23andme gets restrained while others run amok

By now almost everyone in the Paleosphere has heard that the FDA has "censured" 23andme, that organization that provides provided genetic testing along with analyses of risk of certain diseases.  (see this.)

So here's the recap:  The FDA doesn't like that 23andme is providing data that in their minds at least, could be used to treat, diagnose yada yada yada.... some disease.  See, the FDA wants jursidiction over all these activities, supposedly so they can assure the effectiveness of such treatments, preventatives, etc.

But OOPS!  It looks like some other "medical devices" circulating over the internet have been allowed to roam free WITHOUT government censure or comment, even though their treatments and recommendations seem to also fall within the confines of section 201(h) of the FD&C guidelines.

But there is a difference  between the two "devices".  23andme data used to come with recommendations to "take a look at", "consider", that sort of thing.  The other "medical device" comes with stronger exhortative statements.  Check out this link to what is known as the "statin calculator".  Note that this document and attending excel spreadsheet are supplied with the intent to estimate disease risk and to recommend treatment.

Interestingly, the guidelines admit that the calculator has flaws, but that the flaws are minor enough to initiate "lifestyle coaching".  I don't know exactly what that entails, but really, I haven't heard too many stories on the internet about doctors firing their patients who chose to ignore their 23andme results.  (OK, maybe Jack Kruse.)   But, I have heard stories of patients who were fired by their doctors when they chose to ignore their cholesterol or age panel and refused statin treatment after having that Very Important Discussion.

I actually did try out the online calculator (see the link above) and discovered that despite my stellar risk factors, by the time I am in my 70's or so, I would have to either be on statins or out of compliance with my medical professional's recommendations.  Just because I would be old and still alive.  For shame!

(Now gotta admit here that my PC physician isn't a big fan of statins.  He was even a heart specialist in the mother country.  He's not a fan of lots of drugs.  With that in mind though, he finally did prescribe a statin to a buddy of mine, and several months later my buddy got cataracts so bad he couldn't drive.  After two cataract surgeries he still dropped dead of a massive heart attack from his low fat diet.)

Since the recommendations and new calculator came out 3 months ago, there have been so many complaints that it was hard for me to find the link to the calculator.  Perhaps others have been cajoled or shamed into removing their links.  I tried to find a link to the software validation study that they submitted, but no luck.  I did scroll through all the FDA warning letters since the 23andme letter was released, and I could not find a letter addressed to the American College of Cardiology and/or the American Heart Association addressing the deficiencies of their medical device.  (Hmmm, looks like DNA genetek was busted, too.)

OK, now where was I?  Oh yea, the medical device.  In the industry, we have special technical names for such software.  POS, hokkered, bone-headed, lol-what-were-they-thinking,....POS, more lols for everybody.  The use of an Excel spreadsheet for a medical device is absolutely lol.

This Here Post is For My Friends

I have some really great friends who are locked in the stranglehold of current cardiology-thinking.  They have been watching their food intake, especially things like sugar and junque food.  They have tried to up their exercise in between injuries.  Their cholesterol numbers have gone down for a time, then inched up, prompting their doctors to threaten statins if some body doesn't do something.

Here's a nice blogpost from the past by Peter.  It shows lots of charts and graphs of data with a different light shined.  They show the relationship between blood cholesterol levels and cardiac events.  Not a very convincing relationship, is it?

If you aren't into charts and graphs, go to the bottom of the blog post and see the graph of cardiac events and HbA1c.  Wow, not good.  It shows that the relative risk of cardiac events go way up as the HbA1c is higher.

HbA1c is a measure of how much damage blood sugar has done.  Blood sugar goes up when people eat lots of simple carbs.  In normal people, when blood sugar goes up, insulin is released to clear all the sugar out.  These people can keep their blood sugar levels lower by eating low-glycemic carbs.

As things progress, people may develop pre-diabetes or full-blown type 2 diabetes.  At this stage, many can be helped by going on a low carb diet, but sometimes that still doesn't fix everything.  It is surely better than feasting on chips, candy and soda on a regular basis.

I have another friend on metformin and a statin, but while the statin has lowered her cholesterol levels, she is tired and achey, and seems to be suffering from the side effects of the statin drug.  She wants to stop the statin, but her doctor has insisted she continue.  She asked me what she should do, and I gave her the name of another doctor.

I have another friend who is being badgered by her doctor because her total cholesterol is around 240.  This is AFTER SHE WAS DOING ALL THE RIGHT THINGS!!!!!  Unfortunately, I don't know of another doctor in her area, but I would suggest in the meantime that she quit beating herself up over the occasional barbeque dinner and focus more on keeping candy and sugary drinks out of the house.

Anyway, friends, thanks for reading.

Looking Ahead (no, really)

There is trouble in the eat-less-move-more camp.  Water is pouring into the tent, and they are forced to move out of the wash they placed themselves in, running for cover.

Ah, yes, the Look Ahead study.  Here's a nice re-cap.  I went to theHeart to get their latest blurb, and it mentioned that in addition to NOT reducing strokes, heart attacks or losing much weight, there wasn't even a reduction in death either.  They go through all that crap and lose like 10 pounds?

Eleven years of exercise, and listening to a registered dietitian droning on about healthywholegrains and satiating-whatever.  Satiating.  Wow, do I hate that word!  Who else uses that word?  One more reason to ban (most) dietitians from my life.

I loved some of the comments.  Like, surely the sucky results are because of poor study design that failed to show what we all know to be true.  Like, surely not that it could be the sucky recommendations.

One hundred and seventy five minutes of exercise a week, time they could have spend meditating on and eating bacon, and for what?  Just thinking of how many [redacted] points what would amount to.  All that wasted time racking up points that can't be traded in for any actual anything, just like the real [redacted] goodies.  Good for a memory, or for a laugh, but it is not a real goody.

OK, today's post is chocked full of amusing personal stories.  I used to work with this guy who just got another MBA, and he used to wave his hands and throw out the word "salient" when he wanted to weasel out of his responsibilities and evade the point I was trying to make.  Nobody uses that word except a few months after some MBA class.  And, it is always used as a redundant set, a "salient point".  Hear the word, and you know BS is sure to follow.

Oh, anyway, where was I?

I used to work at this place where they had creativity workshops, and one day we were supposed to do this visualization and imagine we were in a hot air balloon drifting over the company.  Now, if we weren't being so meditative with the new age music accompanying the directive, this would have been a hilarious metaphor for the company, since it was so full of the hot-air of the newly-minted MBA's and the company was so adrift.  Oh, anyway, where was I?  Oh, and we were supposed to look into the imaginary windows and see what was going on five years into the future.

Well, that was fun, as I drifted above, and saw some interesting things.  When we were asked to share, I jumped at the chance to recount the salient points of my balloon ride.  As I described what I saw, the leader looked visibly surprised.  Yep, I nailed it.  I accurately described a current super-secret project going on in the very building that I floated over, even though I didn't consciously know anything about it.

OK, fast forward to about 16 years ago, when we were sitting around a large table enduring a lengthy design review.  It was time for lunch.  "Should we order pizza?" 

So I say, "Well, soon you'll be able to order a pizza and then the pizza place will just send a wireless message to your insulin pump for just the right amount of bolus."  And, hardy har har, we all had a good laugh over that until the VP of engineering said, "Hey, you're probably not too far off," but he wasn't as alarmed about it as that visionary balloon guy.

Of course, now we all have wireless and smart phones and cloud computing and everything is sent all over, but at the time, closing all the loops seemed undoable.

Oh, anyway, where am I?  Well, there used to be lots of talk about diabetes and its progression, and the prevailing viewpoint at the time was just coming on the horizon, that T1DM was an autoimmune thing.  And I remember some people arguing violently against this concept and arguing violently for their illness.  The thinking at the time was that T2DM was caused by overeating pizza, being overweight (and also inactive.)  After hearing that again at the pizza party, I just blurted out,

"No, getting fat doesn't make you diabetic.  Diabetes makes you gain weight."   And we all looked around at each other and realized that we were all getting fat and probably creating our own diabetes and secretly thinking that we had better get cracking at a cure for diabetes before we all got it and had to take our own medicine and get our feet cut off or something.

So, people tried to eat even more diet yogurt, washed down with Diet Coke, and entering bike and road races sponsored by the American Diabetes Association so we could lose weight and be more healthy.  And for what?

So, today I am reading here and there about diabetes and wondering why so many of the comments are still peppered with the idea that drinking lots of sody made us this way, and wondering when people are just going to look ahead more carefully.

OK, where am I?   Try this visualization.

Now, look at me, look at Stan's post, now look at me again, now go back to Stan's post and click the link on the training materials.  Imagine yourself sitting with a group of fat pre-diabetic people listening to a presentation of this material by a big balloon of hot air.  Imagine yourself poking holes in both the presenter and in the concepts.  Imagine the balloon of hot air collapsing and the sucky training materials getting smaller and smaller, and soon out of view.

Wow!  Imagine yourself feeling better and better.  Your cortisol is already reducing, along with your weight and insulin level.  Now you are thinking of satiating bacon, only it isn't satiating.  In fact, you don't even know what that word means, only that you are enjoying the bacon and then put the package away and then don't think about eating anything for awhile.  You imagine walking on the beach with your friends and not having your exercise-tracking software update itself.  As you get closer to the water, you hurl your fitbit into the waves and watch it bounce up and down with every wave.

Drawing a Pint

I gave blood today so be nice to me!!

One of the recent topics at that [redacted] place was blood pressure reduction on a low carb diet.  After posting some (research-related) sites explaining how blood pressure can be reduced on a low carb diet, I never did get around to the topic on this here blog, so here it is.

This week marks my two-year anniversary of going on a lower carb diet.   One of the nice things about giving blood is that you get a mini-physical.  It gives me an opportunity to check up on a few things in between doctors visits.

Hmm, did I eat today?  Check
Feeling OK?  Good to go
Weight?  Yep, within 10 pounds of my goal weight after a year and a half in maintenance
Pulse?  Pretty low, especially since I have discontinued chronic cardio
Iron?  14, whatever that means.  Really, it means they smile and continue.  This is not like in the vegetarian days when half the time I would be sent packing.
Temp?  Hmmmm, the thingy beeps.  Could it be that my metabolism has been lowered and my T3 has tanked?  She looks unconcerned.
Blood Pressure?  Hmmm, the same pressures I had as a teen the first time I gave blood at a high school blood drive for an ailing teacher.
Track marks?  Nope

As I go through the questions, I am realizing how stationary I have been, and not just in the cardio way.  I haven't been to any of the long list of banned counties recently.  Then I remember what Coach [redacted] says about blood pressure.  A low carb diet doesn't do anything for blood pressure that simple weight loss doesn't do.  I remember when I saw that, thinking "hmmm, did she just admit that you can lose weight with the disastrous and dangerous diet?"

When I started on the lower carb plan and lost a bunch of weight, the blood pressure went down, too.  Not that it was all that high, but like many, over the years it started to inch up, along with my weight.  For a time, I even tried removing the salt from my diet., and had a tough time in the early weeks of lower carb until I added back the salt.  My blood pressure went down immediately, and it has been going down gradually ever since, even though I have been in maintenance for such a long time.

I love n=1'ing, another myth exposed.

Killing them Softly

Looks like I am killing all my relatives off, one by one, ready to collect the inheritance.

I am still recovering from the house-full of family and their pets during the holidays.  Mom was the last to leave.  Since she is older, she likes to take direct flights when she can.  The only direct flight available meant we had to get up at 5:00 in the morning and rush around.  This meant I couldn't cook the usual large breakfast of bacon, eggs and greens, or serve my mother her favorites.

I decided that it wasn't enough to just have a smoothie and some coffee, so I whipped up a few scrambled eggs with butter.  Usually she eats skim milk, bran cereal, decaf coffee and half a grapefruit for breakfast.

She downed the egg in a few seconds and asked how it was cooked.  I replied that I just cooked it in some butter.  She declared it delicious!  We NEVER had butter at home when I was a kid.  Too expensive.  I did get butter through the subsidized school lunch program, but there was never any butter in the home, even for baking Christmas cookies.

A few days after her trip home, she called and announced that since the visit, she had been eating an egg cooked in butter every morning for breakfast.  This is a big switch, because ever since my teen years, she had been on a low fat diet in order to reduce her cholesterol, which was inching towards a very unhealthy 200.  After her heart disease risk scare more than 30 years ago, we quit eating foods cooked in bacon and had only low-fat cheeses, diet margarine, and skim milk.

Yes, I am contributing to my mother's decline.  I say, if you are close to your last meal, let them all be drowned in butter.

Wow. Just Wow. Did I Read this Right?

Just skimming through the latest issue of Nutrition Action.  The CSPI guy is at it again, this time with an interview of the famous Dr. Willet.
Seems he advocates healthy whole grains, for health and all that.  But, he says he can't go much over 40% grains/carbs because of stomach distress!!!!
I'll have to go back and re-read that.  Didn't he just say:
"The Wonderful Omniheart diet beat out all the other diets (except for, you know, the diets we refuse to test) but I had to dial it back myself because it makes me sick!"

Study Notes for the Quilt - Leptin Part Deux....Liver

This post is about leptin resistance in the liver cells.  Here's Dr. K's reader's summary:
"Readers Summary:
1. Liver is the engine of metabolism and not the thyroid
2. What does the liver do in normal metabolic conditions and in leptin resistance
3. Where does cholesterol (LDL subtypes) fit into this leptin story.
4. How does Metabolic Syndrome commence and why does it happen.
5. Why your regular labs may be completely normal while your slowly dying."
Pretty good, then again, maybe after reading all the posts over and over, it is starting to look easy. Here's the link.

And now, the notes:
1.  Contrary to popular opinion, your liver controls metabolism, not your thyroid gland.
2.  When you eat, 60% goes to the liver for longer-term storage, 40% goes to the muscles and other places to be used right away.
3.  If the muscle cells are leptin-sensitive, all the 40% is used.  Yippie!
4.  If the muscle cells are leptin-resistant, the leftovers go to the liver.
5.  go to the liver => make fat => stored in fat cells or in the liver
6.  If your fat gets full of even more fat => more leptin (bad)
7.  If your liver gets full of fat =>inflammation =>BAD
8.  Uh Oh, here's more trouble!  If the liver cells are leptin-resistant, they tell any extra fat to go away.  ("Go away!  We aren't taking any more of your LDL's") =>LDL's stay in the blood (bad) => liver crams more fat into LDL's.
9.  Carbs go towards the making of small dense LDL
10.  Protein and fat go towards the making of large fluffy LDL
11.  If you are testing your blood lipids, the most important number is the sdLDL.  It should be as low as possible.  SdLDL particles are easily damaged and can cause plaque.
12.  eat too many carbs => make sdLDL => damage =>all sorts of diseases => BAD
13.  eat too much protein and fat => make fluffier LDL => fat storage (location depends on other hormones)
14.  Too much Fructose => makes even MORE sdLDL!!!!! (so don't do this)
15.  When our liver is leptin-sensitive, it sends its stored fuel to muscles, etc. when needed.
16.  When our liver is leptin-resistant, it doesn't send the stored fuel to muscles, but stores it as more fat.
17.  Liver leptin resistance => fatty liver => inflammation => metabolic syndrome + large waist + fatigue + can't lose weight no matter how little you eat + exercise doesn't help weight loss.
18.  So, you can have all these problems with a normal thyroid test.
19.  Waist size and hs-CRP are better measures of health, but start looking at hs-CRP early on.

Here's more to research:
LDL, or Low-Density Lipoprotein.  (Most of the lit still portrays LDL as "bad".)  http://en.wikipedia.org/wiki/Low-density_lipoprotein
Here's some information about a prominent inflammatory chemical:  http://en.wikipedia.org/wiki/Interleukin_6
Here's some general info about the liver:  http://www.umm.edu/liver/liver.htm

Study Notes for the Quilt - Living an Optimized Life "Chapter 1 on Leptin"

Whew!  Where do I begin on this one?  How about the link?  Check it out.

And....Here are the notes:

1.  Leptin is a hormone that controls how your body gets and uses energy and it also controls all other hormones.
2.  Leptin is made in fat and talks to your brain.  It tells your brain how much energy you have.  When it works wonky, we get leptin resistant.
3.  Leptin resistance = BAD!
4.  Symptoms of leptin resistance:
     a.  too fat
     b.  too thin
     c.  having what seems like a thyroid problem
     d.  can't lose weight from exercising
     e.  osteoporosis
     f.  trouble getting pregnant
     g.  inflammation
     h.  belly fat
     i.  low vitamin D levels
5.  Leptin resistance leads to diabetes, high blood pressure, insulin resistance, obesity
6.  Leptin resistance => insulin resistance => adrenal resistance =>cortisol problems =>all sorts of chronic diseases and cancer.
8.  "Leptin resistance always precedes the development of insulin resistance" (by about 5-7 years)

9.  To determine if you are leptin resistant, you can measure reverse T3, ultra-sensitive crp, Vitamin D and look at your waistline.

Here are some interesting links:
Leptin: http://en.wikipedia.org/wiki/Leptin
Cortisol:  http://en.wikipedia.org/wiki/Cortisol
Hormones:   http://en.wikipedia.org/wiki/Hormone

A Really Sticky Smoking Gun

Well, here's something interesting!  A game-changer, perhaps?  Researchers have known for quite awhile awhile that total cholesterol doesn't really mean much as far as heart disease is concerned.  Then they fingered LDL.  But, it turned out that LDL isn't all bad either.  There are different kinds of LDL, and some are good.
In this study, researchers "discovered" a really bad kind of LDL.  It is a super-sticky kind implicated in heart disease.  So, you are probably wondering, what is this "ultra-bad" LDL?  It is an LDL with a sugar attached to it.  Now if you are already a diabetic, your doctor has probably already been measuring something called HbA1c, which is a fancy name for a blood molecule with a sugar attached to it.  Sugar attaches to all sorts of things in our bodies.  It's really bad stuff!  That's why our bodies have been designed to remove excess sugar and provide gate-keepers to keep excess amounts out of our cells.
Try this at home with your cat.  Get a bunch of packing peanuts, rub them, and then call your cat over.  He'll walk by, the peanuts will attach themselves, and then your cat will start to walk and act funny.  Same with LDL apparently.  When the glucose attaches to the LDL, the LDL changes shape and starts to act funny.  Eventually, if enough of these "ultra-bad" LDL's are made, it can lead to heart disease.
The researchers are probably positively giddy that they now might have a new use for a drug called metformin.  It is currently used for diabetics and people with PCOS.  It reduces blood sugar.  Although, people who are regular readers of this here blog probably already know that unless your metabolism is really messed up, you can just reduce your amount of blood sugar by just reducing the amount of sugar and carbs you eat.
Here's an article written for the populace:  http://www.upi.com/Health_News/2011/05/28/Sticky-ultra-bad-cholesterol-discovered/UPI-14841306560212/
Here's the original preliminary abstract:  http://diabetes.diabetesjournals.org/content/early/2011/05/18/db11-0085.abstract  Even reading the abstract is a slog, so again, here are the notes:
1.  We got a bunch of human LDL
2.  We modified it in a test tube just like what happens in your body
3.  Basically, we attached a sugar to an LDL
4.  Not good!  The LDL particle was smaller, stuck to stuff and to itself more
5.  We think we have discovered why diabetics have a higher risk of heart disease and also why metformin reduces heart disease risk.
Now, if you are a real glutton for punishment, you might want to visit this blog by Petro Dobromylskyj:  http://high-fat-nutrition.blogspot.com/search/label/AGE%20RAGE%20and%20ALE%20%281%29%3A%20The%20AGE%20of%20LDL  If and when you can get through this blog post, scroll down to the blog list on the right for similar posts.  This will give you more information than you will want to know about LDL.  Here's another especially interesting post on modification of LDL.  http://high-fat-nutrition.blogspot.com/2008/07/age-rage-and-ale-age-of-ldl.html  Notice the date this was posted.  Researchers have known about this for a long time, but the media and the dietitians haven't kept up.  Petro Dobromylskyj follows a low carb, lower-protein and high fat diet (and he also has a most adorable kitty!)