Another Biased Study? Maybe …

      41 Comments on Another Biased Study? Maybe …

If you follow other paleo or low-carb blogs, you’re no doubt aware of the recent study in which the investigators concluded that while low-carb and low-fat diets work equally well for weight loss, the low-carb diet produced greater improvements in HDL.  Jimmy Moore wrote about the study, and there were online articles with quotes like these:

Over the long term, a low-carb diet works just as well as a low-fat diet at taking off the pounds – and it might be better for your heart, new research suggests.

Both diets improved cholesterol in a two-year study that included intensive group counseling. But those on the low-carbohydrate diet got a bigger boost in their so-called good cholesterol, nearly twice as much as those on low-fat.

Given all the nonsense over the years along the lines of “Sure, you might lose weight on the Atkins diet, but all that fat will give you heart disease!” I was of course pleased to see this study make the news.  But at the same time, something about either the study itself or the reporting of it didn’t feel quite right.  We were told that the low-carb group lost more weight initially, but both diets performed equally well for weight loss after two years … and yet this bit of information didn’t make it into the Associated Press version of the story:

The 153 participants in the low-carb group followed guidelines set out in Dr Atkins’ New Diet Revolution. For the first 12 weeks, they were told to limit carbohydrate intake to 20 g per day in the form of low-glycemic-index vegetables. After this, they could gradually increase their intake of carbohydrates by 5 g per day per week by adding more vegetables, a limited amount of fruits, and later small quantities of whole grains and dairy products until a stable and desired weight was achieved.

The 154 participants assigned to the low-fat diet limited their energy intake to 1200 to 1500 kcal per day for women and 1500 to 1800 kcal per day for men, with approximately 55% of calories from carbohydrate, 30% from fat, and 15% from protein.

Are there alarm bells going off in your head?  Notice any problems with the comparison here?  We’re looking at one group that was told to restrict fat and calories for two years, and another group that was told to strictly limit carbohydrates for just three months, then gradually raise them until a stable and desired weight was achieved! 

If you’re consuming 20 grams of carbohydrates per day at three months and then starting adding an extra 5 grams per day each week, at six months into the study you’d be consuming 80 grams of carbohydrates per day.  At 12 months, you’d be up to 210 grams per day. 

Ask anyone who’s lost weight and kept it off by restricting carbohydrates what happens if the carb count starts drifting up.  The answer:  first you stop losing, then start gaining again.  Most of us find the magic number is somewhere below 100.  So at some point in the first year, the low-carb dieters most likely hit their limit and stopped losing weight.  From then on, it was merely a maintenance diet.

Meanwhile, I couldn’t find anything suggesting that the low-fat/low-calorie group was told to start eating more once they’d achieved a stable and desired weight.  A limit of 1200-1500 calories for women and 1500-1800 calories for men sure sounds like an ongoing weight-loss diet to me, unless we’re talking about people who aren’t very big to begin with. 

But as it turns out, the study subjects were big.  After digging around and sending out distress signals, I managed to obtain a copy of the full study.  According to the researchers, the subjects all had a BMI of over 30.  Two-thirds of them were women, and yet the average starting weight was 226 pounds.  After 12 months, the average weight in the low-fat/low-calorie group was still over 200 pounds.  At that weight, a diet of 1500-1800 calories is a weight-loss diet.

So in theory, we’re comparing a low-calorie weight-loss diet that lasted for two years with a low-carb diet that reached maintenance level within a year.  Strange design for a study in which weight loss was listed as the primary outcome.  The fact that the low-carb dieters still lost the same amount of weight after two years should have been a major headline — especially since they weren’t told to count calories at any point in the study.  But in his press interviews, lead researcher Gary Foster seemed to determined to give low-fat/low-calorie and low-carb diets equal ratings:

Foster, the study leader, said dieters should be less concerned about which diet to use, and focus on finding the support or technique – like writing down what they eat – that keeps them on track.  “It doesn’t make a difference for weight loss how you get there,” he said.

When I read the statistical analysis part of the paper, I ended up scratching my head and trying to make sense out of gobbledygook like this:  (Don’t give yourself a migraine trying to interpret.  I’ll get to that.)

A parallel longitudinal model structure based on main effects for visit, treatment group, and baseline value and visit-treatment interactions was implemented with logistic regression for binary outcomes. We did estimates by using generalized estimating equations under the logistic regression model for correlated longitudinal binary outcomes implemented in the GENMOD procedure in SAS, version 9. Predicted values for each treatment and visit combination at the mean level of the baseline outcome, with corresponding lower and upper confidence bounds, were produced under each model for the figures. The previously mentioned longitudinal models preclude the use of less robust approaches, such as fixedimputation methods (for example, last observation carried forward or the analysis of participants with complete data [that is, complete case analyses]). These alternative approaches assume that missing data are unrelated to previously observed outcomes or baseline covariates, including treatment (that is, missing completely at random). The longitudinal models implemented for this study relax this missing-completely-at-random assumption in different ways.The generalized estimating equation- based longitudinal logistic models assume that missing data are unrelated to previously observed outcomes but can be related to the treatment because it is a covariate in the model. (that is, covariate-dependent missing completely at random) (18). The likelihood-based mixed-effects models further relax the covariate-dependent missing-completely-at-random assumption by allowing missing data to be dependent on previously observed outcomes and treatment (that is, missing at random). To assess departures from the missing-atrandom assumption under informative withdrawal-that is, the missing weights are informative for which patients chose to withdraw or continue to participate in the study-we present sensitivity analyses. As such, we assume that all participants who withdraw would follow first the maximum and then minimum patient trajectory of weight under the random intercept model.

I thought I knew what they were saying, but to make sure, I asked someone who deals with statistics.  My suspicions were confirmed.  Here’s what all that Engfish means:


Yup … they guessed.  So at the end of the day, we’ve got them declaring that low-fat/low-calorie and low-carb diets produce equal weight loss after two years based on estimating the values for the people who quit the study.  Nowhere in the paper do we find statistics based solely on the subjects who actually finished.  Nowhere in the paper do we find any statistics at all on the actual calories or carbohydrates consumed.  Did the low-carb group adhere to the low-carb diet?  Did the low-calorie group keep their calories restricted?  Since both groups regained some weight between the first and second year, the answer to both questions is almost certainly No. 

But the data isn’t there for us to read.  That makes me a little suspicious.  I couldn’t help but wonder if these people set out to prove the superiority of low-fat diets, didn’t care much for the results, then got creative with their statistical analysis to blur the lines.  So I put Google Scholar to work and looked up previous papers by the same researchers.  What I found were studies written by people who clearly believe that weight loss is all about calories and that low-fat diets are the best way to keep calories in check.  Here are some choice quotes.  (I’m not going to italicize them because it’s a lot of text to read.)

“These results show that energy intake increases as dietary fat content increases across the usual range of dietary fat consumed in the United States. Even small reductions in dietary fat could help in lowering total energy intake and reducing weight gain in the population.”

“Our current food supply is high in fat, and high fat diets have been suggested to promote obesity by increasing energy intake, thus increasing the probability of positive energy balance and weight gain.”

“Although there are many environmental factors promoting excess energy intake and discouraging energy expenditure, it is clear that consumption of a high fat diet increases the likelihood of obesity and that the risk of obesity is low in individuals consuming low fat diets. On the basis of the available data, the current public health recommendations to lower dietary fat intake appear to be appropriate.”

“Despite changes in the diet over time, the variables associated with long-term maintenance of weight loss were the same: continued consumption of a low-calorie diet with moderate fat intake, limited fast food, and high levels of physical activity.”

“People definitely lose weight on low-carbohydrate diets. However, there is no evidence that the weight loss can be sustained over time. In addition, there are concerns about the long-term nutritional quality and safety of the low-carbohydrate diet, especially in regards to its effects on cardiovascular health.”

“Weight loss occurs with low-carbohydrate diets because people restrict caloric intake on these diets, producing a short-term negative energy balance. It is less clear whether they can stay with these diets in the long term and maintain their weight loss. It is also not clear whether the diets are safe to use for years at a time.”

“Control of portion size, consumption of a diet low in fat and energy density, and regular physical activity are behaviors that protect against obesity, but it is becoming difficult to adopt and maintain these behaviors in the current environment.”

“Using data from national surveys, we estimate that affecting energy balance by 100 kilocalories per day (by a combination of reductions in energy intake and increases in physical activity) could prevent weight gain in most of the population.”

Read that last one again.  Cutting just 100 per calories per day would do the trick, because it’s all about the calories, right?  Now read this one:

“To determine the optimal energy intake of very-low-calorie diets, 76 obese women were randomly assigned, in a double-blind fashion, to one of three liquid-formula diets: 420 kcal/d, 660 kcal/d, or 800 kcal/d. Weight, body composition, symptoms, mood, and acceptability of the diet were assessed throughout the 6-mo study. There were no significant differences in weight losses or changes in body composition among the three dietary conditions at the end of treatment.”

The difference between 420 calories per day and 800 calories per day for six months is 69,000 calories.  If you believe every 3500 calories equals a pound of fat, the women in the 420-calorie group should have lost an extra 20 pounds.  But they didn’t.  So obviously the body can adjust, which means cutting 100 calories per day isn’t the solution to obesity.  Those last two conclusions are from two different authors on the Low-Fat vs. Low-Carb study.  Perhaps they should get together for a drink and compare previous findings.

I know I’m getting long-winded here, but bear with me.  Given this group’s previous enthusiasm for low-fat diets, I doubt they were excited about the new study’s results, which clearly favored low-carb.  That’s why I’m suspicious that the low-carb group ended up on what amounted to a maintenance diet within a year, and it’s why I’m doubly suspicious that the two-year results included estimates for dropouts.

So just for fun, let’s compare the results at 6 months.  At that point, the dropout rate was still low, both groups were trying to lose weight, and the low-carb group would have been on a true low-carb diet.

Weight Loss:
Low-fat:  25 pounds
Low-carb: 27 pounds

That result alone should be a wake-up call.  We’re talking about people — two- thirds of them women — who weighed an average of 226 pounds.  A 1500-calorie diet is pretty restrictive for someone that heavy.  And yet the low-carb group, with no calorie restrictions at all, lost a bit more.  Did they end up eating less even without a calorie limit?  We don’t know, because the investigators didn’t tell us.  But if they did eat less, that should tell us something about which diet controls appetite naturally, and if they didn’t eat less, somebody owes the country a huge apology for telling us to count calories.

Low-fat:  -24.3
Low-carb: -40.06

Low-fat:  + 0.89
Low-carb: + 6.21

Those two results should have been the final nail in the coffin of the Lipid Hypothesis and the low-fat diet.  Total cholesterol and LDL are lousy predictors of heart disease and always have been.  But the ratio of Triglycerides/HDL is actually a pretty decent predictor, most likely because it serves a proxy for large vs. small LDL.  The lower the ratio, the larger and fluffier your LDL. Ideally, that ratio should be less than 2.0.  (Mine was 1.1 at last checkup.)  Here is the change in that ratio at six months for both groups:

Low-fat at baseline:  124 / 45.4 = 2.73
Low-fat at 6 months:  99.7 / 46.3 = 2.15

Low-carb at baseline:  113 / 46.2 = 2.44
Low-carb at 6 months:   73 / 52.4 = 1.39

After six months, the group not counting calories and eating unlimited amounts of “artery-clogging saturated fat” lost more weight and showed a much more dramatic improvement in cardiovascular markers.  After 12 months, the results still favored the low-carb group, although both groups backslid a bit. 

And then wouldn’t you know it, by the end of two years, results were similar across the board, except for the HDL.  And all the investigators had to do to achieve that convergence was instruct the low-carb group to increase their carbs and include estimated results for all the drop-outs.

I can’t help but wonder if they did that for a reason.


41 thoughts on “Another Biased Study? Maybe …

  1. Lori

    “To assess departures from the missing-atrandom assumption under informative withdrawal-that is, the missing weights are informative for which patients chose to withdraw or continue to participate in the study-we present sensitivity analyses. As such, we assume that all participants who withdraw would follow first the maximum and then minimum patient trajectory of weight under the random intercept model.”

    I read that, too, and wondered if it meant that they just extrapolated. Data? We don’t need no stinking data.

    At the very least, give us two sets of data: one for the people who actually followed the protocols, and another including the drop-outs, if they’re considered relevant.

  2. Frank Hagan

    I did a blog post on the “Intention to Treat” (ITT) statistical method that has the effect of regressing both diets to the mean at Low Carb Age. I have a couple of tables and links to essays done by Richard D. Fineman on ITT where he did get the original data and was able to show how much it masked the results.

    I link to Pal Jabekk’s blog where Dr. Fineman also joins in the comments; its pretty fascinating. It is an issue that could make for some pretty lively posts from you!

    Intention to Treat … so that’s what they call it. I have a more colorful name, but it’s not appropriate for a public forum. (Think Penn & Teller.) Seeing in your post how including the drop-outs narrowed the differences in other studies, I’m even more suspicious now. This looks like intentional blurring of the data to me.

  3. Richard Tamesis, M.D.

    Excellent critique! Have you considered submitting this to the Annals of Internal Medicine?

    Without that M.D. after my name, I’d probably be written off as a crank. But I appreciate the compliment.

  4. Walter Norris

    Dr. Eades had a post maybe 2 or 3 years ago talking extensively about intention to treat.

    He’s a study hound, so that makes sense. I suppose there are circumstances where it makes sense to include those figures, but it sure seems like a dodge to me, at least in this case.

  5. Alex

    I think I recall reading complaints about that study by the hardcore low-fat crowd, saying 30% fat is way too high… that a truly low-fat diet should have restricted fat to 10-15% of calories.

    Every time Ornish’s theories don’t hold up in clinical research, he blames the study. Quite amusing, really, since his claim to fame came from his own studies, where he didn’t control for the variables.

  6. Matt Stone

    Sounds like a pretty lame study. “Here, let’s take a moderate fat diet and a moderate carb diet and use them to compare low-carb vs. low-fat diets with totally unfair rules!” Neato.

  7. Dan

    Some low carb studies have been done to “prove” that low carb diets are bad, but the results didn’t turn out as expected. The low fatties are probably getting desparate. If you don’t get the results you want, resort to Enfish and obfuscation.

    At least they couldn’t get around the fact that low carb is NOT the cardiovascular disaster that it is claimed to be. Even the notion that “the type of diet doesn’t matter” should help the low carb cause. If we can get low carb into the mainstream as a viable option, that would be a major step forward. I’m all for freedom of choice. The message should be, “find the diet that works best for you and stick to it.”

    This also reminds me of the ACCORD study where diabetics in the “intensive treatment” group for lowering blood sugar experienced higher mortality than the normal treatment group. After that, the word got out that it was “dangerous” to lower blood sugar. However, further examination of the data shows that those who didn’t meet the target A1C (6/5%), despite the “intense treatment” with insulin and drugs, experienced higher mortality. Those who achieved the target experienced a reduction in mortality, as well as fewer complications overall. I wish they had tried “intensive blood sugar control” via a low carb diet, but what do you expect from the medical establishment. Sadly, the damage has been done. I still hear stories of low carb diabetics being told to raise their blood sugar.

    I don’t suppose it occurred to them that the problem was high doses of insulin?

  8. Rabbi Hirsch Meisels

    If I understand this correctly, this is a lot worse then ITT. with ITT they include real results for people who dropped out. here they included fictitious results. that never occurred. ITT is a fraud because it doesn’t give us the outcome of exclusive to people who did follow the protocol. Here it’s even worse, they made up the results.

    That seems to be what they’re saying: they estimated results for people who left and didn’t come back. I can’t see how that can possibly be useful or honest.

  9. Paul451

    That’s a very perceptive analysis, Tom! I’ve seen that study mentioned in the press and it also made it to WebMD.

    I believe your point about the LC diet not lasting very long for the subjects in the study also shows the following BIAS built-in to those who ran it, and that is: “Geeez, sooner or later you HAVE to bring carbs back into your diet; they’re too important for good health to leave out for very long!” Yeah, right! What a crock of you-know-what!

    That’s probably true. Tell most of these goofs you’re giving up meat forever and they’ll cheer. But tell them you’re giving up sugar and starch and suddenly it’s “You can’t just give up an entire food group! That’s not healthy!”

  10. Auntie M

    I’m to the point where I just can’t believe that any weight loss study is valid, especially if they just make up results and don’t have a proper double-blind. I think Kurt Harris basically pointed out that observational studies and their stats are all crap. Like you say, Tom: “Learn math. It’s how you know they’re lying to you.” I’ll stick with my n=1 experiment, and throw science at people when they ask questions. That always throws people off. 🙂

    The list of quotes I gave from their earlier works were mostly from observational studies. Imagine their shock when the clinical results didn’t match up.

  11. Sarah

    Drop outs should only be used as an example of what happens when you don’t comply with the study protocols. The end results should be shown as:

    1. The low fat group that completed the study.
    2. The low carb group that completed the study.
    3. Those who quit because it was too difficult for them to stop stuffing their food of choice in their mouths.

    The numbers then reflect the result of each diet or lack thereof. Jumbling the results together is unscientific and fundamentally dishonest. I could give a rat’s rear end about intentions, they tell us nothing about what actually happened.

    Exactly. And I can’t help but think they mixed them up intentionally.

  12. Björn Hammarskjöld

    Protein and fat are essential, we have all nessessary enzymes to digest these essential macronutrients. The digest is taken up by our gut. We get full by fat so you can not overeat fat or protein.

    Carbohydrates are nonessential and we need 3-6 g glucose in the whole blood volume for a 70 kg person. All cells but red blood cells (RBC) have mitochondria (energy plants of cells). All cells with mitochondria can burn acetic acid (from carbohydrates, fat or protein) with oxygen to produce energy.

    RBC need glucose to burn anaerobically to lactic acid to be able to transport and release oxygen to all cells with mitochondria. But glucose is toxic at levels over 6 mM (or 100 mg/dL)

    That’s why we need insulin, a disaster preventing hormone, to restore glucose level to normal values as fas as possible.

    And the authorities tells us to eat 375 g glucose per day. We need no carbs at all as the liver can produce every carbohydrate molecule we need.

    In Sweden 40 % of the newly diagnosed diabetics have died 5 years after the diagnosis according to a medical expert at the swedish social and welfare board (Läkartidningen 1998, p 5167-70) by eating an extreme high carbohydrate (60 E%) low fat (<30 E%) diet.

    So we’ll voluntarily eat ourseves to a premature death by having 60 % of the calories as carbohydrates. This is a very illogical and nonscientific approach to physiology and biochemistry

    At least in Sweden, you’ve got a real national debate going on now. We need to import that one.

  13. Jay

    Hey Tom, great critique!

    When I lecture on how low-carb studies are analyzed and published I do focus on the issue of ITT analysis. This works great for a drug study where the physiological effects of the drug are already understood and you want to know how well it will work at a population level where compliance is a factor. With the diet studies, when you do ITT you are mixing two kinds of results – the physiological effect and the level of compliance. This can blur our understanding of both. I liken it to seat belts. If we did a study to determine if seat belts offer protection in a crash and nobody wore the belts your ITT analysis would suggest they were not useful.

    I have an additional criticism of that study around their exclusion criteria. They basically excluded anyone with metabolic syndrome and insulin resistance. We know now that this is the very population that benefits most from a low carb diet. So I tell people that even when they exclude the people who do best on low-carb and even after an ITT analysis, these guys still had to admit low-carb is better than their cherished low-fat.

    Wow, I didn’t realize they excluded people with metabolic syndrome. That’s stacking the deck a bit. As your film demonstrated, the pre-diabetics can really benefit.

    (For those who haven’t seen “My Big Fat Diet,” it’s terrific.)

  14. monasmee

    “At least in Sweden, you’ve got a real national debate going on now. We need to import that one.”

    Or approach the media as a hot topic. If I’m not mistaken, there was a high school student who discovered a mistake in a previously-accepted scientific theory of which the media recently exposed.

    I missed that one. What was the theory?

  15. JoAnn

    As a recent convert to low-carb I’ve been running a Google Alert on “low carb” to make sure I’m up on the most recent conversations on this subject. I can tell you that literally dozens of news outlets have picked up this story and are spreading the luke-warm results. (All with this tone of astonishment that LC ain’t so bad after all)

    I know my way around an academic study and this one, as many LC bloggers have pointed out, is particularly weak. Of the LC studies I’ve read to date, few have had a long enough intervention to adequately assess results. It disturbs me that the resources for a long term study were wasted on this poorly designed and poorly executed claptrap. They really have no idea who was compliant and what their actual dietary intake was. As I read it, compliance had more to do with showing up for blood tests and counseling, not sticking to the specified food plan.

    Ironically, bad as it is, the study has gotten enough coverage that it might actually create some LC converts whether it deserves to or not.

    That’s the good part of this otherwise poorly-reported study. At least it may convince a few people that low-carb diets don’t induce heart disease.

  16. LeonRover


    “And the authorities tells us to eat 375 g glucose per day.”

    Maybe you are exaggerating for just a tad for dramatic effect? Pure dextrose, I doubt it.

    Surely the 60% of daily calories eaten as food, non grain roots, providing “complex carbohydrates” has a different effect on human digestion ? Benefits of fiber, resistant starches, inulin etc.?

    After all, your Paleo researhcer, Lindeberg, demonstrated that the Kitavans eat a 70% CHO diet. Their averge 370 gm CHO comprises 50 gm from fruit, the rest from roots – tubers, yams – with perhaps a little from coconut.

    The Kitavans do not have our modern killing diseases.

    Advising a population to eat real food, rather than getting rid of glucose in industrialised TV dinners, is a more realistic response.

  17. Rahul

    Hey Tom,
    Wow, I can’t believe how much these scientist and nutritionists and research people are in the government’s pocket. I mean research like this is probably the reason why its just so hard to dig out the truth about everything. But I would blame the mainstream media a lot more critically for never questioning any of these inconsistency or never doing enough research. I mean i think im a smart person and I’m fairly open minded and im sure i do have a “functioning brain” and yet if I hadn’t stumbled into your Fat Head documentary 3months ago I’d still be in the same boat as before worrying about my calorie count and starving myself to a comfortable weight and then gaining it back after i finish that diet. I mean i think all western countries influenced by american research has media just as blind as the american ones.
    Here’s a good example we have show called Target that assesses consumer products and service in general of our country like best daily household products, cafes or just best food or services like drycleaning or plumbers or taxi drivers etc. Usually their standards of research and testing is top notch but in a recent episode they decided to test the best Fast-food chicken burgers between Wendy’s, McDonalds, Burger King and KFC, and all of their research was alright based on taste, consistency, texture etc But when they came to the health part of the testing the show measured all 4 chicken burger’s Calories, Fat Content and ofcourse salt content. and said hey these burgers have too much salt which is not good since it raises BP which increases risk of heart attack, they have too much fat which is due to all that deep frying of the burger and that can raise cholestrol hence heart attack again….and they have very high calories hence its gonna be pretty hard to lose weight with such high calorie burgers, hence these are the very unhealthy food period. At no point of this study was carbz even mentioned even though the main ingredient that makes a meat into a burger is slapping it between two buns. I found the part where they measured calorie the most hilarious since Wendy’s burger came up with the highest calories and if u see all four burgers the chicken is pretty similar size and they probably cooked in same content of oil so i wonder what made it have such a high calorie? now wait a minute unlike the other 3 Wendy’s does use a more thicker and heavier bun to wrap that chicken patty and also if u look in nutrition list it has the most carbs among all 4 chicken burgers almst 10g mre in NZ one(so maybe if i lost one of the buns and had that burger i might not intake that much carbs..). Now how can we expect the common individual to see through this when even a very trusted and well reputable show about testing consumer product, gives incomplete information about nutrition and health factors about a food product. I’m just very grateful for your FAT HEAD production for helping me open my eyes….seriously… Thank You Tom.

  18. T

    Advocates of animal based diets high in saturated fat tend to claim that LDL cholesterol (as well as total cholesterol) does not have a significant relationship with heart disease, most likely due to the preponderance of evidence that shows increases in LDL cholesterol in people who follow carbohydrate restricted diets, even when weight loss occurs. [9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22]. Even researchers paid by Atkins admit that carbohydrate restricted diets tend to increases LDL cholesterol. [23].
    Since numerous studies show that heart disease begins in childhood, with the initial stages of the disease (gross evidence of fatty plaques and streaks) first seen in children over the age of three [24], it is important to consider the relationship between lipid profiles early in life and heart disease later in life. Studies carried out on participants earlier in life show a strong relationship between, total cholesterol, LDL and the HDL to LDL ratio and fatty streaks in the coronary arteries and the aorta, and that HDL alone is not a major risk factor. [25] Also “Findings from the famous Bogalusa Heart Study show that a high saturated fat intake early in life is strongly predictive of later heart disease burden and the higher blood pressure in childhood and adolescence is powerfully predictive of cardiovascular death in adulthood.”[26, 27, 28]
    These are some of over a thousand of studies that demonstrate the relationship between saturated fat and chronic diseases that were overlooked in the recent study paid for by the National Dairy Council that concluded that there was no relationship between saturated fat and heart disease. More information about this flawed study can be found here:
    In studies that have used advance technology to prove reversal of heart disease, the patients were able to reverse their heart disease even when triglycerides increased and HDL decreased, but however, had a significant drop in total cholesterol and LDL cholesterol. [29] The Framingham study showed that 35% of the population in Framingham, Massachusett that had coronary heart disease, had a total cholesterol level between 150 and 200 mg/dl, but that it was rarely encountered in individuals with levels under 150 mg/dl. [30, 31] Dr. William Castelli, the Medical Director of the Framingham Cardiovascular Institute in Massachusetts; Harvard Medical School stated “We’ve never had a heart attack in Framingham in 35 years in anyone who had a cholesterol level under 150…Three-quarters of the people who live on the face of this Earth never have a heart attack. They live in Asia, Africa, and South America, and their cholesterols are all around 150.”

    A thousand studies … really?! Now you’re just exposing yourself as a loon. There have been a handful of badly-designed studies, and that’s it. As for the “never seen a heart attack in anyone who had a cholesterol level under 150,” that’s pure nonsense. Aborigines, with an average cholesterol level of 135, have one of the highest rates of heart disease in the world. But since you’re a fan of observational links, consider this one: people with cholesterol below 160 have shorter lifespans on average, mostly due to much higher rates of cancer.

  19. T

    The true intension of many cholesterol critics needs to be questioned, especially the statement made by Sally Fallon and Mary Enig from The Weston A Price Foundation that claimed “Men who have cholesterol levels over 350 mg/dl are at slightly greater risk for heart disease. For women, there is no greater risk for heart disease, even at levels as high as 1000 mg/dl.” [32]
    If I feel that it is necessary, I may write a follow up post in regards to the link between cholesterol and cancer, stroke and total mortality. However I feel that I need to clear up a response to one of my older posts, written by Mr Naughton when he claimed that the ” In the Framingham study, people whose cholesterol dropped as they aged were more likely to die prematurely. Trying to push your cholesterol down as you get older is stupid.” [33]
    I believe the study he refereed to actually concluded that “Under age 50 years these data suggest that having a very low cholesterol level improves longevity. After age 50 years the association of mortality with cholesterol values is confounded by people whose cholesterol levels are falling–perhaps due to diseases predisposing to death ” [34]. This should be by no means surprising as data linking low cholesterol with excess mortality has been explained in a research paper that stated “Data linking low cholesterol with excess mortality have been gathered from both observational and clinical trials… The association are that low cholesterol is a consequence of disease or is a confounder associated with other variables” [35]. The majority of people over 50 with a falling cholesterol have not achieved this by following methods proven to drastically lower cholesterol, such as following a whole food plant based diet, but due to a preexisting condition that effects the livers ability to produce cholesterol such as an undiagnosed cholesterol lowering cancer including lung, liver, lymphatic and hematopoietic cancer . [36, 37]

    Yes, that’s quite an amazing flip-flop on the part of the cholesterol hysterics. High cholesterol CAUSES heart disease because they’re linked, ya see, but if low cholesterol is linked to cancer … uh, well, uh … in that case it’s the cancer that CAUSES the high cholesterol. Considering the low cholesterol usually shows up many years before the cancer, that’s quite an interesting theory.

  20. T

    In the year 2000, scientists were finally able to show the relationship of different diets in the role of heart disease by showing the underlying disease rather than relying on risk factors such as cholesterol, when Dr Richard Fleming, a Nuclear Cardiologist conducted an experiment using advance technology showing blood flow to the heart. This study has been described as being “An independent, peer-reviewed, extremely comprehensive study on the effects of individuals following an Atkins diet plan studied heart function with before and after blood flow evaluations with sophisticated medical tools including myocardial perfusion imaging, echocardiography and serial blood work. The study showed the blood flow to the heart diminished by an average of 40% after one year on such a high saturated fat, high protein diet, and increased inflammatory markers that predict heart attacks. In contrast, a low saturated fat diet given to the control group improved blood flow to the heart by more than 40%. ” [38] It is more than likely that advocates of carbohydrate restricted diets will blame the increase in heart disease seen in patients following a diet high in saturated fat as the result of also consuming some of the exact same foods (carbohydrate dense foods) consumed by patients in the group that showed reversal of their heart disease.
    The blood flow scans can scans comparing the two diets can be viewed here:
    Also, another study showed that a high-fat Atkins diet is linked with long-term damage to blood vessels and inflammations linked with heart and artery disease. [49]

    In all studies that have used advance technology to prove reversal of heart disease, the patients have always consumed a very plant-based diet, low in saturated fat and have maintained a total cholesterol of under 150 mg/dl and LDL under or around 80 mg/dl. [29, 39, 40].
    Something else that the so-called experts failed to mention in Fat Head was that Nathan Pritkin’s reversed his heart disease that he developed before starting his diet, with proof from autopsies results published in The New English Journal of Medicine showing absence of the disease. [41]

    Just one little problem: the “plant-based diet” regimens that showed improvements in cardiovascular markers were also devoid of sugar and other refined carbohydrates. That’s what made the difference. Controlled clinical studies comparing Atkins to Ornish have shown that the Atkins dieters had the biggest improvements in cardiovascular markers. Even the vegetarian lead researcher for the Stanford study admitted as much.

    But if you want to live on a plant-based diet, knock yourself out. Good luck, however, explaining why heart disease is a modern ailment, whereas animal-based diets go back for millions of years.

  21. T

    Another study that may not change the mind of advocates of carbohydrates restricted diets, is a recent study published in the American Journal of Clinical Nutrition carried out on over 370,000 adults linking meat consumption to long-term weight gain despite the fact that caloric intake and dietary patterns were controlled. The study also stated that “our results do not support that a high-protein diet prevents obesity or promotes long-term weight loss, contrary to what has been advocated.” [42] In another study “Researchers from the American Cancer Society followed 79,236 individuals over 10 years and found that those who ate meat more than three times per week were much more likely to gain weight as the years went by, compared to those who tended to avoid meat. The more vegetables the participants ate, the more resistant they were to weight gain.” [43]
    Yet another study that would be seen as undesirable to these advocates was “A meta-analysis of 12 prospective cohort studies has revealed that high total meat intake increased type 2 diabetes risk 17% above low intake, high red meat intake increased risk 21%, and high processed meat intake increased risk 41%.” [44]
    Furthermore, the evidence on the detrimental effects of processed meat such as bacon, sausages, ham and bologna have been shown to be so significant that The American Institute for Cancer Research has stated that “Research on processed meat shows cancer risk starts to increase with any portion. ” [45]

    Another problem with advocates of carbohydrate restricted diets, is that they fail to give any examples of long lived populations through-out any part of history that have consumed diets similar to their recommendations. The Californian Seven-day Adventists who have the longest life expectancy in Northern America, promote healthy life styles including exercise, strict vegetarian and flexitarian diets, and significantly outlive the average Californian, with studies showing a difference of up 10 years extra life. [50] A review of 6 prospective cohort studies on long-term vegetarians and low meat intake from the Adventist Health Study confirmed that a very low meat intake was associated with significant increases in longevity. [51] The abstract from the 21 year follow-up study on 27,530 adult Seventh-Day Adventist stated; “This report examines the association between mortality from all causes during a 21-year period and frequency of consumption of 28 specific foods among 27,530 adult California members of the Seventh-Day Adventist Church. Food consumption was measured at the beginning of the study (1960) by a self-administered questionnaire. Deaths were identified by computer-assisted matching of study subjects to the file of death certificates for all deaths that occurred in California during 1960-1980. All-cause mortality showed a significant negative association with green salad consumption and a significant positive association with consumption of eggs and meat. For green salad and eggs, the association was stronger for women; for meat, the association was stronger for men. All the observed associations were adjusted for age, sex, smoking history, history of major chronic disease, and age at initial exposure to the Adventist Church.” [52]

    Nice try, but once again your evidence is observational studies with confounding variables. The Adventists are vegetarians, but also don’t smoke, don’t drink, don’t do drugs, and don’t consume candy. Someone finally had the good sense to compare them to Mormons, who shun everything mentioned above, but do eat meat. Guess what? The Mormons had even less disease and longer lifespans.

  22. T

    No matter the quality and the quantity of research showing that an animal centered diet high in saturated fat is disease promoting and can cause premature death, people continue to flame about how healthy they feel on their fad diet. They may not be aware that a fatal heart attack is the first symptom for 50% of men who die from heart attacks, nor the fact that cancer cannot be diagnosed with radiographic technology for over a decade after the initial formation as it needs to be large enough to be seen by the human eye. It was not until the period between 1986 and 1990, 41 to 45 years after the atomic bombs until the largest percent of survivors from Hiroshima and Nagasaki developed radiation related cancers. [46]
    In regards to the damaging effects of dietary cholesterol and saturated and trans fat, the 2010 USDA Dietry Guidelines clearly stated that “In order to reduce the population’s burden from CVD [cardiovascular disease] and T2D [type 2 diabetes] and their risk factors, the preponderance of the evidence indicates beneficial health effects are associated with several changes in consumption of dietary fats and cholesterol. ” [47]

    The “fad” diet is the low-fat diet. High-fat, animal-based diets were the norm for most of human history. The “quality” of studies demonstrating the supposed disease-promoting effects of saturated fat are as piss-poor as anything in science. For just one example, most of the early research in the U.S. labeled trans fats as “saturated fats.”

  23. T

    I agree with many of the topics brought to the attention by Fat Head, including the damage caused by refined carbohydrates and trans fat, and also agree on the importance of exercise. Though I agree that up to a few small servings of clean animal products a week in the diet will not be harmful and may have health benefits for people not supplementing vitamin B12 and certain other supplements if blood tests indicate inadequacy, I do not agree that a significant increase in animal products, saturated fat and salt as being beneficial to health, partially due to the decrease in nutrient dense plant foods accompanied by such changes.

    I also agree that this article requires more editing, but I simply do not have the time to make it sound perfect. I will finish off with the conclusion of one study that I feel should be read by everyone.
    “Saturated fat (SF) intake contributes to the risk of coronary heart disease (CHD) mortality. Recently, the protective effects of fruit and vegetable (FV) intake on both CHD and all-cause mortality were documented. However, individuals consuming more FV may be displacing higher-fat foods. Therefore, we investigated the individual and combined effects of FV and SF consumption on total and CHD mortality among 501 initially healthy men in the Baltimore Longitudinal Study of Aging (BLSA). Over a mean 18 y of follow-up, 7-d diet records were taken at 1–7 visits. Cause of death was ascertained from death certificates, hospital records, and autopsy data. After adjustment for age, total energy intake, BMI, smoking, alcohol use, dietary supplements, and physical activity score, FV and SF intakes were individually associated with lower all-cause and CHD mortality (P < 0.05). When both FV and SF were included in the same model, associations of each were attenuated with CHD mortality, and no longer significant for all-cause mortality. Men consuming the combination of 5 servings of FV/d and 12% energy from SF were 31% less likely to die of any cause (P < 0.05), and 76% less likely to die from CHD (P < 0.001), relative to those consuming 12% SF. Men consuming either low SF or high FV, but not both, did not have a significantly lower risk of total mortality; but did have 64–67% lower risk of CHD mortality (P < 0.05) relative to those doing neither. These results confirm the protective effects of low SF and high FV intake against CHD mortality. In addition, they extend these findings by demonstrating that the combination of both behaviors is more protective than either alone, suggesting that their beneficial effects are mediated by different mechanisms. ” [48]

    There are some badly-designed observational studies linking saturated fat to heart disease, and that’s it. The results don’t hold up in clinical settings, nor do they hold up in populations around the world. People in this country who eat a lot of saturated fat also eat more sugar, among many other confounding factors. And by the way, if people get saturated fat from natural free-range sources — grass-fed cattle, etc. — the food is very nutrient dense … far more than any grains.

  24. kib

    I’d like to address something written by Paul451:

    “… also shows the following BIAS built-in to those who ran it, and that is: “Geeez, sooner or later you HAVE to bring carbs back into your diet; they’re too important for good health to leave out for very long!”

    Yes, I see the exact same premise. The only thing LC diets lack are frugality, because grain and sugar based carbs are CHEAP fillers. We have had about 100 years of glorifying the value of grain in the diet, but it’s NOT for nutritional reasons, unless the population at some point was starving from lack of calories. By and large, grains are easy to grow, easy to store and easy to manipulate, which makes them ideal vehicles for corporate use / profit. Now we’ve added the incentive of farm subsidies to make grain-based carbs even more of an economic staple. “Eat Your Wheaties” is *not* a statement of nutritional necessity, it’s an advertizing slogan!

  25. kib

    Edit to above: I considered corn a “grain”, which isn’t technically correct, but corn can be lumped in with grain-based carbs for the purposes of my post.

    I believe wheat and corn are both technically grasses.

  26. Lori

    Re: frugality, I don’t know about anyone else, but I’m saving over $900 a year eating a low-carb diet. I spend $13 a month more on groceries, but I’m saving money on prescription acid blockers, skin products and trips to the chiropractor for aches and pains that suddenly disappeared when I cut the carbs. The details are on my blog:

    Likewise here. No painkillers, no antacids, no psoriasis creams. We moved to Tennessee a year ago, and I haven’t even bothered to find a doctor yet.

  27. Bruce


    I didn’t know how to send you this, other through comments.

    From “Marks Daily Apple” weekend links.

    I know we had spoke (written) of this before. Finally, a commercial use for the chicken skin!! You had said that this is your daughters favorite part also. Rejoice!

    Your timing is impeccable. My wife just decided this past weekend to fry up some chicken skins. She used a bit too much salt on the first attempt, so we’ll have to try again next we remove the skin from some chicken.

  28. Laurie

    J. Swift “It is useless to attempt to reason a man out of a thing he was never reasoned into”. I think the Ornish trolls are seeking comfort and explanations for why they feel so cr@ppy (just like I was BT- before Taubes), and no amount of reasoned argument will convince the ‘carbo-brain’ addled to stop eating neolithic ‘foods’. It is sad really, but I have enough work running my own (better now) life and cannot waste time arguing for high animal fat fat fat fat diets. The poorly concluded observational studies are worthless and there is a vast sea of informative, intriguing studies and papers linking hyperinsulinemia to diseases of civilization, leaky blood-brain barriers, allowing opioid addictive compounds in wheat (which can get across that once thought inviolable BBB) to penetrate the brain, that wheat proteins stimulate insulin secretion, insulin can cause artery cells to convert to BONE cells (osteoblasts), and etc.
    That, and much much more information, is totally more compelling than any ‘study’ confirming the ‘carbs-are-essential-to-human-health-in- the- 21st-century’ error. YOU CANNOT REALLY PROVE A POSITIVE. You can get closer and closer to the most likely cause of DOC’s, and you can absolutely DISPROVE a positive. The ‘lipid causes heart disease hypothesis’ is DEAD, disproven, moribund, wrong. We need to move on to greener pastures for more fruitful research ideas and let the ruminants eat those grasses instead of us and let the fruit bats eat the fruit because the grasses are driving humans (the ones still eating those unfit for human consumption cereals) insane and killing the rest by a thousand slow, debilitating cuts.

    It’s kind of amusing the way these vegetarian evangelists keep showing up and 1) spouting the same old poorly-designed observational studies as some kind of proof, and 2) expecting (apparently) that they’ll convert me to vegetarianism. Considering that I already tried vegetarianism and only got fatter and sicker as a result, citing a handful of biased studies conducted by other vegetarian evangelists isn’t going to convince me to repeat that mistake.

  29. Dan

    Speaking of flawed studies and flawed actions, I recently saw two articles at Diabetes Health. The first was a government-sponsored healthy kids program that failed to produce any difference in weight loss over the “control” schools.

    Of course, even though one government intervention failed, our elected representatives in the senate voted unanimously to start another “healthy eating” program for schools.

    What do you expect????

    I also want to add that Diabetes Health does publish low carb stories and information along with low fat, so it is a good resource. On the same page is an article about a successful low carb study.

    Too bad our elected representatives didn’t see that. However, I wish the government would just get out of the nutrition business.

    Like I’ve said before, when a government program fails, they treat it as evidence that we need to do the same thing again, only bigger.

  30. Paul451

    I hate to comment twice on the same thread, but I have to say the exchange with “T” was worth at least the price of admission! (lol).

    Note to T: Please, please, please read “Good Calories, Bad Calories”.

  31. T

    Diets that focus on the macronutrient content of a diet such as low carbohydrate diets or low fat diets are doomed to fail as the focus of these diets do not tend to incorporate micronutrient density, and fail to encourage people to consume foods that are dense in micronutrients, which is why many studies simply end up merely comparing two rubbish dumps. Unless an effort is made to focus on the nutrient density of the carbohydrates being consumed in diets high in carbohydrates, studies are generally just comparing patients who consume a large percentage of their calories from low-nutrient refined carbohydrates, such as flour and sugar, not micronutrient dense foods like tomatoes and berries. Many studies place all carbohydrate rich food together despite significant differences that different types of carbohydrates rich foods play in the role of weight loss and human health.
    One of the reasons so many bloggers and advocates of carbohydrate restricted diets believe they can significantly limit carbohydrates is because they are simply looking at whether the macronutrients are essential part of the diet, and fail to understand the important role in prevention of disease played by tens of thousands of micronutrients including photochemicals, antioxidants and carotenoids, nutrients that are exclusively found in plant foods, of which contain at least modest amount of carbohydrates. For example, “a 60-year study of 4,999 participants found those who consumed more fruit in their childhood (highest quartile) were 38 percent less likely to develop cancer of all types as adults.” [1]

    A study published by Joel Fuhrman, MD, author of the best seller “Eat to Live”, took a micronutrient dense vegetable based approach, that had tremendous success with patients who adhered to the diet, with an average weight loss of 53 pounds (24kg) over the period of two years, with none of the patients ever gaining weight over the entire period of the study. [2] Not only has the diet advocated by Dr Fuhrman shown to decrease LDL cholesterol greater than what is achievable with other diets, it can also decreases LDL further than what is achievable with cholesterol lowering statins. [3]
    Joel Fuhrman is also about to publish a peer-reviewed study in a medical journal carried out in conjunction with researchers from the University of Sothern California, called “The Changing Perception of Hunger Study” with over 700 participants, of which 90% who followed this diet 90% of the time reported a change in perception of hunger, and over 500 reported a loss of the addictive drive to overeat. More information about this study, including the reasons to why a high nutrient diet is the most effective way to lose and keep weight off can be viewed in the following presentation:
    Joel Fuhrman MD will also soon be publishing a study on patients following his recommended diet that “demonstrated that 9 out of 10 diabetics were able to come off all medications and have normal glucose readings “. More information can be found here:

    Once again, you are taking the benefits of giving up sugar and white flour and ascribing them to a “plant-based diet.” Yes, it’s important to eat nutrient-dense foods. So any diet that eliminates garbage like sugar and white flour will produce improvements. That’s not proof that “plant-based diets” are superior. It’s proof that giving up garbage foods is a great idea, and exactly what we recommend here.

    You are also assuming, based on nothing whatsoever, that proponents of paleo or low-carb diets recommend giving up all plant foods. We don’t. (You might try reading a book or two by paleo-diet authors.) We recommend giving up sugar and grains, certainly, but encourage people to eat a wide variety of low-starch vegetables and low-sugar fruits.

    If Furhman’s diet truly drives LDL levels very low, to me that’s a reason to avoid his advice. I don’t want my LDL level low. I kind of enjoy having a body that’s highly resistant to infections, despression, stroke and cancer. I want my LDL nice and high. I also want my LDL to be the large, fluffy variety … and given my very low triglycerides and very high HDL, that’s almost certainly the case.

  32. k_the_c

    Example of someone giving up veganism:


    The main reason I made the switch is this: there are too many people an each side of the fence. Half of nutritional scientists say that meat is the best thing ever for you. The other half say that it will kill you. On the other hand, EVERY nutritional scientist says that refined carbohydrates will kill you.”

    Well done.

  33. Merope

    “T” accuses “low-carb advocates” about “flaming about how good they feel on their fad diet”, but neglects to acknowledge that he is, himself, flaming.

    His very long text, unbroken by any kind of editing to make it easier to read, which would at least have been a polite thing to do, seems to have been authored in one piece and then inserted into the comments area according to how many words were allowed at a time.

    I wonder, if I search for his phrases, will I find that he routinely posts them to all the low-carb-friendly blogs and sites he finds?

    I had to chuckle when he referred to low-carb as a “fad” diet. Grains and sugar have been part of the human diet for a tiny fraction of our time on earth. If anything is a “fad” diet, it’s the low-fat diet.

  34. Janice H

    Here’s a little background on my “healthy diet” that I ate for years. After I got married I put on about 20 pounds which slowly crept up. I always had digestion issues, constipation, canker sores, chronic muscle pain, edema, high blood pressure and the list goes on. Gosh I did have really low cholesterol though!
    I tried the low fat diet for years where I would eat plates of rice (yes even brown) with chicken breast and topped with salsa. I exercised. I still had these issues.
    Now that I am 53 my issues have worsened. I did start reading up on the issues I have been dealing with and a bell finally went off in my head. Good Calories, Bad Calories made me cry. This could be from grain not from fat and meat. So I started slowly shifting over and what did I find? My edema, high blood pressure, canker sores, muscle pain have either totally gone away or lessened. Unfortunately I did not find out in time & found out I have osteopenia & also just found out I have celiac disease. I’m convinced that it’s not just me that shouldn’t eat wheat, it’s everyone. I can’t tell you how many people around me (family & friends) have the same symptoms. My SIL has fibromyalgia and is in chronic pain. She has bone loss everywhere, especially in her jaw. I have tried to talk to her about the danger of wheat/gluten but is on overload with so much conflicting info out there. So she continues her “healthy diet”.
    My parents had similar symptoms: muscle pain, edema, diabetes, canker sores, high blood pressure and then unfortunately they both died way too young from cancer. I pray I’m not too late to have their fate & can turn this around. I’m tired of the bad information shoved down our throats by people who don’t know what they are talking about. We’ve been doing the so called healthy diets for years and look at us all. We’re a mess.

    That’s the real shame of it: the people who want to be healthy, try hard to be healthy, but have been given the wrong information.

  35. Be

    I appreciate that you gave T the air space here. Of course I am perplexed that he cited footnotes that never followed. Nah – not really as we all know most of the studies he cites and know how flawed and contradictory they are. For the life of me I can’t understand how even the scientifically curious mind can ignore facts and reality to support their pet positions (or “fad” diets). Real scientists question everything, but most of all those things they hold to be most self evident. These Diet-Heart, Low Fat, Vegans, et al are gonna have to come up with something more that scientifically explains their position let alone overrides what so many of us know from anecdotal life experience. Have you ever met a vegan who even LOOKED healthy? I haven’t and those I know have horrid health issues.

    It’s the True Believer mindset. In real science, you consider contradictory results as evidence that there’s something wrong with your hypothesis. True Believers simply sweep the contradictory evidence under the rug and focus on the few studies that support their beliefs.

    Honestly, does anyone think Joel Fuhrman and John McDougall would admit to being wrong at this point in their lives, no matter how overwhelming the proof?

  36. Carol Bardelli

    I bet whoever started the old adage “your brain needs carbohydrates,” and that equally nonsensical “you can’t cut out a whole macro nutrient group,” were big agricultural lobbyists. Our it might have been, “The Guy From CSPI!”

  37. Debbie

    It seems they keep changing the criteria too. My own HDL (just measured last week) is decent – 66. And you can’t argue with my triglycerides – 49. But no total cholesterol number has jumped up to 280 in the past year and has my doctor just about in hysterics to get me on statins. And now suddenly LDL numbers are becoming the big players. She finally agreed to do an NMR test for me when I kept insisting that the LDL particle type was more important than the numbers. And the test showed that 90% of my LDL particles are the large, fluffy, pattern A, benign sort. But now she is saying that my ABSOLUTE NUMBER of LDL particles is what matters far more than what type they actually are. And that my LDL-P total particle count of 2018 puts me in a major high-risk category for heart disease REGARDLESS of my HDL, triglycerides, or percentage of pattern A LDL. And on it goes, until your head starts to spin and you don’t know who or what to believe.

    I’m guessing your doctor’s information on the matter was supplied by a statin-maker. They sponsor many of the continuing-education seminars. If you need more assurance that you’re not developing heart disease, perhaps you should get a plaque test.

  38. Richard David Feinman

    In answer to the suggestion of Dr. Richard Tamesis, M.D., I submitted my original ITT paper ( to Annals of Internal Medicine. Abstract of that version included this summary:

    It is argued here that because the idea is counter-intuitive it requires justification in individual cases. In addition, there is an inherent statistical fallacy leading to wide misuse. In these case, ITT tends to reduce information by collapsing independent variables, compliance and effectiveness, into a single variable without necessarily demonstrating that they are linked. ITT is appropriate in large epidemiologic trials where all that is known is the assignment or identification with a particular group, but here it needs no special name. Because misuse is so common and has the consequence of making an effective treatment look worse, ITT should probably never be used.

    This is stronger but probably more accurate than my recent post
    I couldn’t find the reply from Annals but, while they didn’t say I was a crank, neither were they inclined to publish the paper. Foster’s paper was in Annals which tells you something.


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