Welcome to Saturday's Potluck
“Learn the rules like a pro, so you can break them like an artist.”
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.
Some PDFs of Package Inserts as of July 23, 2921
aspirin product (for some individuals aspirin has significant risks)
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.
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.
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.
The little quail is still sitting on her nest. We have worked out an agreement so the plants near her can be watered.
What is on your mind today?