Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, July 3, 2012

Going Back To Pure Foods

I originally wrote this 6/26 and am just now posting it. Life, man. It calls. And obviously too fast and furiously for me to click on that Publish button. So I deprived you all for a solid week of a really good recipe. My apologies.

This past week has been odd. A niggling in the back of my head keeps saying, "look up this" and "research THAT".... "*impatient foot tap* ....NOW!" ... and it ain't about rediscovered gnostic codices or lost and now rediscovered mega-cities, although I have been reading about those, too, gosh darn it. I am writing three blog posts at once here. Keep getting side-tracked. Damn YouTube. I hate those "you might like" video offerings when you're done watching the one you were. I end up chasing my tail for three hours. 

Anyway! Going back to pure foods- that is what the topic has been from my Divine Nag. That's what I'm calling him now. With much love. Because he is lovely. And most definitely silly, waking me up this morning at 4:30am saying, "Ya know, flax seeds might actually give that bland thing some taste..." After today's lunch, I have to concur that milled flax seeds made it awesome. He does have some good culinary ideas. So now I'd like to share a recipe with you to tuck away for some rainy day experimentation. Or even for dinner tonight! This is a very flexible recipe. I've included pictures.

The thing which got my brain churning to create this recipe today was to get away from all the sugar in my diet. The high fructose corn syrup, plain sugar, aspartame, and white flour in my diet has been making me feel pretty crappy. In my teens when I danced and was so athletic I ate insanely healthy and didn't have the physical problems I have now.

I've noticed that the more soda I drink the more anxious(and obnoxious) I feel, the more white flour items I consume the more of them I want, and overall- I make really bad choices! I have almost no fresh vegetables in my diet or whole grains. Yeah, it's fine and dandy to buy whole wheat bread by the loaf, but what about all the other ingredients in there? What if you want to make it more nutritious and make it more versatile?(Sorry, but I'm cheap. I don't want to pay $3+ for a loaf of super-yuppie bread) I haven't found a product out there like that. These pancakes seem to be it, at least they are for me. Try them and tell me what you think.

Because the pancakes are so neutral tasting you can dress them up with fruit and even make a fruit glaze to drizzle on top, or slap a few eggs on top of them and call it a meal. So it can be sweet or savory. Again, there's NO SUGAR in these! IHOP these are not. But they do taste kinda nutty, because of the flax.

What is this, you ask? This was my lunch just a few short minutes ago. The second picture is the finished plate before I noshed on it. Here we have two medium sized graham-and-flax pancakes with one piece each of sliced smoked turkey and topped with shredded five-cheese blend. I moved a slice of turkey so you could see the pancake underneath.   

I popped  my pancakes in the microwave for a minute to melt the cheese and warm it all up and voila! An... open faced... pancake/sandwich thingie with a side of sliced apple. I don't know what to call this thing. Help me out.

I tried eating it with a knife and fork but that didn't work out very well because the meat kept sliding off. So I rolled them up and ate them like a pita. YUM! I was like the richest whole wheat turkey cheese sandwich ever made! My tastebuds were smiling. My fingers were a little buttery, but my tastebuds were dancing happy.

Here's the recipe for the pancakes; other great topper ideas are below. It's the basic pancake recipe from Joy of Cooking Cookbook(yes, I actually have the original hardback which is three inches thick) but tweaked with healthier ingredients and measurements.

Graham and Flax Pancakes, makes about 12-15 medium sized pancakes.

1.5 teaspoons aluminum-free baking powder
1/2 teaspoon salt
1.5 cups of milk(your choice of fat content)
2 tablespoons of butter, melted
2 large eggs
1 heaping tablespoon of milled flax seeds

Mix dry with dry and wet with wet in two separate bowels. Combine the two, gently folding in the wet ingredients taking care not to over mix. Don't whip out all the lumps. Finished batter consistency will be like a runny porridge. Cook pancakes like normal, on medium heat and flip once golden brown on one side.

Other topping ideas for meals: 
shredded meat
bacon and cheese
peanut butter
raisins/craisins
plain sliced fruit
curried okra in tomato sauce
humus
cottage cheese
pecans, walnuts, almonds, etc
guacamole and sliced tomatoes
scrambled sausage, onion, and garlic
agave or honey

Sheesh, the sky is the limit for these things. If you make large pancakes, because they're so thin, you can roll them up and stuff them with virtually anything. You can also use them in place of cornbread to mop up drippy sauces that are part of the main course, like a gumbo or bean or meat stew. 

When I made this today I fully expected the pancake to be dry and stiff, like a brick. I haven't had much luck using graham flour before now with muffins. But these pancakes were very flexible. The secret is the flax seed PLUS the melted butter. See, you can use milled flax seeds to substitute a large portion of the butter or oil in a recipe; it's a very oily seed. Loaded with Omega 3 fatty acids. 

The original Joy of Cooking recipe called for 3 tablespoons of butter. I decreased that down to 2 tablespoons and replaced it with one tablespoon of a healthier fat- flax seeds.

Once the seed is milled/shredded the shell is cracked and you have these superfine little spindle shaped threads and chips. Inside the seed is where the good stuff lies and that's what you want to use in your baking. Some of the fatty acids are destroyed during cooking but the oil itself is much healthier to use. Just don't go trying to use actual flax seed oil in your cooking unless it calls for it. The oil in the bottle is insanely good, yes, but I don't know the conversion. And besides, it's highly unstable. The dried seeds are easier to keep fresh. If you can't find milled flax seeds(they're in the flour section) then you can purchase the whole flax seeds and just pop them in your blender/food processor for a minute or three. Never tried it. But I've heard it's pretty easy.

I made about 15 of these pancakes today and shoved 13 of them in a gallon sized freezer baggie, squeezed the air out, pressed it shut, and the tossed them in the freezer. The butter they're cooked with in the pan will make really easy to separate when I need to grab a few. Or just wack the bag on the counter(or floor) to separate and there ya go- instant pancakes.

Now I am off to stuff my blender full of peanuts to make peanut butter....  Hydrogenated vegetable oils are next on my hit list.

Tuesday, December 21, 2010

Cringe-Worthy News

I cannot, absolutely cannot, believe I am writing this blog post. I cannot believe that the legal system in my country resorts to the kind of twisted entrapment just to get a pervert off the streets.

Looking up the actual legal definition for "entrapment" leads me to believe that it's not so much a standard case of entrapment, but still a legal nightmare nonetheless. I happen to live close to where this pedophile will(eventually) be jailed and I cannot believe I am defending any part of his case but that's just the way the cookie crumbles sometimes. My comments are below the short article, attention given to red text.

Pedophile's Guide author locked up in Polk County Jail

Bartow, Channel 13 News. Article last updated: Tuesday, December 21, 2010 1:15 PM

Polk County Sheriff's Office detectives are in Colorado making an arrest for violation of obscenity laws.

According to Polk Sheriff Grady Judd, the sheriff's office, along with authorities in Pueblo, Colo., have arrested Phillip R. Greaves II, the author of the book "The Pedophile's Guide to Love and Pleasure: A Child-Lover's Code of Conduct."

Greaves was arrested on charges of distribution of obscene material depicting minors engaged in harmful conduct, which is a third-degree felony.

Judd said Internet Crimes Division detectives who were investigating the case researched the book and inquired about receiving a copy. Judd detectives paid $50 and Greaves sent the book to an address in Lakeland, which violated state obscenity laws and led to the arrest. Judd said Greaves even signed the book he sent.

Investigators said the book contained graphic stories describing sex acts involving adults and minors.

Officials requested a warrant and made an arrest Monday. Greaves has no other connection to Florida.

Judd said Greaves could be extradited to Polk County as soon as today. Even if Greaves were to fight extradition, Judd said he likely would be brought to Polk County within 30-60 days.

Amazon pulled the book off its website earlier this year after an online boycott against the book led by a Lakeland woman.

"He wrote this book specifically to teach people how to molest and rape children,'' Judd said. "You cannot engage in or depict children in a harmful light.

"There may be nothing the other 49 states can do but there is something Florida can do. We can prosecute (Phillip Greaves) for this manifesto.''

************************************

So, Colorado detectives had the author send the paid-for book to an address in Florida, thereby breaking the law. Because Florida is the only one of fifty freaking states which has obscenity laws?!!

I'm not condoning pedophilia. I am in no way supporting this bastard's sick book. But I am opposed to someone in law enforcement requesting an author ship out their book to a place in order to take advantage of the law there. What, was the book for a "friend" in Florida? A Christmas gift, perhaps?

Ugh. It just sickens me. It sickens me on so many levels that it's all just a big mushy mess in my head. There's right and there's wrong. Their are shades of gray. Then there are those tricky little legal scenarios which make mutter to yourself, "Wow, wonder how that's going to turn out?"

It's like with the whole Wikileaks deal going on now. The guy leaks tons of classified military documents on wars and actions taken by governments and you've got half the people commenting on how heinous a thing it is for Assange to do what he does and the other half screaming about what a saint he is. Then when new leaked reports about certain American pharmaceutical company's criminal testing activities are brought forward and discussed, all of a sudden everyone swings over to Assange's side in vilifying the US government and the FDA. Oh come on now. What happened to all that patriotism?

When it involves killing people in wars it's ok with half of the population because, let's face it, there are a lot of veterans and relatives of veterans who have strong feelings. But when it comes to our household medicine cabinet then that hits a little too close to home for comfort.

Conclusion: "patriotism" is just a PR tactic to divide and control populations. I think the only loyalties we should have is to one another as part of the human race. And in order to be true "patriots" for ourselves and others that means doing the difficult thing, even if it means giving up our own comforts. Unselfish behavior is so rarely seen today that we have difficulty quantifying it let alone understanding it when it is a pure thing.

Wednesday, October 27, 2010

Vital Drug Shortages- Who is to blame??

I find this news topic intriguing on a number of levels. First, why wouldn't the FDA slap a 'negligent attitude' type lawsuit against Big Pharma? Because that's exactly what they are, negligent. Second, can anyone else read between the lines here? We're being exterminated, one sick population segment at a time. I smell something in the air.... could it be.. maybe? .... a newly formed underground black market for these types of 'discontinued' or 'unavailable drugs.' Either way, the company gets it's money.

When vital drugs run out, patients pay the price

150 medications in short supply so far this year; deaths, injuries have followed



By JoNel Aleccia
Health writer
msnbc.com msnbc.com
updated 10/27/2010 8:24:19 AM ET

Cancer patient Bob Dierker had just finished eight of 12 chemotherapy sessions when technicians broke the news.

Next time, they said, he'd get no leucovorin, the generic medication long used to battle his type of aggressive Stage 3 colorectal cancer. The drug was in short supply across the nation and he'd have to go without.

“It was like getting shot in the stomach,” said Dierker, 64, a lawyer from Fairfax, Va. “My odds just dropped dramatically because I can’t get this drug.”

Exactly how Dierker’s chances of beating the cancer will be affected is unclear, said his oncologist, Dr. Alexander Spira. Leucovorin has been used to boost the effectiveness of cancer drugs for decades, so no one knows how badly patients will fare without it. But Dierker is not alone.

Across the United States, life-saving or medically necessary drugs are running low — or running out — endangering care and increasing the odds of medication mistakes for a broad swath of patients.

Health officials say drug shortages pose a growing public health crisis, fueled in large part by financial motives of drugmakers who’ve watched low-cost generics erode their profits.

Numerous drugmakers contacted by msnbc.com either refused to comment on the shortages or confirmed only that they exist. None would discuss financial considerations.

Unprecedented numbers

“It’s disaster management, daily,” said Erin Fox, manager of the Drug Information Service at the University of Utah Health Care, who has tracked drug shortages for a decade. “The numbers are unprecedented.”

In 2005, Fox recorded 74 drug shortages in the U.S. By 2009, the number had jumped to 166. As of Sept. 10 this year, Fox had logged 150 new shortages — in addition to 30 drug shortages still unresolved and more being reported every week.

Worse, the drugs that are in short supply are often the ones needed most. This year has seen shortages of common drugs used for basic treatments: morphine for pain relief, propofol for sedation, Bactrim injections for infections.

Sterile injectables, including the pre-filled epinephrine syringes used in emergencies for heart attacks and allergic reactions, have been particularly hard to get.

“Our usual, everyday workhorse drugs are no longer available,” said Fox. “It’s just the unavailability of everything that we need every day.”

About 40 percent of the shortages are caused by manufacturing problems, including safety issues, said Valerie Jensen, associate director of the Food and Drug Administration's drug shortage program. Nearly 20 percent are caused when firms simply stop making drugs and another 20 percent are due to production delays. The rest are chalked up to raw material shortages, increased demand, site issues and problems with parts such as syringes or vials.

But underlying them all is the profitability problem, said Jensen.

“Normally, it’s a business decision. That does lead to shortages,” said Jensen. "These are just not usually money-makers."

FDA can't require drug production

Despite the concerns of doctors and pharmacists — and the distress of patients — no one can force the drugmakers to address the problem.

The FDA has no authority to compel drugmakers to continue producing a certain drug, or to require them to make a drug that’s in short supply, Jensen confirmed. And companies aren’t required to inform the agency about impending shortages unless the drugs don't have an alternative. Even then, there are no sanctions if they don’t.

When firms do tell FDA about a problem, the agency can’t publicly divulge proprietary information, Jensen said. Shortages on the FDA’s website are often chalked up to mysterious “manufacturing delays,” or frequently, no reason at all.

That has created a system in which pharmacists, doctors and patients may not know that a shortage exists until a drug is needed — and even then they don’t know how long it will last.

“There has been a lot of 11th hour scrambling,” said Dr. Richard L. Schilsky, a professor of medicine and chief of hematology/oncology at the University of Chicago. “We literally don’t know from week to week who’s going to be able to be treated.”

The problem has reached such a peak that four leading groups representing cancer doctors, anesthesiologists, pharmacists and safety advocates have convened an invitation-only meeting in Bethesda, Md., on Nov. 5. They’re asking drugmakers and supply chain representatives to join health experts and observers from the FDA to hammer out solutions.

“I’m going to give these folks the benefit of the doubt and assume they don’t know the impact at the patient care level,” said Bona Benjamin, director of medication-use quality improvement at the American Society of Health System Pharmacists.

But a nationwide survey of 1,800 health care workers conducted this summer by the Institute for Safe Medication Practices left little doubt about the impact on patients.

Two deaths blamed on morphine shortage

“It’s really a mess out there,” said Michael Cohen, director of ISMP, a nonprofit group that aims to reduce medical errors. “It is making us compromise the way we do things normally.”

More than half of the respondents to ISMP said that in the past year they had “always” or “frequently” encountered shortages of a list of common drugs.

One in three reported that the shortages caused medication errors that could have harmed patients and one in four said the mistakes reached patients. One in five said patients were actually harmed.

“We had two deaths where there was a morphine shortage,” Cohen said, explaining that a much more potent replacement drug, hydromorphone, was given at the level of the original, overdosing the patients.

Another patient woke up mid-way through surgery because medical crews trying to conserve the sedative propofol had given too little medication for the patient’s weight.

Such critical mistakes are bound to happen when shortages of so many drugs start to add up, said Thomas Burnakis, clinical coordinator of pharmacy services at Baptist Medical Center in Jacksonville, Fla.

“If I am the best centerfielder in the world, you can hit me a pop fly and I’ll catch it. You can hit me two or even three and I’ll catch them,” he said. “If you start hitting me 15, I’m going to start dropping them.”

It’s not just the mainstream drugs that are the problem. Shortages of niche drugs or those used for rare conditions have occurred, too.

In January, sufferers of a potentially blinding condition called birdshot retinochoroidopathy uveitis learned that Zenapax, the best drug for keeping symptoms at bay, had been discontinued by drugmaker Roche.

“I cannot tell you the panic I felt,” said Lynn Shaw, a 60-year-old nurse from Franklin, Mass., who was diagnosed with the disease 2 ½ years ago. “I was positive I was going to lose my vision. I thought, ‘Oh, my god, I’m going to go blind because of these jerks.'”

Chris Vancheri, a spokesman for Roche, said the company decided to stop making the drug, which is normally used in kidney transplant patients, because there were alternative treatments available. The problem, Shaw and other patients said, is that alternative drugs are either less effective or pose unacceptable side effects such as life-threatening high blood pressure and liver damage.

Drug companies won't talk

Shaw believes that Roche, like many manufacturers, stopped production when generics undercut the brand name price. Vancheri would not comment on the profitability of Zenapax.

Nor would representatives for Teva Pharmaceuticals and Bedford Laboratories, the makers of leucovorin, discuss the reasons for the shortage of the generic drug that has left Bob Dierker, the Virginia lawyer, with depleted cancer treatments.

Bedford representatives did not return repeated calls and e-mails from msnbc.com. Teva representative Denise Bradley would only confirm what patients have known for months, that the drugmaker halted production at its Irvine, Calif., plant in April.

"I do not have an estimated date of when we will resume manufacturing at this time," Bradley wrote in an e-mail.

Representatives for the drug manufacturers’ trade group, PhRMA, declined to discuss the largest-ever drug shortage in the nation, referring questions to individual manufacturers.

But Dierker thinks he knows what’s behind the recent shortage of generic leucovorin, the second since 2008. In some regions, a 50-milligram dose of generic leucovorin costs 98 cents; a newer brand-name alternative called Fusilev costs $184.08. But many insurance companies, including Dierker's, won't pay for it.

“It’s money, pure and simple,” said Dierker, a new grandfather who fears he won’t see 6-month-old Rhett grow up.

He’d like to do something about the shortage: organize a class action lawsuit, get a colleague to pursue a criminal case. But for now, he’s just angry.

“To have some faceless, nameless coward running a pharmaceutical lab decide he wants a bigger BMW and isn’t going to make your drug — I feel helpless,” Dierker said. “That’s the really frustrating thing, not to be able to do anything about it.”