cholesterol’ on the front pages, I could have guessed at the infomercial that followed.
It is criminal that such shoddy journalism should pass for news. It raised a wry smile because I had this hunch that the miracle of Crestor was a new tux for the emperor. One thing that alerted me to this was the early stopping of the trial, particularly for a statin trial what with their chequered history – you see I adopt a similar approach when gambling! If ever I am up, I quit!
Your piece above (including the classic Eadsian “by God we’re going to prove that statins prevent something”), confirmed my suspicions in great detail.
Finally, I am not sure if I posted this before, but here is a useful free book to assist with navigating the mire of Clinical Research which your readers may find useful:
http://www.jameslindlibrary.org/pdf/testing-treatments.pdf
Regards,
Thanks for the little book in pdf. And thanks for the kind words.
Cheers–
MRE
How can the statinators get away with this stuff? Because it’s based on the age-old myth of cholesterol that most people accept without question.
You were the first thing I thought about when I heard this-“wait till Dr Mike sounds off” 🙂 🙂 Yes, they want to sell this stuff-they have too much $ invested in it. The minute I heard AstraZeneca did the study I laughed out loud.
According to Jenny Ruhl at http://diabetesupdate.blogspot.com/
“You need to also look at who was excluded from the study: Women taking hormone replacement therapy, people with any indicator of liver or kidney abnormality, people with high blood pressure, people with thyroid disease, people with autoimmune disease and people with a history of alcoholism or drug abuse.”
Why the exclusion of ‘normal’ people? Is it to reduce the amount of noise in the data or reduce the confounding variables, or to ensure the desired result has the best possible chance of coming through?
I suspect the latter. They did the same thing with the 4S study. They kept slicing and dicing the criteria for the study population until they finally came up with one in which statins showed some mild benefit, then called it a ‘smoking gun.’ It’s truly Orwellian.
Dr. Michael, Thank you.
In the past, I’ve always believed in any new ‘scientific’ study I passed upon, beliving it’s ‘science’, and you can not argue with it.
Being a following reader for months now, I’ve learned that things are actually very different from their shiny titles. This does not mean to dismiss everything or accusing all studies of fraud too, but I’m trying to follow my gut, which gets new experiences from articles like yours.
I’m not in the medicine field, I’m an engineer. Here’s what I’ve discovered so far, Medicine is really putting too much focus on treating diseases (*and* causing new diseases from such treatments) than finding the *original* causes. It really strikes me so hard that I find this mindset in a lot of doctors I speak with around. I may be utterly wrong or my sample is biased 😉
Why not instead of recommending a new medicine in public newspapers, recommend that people lift heavy weights(in strict and healthy form), do funny and interesting workouts (crossfit and the likes), minimize/zero their sugar and refined foods intake? .. I don’t understand.
Really the best way for living is to always enlighten your self by reading ‘responsible’ books and articles and their oppositions, get this sixth sense feeling of the fads, try things for different months and do your own , and hopefully informed, judgment.
Warm regards
I think organized medicine doesn’t recommend the obvious things that will improve health because a) they think no one will follow the recommendations, and b) there is no money in them.
Hi Dr Eades,
Jenny of Diabetes Update discovered another statistic which was obfuscated in the paper. In her words:
“In fact, though the way the data was reported was carefully arranged to obscure this finding, it appears that while there were indeed slightly less than half as many heart attacks within the group taking Crestor, there were more fatal heart attacks in the group taking Crestor.
“The way that this is reported is thus:
“Nonfatal myocardial infarction: Crestor 22 Placebo 62
“Any myocardial infarction: Crestor 31 Placebo 68
“Subtract “Nonfatal myocardial infarctions” from “Any myocardial infarctions” and you get Fatal Myocardial infarctions, a statistic which is NOT reported in the list of “end points.” But simple math gives us the information that there were 9 fatals in the Crestor group as opposed to 6 in the placebo group.
“Okay, so it looks like taking Crestor cut down the incidence of heart attack by 37 cases, but did not cut down on the deaths from heart attack. In fact, the proportion of heart attacks that were fatal in the Crestor group was 29% compared to the 9% that were fatal in the placebo group. Why is this not noted by the authors of the study? ”
http://diabetesupdate.blogspot.com/2008/11/should-you-be-taking-statin-what.html
Kudos to her for finding this gem.
Michael Richards
There are many, many intriguing elements and glitches in this study. If I had written about them all, the blog post would have gone on forever. I just wanted to hit the high spots.
They way Jenny and I and others have gone through this study is the way the entire scientific community should be going through it. It’s sad that they have abdicated their duty to rush off and worship at the alter of statins.
I thought the best summary I saw came from an Australian physician who said that 180 people would have to be treated for two years to prevent just one death. If that is indeed what would happen, I can see that the total number of deaths prevented by putting millions more people on statins (or maybe just Crestor) would be impressive. But the advantage for any single person would be very minimal.
That information was actually buried in the paper itself. I’ve seed estimates that given the price of Crestor it would cost about $500,000 per each cardiac death prevented. A pretty high price when you consider how cheap a good diet is in comparison.
I read this in the study:
“we did not include people with low levels of high-sensitivity C-reactive protein in our trial, since our hypothesis-generating analysis of high-sensitivity C-reactive protein in the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)12 showed extremely low event rates and no evidence that statin therapy lowered vascular risk among persons who had neither hyperlipidemia nor elevated high-sensitivity C-reactive protein levels. Thus, a trial of statin therapy involving people with both low cholesterol and low high-sensitivity C-reactive protein levels would have been not only infeasible in terms of statistical power and sample size but also highly unlikely to show a benefit.”
So does that mean they’re actually admitting that truly ‘healthy’ people don’t benefit from statins ?
Anne
Yup, that’s what they are admitting. I contemplated adding this to the post, but it was getting too long as it was. Thanks for bringing it up.
Thank you Dr. Eades. Your analysis is much appreciated and will be passed on. Did you catch that this post: http://high-fat-nutrition.blogspot.com/2008/11/cholesterol-heart-attacks-and-jupiter.html
It also seems to suggest much ado about nothing, in terms of statin benefits.
Thanks again.
Hyperlipid has another good take on this study. Too bad the bloggers have to do the job the scientific community should be doing.
Dr Mike, thanks so much for this post. I had wondered what the real study was about, it’s controls and it’s findings, when I heard the news reports. It was so contrary to all the previous findings we have been reading. So, once again, the conclusions mask the data and the news media have bought the hype and not the science. And I too, with you, feel sorry for all those patients who will be put on statins unnecessarily as a result of this study. Thanks again for this clarifying comment.
Dr. Eades,
I blogged about this at http://diabetesupdate.blogspot.com. In addition to many of the points you cite, I noticed that the “End Points” had been reported in a way that obscures what looks like a very significant finding: Though people taking Crestor had fewer heart attacks they had MORE FATAL HEART ATTACKS than those taking placebo.
Details in my blog.
I suspect that the Crestor/diabetes link may have something to do with it’s liver toxicity but that’s just a guess.
Hi Jenny–
Too bad we have to police the scientific community. In an ideal world they would be doing it themselves.
Cheers–
MRE
From the chart, it looks like the difference in death rates narrowed a few months ago, and then the very moment it widened again, they stopped the study. They’re probably sorry they didn’t stop it half a year ago when the difference was widest. A crossover could have seriously hurt someone’s bottom line. I guess we shouldn’t be surprised; raping and pillaging have been pretty popular pastimes (ooh, look at all those p’s) through most of human history.
Yep. I suspect that’s one of the motivators (if not the primary motivator) for this study to be stopped.
Take a look at that compressed curve. They stopped the study just as the treatment and placebo groups were about to meet again!
We just booted HS-CRP out of our lab last month- not enough demand. Sent it out to a reference lab because we were losing money on it. Hmmmmmmm, maybe we should have waited a month or two?
Yep, you’ll probably have a rush of orders now. Then you’ll see how unusual it really is for someone to have normal LDL-cholesterol levels AND a markedly elevated hs-CRP.
http://junkfoodscience.blogspot.com/2008/11/when-news-sounds-too-good-statins-new.html
Highly recommend this write up too.
Thanks. Yet another take. And another blogger doing what should have been done by the scientists involved.
When I first read the headlines declaring that statins are, once again, the great life savers of the drug world, I immediately thought, “This is just another way for the drug companies to sell more statins, thus making a whole lot more money, at the expense of totally clueless people who never question the decisions of their doctors, who probably are also making a ton of dough from pushing the drugs.”
I’m sure I’ve read somewhere that eating low carb will help reduce levels of c-reactive protein. I just haven’t had the time to research it. I might have even read it here on your blog.
According to all the news hype, everyone “knows” that eating low carb will kill you, but taking an expensive pill each day is sure to save your life. Makes you want to quit reading the news.
A number of studies have shown that eating a low-carb diet will reduce C-reactive protein. As well as a number of supplements, all of which cost way less than $3.50 per day.
Absolutely unbelievable. They will quit at NOTHING to push those horribly dangerous pills. It’s criminal. Thanks SO much for all you do to keep us educated and for your tireless quest for truth in the midst of so much deception and greed. Hippocrates must be spinning in his grave these days…
Great review Dr. Mike. I’ve been eagerly awaiting your take on this study. I did wonder about the early termination of the study, but really couldn’t put it in context as you have. Also, I completely missed the inclusion of a higher proportion of patients with family history of CHD and metabolic syndrome in the placebo group.
Great post.
Sandy Szwarc at Junkfood Science has another excellent analysis:
http://junkfoodscience.blogspot.com/2008/11/when-news-sounds-too-good-statins-new.html
Dr. Eades: Thank you for your work to continue to enlighten us ‘normal folks’ about the true story behind these studies and news releases. I have learned so much from reading your blog and I can’t thank you enough for doing this!
I’m glad you’ve enjoyed the blog. And found it enlightening.
Yet another example of the one thing standard statistical analyses are good for: obfuscating the actual results in apparent favor of a predetermined outcome. What we need is a new “watchdog” group, the Probability Police, who re-evaluate and report on such scientific results using rigorous and consistent mathematics applied to a relevant hypothesis, ensuring an accounting for ALL of the relevant information.
In the JUPITER case, perhaps our relevant hypothesis would be “Treatment with Crestor extends life by one year or greater.” The proper analysis would yield a probability for this hypothesis, accounting for all of the info, including differences in treatment/placebo group parameters (e.g. family history of CHD) and the fact that the treatment group developed more diabetes. This probability can then be used to make a decision about whether to take Crestor, e.g. in the simplest decision model, the value of that extra year of life should be worth the cost of Crestor divided by the probability you’ll live that extra year. If the probability is 0.01 percent (which might be generous given Dr. Mike’s analysis), the value of the extra year must be greater than $1300/0.0001, or $13 million, because paying a guaranteed $1300 for a 0.01% percent chance of an extra year is equivalent to paying $13 million for a guaranteed extra year. A better model would account for the negative value of side effects, etc.
Unfortunately, establishment of the Probability Police only benefits the public, not those who have the money to actually fund such an organization, so I’m not holding my breath . . .
Nice analysis, Dave. The Probability Police. Nice. Maybe that can become my new expletive of exasperation when reading about such as the Jupiter study. The Probability Police wept.
Cheers–
M
When they first looked at Folic Acid supplementation to prevent birth defects, didn’t they stop that study mid-term because it was being so dramatically successful? I don’t think this Jupiter study compares to those results, it just is a precedent for stopping a study do to success that comes to mind.
I still wonder why they could get away with stopping a successful study. I could see releasing interim results recommending the protocol being studied, but shouldn’t they keep on studying the results anyway to make sure there aren’t any surprise developments?
I would expect the scientific community to insist on that. But maybe I just have high expectations.
Sadly, your expectations are way too high. Especially when you consider all the money at stake. Think of the difference in dollars from a study showing no benefit to statins and one showing a benefit. Makes it pretty easy to see why the drug companies and statinators would like to quit while ahead.
Thanks Mike. I had wondered about them stopping the test so soon – I kind of suspected that the reason was that they had good news NOW! Two years into the study really doesn’t fully evaluate the benefits or dangers. What’s really scary is the way they have extrapolated the benefit to the general population……
Re: The media on the election
Re: The media on the benefits of statins
I used to consider myself a free marketeer, but things are getting ugly. Let’s face it: corporations own the media, and they report only what’s good for themselves.
Come to think of it, I still consider myself a free marketeer. Alas, we live in a world run by corpo-government.
You wrote:
Hmmm. Obama has avowed publicly that he wants to increase the capital gains tax, increase the corporate tax, and redistribute wealth in general – all things that are bad for corporations. Corporations own and run the media. The media was vastly pro-Obama. (They are all coming out now, after the dust has settled, and saying, yeah, looking back on it, I guess we were way pro-Obama and anti-McCain. Oops. Sorry. (Here is the Washington Post’s mea culpa; others were even worse.) ) So, corporations promote Obama, and Obama is bad for corporations. It makes one wonder, doesn’t it?
That was a great interpretation of the the study and the reasons for the outcome.
I just wish more people would open their eyes and realise what is happening in reality and not what they are being told by some highly paid company lapdog. The truth of the matter is that while these lapdogs are getting people to believe in their magic pills, so many unsuspecting patients are getting various symptoms that they cannot find the cause of. Most Dr s don’t even know or believe that statins can and do cause the vast majority of those symptoms and why, because of those stupid lapdogs playing down the problems as rare or mild or even non existent.
I think the worst of the lapdog situation is that they get away with the false information and misleading that they are getting paid for, while thousands of people become permanently damaged and may never work again and their quality of life will be extremely poor and their health still continues to deteriorates even after cessation of the poison.
Please keep your blog going with honest open eyed opinions and facts as above and if you happen to come across one of those lapdogs please give it a pat on the head (preferably with a baseball bat) and tell it to stop defecating on everyone who is not on the payroll.
Allen.
Holy crap, Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin?!? I’m always amazed by the creativity of Americans in coming up with these acronyms. Of course you refer to your own country as an acronym. Anyway… 🙂
Is it just me or would this study (as reported) kinda clear cholesterol as a major risk factor for heart disease? Obviously the statin “saved” these participants through another mechanism than cholesterol reduction. Inflammation would be the most likely culprit here.
Or would they presume that had these participants had high cholesterol too the benefits of the statin would have been even greater?
Yeah, the name of the study is positively Orwellian. In fact, I doubt that Orwell could have come up with one so brilliant.
The study does pretty much clear cholesterol as a major risk factor. And almost admits as much.
This study does show a more significant benficial effect than the studies focused on high cholesterol, doesn’t it? Don’t the results of this study, then, argue that the beneficial effects of statins have nothing to do with cholesterol-lowering?
Indeed it does.
Leave it to a drug-company study to try and prove a money-making hypothesis right instead of testing a null hypothesis (that the statin wouldn’t make a difference).
Interesting how the increase in diabetes was reportedly “small, though significant” and
“could reflect the play of chance, further study is needed”, only the study was halted before it could go an further.
Doc, when they say that the “reports of diabetes were not adjudicated by the end-point committee” does that mean that those who called the study to a halt didn’t know about the increase in physician-reported diabetes in the treatment group? Or does it mean that the study wasn’t halted due to that emerging effect? Wouldn’t an increase in treatment-group diabetes be germane to those looking in on the study, especially if it was statistically significant?
It would indeed be germane. I just don’t know how much of a role that played in stopping the study. I suspect it was stopped because they were ahead of the game and worried that their luck wouldn’t last. Think of the difference in dollars if this study had been a bust versus having it show a positive effect. There would be huge financial motivation to quit while ahead.
Thank you so much Dr. M. for your post.
This was one of the main news stories on the BBC yesterday (I live in England) and I sensed things were so obviously wrong with this trial, but had a problem searching for and identifying the information that I wanted.
In the same news bulletin, an item on how the internet was encouraging people to use
-unproven- remedies. You couldnt make it up!
Thank you for your clarifications and the time this must have taken you to do it so swiftly.
Dr. Eades,
I actually did a review of this protocol before the trial started. I think the overall take you have is correct (interesting trial but very small absolute differences).
On stopping the trial early, it’s not a new technique — people have been working on statistical methodologies for this for a while. I don’t remember the details for this protocol, but typically, the stopping boundaries are assessed blinded, and you take a hit on statistical power to do an early stop.
The most significant thing about this trial, in my opinion, is the degree to which it calls in question the lipid hypothesis. Here are a group of patients who got clinical benefit despite starting with lipid levels supposedly consistent with a low level of cardiac risk. Is the main benefit of statins their power to reduce lipids, or their power to decrease inflammation?
If so, are their simpler, less costly, safer ways of reducing systemic inflammation? Such as, perhaps, reducing sugars and high glycemic sources of carbohydrate, and taking fish oil? Maybe a bit of exercise on top of that? (Note the high carb/med diet/low carb trial reported in NEJM a few months back showed a significant reduction in CRP for the low carb group).
I agree that the trial really does undermine the lipid hypothesis. But this isn’t the first time. I think most people in the field recognize that the benefits of statins (such as they are) are what are referred to constantly as pleiotripic, which, as I’m sure you know, is a fancy (scientific sounding) way of saying producing more than one effect. Early on I think it was realized that whatever benefits statins provided were not particularly correlated to their ability to lower lipids. And, in recent years, the lipid hypothesis has been taking a pounding as more people are looking to the inflammatory hypothesis of heart disease as being closer to the mark. Since statins are the drugs with the highest sales worldwide bringing billions into the coffers of the pharmaceutical industry, I suspect this study was done in an attempt to generate another risk factor involving inflammation that can be exploited for increased statin sales. Elevated cholesterol isn’t a disease, but has been elevated to that status by the Big Pharma. I think the same is in store for elevated CRP, which really is nothing but a marker for inflammation.
“Obama has avowed publicly that he wants to increase the capital gains tax, increase the corporate tax, and redistribute wealth in general … ”
Grossly off-topic, of course, but this was pure demagoguery. He didn’t get those $600 MM from intertubez donors at 5 bucks a pop.
We’ll have to see what happens, unfortunately. My guess is that any corporations that get taxed to hellandgone will get some kind of quid pro quo, likely in the form of favorable regulations. And why not? Hey! Statins are good for ya! That’ll bring on wealth redistribution, all right–from our pockets to theirs.
You wrote re Obama’s promises:
My point precisely. Although now that it’s over and the markets have cratered, I suspect that the corporations that funded him may be having second thoughts.
And taking as a given that high inflammation is a marker for something detrimental, surely the question they should be asking is ‘What causes the high inflammation?’ rather than ‘What expensive drug will reduce the marker for inflammation?’
Precisely. And they should be asking how inflammation can be reduced by using something less expensive and less fraught with dreadful side effects than a drug that costs $3.50 per day.
The book OVERDOSED suggested in general that most drugs could be effective at FAR lower doses than are generally prescribed. He also explained the reason for it, and the main one seemed to be that doctors do not have the/want to spend the time to properly titrate dosages. From a patient point of view if the drug companies are not willing to address this problem and do the studies us increasingly drug phobic folks are going to drop increasingly large numbers of drugs.
I agree. Generics are also infinitely less expensive, but they make less money for the drug companies. So Big Pharma is always coming out with newer versions that are much more expensive but not particularly more effective. This is why people need to take more control of their own health. They need to read and be aware so that they don’t get hoodwinked. Sadly, for the most part, the doctors have already been hoodwinked, so they can’t help.
Even Dr. McDougall took this study to task for being misleading: http://www.drmcdougall.com/misc/2008other/news081110crestor.html calling it “Advertising being passed off as research”.
As I live and breathe… And I never thought McDougall and I would ever see eye to eye on anything.
Thanks so much for a sensible take on a sensationalised story!
I think, considering how good statins are for us, that a law should be passed making consumption of statins mandatory for every citizen from birth to death. That would really save us all from heart disease. Maybe I had better shut up before our now Democrat-majority Congress and our knight on a white horse President-elect, with their “government will take care of you” mentality, get any ideas. Actually, what does scare me is the thought of a national health-care system being billed to cover all these statin prescriptions and high-end heart procedures, etc. I think I remember reading somewhere that medical care not uncoincidentally got very expensive concomitant with the availability of health insurance. How high will taxes go in order to cover everyone entitled to “free” nationalized health care, including all these useless statin prescriptions? Insurance seems like such a good, compassionate idea, but greed has perverted it, and you can bet greed is going to open its slobbering maw even wider if the perception is that it’s all “free” from the government. So horrifying, when you consider that the more people go on statins, the sicker the population is going to be.
God bless you for taking the time to expose the flaws in all these bogus studies.
Thanks for the kind words, but I fear it is going to take a lot more than my scribblings to get us out of this mess.
A really great read. Thanks Doc.
You know, I can’t help but think that it’s a crying shame this information –your blog– is limited to the audience scope that it is. It’s primarily, I suspect, preaching to the converted. My first thought was that I hope some of these talented and appropriately educated and authoritative experts (such as yourself) who blog on important topics like this, actually hold the media’s feet to the fire by writing letters to the editors of those publications pointing out the failings of their journalistic competence.
If nobody complains when they take the easy way out and simply publish pharmaceutical industry press releases, and assume them to be factual and fair or just don’t care if they are either, then why bother hiring journalists when the receptionist can transcribe the press release for them between answering calls. It’s a sad state of affairs.
I appreciate the education you provide.
Sadly, Todd, that’s what the ‘journalists’ often do: they simply transcribe. Take a look at the AP release on this study, then look at all the various media outlets that reported it. The vast majority made up their own headline (if they did anything) and simply copied the release verbatim and put it out under some reporter’s byline as if it were written by him/her. Pitiful.
You had a post some time ago in which you described being at a medical conference and some guy was presenting on how L-Arginine reduces inflammation as well as statins, and that was when he realized that it was inflammation that statins helped with….(well, that’s when I started taking L-argenine,) but I can’t find the post, and I want to send to folks who are all agog about this statin news.
Can you send us a new link to it?
I can. Here it is.
Since seeing that article in my local paper, I’ve been checking your blog daily, waiting for the commentary. Thanks for a great read and all the work you put into it. That study title is just plain silly.
It’s more than silly. It’s Orwellian.
Why is it that the raw data is never released? I suspect it’s considered proprietary, but what about publicly funded (as via NIH) studies?
I’ll note that the comments at NEJM are mostly negative:
http://www.nejm.org/clinical-directions/jupiter-statins-trial/
I also have to say that I’m among those who, after reading the recent reports on Jupiter, though, “I wonder what Dr. Eades has to say about this”. Like a reflex 🙂
I think raw data should be released. That’s one of the things I like about the journal Nutrition&Metabolism – it almost always makes the data available.
I wonder what would have happened if they had a third high CRP group that was treated with a nutritious low-carb diet that minimized sugar and polyunsaturated fat? Maybe fewer deaths than the statin group? I think Barry Groves is right about trick and treat!
I suspect you would be correct about the survival of those in that third group.
What Todd said… I was just reading today in Beautiful Evidence, by the Edward Tufte, who writes on truth in evidence (specially those graphs!) that just as presenting evidence is a moral act, so is receiving it. (An article about Tufte: http://nymag.com/arts/books/features/33156/)
If we all call and email BS!! (or bushwa!!!) to the editors and authors, that will at least make us feel better. And we will have done a civic duty.
I’m a big fan of Tufte’s. Been to his conference. Have all his books (and even his mother’s book).
This just came across the medical research ticker a few minutes ago. I suppose this press release will die a silent death in the in-boxes of the big publications. But at least it’s heartwarming to see some scientific interest in all the anecdotal stuff we hear about. They (MSU) should take a tip from the Obama campaign and put a Donate button on their department home page.
“A Michigan State University researcher is studying whether the most popular class of cholesterol-lowering drugs may cause muscle problems in users. There is accumulating evidence that the effect statins can have on skeletal muscle– including muscle weakness, fatigue and deterioration– is underestimated, said Jill Slade, assistant professor of radiology and osteopathic manipulative medicine at MSU.”
I’d like to see this study when (and if) it comes out. According to the reported side effects in the Jupiter study, one would think that statins don’t cause any more side effects than placebo. Hmmm.
A 25 percent increase in diabetes??!! No wonder they stopped the study! Over time, the diabetes will kill more people than the drug could possibly save.
By the way, to those who are wondering why big corporations would support a statist for president, it’s important to remember that free marketers are not pro-business — we’re pro-freedom — and business leaders are not necessarily fans of the free market. There’s no shortage of businesses willing to suckle on the government boob or use government regulations to stifle competition.
When Thomas Sowell was still a professor of economics, he offered an automatic “A” grade to any student who could find a single positive remark about businessmen in Adam Smith’s “The Wealth of Nations.” No student ever cashed in. Smith believed merchants were self-interested, period. His point was that if government stays out of the picture, self-interest leads to competition and higher productivity, and thus produces more positive effects than negative. (Every economic system produces some negative outcomes.)
The real danger, as Smith explained, is when self-interested businessmen cross paths with self-interested government officials. Then you end up with goofy regulations or tariffs that benefit a particular business at everyone else’s expense –or a National Cholesterol Education Program that declares everyone’s cholesterol should be below 200, thus ensuring a huge market for statins.
Hey Tom–
I like P.J. O’Rourke’s recent definition of the free market in a rant of his:
M
http://content.nejm.org/cgi/content/full/NEJMe0808320
Here is the accompanying editorial in NEJM. It was more balanced than I expected.
It was indeed more balanced than I expected as well.
Your blog is wonderfully informative, enlightening, and valuable to several debates. And I agree that it’s your blog and you can say anything you want. Somehow, however, bringing presidential politics into your discussion creates noise that detracts from the health and research messages I believe you’re trying to get out there.
I didn’t realize I brought presidential politics into this post.
It took some slogging through the paeons of unconsidered praise, but I finally found your excellent analysis. I have taken the liberty of using some excerpts in my next newsletter, with full acknowledgment and a link. Thank you!
Be my guest.
Thanks, Dr. Mike, for enlightening us once again. I wonder if you realize how essential you’ve become to your followers?
I’m glad I can be of help. Thanks.
Dr Mike,
Does there exist any “independent”, un-biased and objective studies of the performance of statin drugs? I suspect there are, but they are not publicized as the stories are not “hot” enough.
The garbage in this study looks like marketing dressed up as science.
Love your blog!
Regards
David
Yes, there are the studies I discuss in this post. There aren’t many, however.
Dr. Mike said: “I think organized medicine doesn’t recommend the obvious things that will improve health because a) they think no one will follow the recommendations, and b) there is no money in them.”
I would have to agree with both of these. As a beginning medical writer, I have actually written needs assessment in the past detailing why doctors shouldn’t trust their patients about medication use (among other things) and why we need to educate doctors about how to get patients to take their meds. Blegh. This “needs assessment” is then used to get pharma to fund an educational product that… you guessed it… educates doctors about how to medicate their patients more and get their patients to more consistently take meds. Of course, the project will be more likely to be funded by pharma (due to fear of the government) if it is a needs assessment that relies heavily on government sources of information, since we all know that a government source like the FDA or the CDC is the fountain of truth!!
I hope you can sense my sarcasm coming through?
I am not against meds when necessary but it is becoming more and more apparent to me in my readings (here and elsewhere) that many of the solutions to our health problems are deceptively simple and medical science could be so much farther along than it is if we were spending time and money on the right things. Instead of trying to implicate fat and glorify statins, we could most of us be on low carb diets and the millions which have been picked from our pockets for the past 5 decades in a forever vain attempt to “prove” things long discredited would instead have been spent on research to help us live 120 years or longer…
Oy.
I have a third proposition, Dr. Mike, and it is something you have mentioned before in passing with reference to the American Pediatrics Assoc. guidelines… Could it be that organized medicine doesn’t recommend the obvious because it could make the doctor more subject to a lawsuit? Do they perceive advocating low carb diets as a potential threat to their career because of current professional guidelines and/or government regulations?
I know comments are closed but I have saved and can repost later. I’d like your thoughts on that last one.
There is some truth to the idea that doctors, especially pediatricians, try to stick to their academy guidelines because if they do, they are pretty much immune to lawsuits. But a lot of doctors don’t not recommend low-carb diets because they’re worried about getting sued – most don’t recommend them because they don’t know much about them and don’t want to take the time to learn. They’ll spend thousands of dollars to go to a conference somewhere to learn the latest drug therapy or the latest surgical procedure, but won’t spend the couple of hours it takes to get enlightened about nutrition. If you ask them what they know about nutrition, they will often say (and I’ve actually heard this countless times) ‘If you want to lose weight, quit eating so much and start exercising.’
What is truly outrageous and deeply disturbing is that the Jupiter study, which implies that statins will benefit anyone who is still breathing, has been the headline story for days now in every form of media, at least here in Canada. Even more disturbing is the concurrent sideshow of feature stories reporting that such things as vitamins and anything other than statins are worthless in preventing heart attacks.
The current promotion of statins pretty much guarantees that any and everyone who goes to their MD for any reason will end up with a prescription for statins based on the “at the worst statins won’t do any harm and will probably do a lot of good” premise. Meantime MDs will continue to ignore obvious things that can cause huge health problems like magnesium deficiency or excess iron storage because there are no blockbuster drugs to treat them.
I think your last paragraph nicely sums up the strategy of the companies promoting the drugs. Sad.
Dr. Eades,
Although I wish there were a “Dr. Eades Health Eating for Dummies” book to interpret some of the details for this old granny, I DO so appreciate your information – what I understand, at least. LOL )
I had just finished reading your Jupiter Study blog when my 47 year old daughter called to tell me that she was told yesterday by her internist that blood work shows she is “pre-diabetic” (overweight, too). She has been given three months to turn it around “or she’ll go on drugs”, and was told to cut down on SUGARS and FATS. (No intent to get your personal medical advice here at all – just clarifying the truth versus hype issue.)
Reading your blogs over time makes me skeptical of any general advice like she received. In order to help her, I did some research today on the web and found a ridiculous variety of nutritional advice. There was also an article quoting the ACCORD study – (It, too ended early). The article at
http://www.everydayhealth.com/diabetes-awareness/type-2-diabetes-and-heart-disease.aspx
quotes Dr. Angatston: “The researchers actually had to stop the study because those people with lower A1C levels died more often than those who had the standard care. This result was the opposite of all the conventional wisdom and the current guidelines — which basically say that the closer we can get A1Cs to the normal range, the better.… What is becoming clear is that the COMPLICATIONS ASSOCIATED WITH TYPE 2 DIABETES ARE MUCH MORE RELATED TO ABNORMAL LIPIDS (BLOOD FATS) THAN TO MODERATELY ELEVATED BLOOD SUGARS.” He does go on to say that it’s the quality, not the quantity of fat, carbs and protein that matters in healthy eating, which doe seem to make perfect sense. Am I mis-understanding his comments that the supposed study again blamed fats for the problem of diabetes, rather than sugars?
I couldn’t find any info on the ACCORD study when I did a search within your blogs, so just wondered if this is the “same old, same old”.
Thanks so much for your continued efforts to enlighten everyone, (including us laypeople), with regard to healthy eating and the untruths being perpetuated in the drug and medical community. You are a blessing!
Corky
I absolutely do not believe that the COMPLICATIONS ASSOCIATED WITH TYPE 2 DIABETES ARE MUCH MORE RELATED TO ABNORMAL LIPIDS (BLOOD FATS) THAN TO MODERATELY ELEVATED BLOOD SUGARS. I believe that is total nonsense. The elevated sugar levels are much worse. Read here.
I did do a post on the ACCORD study.
I knew the study was bunk when they stopped it early.
You stop a study early because the intervention is killing people. You don’t stop a study because the intervention is saving people, because you want the data on long-term safety.
Or I guess maybe you don’t. (This is obviously the “rhetorical you,” not you-Dr.-Eades!)
Most of us are not intervened upon; the placebo group was not facing any additional risk than they would in normal lives. While I can see the point doing this if dramatic results are shown for treating a life-threatening, acute problem (this cures cancer in some people! or something like that), stopping an intervention study on supposedly healthy normal people means they don’t know what the hell they’re doing. (Or rather, that they know exactly what they’re doing, but it’s not what they claim.)
I think (I won’t say “agree” because you hedged that very politely) that they got out while the gettin’ was good. Even if one takes the conclusions at newspaper-headline value, the increased rate of diabetes (which works rather more slowly than heart attacks) suggests that the long-term data might be problematic.
Hello Dr. Eades: And i agree, the mainstream media is too biased in favor of drug companies. I have an off topic question. In your book and in your articles you stated the importance of weight-training exercises, but not so much the aerobic exercises. Is it possible to lose weight without doing any aerobic exercises, and only with anaerobic exercises (Weight training)? And how come you don’t think it’s important to do aerobic cardiovascular exercises?
I do think it’s possible to lose weight without doing aerobic exercise. I wrote an entire book on why. It’s called Slow Burn, and you can get it most anywhere books are sold.
Wonder if you have any thoughts on the following:
“The National Cancer Institute has halted the testing of vitamin E and selenium for preventing prostate cancer after early trial results showed that the supplements not only didn’t help but might actually cause harm.”
http://blogs.consumerreports.org/health/2008/11/vitamin-e-prost.html?EXTKEY=
I haven’t seen the actual data from this study, so I can’t comment intelligently. I
am certainwould bet they used an intention to treat analysis, which makes all such studies suspect to me.What looks like even more bunk science:
http://www.sciam.com/podcast/episode.cfm?id=pregnant-moms-who-chew-fat-pass-on-08-11-13
Pitiful.
Total drek. And dishonest, too. Look at the headline: Pregnant Moms who Chew Fat Pass on Habit. It’s not ’til you read down that you discover that the pregnant moms were rats.
Morning Edition on National Public Radio did a disgusting, fawning piece on the study this morning. It made me so mad I was yelling at the radio. My 3yo daughter in the back seat was pretty confused. They had doctors repeatedly say, on the air, things like how they would put pretty much anyone over 50 on statins now. They interpreted the result as “you can have low cholesterol, and still get a heart attack, and statins will cut your risk in half!” Absolutely not a single critical question in the entire piece, it was a pure puff job for idiot doctors and Astra Zeneca.
in response to low-carber’s question re: weight training in lieu of aerobics…i pigheadedly continued massive amounts of aerobics with minimal if any weight training and watched my weight loss stall considerably. three weeks ago i stopped aerobics completely (other than my daily lunch hour stroll around nyc) and focused on weight training. today i’m down 11 pounds from when i started! not sure if anything else is at play here but the switch to weight training was the only change i made. amazing stuff happens when you stop being pigheaded!
It may be too late for this, but could you ask Gary Taubes to weigh in on the Jupiter study when he answers the other questions?
I did ask him. He hadn’t read about it yet.
NPR seems to have bought into all the hype, from what I heard this morning…disappointing.
The Jupiter Study – how sad… how very sad. Yet how great to see so many enlightened readers! Thanks, Dr. Eades, for another opportunity to spread the word. Buyer, beware. “Insured,” take care. Think. Since when do side-effects become obsolete? How absolutely irresponsible! First, do no harm… hmmmmm… When will the ‘medical professionals’ learn the difference between true “prevention” and “treatment?” Isn’t it time for them to stop dealing with “disease-care” and take a serious look at “health care?” Many years ago, my husband and I decided to find alternative answers that have become our “health insurance.” We DO have choices. We can choose to read between the lines, find the flaws, share the information, and make the best possible personal decisions – hoping to help others along the way.
I was looking over your http://www.mreades.wpengine.com/drmike/statins/statin-panic/ post and I wonder something. If a person once smoked, say for 20 years, and quit, say 14 years ago how much would that affect risk? How long after quitting does it start to make a big difference?
The short answer is that I don’t know. Data seems to be all over the place with some showing that 10 years after smoking cessation heart disease risk is the same as if one never smoked. Other data indicates that any history of smoking increases risk for heart disease irrespective of how long it’s been since one quit. My own hunch is that the longer one has quit, the lower the risk.
This is a good one. Apparently Colbert can get some things right:
http://www.sciam.com/blog/60-second-science/post.cfm?id=stephen-colbert-for-fda-commissione-2008-11-13
The part on Crestor is priceless.
I heard about this study earlier this week while listening to public radio (Minnesota pr, to be exact). Unless I’m totally losing it, I swear they stated that the doctor leading this study also happen to have the patent on the test needed to determine who should be getting the statin. since they are suggesting that people with seemly no symptoms be treated, it would mean hundreds/thousands of additional tests ordered (or requested) to see who actually had the elevated c reactive protein level. MPR reported that the dr stated that this connection did not taint the results and have nothing to do with his enthusiasm. Any thoughts?
He does indeed have a patent on the test, but I don’t think this study is all his doing in an effort to sell more of the tests. It’s an effort on the part of statin makers to come up with any reason possible to frighten people with normal cholesterol levels into taking their drugs.
Dr Mike,
Thanks for writing this one and it serves as an eye opener for us.
As I have mentioned in the past, Jan 08 my CRP was 12.0 and I started Low carbing this June 1st week 2008. I tested CRP on July 23rd 2008, my CRP was <1. My Dr was shocked to see and he was speechless when he saw the result. In Jan 2008, he almost pushed statins in my throat and I refused to take more medicines to “cure” the problems I had.
Thanks for your service once again..
Thanks
Venkat
I’m glad you resisted the pressure.
My favorite quote from the news reporting: “Scientists said the research could provide clues on how to address a long-confounding statistic: that half of heart attacks and strokes occur in people without high cholesterol.” Umm…doesn’t that mean that cholesterol pretty much can’t be the causative factor in heart disease?
Yep.
By the way, I hope you-all are safe.
I’ve been watching the fires on TV news.
Thanks. We’re safe and sound.
An unrelated question: I just had my physical, after eating low-carb fairly consistently for a year, and my doc found some blood in my stool. Given my family history, age, etc., he thinks it is most likely due to the high amount of rare meat in my diet. But just to be sure, I have to go through an annoying couple weeks of changing my diet and doing some more hemascreens.
My question is, is this common among low-carbers? Am I going to have to go through this every year? (Of course, it is better than the alternative.)
Thanks.
In my experience with patients on low-carb diets – which is considerable – I’ve never seen this happen. Knowing how the hemocult test works, though, would lead me to believe it could happen. I’ve been on a low-carb diet for years and so has MD, but neither of us has ever had a positive hemocult test. And we eat a lot of carpaccio and steak tartare, which are both raw meat, which is as rare as it gets. Let me know what happens after you switch your diet and get retested.
Dr. Mike, I hope all is well with you and MD with the fires in your area.
We are safe, and our house is still standing unharmed.
Have there been any RCT low carb studies with statistical power that have mortality endpoints (both all-cause & cardiac related)? This would seem to be a good antidote for the way JUPITER is about to be leveraged.
No such studies with mortality endpoints and there probably won’t be – at least not in humans. It would be too difficult to randomize people to diets and expect them to stick with them long enough to provide reliable evidence.
You had once written about a study showing that Statins could increase Vitamin D. could that possibly be the mechanism by which it reduces inflammation (if it did)?
Rabbi Hirsch Meisels
Jewish Friends With Diabetes International
http://www.FriendsWithDiabetes.org
It’s possible, but it probably works more by increasing the production of nitric oxide.
Hi Dr. Mike,
FYI…. I found this to be interesting today.
http://www.boston.com/news/health/articles/2008/11/17/options_beyond_statins/
Dear Dr Mike,
It appears that journalists have a short memory.
Only four year ago, Dr. David Graham, associate director in the FDA’s Office of Drug Safety gave senate testimony that Crestor was one of five drugs with safety concerns. The drug causes muscle breakdown and renal failure.
To read more…
http://jeffreydach.com/2008/11/14/crestor-jupitor-crp-and-heart-attack–by-jefffrey-dach-md.aspx
Hi Jeffrey–
Thanks for the link. Nice post.
Mike
Dear Dr Mike,
It appears that journalists have a short memory.
Only four year ago, Dr. David Graham, associate director in the FDA’s Office of Drug Safety gave senate testimony that Crestor was one of five drugs with safety concerns. The drug causes muscle breakdown and renal failure.
To read more…
http://jeffreydach.com/2008/11/14/crestor-jupitor-crp-and-heart-attack–by-jefffrey-dach-md.aspx
Hi Jeffrey–
Thanks for the link. Nice post.
Mike
Good post. Glad to see some clear thinking. I like this post too from The People’s Chemist.com:
JUPITER Study highlights Four Reasons to Say No To Crestor
November 30th, 2008
There’s been a deep lying suspicion that a deliberate push to get each and every American hooked on drugs, while at the same time bankrupting them, exists among Big Pharma, the U.S. government and the popular media. But now, a new study confirms this suspicion as fact. It’s the JUPITER study.
JUPITER stands for Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin. It’s not a clinical trial. It’s a rouse to promote drugs as vitamins. Dr. Timothy J. Gardner, president of the American Heart Association, was so excited by it that he insisted, “this one [JUPITER] is pretty clearly a winner for statin therapy.”
The New York Times gave us the infomercial, scripted response of, “Taking the statin Crestor, also known as rosuvastatin, slashed the risk of heart attack by more than half according to the JUPITER results.” But if you believe this, then you’re already on too many drugs.
Big Pharma money can be intoxicating. Like a frat boy with beer goggles, few health professionals or popular media outlets could see the ugly truth. Four important points of the JUPITER rouse were missed, which serve as four reasons to avoid Crestor.
The media failed to mention that Crestor makers – AstraZeneca – funded the study. When a company pays for a study, they pay for the interpretation of results, which always involves statistical trickery. Most of us learned this with the heart attack inducing, pain killer Vioxx. Touted as the safest NSAID of all time, it proved to be the deadliest once unleashed with the rubber stamp approval of the Food and Drug Administration (FDA) – it snuffed out an estimated 40,000 lives, fast. Its’ wake of destruction still resonates within Americans, but apparently not with the media.
The media failed to mention the statistical trickery at work. Cardiovascular events were reduced by an absolute, paltry 0.9% with Crestor use. Using a few tricks of the statistics trade, this bland number was converted into the more lucrative, “relative risk reduction” of 53%. This trickery happens so fast, it’s like watching magician David Blaine pull his heart out of his chest. You don’t know if it’s real or just a cheap magic trick. Dr. Mark Hlatky of Stanford shows that it’s just a trick.
Commenting on the trickery, he told the New England Journal of Medicine that, “absolute differences in risk are more clinically important than relative reductions in risk in deciding whether to recommend drug therapy, since the absolute benefits of treatment must be large enough to justify the associated risks and costs.” But, using statistical sleight of hand helps AstraZeneca make some serious cash.
The media failed to mention that it would cost bookoo bucks to follow JUPITER’s recommended Crestor protocol. The drug giant stands to pocket an estimated $500,000 per patient, courtesy of their insurance company, if the drug is used as recommended by the study – over a patient’s lifetime.
And finally, the media failed to mention that Crestor users risk the particularly, nasty side effect of liver failure, rhabdomyolysis, diabetes and more. If you really needed another one, that’s the fourth reason to say no to Crestor: It’s a seriously expensive way to get sick.
Falsely promoting ineffective and dangerous drugs, while pillaging bank accounts, is illegal. Street thugs go to jail every day for it. If the JUPITER rouse is to be condoned by the federal government and supported by the media, then there is no need for the FDA since Big Pharma can violate the laws with predatory prescription hype disguised as science. Say no to Crestor and all the other cholesterol-lowering drugs. Otherwise, face the outcomes of government mandated drug addiction.
Loved the first two sentences of the last paragraph. Thanks for sending.
Dr Mike
What relationship does CRP have with MBP, and the effects?
You’ll have to clue me in. I don’t know what MBP is.
The study was stopped because of an overwhelming benefit (i.e. not ethical to continue). Anyone who is involved in basic or clinical research knows about a DSMB (Data Safety and Monitoring Board) For those skeptics, this board is INDEPENDENT of those involved in the trial. They are required to ask to stop the trial for harm OR benefit.
I agree that the absolute risk is not impressive, but to completely dismiss this study is as ridiculous as the hype it has received.
Argue the merits: 40% had metabolic syndrome (not low risk).
Of course you exclude those on HRT, hypothyroid, liver dysfunction and kidney dysfunction. You are eliminating confounding factors (things that make it difficult to figure out why someone died or had an adverse event.)
In the studies looking at folic acid in pregnancy referenced in previous post, would you include or exclude mom’s who took crack cocaine? Exclude them! They are not the population you are looking at.
Mike, while I respect your right to an opinion, if you are going to claim to be scientific than please also be academically honest and don’t mislead those who do not know better.
Paul Ridker actually expected the DSMB to call him telling him that the side effects were too high; not that there was a margin of benefit outside of those set BEFORE the trial is conducted.
Cholesterol is not the only answer. Inflammation clearly plays a role. But, without the cholesterol forming foam cells and yellow gook in the arteries, heart attacks and strokes don’t happen.
Daniel
I wouldn’t say the benefit was overwhelming enough to justify stopping the study. I suspect a little confirmation bias was in play.
You’ve misrepresented my point on the study exclusion factors. I’m making the point that the criteria for inclusion was so narrow that the findings of the study apply to an extremely small group of people, yet the message is that statins work (not just this specific statin, but all statins) are beneficial to people even with normal LDL levels.
I’m not trying to mislead people, but to present these studies as I see them. And I don’t think I indulged in academic dishonesty.
To think that those involved in the “nutraceuticals” industry. Rescue 1250, etc do not have a vested interest in “hooking America on drugs” is naive.
IF the companies are soooo interested in helping people to stay healthy then why not spend the money required by the pharmaceutical industry to test if bilberry or saw palmetto really does anything that they claim it does? Oh wait, then they might not show benefit and people won’t skip a heating or electric bill to get their “supplements” if they show it does NOT work.
Snake oil is snake oil, no matter who sells it.
I agree 100 percent. But there is no patent protection for individual nutraceuticals, so there simply isn’t the money to test them extensively. And as far as snake oil goes, if I’m going to take snake oil, I would rather take snake oil that costs me $15 per month than snake oil that costs me $150 per month and carries with it a host of side effects, some of which can be fatal. As far as I know, no one has ever died from bilberry or saw palmetto.
Dr. Mike,
I recently subscribed to your weekly newsletter and am still exploring the wealth of information on your various sites.
However, there are two very annoying aspects to the weekly publication. First, I get a script error message every time I attempt to access your emailing. Every time I return, the message also returns, and must be disposed of. Please try to have this fixed.
Secondly, today’s communique about Fat Head had the very irritating defect of having a double-space in the place of every apostrophe. This interrupts the reading flow, and makes it very difficult to appreciate the content. Surely this can be fixed easily.
Aside from those two problems, I’m loving it. I bought “The Slow Burn…” a couple of years ago, and it’s fantastic. Now I’m also a low-carb eater, and a disciple of Dr. Malcolm Kendrick’s opinions regarding cholesterol and heart disease. What a bill of goods the public has been sold by the Judas-like physicians and others who make up the NIH, the NCEP board and the FDA. As far as I’m concerned the facts are irrefutable: Cholesterol does not cause heart disease, and low cholesterol can be dangerous or fatal. But Big Pharma has so enslaved the medical establishment that it will be a long, long time before your personal physician is likely to accept this truth.
I am clueless as to what’s going on here. I don’t have a weekly newsletter, so I don’t know what you’re actually getting. Second, I’ve looked at the Fat Head post on a couple of other computers, and it looked fine on all. Maybe some other readers can chime in on this one because I don’t know what to tell you.
I am clueless as to what’s going on here. I don’t have a weekly newsletter, so I don’t know what you’re actually getting.
Possibly he is calling this a newsletter, it seems to be the blog posts delivered by email instead of a blog reader:
Subscribe via Email
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Ah, maybe so. I don’t even know how that got set up. Maybe one of my former tech gurus set it up, because I certainly didn’t. Not that there is a problem with it, I just don’t even know how it works. Do you get it that way? If so, were the apostrophes screwed up? Maybe I had better subscribe myself so I can see what comes.
Ah, maybe so. I don’t even know how that got set up. Maybe one of my former tech gurus set it up, because I certainly didn’t. Not that there is a problem with it, I just don’t even know how it works. Do you get it that way?
I’m subscribed to both posts and comments with Bloglines. Most blogs don’t have a way to subscribe to comments without subscribing to each post’s comments individually. I sure hope you keep it.
I’ll keep it. I don’t have a clue as to how to get rid of it even if I wanted to.
Hi Dr. Eades:
Have you checked out Stephan’s post on his blog “whole health source?”
It’s a very interesting review of a recent Dutch study on the effects of Vitamin K2 on heart disease. Here’s the link:
http://wholehealthsource.blogspot.com/
Interesting. Thanks for the link.
The JUPITER data have been further tortured! That’s my recommendation for the title of your forthcoming blog post about the following new information that is now being presented about JUPITER. You should come up with a list of ailments that statins prevent … in the same vein as that list of ills of global warming. By the way you’ve got me looking a little more critically about the presumed consensus there … and I’m starting to reformulate my opinion. Thanks for opening my eyes.
http://www.nytimes.com/2009/03/29/health/research/30heart.html?hp
As long as there are big, big bucks in statins, the data will continue to be tortured. I haven’t read the paper on statins and clotting yet, but when I do, I’ll let everyone know my opinion. It may be that the drugs work for clot prevention, but at what expense? And do they work better than the old tried and true methods? Who knows?
Great read Dr. Eades!
Looking back at the exclusion criteria:
1) Post-menopausal hormone-replacement therapy
2) Long-term oral glucocorticoids
3) History of alcohol or drug abuse
4) DM
5) Cancer within 5 years
6) Uncontrolled hypothyroidism
Why exactly were these specific patients excluded from the study?
I don’t know the precise reasons these criteria were excluded, but most studies have exclusion criteria to make both arms of the study as equal as possible while limiting confounding variables.
Hi Dr. E,
My latest blood test showed elevated CRP, cholesterol and tri. Gloogling about CRP on the Internet I came across your blog. And I’m so happy that I did! You clarified all I needed to know! But before I read your blog I have already purchased “Country Life Ultra Concentrated Omega 3-6-9 ” with the following ingredients:
“Vitamin E (as mixed tocopherols) 20 International Unit 67%
Fish Oil Concentrate (from anchovy, mackerel, sardine) 800 Milligrams *
Borage Seed Oil 800 Milligrams *
Flax Oil (seed) 800 Milligrams *
alpha -Linolenic Acid (from flax seed oil) 424 Milligrams *
Linoleic Acid (from borage & flax seed oil) 416 Milligrams *
Oleic Acid (from borage & flax seed oil) 362 Milligrams *
Eicosapentaenoic Acid (EPA)(from fish oil concentrate – anchovy, mackerel, sardine) 240 Milligrams *
Docosahexaenoic Acid (DHA)(from fish oil concentrate – anchovy, mackerel, sardine) 160 Milligrams *
Gamma -Linoleic Acid (GLA)(from borage seed oil) 152 Milligrams”
Having read your opinion about GLA, do you think I should avoid this formula all togother and stick to just omega 3 EFA and DHA? I’ll also purchase NKO and curcumin as you suggested because I believe it will help me. I’m sticking to a low carb lifestyle, avoiding cow dairy but I’m occasionally eating goat cheese. I need your input!!!
Thank you so very much for doing so much good to all of us with such great research, info.
and knowledge.
1st timer
If you are truly following a low-carb lifestyle, I would avoid borage oil and other oils with a high content of GLA. Lower insulin levels seems to allow these to convert to arachidonic acid more easily. I have had many patients who were taking GLA (from whatever source) for back and/or joint pain. When they switched to a low-carb diet, their pain got a little worse. When I had them stop the GLA, the pain went away. So, I always have people on low-carb diets avoid GLA.
Great post!
This information came in very handy when I was researching the negative impact that statins have on glial progenitor cells in the brain.
Doctors like you are truly a blessing by providing straight forward and unbiased information to the public.
Thank you very much and keep up the good work!
– Julie
Glad you enjoyed the post.
Hello,
Great analysis, reading your blog is a true bliss for me. Thank you doctor!
The only rant I have is a bit off-topic and has to do with the quoted 1300$ yearly in the last paragraph.
Calculating the yearly cost of just the basic supplements that are recommended (Fish/Krill Oil, Good Multi, coQ10, Magnesium, Potassium) the sums turns back much higher… :/
Here in Israel statins are pretty much subsidized so its always a hard sell for me to switch people off prescription (&subsidized) drugs into a healthy diet with worthwhile (&costly) supplements.
If only staying healthy was more affordable somehow…
I think it is outrageous that doctors would come away from this study thinking that people with LDL cholesterol of 130mg with no associated risk factors should be put on Statin drug at all, especially a statin as powerful as Crestor. I don’t remember even reading in the ABC news article that these people had a high C. reactive protein. That seems to have been conveniently left out. Two of my family members are on statins, both are suffering from depression. I’ve often wondered particularly about my father’s depression, as it has increased markedly over the years since he’s been on Lipitor. I definitely see behavioral changes that really worry. The problem is that older people you can always attribute behavioral changes, memory loss and confusion to aging, so it’s very difficult to determine when a statin might actually be contributing to diminished mental function. Thanks for the article, I will pass it on to others. It is important that there is a dialogue with regards to the use of these powerful drugs which in many cases yield little benefits and pose a very real dangers in terms of side effects.
What is the current thinking since the FDA, on Feb 8, 2010, approved the use of Crestor to reduce the risk of heart attack and stroke?
What is your problem?
This was a study cut short because scientific analysis revealed it was unethical to continue.
While death rates did not differ (and why would they with one year of therapy) all other outcomes were better.
Stop complaining be happy we have a drug that works, and OH, by the way, get your carotid screened for atherosclerosis and if you have it, ask your doctor for Niacin SR and Crestor. You will live longer, and in better health
Thanks for your excellent advice, but I think I’ll pass.
I am very thankful to this topic because it really gives great information ,*`