Op by Sunlit7
Until recently my family had managed to escape the corona virus. I had noticed my grandson started getting sick the last couple of days I took him to school one week. The following week he seemed to be getting sicker so I called his mom who happened at that time to be at the hospital because she came down sick. She said she had noticed he was getting sick and was going to take him to the doctor but she got so sick herself she was literally in pain which is why she was at the emergency room. They did a cat scan and told her she was really congested but she didn't have covid. The next day she called and said she was staying home with the kids because they were all sick. When she called into the school to report them sick they told her they would need to be tested to return. During that time my son started getting sick but he said he still felt well enough to go to work. That all ended when the test came back the kids had covid. Now he had to get tested also. He too had covid. I don't fully understand how mom got sick first but didn't have but everyone else did. Now they were all on quarantine.
Since I was exposed to my grandson, though I took precautions and kept my distance and wore a n95 mask while driving him to school I decided to look up the protocol recommended by American Frontline Doctors I had saved. The first thing they advised was to see if your doctor would work with you if you were exposed or caught covid. I called the doctors office and it said to hang up if you had covid and call their covid hot line. I explained all of the above to her and asked if I could get a seven day regiment of hydroxychloroquine to go with my zinc regiment to act as a prophylactic since I had been exposed to covid. She replied to me she wanted to know where people were getting all these conspiracy theories from. I told her from doctors more qualified than those at the cdc. She said she would transfer me over to my doctors office after advising me I needed to go get tested within five days and quarantine for fourteen days. My doctors office the nurse told me that she would have him call me after I explained the above to her. They never called back until six days had gone by. She said the doctor advised that I come in and get the vaccine, I told her they were retarded and she hung up on me. I didn't mean retarded retarded just when it came to the vaccine but she never let me get that far. I had already went to using the protocol of American Frontline Doctors, upping my regiment of d3, zinc, vitamin C until I had some quercetin sent to me overnight in supplement form that had those ingredients along with it. Quercetin is what they make hydroxychloroquine out of, it's not as strong as hydroxy but it helps booster the zinc into your cells better. I didn't end up getting sick nor even feeling sick so I decided I wasn't going to go have a swab stuck up my nose and continue to quarantine for fourteen days, I barely go anywhere anyway and if I go into a public place I always wear a n95 mask. I've worn one since day one of the pandemic when out in enclosed public areas. It's not that bad anymore since they relaxed the mask mandates for everyone, around here, at least, everyone seems content to be able to do their own thing.
That whole thing really bothered me though about the doctor ignoring those first crucial days and then advising I get a vaccine. I've seen a couple of articles in the news here in Michigan where doctors tell their patients you didn't get a vaccine so now you are going to die. I ain't kidding either, one lady doctor in the UP told one lady off to hospice, you're dying because you failed to get the vaccine. She was on the yahoo news site, if I had known I'd run into another on the same site a few days later I'd saved that one to. He called those who believed in Ivermectin and Hydroxychloroquine conspiracy theorist too. When linking to the article yahoo was reporting off it even listed what he called venting his exasperation with the unvaccinated whom he then declared were endangering everyone else. These types of things behooves me really, I've done enough reading on the studies available to know this doctor, who has lost one hundred patients to covid so far has done used up more than his fair share of the five percent that has died of severe disease that hydroxychloroquine, zinc and a z pack couldn't help. Not everything is a cure all but this man has done reached his limit in my opinion. These people are dying....what does it matter if he give them a drug for off label use? Even a prisoner going to execution gets better treatment than that, at least they get offered a last meal. So I called a prosecutor to bring their attention to it, they said it wasn't their job they said to call the police, I called the police and they told me it wasn't their job either to call the hospital and complain or the medical board in the state. I even called the Dr Kevorian lawyer Jeffrey Fieger and tried arguing they should put out an advertisement taking these cases on the reverse of the Kevorian case, a right to live instead of dying. They just plain said they were not taking any covid cases. It's really disheartening to see them getting away with what they are doing, these people are dying, thousands of people and you just can't help but wonder what the big deal is with prescribing off label use.
A few days ago I ran across another article, this one was more aspiring than the rest because it does seem as though there is one brave sole of an attorney willing to give those folks a voice.
NEW YORK (AP) — Mask rules, vaccination mandates and business shutdowns have all landed in the courts during the COVID-19 outbreak, confronting judges with questions of science and government authority. Now they are increasingly being asked to weigh in on the deworming drug ivermectin.
At least two dozen lawsuits have been filed around the U.S., many in recent weeks, by people seeking to force hospitals to give their COVID-stricken loved ones ivermectin, a drug for parasites that has been promoted by conservative commentators as a treatment despite a lack of conclusive evidence that it helps people with the virus.
Interest in the drug started rising toward the end of last year and the beginning of this one, when studies — some later withdrawn, in other countries — seemed to suggest ivermectin had some potential and it became a hot topic of conversation among conservatives on social media.
The lawsuits, several of them filed by the same western New York lawyer, cover similar ground. The families have gotten prescriptions for ivermectin, but hospitals have refused to use it on their loved ones, who are often on ventilators and facing death. (https://www.yahoo.com/news/lawsuits-demand-unproven-ivermectin-covid-134103606.html)
The article further highlights a counterpoint that we all know isn't true, a professor in bioethics trying to make a claim that it's a bad precedent to start allowing courts to make medical decisions when we all know we've seen court cases where the courts have intervened in situations where patients face the prospects of dying if medical intervention isn't ordered.
“The way medicine works is, they are the experts, the doctors and ... the hospitals," said Arthur Caplan, professor of bioethics at New York University's Grossman School of Medicine. “When you go there, you’re not going to a restaurant. You don't order your own treatments."
“You can’t have a medical field that’s subjected to having to practice according to patient demand backed up by court orders. That is positively horrible medicine" Caplan said.
That actually may be true IF the person wasn't DYING!!! What difference does it make at that point. The attorney suing on behalf of patients obviously disagrees with him and he has won cases where the drugs were ordered and he save elderly peoples lives. There are so many of these cases calling him now he's had to hire two attorneys to help him with them all.
As for the assertion that Ivermectin was made for horses, which by now we all know there is a version for human use, he stated:
Lorigo said his clients haven't sought those kinds of doses, only the versions of the medication made for humans.
Of doctors refusing to treat patients with ivermectin, Lorigo said, “they are not gods because they wear white jackets,” he said. “I take issue with their stance.”
And as for hospital administrators, “it’s like only they rule the roost, only they make a decision in their hospital. I’m not accepting that as a rule of law for us.”
I've got more on those administrators coming up but want to spend a minute clarifying another argument you often hear on off label use. The FDA only approves drugs they do not approve the way doctors dispense drugs. One in five prescriptions in the US is off label use prescribed. So let's clarify how the rule works:
To get FDA approval for a drug or medical device, a company must put its product through a rigorous and expensive testing process. It then submits medically sound data to the FDA to prove that the product works.
If the company gets FDA approval for a specific use of a product, it can market the product only for that. Marketing includes advertising and communication, such as training with doctors.
Your doctor, however, doesn't have the same limitations. They can use a drug or medical device in any way they see fit and recommend that use to colleagues, even if there wasn't FDA approval for that particular illness, dosage or demographic. As long as the doctor thinks it will be safe and effective, they can use the drug or device in what the industry calls an off-label fashion. (https://edition.cnn.com/2016/11/11/health/fda-hearings-off-label-drugs/index.html)
Therein lies some of the confusion because marketing means the way a pharmaceutical company or one who sells pharmaceuticals can do so, they're limited in what they can say about a drug to what the FDA releases the drug for...it does not stop a doctor from using the drug differently it's just a vendor can't promote a drug for off label use. Remember this point because you'll fine it rather interesting further into this article. The FDA has fought, which the link shows, cases where drugs were promoted for uses other than the FDA released them for. Most of the fights are between pharmaceutical companies with the same or similar product on the market, one licensed to do one thing and the other another but are often found they also work for the other. One drug may be cheaper than the other so they end up getting promoted because they are cheaper...so it ends up in a fight between the companies and sometimes they have been overruled because the drugs are so similar it didn't matter except for the cost factor involved. Remember this point as we move further on.
Now back to those hospital administrators. In the article above involving the attorney the hospital(s) state:
Hospitals have pushed back, saying their standards of care don't allow them to give patients a drug that hasn't been approved for COVID and could potentially cause harm, and that allowing laypeople and judges to overrule medical professionals is a dangerous road to go down.
It's not their standard of care they are talking about, the most important thing that stands out is "approved for covid". In the CARES ACT and codified under the HEROES ACT it's legislated that insurers must pay for covid care to hospitals without cost sharing to individuals but hospitals will be reimbursed for approved covid drugs and medical devices.
(a) IN GENERAL.—Notwithstanding 2713(b) of the
14 Public Health Service Act (42 U.S.C. 300gg–13), the Sec15 retary of Health and Human Services, the Secretary of
16 Labor, and the Secretary of the Treasury shall require
17 group health plans and health insurance issuers offering
18 group or individual health insurance to cover (without
19 cost-sharing) any qualifying coronavirus preventive serv20 ice, pursuant to section 2713(a) of the Public Health Serv21 ice Act (42 U.S.C. 300gg–13(a)) (including the regula22 tions under sections 2590.715-2713 of title 29, Code of
23 Federal Regulations, section 54.9815-2713 of title 26,
24 Code of Federal Regulations, and section 147.130 of title
25 45, Code of Federal Regulations (or any successor regula-
234
O:\HEN\HEN20312.xml [file 1 of 2] S.L.C.
1 tions)). The requirement described in this subsection shall
2 take effect with respect to a qualifying coronavirus preven3 tive service on the specified date described in subsection
4 (b)(2).
5 (b) DEFINITIONS.—For purposes of this section:
6 (1) QUALIFYING CORONAVIRUS PREVENTIVE
7 SERVICE.—The term ‘‘qualifying coronavirus preventive service’’ means an item, service, or immunization that is intended to prevent or mitigate
10 coronavirus disease 2019 and that is—
11 (A) an evidence-based item or service that
12 has in effect a rating of ‘‘A’’ or ‘‘B’’ in the cur13 rent recommendations of the United States Pre14 preventive Services Task Force; or
15 (B) an immunization that has in effect a
16 recommendation from the Advisory Committee
17 on Immunization Practices of the Centers for
18 Disease Control and Prevention with respect to
19 the individual involved.
20 (2) SPECIFIED DATE.—The term ‘‘specified
21 date’’ means the date that is 15 business days after
22 the date on which a recommendation is made relating to the qualifying coronavirus preventive service
24 as described in such paragraph. (https://s3.documentcloud.org/documents/20059055/final-final-cares-act.pdf)
I found that little tidbit while scrolling around for something else, it was like a little lightbulb going off in my head considering the fact that the US government has control of all approved drugs and medical devices for covid. So you see the hospital administrators wouldn't get reimbursed if they used any other drugs not approved by the government. In particular when it came to medicare/medicaid were talking millions in losses. Here's another harbinger for you. In 2017 the government changed how stockpiles for emergency use is used in the US. In a national emergency the government takes control of all aspects in regards to response, some highlights:
Countermeasures
Oversee advanced research, development, and procurement of qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title).
Coordinate with State, local, and tribal public health officials, the Emergency Management Assistance Compact, health care systems, and emergency medical service systems to ensure effective integration of Federal public health and medical assets during a public health emergency.
Promote improved emergency medical services medical direction, system integration, research, and uniformity of data collection, treatment protocols, and policies with regard to public health emergencies.
In coordination with the Secretary of Veterans Affairs, the Secretary of Homeland Security, the General Services Administration, and other public and private entities, provide logistical support for medical and public health aspects of Federal responses to public health emergencies. Such logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 247d(a) of this title or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise. (https://uscode.house.gov/view.xhtml?req=(title:42%20section:300hh-10%20edition:prelim)%20OR%20(granuleid:USC-prelim-title42-section300hh-10)&f=treesort&num=0&edition=prelim)
That's the first time in history the government changed the rules to encompass all aspects of emergency response during an emergency. If you still don't believe they have total control over everything, ventilators, vaccines, drugs, pcr test and other medical devices just look up what they have approved and find the following statement on each one.
“Today’s action demonstrates the FDA’s commitment to making new therapies available through every stage of the global COVID-19 pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalization, providing additional therapies for those who do become hospitalized is an important step in combating this pandemic.”
Orders for medical goods and supplies are procured through the government then sent out from the manufacturer. Still not convinced? Here's another drug approved for emergency use:
On October 8, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the May 26, 2021 letter in
its entirety, to reflect that the distribution of the authorized sotrovimab will be controlled by the
United States Government. (https://www.fda.gov/media/149532/download)
There's actually one that gives the step by step process if I could find it again among the twenty papers I have read today. What also you find interesting in all this is they are exempt from the dissemination rules that apply under other drugs. The rule I mentioned above the FDA usually goes after vendors for misrepresenting what they labeled the drug for. Under emergency authorization use they only have to believe it is a reasonable benefit to people so a vendor, regardless of whether it works or not can promote it any way they like, it could have a lousy track record but he doesn't have to advise them it does.
The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Actemra may be effective in treating COVID-19 for the authorized population. And, when used to treat COVID-19 for the authorized population, the known and potential benefits of Actemra outweigh the known and potential risks for the drug. (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-treatment-covid-19)
In this particular product they read four studies but based if off two, you'll see why here:
The data supporting this EUA for Actemra are based on four clinical trials. These included one randomized, controlled, open-label, platform trial [Randomised Evaluation of COVID-19 Therapy (RECOVERY)] and three randomized, double-blind, placebo-controlled trials (EMPACTA, COVACTA and REMDACTA). While all four clinical trials contribute to the FDA’s understanding of Actemra for the treatment of COVID-19, the most important scientific evidence on the potential benefit of Actemra for its authorized use came from the RECOVERY and EMPACTA trials.
In the RECOVERY trial, 4,116 hospitalized patients with severe COVID-19 pneumonia were randomized to receive either Actemra in addition to usual care (2,022 patients) or usual care alone (2,094 patients). The primary endpoint evaluated death through 28 days of follow-up, and the results of the primary analysis were statistically significant. The probabilities of death by day 28 were estimated to be 30.7% for patients receiving Actemra and 34.9% for patients receiving usual care alone. The median time to hospital discharge was 19 days for patients receiving Actemra and more than 28 days for patients receiving usual care alone.
In the EMPACTA trial, 389 hospitalized patients with COVID-19 pneumonia were randomized to receive Actemra (249 patients) or placebo (128 patients). The primary endpoint evaluated the need for mechanical ventilation or death through 28 days of follow-up. For patients receiving Actemra, there was an observed reduction in progression to mechanical ventilation or death compared to patients who received placebo, with the primary analysis results being statistically significant. The proportion of patients who required mechanical ventilation or died by day 28 was estimated to be 12.0% for patients receiving Actemra and 19.3% for patients receiving placebo.
In the COVACTA trial, 452 hospitalized patients with severe COVID-19 pneumonia were randomized to receive Actemra (294 patients) or placebo (144 patients). The primary endpoint was clinical status through 28 days of follow-up assessed on a 7-category ordinal scale. While there was no statistically significant difference observed in clinical status on the 7-category ordinal scale at day 28 between treatment groups, the COVACTA trial contributed to the assessment of the safety for Actemra when used for the treatment of COVID-19.
In the REMDACTA trial, 649 hospitalized patients with severe COVID-19 pneumonia were randomized to receive Actemra in combination with remdesivir (430 patients) or placebo in combination with remdesivir (210 patients). The primary endpoint was time to hospital discharge or “ready for discharge” through 28 days of follow-up. Additionally, while there were no statistically significant differences observed between treatment groups with respect to time to hospital discharge or “ready for discharge” through 28 days of follow-up, the REMDACTA trial contributed to the assessment of the safety for Actemra when used for the treatment of COVID-19.
So in other words you were probably better off with the horse dewormer, full strength at that because the end result looks about as promising. You see this slight of hand works both ways, they cherry pick what studies they want to approve drugs and they do the same regarding drugs they don't approve, so that's how hydroxychloroquine and ivermectin got thrown to the curb. No worries though as there is one approved sedative on the list of the less than half a dozen drugs they've approved at least you know you'll be sedated while they are killing you. The actual fact they have a emergency use sedative involved in all this shows you how corrupt this is, why do you need an emergency authorized sedative? They've limited themselves so far to choosing about three drugs, a sedative and the vaccines, this far into it and studies with better results and early treatment protocols they won't approve make what they are doing look like euthanasia while knee capping anyone from preventing it. While they are at it they've also under the Cares Act exempted not just the pharmaceutical companies but themselves and anyone else involved from liability.
(a) LIMITATION ON LIABILITY.—Except as provided
5 in subsection (b), a health care professional shall not be
6 liable under Federal or State law for any harm caused
7 by an act or omission of the professional in the provision
8 of health care services during the public health emergency
9 with respect to COVID-19 declared by the Secretary of
10 Health and Human Services (https://s3.documentcloud.org/documents/20059055/final-final-cares-act.pdf)
They covered all the bases, they took control of every aspect of emergency response, then initiated through legislation protocols to stranglehold the pandemic into historic profits margins for the government and stakeholders, as one person put it when it comes to looking out for people's health or money the government will choose the money every time.