The problem with the new US Dietary Guidelines

I've seen quite a few comments in opposition to the new, inverted food pyramid that the USDA released early last month. Most of these comments are from the groups and individuals that wanted the old pyramid the way it was, or who wanted the food pyramid to completely ban not just meat but anything that an animal was involved with in any way. But I've only seen one person who actually mentioned a genuine problem with what the USDA said, and that person is Nina Teicholz who wrote an extremely influential book on diet, called the Big Fat Surprise back in 2014. In this article I'll quote from Nina's substack on the subject; I've been a subscriber to her substack since she started it. When you click on this link, you'll be offered a prompt to read it for free or subscribe. I've never paid a cent.

Getting back to the subject, though, the problem with the guidelines is simple: the math doesn't work. 

See, the food guidelines have always had an absurd emphasis on the reduction of fat in the diet, especially "dat ol' debil" saturated fat, largely due to some studies from the post-WWII days that have been discredited - mainly by not having measurable positive effects - and at least one that reeks of fraud. Both HHS Secretary Robert F. Kennedy, Jr., and FDA Commissioner Marty Makary have repeatedly pledged to “end to the war on saturated fat” since they took office. To quote from Nina's article on this:

The cap on saturated fats has been a bedrock piece of advice since the launch of this policy in 1980, and it is why so many Americans avoid red meat, drink skim milk, and opt to cook with seed oils over butter.

Yet I learned from two administration officials that saturated fats will not be liberated after all. The longstanding 10% of calories cap on these fats will remain.

At the same time, the guidelines’ language will encourage cooking with “butter” and “tallow,” both of which are high in saturated fat. It will also introduce a colorful new food pyramid with proteins—including red meat—occupying the largest portion. These are powerful messages, never before conveyed by our national food policy, and are likely to influence consumer behavior. 

Let me put the food pyramid here, from her article again.

Her concern is that it isn't clear from this display that the old low fat diet guideline of 10% calories from fat (CFF) still applies. For individuals on their own, at home or free-living anywhere: Fine. As always, if you ignore it, it can't hurt you. 

But there’s another audience: the roughly 30 million children eating school lunches daily, plus military personnel, and the vulnerable populations—elderly and poor Americans—who receive food through federal programs, roughly 1 in 4 Americans each week. These programs are required by law to follow the Dietary Guidelines. For them, the numerical cap will trump any contrary language about butter and tallow. Cafeteria managers and program administrators will continue to adhere to the 10% limit, because that’s what the law requires.

For these captive populations, seed oils will remain the mandated cooking fat. The encouraging words about butter and tallow will essentially be meaningless.

For someone on a 2000 calorie/day diet, 10% calories from fat means 200 calories in a day; with fat at 9 roughly calories per gram, that's 22 grams/day. Nina goes on to show how little that is in a day. 

• 1 cup whole-fat yogurt for breakfast: ~5 grams

• 1 chicken thigh with skin, cooked in 1 tablespoon butter for dinner: ~12 grams

Total: ~17 grams of saturated fat for two small meals.

or

• 2 eggs cooked in 1 tablespoon of butter: ~13 grams

• 4 oz ribeye steak: ~6 grams

• Broccoli with 1 tablespoon butter: ~7 grams

Total: ~26 grams of saturated fat for two small meals

Her next topic is that the limit on fat impacts another good aspect of the recommendations, to increase protein. 

I’ve also learned that the new guidelines will increase the recommended amount of protein from the current RDA minimum of about 0.8 grams per kilogram of body weight to 1.2-1.5 grams. This is genuinely good news. Studies show this higher range is far better for weight loss, muscle maintenance, recovery from serious illness, and overall well-being—especially for school-aged children and older adults, two populations whose protein needs have been chronically underserved by current recommendations.

But here’s the paradox: with the cap on saturated fats still in place, this increased protein cannot realistically come from animal sources. A 4-ounce serving of lean beef provides 24 grams of protein but also delivers about 6 grams of saturated fat. Meeting the higher protein targets through beef, pork, or chicken thighs with skin would blow through the saturated fat limit by lunchtime.

So where will this protein come from? The only options that fit within the 10% saturated fat cap are peas, beans, and lentils—plant proteins that are mostly incomplete (lacking at least one of the nine essential amino acids), harder for the body to absorb, and packed with starch. To match the protein in 4 ounces of beef, you’d need over 6 tablespoons of peanut butter—between 500 and 600 calories, compared to 155 for the beef.

This isn't news to pretty much anybody that takes their fitness and health seriously, whether gym bros, marathon runners, distance cyclists, you name it. Vegetarian sources of protein are generally incomplete and require combing sources that complement each other and turn it into a proper mixture of the nine essential amino acids. Most people just reflexively believe that vegetables are good for you; so much that "fruits and vegetables" turn into one word. "Don't forget your fruitsandvegetables!" 

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Nina devotes a few inches of column space to look at the "why" of the updates, especially with the consideration that much of what secretary Kennedy and others had said they wanted to do in the guidelines either never got added or the addition got deleted along the way. It all comes down to silly political decisions. Things like how repeated reviews by teams of scientists around the world have concluded that things like the 10% calories from fat and limiting saturated fat are contradicted over and over again yet they still didn't want to get rid of those. 

"The large, rigorous clinical trials on saturated fats—on 60,000 to 80,000 people worldwide—could never demonstrate that reducing saturated fat lowered a person’s risk of death from heart disease or any other cause." 

Same Old, Same Old

Holiday aside, it's a typical last week of May. It has been pretty much fully summer for a week or two, although our pattern of afternoon thunderstorms much of the week hasn't developed yet. A couple of days ago, the National Weather Service forecast site for central Florida posted warnings of heat indices to around 105 or more but it didn't seem to materialize. This afternoon, the nearby Melbourne airport said it was 93 with a "feels like" temperature of 102. I tend to dismiss those, thinking that's what 93 feels like here, but those warnings seem most appropriate for people visiting or spending their first summer here. 

Gee summer already? Only four months left to late September.

The same day as the heat warnings, the Weather Underground posted this UV warning. I want to direct your attention to the text at the bottom. I didn't select the skin type, that's the way it was displayed by default so I didn't think to see if it said something different for other colors.

This is the UV warning I generally refer to as "Fatal within 15 minutes" but it really says 18 minutes. No more than 8 to 18 minutes exposure to the sun? Is that total sun for a full day or 8 -18 minutes at a time? Doesn't seem like it could be the second one because then they should instruct us about how many 18 minute exposures we can get and how long we need to hide inside between them.

A regular part of my life since about the time I turned 17 has been inhalant allergies. I was in high school and I'm pretty sure I remember seeing my parents' doctor in the fall of my senior year.  He prescribed an antihistamine called Teldrin, which was good for 12 hours and helped me through the allergies, which tended to be all day things when the grass fields by our house or everglades were burning. By the time I was in my mid-20s and working for a living, I decided to see an allergist. 

If you've never gone through this exorbitant ritual, the "gold standard" treatment is they first find out what you're allergic to, and then desensitize you to it with a series of injections. The test is done by injecting a tiny amount of the allergen under your skin and judging your degree of sensitivity by how big of a welt you get. 

I'll never forget this. I was tested for 60 different allergens - 60 different pin prick shots - and I was allergic to all 60. On a scale of 1 to 4 ++, I only scored less less than 3 on two things: newsprint and "common skin bacteria." My usual summary is "I'm allergic to everything that is now, or once was, alive."

I'll cut the story short and not give thousands of details, but in the 53 years since I first saw that doctor when I was 17, I've had four allergists, had the 60 (or 120) injections test done at each of those doctors, had a nose surgery that one quack, um, doctor swore by and did nothing I could tell, I've been put on the latest, most modern, "non-drowsy" antihistamines that last 24 hours, more eye drops for (maddeningly itchy eyes), glucocorticoid nose sprays and every modern alternative.  

53 years later, I still get maddeningly itchy eyes, runny nose, sneezing and everything else. I've switched from prescription antihistamines - that have gone to being nonprescription - to an old four hour OTC drug called chlorpheniramine maleate, which happens to be the exact same drug as the Teldrin I was taking 53 years ago; it's just that Teldrin was designed to be slow release so it lasted 12 hours. Do I have allergy problems less often? I don't know how to know that. In the last week, I've taken the antihistamine tablets a few times, not continually, but I live in a different part of the state and I'm sure there are different plants and allergens here. 53 years of the state of the art care and taking exactly what I took at the start. The only progress is that it doesn't require a prescription and is a penny or two per pill.

The War on Meat

While it turns out that the widely reported story that the latest Biden "infrastructure" bill had provisions to limit beef consumption to a few ounces a month was a fake news story tracked to the UK Daily Mail, that's a minor distraction.  There really is an all out war on eating meat, especially beef, which is grounded in nothing but pseudoscience and propagated rumor.  It has been going on for years and if you're like most people, you've probably have heard some of the arguments so long you tend to think they're true. 

We've covered some of this sort of stuff here.  Junk science is a pet peeve of mine and you'll hardly find an area of science more filled with junk than diet recommendations.  I'll link to this piece because it carries a great table of spurious correlations of the kind that show up in what I've called "he-who" studies:  "he who eats (or does) X is more likely to get Y;" that sort of thing.  There's a great deal of desire on the part of many people to know what they should eat.  Simply saying, "eat what your grandparents ate, not industrial foods" which is honestly as a good a recommendation as anything, doesn't get accepted well.  The alternative, real, randomized controlled experiments that would last for decades, is prohibitively expensive, hard to do, and nobody wants to wait.  As we noted while going through my wife's cancer 24 years ago, it takes five years to get five year survival data; extrapolate that to it takes a lifetime to get life extension data. 

The rest of the world does appear to want to institute a carbon tax on meat because of grossly exaggerated figures on the amount of impact animal farming has on methane production.  First off, the methane from cows is 1.8% of the greenhouse gas emissions in the US.  Second off, methane doesn't come from cattle farts, it comes from cattle burps.  I realize that might be a minor distinction, but the EPA, those high priests of junk science, jumped on the "regulate cattle farts" bandwagon under Obama.  The UN claims cattle create 18% of global greenhouse gas emissions - more than comes from transportation - but they're lumping in all livestock, not just cattle, to include poultry, lamb and all sources of meat.  They're also including the effects of animal feed production, feed harvesting, feeding the animals, the farm vehicles that tend to these animals and everything up to the emissions from the slaughterhouse.  A third of that 18% is blamed on deforestation specifically in Brazil.

Both of those summaries are dishonest.  First, it's not fair to blame methane production in chicken farming on cattle farming, and it's unfair to include everything that the goes into food production to just the tailpipe emissions of vehicles rather than the equivalent entire life cycle associated with transportation.  Second, the part about deforestation is dishonest for two reasons; the easiest being that there's no equivalent deforestation in the US, or in other parts of the world.  In the US the story is reforestation.  We have more trees today than a hundred years ago.  The other reason is that not all grassland could be forest and not all forest can convert to grasslands.  There is some relation between the two, but it's not simple subtraction.  Simply, much of the planet can't be dense forest and can only be grassland. 

Chances are, you've heard until you're subconsciously convinced that low fat foods are healthier.  That data was always suspect, but that cynical observation applies that says old science theories don't go away because the weight of evidence pushes them aside; they go away because old scientists who support them die off.  Since about 2000 there have been many good quality meta-analyses of all the studies that have been done before and concluded the evidence is just too weak to matter.  The diet-heart hypothesis that lifetimes of eating fatty foods and having elevated cholesterol levels led to heart attacks has had conflicting data, like that in older adults higher LDL is associated with longer life, long enough for studies to have essentially concluded the diet-heart hypothesis is dead. 

What about vegetarianism?  It's another belief that has far more faith behind it than evidence.  Seven years ago, I ran a review on a book I'd read by health writer Denise Minger, called "Death by Food Pyramid."  Denise was a 17 year old who had thought she should become a raw food vegan but was unaware of the constant effort required to not destroy her health.  Vitamin B12, for example, just doesn't come in plant matter, at least not to any level that eliminates the need for supplementation.  In Denise's case, she simply needed 17 teeth fixed.  At 17, she went to the dentist and after way too many disconcerting "hmm" sounds, heavy sighs, and pokes with pointy metal objects, found she needed to have 17 teeth worked on - coming from never having had dental problems before she became a vegetarian.  In the space of one year. 

In all of these struggles over diet, we have the same conflicts of interest of special interests that we've had with the Covid fiasco.  Everyone pushes to get their favorite industries pushed by the USDA Dietary Guidelines.  The vegetarian movement is largely pushed by the Seventh Day Adventist church, and some influential doctors they've won over to their side, like Dean Ornish, a diet book author and M.D., and Walter Willet, the very influential head of Harvard's School of Public Health.  The lowfat crowd is pushed by the grain and cereal industry.  The push to get people to eat less meat and saturated fat is pushed by the vegetable seed oil industry, which may well be the absolutely worst things in our processed foods. 

Someone who has spent the last several years fighting to get the USDA Dietary Guidelines fixed is Nina Teicholz, who went from being a low-fat, vegetarian food writer to an omnivore heading the Nutrition Coalition, an organization trying to get the dietary guidelines to more honestly assess science that has been pouring in within the last 20 years.  This an hour long, but very worthwhile talk on many of these topics. 

At the risk of overstating the obvious, If a Government Committee Recommends Something, Do The Opposite, as I said here.  If they tell you to limit red meat, maybe you should eat more of it.

Turns Out the FDA is Blocking Another Covid-19 Vaccine

Remember this post from the end of December, about how the first Covid-19 vaccine was available in January of 2020, but the FDA wouldn't approve it?  They wouldn't allow volunteers who would take the vaccine be exposed to the virus because it wasn't protocol. 

The FDA prohibited rapid "challenge trials"—where volunteers take the vaccine and then expose themselves to the virus in a lab, rather than waiting agonizing months to see how many catch the virus "in the wild." The challenge trials could have proved the effectiveness of the vaccine in weeks or a month or two. The FDA considered the risk to the volunteers to be too high.

The December article was based on one from the Foundation for Economic Education, and FEE does it again this weekend with "The FDA Is Holding Up a Cheap Vaccine as COVID Deaths Surge" by John Miltimore, Managing Editor.  This one concerns the Oxford-AstraZeneca vaccine, developed as its name implies, by Oxford researchers and produced by AstraZeneca.  In summary, it's based on a better known technology than both Pfizer and Moderna's vaccines (modification of an adenovirus - a cold virus), it's easier by far to handle than Pfizer's, still easier than Moderna's and it's the cheapest of the three vaccines by far. 

From American Council on Science and Health, November 2020.

The ability to handle the vaccine by keeping it between 36 and 46 F which most standard refrigerators will do, as opposed to -94F (Pfizer) which takes extraordinary measures and -4F (Moderna) which most standard freezers can do, will save money in getting the vaccines distributed.  Add that to $4/dose instead of $19.50 (Pfizer) and $37 (Moderna) and the economics are a slam dunk win for AstraZeneca.

The strongest argument for the AstraZeneca vaccine, though, may be the bottom line in that comparison.  AstraZeneca can produce and ship almost three times the amount of vaccines that Pfizer and Moderna can ship - combined.  Between the three, should we keep a commitment to using all three, that's likely enough to vaccinate everyone in the US that would accept vaccination.  (Note that all three require two doses)

Oh, the AstraZeneca vaccine has been approved by and is being administered in the UK.  It is being produced in Baltimore.  Really.  Baltimore.

It's worth pointing out the story behind the strange effectiveness rating of the AstraZeneca vaccine, of "62% to 90%" in the third row of that chart.  In the initial test, someone accidentally miscalculated the dosage and the experimental group got half the required dose on the first shot.  The mistake was found and the dosage doubled to normal for the second shot.  That group had 90% effectiveness.  When they did the second group with the "proper" dosage for both shots, the effectiveness was 62%. 

Peter Openshaw, professor of experimental medicine at Imperial College London, said the finding that a smaller initial dose is more effective than a larger one is good news because it may reduce costs and mean more people can be vaccinated.

“The report that an initial half-dose is better than a full dose seems counterintuitive for those of us thinking of vaccines as normal drugs: With drugs, we expect that higher doses have bigger effects, and more side effects,” he said. “But the immune system does not work like that.”

So what's up with the FDA?  Last time I remarked that it was a CYA move.  Someone said why should they care when nobody is ever held responsible for mistakes in Washington.  It's a bit more than that.  The FDA, like all agencies, is not there to protect the population, it's there to establish and follow procedures, as this two year old twitter exchange between Thomas Sowell and Christopher Manion talks about.  Both of them are very right.

In the Aerospace world where I worked all my career, the situation at my level was more results oriented than a bureaucrat, but it was common knowledge to talk about the guy who would sit in front of the Senate or House, on the evening news, saying he had no knowledge of the bad things going on.  

In a situation like this, think of the two errors that the FDA could possibly make.  Think of some dude at a desk where he wants to work without making waves for 40 years and retire with a fat pension.  Most especially, he really, really doesn't want to be the guy telling the senators running the inquiry that he did anything other than the black letter procedures he's supposed to follow.  He can make two mistakes.  He could approve a bad drug and cause lots of harm to people, or he could fail to approve a very good drug and still cause lots of harm to people.  In the first case, he's more likely to be sitting in that seat in front of the inquisition committee explaining why approving the bad drug was following procedures properly.  In the second case, when he fails to approve a good drug, people die but the bodies are buried in an invisible graveyard.

Bureaucrats get in trouble for doing the wrong thing, not failing to do the right thing.

Clap For The Covid

Sung to the tune of Clap For the Wolfman because it has the same rhythm.  Now that I've implanted that ear worm...

In the most bizarre news story of at least the last 15 minutes (hey, it's still 2020 after all) we find that Covid-19 is being blamed for a particularly nasty strain of "the clap:" gonorrhea.  The New York Post covers the story, H/T to Twitchy by way of PJ Media.

The unnecessary overuse of antibiotics during the coronavirus pandemic has created a rise in drug-resistant strains of super gonorrhea, according to a new report.

Azithromycin, a common antibiotic used to treat chest and sinus infections, has been used during the pandemic to prevent co-infection of hospitalized coronavirus patients and to treat inflammatory symptoms of severe infections.
...
“Overuse of antibiotics in the community can fuel the emergence of antimicrobial resistance in gonorrhea,” a WHO spokesman told the outlet, noting that azithromycin was used for COVID-19 treatment earlier in the pandemic.

Covid-19: is there nothing it can't do? 

I have lots of issues with this story.  The big summary is that it's just more fear mongering.  There is not one study cited to justify the claim, not even the associational "he who" studies that are the bulk of all the junk science in the press.  They didn't say anything like Covid patients treated with azithromycin were more likely to have antibiotic-resistant gonorrhea, and at least that makes some sense.  They presented no data whatsoever, except that there's more of this "super gonorrhea."  So frickin' what?  There could be reasons not even remotely related to using antibiotics to treat Covid-19.  Don't forget, there's this thing called coincidence, too.  

Besides, think of a Venn diagram of the sets of people who are fooling around with anyone they can find regardless of how sick they are and the set of people who are being treated for Covid.  How big do you think the intersection of those sets is? Who do you think comprises that intersection?  As a rough guess I'd say there aren't many 80 year old nymphomaniacs in nursing homes.  I can't say for sure, but I bet if an ICU nurse walked in on a patient hooked up to a ventilator having sex with anyone, that would be the stuff of legends in that hospital. 

(iStockphoto of a petri dish culture of something or other, used by the NY Post.  You know they meant to use a scary looking picture for their scary junk article.  Judging by the accuracy of the rest of the article, this is probably a cell culture of cucumbers)

There.  I saved you the time of reading this so I could make fun of the study.  Just doing my part to be a full service blog.

We Had a Covid-19 Vaccine Just Under A Year Ago

But first a B-i-i-ig R-o-o-und number.  This is post number 3,700 in the life of this blog with my 11th blogiversary just under two months away.  For quite a while I've been averaging just under a post a day; maybe missing one or two a month.  At this rate, I'll reach post number 4,000 around mid-July.

Self-congratulations aside, it has been slow news week as I'm sure you've noticed.  An interesting thing I came across earlier in the week is an article on the Foundation for Economic Education (FEE's) website and daily email that said the Moderna vaccine was actually developed last January.  It could theoretically have been allowed to enter testing last January and might have been available months earlier than when it entered use a couple of weeks ago.  All except for one big thing: the Food and Drug Administration. 

The vaccine, a triumph of medical science known as mRNA-1273, was designed in a single weekend, just two days after Chinese researchers published the virus's genetic code on January 11, 2020.

For the entire duration of the pandemic, while hundreds of thousands died and the world economy was decimated by lockdowns, this highly effective vaccine has been available.

Why?  The FDA prohibited rapid "challenge trials"—where volunteers take the vaccine and then expose themselves to the virus in a lab, rather than waiting agonizing months to see how many catch the virus "in the wild."  The challenge trials could have proved the effectiveness of the vaccine in weeks or a month or two.  The FDA considered the risk to the volunteers to be too high.

The easiest word for a bureaucrat to say is "No" and that's what the FDA did here.  Now, I can understand the FDA's desire to make sure the volunteers don't get killed by the virus, but following blanket policies that apply at all times and in all circumstances doesn't make allowances for unusual circumstances.  As the author at FEE points out, somewhere close to the first 200,000 people to die of Covid-19 in the US died after this vaccine could have been available.  During a raging pandemic, might the balance of risk that's allowed be a little different? After all, the potential deaths of volunteers is not the only cost.  The monster cost is the death toll on the world's population from the virus.  The Godzilla: King of the Monsters cost is the suffering caused by lockdowns, especially the economic suffering.

There can be no other conclusion than the acronym CYA - Cover Your Ass.  The FDA was covering their collective asses rather than trying to help the population.  It's a tragic truth that they're a cowardly medical bureaucracy that would rather allow hundreds of thousands of people to die than face any potential criticism for allowing an accelerated vaccine trial.  CYA, unlike "no", is not a word that bureaucrats say.  It's just how they live their lives. 

The author at FEE suggests that based on what we know about how quickly the vaccines are produced and how quickly they could have been tested, that the Moderna vaccine could have been available last March or April.  Instead of the first wave of COVID deaths and lockdowns in the United States, we could have seen a wide vaccine rollout, leading to rapid herd immunity, and the pandemic being curtailed before it really got started. 

The Moderna vaccine being administered.  Photo from FEE.

The answer is more freedom and less Tyranny of Experts. 

The Virus Response Goes Far Beyond Sanity

Two stories have emerged in the last few days.  One just stupid, the other ominously stupid.  The simply stupid one first

You may have seen this story at Western Rifle Shooters; Ireland, a country of about 5 million people, has gone to a severe lockdown system where people are forbidden to go more than 5 km, or 3 miles, from their homes. 

Irish biochemist and podcaster, Ivor Cummins shows data that during the worst of epidemic in Ireland, the death rate was approximately one person per million per week.  A total of 1,852 people are listed as fatalities of the virus, but as Ivor points out in the video, during the worst of the epidemic, when fatalities were rising almost vertically on the graph he shows, 95% of the people diagnosed with Covid were not given treatment (!) because they were considered too ill or weak for ICU treatment, and left to die (it's a Nationalized Health System there; they let people die all the time).  The 5% remnant that was treated represents 93 deaths, or just over 13 weeks at 1 death per million.  The situation isn't that bad now.  The current ICU population is around 7 people in ICU per million population. 

Why? This video from Ivor last week has the same question but outlines what seems to be the plans for the new lockdown.

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The other case, as I said, is more ominous.  This story broke a couple of days ago and was picked up by Breitbart, linked from Watts Up With That.  Dr. Michael Levitt, winner of the 2013 Nobel Prize for Chemistry was cancelled from a biodesign conference, a specialty he practically founded, because of things he as published about Covid-19.  Read that again: the conference had nothing to do Covid-19, he was cancelled because conference organizers had received ‘too many calls’ from other speakers ‘threatening to quit’ because of his views on Chinese coronavirus. He has long maintained that the threat is overblown and that ‘we’re going to be fine.’

Professor Levitt – Professor of Structural Biology at the Stanford School of Medicine – was one of the earliest critics of what he sees as the worldwide overreaction to Chinese coronavirus. He describes the extreme measures taken by many governments to control it as ‘another foul-up on the part of the baby boomers.’

He told the Unherd podcast:

I am a real baby boomer – I was born in 1947, I am almost 73 years old – but I think we’ve really screwed up…We’ve left your generation with a real mess in order to save a relatively small number of very old people.

Though his position has earned him many enemies within the scientific establishment,  his predictions of the disease’s trajectory have proved a lot more accurate than the scaremongering models of alarmists like Neil Ferguson.

Dr. Levitt put it this way in his Twitter statement:

His thought crime was to observe that in outbreak after outbreak of this disease, a similar mathematical pattern is observable regardless of government interventions. After around a two week exponential growth of cases (and, subsequently, deaths) some kind of break kicks in, and growth starts slowing down. The curve quickly becomes “sub-exponential.”  Pretty much everyone who has analyzed the numbers has seen this pattern, and  - Newsflash! - it's so common among viruses that it has a name, the Gompertz curve.  I know I've written about this before, referencing an article from April.  

This may seem like a technical distinction, but its implications are profound. The ‘unmitigated’ scenarios modelled by (among others) Imperial College, and which tilted governments across the world into drastic action, relied on a presumption of continued exponential growth — that with a consistent R number of significantly above 1 and a consistent death rate, very quickly the majority of the population would be infected and huge numbers of deaths would be recorded. But Professor Levitt’s point is that that hasn’t actually happened anywhere, even in countries that have been relatively lax in their responses.

Now practitioners in the field of Computational Biology and Biodesign are rejecting the father of the field because he points out a simple truth that anyone who can do computations should be able to recognize.   And yet these people call themselves scientists. 

As Dr. Levitt says, A New Dark Age Cometh.

Two Cents on the Debate

I seriously doubt I'll watch the debate tomorrow night.  These aren't debates, they're press events.  A moderator asks some questions and the candidates recite their platform.  Sometimes they throw a barb at each other.  Whoop-ti-do.  These things have been very over-rated (IMO) ever since the Nixon-Kennedy debate in 1960.  Very few are as big as that one was.  Early in the life of this blog, I summed up my feelings about day-to-day politics this way:

Preparing for an election is like cleaning out the litter box.  It's a disgusting, revolting task that exposes you to all sorts of dirty, filthy things you'd rather never see, but if you don't do it, the job gets even more disgusting and revolting.

My two cents is that the right has so thoroughly and dramatically lowered the bar for Biden that all he has to do is not obviously soil himself and it'll be his win to the media.   He just needs to stay mostly coherent for the duration.  

I've seen and smiled at the memes as much as anyone, like this meme from 90 Miles From Tyranny:

His campaign office has put a lid on stopped taking calls or letting him talk after mid-morning.  People make references to him displaying Sundowner's syndrome, a recognized symptom in certain types of dementia that cause patients to lose coherence in the evening.  This is just lowering expectations; lowering the bar.  He's a doddering old senile fool, we expect him to start talking about Corn Pop or the hair on his legs. 

Has anybody been considering that maybe they're shifting his body clock so that he's at his best at night?  Have him sleep all day, get up at 7PM and prepare for the debate, knowing that to his body clock this is the best time of day.  At the worst, that change takes one day per time zone, but I'm sure age and general health affect that.  I've flown 8 time zones away and was doing fine the next day.  How long have they been shutting down in the morning?  A week?  12 days, so that he gets up at 6 or 7 PM instead of 6 or 7 AM?  Practically, if someone is shut off from all external cues, like seeing the sun, they can live by any arbitrary clock, so all his handlers need to do is keep him indoors with no windows and get compliance to the clock.  They do this for everyone working on a submarine, after all.  It's not "cruel and unusual."  With no external cues, you go to bed when you're told and wake up when you're told.  It doesn't matter what the time of day really is somewhere outside. 

Last week, Bayou Renaissance Man ran a post positing that Biden's campaign was Elder Abuse and that “we” shouldn't stand for it.  Peter, should you happen to be reading this, recognize that the one pushing Joe Biden isn't just the Democrat establishment, it's his wife, Dr. Jill Biden.  She's pushing him because she's wanted to be first lady, and the power behind the throne, for ages.  People are betting who replaces Joe when he obviously can't do the job.  Kamala?  Mooch Obama?  Don't overlook Dr. Jill re-enacting how Woodrow Wilson's wife Edith took over the country. 

An Interesting Economics Experiment

Economics is regularly derided as "the dismal science" but in my experience contains the only social science law that approaches the character of physical law: supply and demand.  More relevant to my peripatetic writings tonight is that economics frequently studies incentives and how they work.  

The Silicon Swamp area isn't a big city or anything the size of Silicon Valley, but it's not a small town either.  The entire county, 70 miles long and mostly along the coast, has a population of about 600,000.  As of this afternoon, there have been exactly 2 confirmed COVID-19 cases in the county.

Last week on our weekly grocery store run (a Publix), the only things that were in short supply were toilet paper and Clorox wipes (Mrs. Graybeard prefers those for cleaning the stove so they're something we buy regularly).  Today was different.  The entire toilet paper, facial tissues and paper towels aisle was stripped clean, and all around the store other sections were either bare-shelved or stripped close to bare.  Rice and pastas had a couple of packages left.  There was not a single package of chicken, or turkey to be had.  Do I need to say I've never seen anything like this?

Many sections had a "Limit 2 per customer per day" sign, including eggs, prepared meats and cheeses, prepared sauces of all ethnicities (like Italian, Mexican, etc) and more.  It got me thinking this is an interesting economics experiment, in that sense of economics as the study of incentives.

In particular, when faced with a sign like that and a need for one, do you buy one like every week or do you buy two on the possibility it's worse next week and there are none to buy?  We had that with eggs.  There were very few eggs out; not stripped clean but close.  We ordinarily get a local brand of "pasture raised, all natural" eggs (because the package has picture of a manatee on it, we refer to these as manatee eggs).  Ordinarily, we go through about a dozen eggs a week.  We bought two dozen this week on the possibility these are the last eggs we'll get for a while.  

As I said, that was all around the store.  My guess is that the limit causes more people to increase what they would buy rather than limit it.  People coming for a few giant packages of paper towels or TP will stop at two because they have to.  There's no saying they won't come back the next day, though, while it's pretty sure that we won't. 

To be honest, the response to the Coronavirus scares me more than the virus does.  The only scary thing about the virus is that it reproduces.  Eventually, everyone gets it and gets over it (or not, whether the fatality rate is 1% or 3% or 0.2% is still hard to know); the essence is that it's still self-limiting in the long run.  Gradually, the population develops immunity to the virus and the toll lessens.  The reaction of sending everyone in the country a "four digit" check is terrifying.  It seems like Modern Monetary Theory springing to life and I've always been critical of these ideas.  They believe they can make up whatever amount of money they want out of thin air, and I say that devalues every dollar we have.  I've said a thousand times that printing money out of thin air is painting a target on the backs of the middle class and especially anyone living (or planning to live) on savings.

Stupidity in the response to the virus?  As Einstein said, “two things are infinite: the universe and human stupidity; and I'm not sure about the universe.” 

Quarantined Cruise Ship in Japan May Now Be The Best Place to Study the Virus

The news broke today that the cruise ship Diamond Princess that has been in the news for being quarantined in Japan now has 175 confirmed infections from the 2019 novel coronavirus (2019-nCoV).  There are 39 new confirmed cases among passengers and crew members and one confirmed case in a Japanese quarantine worker.

Since the outbreak began in December, there have been over 45,000 confirmed cases of COVID-19 worldwide and at least 1,115 deaths. But while 2019-nCoV has spread to at least 24 countries beyond China, nearly all of the COVID-19 cases and all but one death have occurred in China.

According to the latest figures from the WHO, 44,730 cases are confirmed in China, while a remaining 444 are outside the country—including the 175 cases linked to the Diamond Princess. The tally is by far the largest outside of the outbreak’s epicenter; the country with the next-largest COVID-19 outbreak is Singapore, with 50 confirmed cases, according to WHO.

It's reported that the Japanese quarantine worker wasn't wearing highly protective clothing for high biosafety level areas, just wearing a mask and gloves.  He was handing out questionnaires and checking the health of passengers and crew members. 

Assuming passengers don't jump overboard and find ways to get back onshore (always easier at a dock than when miles at sea), this seems like a good opportunity to study the virus.  It could allow study of how long the virus survives on surfaces, and how effectively it spreads.  This is an isolated population, after all.  Patient zero, the first patient to contract the virus on the ship, is known:

Screening for COVID-19 on the ship began after a previous guest tested positive for the virus in Hong Kong on February 1. The man, who is from Hong Kong, boarded the Princess January 20 in Yokohama at the start of a 14-day round-trip voyage. The man sailed a leg of the voyage before disembarking during a stop in Hong Kong on January 25. Meanwhile, the ship sailed on. Upon news that the guest tested positive on February 1, the Diamond Princess returned to Yokohama a day early and has been quarantined ever since, with guests in isolation in their cabins.

It is still unclear when and where the man from Hong Kong became infected and how the virus has spread among people on the ship. It may be that the outbreak involved a so-called “super-spreader,” which means that a single infected patient sheds the virus extremely efficiently and infects an inordinate number of people. But again, it is unclear how many people may have brought 2019-nCoV aboard and how—or if—the 175 cases are all linked.  

I suspect that most of you have been reading what Aesop at Raconteur Report posts about the virus, like this one.  I sure have.  Having an isolated population like this might be a good way to study this virus and perhaps reduce the uncertainties that seem to apply to just about every characteristic.  There are 3,711 people on board the Diamond Princess; Reuters reports that roughly 80 percent of the passengers (over 2,900) are aged 60 or older, with 215 being in their 80s and nearly a dozen over 90. Those age groups have been among the most vulnerable demographics in the outbreak overall.  If those same percentages apply to the 175 cases and 80% of the cases (140 people) are over 60 years old, I'm afraid that will be where the largest number of deaths come from. 

The Diamond Princess at dock in Yokohama.  Getty Images photo.

Texas Jury Blocks Father From Preventing His Son's Sex Change

I want to copy and paste some of the Washington Examiner news story here to get the wording exactly right.  It says:

Texas father blocked from stopping gender transition of son James, 7, to girl called Luna.

That's correct but incomplete.  It should read:

Texas father blocked from stopping his ex-wife forcing the gender transition of son James, 7, to girl called Luna.

Sounds different, doesn't it?  A little farther down in the story it becomes clear that the father, Jeffrey Younger, had petitioned a court in Texas to grant him sole custody of his twin sons, James and Jude specifically to avoid this and his ex-wife was granted the sole custody of the boys.  

Anne Georgulas, the mother of the two boys, has advocated for James to transition into Luna and has strongly backed the idea of chemically castrating her son and beginning hormone replacement therapy. The ruling on Wednesday will prevent Jeffrey from having sole custody of his children and paves the way for Georgulas to proceed with the procedure.

The court has ruled that Georgulas will maintain sole custody of her two children and go forward with plans to give James life-altering medical procedures. Her original court filing had sought to limit her ex-husband's visits with their children and require that he now refer to James as Luna.

What caught my attention in this story is that they're talking about puberty blocking drugs for seven year old James, a type of drug I did a story on back on October 7th.  One of the main takeaways from that article is that these are very dangerous drugs and have a disruptive effect on the complete endocrine system of the child, likely putting them onto hormone disrupting drugs for life.  The problems associated with forcing these drugs on a child who may not even need them are irreversible and include cancers, cardiovascular events such as heart attacks and blood clots, suicidal behavior and other psychological disorders, brittle bones, painful joints, and sterility. 

The various news stories go back and forth on it, but to me, the biggest point is that there was testimony from medical professionals (admittedly witnesses for the father) who said James doesn't meet the diagnostic criteria to have gender dysphoria according to the DSM-V, and that his behavior may be trying to fit in with whomever he's around: mother or father.  The doctor claims James doesn't appear to exhibit "distress" when associated with his male identity, a requirement for diagnosis.  Could it be the annulment of the parents' marriage and being involved in a custody dispute is what's bothering James and that's the real issue?  J. Kb at Gun Free Zone put it like this. 

I am usually the first to say “no, there probably shouldn’t be a law” but when it comes to letting a child who still thinks Santa and the Easter Bunny are real decide to claim an alternate gender identity and then use that as evidence for chemical and surgical mutilation of that child, there should be a law against that.

I think this cartoon gets it right for the societal question.  For this family, it seems like the root is the conflict between the parents.  It seems like the mother is trying to get back at the father and, unfortunately, is going to sacrifice and quite possibly kill her son to hurt his father.  I'm sure she'd somehow see it differently.

Pat Cross Cartoons for October 8th.

Hey, what do I know?  I fix radios, not people.  If one of the radios is really behaving oddly, I can redesign it or replace a lot of parts and rebuild it. 

The Awful Human Toll of Puberty-Blocking Drugs

Today I tip my hat to FreePressers for an article on the awful death toll of the puberty-blocking drugs being prescribed more often over the last few years for children with gender dysphoria.

Let's get right to the numbers:

The FDA between 2013 and June 2019 reported 41,213 adverse events, including 6,379 deaths and 25,645 “serious” reactions in patients who took Leuprolide Acetate, the hormone blocker known as Lupron.

Lupron is being used — without formal FDA approval — as a puberty blocker on an increasing number of children and adolescents who say their gender identity is not consistent with their biological sex, Breitbart News noted in an Oct. 2 report.

That's 6,379 deaths in about six years or well over 1,000 per year (1063).  The wording says that there were 34,837 adverse events with 25,645 of them being classified as “serious.”  I rush to point out that this is considered "off label" use for the drug; which means it's not formally approved to block puberty in children.  Lupron, is clinically approved for treatment of prostate cancer in men, endometriosis in women, and, for a short period of time, “precocious puberty” — a condition in which children begin puberty at a significantly younger age than is considered normal.  Because the approved uses are in much older patients, the data don't tell us how many of those deaths and side effects are in children. 

Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, told Breitbart News that Lupron “is off-label for lack of long-term studies,” adding it “undoubtedly causes irreversible loss of fertility and many other adverse effects that are potentially lethal. It does not turn a male child into a female child, only into a eunuch who will lose his full potential for growth and strength. Children have no capacity to comprehend these long-term consequences, so the use of this drug in gender-confused children constitutes unethical experimentation; informed consent is not possible.”

Dr. Orient hits an important point.  We're giving these children these powerful endocrine disruptor drugs at the time in their lives when they're building their bones and bodies for the rest of their lives.  Are we going to ruin their health as adults?  California-based endocrinologist and specialist on childhood gender dysphoria Dr. Michael Laidlaw spoke out about the use of Lupron.

Laidlaw said in an interview with the Christian Post that Lupron may be therapeutic for men coping with prostate cancer, but that “gender dysphoria is not an endocrine condition, but is a psychological one and should, therefore, be treated with proper psychological care.”

Laidlaw warned that once puberty blockers and cross-sex hormones are injected into children, an “endocrine condition” in these children will develop.

Complications related to the use of Lupron include cancers, cardiovascular events such as heart attacks and blood clots, suicidal behavior and other psychological disorders, brittle bones and painful joints, and sterility.  Unless we're abandoning these young people, essentially saying that because they feel this dysphoria now we're going to conduct medical experiments on them with care if they live or die, the use of this drug needs to be stopped.  In children, five year tests for adverse effects are inadequate.  We'd like perhaps as much as 15 or 20 year tests for long term lack of side effects.  St. Louis-based pediatric endocrinologist Dr. Paul Hruz said

“It’s often claimed that medical blockade of puberty allows a child more time to sort out issues of their gender identity, that it alleviates dysphoria in affected children, and that it makes it easier if and when they choose to go on and get other treatments, namely [sex change] surgery,” Hruz said. “It’s also claimed that it’s completely safe and reversible.” [but],

“The reality is that there is no long-term data about treating children, and the only data that we have in adults indicates that medical interventions to align the appearance of the body to a transgendered identity does not fix the problem,” Hruz said.

I feel tremendously sorry for people with real gender dysphoria, and the numbers they face for a long term prognosis make many cancers look positively benign.  I know since this fuss over gender reassignment started reaching Category 5 storm levels, I've heard several people say they've gone through the treatments, had the surgery, and they still don't feel what they think is right - just as Dr. Hruz says.  Medicine needs to find a way to treat these people. 

On the other hand, when the whole “let's redefine words again” way of pushing for privileges came to gender a little while ago and we started suddenly hearing that a condition, formerly referred to as being rare, less than 1/2% of the population, was everywhere, I could see a problem coming.  We began hearing of parents apparently pushing their children into these sorts of treatments, more than I'd think seemed to be justified by that half percent.  I've run across people in my life who seem to live vicariously through their children.  If you couple that desire to live through their children with the desire to be victims, I can imagine some making their children the victims of gender dysphoria so they have the socially cool condition.  Dr. Laidlaw mentions the concept of treating a child with Lupron from the age of 5.  Five!!  Without some really strong backing, I'm not going to believe that's anything but the parents pushing this. 

Photo from Wikimedia Commons

Last words to Dr. Laidlaw:

“I think it’s very obvious that the Surgeon General needs to step in and become seriously involved in an investigation as to why drugs like Lupron, which are obviously extraordinarily risky, are being used off label to arrest the normal development of thousands of healthy adolescent bodies,” Laidlaw told Breitbart News.

“If this were any other (non-politicized) situation and this sort of harm was occurring, the doctors and pharmaceutical manufacturers behind it would be investigated immediately, and it would be all over the press,” Laidlaw said.

New Hope for People With Skin Ulcers

It's probably safe to assume that you know we're in the midst of a diabetes epidemic.  While there are some very promising treatments that will reduce or eliminate the overt presentation of the most common forms of the disease, there are millions suffering right now.  Among the common diabetic complications are skin ulcers; miserable, painful open sores that require many treatments.  It has been reported that a single diabetic foot ulcer can cost approximately $50,000 to treat.

This week brings news via Machine Design that the Wake Forest Institute of Regenerative Medicine (WFIRM) has developed a new 3D bioprinting technique to help enhance treatment response time and create overall better skin graft results.  WFIRM published their results in Nature, which is currently allowing us to read and download the paper (pdf).  Due to the need for a sterile environment, the treatment is done in an operating theater.  The patient then lies in the printer while it sprays layers of cells onto their wound. The end result is that it builds up, layer by layer, what will function as a skin graft.

The new bioprinter from WFIRM combines the delivery systems of inkjet printers with mobility and the scanning capability of different topographies. The research team outlined its design and printing approach in the paper “Bioprinting of Autologous skin Cells Accelerates Wound Healing of extensive excisional Full-thickness Wounds.” The main components of the system are a handheld 3D scanner and a print head that can move in any XYZ direction. The print head contains eight 260 μm diameter nozzles, each driven by an independent dispensing motor. The printer components are mounted on a small frame which can be used in an operating room. The system is 79 cm wide (patient head-to-toe direction) by 77 cm deep (cross-patient direction). The system includes a robotic arm and, when fully extended, adds an additional 50 cm—combining for a full reach of 127 cm.

The scanner attached to the printer system is the ZScanner Z700 scanner from 3DSystems. As noted, the scanner is handheld and easy to use. It can capture the entire wound in one continuous scan which results in a computer model of the wound. The model is processed via Geomagic Studio and imported into Artcam 3D software to obtain the full volume and the nozzle path needed to print the fill volume. The wound is split into Z axis layers for its depth, corresponding to dermis and epidermis layers, and each Z-axis layers is overlaid with XY lines that cover the entire wound.

The printer uses the same sorts of techniques as inkjet printers: the delivery system is based on cartridges, and each cartridge contains a different type of sterile compound rather than a different colored ink.  Each nozzle is connected to a separate cartridge, and each cartridge contains a matrix of fibrinogen and collagen. Separate atomizing nozzles deposit thrombin on the fibrinogen matrix to produce fibrin simultaneously (clotting, to hold everything in place).  The system is just barely pressurized - a mere 1 pound per square inch difference drives the material.

Skin bioprinter prototype. (A) Schematic demonstrating scale, design, and components of the skin bioprinter. (B) The main components of the system consist of 260 µm diameter nozzles, driven by up to eight independently dispensing systems connected to a print-head with an XYZ movement system, in addition to the 3D wound scanner. All components are mounted on a frame small enough to be mobile in the operating room. (C) Skin bioprinting concept. Wounds are first scanned to obtain precise information on wound topography, which then guides the print heads to deposit specified materials and cell types in appropriate locations (Images courtesy of LabTV - National Defense Education Program, Washington, D.C.). (D) Example of skin bioprinting process, where markers that are placed around the wound area used as reference points: (a) prior to scanning with a hand-held ZScanner Z700 scanner (b). Geometric information obtained via scanning is then inputted in the form of an STL file to orient the scanned images to a standard coordinate system (c). The scanned data with its coordinate system is used to generate the fill volume and the path points for nozzle head to travel to print the fill volume (d). Output code is then provided to the custom bioprinter control interface for the generation of nozzle path needed to print fill volume (e, f). (E) This system facilitates the depositing of multiple cell types with high precision and control. The layering of fibroblasts (green) and keratinocytes (red) is shown.

Based off this delivery system, the keratinocytes [skin cells] and fibroblasts [cells which form the collagen matrix that supports the skin cells] are mixed into a hydrogel and delivered directly on top of the wound layer by layer, replicating the skin structure and accelerating the healing of normal skin and function. The research team has had successful results on mice in clinical trials. The new skin begins to form outward from the center of the wound and, by using the subject’s own unaffected cells for new cell delivery, it allowed the subject’s body to accept the new skin and prevent tissue rejection.

“The technology has the potential to eliminate the need for painful skin grafts that cause further disfigurement for patients suffering from large wounds or burns,” said WFIRM Director Anthony Atala, M.D., a co-author of the paper.

“If you deliver the patient’s own cells, they do actively contribute to wound healing by organizing up front to start the healing process much faster,” added James Yoo, M.D., Ph.D., who led the research team and co-authored the paper with Atala. “While there are other types of wound healing products available to treat wounds and help them close, those products do not actually contribute directly to the creation of skin.”  Note: anything in square brackets added by me - SiG

All work done so far has been done on experimental animals, as medical regulators demand.  The next step is to conduct a clinical trial on humans, and hopefully replace the traditional donor or artificial skin graft treatment with the patient’s own 3D-printed skin.

The King of Junk Food Science is Out

Last February, I ran a story about Brian Wansink, whom I called the King of Junk Food Science.  According to ARS Technica yesterday, Wansink is out at Cornell University.

Brian Wansink, the Cornell nutrition researcher who was world-renowned for his massively popular, commonsense-style dieting studies before ultimately going down in flames in a beefy statistics scandal, has now resigned—with a considerably slimmer publication record.

JAMA’s editorial board retracted six studies co-authored by Wansink from its network of prestigious publications on Wednesday, September 19. The latest retractions bring Wansink’s total retraction count to 13, [Note: that page shows 35 papers retracted at this time - SiG] according to a database compiled by watchdog publication Retraction Watch. Fifteen of Wansink’s other studies have also been formally corrected.

Amid this latest course in the scandal, Cornell reported today, September 20, that Wansink has resigned from his position, effective at the end of the current academic year. In a statement emailed to Ars, Cornell Provost Michael Kotlikoff said that an internal investigation by a faculty committee found that “Professor Wansink committed academic misconduct in his research and scholarship, including misreporting of research data, problematic statistical techniques, failure to properly document and preserve research results, and inappropriate authorship.”

The important part of the article last February is what ultimately got Wansink out of his job: he wasn't doing science, he was trying to find things that would catch public attention and go viral.  The way it's supposed to work is that a researcher comes up with a hypothesis and then does an experiment to determine if their hypothesis is true; more precisely, they evaluate the null hypothesis that the experimental results were random and not due to their hypothesis.  Wansink would collect gobs of data and then try to find hypotheses that are true based on that data.

But, in a November 2016 blog post, Wansink inadvertently sank his own fame by noting that he encouraged his graduate students to go on statistical fishing trips, pushing them to net unintended conclusions from otherwise null nutrition experiment results. This is a huge red flag to researchers because such statistical fishing is a well-established method for reeling in false positives and meaningless statistical blips, like finding a link between cabbage and innie belly buttons. Moreover, many researchers see the dubious approach as fueling a crisis in social sciences in which findings from key studies—like Wansink’s—are not reproducible by other researchers, calling into question their original validity.

The blogged confession led to several other researchers sifting through Wansink’s studies and stats. Prime among those researchers is education researcher and blogger Tim van der Zee of Leiden University in the Netherlands. By last year, van der Zee and colleagues had identified at least 42 Wansink studies with alleged issues ranging from minor to severe. Those studies had collectively been cited by other researchers 3,700 times, been published in over 25 journals and eight books, and spanned 20 years of research, van der Zee noted.

As I've talked about in these pages before, there are several serious crises going on in science these days.  The biggest is reflected in the August 2005 paper by John P. A. Ioannidis which has become one of the most downloaded papers ever, "Why Most Published Research Findings are False".  Ioannidis points out that the majority of scientific papers are wrong; as much as 70% of published science is wrong.  Not just biomedical but hard sciences like particle physics. 

But maximising a single figure of merit, such as statistical significance, is never enough: witness the “pentaquark” saga. Quarks are normally seen only two or three at a time, but in the mid-2000s various labs found evidence of bizarre five-quark composites. The analyses met the five-sigma test. But the data were not “blinded” properly; the analysts knew a lot about where the numbers were coming from. When an experiment is not blinded, the chances that the experimenters will see what they “should” see rise. This is why people analysing clinical-trials data should be blinded to whether data come from the “study group” or the control group. When looked for with proper blinding, the previously ubiquitous pentaquarks disappeared.

Simply, the peer review process is broken - perhaps irreparably.

Science itself, as it currently works, may well also be badly broken. In the Spring/Summer 2016 issue of the new journal The New Atlantis, some important points were brought up.  As I excerpted in August of 2016.

As WWII came to a close, there was an acknowledgement of how much that scientific teams had contributed to the victory and a deliberate effort to keep those teams together.  Vannevar Bush, the MIT engineer called the “General of Physics” by Time Magazine, was the public face behind this push.  He pushed a vision so appealing in its imagery that everyone bought into it.

Scientific progress on a broad front results from the free play of free intellects, working on subjects of their own choice, in the manner dictated by their curiosity for exploration of the unknown.

Through example after example Sarewitz demonstrates that the progress of the late 20th century was virtually never, “free play of free intellects, working on subjects of their own choice”, but instead was almost always science being managed, being driven on specific topics for specific applications.   Scientific knowledge advances most rapidly, and is of most value to society, when it is steered to solve problems — especially those related to technological innovation.  Could it be that the War on Cancer has floundered because there's nobody in charge; nobody driving toward a goal and asking specific people specific questions? 

The typical academic scientist in a university lab may bristle at the thought of being given an assignment by a boss somewhere, and being held accountable for results.  Nevertheless, a persuasive argument can be made that this might be the way to fix science.

Five Thirty Eight did an experiment to show the kinds of spurious correlations that arise from using the typical tools of dietary studies: food frequency questionnaires and recall studies.  Their study demonstrated that eating egg rolls was strongly associated with dog ownership, and that eating cabbage was strongly associated with having an "innie bellybutton".  That's some real Brian Wansink quality science there!

Brian Wansink in a publicity photo.  AP Photo by Mike Groll - from Buzz Feed 

Dr. Salim Yusuf and the PURE study

The PURE study is the Prospective Urban and Rural Epidemiology study, chaired by co-investigators Drs. Salim Yusuf and Koon Teo of McMaster University in Hamilton, Ontario, Canada.  PURE is the largest global study looking at environmental, societal and biological influences on obesity and chronic health conditions such as heart disease, diabetes and cancer.  The PURE Study consists of over 150,000 participants from 17 countries of low, middle and high income.

A side track around here is that a dear friend of ours has been in and out of hospitals most of the last month.  He had been having some shortness of breath, and some swelling in his legs, so went to see his primary care doctor.  The PCP did an EKG, took one look and told him to get to the ER.  To keep this short, over the course of the next three weeks he was in and out of two hospitals, home and back to an ER a few times, eventually getting a pacemaker and oxygen at home.  He has been home for about a week, now and we went by today, finding him looking much better than earlier in the week.  There are many more doctor visits and tests in the near future.

His discharging physician (not his regular doctor) told him to eat a heart healthy, low sodium diet.  Right away, most of you have a picture in your mind of what that is.  I invite you to watch this video of Dr. Salim Yusuf describing their results.  Yes, it's a 22 minute video.  It's important to underline that Dr. Yusuf is about as mainstream as it gets.  He's the president of the World Heart Federation and the Department Chair in Cardiovascular Disease at McMaster University Medical School.  This is not "quack alert" time.

[EDIT 03/22/17 1030 EDT - The video has had embedding turned off.  You may still watch it at this link.  SiG] 

Note that the ideal sodium consumption for minimization of cardiac events was in the range of 3-5 grams of salt/day.  3 grams is approximately twice the MDR of salt and twice what my friend's discharging physician recommended for salt consumption.  Sodium was especially interesting because for some people there was a "check mark" shaped curve of cardiovascular disease (CVD) vs sodium intake; that is, when the sodium intake got too low or too high, CVD went up. 

Now - some important stuff.  Studies like the PURE and virtually everything you get on the evening news are observational studies, and I maintain my belief that when most of those stories break, like last week's buzz story about gluten, they're not worth much attention.  Observational studies are essentially not able to distinguish cause and effect, but are useful for determining what needs to be studied in randomized, controlled studies.  There's somewhat of an exception to this, the Bradford Hill criteria, which basically say that if the effect is "ginormous" like it was with smoking (smokers got lung cancer something like 15 times more frequently than non-smokers), and if there's a plausible mechanism, and if a few other criteria are met, then you can attribute causality.  On the other hand, lack of correlation in an observational study can prove lack of causality.  If something causes another they have to be correlated, but being correlated itself doesn't prove anything.  (Easy example: there's a 100% correlation between people that breathed and people that died so that dying and breathing are correlated, but breathing doesn't cause dying). 

The conclusions through the 9th year of the PURE study are shown below:

Key:

• CVD = cardiovascular disease.
• MUFA = monounsaturated fatty acids - monounsaturated fat as found in olive oil, some nuts (e.g. almonds), and famously recommended in the "Mediterranean Diet"
• PUFA = polyunsaturated fatty acids - typically found in vegetable oils, and in some nuts (e.g. walnuts) and recommended for years.  This is saying that despite at least 30 years of promoting vegetable oils - margarine over butter - there is no data showing it's protective
• CHO = carbohydrate.  No distinction is made between complex sugars (starches) and simple sugars.  Restrict to less than 50% of caloric intake.  For the last 30 years, authorities have been recommending more like 65%. 

Not clear from the conclusion chart is that there was some evidence that saturated fat is protective; certainly not harmful.  There is no evidence that drinking 1% or 2% milk instead of full fat milk is protective; in fact, dairy fats appear protective.  All of which shows, according to this study, that a bacon cheeseburger - without the bun - might be the best food you can eat.  Do you like a salad with that?  Dr. Yusuf says "you have to eat something - if you like vegetables, eat vegetables".  So go have some bacon!

Tales From the Over Regulated State # 23 - Watch What You Eat

No, that doesn't mean, "You should watch what you eat" it's "They watch what you eat".

Perhaps we can get a break this time with the Trumpening, but new regulations from the FDA on restaurant food labeling take effect this May, and restaurants are struggling to comply.  Any restaurant with 20 or more locations as well as supermarket and convenience stores must post the calorie counts of their prepared food.   In case you were wondering, the evidence is that the requirement to post calorie counts affects restaurants and raises prices but consumers don't care.

To begin with, what they're asking isn't easy.  Yes, the restaurants can add up the calorie content of every food in a recipe and divide by the number of portions, but even that is tricky.  What about different suppliers?  Consider a pizza shop that buys their "special, secret sauce" from a few suppliers and they might use different ingredients with different calorie counts.  The FDA's answer?  Just use the largest number you can find.  In other words, just lie to make it sound worse.

Some restaurants get their ingredients from multiple suppliers. How would the calorie discrepancies figure into the total calorie count? The FDA has an answer for that: count the fattiest version. “You would not be penalized for over-declaring calories versus under-declaring,” the agency responded.

This could get out of hand fast and shows how out of touch the FDA is with the industry.  This might work for industrial producers with everything being made by machines, but most restaurants still use a lot of hand work and a lot of places for differences to creep in between the stated counts and the real counts.  

Let's go back to the hypothetical pizza (I saw them in concert with Ultimate Spinach in 1968).  How many calories in a slice of pizza?  That depends, doesn't it?  The best guess anyone can come up with is to find the caloric content of everything in the pizza, add it up, and divide by the number of slices, even though every slice will be different.  What about what's called a "party pie", where a rectangular pizza is cut into rectangular pieces?  Same concept, right?  Silly person!  You're trying to be logical, and this is the Federal Government we're talking about!

Initially, the FDA told a Chicago-based pizza chain it would need to declare calories for the entire pizza, if the pieces weren’t uniform. But Marla Topliff, president of Rosati’s Pizza, said the agency subsequently agreed to allow the chain to post calories for an average piece in a party-cut pie. Topliff said having to list calories for an entire pie would be unfair to party-cut pies, if traditionally cut pies were listed per slice. 

I don't know if you caught that, but the FDA originally said to count the calories for the entire pizza for every slice.  That's insane!  But let's go back to that question again.  How many calories in a slice of pizza?  Who cares?  Let's be honest here;  nobody going out for a pizza really cares about that.  Let me rephrase that: anybody going out for pizza who cares about it already has a pretty good idea of how many calories to expect.  Maybe they believe in having a treat meal once a week/month/year/whatever and this is it.  Why does the FDA insist on thinking that whatever restaurant meal someone has is their regular, everyday diet?

Side note.  Although I don't talk about it anywhere near as much as Denninger, I follow a similar low carb lifestyle as he does.  I've also read virtually everything I can find on the topic and listened to hundreds of hours of conference talks, presentations for the Obesity Medicine Association (formerly the American Society of Bariatric Physicians) and other MD practitioners.  The idea that weight control is as simple as calories in vs. calories out was almost discarded in the 1930s, and only survived because the preeminent obesity researchers were gone in the postwar years. Today's successful physicians find (1) no one approach is universal but (2) for the patients who are getting fatter on the currently recommended food pyramid, their problem is hormonal and not caloric.  In other words: they don't get fat because they overeat; they overeat because they're getting fat.  Not enough space to get into this here, but the best overall book is this. 

These regulations are a flaming waste of time and resources for the restaurants and will present costs that inevitably will get passed on to their customers who don't care about the information.  The only group that is made happy in any way is the idiots at the FDA.  The FDA is not only wasting time and consumer's money, they're doing the wrong things.  What they're requiring will have not have an effect on "the obesity problem".  It's probably too much to hope for, but I'm hoping some sanity in the coming Trumpening will stop these regulations before they waste too much more money.

Stock hypothetical pizza photo from PJMedia.