April 23

Nominee for the Reckless award


This is the cover of what’s called in the doctor biz a throw-away journal. These journals are supported by the pharmaceutical industry and are sent out free to licensed physicians. The things come in droves. Most docs glance at the covers to see if there is anything pertinent to their specific practice, maybe flip through them, glance at an article or two, then toss them in the trash. Thus the name.
Notice in this one the headlined article.

Should you put all diabetic patients on statins?

Given that this journal is supported by big pharma, see if you can predict the answer.
Once I fought through all the drug ads (38 pages in a 115 page journal) to get to the article on statins and diabetes, I found that the author, Dr. Lawrence A. Leiter of the University of Toronto, heartily recommends the use of statins in all diabetics over the age of 40.
The way this particular journal is laid out, the recommendations made by the authors of the various articles are graded from A to C as follows:

Strength of recommendation (SOR)
A Good quality patient-oriented evidence
B Inconsistent of limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

The recommendations are listed at the very start of the article so that the busy physician can read just the take-home message of the piece and have a qualitative method of assessing the strength of any particular recommendation.
The practice recommendations at the very start of this article on statins are printed in red and stand out like a sore thumb. They boldly state:

* Statins are the therapy of choice for lowering LDL cholesterol in patients with diabetes (A).
* All diabetes patients over the age of 40 should receive statin therapy, regardless of baseline LDL cholesterol (A).

So, two ‘A‘ recommendations, the strongest, most supported by the scientific evidence at hand.
The first paragraph following the bright red recommendations let’s any busy doc who only glances at the beginning know the score:

Dyslipedemia in patients with diabetes is underdiagnosed and undertreated, and diabetes patients not receiving statin therapy are at high risk for cardiovascular disease. Clinical trial data show that we should consider statins for all adults with diabetes, irrespective of cardiovascular disease status or baseline low-density lipoprotein (LDL) cholesterol levels. Furthermore, aggressive statin therapy is more beneficial than moderate treatment. Patients with diabetes typically have elevated triglycerides and low high-density lipoprotein (HDL) cholesterol levels, but their LDL cholesterol levels are similar to those in the general population. Nevertheless, emerging evidence shows that patients with diabetes may benefit from statins even in the absence of of elevated LDL. Though various agents can reduce LDL cholesterol, the most impressive cardiovascular outcomes are associated with statins.

Is it any wonder that every doctor in the world wants to put every patient on a statin?
Here we have a journal article recommending that ALL adult diabetic patients be started on statin drugs and giving this recommendation an ‘A’ rating in terms of how much scientific evidence underlies it.
If we read on down in this article we are presented with a number of studies showing us just how strong this ‘A’ evidence is. Here is what the author has to say about the Atorvastin Study for Prevention of CHD Endpoints in Non-insulin-dependent diabetes mellitus (ASPEN) which was published in Diabetes Care last year. The ASPEN study is one designed to address the very issue of statins and patients with diabetes, so it should tell us the score.

In the ASPEN [study], atorvastatin [Lipitor] 10 mg reduced the primary endpoint by 10% compared with placebo. The difference did not reach significance, perhaps due to study design, the patient population recruited, the nature of the primary endpoint, and protocol changes needed during the trial due to revised treatment guidelines [or maybe the Lipitor just doesn’t work, but this is never mentioned]; the lack of significance does not detract from the known benefits of statin therapy in diabetes patients.[my italics]

Well, that’s certainly an ‘A’ rating for strength of scientific evidence in my book.
If you read on through the rest of the studies, you find that one has a relative risk ratio of 1.37 while the rest are well below that. Since, in my opinion, the relative risk needs to be at least 2 to be meaningful, all these studies fall far short of having the scientific validity to put the 16 million adults with type II diabetes on statin drugs at a cost of $28 billion per year. Unless, of course, you’re a seller of statin drugs, then you might think differently.
Let’s see, when we look at the fine print in this article (literally, it’s the smallest print in the piece), we find that

Dr. Lawrence Leiter has received research funding from, has provided CME on behalf of, and has acted as a consultant to Astra Zeneca, Merck, Merck Schering Plough, and Pfizer. Editorial support was provided by Dr. Fiona Steinkamp of Envision Pharma Ltd. and was funded by Pfizer, inc. Dr. Leiter takes full responsibility for manuscript content.

Hmmm, let’s see now.
Pfizer makes Lipitor (a statin)
Astra Zeneca makes Crestor (a statin)
Merck makes Zocor (a statin)
Merck Schering-Plough makes Zetia (a non-statin cholesterol lowering drug)
Think Dr. Leiter might have some motivation to get a whole bunch of people on statin drugs?
Clearly, Dr. Leiter and The Journal of Family Practice are definite candidates for the Reckless award.

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  1. I feel absolutely sick to my stomach reading this because I know that the majority of doctors and health care workers support this theory. I am completely overwhelmed with anger at these idiots who pretend to have patients’ best interest at heart and I often wonder how on earth we are going to stop these reckless bastards. Honestly, sometimes I feel totally helpless. A lot of doctors won’t even keep you as a patient if you don’t take their garbage and up here in Canada, we are very lucky to even have a family doctor. What a predicament.
    Hi Cathy–
    Believe me, I understand your frustration.  I don’t know about Canada, but here in the US -because of articles like this one and others – most docs are afraid not to put all their patients on statins because if one does have a heart attack and then sues, all the other misguided docs will queue up to testify that had the patient been on statins the heart attack would never have happened.  So its not simply recklessness on the part of all the local docs, it’s self preservation.  And, because of articles such as this one, they believe they are doing the right thing.

  2. If the mayor of New York City can ban fats in fast food places without public outcry as to his legal right to do so, how far away are we from some public official declaring that statin drugs will be put in the water supply? They think that statins are some kind of wonder drug that will cure all that ails you. The more garbage big pharma puts out the scarier it gets. Recently I read where the FDA is looking into controlling the sale of supplements. You don’t have to look far to see who is pushing for this.
    Nope, you don’t have to look far at all.  But it’s not totally big Pharma pushing it.  The FDA has been itching to regulated supplements for years.  That’s why they call them ‘regulators.’  They want to regulate.  They think they know better than we what’s good for us.  Whenever I read about regulators wanting to regulate, I always think of my favorite C.S.Lewis quote:

    Of all tyrannies, a tyranny sincerely exercised for the good of its victims may be the most oppressive. It would be better to live under robber barons than under omnipotent moral busybodies. The robber baron’s cruelty may sometimes sleep, his cupidity may at some point be satiated; but those who torment us for our own good will torment us without end for they do so with the approval of their own conscience.


  3. The things doctors DON’T know is pretty scary. With at least 8 years of school you think they could fit in a critical thinking class. I only need a primary care physician for insurance reasons and to monitor a pretty stable blood condition. Every six months I visit him and every six months his office mails me a low fat diet because my total cholesterol is a little high. Every six months I put it through shredder and recycle it. He knows I lowcarb but I bet he DOESN’T know the office mails out the diet. Is that possible? Could some sort of automation send out the diet when he enters a total cholesterol over a certain number?
    I’m sure that some practice consultant or some article in a throw-away journal has warned him that if he isn’t seen to be doing something proactive about his patients with even minimally elevated cholesterol levels, he could be hammered in a lawsuit should such a patient suffer a heart attack.
    He has nightmares about being on the stand and having a plaintiff’s attorney (such as that swine John Edwards) say to him: Doctor, you knew this man had an elevated cholesterol level and yet you did nothing.  Now, he’s disabled, he can’t perform sexually with his wife, his marriage is at risk, he can’t even play golf anymore.  His life is ruined.  And why, Doctor?  Could it be because you were just too busy trying to earn your – let’s see, Doctor, how much was it you told this jury you earned last year? $175,000 wasn’t it?  We’re you just too busy trying to earn your $175,000  to take the time to put this patient on a diet or a drug or do anything to treat his dangerously elevated cholesterol level?
    This goes on in courtrooms all over America countless times every single day.  Your doctor can say: I send each patient with elevated cholesterol levels a letter advising a low-fat diet.  By doing so, he basically vaccinates himself against such a lawsuit because everyone ‘knows’ that a low-fat diet is the proper first step in the treatment for elevated cholesterol levels.

  4. Interesting how they changed to a bolder font in the headline “Should you put all diabetic patients on statins?
    From dabbling in NLP, I’ve become very sensitive to statements phrased as questions, negations, subtle reframes, and things of that nature.
    Interesting, indeed.  I never notice the font change until you pointed it out.

  5. Went to GYN today and on the back of the door was a huge poster to “check your cholesterol”. The recomendations were for total under 180, and if you have diabetes LDL below 80?!?!? (are these new numbers? I’ve always heard 200 & 100)
    Isn’t that rediculous!!! In an office that caters to women! Women, who show no benefit from statins!! This poster was from the AHA, suprisingly, no ads on it at all!
    I can understand the docs being nervous….we are in a very lawsuit happy world!!
    I’ve read that there are many docs who will talk about a low carb diet only if the patient brings it up first.
    And then there is the doc that makes you sign a written statement saying you are refusing treatment….and of course the docs (like mine) that “fires” a patient because they refuse treatment!
    Thank God I’m not a doctor any longer. 

  6. More fraud to sell more drugs. When I was first diagnosed with type 2 diabetes, my LDL cholesterol was high and HDLs low. My doctor prescribed Lipitor. I had the good fortune to run into 2 people who had muscle pains from Lipitor, one of them my mother-in-law. After researching the side effects, especially those the medical-pharmaceutical establishment don’t acknowledge, I didn’t get the prescription filled. It was also about that time that I went on low carb. When I had to face my doctor again, we checked my cholesterol and it had improved to the point that he no longer pushes Lipitor. My most recent lipid panel is good enough to avoid pressure to go on statins for a while longer. It’s ironic that my intake of dietary fat & cholesterol increased with low carb, yet my serum cholesterol improved. 🙂
    Further research revealed that there are several folks out there who say that all diabetics should be on statins. I heard of one study, CARDS, that showed benefit to diabetics from Lipitor of all things. When I looked into the details of the study, they say that they expect 95 out of 1000 diabetics to have a heart attack in 4 years. The study was cut short due to what they considered great results. They estimated that they reduced the incident of heart attack to arout 50 in 1000 with Lipitor. They make it sound impressive that you get a 40-some odd percent reduction in heart attacks. Yet going from a 9.5% chance to a 5% chance in absolute terms doesn’t seem like a big enough deal to justify the side effects. I’ll take my chances without statins.
    Hi Dan–
    Sounds like you sussed the situation out pretty well.

  7. I noticed the font thing, too.
    I can’t help wondering who the next group of folks that they’ll want to put enmasse on statins will be. You just know that Big Pharma is out there looking for them.
    Dr Jarvik is back on the airwaves with yet another ad for Lipator. I don’t know why that guy bugs me so much but he just does. This time around, he’s slicing a banana into a bowl of cold cereal while talking about how diet and exercise were not enough to lower his cholesterol.
    As Jarvik ages he reminds me more and more of Gollum from the Lord of the Rings.  Not necessarily the movie version, although that a little, but the version I created in my own imagination as I read the books years ago.

  8. I’m confused. If excess carbohydrates cause the body to produce palmitic acid, and excess carbs are bad for our health, ergo, shouldn’t palmitc acid also be bad for our health? Is it possible that a contributing factor of bad health from eating excess carbs could be the production of palmitic acid?
    Hi Chris–
    Excess carbs aren’t bad because they convert to palmitic acid, excess carbs are bad because they run up insulin levels, causing insulin resistance and hyperinsulinemia.  When we eat carbs the body burns as many as it can, stores as much of the rest as it can as glycogen, then converts the excess to palmitic acid.  I would look at it as a way the body has of converting something bad into something good.

  9. Gollum!! Haaaaaa, that’s hilarious! I can see him now, huddled around a bottle of Lipitor…”My Precioussss!” Or is it the money that Pfizer gives him for his service to humanity that maybe is his precious? I’ve wanted to write to his wife at Parade’s “Ask Marilyn” if it is ethical for doctor to endorse a product for money.
    What he’s doing is no better or worse than what those do who promote statins in the medical journals and at conferences and get paid large amounts of money given to them as research grants.

  10. Aha! Robert (post #10), thank you. I knew that “Marilyn” was married to a cardiologist, but didn’t know it was Jarvik. HaHaHa! That explains a lot- considering some of the silly answers she sometimes gives out when it comes to health.
    He probably looks like Gollum because the poor man isn’t eating enough “artery clogging” saturated fats.
    Obviously Marilyn isn’t a ‘savant’ in all subjects. 

  11. Dr. Eades
    What would you say the biggest peice of evidence against the Lipid Hypothesis is?
    I know it is completely false, but I am curious what peice of evidence you cite most?
    Thank You.
    Hi Razwell–
    I wouldn’t rely on a single piece of information just as I never rely on a single study.  The evidence has to be considered in its totality.  But if I had to pick a single thing, it might be a piece of anecdotal evidence: Michael DeBakey, one of the pioneers in heart surgery, has famously stated that in all the thousands (probably more than any other heart surgeon) of patients he’s treated for heart disease, about half had low or normal cholesterol levels.  If high cholesterol truly causes heart disease, one would expect that way more than half the people who have it would have elevated cholesterol.   And one would figure that low cholesterol would be protective, which isn’t the case.

  12. Dr. Eades
    My favorite piece of evidence against the Lipid Hypothesis is what Dr. Ravnskov points out in his book
    “The fact that coronary atherosclerosis gets worse just as fast or faster when cholesterol goes DOWN as when it goes up the OPPOSITE of exposure – response should have led scientists to question the whole Lipid Hypothesis – but no one did”
    What do you think of that one?
    I think it’s a good one, but I still prefer the total volume of evidence rather than a single idea.

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