Tag Archives: FDA

CDC/FDA Boundary Creep

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The Center for Disease Prevention (CDC) is raising national alarms about salmonella in backyard flocks of chickens.  It advises a washing hands every time you touch your chickens, and not keeping them in your house or around food.  The CDC goes beyond reasonable with some of its other recommendations, suggesting the bureaucrats who wrote the guidelines know nothing about keeping live chickens.  Salmonellosis is generally a self-limited case of diarrhea that lasts from four to seven days without complications, except in special cases.  Pig ears that are used as dog chew toys are also suspected.

This flies all over me, because the CDC meanwhile is advertising measles vaccines for children, within the same Yahoo article.  The CDC website at https://www.cdc.gov/salmonella/backyardpoultry-05-19/index.html gives the CDC’s version of the salmonella story.

I know something about chickens, having kept them for over 11 years, and I know something about salmonella, having gone to medical school, where I learned it is rampant in the environment.  My medical texts say there are over 1000 strains of salmonella.  It says “salmonellosis” is caused by inadequately cooked food, especially meat, poultry, and eggs.  Fruits and vegetables which are fertilized with animal manure are also implicated.  What the medical texts say that the government agencies don’t tell you, is that processed food is also a source, because the bacteria survives drying.  Incidentally, a dried taco seasoning distributed by Walmart and others has recently been recalled because it is suspected of containing salmonella-contaminated cumin, a spice.

I’ve also been tracking the FDA and its food scares since the E. coli in the spinach scare in 2006.  E. coli usually is considered “normal flora,” in the human gut and aids in digestion.  It only becomes pathological when natural barriers break down.  Antibiotic therapy, which is widely used, not only in human but in animal diseases and as a preventative, wipes out bacteria indiscriminately, but it never completely eliminates the pathogens, giving rise to antibiotic-resistant strains that then proliferate, with nothing able to curb them.  That’s why hospital germs are the most dangerous of all.  Methacillin-resistant Staphlococcus aureus (MRSA) is a universally recognized strain of Staph aureus that requires extreme measures to control, and it can be fatal.

Meanwhile, the CDC is busy promoting the measles vaccine, as a new “epidemic” of measles is sweeping he world, with pockets of outbreaks, we are told, among un-vaccinated children.  The controversy over vaccines comes in tandem with the explosion of patented, prescription vaccines for everything from flu to Zika virus, but the controversy is political, not medical or scientific.  While the medical or scientific institutions take pro-or-con stands, there is little in the news or from “educated” sources giving both pros and cons, and few (maybe none) who understand or want to understand the larger picture.  Or, it may be too early to tell what the ramifications are.

We are all caught in context, and predictions abound, but the past gives more information because we have a sense of the outcomes.  The bubonic plague, which wiped out a third of Europe in the 1340s and 1350s, was blamed on God’s wrath and witchcraft back then, but was later discovered to be carried by fleas on the rats that infested the cities and ships.  We still have rats and fleas, but we don’t hear much about bubonic plague anymore, partly because sanitation and nutrition have improved and partly because centuries if exposure have produced varying degrees of resistance.  Even HIV, which was identified in 1983, has evolved from carrying a quick death sentence to becoming more of a chronic disease.  While the advances of modern medicine have contributed to the long-term survival of HIV and AIDS patients, it’s also possible that the disease itself goes through cycles of infectivity and potency.

The media publishes federal agency press releases as though they are news stories, without question, investigation, or suspicion that they are anything less than gospel.  But federal agencies like the CDC and FDA are increasingly guilty of “boundary creep” by taking on more and greater advocacy roles for patented vaccines and other drugs, or alternatively, against small, independent food producers.  In the years I’ve been monitoring the FDA, it has initiated food scares over spinach, peanuts, eggs, cantaloupes, poultry, and pet foods, to name a few, yet while the scares make national news, precipitate food recalls, and have forced some companies into bankruptcy, the scares generally are hyped-up bluster over limited illness and almost no mortality.

About this salmonella outbreak that has killed two people and hospitalized over 122 in multiple states so far, any discriminating reader, especially one with a medical background, might naturally question how the CDC arrived at this reported chain of events.  How did they know the salmonella outbreak was “caused” by chickens or pig ears?  How do they know the hospitalized cases are even the result of salmonella toxicity?  The processes involved to isolate a pathogen are time, labor, and financially intensive.  Most cases of infectious disease are treated with broad-spectrum antibiotics.  Salmonella is so widespread in the environment that anyone with low resistance—as from poor nutrition, bad sanitation, antibiotic use (which reduces normal, protective flora), or pre-existing illness–might be susceptible.

If the CDC is truly interested in public health, it might do more to educate the public about the broader aspects of health, instead of pushing the panic button over speculative claims and unverified reports.

In my eleven years of hugging and kissing my chickens—they are very affectionate—I have developed some health problems, but salmonella has never been one of them.  I have minor scars on both arms from being scratched, but the worst is the deformed left wrist, which I broke when I fell chasing the fox that was chasing my Squire.

When I picked Squire up with my dangling left wrist, it was the sweetest, most healing hug I’ve ever experienced.  I didn’t stop to clean the mud off my arm, and neither the “health care professional” who wrapped it, nor the one who set it in a cast, bothered to clean it , either.

This is the institutionalized version of “health care” today.

 

 

 

 

 

 

 

 

Drugs, Drugs, and More Drugs

The pharmaceutical industry in the United States has hoodwinked the public into believing its snake oils are worth the money you pay.  The government, “health care industry,” and insurance companies are happy to comply, and maybe some of them even believe their hype.

This does not stop them from jacking up the prices of necessary medications, like insulin for diabetes.  According to the New York Times, Martin Shkreli set a new record for Wall Street greed when he acquired the rights to Daraprim, a life-saving anti-parasitic drug, in 2015 and hiked the price from $13.50 to $750 a pill overnight.

The NYT says the Trump administration “went ballistic” when Pfizer increased prices a few weeks ago.  This has deterred Pfizer, along with Merck, Roche, and Novartis from raising prices, for now.

But not to worry, if you have stock in a pharmaceutical company, because the FDA and its sympathizers are on your side.  Only worry if your insurance company doesn’t cover the cost of your medications.

You might profit from buying stock in the companies whose drugs the FDA, the “health care industry,” and the insurance companies are pushing, such as the over-the-counter naloxone that is one of four medications promoted for “opioid use disorder.”  In terms of reputation, this “opioid crisis” has spread far and wide, to the highest government offices, academia, psychiatry, newspapers, magazines, television, the internet, the courts, and dinner-table talk.  Its funding has been greatly enhanced by the promoters of public disinformation, yet relevant facts are few.  All the stories have the monotonous flavor of canned worms, opened, sampled and regurgitated for yet another meal.

We are told about opioid-related deaths, the evil drug company that promoted its opioid drug as non-addictive, the lazy or greedy doctors who over-prescribe narcotics, and the glories of “medication-assisted treatment,” or MAT.  Somehow, heroin comes up in all these stories, yet most people should know heroin is nowhere legal in the United States, not even by prescription.  We are rarely told that this magical MAT consists of four drugs, two of which are opiates themselves, or that the federal government has added special training and licensing requirements for administration of its approved protocol. We are not told that “treatment” does not mean “cure.”  No, “cure” would imply eventual freedom from all drugs, a notion that doesn’t serve Wall Street profits.

So let me give you one example of how this scam works.  I hesitate to call it a “conspiracy” (wink, wink), because of the paranoia such a word implies.  I’d rather call it a “consortium” of interrelated interests, all of which stand to profit by exaggerating the problem and presenting expensive but ineffective solutions.

We are told opioid-related deaths have skyrocketed this century, and Oxycontin (oxycodone) is the precipitating culprit.  OxyContin is produced by Purdue Pharma, which indeed does have a shady background.  In 1952, three brothers—Arthur, Raymond, and Mortimer Sackler–all psychiatrists from Queens, New York, purchased Purdue Frederick Company.  Arthur was reputed to be brilliant in psychiatric research and pharmaceutical advertising.  Working for Roche, he found enough uses for Valium (diazepam) to make it the first drug to hit the $100 million mark in revenue.  He also “positioned” Librium (chlordiazepoxide) for Roche.  Valium and Librium are members of the “benzodiazepine” class of drugs, a class that includes Xanax (alprazolam), Ativan (lorazepam), Klonopin (clonazepam), and others.  Alternatively, oxycodone is a semi-synthetic opioid from thebaine, an opioid alkaloid in the Persian poppy.  It was developed in 1919 in Germany.

In December, 1995 the US Food and Drug Administration (FDA) approved Purdue’s OxyContin (oxycodone), to treat pain.  It hit the market in 1996. Direct-to-consumer (DTC) advertising of drugs was approved by the FDA in 1997.  Purdue marketed the drug to doctors and the public as a non-addictive treatment for pain.  It reached $45 million in sales the first year, and $1.1 billion by 2000.  By 2000, it was becoming evident that OxyContin was, indeed, addictive, but the FDA still approved a larger, 160-milligram pill for those with high tolerance.

In 2007, in US vs. Purdue Frederick Company, Inc., Purdue pleaded guilty to intent to mislead doctors and patients about the addictive properties of OxyContin.  It paid $600 million in fines, among the largest settlements for pharmaceutical companies in US history.

By 2010, revenues had hit $3.1 billion, or 30 percent of the painkiller market.  Purdue remains a privately held company, in the hands of the Sackler descendants.  It is being served with multiple lawsuits from different states for its role in contributing to the “opioid epidemic.”  According to The Week, Kentucky is one of the worst-hit states.  It has filed twelve claims against Purdue, for false advertising, Medicaid fraud, unjust enrichment, and punitive damages, among others.  The Week also says there was a four-fold increase in prescription painkillers supplied to pharmacies and MD offices between 1999 and 2010.

Meanwhile, The Guardian reported in 2017 that the US constitutes 80 percent of opioid pill production but has only five percent of the world’s population.  It claims the pharmaceutical companies made false claims of an “epidemic of pain,” in the 1990s, and the federal agencies went along.  Pharmaceutical lobbyists got Congress to loosen restraints, and doctors were often reprimanded for not supplying enough.  “Regulators became facilitators,” as the FDA approved one opioid pill after another.

How does this relate to heroin, a known street drug, one might ask.  It’s a good question, for which there are no easy answers.  The idea that prescription painkiller pills are “gateway” drugs to heroin use has been mentioned.  One source notes that heroin is less expensive on the street than OxyContin, which can cost $1/milligram, or $80 for an 80-mg pill.  A more significant problem with heroin, we are told, is that it is increasingly laced with fentanyl, another opiate that is up to 5000 times stronger than heroin.  Synthetic fentanyl is being smuggled in from China.  Heroin is coming from Mexico, some say.  Fact is, there are few facts available in this gigantic obfuscation of facts that characterizes sensationalism.

So we don’t exactly know how prescription pain-killers are related to heroin/fentanyl deaths.

Death from opioids usually comes from respiratory depression.  In other words, people who overdose pass out and stop breathing.  Many other drugs cause respiratory depression, too, and a mixture can have cumulative effects.  It is common for people with chronic pain to take both a narcotic (opioid) and a muscle relaxant/sedative of the benzodiazepine class mentioned above.  The benzodiazepines also cause respiratory depression, as does alcohol.   Too, it’s not clear how many of these opioid-related deaths are complicated by other substances.  One psychiatric journal mentioned that a third of opioid deaths were complicated by benzodiazepines.  It’s probably safe to say that hard-core street addicts could be taking many drugs at any given time.

But our “medication-assisted treatment” bypasses all these inconvenient details.  It does include a drug, naloxone, which reverses the effects of opioids and can save lives in a primary opioid emergency.  It has been around over 45 years and is well known in emergency rooms for its life-saving effects.  Since this crisis began, police and ambulance drivers have had to use it on numerous occasions.  Now, the US Surgeon General Jerome Adams, MD, MPH, has encouraged over-the-counter preparations of naloxone for those with opioid use disorder and their loved ones.  FDA head Scott Gottlieb is also advocating expanded access to treatment, Medicaid funding, and other systemic changes to pay for the problem.

Manufacturers of OTC naloxone have jumped to increase prices accordingly.  Narcan intranasal (Adapt Pharma Inc.) retails for $135/dose, more than double its price a few years ago.  Kaleo’s Evzio auto-injector now retails for $4,500, more than 6.5 times its $690 average price in 2014.

What’s not clear about this scenario is how a passed-out opioid over-doser who has stopped breathing will be able to administer the naloxone.  Irreversible brain damage occurs mere minutes after a person stops breathing.  The life-saving medication requires someone alert, quick to recognize the problem, and to administer the antidote.

With all the calls for funding, research, and treatment, no one is admitting that substance use treatment is notoriously ineffective.  FDA head Gottlieb and others are begrudgingly accepting the idea that cure may not be practical, and long-term maintenance must be considered.  So the magic bullet, the aforementioned MAT, or “medication-assisted treatment,” is not a cure.  It is designed to convert illegal opioid use to legal opioid use for perhaps a lifetime.  Of course this will require funding for treatment, for the treating facilities, support staff, the researchers, and for the prescriptions.

Who benefits from this crisis?  Well, the National Institute of Health has earmarked $1.1 billion to develop “scientific solutions,” backed by a $1.3 trillion omnibus package passed by Congress, according to Psychiatric News.

US President Donald Trump has declared the “opioid crisis” a public health emergency.  We have the White House Opioid Commission looking for ways to fund and treat the problem, including such issues as insurance coverage.  It recommends funding for no less than eight professional organizations.

The four approved medications in MAT are naloxone, mentioned above, naltrexone, and opioids buprenorphine and methadone, in case you want to buy stock in the companies.  Insurance company stock will most likely benefit, too.

The common denominator in this “emergency” is the use of more drugs to treat the drug problem in the drug-crazed culture we have created.

Urban Gardening

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S. Squire Rooster and Lady Brownie Hen, standing around and on concrete block herb garden. Chickens don’t bother herbs, but they love worms, grubs, termites, roaches, lizards, and fiddlers. I keep my yard as free of artificial chemicals and traps as possible, but I can’t stop the county from dumping malathion on our heads.

August 18, 2017

As people starve in Venezuela and other places, I remind myself Americans don’t know what starvation feels like.  We suffer from the opposite problem, obesity, diabetes, heart disease, life-style-related diseases resulting from consuming too much of the wrong things.

 

My herbs begged for pruning the other day.  It took several hours to cut, sort, wash, chop, and store, but I got a half-gallon of mint-stevia tea and almost a pint of basil-chive pesto.  My mind is free when I’m doing finger-trained things like chopping herbs.  I thought about how easily herbs grow on my deck, and how even urbanites with window sills, balconies, or patios could grow food.

I thought about my “green footprint” and how all greenery—even so-called weeds—contribute to cooling the earth and re-claiming oxygen from CO2.  So even growing an herb or a potted tomato on the patio adds to your oxygen green print.  Citrus grows well in patio pots, too, depending on where you live.

When the government controls the food supply, it’s a set-up for famine.  Julius Caesar used that to advantage, and so have rulers the world over.  That’s what makes centralized power so fragile.  We’re seeing that now, with President Nicolas Maduro in Venezuela.   He has the military guarding the food.  I’ll bet lots of folks now regret leaving the farms to work in factories and oil refineries.  At home, they could grow their own food.

We have the same situation brewing in the USA, but here the strategy is more insidious. We can see it being played out in all the mergers and acquisitions in the food, drug, and poison industries.  Most notable is the planned purchase of Monsanto by Bayer, based in Germany.  So Monsanto will go underground, should these two poison giants (depending on your point of view) merge.  Second, a little different but no less significant, is the merger of Dow and DuPont, two chemical giants.  Dow has the trademark on Styrofoam and has its own versions of genetically modified (GM) corn and other patented plant products.

Finally, we have the impending merger of Swiss Syngenta, the world’s largest crop chemical producer, and China National Chemical Corp., a state-owned outfit.  More than half of Syngenta’s sales come from “emerging markets.”  At a $42 billion price, Wikipedia reports the purchase of Syngenta to be the largest for a foreign firm in Chinese history.

The farming industry (which is often distinct from and at cross-purposes with “farmers”) is supposedly opposed to the Montsanto/Bayer merger.  The opposition claims it will increase prices and reduce innovation.  The poison companies say they will increase research and development.  (That’s what scares me most.)

In the US, the ethanol mandate represents the biggest government power grab of the food supply to date.  GM corn manufacturers are now making “ethanol-grade” corn.  Well, folks, what does that mean to you?  It means to me that Monsanto, Dow, Syngenta, and other GM manufacturers are busy downgrading everyone’s food supply to generate electronic profits on Wall Street.  Of course Archer Daniels Midland, ConAgra, Cargill, and other Big Food are all for burning perfectly good corn whiskey in cars.  Cars consume it faster than alcoholics do, and the government gets more in taxes, so of course the FDA, CDC, and EPA are complicit.

So with the mergers of the world’s six largest seed, agrochemical, and biotech corporations, which are in the business of poisoning us from the ground up, it behooves all of us to start producing our own food, individual by individual, as space and sunshine allow.

 

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Deck herbs, some in concrete blocks, others in clay pots.  Cat litter boxes do a good job of catching water.  Can water and/or fertilize from the base.

Herbs are probably the easiest plants to grow, and many are perennial.  My chickens don’t like them, the deer don’t like them, and they are amazingly bug-resistant.  Stevia, chives, mint, oregano, and rosemary are all perennial.  The rosemary bush is taller than I am.  Since stevia was approved by the FDA as a natural sugar substitute a few years back, corporate marketing has improved its image. Less well known is that it’s a perennial extra easy to grow in a small clay pot.

So I harvested overgrown stevia, mint, chives and basil.  I made stevia-mint iced tea and basil-chive pesto.

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Set-up for making mint-stevia tea.  Mint is on the chopping board.  kco081717

I use a one-half gallon container for the tea, fill with cold water, let the water come to a boil, and turn the burner off.  I stir in the chopped mint and stevia, replace the lid on the pot, and let it steep all night.  In the morning I strain the tea and transfer it to the refrigerator container.

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Set-up for making basil-chive pesto.  Curved knife blade with rocking motion works best for fast and safe herb and veggie chopping.   kco081717

Making pesto is a breeze with a mini-food processor.  Pesto keeps weeks in the refrigerator and infinitely in the freezer.  I freeze fresh pesto and gouge chunks out of the mix as needed.  I use it in salad dressings, spreads, sauces, marinades, and Italian dishes of all kinds.

I use a standard blend of ingredients with whatever herbs I have.  Two to three cloves of crushed or chopped garlic, a couple of handfuls of chopped herbs, a handful of grated parmesan cheese, a handful of chopped nuts, and enough olive oil to make the processor work right.  I use soy sauce or olive brine instead of salt.  I like red pepper, too.  If you overdo the red pepper, extra olive oil helps a lot.

More traditional pesto recipes call for pine nuts, but they are expensive, somewhat hard to find, and not worth the price.  I prefer walnuts or almonds, but any nut will do.  Put them in the processor early, as they take time to grind up right.

Cheese is also variable.  Hard cheeses, like grated parmesan or romano, tend to last longer in storage, but I’ve used jack and cheddar, too.  Pestos are as versatile as your imagination.

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My version of pesto pizza.  Rye toast smeared with basil-chive pesto, topped with parmesan cheese and salad olives.  Broiled in toaster oven 3-5 minutes. kco081717