Why does the FDA not crack down on supplements?

The FDA does not crack down on supplements.  It's not their role. The FDA cracks down on “claims”. That’s what the FDA is about. If you don’t make a claim in the packaging or the advertising, then it’s not a “drug” in FDA-speak. If you make a claim, in the packaging, then it is claiming to be a “drug” and requires FDA approval. This is an important distinction. The FDA does not approve products, it does not approve drugs, it does not approve supplements, it approves claims.

Label Claims for Conventional Foods and Dietary Supplements

This is an important aspect of freedom.

I am free to buy garlic, as plants, or as foods - bulbs, or as pills - as supplements. I’ve free to eat them whole, to roast them, to add them to anything I am cooking and to buy garlic sausage - and other foods that have garlic added.

Anyone is free to sell garlic, as plants, as food, as supplements or as pills, as long as their sales literature does not make a “health Claim” and as long as it makes no “substance function claim”.

I am free to believe what I want about garlic.

If someone sells garlic pills, or bulbs, or plants, claiming that they “are good for disease X”, they are selling a drug, not a supplement. The claim must be approved by the FDA, or the FDA will crack down. If someone sells garlic plants, or bulbs, or plants, with a printed claim that garlic “helps digestion”, they are making a substance function claim, which must be approved by the FDA or the FDA will crack down.

The FDA is the “Food and Drug Administration”. They regulate, and crack down on drug claims and on a substance function claims.

There is another important aspect to freedom.

Anyone can claim that garlic is good for colds, flu, for keeping vampires away. We are free to make claims - as long as we are not packaging and selling garlic.

Frankly, a lot of what the FDA does is a scam. The FDA approves CLAIMS, not products. The FDA does not evaluate any products, it only evaluates claims. The FDA does not care about disease, or illness, or health. They care about claims. It’s a bureaucracy. 

The FDA approves HEALTH CLAIMS. What the FDA calls a “health claim” is actually a “disease claim”. It is not possible to submit a “health claim” to the FDA unless it contains reference to a disease. The FDA also approves “substance function claims” - which are closer perhaps to a health claim. However, it only approves, or refuses to approve, those claims when they are submitted as part of a product package or marketing initiative.

The FDA will accept minimal evidence for any “drug” if the drug is patented. If you manage to patent a “garlic extract pill” and then do a series clinical studies that demonstrate it helps people with disease X, a statistically significant percentage of the time (note statistically significant can be a very small percentage), then you can PAY THE FDA a lot of money and get it approved as a drug. Once you have it approved as a drug, you can label it as a drug. If your patented recipe is dangerous to the health of normal people, when taken in large quantities, it might become a “prescription drug”.

The FDA will not accept any scientific evidence for a product that is not marketed with a claim. In similar logic, the EEU drug approval agency was asked if  they would approve 'water' as a drug, because they could claim it prevents the disease 'dehydration'.  The response was basically "We only evaluate claims when the paperwork is completed. (and the fees are paid)"  eg. Until someone prepares marketing material for a product, with a claim that it "prevents dehydration", the claim will not be evaluated. 

The FDA does not care if you say “an apple a day keeps the doctor away”. They don’t care if it’s true or false. It’s not a “health claim” in FDA-speak. But if you print a message on your apple boxes that says “apples help treat patients with disease X”, they care, and they will ask for proof, or crack down and possibly confiscate your packaging, and your “dangerous product” as well.

to your health, tracy
Founder: Healthicine

The Old Erebus (The New Colossus Revised for the current times)

The Old Erebus

But, like the depraved giant of Greek fame,

With conquering whims that tweet from hand to hand;

Here at our white-washed, prison wall shall guard

A weighty no-man with a lurch, whose lame

Excuses rain like lightning, and his name

Hater of Others. From his bacon-hand

Grows mouth-wide sneer; his blind eyes command

The liar. Rigged ardor, that gives citizens blame.

“Keep, lands ancient, your pomp storied!” cries he

With widened lips. “Send not your tired, your poor,

Your huddled masses yearning to breathe free,

The wretched refuse of my egoistic snore.

Send those, the homeless, tempest-tossed home,

or to light my lamp beside the golden door!”  © Tracy Kolenchuk, Healthicine

How to Pull your Cat's Tail

A few days ago, I was wandering around a used bookstore, one with cats on staff, perhaps to calm the customers into reading. 

As I knelt down to browse a lower shelf, the local grey, one I'm very familiar with, walked between me and the shelf.  I reached out and scratched his head, then under the chin.  As he passed by, I rubbed his back and then wrapped my fingers around his tail to give him a nice back stretch. He pulled slowly and when the tail released, he came back for another round. We had met before. I rubbed under his chin, but he seemed distracted by that. As he passed, I touched his back and again took his tail.  He pulled slowly, stretching his back, and then, just as his tail released, a staff member came out of an office door.

"Please don't pull the cat's tail!" she admonished.

To be honest, I was at a loss for words. There was little to be said. She has three cats, but evidently never pulls their tails.  Pity.  I was guilty.  The cat, as cats do, strolled away unaware of any issue.  I bought a book and left. And then I wondered... how many people don't know how to pull a cat's tail?

Cats vs Dogs 

Maybe you've seen the internet image of How to Pet a Dog - everywhere is good, and How to Pet a Cat - lots of forbidden territory.  It's  cute image, but not very accurate.

Not every dog likes to be touched, and not every dog likes to be touched everywhere. Dogs can be dangerous. When in Peru, I walk a Dalmatian, every day.  He's not fond of touch - and deaf in one ear.  If I touch his left ear, he will snap, bark, and bite. Even if I only pretend to touch that ear - he will snap. The other ear? No problem.

Dogs are Babies, Children

Although many dogs love attention, love to be touched, even carried, every dog is in individual. Dogs are social animals. Domesticated dogs are babies, or immature children, never attaining adulthood, but even children can be touchy, angry, or dangerous.

Cats are Adults

Cats, on the other hand, are independent adult animals, with independent adult behaviors.  Cat's don't care if you care about them. They have little desire to please you, unless it brings them some reward. For dogs, attention is their reward. Your cat? meh.

Cats like to be touched, rubbed, caressed, on their own terms. Cats will snuggle up, even rub, lick, or bite your hand it they want to be petted.  But sometimes, when you reach to pet them - they change their minds and walk away.  Sometimes, they decide to play - to attack your hand. Sometimes, they want you to pet them, but just so. And sometimes not. Cats have boundaries.

As an adult, when a cat decides it's time to leave, to do something else, even to do nothing else, they go. Cats have boundaries. Attempting to pet them when they don't want to be petted, is crossing the boundary, and can lead to trouble. Cats have claws.

Many cat's don't like people touching their tummy - ours is usually just fine with that, but she's been around us for 18 years.

And then there's the tail.

The Tail of A Cat

A cat's tail is complex. It often seems the cat is not conscious of their tail. Most of the time, it follows them around. Sometimes it gets stuck in doorways, as the cat decides to go in, or out, or to take time to decide. 

When a cat is hunting, the tail is interesting.  Maybe you seen the hunter's tail, flicking as the cat stalks a real or imaginary prey, and thought "doesn't that warn the prey?" There are several human attempts to explain this behavior - but the simplest is that it works. Somehow, it helps the cat to hunt.

Cats, and tails, and children, on the other hand, don't mix well. Children see the cat, and would like to touch, hold, pet, eg. control, the cat. Cat's don't want to be controlled. They leave, and their tail trails behind.  The child grabs the cat - by the tail of course, and a battle ensues.

This is what we usually envision as "pulling the cat's tail".

It leaves the impression that cat's don't like to have their tails pulled.  Cats love having their tails pulled - on their own terms. They just don't want to be pulled by their tails. That's crossing their boundary - unless they decide to like it, which sometimes they do.

How to Pet a Cat's Tail

When you pet a cat along the back, they raise up their hind legs, to rub the tailbone against your hand. Often the cat will circle back for more. The spine, the tail is wanting attention.

It's easy to pet a cat.  It's harder to pet the cat's tail.  But you can learn. It's the first step to successfully pulling a cat's tail. Pet the cat's back and as it passes by, or lies there, or does whatever your cat does, extend the petting action to the tail. Almost all cats cat will tolerate this. Most will enjoy and circle back for more. Or just purr....

How to Pull a Cat's Tail

Once you learn to pet the cat's tail, you can advance to the next stage. As the cat passes under your hand, you gently hold the tail - and let the cat pull. Now you are petting the entire tail, not just the top. Your cat might arch their back in satisfaction, and circle back for more, or leave. Cats are like that.

As you build confidence in yourself, and in your cat, you can grasp tighter.  As your grasp tightens, the petting action becomes a massage, stretching the cat's spine.  Cats quickly learn to love this, even more than being petted.  And then they get tired of it. And go away.

Caution

If the cat has spent some time with young children, any attempt to grab the tail can bring back bad memories - and the cat might fight or flee.  If you try too hard, the cat will take offence. If you relax, the most cats can learn to relax as well.

Pulling Cat's Tails, for the Health of It

I practice pulling tails on many cats, and I often see cats in conflict. Some love it. Some want to flee, to protect themselves, but they want their back rubbed, or stretched, by having their tail pulled.  They move away, and circle back for more.  Gradually, as they learn to trust. I am not pulling them by their tail. They are pulling. They are in charge, they enjoy the stretch. If they pull a bit harder, in enjoyment, I help them.  If they show distress, I release and they escape. They understand that they are in control. Often, they come back.

Cats like to be in control. Cat's like to have their back stretched.  But they can't do it themselves. As they learn, and their 'person' learns, both can enjoy a new perspective on "how to pull a cat's tail", for the health of it.

I know one cat, a large male, that loves, loves, loves to have his tail pulled. He lets me grasp his tail and then pulls himself away by his claws on the carpet. The first day we first met, his owner exclaimed in total surprise - "He likes having his tail pulled?", watching him coming back for more, and more, and more. Rubbing up against my leg, purring loudly.

The cat in the bookstore?  It enjoyed having it's tail pulled. It wasn't scared, or offended. I crossed no cat boundaries. The boundary I crossed was in the perception of the clerk. The cat returned for a second round, and then - off to attend to other cat matters. Cats are independent.

to your health, tracy
gentle cat-tail-puller

What is the Highest Form of Intelligence?

What is the highest form of intelligence? To find the 'highest form of intelligence', the place to start is the 'lowest form of intelligence', then work our way up and see where it takes us.  This exercise was started, very effectively, by Frank T. Vertosick Jr. in the book, The Genius Within: Discovering the Intelligence of Every Living Thing. Unfortunately, Vertosick stopped short of the goal, probably due to the common error in scientific thinking - that we must separate 'science' from 'spirit'. 

Intelligence comes from life. Rocks, planets, and even stars are not alive - they don't have any intelligence, nor any need for intelligence. They have no goals, no reason to develop or apply intelligence. The lowest form of intelligence resides in chemicals that learn to cooperate to reproduce. Vertosick wrote "When I speak of intelligence, I mean the general ability to store past experiences and use that information to solve future problems. I'm not limiting my discussion to human intelligence... I call this 'brain chauvinism', and I will refute it by showing that all living things -- even those entirely devoid of nervous systems -- can (and must) use some sort of reason to survive... In other words, to be alive, one must think."

Vertosick then goes on to explain the source of intelligence "This book looks at intelligence as an emergent property of large groups. An emergent property is a property manifested by the whole group, even though the same property isn't apparent in any of the individuals comprising the group.... human intelligence is an emergent property of groups of nerve cells. And immune intelligence is an emergent property of a group of immune cells, cellular intelligence is an emergent property of a group of enzymes, and so on.... Networks are the basis of living intelligence in all scales of life from cell to ecosystem."

Vertosik missed a small point.  It's not 'groups' that are intelligent, it's communities. Groups of rocks or groups of planets, or groups of stars have no need for intelligence.  They do not act with intent, and do not benefit from any of their 'actions'.  Communities, communities of individual entities that compete and cooperate, create intelligence.  Communities of chemicals, that persist long enough to create communities of life, create intelligence.

Cooperation and competition are two sides of the coins of life, actions in a community. Like left and right, light and dark, inside and outside, each must exist for the other to exist.  Community is a group of life entities acting as a group.  Every community of cells is a community of cooperation and competition.  Even actions that are taken in self-interest, often aid the community, if only by producing stronger siblings. Even actions that are intended to be cooperative, can be interpreted as self-interest, if only to ensure the health, life, and reproduction of your siblings. 

Genes and other genetic components network and compete and cooperate to create the component of DNA, of viruses, and of life. This networking, competition, and cooperation creates life, health, and intelligence from lower level components.  These form networks, or communities, with other active chemicals, enzymes, etc. which compete and cooperate to create cells - which have a higher level of intelligence that simple genetic components, viruses, etc..  

Cells compete and cooperate to create cell masses and then tissues comprised of different cell types, that have intelligence higher than any simple cell. Cell masses and tissues compete and cooperate to create a body, with limbs, bodily organs, and organ systems through competition and cooperation that rises above the intelligence of cells. The body develops sensory systems, that evolve into nervous systems - an even higher level of intelligence.  Nervous systems mass and compete and cooperate to create brain components for vision, hearing, etc that are more sophisticated in their ability to sense, to learn, to predict.  Brain components compete and cooperate to create the mind, which rises above the body and learns to control the body.  A higher level of intelligence.  

Vertosick stops here and does not proceed further up the hierarchy in a comprehensive fashion. However, this hierarchy of life is also the hierarchy of healthicine (Hierarchy of Healthicine- History and Exploration), and we can use that model to rise higher in the levels of intelligence.  

Minds and spirits evolve together.  Every mammal clearly has 'spirit', feeling and acting excited, depressed, happy, hungry, etc. at different times. When we look closely, even a single cell has the spirit of life, and a community of cells has higher level spirits. As we climb the hierarchy of life, these feelings rise above the level of 'senses' and above the simple functions of the mind - memory, calculation, etc. The spirit that emerges from mind components working together, competing and  cooperating, creates a higher, more intelligent intelligence. 

Above spirits, we have communities of people. Which would include communities not just of body, not just of minds, but communities of spirits as well.  Clearly communities of people can remember more, and resolve problems that single humans cannot resolve.  We can write problems down, and work at them over centuries, and solve them by community cooperation and effort over time. History provides many examples of intelligence of communities operating over hundreds of years. 

The logical conclusion is that no human, no single being, not even any group of humans can attain the highest form of intelligence. 

Now we can see the common thread. Communities of genetic components create DNA and simple life forms like viruses. Communities of simple life forms create cells.  Communities of cells create tissues, which create organs, and bodies, communities of organs and body parts create living systems like our digestive systems, respiratory systems, hormonal systems, immune systems, nervous systems and more. Communities of systems create more and more complex, more and more intelligent bodies, which develop more complex, more and more intelligent minds and spirits. Communities of individual bodies, minds, and spirits cooperate to create The Beatles, Symphony Orchestras, religions, and many more thing that no individual could create or be by themselves. The intelligence of a city clearly rises above the intelligence of individuals, solving memory and logical problems that individuals cannot solve - even though it is not 'conscious' of its own intelligence.

Of course not every group, or community, of people creates a higher level of intelligence.  A group can just as easily, perhaps easier, create an unintelligent mob, that does really stupid things.  These groups too can exist over long periods of time - longer than any single lifetime. One of the most important aspects of intelligence includes the ability to make errors, and hopefully, eventually, to learn from those errors. 

The highest form of intelligence is also the lowest form of intelligence. It is the intelligence of communities, knowingly, or unknowingly cooperating and competing to create a new intelligence at a higher level. 

The highest form of intelligence is the intelligence of cooperation and competition to attain goals that were not even seen as possible, or useful, or anything, by the individual components that are creating it. 

Thinking that some aspect of human intelligence could be the 'highest form of intelligence' is simply, to use the words of Vertosick "brain chauvinism". We are not as intelligent as we think. We are only as intelligent as we can work together to attain goals at levels higher than those of the individual.


to your health, tracy
Founder: Healthicine

Fake News Warning: Gluten Free Diet

The last few days we have seen a flurry of FAKE NEWS headlines about gluten free diets.

FOX News: A gluten-free diet may raise your risk of heart disease
GLOBAL: Going gluten-free to ward off heart disease might have opposite effect: study
CBC: Healthy hearts: Gluten-free diets don't help people without celiac disease, study finds
MedicalNews.Net: Study finds no link between gluten intake and heart disease risk in people without celiac disease
Irish Mirror: Eating a gluten free diet when you're not coeliac could damage your health
NEJM: (email teaser) Low-Gluten Diet Not Tied to Lower Coronary Risk. (article header) Gluten-Restricted Diets Seem Not to Lower Coronary Risk

Are these reports fake news?  Yes, every one of them.  Let's check the facts.

Placebo Effect Ignorance

I was recently asked this question on Quora: "What is the true impact of placebo effect on science?" My answer:

Ignorance. The true effect, at present, of placebo effect on science is ignorance. Ignorance of cause, ignorance of consequences.

I am talking about the actual impact of placebo effect on science, and doing so in the hope that someday we can change that effect to something as powerful and useful as placebo effect actually is.

First, we need to clearly define some terms. I'll use Webster's. It's a a good place to start. Placebo effects don't “work”. We know that placebos work. But the question is about placebo effects, not placebos.

When Doctors hate Doctors We all Lose Health

Medicine is broken. Fractured. We need medicine based on love, on caring, on helping each other.  Instead, much of modern medicine is based not just on competition, but on hatred.

Of course it's not everyone, and for the most part, I don't believe it's personal. Few, doctors, hate other types of doctors.

It's the system. The so called 'conventional medicine' system. It's a paradigm that hates other paradigms.

Is Wikipedia Fake News: Can Wikipedia be Cured?

Is Wikipedia 'fake news'? Does Wikipedia contain 'fake news'? How would we know?  Well, first of all, we need to understand the concept of fake news, and distinguish clearly between fake news and lies, truths, facts, non-facts, and bullshit. Perhaps we should begin with 'bullshit'.  Harry Frankfurt's essay, "On Bullshit" explores that concept in detail, and also in a nutshell.  "Bullshit is unavoidable whenever circumstances require someone to talk without knowing what he is talking about." Frankfurt distinguishes clearly between lies - the presenter clearly does not believe what they are saying, and bullshit, where the speaker is simply talking about which they know little.

The Death of Skepticism and The Rise of Fake News

Skepticism is dead.  Skepticism has been captured and converted to dogmatism. When I was young, I remember one of my cousins commenting "You are such a skeptic." It made me feel proud to be skeptical, to search for the truth.  But today's, skeptics don't search for the truth. Most claim to have found it.

Skepticism has become the new religion. It's not a religion of analysis, nor thoughtfulness, nor of skepticism.  It's the religion of dogma. Skepticism has been co-opted, in service of the prevailing dogma, the invisible dogma.

Freedom: Why all Our Bosses are Idiots

Did you ever wonder why your boss is an idiot? I mean, really.  It's a universal concept.  Do only idiots become bosses? Are bosses more likely to become idiots because of the pressures make them stupid? What's going on?

Actually, it's very, very complicated - but relatively easy to explain. Let's begin before the first boss, with the first sign of life.

Dead things, after all, don't have bosses.

How Healthy are Your Freedoms?

Are our freedoms healthy?  In healthicine, we say "Everyone has a right to life, liberty and the pursuit of healthiness" because healthiness includes all freedoms and more, and is therefore superior to freedoms. We often think of freedoms with the phrase "life and liberty", but there is much more to freedom.

A True Placebo has No Effects

Do clinical studies lie? A true placebo has no effect. Is the Gold Standard of medicine, the double blind placebo controlled trial, scientific nonsense, based on "fools gold"?

A placebo effect, is defined by Webster's dictionary as: "improvement in the condition of a patient that occurs in response to treatment but cannot be considered due to the specific treatment used".

In other words, a placebo is not caused by a placebo. If it is a true placebo, then it did not cause the placebo effect. Only false placebos can cause placebo effect.