Thursday, October 29, 2015

The FDA regulatory functionality

What's a drug? I'm not being facetious, most people don't have any idea what the legal definition of a drug actually is. Nor do they understand the processes (or costs) involved with creating, testing and receiving approval for new drugs. Well, the feds define a "drug" in the 21st US Code of Federal Regulations 802 section 321 G subsections A, B, C, and D. You can read them at the bottom. Of particular interest is subsection B that states drugs are articles for use in prevention of diseases. Things like Vitamin C that prevents scurvy, or the B vitamins that prevent blindness, rickets or a number of bone problems. These are proven cures and preventative measures any person can use to prevent specific diseases. However, the FDA has added in there the famous subsection D to the Code and that part disallows any manufacturer that produces any vitamin or supplement or dietary product from adding information to the label that would in any way make a claim as to whether or not the vitamin or supplement would be beneficial for any disease. That's sort of counterintuitive though, as we know, there is absolute proof that certain substances will indeed prevent or even CURE a large number of diseases. However the CFR was amended to prevent any manufacturer from making such a claim.

The purpose for that of course is to never again have snake oil sales in this country. Snake oil. Sort of a generic term used to categorize the huge numbers of unscrupulous charlatans that concocted home brewed elixirs that contained widely varied ingredients from wood alcohol to cocaine to mercury to powdered skunk glands to just about anything. The movie version is of old by traveling side shows complete with fast talking gentlemen, testimonials and often free drinks and food. Hmmm, sounds like detail men doesn't it? If you don't know or never heard the expression, detail men or women, they are sales staff from the big drug companies that go into doctor's offices and dispense promises of wondrous health benefits of their employer's new drugs along with prizes, money, food and free samples. ((just for fun watch the movie 'Love and other Drugs' and watch the Jake Gylenhaal character when his company invents the boner pill))  Actually when you get right down to it, Coke, Dr. Pepper and a surprising number of now large drug manufacturers got their start in business by hawking the snake oil products of the day. 

The way to prevent Snake Oil in America is pretty simple. The FDA has decreed that anyone making and marketing any drug cannot put any claims of health benefits unless that drug manufacturer puts the stuff through a somewhat rigorous (and expensive) process that will definitively show that the substance is not harmful and indeed does exactly what the maker claims. No more Snake Oil. Well, sort of. The FDA does sort of tip the scales towards the really big drug companies and allows them to bring drugs out into the world that do seem to not have been all that rigorously tested after all. A lot of recalls and black box warnings. Which realistically the end consumer never gets to see. However, the FDA allows the big guys to market those drugs to doctors and hospitals and of course now days, to patients everywhere via the wondrous concept of mass media. TV, magazines, coupons in newspapers, wherever advertising space is available, drugs will be hawked to the world. 

Now the problem for me is that I have for some time now realized that human health depends almost entirely with how your body is fed and cared for. Feed it crap, you get a crappy body. And of course the more crap, ie. chemicals, additives, toxic pesticide residues etc going into the body, then the more the body has to work to eliminate the crap and has little left over to create healthy new cells and cure any problems that might be showing up. Probably from too much crap, but that's the way it works. So the problem is a simple one. The FDA means well, but the restrictive rulings about the claims vitamin and supplement manufacturers want to make about their products prevents people from understanding that simple supplements can help the body get past the crap; especially when all you put into the body is crap. There are others that the FDA has stopped, like the cherry juice processor that labeled their juice with the statement that it helps gout. They got shut down pretty quick, even though virtually every doctor in the world knows that information. The little company never spent the 5 to 8 HUNDRED million dollars for the report that would verify the claim. 

So, what to do. Should you take vitamins, or not. And if you think the above statements about crap in makes for a crappy person and want to at least try something different; well, you will find that the labels do not in any way give you any information. 

I think that's wrong. I believe basic science has justified many many many of the benefits of modern supplements and that the continued ban is just one more example of the FDA harassment of small businesses. 


(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343 (r)(1)(B) and 343 (r)(3) of this title or sections 343 (r)(1)(B) and 343 (r)(5)(D) of this title, is made in accordance with the requirements of section 343 (r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343 (r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

Wednesday, October 14, 2015

The cost of doing business.

Business is, well, in business to make money. It's not rocket science, you buy or make something to sell, you sell it, and at a profit. Most people know that some products allow for larger profits than others, and those are the ones produced by the giant mega corporations. They know what they're doing, they've done it for some time and know that consumers everywhere will pay the prices and allow the giants to make mass quantities of money. The big ones are bottled water, at up to 4000% profit. Tobacco products are not as high, designer clothes are just about there, carbonated beverages, jewelry, eyeglasses and designer frames, non-unlimited plan text messages, coffee from retailers and of course, movie theater popcorn and drinks. All have just huge markups. 

And then there are prescription drugs. In America, the profit margins are in the 6000% range. At least that's based on production costs. Granted, there are costs associated with development of the actual drug itself being marketed; but also money that has to go into research on new drugs for the future. There is also marketing. In today's world, most of the big pharmaceutical companies spend more on marketing their products than they actually spend on research. (Washington Post)  So that eats into their profit margins. One of the weird things that ALL the big drug companies do though that also cuts into profits is pay the FDA huge fines for doing things that are illegal. (Wikipedia list) If you add all the fines up, it's very nearly 20 billion dollars. 

Think about that for a minute, TWENTY BILLION DOLLARS.

Now granted, most of that money was in civil penalties. A large part of it was for criminal fines. 

Not one single person, no CEO's, no Directors, no Managers, no one, went to jail.

For them, it's a cost of doing business.

The most profitable industry in the world believes that they need to do things to make even more money and so they willingly and continuously engender and promote activities that are illegal and if caught they are aware of that they will pay substantial monetary penalties. 

Don't you wish you made that kind of money and could just write off billions as a cost of doing business.

Time on why GlaxoSmithKline got stuck with a 3 billion dollar fine. (Time Mag Report)

There's something wrong with our world.


Wednesday, October 7, 2015

Why be normal? Rolls the Chef Roy Way

So my son asked me to make some stuff for him. Lunch meat sandwiches that are in reality, well, rolls. Easy to do, so I went to Winco for groceries. (I love Winco, employee owned, fair pricing and huge selection, and not supporting the mega corporations funding of personal excesses) I purchases some dry salami and turkey breasts. And some jalapeno jack cheese. I cut thick slabs of the cheese and rolled it up in alternating layers of the cold cuts.

Then I made basic whole wheat bread dough, let rise an hour and then took golf ball sized bits and pressed out into rectangle on counter. Placed the rolled cheese and luncheon meats onto the bread dough and just pulled the sides up and pinched them all together to form little loaf. Make sure they are sealed well because if they aren't, then the cheese will melt and leak out all over the sheet pans. Let rise in warm place. Right now since it's raining and I have the windows open (YAY summer is over) it's pretty cool and so I let oven warm up a bit and then just let the rolls rise in the warm oven. Let double in size. Then take out and preheat the oven to 425. Throw a few ice cubes in and that steam helps let the rolls rise in those first couple minutes in the oven.  Let bake until golden brown, rotating the pan about 10 minutes into the baking. Total baking time was about 22 minutes. Cool on rack and bag them, suck the air out and throw in the freezer. A couple minutes in the microwave and a nice hot sandwich for on the go or nice snack at work


Monday, October 5, 2015

Just about the heartiest soup ever made

Yikes, bold statement, but make it once, and you will agree with me. The soup is pretty easy, and unbelievably nutritious as well as tasty as all get out. To start, take a half cup of lentils, a half cup of wild rice, and a half cup of rye berries. Rye is very hearty and bold, so I thought it would go well in this mix. Feel free to use whole oats, wheat or barley. In a pinch, brown rice would work as well. Rinse, put in pressure cooker and cover with a quart of water, bring to boil and pressure for 20 minutes. Let cool until pressure drops, open cooker and pour all the stuff into a bowl. Put the cooker back on the stove and heat back to medium high and film with 3 tablespoons olive oil and then add two sliced leeks, 4 ribs celery sliced, a red pepper diced and 3 jalapenos seeded and diced. I also added a cup and a half of chopped smoked mushrooms. Not something everyone has around the house, I have them because I smoke a lot of stuff in my smoker (mostly my goat cheese that I sell) and so I often just slice up mushrooms and put out there. You can omit or just add regular mushrooms. They add just a nice faint smokiness that I find pleasant. Cook over medium high about 8 to 10 minutes, a little color on the veggies is fine and adds to the flavor. When getting a bit softened, dump the grains back into the pot. Now, here I added 2 packages of my Tuscan Sun Dip Mix for a fantastic seasoning combination. You know, not necessary to use that specific product, but if you want to try it, come see me at the farmers market or order online (upper right corner) or just add a bunch of your favorite Italian seasoning blend. And I mean a lot, at least two ounces or so. Then I added a bunch of fresh ground black pepper, brought the thing to a boil, then added four finely chopped Kale leaves. Add the lid to the pressure cooker and cook under pressure for about 12 to 14 minutes. Remove from stove and cool to remove lid. Serve as is or with chopped parsley and a whole wheat roll on the side. 

You know, this was sooooo easy and it tasted fantastic. Even my son got up from his office (work from home day) and went out to the kitchen when he smelled the stuff. He had told me he wanted a burrito but ended up eating this. 

It makes a huge pot, and I imagine that tomorrow it will taste even better than today.  

Tomorrow I am going to take this thick soup, really a stew, and mix in a skillet with some cooked brown rice. Let the rice absorb all the liquid, let it cool and mix in some shredded cheese and stuff into green bells that I cored. I'll put them into another pressure cooker and cook under pressure about 8 minutes or so to cook the peppers through. More cheese on top to serve and I think the entire neighborhood will be knocking on the door cuz it will smell that good.