Welcome to Saturday's Potluck

“Learn the rules like a pro, so you can break them like an artist.”
Pablo Picasso

From the various discussion medical discussion thought I would do a short series on self-care. Good resources of drug information is essential. One of the foundational sources I use to gather information on medications is the Package Insert (PI). The current format of the PI has been consistent since 2006. The content is not as readily influenced by shifts in political winds. Dosing information will be limited to FDA approved treatments for specific dosage formulations. Other sources need to be used for off label information.

One tool used by the courts as evidence of standard of care has been the PI. Notably though, the FDA cannot regulate the use of a drug by the prescriber. Thus, once a drug is approved for use in the U.S. market, a clinician using professional judgment may use a drug in a manner that is different from that described in the PI; for example, for a non–FDA-approved (off-label) indication. Jurisdictions differ in the manner by which they utilize the PI as evidence of standard of care.16 Some states, such as Florida and Illinois, generally allow the standard of care to be established solely through information contained in the PI.

The FDA has a very good overview of the layout of the Package Insert.

Sample search for the Package Insert, using the phrase "full prescribing information" with the brand or generic name. The Highlighted or Patient Package Insert will not include all the significant information for a full evaluation. I will use PDR (Prescriber's Digital Reference)to identify prominent brand names of prescription drugs and prescription strength formulations of over-the-counter medications. When PDR was Physician Desk Reference is had a reputation of only printing information on products the manufacture had paid for publication.
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Some PDFs of Package Inserts as of July 23, 2921
Moderna
Janssen
Pfiser-BioNTech
aspirin product (for some individuals aspirin has significant risks)

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An overview of the developmental steps for new drugs and approved treatments.

A phrase which seems to trigger heated discussion is "Longterm effects of vaccines area not known". I have used the phrase myself as an acknowledgment Phase 3 and Phase 4 trials are still ongoing for some of these products. As adverse reactions of the vaccines are being identified and verified through the FDA process the Package Inserts are being updated.

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Vaccine hesitancy, vaccines for profit and lab controversies are not a news issue which just cropped up with the Covid vaccine. An article in National Geographic first published in Feb, 16 2017 (updated 9-28-2019) discusses some of the past vaccine abuses. Our current process of ridiculing someones concerns or encouraging the mandate of vaccines by business and necessary services creates an unspoken resentment and longterm social tensions.

Leonard Hayflick’s story is at the heart of your book. Introduce us to this cantankerous scientist—and tell us about the long battle he would eventually fight with the U.S. government over ownership of the WI-38 cells.
...
Leonard Hayflick was a brilliant, ambitious, dogged young scientist who grew up in working-class Philadelphia, one generation away from immigrant poverty. He was determined to make his mark in the world of biology, which he loved. He was 34 years old when he derived the WI-38 cell line.
...
Four months earlier, he had signed a contract with the U.S. government, with the National Institutes of Health (NIH). So the cells were derived under that contract. There was a stipulation that title to the cells would pass back to the U.S. government when the contract was terminated, as it was in 1968.
...
Some people in the biological community were irate with the government for turning Hayflick into a thief. But, in 1974, Hayflick inked a deal with Merck worth up to $1 million to him personally to provide cells for Merck’s rubella vaccine. I believe that was the death knell for the government, in terms of how hard they came after Hayflick.
...
In the midst of World War II, it became an imperative to combat the spread of infectious diseases on the front lines. People in powerless positions were conscripted for tests, like an experimental flu vaccine involving young offenders breathing in flu virus through a gas mask. Or they were infected with typhus, with terrible results. When the war ended, the mentality of privileged access to these people for the greater good continued in the American medical establishment, not only among high-profile researchers, like Jonas Salk, but also the institutions that backed them, like the NIH.
...
Fast forward to 2013. I was able to track down Mrs. X but, through my Swedish translator, I learned that she did not want to be interviewed. Understandably, she wanted to leave this chapter of her life behind. She did say one thing, however, which was, “I was not asked. Today, this would never be allowed." Merck makes more than $1 billion per year from vaccines using these cells. But Mrs. X’s fetus was used without her consent or knowledge.

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Federal control of medical treatments and information is not a new power. Suppression of herbal remedies was decreased in 1994 with the Dietary Supplement Health and Education Act. Not everyone agrees the general public should have free access to the products.

Dietary and other nutritional supplements are largely exempt from FDA oversight. This is due to a law passed by Congress and signed by President Bill Clinton in 1994, the Dietary Supplement Health and Education Act (DSHEA). It was the brainchild of Sens. Harkin and Hatch -- the former a lover of woo and the latter a champion of the supplements industry -- and the NCCAM provided much of the "scientific" justification for the law.

Essentially, the law declared vitamins, minerals, and even herbal "remedies" to be dietary supplements. The effect of the law was to remove the pesky FDA from ensuring that the products are safe. As the Mayo Clinic explains, "Regulations ensure that herbal supplements meet manufacturing standards but don't guarantee that they're safe or effective."
...4Alas, the $37-billion dietary supplements industry likely will remain unregulated for the foreseeable future. The fight against junk science and bogus health must soldier on.

Marijuana is still an illegal substance per Federal laws and actively enforced.

November 2016 California - Medical marijuana collective raided, CEO arrested

The Ventura County Sheriff’s Department claims Sutula has been running Sespe Creek in violation of California’s medical marijuana regulations. The department has not been more specific than that and the search warrants in the case are sealed.

April 2021 Oklahoma - OKC marijuana stash house led to Logan County drug raid

“We are basically looking at this as a criminal organization that is simply using Oklahoma’s medical marijuana program to continue to operate their illegal operation under the guise of a medical marijuana farm,” Mark Woodward, spokesman for OBN said.

May 2021 California - $146 million in cannabis plants seized in bust spanning several California counties

While cannabis and hemp cultivation can be legal depending on the local ordinances, according to the Solano County Sheriff’s Office (SCSO), “it is a crime when it is not done in compliance with the law.

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The little quail is still sitting on her nest. We have worked out an agreement so the plants near her can be watered.

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What is on your mind today?

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full effect here. High smoke mixed in, can see but not smell. Cool, no sun to be seen.

I learned a new trick, old dog that I am, taught by a guy not even thirty.
Most mechanically inclined people know about using grease hydraulicly to punch out bearings and such.
This guy mentioned bread. I thought I misheard him, I had to ask, Bread? Bread.

Background;
I had to replace the pressure plate in the youngests Suby, figured while I’m in there, get it All done, ya know? Problem was the pilot bearing is so small, I couldn’t find a puller that fit and grease makes a mess over the flywheel that’s no bueno for the friction plate.
Kid behind the counter mentions bread.
I went home, put on half a pot of coffee, grabbed a slice of bread and the correct size bolt and hammer, lit up a doob and before I could take two tokes had that pilot bearing popped out, laying in the palm of my hand.
Used a straight pick and had the bread cleaned out before a third toke.

Fucking Bread.

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Ya got to be a Spirit, cain't be no Ghost. . .

Explain Bldg #7. . .

If you’ve ever wondered whether you would have complied in 1930’s Germany,
Now you know. . .
Sign at protest march

studentofearth's picture

@Tall Bald and Ugly definitely less clean up than grease.

Working on the engines and more mechanical stuff has become a new part of life. Fortunately have access to the tools been working on the knowledge and skills.

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Still yourself, deep water can absorb many disturbances with minimal reaction.
--When the opening appears release yourself.

snoopydawg's picture

@Tall Bald and Ugly

I smelled smoke during my walk but just thought it was from the smoke. Nope. It’s close to Park City and has closed the major highway.

From S SLC

Just something funny…

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It is not until the tide goes out that you discover who has been swimming naked.

It seems the government, in league with Big Pharma, would have you to believe all natural supplements are untrustworthy. By the same token, it takes forever to recall a drug that harms or kills people.
That said, even my drs. over the years have suggested Vitamin E creams for healing wounds.
I see nothing wrong with relying on herbal treatments, and I am a believer that biotin is effective in the care of hair and nails.
Had I know that terbafine can cause psoriasis, I would not have taken it. Too late now.

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studentofearth's picture

@on the cusp significant lobbying. Government controls the Patent rules and includes restrictions of Intellectual Property in foreign treaties to protect "private property" over lives. Might find this an interesting read. Playing for time: strategies that can help extend a drug's patent life

Effective patent lifecycle management is mission -critical in the field of medicine,' says C Hunter Baker, chair of the pharmaceutical practice group at US intellectual property law firm Wolf, Greenfield & Sacks PC. and a Harvard-trained medical doctor.

Government has also allowed the merger of multiple pharmaceutical companies to now just a handful of mega sized International corporations.

Isn't it frustrating after experiencing a serious side effect to find out the possibility was already known. One school of thought in medicine is if the patient is told of potential side effects they wont take the drug. Another concept is patients are too suggestible and if provided a list of side effects will imagine they experiencing adverse reactions.

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Still yourself, deep water can absorb many disturbances with minimal reaction.
--When the opening appears release yourself.

@studentofearth I wouldn't have taken a drug that was known to cause an autoimmune disease that is incurable, for damn sure.

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enhydra lutris's picture

@on the cusp

used in China for treatment of x and y since 76 AD, or used on wounds by the natives in Belize, Costa Rica and Panama for centuries, etec.

be well and have a good one

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That, in its essence, is fascism--ownership of government by an individual, by a group, or by any other controlling private power. -- Franklin D. Roosevelt --

@enhydra lutris @enhydra lutris on the sales brochure. Coca tea leaves available for sale at the airports of Peru and Ecuador list uses and descriptors such as you suggest.
So does China for their herbal remedies.
They are clearly not first world.

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enhydra lutris's picture

so off to yardwork and such. I have a vast pile of snark here regarding use of the PI or PDR instead of some random dude's blog or website, so I'd better talk about the weather or something else. It's been warm and the warm continues. Got distracted there for a bit. Heh. finally, after much ado and workarounds, got my official CA e-certificate of vaccination for those occasions likely coming soon to an airport near you when a paper record just won't do. It still isn't the approved package of course, which is where the jury rigging and workarounds come in. Like everything else today it is a QR code that is supposed to save to your phone but won't, at least on mine, so I got it well displayed on said phone and took a screen grab.

be well and have a good one

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That, in its essence, is fascism--ownership of government by an individual, by a group, or by any other controlling private power. -- Franklin D. Roosevelt --

@enhydra lutris that no court officer (judge, bailiff, court reporter, clerk, or attorney) may inquire if anyone in the courtroom has been vaccinated due to HIPPA protections.
I have a problem with delivering over my health info to TSA and NSA, whom I, like you, want to stop.
Our constitutional right to privacy and our HIPPA law specifically aimed at protecting our health decisions or health condition is a completely different issue than to vax or not to vax.
To all searches and seizures, I demand a search warrant.

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enhydra lutris's picture

@on the cusp

We love to travel and I have a past. I'm tired of having to run my ass off at 75 in order to not miss my flight because the TSA has decided that I need to follow them to room 101 and explain myself, my trip and the nature and purpose of every possession in my pockets, hiking/travel vest, and backpack. That shit is especially grievous when one has a stopover involving a change of planes and they pull it then. Especially because I don't give a shit who knows about all of my vaccinations, including rabies In fact, somewhere I have a document that I used to carry when traveling to select locales that lists them all in case I get some bizarre ailment in Kenya or Panama. My medical record is on a memory stick in my travel vest and my password is written on the side. I expect that they already know that shit anyway. Hell, I got my shots from a county paramedic at a fire station with all preprinted forms and computerized print out of the schedule etc.

be well and have a good one

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That, in its essence, is fascism--ownership of government by an individual, by a group, or by any other controlling private power. -- Franklin D. Roosevelt --

@enhydra lutris is only shown to customs at foreign destinations. The TSA and NSA had no interest, or legal right, to know if I would be barred from entering into Tanzania from Kenya.
Travel in good health, give the agencies what they want.
There are a couple, or more, hills I prefer to die on. I accept being "watched" by a foreign government, but not my government.
Different hills for different folks.

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enhydra lutris's picture

@on the cusp

but foreign countries are different, as you know, and I fully expect to fly in from east jesus some day with a connection to CA and run into it whereupon I'll probably go along with it and file a complaint later.

be well and have a good one

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That, in its essence, is fascism--ownership of government by an individual, by a group, or by any other controlling private power. -- Franklin D. Roosevelt --

@enhydra lutris that I do not have to go along to get along.
I cannot emphasize enough, do whatever you want insofar as giving your info to agencies.
I have to live by the laws I have to abide by daily.
Your life, your education and mine. Different.

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studentofearth's picture

@enhydra lutris The only random guy I recommend is Joe Graedon who wrote The People's Pharmacy in 1976 and created www.peoplespharmacy.com. I was given a copy of The New People's Pharmacy by a customer shortly after graduating. It started eroding my blind faith in the facts taught in college. Add experiencing developing drug information databases and coming to recognize the "official" texts did not always agree on the facts. College was much easier only the assigned drug reference book needed to be memorized for a test, all facts were absolute.

Thanks for stopping by.

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Still yourself, deep water can absorb many disturbances with minimal reaction.
--When the opening appears release yourself.

enhydra lutris's picture

@studentofearth

was talking about avoiding getting snarky about the use of the PI and PDF. In my younger days I never went to the pharmacy with a new script without first checking the PDF.

be well and have a good one

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That, in its essence, is fascism--ownership of government by an individual, by a group, or by any other controlling private power. -- Franklin D. Roosevelt --

studentofearth's picture

@enhydra lutris state of medical information with examples of potential harm prevented when good resources were used prior to treatments. Each of us could probably recollect too many actual examples.

My frustration point is too low regarding people harmed by medical care.

Continual exposure to smoke and heat could be effecting my ability to communicate clearly. Written satire requires clear thought.

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Still yourself, deep water can absorb many disturbances with minimal reaction.
--When the opening appears release yourself.

Lookout's picture

In addition to Vit D etc...
https://covid19criticalcare.com/wp-content/uploads/2020/11/FLCCC-Allianc...

PREVENTION PROTOCOL
Gargle mouthwash 2 x daily – gargle (do not swallow) antiseptic mouthwash with cetylpyri­dinium chloride (e.g. ScopeTM, ActTM, CrestTM), ListerineTM with essential oils, or make your own povidone/iodine 1% solution as alternative.

https://covid19criticalcare.com/wp-content/uploads/2020/11/FLCCC-Allianc...

If there's no big profit it seems we will not be informed. Glad I to have you all to help educate me!

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“Until justice rolls down like water and righteousness like a mighty stream.”

@Lookout I gargle less frequently than they suggest. I am now compelled to live, in person court, and jury trials. Tiny rooms, lots of people.

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studentofearth's picture

@Lookout instructions for treating some acute conditions by the medication. I figure if I happen to get sick or exposed to a toxin my mind might not be clear enough to remember where the information is stored on a computer, website or book. It is simply insurance that I hope is never used. Time and money spent will appear as a wasted activity.

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Still yourself, deep water can absorb many disturbances with minimal reaction.
--When the opening appears release yourself.

I attended this event, saw this ride. I now have no horses. But if I did ride...

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@on the cusp Piaffe, passage, pirouette, single tempi…… Exquisite!

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@TB mare and stood up and screamed at his final tempis to the halt and salute. We were told not to stand up. We just became a wild, screaming mob!

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studentofearth's picture

@humphrey

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Still yourself, deep water can absorb many disturbances with minimal reaction.
--When the opening appears release yourself.

It's good to have your expertise on this. It also reminded me of this article I read recently on Kratom regulation by the FDA:

The FDA Shouldn’t Support a Ban on Kratom

The herbal supplement can be abused, but given the explosion in opioid deaths, eliminating this safer substitute will almost certainly lead to more deaths

I hope they do the right thing. I've lost a few friends over the years, some from opioids directly, others from being cut off by their doctors.

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studentofearth's picture

@peachcreek
regulate criminalize kratom is to maintain a market base for other products in international trade. Before the "Opioid crisis" created by some government agencies in cooperation with private business illegal abuse was going down significantly.

Unfortunately, kratom prohibition may be coming: the FDA is now asking for public comment about whether the U.S. should support an international ban on the drug, which the United Nations, through the World Health Organization, is considering.

The agency’s own position is clear: it opposes over-the-counter sales of kratom as a health supplement and wants its sales to be illegal unless it is proven medically effective. An international ban would automatically require the U.S. to prohibit the drug domestically, under its treaty obligations.
newsletter promo

In concert with the Drug Enforcement Administration, the FDA previously has sought to ban kratom. In 2016, the DEA announced that it planned to place kratom into Schedule I of the Controlled Substances Act—the category intended for drugs that have potential for misuse and have no medical use. Along with drugs like cocaine, this is where marijuana, MDMA (ecstasy) and LSD currently languish; the classification itself makes research to determine medical usefulness extremely difficult, creating somewhat of a catch-22.

But for what is apparently the first time since the Harrison Act of 1914 legally enshrined drug prohibition, consumers successfully fought back.

If this process of banning a substance due to international treaties works it will be used for other products and substances. The politicians will have an easier excuse for inaction on matters important to their voters.

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4 users have voted.

Still yourself, deep water can absorb many disturbances with minimal reaction.
--When the opening appears release yourself.