Posts Tagged ‘red meat,’

As the nutrition world implodes, there are a lot of accusations about ulterior motives and personal gain. (A little odd, that in this period of unbelievable greed — CEO’s ripping off public companies for hundreds of millions of dollars, congress trying to give tax breaks to billionaires — book authors are upbraided for trying to make money). So let me declare that I am not embarrassed to be an author for the money — although the profits from my book do go to research, it is my own research and the research of my colleagues. So beyond general excellence (not yet reviewed by David Katz), I think “World Turned Upside Down” does give you some scientific information about red meat and cancer that you can’t get from the WHO report on the subject.

The WHO report has not yet released the evidence to support their claim that red meat will give you cancer but it is worth going back to one of the previous attacks.  Chapters 18 and 19 discussed a paper by Sinha et al, entitled “Meat Intake and Mortality.”    The Abstract says “Conclusion: Red and processed meat intakes were associated with modest increases in total mortality, cancer mortality, and cardiovascular disease mortality,” I had previously written a blogpost about the study indicating how weak the association was. In that post, I had used the data on men but when I incorporated the information into the book, I went back to Sinha’s paper and analyzed the original data. For some reason, I also checked the data on women. That turned out to be pretty surprising:

Sinha_Table3_Chapter18_Apr22

I described on Page 286: “The population was again broken up into five groups or quintiles. The lower numbered quintiles are for the lowest consumption of red meat. Looking at all cause mortality, there were 5,314 deaths [in lowest quintile] and when you go up to quintile 05, highest red meat consumption, there are 3,752 deaths. What? The more red meat, the lower the death rate? Isn’t that the opposite of the conclusion of the paper? And the next line has [calculated] relative risk which now goes the other way: higher risk with higher meat consumption. What’s going on? As near as one can guess, “correcting” for the confounders changed the direction….” They do not show most of the data or calculations but I take this to be equivalent to a multivariate analysis, that is, red meat + other things gives you risk. If they had broken up the population by quintiles of smoking, you would see that that was the real contributor. That’s how I interpreted it but, in any case, their conclusion is about meat and it is opposite to what the data say.

So how much do you gain from eating red meat? “A useful way to look at this data is from the standpoint of conditional probability. We ask: what is the probability of dying in this experiment if you are a big meat‑eater? The answer is simply the number of people who both died during the experiment and were big meat‑eaters …. = 0.0839 or about 8%. If you are not a big meat‑eater, your risk is …. = 0.109 or about 11%.” Absolute gain is only 3 %. But that’s good enough for me.

Me, at Jubilat, the Polish butcher in the neighborhood: “The Boczak Wedzony (smoked bacon). I’ll take the whole piece.”

Wedzony_Nov_8

Boczak Wedzony from Jubilat Provisions

Rashmi Sinha is a Senior Investigator and Deputy Branch Chief and Senior at the NIH. She is a member of the WHO panel, the one who says red meat will give you cancer (although they don’t say “if you have the right confounders.”)

So, buy my book: AmazonAlibris, or

Direct:  Personalized, autographed copy $ 20.00 free shipping USA only.  Use coupon code: SEPT16

 

Carrot_Nation-3c

I was walking on a very dark street and I assumed that the voice I heard was a guy talking on a cell phone. Apparently about a dinner party, he was saying “Remember, I don’t eat red meat.” Only a few years ago, that would have sounded strange. Of course, a few years ago a man talking to himself on the street would have been strange. He would have been assumed to be deranged, more so if he told you that he was talking on the telephone. But yesterday’s oddity pops up everywhere today. Neo-vegetarianism affects us all. It’s all described very well by Jane Kramer’s excellent review of veggie cookbooks in the April 14 New Yorker,

“…from one chili party to the next, everything changed. Seven formerly enthusiastic carnivores called to say they had stopped eating meat entirely…. Worse, on the night of that final party, four of the remaining carnivores carried their plates to the kitchen table, ignoring the cubes of beef and pancetta, smoky and fragrant in their big red bean pot, and headed for my dwindling supply of pasta. “Stop!” I cried. “That’s for the vegetarians!”

Illustration by Robin Feinman. Reference: http://en.wikipedia.org/wiki/Carrie_Nation.

(more…)

TIME: You’re partnering with, among others, Harvard University on this. In an alternate Lady Gaga universe, would you have liked to have gone to Harvard?

Lady Gaga: I don’t know. I am going to Harvard today. So that’ll do.

— Belinda Luscombe, Time Magazine, March 12, 2012

There was a sense of déja-vu about the latest red meat scare and I thought that my previous post as well as those of others had covered the bases but I just came across a remarkable article from the Harvard Health Blog. It was entitled “Study urges moderation in red meat intake.” It describes how the “study linking red meat and mortality lit up the media…. Headline writers had a field day, with entries like ‘Red meat death study,’ ‘Will red meat kill you?’ and ‘Singing the blues about red meat.”’

What’s odd is that this is all described from a distance as if the study by Pan, et al (and likely the content of the blog) hadn’t come from Harvard itself but was rather a natural phenomenon, similar to the way every seminar on obesity begins with a slide of the state-by-state development of obesity as if it were some kind of meteorologic event.

When the article refers to “headline writers,” we are probably supposed to imagine sleazy tabloid publishers like the ones who are always pushing the limits of first amendment rights in the old Law & Order episodes.  The Newsletter article, however, is not any less exaggerated itself. (My friends in English Departments tell me that self-reference is some kind of hallmark of real art). And it is not true that the Harvard study was urging moderation. In fact, it is admitted that the original paper “sounded ominous. Every extra daily serving of unprocessed red meat (steak, hamburger, pork, etc.) increased the risk of dying prematurely by 13%. Processed red meat (hot dogs, sausage, bacon, and the like) upped the risk by 20%.” That is what the paper urged. Not moderation. Prohibition. Who wants to buck odds like that? Who wants to die prematurely?

It wasn’t just the media. Critics in the blogosphere were also working over-time deconstructing the study.  Among the faults that were cited, a fault common to much of the medical literature and the popular press, was the reporting of relative risk.

The limitations of reporting relative risk or odds ratio are widely discussed in popular and technical statistical books and I ran through the analysis in the earlier post. Relative risk destroys information.  It obscures what the risks were to begin with.  I usually point out that you can double your odds of winning the lottery if you buy two tickets instead of one. So why do people keep doing it?  One reason, of course, is that it makes your work look more significant.  But, if you don’t report the absolute change in risk, you may be scaring people about risks that aren’t real. The nutritional establishment is not good at facing their critics but on this one, they admit that they don’t wish to contest the issue.

Nolo Contendere.

“To err is human, said the duck as it got off the chicken’s back”

 — Curt Jürgens in The Devil’s General

Having turned the media loose to scare the American public, Harvard now admits that the bloggers are correct.  The Health NewsBlog allocutes to having reported “relative risks, comparing death rates in the group eating the least meat with those eating the most. The absolute risks… sometimes help tell the story a bit more clearly. These numbers are somewhat less scary.” Why does Dr. Pan not want to tell the story as clearly as possible?  Isn’t that what you’re supposed to do in science? Why would you want to make it scary?

The figure from the Health News Blog:

Deaths per 1,000 people per year

    1 serving unprocessed meat a week   2 servings unprocessed meat a day
    Women    

7.0

8.5
    3 servings unprocessed meat a week   2 servings unprocessed meat a day
    Men

12.3

13.0

Unfortunately, the Health Blog doesn’t actually calculate the  absolute risk for you.  You would think that they would want to make up for Dr. Pan scaring you.   Let’s calculate the absolute risk.  It’s not hard.Risk is usually taken as probability, that is, number cases divided by total number of participants.  Looking at the men, the risk of death with 3 servings per week is equal to the 12.3 cases per 1000 people = 12.3/1000 = 0.1.23 = 1.23 %. Now going to 14 servings a week (the units in the two columns of the table are different) is 13/1000 = 1.3 % so, for men, the absolute difference in risk is 1.3-1.23 = 0.07, less than 0.1 %.  Definitely less scary. In fact, not scary at all. Put another way, you would have to drastically change the eating habits (from 14 to 3 servings) of 1, 429 men to save one life.  Well, it’s something.  Right? After all for millions of people, it could add up.  Or could it?  We have to step back and ask what is predictable about 1 % risk. Doesn’t it mean that if a couple of guys got hit by cars in one or another of the groups whether that might not throw the whole thing off? in other words, it means nothing.

Observational Studies Test Hypotheses but the Hypotheses Must be Testable.

It is commonly said that observational studies only generate hypotheses and that association does not imply causation.  Whatever the philosophical idea behind these statements, it is not exactly what is done in science.  There are an infinite number of observations you can make.  When you compare two phenomena, you usually have an idea in mind (however much it is unstated). As Einstein put it “your theory determines the measurement you make.”  Pan, et al. were testing the hypothesis that red meat increases mortality.  If they had done the right analysis, they would have admitted that the test had failed and the hypothesis was not true.  The association was very weak and the underlying mechanism was, in fact, not borne out.  In some sense, in science, there is only association. God does not whisper in our ear that the electron is charged. We make an association between an electron source and the response of a detector.  Association does not necessarily imply causality, however; the association has to be strong and the underlying mechanism that made us make the association in the first place, must make sense.

What is the mechanism that would make you think that red meat increased mortality.  One of the most remarkable statements in the original paper:

“Regarding CVD mortality, we previously reported that red meat intake was associated with an increased risk of coronary heart disease2, 14 and saturated fat and cholesterol from red meat may partially explain this association.  The association between red meat and CVD mortality was moderately attenuated after further adjustment for saturated fat and cholesterol, suggesting a mediating role for these nutrients.” (my italics)

This bizarre statement — that saturated fat played a role in increased risk because it reduced risk— was morphed in the Harvard News Letters plea bargain to “The authors of the Archives paper suggest that the increased risk from red meat may come from the saturated fat, cholesterol, and iron it delivers;” the blogger forgot to add “…although the data show the opposite.” Reference (2) cited above had the conclusion that “Consumption of processed meats, but not red meats, is associated with higher incidence of CHD and diabetes mellitus.” In essence, the hypothesis is not falsifiable — any association at all will be accepted as proof. The conclusion may be accepted if you do not look at the data.

The Data

In fact, the data are not available. The individual points for each people’s red meat intake are grouped together in quintiles ( broken up into five groups) so that it is not clear what the individual variation is and therefore what your real expectation of actually living longer with less meat is.  Quintiles are some kind of anachronism presumably from a period when computers were expensive and it was hard to print out all the data (or, sometimes, a representative sample).  If the data were really shown, it would be possible to recognize that it had a shotgun quality, that the results were all over the place and that whatever the statistical correlation, it is unlikely to be meaningful in any real world sense.  But you can’t even see the quintiles, at least not the raw data. The outcome is corrected for all kinds of things, smoking, age, etc.  This might actually be a conservative approach — the raw data might show more risk — but only the computer knows for sure.

Confounders

“…mathematically, though, there is no distinction between confounding and explanatory variables.”

  — Walter Willett, Nutritional Epidemiology, 2o edition.

You make a lot of assumptions when you carry out a “multivariate adjustment for major lifestyle and dietary risk factors.”   Right off , you assume that the parameter that you want to look at — in this case, red meat — is the one that everybody wants to look at, and that other factors can be subtracted out. However, the process of adjustment is symmetrical: a study of the risk of red meat corrected for smoking might alternatively be described as a study of the risk from smoking corrected for the effect of red meat. Given that smoking is an established risk factor, it is unlikely that the odds ratio for meat is even in the same ballpark as what would be found for smoking. The figure below shows how risk factors follow the quintiles of meat consumption.  If the quintiles had been derived from the factors themselves we would have expected even better association with mortality.

The key assumption is that the there are many independent risk factors which contribute in a linear way but, in fact, if they interact, the assumption is not appropriate.  You can correct for “current smoker,” but biologically speaking, you cannot correct for the effect of smoking on an increased response to otherwise harmless elements in meat, if there actually were any.  And, as pointed out before, red meat on a sandwich may be different from red meat on a bed of cauliflower puree.

This is the essence of it.  The underlying philosophy of this type of analysis is “you are what you eat.” The major challenge to this idea is that carbohydrates, in particular, control the response to other nutrients but, in the face of the plea of nolo contendere,  it is all moot.

Who paid for this and what should be done.

We paid for it. Pan, et al was funded in part by 6 NIH grants.  (No wonder there is no money for studies of carbohydrate restriction).  It is hard to believe with all the flaws pointed out here and, in the end, admitted by the Harvard Health Blog and others, that this was subject to any meaningful peer review.  A plea of no contest does not imply negligence or intent to do harm but something is wrong. The clear attempt to influence the dietary habits of the population is not justified by an absolute risk reduction of less than one-tenth of one per cent, especially given that others have made the case that some part of the population, particularly the elderly may not get adequate protein. The need for an oversight committee of impartial scientists is the most important conclusion of Pan, et al.  I will suggest it to the NIH.

April 1, 2012.  Piltdown, East Sussex, UK . Two prominent researchers, Drs. Ferdinand I. Charm and June E. Feigen of the University of Piltdown Center for Applied Nutrition (PCAN), submit the following guest review on a ground-breaking area of nutrition.

Nutrition is frequently accused of being a loose kind of science, not defining its terms and speaking imprecisely.  Complex carbohydrates, for example, still refer, in organic chemistry, to polysaccharides such as starches and for many years, it was absolute dogma in nutrition that complex carbohydrates were more slowly absorbed than simple sugars.  Science advances, however, and when measurements were actually made it was found not to be so simple, giving rise to the concept of the glycemic index.  The term “complex,” had since then been used loosely but has currently evolved to have a more precise meaning derived from mathematics, that is, as in complex numbers, having a real part and an imaginary part although the recent Guidelines from the USDA make it difficult to tell which is which.  In any case, the glycemic index has expanded to the concept of a glycemic load and now there is even more hope on the horizon.

Nutrition has borrowed a page from particle physics in the application of quantum chromodynamics. In the way of background, the discovery of the large number of subatomic particles and the need to classify them meant that designations had to go beyond charge and spin to include strangeness and the three flavors of quarks.  Ultimately, it was decided that quarks have an additional degree of freedom, called color and the strong interaction was identified as a color force.  A large amount of evidence supports this idea with interaction via the gluons.

Nutritional Chromodynamics.

A similar idea has arisen in nutrition and it is now clear that the more color, the better and extensive experimental work at CARN is currently under way (Figure 1). The recent CRAYOLA  study showed the value of spectral nutrient density. Support for the theory was summarized in a recent press release:

Blueberries were up there, the wild type being the best.

 “The wild blueberries are blue inside as well as blue outside. The ones we normally eat are sort of white inside. So there are more of the antioxidants in these all-blue blueberries.”

Along the line of color is good, cranberries were close behind as were blackberries.

 But what about vegetables?

 Dried red beans topped the list overall–red kidney and pinto beans were also in the top 10. But surprisingly, so are artichokes. “This is sort of interesting because they are not deeply colored, the inside, the part that we actually consume is white or very pale green but never the less they contain very large amounts of antioxidants.”

 There are nuts that did not make it into the top twenty but did have high enough content worthy of mention– pecans, hazelnuts and walnuts were the ones with the greatest antioxidant content. But the antioxidants are concentrated, so you need only a handful a day to get the amount you need.

 The problem here may be the bland coloration of the nuts. This has been jarring to some theorists, leading many to question whether the Standard Model of nutrition will last, or whether the highly abstract bean-string theory will ultimately prevail.  The recent identification of chocolate with the dark matter that fills the majority of the universe, however, has established the field of nutritional chromodynamics.  Still, critics point to the problem of red meat, one of the very few foods that actually decreased during the epidemic of obesity.  By applying the USDA Nutritional Guidelines, however, this result can be made to vanish.

Figure 1 Souper-Collider at CARN (Centre Alimentaire de Recherche Nucléaire).

Although this is pretty convincing, there is the uncertainty principle.   Because the outcome of a nutritional experiment and its support for the experimenter’s theory rarely commute, it is impossible to simultaneously measure outcome and whether the results mean anything.  Again borrowing from particle physics, there is the concept of the virtual particle that mediates interaction between other particles.  The evolving principle in the field of nutritional chromodynamics is the existence of the  mayon, the virtual particle that mediates the so-called Dietary Weak Interaction or DWI, as in “phytochemicals may prevent cancer.”

And then there is the matter of Quark. Most physicists know that Quark is the German word for sour cream and many physicists on tour in Germany have their picture taken in front of delicatessens selling Quark (at least those who don’t have their picture taken in front of a jewelry store).  Less widely known outside of the German-speaking countries is that Quark colloquially means nonsense or trash.  In any case, it’s pretty clear at this point that, the Tevatron results notwithstanding, blueberries and sour cream are the real Top Quark.

I thought that, for a change of pace, I would take a Mediterranean perspective.  The Mediterranean Diet is widely considered as an ideal diet since it is not explicitly low-fat (most of the time) while still allowing people to avoid saying low-carbohydrate which is not fashionable in many circles.  At the end of this post, however, I have included a couple of recipes from Judy Barnes Baker’s new cookbook, Nourished; a Cookbook for Health, Weight Loss, and Metabolic Balance.  For general health, Mediterranean diets have the advantage that nobody is really sure what they are and hence there are no long term trials of the type that makes low-fat diets look so bad, as in the Women’s Health Initiative.

Tournedos Rossini

Start with Giochino Rossini.  It is generally known that his life as a composer included significant time for food. He retired at a relatively early age and devoted the rest of his life to cooking and eating. (William Tell was his last opera). Rossini said that he had only cried twice as an adult. The first time was when he heard Paganini play the violin and the second, when a truffled turkey fell in the water at a boating party.

 

Because his later life was more or less in seclusion, there is some confusion about his gastronomic experiences.  It is not even clear whether Tournedos Rossini was made for him or by him.  In fact it is not even clear where the name Tournedos comes from.  Derived from tourner en dos, turning to the back, it may refer to the method of cooking or possibly that somebody had to turn their back during the preparation so as not to let anyone see the secret of the final sauce.  The recipe, although simple in outline, has expensive ingredients and the final sauce will determine the quality of the chef. It simply involves frying a steak and then putting a slab of pate de foie gras with truffles on top. The sauce is based on a beef reduction. More at Global Gourmet.

  1. Sauté the 4 center-cut filets mignons, chain muscle removed, 6 ounces in the 2 tablespoons (30 milliliters) clarified butter or vegetable oil on both sides until rare.
  2. Remove excess fat with with paper towel and place on heated plates.
  3. Place warm pate de foie gras slices on each tournedo.
  4. Cover with Périgueux Sauce:

Bring 1-1/2 cups (375 milliliters) of demi-glace to slow simmer. Add 5 tablespoons (75 milliliters) of truffle essence and 2 ounces (50 grams) of either chopped or sliced truffles. Off heat and cover with tight-fitting lid, allow truffles to infuse into the sauce for at least 15 minutes. (The sauce using truffles sliced into shapes rather than pieces is called Périgourdine).

5. Finish with a little truffle butter.

Lardo di Colonnata

Not really a make-at-home item, this traditional creation from Tuscany captures the care in processing  that makes Italian food famous.  The original curing method supposedly goes back to the year 1000, and has been handed down from generation to generation.  The lard, of course, comes from pigs that have not undergone the genetic transformation that American pigs have.  In any case, you will need marble tubs which you should keep in the basement assuming that there are no caves in your neighborhood.  You rub the tubs with garlic and then layer the pork lard and cover with brine, add sea salt and spices and herbs. You continue with additional layers until the tub is full and then cover with a wooden lid. Curing time is about 6 to 10 months.

Greek Barbecue

As described on one of the Greek food sites “anyone visiting Greece would wonder exactly what is meant by the Mediterranean diet for while those of us outside the Med have been eating more whole grains, extra virgin olive oil and fresh vegetables…. as the Greeks become more affluent they eat more meat.” I haven’t been in Greece for many years but I remember quite a bit of meat then. Of course, affluence is a sometime thing but the trend, as in other countries, is for festive holiday foods to be increasingly available all year round.  The most popular food for Easter is whole lamb roasted on a spit  The recipe is simple, if not convenient for the small family “You will need 1 whole lamb, skinned and gutted…”  Seasoning can be simple salt and pepper or basted with ladolemono, mixture of lemon juice, olive oil and oregano.

As the site points out, Lamb on the spit “is especially popular [at Easter] because it follows 40 days of fasting for lent and people are definitely ready for some meat, though not everyone fasts the entire forty days.” This reminds me of little known angle on the Seven Countries study.

Ancel Keys auf Naxos

The idea of a Mediterranean diet derives, in some way, from Ancel Keys’s Seven Countries study. He discovered that the two countries with the highest consumption of fat, had the lowest incidence of cardiovascular disease (Crete) and the highest (Finland), and he attributed this to the type of fat, olive oil for Crete and animal fat for Finland.  It was later pointed out that there were large differences in CVD between different areas of Finland that had the same diet.  This information was ignored by Keys who was also a pioneer in this approach to conflicting data.  Another of the rarely cited responses to the Seven Countries study was a letter written by Katerina Sarri and Anthony Kafatos of the University of Crete and published in the journal Public Health Nutrition: 8(6), 666 (2005):

“In the December 2004 issue of your journal…Geoffrey Cannon referred to … the fact that Keys and his colleagues seemed to have ignored the possibility that Greek Orthodox Christian fasting practices could have influenced the dietary habits of male Cretans in the 1960s. For this reason, we had a personal communication with Professor Christos Aravanis, who was responsible for carrying out and following up the Seven Countries Study in Greece. Professor Aravanis confirmed that, in the 1960s, 60% of the study participants were fasting during the 40 days of Lent, and strictly followed all fasting periods of the church according to the Greek Orthodox Church dietary doctrines. These mainly prescribe the periodic abstention from meat, fish, dairy products, eggs and cheese, as well as abstention from olive oil consumption on certain Wednesdays and Fridays….”

“this was not noted in the study, and no attempt was made to differentiate between fasters and non-fasters. In our view this was a remarkable and troublesome omission.”

Kokoretsi.

Leopold Bloom ate with relish the inner organs of beasts and fowls. He liked thick giblet soup, nutty gizzards, a stuffed roast heart, liver slices fried with crustcrumbs, fried hencod’s roes. Most of all he liked grilled mutton kidneys which gave to his palate a fine tang of faintly scented urine.

— James Joyce, Ulysses.

Along with Greek Barbecue, it is traditional at Easter to serve kokoretsi which is  made from the internal organs of the lamb. Liver, spleen, heart, glands are threaded onto skewers along with  the fatty membrane from the lamb intestines. When the skewer is full, the lamb intestines are wrapped around the whole creation. It is then barbecued over low heat for about 3-5 hours.

 

One of the regrettable aspects of the decline in food quality in the United States is the general disappearance of organ meats although the Paleo movement may help with this.  Organ meats were once very popular; the quotation above is probably the second most widely quoted passage from James Joyce’s Ulysses. Because of various ethnic influences, they were probably more popular in New York than in America (which begins somewhere in New Jersey).  I found Jimmy Moore’s confrontation with beef tongue  quite remarkable in that (in its corned form (like corned beef)), tongue was once a staple of my diet.  When I was in grade school, there were many weeks where I would bring tongue sandwiches on Silvercup bread for lunch every day.  Silvercup, made in Queens was the New York version of Wonder Bread. The Silvercup sign is still a fixture of the New York landscape — it is now the site of Silvercup Studios, the major film and television production company that kept the name (and the sign) when the Bakery folded and the studio bought the building in 1983. (You name the TV show, it was probably produced at Silvercup).

Of course, everybody draws the line somewhere. Although I used to eat with my friends at Puglia, the Little Italy restaurant that specialized in whole sheep’s head, I passed on this delicacy mostly because of the eyeballs.  Also, although you gotta’ love the euphemism Rocky Mountain Oysters, bull testicles don’t do it for me, at least if I know for sure in advance. (I don’t really mind, in retrospect, if the folk-myths about the tacos outside the bullring in Mexico City were really true).

Etymology of Food Words

Whether it is the steak or the cook whose back is turned in Tournedos, it is generally difficult to find the etymology of food words, although some are obvious. The conversion of Welsh Rabbit to Welsh Rarebit is surely an attempt to be more politically correct and avoid Welsh profiling.  One disagreement that I remember from way back when I was in college is now settled. There used to be many ideas about the origin of the word pumpernickel.  One of my favorites at the time was that Napoleon had said that it was “pain pour Nicole” (his horse). Great but not true, it is now agreed that it comes from the German, pampern, to fart and Nickel meaning goblin, along the lines of Saint Nick for Santa Claus.  So pumpernickel means Devil’s Fart presumably due to the effect of the unprocessed grain that gives it its earthy quality.  Which reminds me of the ADA’s take on fiber that I quoted in an earlier post: “it is important that you increase your fiber intake gradually, to prevent stomach irritation, and that you increase your intake of water and other liquids, to prevent constipation.”  foods with fiber “have a wealth of nutrition, containing many important vitamins and minerals.” In fact, fiber “may contain nutrients that haven’t even been discovered yet!” (their exclamation point).

In Brooklyn, the Mediterranean diet means Italian sausage, largely from Southern Italy.  I had always assumed that Soppresata (pronounced, as in Naples, without the final vowel) was so-called because it was super-saturated with fat, but I have been unable to confirm this; since first writing this post, Italian friends have suggested that it comes from Sop-pressata, that is “pressed on,” but this is also unconfirmed.  There are many varieties but supposedly the best is from Calabria.  For something like this, with so many varieties which each cook is sure is the best, there is no exact recipe, but you can get started with this from About.com Italian Food.

 6.6 pounds (3 k) of pork meat — a combination of loin and other lean cuts

1 pound (500 g) lard (a block of fat)

1 pound (500 g) pork side, the cut used to make bacon

Salt, pepper

Cloves, garlic and herbs (rosemary, lemon peel, parsley etc

1/2 cup grappa (I think you could also use brandy if you want)

The basic ideas is to remove all the gristle, and chop it with the lard and the pork side. About.com recommends a meat grinder but I suspect that the knife blade of a food processor is better.  Then, wash the casing well in vinegar, dry it thoroughly, and rub with a mixture of well ground salt and pepper. “Shake away the excess, fill the casing, pressing down so as to expel all air, close the casing, and tie the salami with string. Hang for 2-3 days in a warm place, and then for a couple of months in a cool, dry, drafty spot and the sopressata is ready.”

At exactly what moment these simple, natural ingredients turn into processed red meat is unknown.

Simple Mediterranean

I’ve included two recipes from Judy Barnes Baker’s new book, Nourished; a Cookbook for Health, Weight Loss, and Metabolic Balance.  Currently in press, publication will be announced on her website.  For very simple Mediterranean, she suggested the following from the The Silver Spoon. Translated from  Il cucchiaio d’argento, published in 1950 by Editoriale Domas, the back cover describes it as “the bible of authentic Italian cooking and Italy’s best-selling cookbook for the last fifty years.”

Eggs En Cocotte with Bacon Fat

Serves 4

4 small slices bacon fat

4 tablespoons heavy cream

4 eggs

2 tablespoons Parmesan cheese, freshly grated

 Preheat the oven to 350º, if you wish to bake the eggs. Parboil the bacon fat in boiling water for about 1 minute, then drain. Put 1 tablespoon cream and a slice of bacon fat in each of four ramekins, break an egg into each and sprinkle with the Parmesan. Place the ramekins in a roasting pan, add boiling water to come about halfway up the sides and bake for 6-8 minutes or until the egg whites are lightly set. Alternatively, place the roasting pan over low heat for 6-8 minutes. The combination of bacon fat and cream—a strong savory taste and a milder flavor—gives the eggs a very delicate flavor.

Recipes from: Nourished; a Cookbook for Health, Weight Loss, and Metabolic Balance  (Judy Barnes Baker is the author although I and others are mistakenly listed by Amazon as co-authors).

Καλή όρεξη

Asher Peres was a physicist, an expert in information theory who died in 2005 and was remembered for his scientific contributions as well as for his iconoclastic wit and ironic aphorisms. One of his witticisms was that “unperformed research has no results ”  Peres had undoubtedly never heard of intention-to-treat (ITT), the strange statistical method that has appeared recently, primarily in the medical literature.  According to ITT, the data from a subject assigned at random to an experimental group must be included in the reported outcome data for that group even if the subject does not follow the protocol, or even if they drop out of the experiment.  At first hearing, the idea is counter-intuitive if not completely idiotic  – why would you include people who are not in the experiment in your data? – suggesting that a substantial burden of proof rests with those who want to employ it.  No such obligation is usually met and particularly in nutrition studies, such as comparisons of isocaloric weight loss diets, ITT is frequently used with no justification and sometimes demanded by reviewers.   Not surprisingly, there is a good deal of controversy on this subject.  Physiologists or chemists, hearing this description usually walk away shaking their head or immediately come up with one or another obvious reductio ad absurdum, e.g. “You mean, if nobody takes the pill, you report whether or not they got better anyway?” That’s exactly what it means.

On the naive assumption that some people really didn’t understand what was wrong with ITT — I’ve been known to make a few elementary mistakes in my life — I wrote a paper on the subject.  It received negative, actually hostile. reviews from two public health journals — I include an amusing example at the end of this post.  I even got substantial grief from Nutrition & Metabolism, where I was the editor at the time, but where it was finally published.  The current post will be based on that paper and I will provide a couple of interesting cases from the medical literature.  In the next post I will discuss a quite remarkable new instance — Foster’s two year study of low carbohydrate diets — of the abuse of common sense that is the major alternative to ITT.

To put a moderate spin on the problem, there is nothing wrong with ITT, if you explicitly say what the method shows — the effect of assigning subjects to an experimental protocol; the title of my paper was Intention-to-treat.  What is the question? If you are very circumspect about that question, then there is little problem.  It is common, however, for the Abstract of a paper to correctly state that patients “were assigned to a diet” but by the time the Results are presented, the independent variable has become, not “assignment to the diet,” but “the diet” which most people would assume meant what people ate, rather than what they were told to eat. Caveat lector.  My paper was a kind of over-kill and I made several different arguments but the common sense argument gets to the heart of the problem in a practical way.  I’ll describe that argument and also give a couple of real examples.

Common sense argument against intention-to-treat

Consider an experimental comparison of two diets in which there is a simple, discrete outcome, e.g. a threshold amount of weight lost or remission of an identifiable symptom. Patients are randomly assigned to two different diets: diet group A or diet group B and a target of, say, 5 kg weight loss is considered success. As shown in the table above, in group A, half of the subject are able to stay on the diet but, for whatever reason, half are not. The half of the patients in group A who did stay on the diet, however, were all able to lose the target 5 kg.  In group B, on the other hand, everybody is able to stay on the diet but only half are able to lose the required amount of weight. An ITT analysis shows no difference in the two outcomes, while just looking at those people who followed the diet shows 100 % success.  This is one of the characteristics of ITT: it always makes the better diet look worse than it is.

         Diet A         Diet B
Compliance (of 100 patients)   50   100
Success (reached target)   50    50
ITT success   50/100 = 50%   50/100 = 50%
“per protocol” (followed diet) success   50/50 = 100%   50/100 = 50%

Now, you are the doctor.  With such data in hand should you advise a patient: “well, the diets are pretty much the same. It’s largely up to you which you choose,” or, looking at the raw data (both compliance and success), should the recommendation be: “Diet A is much more effective than diet B but people have trouble staying on it. If you can stay on diet A, it will be much better for you so I would encourage you to see if you could find a way to do so.” Which makes more sense? You’re the doctor.

I made several arguments trying to explain that there are two factors, only one of which (whether it works) is clearly due to the diet. The other (whether you follow the diet) is under control of other factors (whether WebMD tells you that one diet or the other will kill you, whether the evening news makes you lose your appetite, etc.)  I even dragged in a geometric argument because Newton had used one in the Principia: “a 2-dimensional outcome space where the length of a vector tells how every subject did…. ITT represents a projection of the vector onto one axis, in other words collapses a two dimensional vector to a one-dimensional vector, thereby losing part of the information.” Pretentious? Moi?

Why you should care.  Case I. Surgery or Medicine?

Does your doctor actually read these academic studies using ITT?  One can only hope not.  Consider the analysis by Newell  of the Coronary Artery Bypass Surgery (CABS) trial.  This paper is astounding for its blanket, tendentious insistence on what is correct without any logical argument.  Newell considers that the method of

 “the CABS research team was impeccable. They refused to do an ‘as treated’ analysis: ‘We have refrained from comparing all patients actually operated on with all not operated on: this does not provide a measure of the value of surgery.”

Translation: results of surgery do not provide a measure of the value of surgery.  So, in the CABS trial, patients were assigned to Medicine or Surgery. The actual method used and the outcomes are shown in the Table below. Intention-to-treat analysis was, as described by Newell, “used, correctly.” Looking at the table, you can see that a 7.8% mortality was found in those assigned to receive medical treatment (29 people out of 373 died), and a 5.3% mortality (21 deaths out of 371) for assignment to surgery.  If you look at the outcomes of each modality as actually used, it turns out that that medical treatment had a 9.5% (33/349) mortality rate compared with 4.1% (17/419) for surgery, an analysis that Newell says “would have wildly exaggerated the apparent value of surgery.”

Survivors and deaths after allocation to surgery or medical treatment
Allocated medicine Allocated surgery
  Received surgery     Received medicine   Received surgery     Received medicine
Survived 2 years   48   296   354   20
Died    2    27    15    6
Total   50   323   369   26

Common sense suggests that appearances are not deceiving. If you were one of the 33-17 = 16 people who were still alive, you would think that it was the potential report of your death that had been exaggerated.  The thing that is under the control of the patient and the physician, and which is not a feature of the particular modality, is getting the surgery implemented. Common sense dictates that a patient is interested in surgery, not the effect of being told that surgery is good.  The patient has a right to expect that if they comply, the physician would avoid conditions where, as stated by Hollis,  “most types of deviations from protocol would continue to occur in routine practice.” The idea that “Intention to treat analysis is … most suitable for pragmatic trials of effectiveness rather than for explanatory investigations of efficacy” assumes that practical considerations are the same everywhere and that any practitioner is locked into the same abilities or lack of abilities as the original experimenter.

What is the take home message.  One general piece of advice that I would give based on this discussion in the medical literature: don’t get sick.

Why you should care.  Case II. The effect of vitamin E supplementation

A clear cut case of how off-the-mark ITT can be is a report on the value of antioxidant supplements. The Abstract of the paper concluded that “there were no overall effects of ascorbic acid, vitamin E, or beta carotene on cardiovascular events among women at high risk for CVD.” The study was based on an ITT analysis but,on the fourth page of the paper, it turns out that removing subjects due to

“noncompliance led to a significant 13% reduction in the combined end point of CVD morbidity and mortality… with a 22% reduction in MI …, a 27% reduction in stroke …. a 23% reduction in the combination of MI, stroke, or CVD death (RR (risk ratio), 0.77; 95% CI, 0.64–0.92 [P = 005]).”

The media universally reported the conclusion from the Abstract, namely that there was no effect of vitamin E. This conclusion is correct if you think that you can measure the effect of vitamin E without taking the pill out of the bottle.  Does this mean that vitamin E is really of value? The data would certainly be accepted as valuable if the statistics were applied to a study of the value of replacing barbecued pork with whole grain cereal. Again, “no effect” was the answer to the question: “what happens if you are told to take vitamin E” but it still seems is reasonable that the effect of a vitamin means the effect of actually taking the vitamin.

The ITT controversy

Advocates of ITT see its principles as established and may dismiss a common sense approach as naïve. The issue is not easily resolved; statistics is not axiomatic: there is no F=ma, there is no zeroth law.  A good statistics book will tell you in the Introduction that what we do in statistics is to try to find a way to quantify our intuitions. If this is not appreciated, and you do not go back to consideration of exactly what the question is that you are asking, it is easy to develop a dogmatic approach and insist on a particular statistic because it has become standard.

As I mentioned above, I had a good deal of trouble getting my original paper published and one  anonymous reviewer said that “the arguments presented by the author may have applied, maybe, ten or fifteen years ago.” This criticism reminded me of Molière’s Doctor in Spite of Himself:

Sganarelle is disguised as a doctor and spouts medical double-talk with phony Latin, Greek and Hebrew to impress the client, Geronte, who is pretty dumb and mostly falls for it but:

Geronte: …there is only one thing that bothers me: the location of the liver and the heart. It seemed to me that you had them in the wrong place: the heart is on the left side but the liver is on the right side.

Sgnarelle: Yes. That used to be true but we have changed all that and medicine uses an entirely new approach.

Geronte: I didn’t know that and I beg your pardon for my ignorance.

 In the end, it is reasonable that scientific knowledge be based on real observations. This has never before been thought to include data that was not actually in the experiment. I doubt that nous avons changé tout cela.

…the association has to be strong and the causality has to be plausible and consistent. And you have to have some reason to make the observation; you can’t look at everything.  And experimentally, observation may be all that you have — almost all of astronomy is observational.  Of course, the great deconstructions of crazy nutritional science — several from Mike Eades blog and Tom Naughton’s hysterically funny-but-true course in how to be a scientist —  are still right on but, strictly speaking, it is the faulty logic of the studies and the whacko observations that is the problem, not simply that they are observational.  It is the strength and reliability of the association that tells you whether causality is implied.  Reducing carbohydrates lowers triglycerides.  There is a causal link.  You have to be capable of the state of mind of the low-fat politburo not to see this (for example, Circulation, May 24, 2011; 123(20): 2292 – 2333).

It is frequently said that observational studies are only good for generating hypotheses but it is really the other way around.  All studies are generated by hypotheses.  As Einstein put it: your theory determines what you measure.  I ran my post on the red meat story passed April Smith  and her reaction was “why red meat? Why not pancakes” which is exactly right.  Any number of things can be observed. Once you pick, you have a hypothesis.

Where did the first law of thermodynamics come from?

Thermodynamics is an interesting case.  The history of the second law involves a complicated interplay of observation and theory.  The idea that there was an absolute limit to how efficient you could make a machine and by extension that all real processes were necessarily inefficient largely comes from the brain power of Carnot. He saw that you could not extract as work all of the heat you put into a machine. Clausius encapsulated it into the idea of the entropy as in my Youtube video.

©2004 Robin A. Feinman

 The origins of the first law, the conservation of energy, are a little stranger.  It turns out that it was described more than twenty years after the second law and it has been attributed to several people, for a while, to the German physicist von Helmholtz.  These days, credit is given to a somewhat eccentric German physician named Robert Julius Mayer. Although trained as a doctor, Mayer did not like to deal with patients and was instead more interested in physics and religion which he seemed to think were the same thing.  He took a job as a shipboard physician on an expedition to the South Seas since that would give him time to work on his main interests.  It was in Jakarta where, while treating an epidemic with the practice then of blood letting, that he noticed that the venous blood of the sailors was much brighter than when they were in colder climates as if “I had struck an artery.” He attributed this to a reduced need for the sailors to use oxygen for heat and from this observation, he somehow leapt to the grand principle of conservation of energy, that the total amount of heat and work and any other forms of energy does not change but can only be interconverted. It is still unknown what kind of connections in his brain led him to this conclusion.  The period (1848) corresponds to the point at which science separated from philosophy. Mayer seems to have had one foot in each world and described things in the following incomprehensible way:

  • If two bodies find themselves in a given difference, then they could remain  in a state of rest after the annihilation of [that] difference if the  forces that were communicated to them as a result of the leveling of  the difference could cease to exist; but if they are assumed to be indestructible,  then the still persisting forces, as causes of changes in relationship,  will again reestablish the original present difference.

(I have not looked for it but one can only imagine what the original German was like). Warmth Disperses and Time Passes. The History of Heat, Von Baeyer’s popular book on thermodynamics, describes the ups and downs of Mayer’s life, including the death of three of his children which, in combination with rejection of his ideas, led to hospitalization but ultimate recognition and knighthood.  Surely this was a great observational study although, as von Baeyer put it, it did require “the jumbled flashes of insight in that sweltering ship’s cabin on the other side of the world.”

It is also true that association does imply causation but, again, the association has to have some impact and the proposed causality has to make sense.  In some way, purely observational experiments are rare.  As Pasteur pointed out, even serendipity is favored by preparation.  Most observational experiments must be a reflection of some hypothesis. Otherwise you’re wasting tax-payer’s money; a kiss of death on a grant application is to imply that “it would be good to look at.…”  You always have to have something in mind.  The great observational studies like the Framingham Study are bad because they have no null hypothesis. When the Framingham study first showed that there was no association between dietary total and saturated fat or dietary cholesterol, the hypothesis was quickly defended. The investigators were so tied to a preconceived hypothesis, that there was hardly any point in making the observations.

In fact, a negative result is always stronger than one showing consistency; consistent sunrises will go by the wayside if the sun fails to come up once.  It is the lack of an association between the decrease in fat consumption during the epidemic of obesity and diabetes that is so striking.  The figure above shows that the  increase in carbohydrate consumption is consistent with the causal role of dietary carbohydrate in creating anabolic hormonal effects and with the poor satiating effects of carbohydrates — almost all of the increase of calories during the epidemic of obesity and diabetes has been due to carbohydrates.  However, this observation is not as strong as the lack of an identifiable association of obesity and diabetes with fat consumption.  It is the 14 % decrease in the absolute amount of saturated fat for men that is the problem.  If the decrease in fat were associated with decrease in obesity, diabetes and cardiovascular disease, there is little doubt that the USDA would be quick to identify causality.  In fact, whereas you can find the occasional low-fat trial that succeeds, if the diet-heart hypothesis were as described, they should not fail. There should not be a single Women’s Health Initiative, there should not be a single Framingham study, not one.

Sometimes more association would be better.  Take intention-to-treat. Please. In this strange statistical idea, if you assign a person to a particular intervention, diet or drug, then you must include the outcome data (weight loss, change in blood pressure) for that person even if the do not comply with the protocol (go off the diet, stop taking the pills).  Why would anybody propose such a thing, never mind actually insist on it as some medical journals or granting agencies do?  When you actually ask people who support ITT, you don’t get coherent answers.  They say that if you just look at per protocol data (only from people who stayed in the experiment), then by excluding the drop-outs, you would introduce bias but when you ask them to explain that you get something along the lines of Darwin and the peas growing on the wrong side of the pod. The basic idea, if there is one, is that the reason that people gave up on their diet or stopped taking the pills was because of an inherent feature of the intervention: made them sick, drowsy or something like that.  While this is one possible hypothesis and should be tested, there are millions of others — the doctor was subtly discouraging about the diet, or the participants were like some of my relatives who can’t remember where they put their pills, or the diet book was written in Russian, or the diet book was not written in Russian etc. I will discuss ITT in a future post but for the issue at hand:  if you do a per-protocol you will observe what happens to people when stay on their diet and you will have an association between the content of the diet and performance.  With an ITT analysis, you will be able to observe what happens when people are told to follow a diet and you will have an association between assignment to a diet and performance.  Both are observational experiments with an association between variables but they have different likelihood of providing a sense of causality.