Why the Sudden Hostility Toward Off-Label Medicines?
American Thinker,
by
Brian C. Joondeph MD
Original Article
Posted By: Magnante,
2/7/2022 8:27:35 AM
The US Food and Drug Administration has an exhaustive process, “to evaluate new drugs before they can be sold.” (snip) When drugs are used as described by the label, this is referred to as “on-label” use. (snip) “Unapproved use of an approved drug is often called ‘off-label’ use.” The FDA does not object to this (snip) Except for two particular FDA-approved drugs. (snip) Over the past two years, the medical establishment and media has reversed course on off-label medications, not only dismissing them but shaming and vilifying anyone promoting their use. The two drugs in question are well known, hydroxychloroquine and ivermectin.
Reply 1 - Posted by:
Venturer 2/7/2022 8:41:24 AM (No. 1064183)
Money: Follow the Money.
Big Pharma cannot get rich selling a cheap drug that works.
They get rich selling an expensive vaccine that doesn't work.
26 people like this.
Reply 2 - Posted by:
TLCary 2/7/2022 8:50:33 AM (No. 1064190)
Harvard Med published a few years ago research that showed between 40% and 60% of all prescriptions were "Off-Label". They can count on the ignorance of the masses to let them get away with pretending that it's some atrocity when it upsets their narrative. If their public education or CNN didn't tell them, how would they know any better?
11 people like this.
Reply 3 - Posted by:
lakerman1 2/7/2022 9:13:45 AM (No. 1064209)
I blame Lady Lucifer (aka) Hillary Clinton and the Kenyan Klown.
When Hillary came up with Hillarycare, health insurance system so fouled up that she could not find one dimocrat in the House to introduce it, and so bad that Newt Gingrich threatened to introduce it as a bill, which caused the dimocrats to howl against Newt.
How heavy was the hand of the federal government in Hillarycare? It created racial quotas for teraining specialists, so that there was minority representation in each specialty. And if it didn't take place du8ring the normal selection process, the federal government would reassign minorities to the various specialties. (I did a comedy routine for my students at that time, creating an i9maginary young black graduating M.D. whose choice of specialties was OB/GYN, but Hillarycare reassigned him to Proctology. Racial quotas made that happen._
Hospitals saw Hillarycare as the writing on the wall, and in a preemptive move, a wave of consolidations in the health care industry took place, prior to the passage of Obolacare. Larger hospitals then began hiring independent physicians, making them paid employees of the hospital.
Obolacare increased the consolidations and the hiring of physicians.
All of that created health provider bureaucracies, and once proud independent physicians had to practice under the rules of the employer, and off label prescribing was frowned upon.
Changes in medical malpractice laws also changed.
10 people like this.
Reply 4 - Posted by:
IowaDad 2/7/2022 9:19:09 AM (No. 1064217)
Ivermectin and hydroxychloroquine are cheap, safe and freely available. Neither of them is effective enough to be recommended for the prevention, early treatment or late treatment of Covid.
4 people like this.
Reply 5 - Posted by:
Bassman1911 2/7/2022 9:56:56 AM (No. 1064263)
#3, you hit the nail right on the head. I asked my doctor this question,” If I come down with Covid, how will you treat me?” She didn’t have an answer. I asked her if she would prescribe Hydroxychloroquine or Ivermectin and she said her medical group would not allow her to do that. Most doctors today belong to large medical groups and have to follow their dictates. What a sorry state for someone who has spent a fortune and a lot of hard work to become a doctor only to be controlled by a bunch of suits. I encourage everyone to ask their doctor that same question. You might find yourself looking for a new doctor.
16 people like this.
Reply 6 - Posted by:
DVC 2/7/2022 10:18:13 AM (No. 1064293)
#1 nails it. And they want us dead, near as I can figure it. And these shots are the way to kill us. Gotta scare everyone into getting The Shots, cannot have cheap, safe, simple treatments which cut the mortality by 90%.....people wouldn't be fearful enough to take their Shots.
The Shots seems to be the real goal. Whether that is money alone, or money and population reduction, still too soon to tell. Going to need to waterboard Dr. Fraud and a couple of dozen top Pfizer pukes before we get the real story.
12 people like this.
Reply 7 - Posted by:
weirdone 2/7/2022 10:20:03 AM (No. 1064298)
#4 Take a look at Africa, the vast interior of the continent has less covid and fewer deaths then elsewhere. The only explanation for this is the fact the use of Ivermectin to control parasites and hydroxychloroquine to treat malaria.
16 people like this.
All about the money, it always is. So they will vilify anything cheap that works to help people. Unlike the burgeoning crisis in our medical establishment, forcing sick people to make the choice of living by getting the jab, or dying because they really aren't supposed to take that jab.
As a cancer survivor with only one kidney and continuing medical issues, I cannot take that jab, and I will not.
7 people like this.
Reply 9 - Posted by:
DVC 2/7/2022 11:11:34 AM (No. 1064392)
Three falsehoods in one post, for the person who pretends to be from a corn state.
NOT freely available, must get a prescription and even then, I have had friends have to go to three different pharmacies when the damned pharmacies refused to fill valid scripts.
And then....they ARE effective at both prevention and treatment.
18 people like this.
Reply 10 - Posted by:
slipstik 2/7/2022 11:23:50 AM (No. 1064406)
As David E. Martin has said, the bioweapon is the pathogenic "vaccine". VAERS, imperfect as it is, tells us what we need to know. The military whistleblowers tell us more. The embalmers are the final proof. There is something in the "vaccine" that severely shortens lives. The government position is "vaccinate or die". I see it as "vaccinate and die". People are collapsing all around us. The death rate in the 18-64 age range is up 40%. And it isn't covid. People like #4 can't keep the lid on this much longer. The rubber band of reality is about to snap in their faces...
14 people like this.
Reply 11 - Posted by:
john56 2/7/2022 2:30:15 PM (No. 1064613)
Basically, the only way for an off-label use to be an on-label use is for the manufacturer of the drug to fund research and present it to the FDA, which is not an insignificant sum of money.
Since the drugs in question are generic, no manufacturer would have a chance to recoup that investment.
Occasionally, a manufacturer of a patent protected drug nearing the end of its protection may find one of these off-label uses and file, as to extend their patent exclusivitvity.
But HCQ and ivermectin are far past those dates.
State legislators should introduce bills prohibiting pharmacies from restricting FDA approved medicines as prescribed by a licensed physician.
3 people like this.
Reply 12 - Posted by:
cheeflo 2/7/2022 2:36:15 PM (No. 1064616)
Actemra, an expensive biologic drug developed to treat rheumatoid arthritis, was in short supply late last year because it was discovered to suppress what's called a cytokine storm, which is an immune system over-reaction to invasion that floods the body with cytokines, essentially causing a kind of drowning in one's own bodily secretions. It is a very serious, but uncommon, immune system response.
I had been treated effectively for RA with Actemra for several years until last fall when the drug was given priority for off-label use to treat/prevent extreme cases of COVID triggering cytokne storms. I hadn't had a serious RA flare since I began treatment with it, but for the months I missed my monthly infusions due to unavailability, I was a wreck.
The manufacturer ramped up production to meet the unanticipated demand of off-label use and it became available again in December for its original use. Since resuming monthly infusions, my RA has since settled down and life is worth living once more.
Because all potential effective treatments for COVID had been marginalized or discredited by the CDC and the medical establishment, in spite of empirical evidence of success worldwide, those extreme cases of COVID might have been avoided and patients for whom Actemra was intended would have received timely treatment.
1 person likes this.
Reply 13 - Posted by:
john56 2/7/2022 4:06:35 PM (No. 1064696)
Sometimes, these off-label uses are found in strange ways.
HCQ and its predecessor drugs were used to treat Malaria. It is still widely prescribed for that reason to missionaries in Africa, Asia, and other areas where malaria is a serious concern. I have a friend who is a missionary in Uganda and tales HCQ regularly (but he's had about 18 bouts of Malaria during his eight or ten year stay, anyway).
Long ago, a number of missionaries who were affilicted with Rheumatoid Arthritis noticed their disease subsided while on mission. When they'd come home, the disease would flare up and it was realized that the quinine drugs that they were taking also affected RA as well as Malaria. HCQ, under the brand name of Plaquenil, was the only brand available until sometime in the mid 1990s, although it had been off patent for a number of years prior to that.
In a past life, I used to sell that product. Extremely safe for RA use. Only "caveat" was that there was some rare cases of macular degeneration (eye disease) with long-term use. The indications on the drug (for long term use) was to obtain a baseline eye exam at onset of drug therapy and annual follow ups to assess any changes.
I've taken both HCQ and ivermectin to prevent COVID (my son has had it twice, my wife had it last week). Only complaint I have on ivermectin is the packaging is a pain in the backside to open, you have to take about 80 pills per dose (really just 8 for my weight), they're really small pills, and they taste terrible. Well, as my dear sainted Irish Catholic nurse mother uses to tell me as a little boy, medicine isn't supposed to taste good.
1 person likes this.
Reply 14 - Posted by:
JimBob 2/7/2022 4:16:59 PM (No. 1064708)
It seems pretty obvious to me that the Political Goal is to force the Clot Shot on everyone.
The 'powers-that-be' are obviously not trying to stop the Covid. Their action to take thousands of illegal border-crossers, cram them together, untested, in buses or airplanes, then distribute them across Small Town America sounds to me like an effort to keep re-seeding America with the 'Rona.
Hydroxy works well when applied in the first stage of the 'Rona, and great effort was made in the USA to cover this up.
Uganda, a definite 3rd-world nation with a population of -what, 30 million?- had had something like 325 Covid deaths..... and everyone takes Hydroxy to ward off malaria.
Ivermectin works well, and again, great effort was made to cover this up.
Every inexpensive remedy has been suppressed.
So.... it seems to me that the objective is to force everyone to take The Clot Shot, the evil effects of which are being hidden.
The question, to me, is..... WHY?
Is it just the Ca$h, or is there another, more nefarious motive at work here?
3 people like this.
Reply 15 - Posted by:
MickTurn 2/7/2022 10:30:18 PM (No. 1064968)
Come on Doc...you know Big Pharma owns the world!
0 people like this.
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