Vaccinations are free, unlike the very costly treatment of antibody therapy. Additionally, for those who have moral, ethical, or conspiracy-based issues about taking the Covid vaccine, the same logic should apply to this treatment.

Both treatments originate from the pharma industry and if someone wanted to slip you magnetized tracking chips, the infusions offer a far more appealing medium. AI can also elicit reactions, which for some patients can prove life-threatening.

How do monoclonal antibody infusions work and do they help?

It’s the million-dollar question and before we look at data let’s examine the mechanism of action of AI’s and then consider the EUA conditions under which these drugs were approved for early Covid treatment. The text in italics below is drawn from the CMS advisory page on monoclonal antibody therapies.

This type of therapy relies on monoclonal antibodies, antibodies that are similar to the ones your body would naturally make in response to infection. Monoclonal antibodies are mass-produced in a laboratory and are designed to recognize a specific component of the Covid-19 virus — the spike protein on its outer shell.

By targeting the spike protein, these specific antibodies interfere with the virus’s ability to attach and gain entry into human cells. They give the immune system a leg up until it can mount its own response. There are however conditions attached to the use of the therapy for Covid-19 patients.

The FDA authorized the use of these monoclonal antibody therapies to treat mild-to-moderate COVID-19 in adults and pediatric patients when both of these apply:

• The patient has a positive COVID-19 test result
• The patient is at high risk for progressing to severe COVID-19, hospitalization, or both

Health care providers may administer these monoclonal antibody therapies only in settings where they have both of these:

• Immediate access to medications to treat a severe infusion reaction, such as anaphylaxis
• The ability to activate the emergency medical system (EMS)

The infusions are not without risk, which in some instances, can be life-threatening. It’s also worth noting that this risk is balanced by the advisory on who should receive the treatment. It is only recommended for those who are at high risk of developing serious Covid-19, in other words, patients with known risk factors.

A strong argument, therefore, exists that the average person who is not at high risk of developing serious Covid-19 should not be advised to take AI’s. Here are the current recommendations in place for their use.

Monoclonal antibody treatment is available to individuals who:

• Are high risk for developing severe COVID-19 and
• Have a positive COVID-19 test and have not yet been admitted to the hospital and
• Are 12 years of age or older (and at least 88 pounds)

Post-exposure preventive monoclonal antibodies are available to those who have been exposed (consistent with the CDC’s close contact criteria) and who are:

• High risk for developing severe COVID-19 and
• 12 years of age or older (and at least 88 pounds) and
• Not fully vaccinated or vaccinated but immunocompromised

You can also qualify for treatment if you’ve been exposed to someone who is Covid positive and you are in a high-risk category. There is evidence to suggest that there is a mildly prophylactic benefit for this group of patients.

Does it work?

Realistically, it’s almost impossible to tell and it isn’t difficult to figure out why. As the vast majority of people who contract Covid-19 recover on their own, this muddies the water. Simply put, how do we know if the patient has simply recovered as he was never going to develop serious Covid to start with, or did the treatment itself prevent the development of serious Covid?

Data are mixed on outcomes and as with most studies conducted at the behest of the pharma industry, there is the intent to skew the data in favor of the treatment. In this instance, however, the presence of a control group is of absolutely no benefit for the reason given above.

As a prophylactic, there may well be some benefit, but again, timing and speedy administration are of the utmost importance for the treatment to have any effect. That alone renders AI therapy more or less redundant for the majority of Americans. Here’s why.

Timing is everything

Like most things in life, the timing of the administered infusion matters. Leave it too late and you may as well not bother. The antibody infusions are only helpful if administered in the early phases of a Covid infection (the first few days) and that’s where the catch lies for most people in the U.S.

Currently, most Covid tests are administered in places like CVS, Walgreens Pharmacies, urgent care, and ER’s. None of these business or medical facilities have the faintest idea of how to refer the Covid positive patient for AI treatment. That may seem completely bizarre and requires a little explanation.

Most hospitals and medical facilities deal with serious cases of Covid-19. People only arrive for care when they are struggling to breathe and by that time, antibodies are of no use as a treatment. A simple analogy is a delivery ward selling contraception to its pregnant mothers. Not much point, as the ship has already sailed.

As a newly diagnosed Covid-19 patient, right now, as the Delta variant surges, you stand absolutely no chance of getting near a doctor or nurse in most U.S. towns and cities unless you’re close to death. There simply aren’t staff or beds and if you can reach one, chances are they have even less knowledge about the AI treatment or availability than you do. They don’t have any use for it in their medical setting.

This creates a huge problem for a Covid-19 positive patient who wants or needs to take advantage of the early benefits of AI.

Hospitals are now in the process of receiving detailed instructions for assisting patients to secure a referral, but the process is convoluted, and multiple steps before appointments are confirmed will arguably remove any benefit the patient may receive from the treatment as it will be too late when it is administered.

For example, in Texas hospitals are receiving literature explaining the referral mechanisms. Interestingly, Texas will cover the costs of this therapy, and patients and providers will not be required to make any contribution.

Hospitals, Freestanding EDs, and other physicians can refer patients who meet the criteria for monoclonal antibody treatment to the RIC in Fort Worth. Patients will only be able to schedule an infusion by calling the hotline number, 1–800–742–5990, if they already have orders from their physician to get the infusion therapy. Majority of the scheduling will be completed when a physician sends their referral form to the RIC. A representative will review the referral and contact the patient to schedule a date and time.

What this means, in effect, is that a lot of back and forward paper shuffling and administrative red tape will delay actual appointment dates. So much so, that there remains no benefit to the patient when he or she eventually receives the AI therapy.

For pregnant mothers, there is the additional complication of having to have the treatment cleared with their OBGYN before they are approved for an appointment. More delays for arguably one of the most important patient communities.

There are currently no clear national guidelines and for the present time, AI remains the preserve of wealthy or influential individuals who are deemed worthy of swift treatment to minimize risk. Donald Trump. the ex-president and Greg Abbott, Texas governor, are examples in point.

This is simply another telling example of the general failure of the healthcare infrastructure to provide fair and equitable access to care for all Americans, but in this instance, it may not matter. We may never know whether this treatment is simply a cash cow being milked by political powers and pharma or a really telling tool in the fight against Covid.

A tool virtually no one has access to.

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Monoclonal antibodies were first used in humans in the 1980s². They have gradually become more prevalent with Regeneron, producing and selling this treatment for those with severe COVID-19¹.

Monoclonal antibodies work like our own antibodies to “tag” targets to be attacked by our immune systems. This treatment works for COVID-19 by targeting the virus in the blood and marking it for destruction¹. While potentially life-saving for COVID-19, it comes with risks ranging from flu-like symptoms to an anaphylactic reaction³.

This is why the decision to start such a treatment must be made by a physician working with a patient or a patient’s family to determine if the benefits of the treatment outweigh the risk.

Most current antibody treatments target an aspect of the virus that helps it enter cells, the ACE-2 receptor binding domain¹. The authors created a model that studied how different mutations impacted this viral protein’s function and sensitivity to antibody treatments².

Using this analysis, the authors identified mutations that would prevent the antibodies from appropriately targetting this viral protein¹. While most mutations only prevented targetting by one of the two antibodies in these treatments, mutations that blocked both were identified, the key finding of this paper¹.

This paper’s conclusions are not alarming and do not suggest the current pandemic will immediately get worse. This paper demonstrated that current treatments may need to be revised or have deficiencies addressed where viral evolution to go in a particular direction¹. We already know that the virus evolves. This paper addresses one point that requires surveillance so we can respond appropriately.

Remarks:

The title of source 2 portrayed monoclonal antibodies as “magic bullets”². If not otherwise clear, this treatment has limitations just as other clinical treatments discussed in this article.

References:

1. https://science.sciencemag.org/content/371/6531/850/tab-pdf
2. https://link.springer.com/article/10.1023/A:1015860525341
3. https://pubmed.ncbi.nlm.nih.gov/23835249/

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Six months have passed since then, thousands of Americans have died and this article is a direct call on the FDA for an explanation. Why was ivermectin not immediately placed into sanctioned human trials? It is approved for use in humans by the FDA, and the in vitro results should have pointed to a possible candidate to treat Covid. Clearly, six months later, nothing has been done and this raises very worrying questions,

If a candidate like ivermectin has been ignored, what other drugs has the FDA blindsided? Why is there no official NIH or FDA body to examine the efficacy of existing drugs and fairly evaluate any that show potential to combat covid? Could this simply be another of the many administrative oversights or is there something more sinister lurking behind it? Read on, as we examine the ivermectin issue.

An introduction

I am thrilled we have the covid vaccines being released into the public as I write this. It’s a technical miracle and evidence of what a community can achieve with a common goal, the proper motivation, and the removal of restrictive red tape, which, under normal circumstances, is required to safeguard us. The vaccines are however going to take months before their effects become evident in the general population. 

While individual states dick about with their vaccination strategies, sell vaccines to wealthy donors and country club members, and try their best to get all the healthcare workers vaccinated, despite some trying to sabotage the process, people are still contracting Covid at record numbers in the US. Hospitals are nearing, or at capacity in many states, and Americans are dying in record numbers from Covid-19. On the 7th of January, more than 4000 Americans died in a single day.

That shouldn’t be acceptable in anyone’s eyes and every action we can possibly take to prevent these deaths needs to be explored. Explored thoroughly, so that it can either be discounted or implemented and we don’t have time to waste, people are dying. Trials need to be rapidly implemented with the active approval and involvement of the FDA. 

It’s not as though we don’t have a queue of willing trial subjects. People are literally dying to try anything that suggests even a hint of efficacy.

Months ago (April) I wrote an article on Ivermectin and the success the drug had shown in-vitro against the coronavirus. I was excited when I came across the study as I have had personal experience with this drug and its efficacy against Nile River Blindness in the human population. It works spectacularly well, so much so that it won the Nobel Prize. It is not hydroxychloroquine.

In fact, in the world of drugs, Ivermectin is something of a fairy tale story, literally picked up out of the soil by a Japanese scientist and carried to glory on the first philanthropic donation of drugs in the world by Merck. 

We know a great deal about Ivermectin’s safety in human use. Its application is in the destruction of nasty parasitic visitors and reactions to the drug are for the most part associated with the parasites attacking their hosts on the way out, rather than the drug affecting the host. Arguably, without parasites present, the risk of adverse reactions to Ivermectin would decrease significantly.

So back to my opening question. Why hasn’t the FDA and NIH trialed this drug in hospitals across the US, six months after in vitro trials suggested it as a possible candidate? To be clear, if Ivermectin can save one life in fifty, then it’s a worthy treatment. If it does more and is proven to show prophylactic properties, then that is a huge win.

Every additional benefit is a win, but the point is this. Until we actually try it, WE DO NOT KNOW! And in case I didn’t stress this sufficiently, people are dying daily, by the thousands.

I was sent a link this morning to a video posted by a Republican senator, Ron Johnson, chair of a Senate committee entitled ‘Early Outpatient Treatment: An Essential Part of a COVID-19 Solution’. I’ve included it below and before we get to it, I’ve done a little homework on your behalf regarding referenced materials in the video and the doctor presenting it, Pierre Kory, and his organization, the AFCCC. Here are the facts as they now stand, note, not my interpretation, but actual facts.

Who is Dr. Pierre Kory?

Dr. Pierre Kory is an Associate Professor of Medicine at St. Luke’s Aurora Medical Center in Milwaukee. He testified on December 8, 2020, at the U.S. Senate Committee on Homeland Security and Governmental Affairs. You can view the Committee’s entire hearing by following this link or you can download a transcript of Dr. Kory’s testimony here.

Kory is a founding member of FLCCC or in long-form, Front Line COVID-19 Critical Care Alliance. Their stated goal on their website is this. ”Prophylaxis & Treatment Protocols for COVID-19″. Let’s first deal with this entity and its members. 

FLCCC push their treatment protocols for early intervention in covid patients requiring supplemental oxygen. This article isn’t about the FLCCC’s credibility or agendas, which may or may not be above reproach. Nor does it speak to Dr. Kory’s credentials. This is about Ivermectin and its potential as a covid treatment. 

Clearly, as can be seen from the FLCCC site, Ivermectin is one of the treatments they recommend. They claim to base this on their actual experience and various trials, some of which we will examine below,

Let’s get to the Kory video, here it is, and you can watch it now or later.

The response to Kory’s claims around Ivermectin has been as follows from the medical community, the FDA, and NIH. Firstly, from infectious disease expert at John Hopkins University, Dr. Amesh Adalja. who said most of the research around ivermectin at the moment is made up of anecdotes and studies that are not the gold standard in terms of how to use ivermectin.

“We need to get much more data before we can say this is a definitive treatment,” he said. “We would like to see more data before I recommend it to my patients.”

The U.S. Food and Drug Administration and the National Institutes of Health have said that the drug is not approved for the prevention or treatment of COVID-19. According to the FDA, side effects of the drug include skin rash, nausea, and vomiting. So just exactly what is Ivermectin approved for in the US? 

It does have FDA approval. Ivermectin is approved in the U.S. for human consumption in tablet form to treat parasitic worms as well as a topical solution to treat external parasites. The drug is also available for animals, but that’s neither here nor there. Many of the same drugs and antibiotics are used in both human and animal populations. 

Documented and Published Studies

You can find links below to various studies that claim to prove the efficacy of Ivermectin against Covid-19. It should be noted that the trials listed below are riddled with flaws and inconsistencies. None, in our opinion, offer conclusive evidence to the efficacy of ivermectin as a treatment or prophylaxis for the coronavirus. They do however hint at a potential that cannot be ignored, particularly given skyrocketing deaths.

November 16, 2020 | Egypt: Efficacy and safety of ivermectin for treatment and prophylaxis of COVID-19 pandemic – Elgazzar A, Basma H, Shaimaa Abo Y, Basma H, Mohy H, Hany M (Research Square; 100956) https://doi.org/10.21203/rs.3.rs-100956/v2

November 3, 2020 | India: Role of Ivermectin in the prevention of COVID-19 infection among health care workers in India – A matched case-control study; Behera P, Patro BK, Singh AK, et al. (medRxiv)https://doi.org/10.1101/2020.10.29.20222661

October 27, 2020 | Iraq: Controlled randomized clinical trial on using ivermectin with doxycycline for treating COVID-19 patients in Baghdad, Iraq – Hashim HA, Maulood MF, Rasheed AM, Fatak DF, Kabah KK, Abdulamir AS (medRxiv) https://doi.org/10.1101/2020.10.26.20219345

October 22 | Peru: Antiviral and anti-inflammatory properties of ivermectin and its potential use in COVID-19 – Portmann-Baracco A, Bryce-Alberti M, Accinelli RA (NCBI/Arch Bronconeumol/ScienceDirect) https://dx.doi.org/10.1016%2Fj.arbr.2020.06.006

October 12, 2020 | USA: Use of ivermectin is associated with lower mortality in hospitalized patients with COVID-19 – Rajter J-C, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter J-J (ICON study; Chest) https://doi.org/10.1016/j.chest.2020.10.009

October 2020 | Peru: Real-world evidence: The case of Peru. Causality between ivermectin and COVID-19 infection fatality rate – Juan Chamie (ResearchGate) https://www.researchgate.net/publication/344469305_Real-World_Evidence_The_Case_of_Peru_Causality_between_Ivermectin_and_COVID-19_Infection_Fatality_Rate

August 24, 2020 | Bangladesh: Clinical trial of ivermectin plus doxycycline for the treatment of COVID-19 infection – Dr. Reaz Mahmud, Dhaka Medical College (ClinicalTrials.gov; NCT04523831) https://clinicaltrials.gov/ct2/show/NCT04523831

June 11, 2020 | Argentina: Usefulness of topical ivermectin and carrageenan to prevent contagion of COVID-19 (IVERCAR) – Hector E Carvallo, Eurnekian Public Hospital (ClinicalTrials.gov; NCT04425850) https://clinicaltrials.gov/ct2/show/NCT04425850

June 9, 2020 | Egypt: Prophylactic Ivermectin in COVID-19 Contacts – Waheed Shouman, Zagazig University (ClinicalTrials.gov; NCT04422561) https://clinicaltrials.gov/ct2/show/NCT04422561

June 2020 | Australia: The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro – Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM (Antiviral Res.; 178:104787) https://doi.org/10.1016/j.antiviral.2020.104787

A very balanced and well-structured analysis of these studies can be found on Rebel EM and we recommend you read it. Their clinical takeaways from the available evidence on ivermectin are as follows. (Bold text highlighted by Medika).

• Evidence for the use of Ivermectin is based on in vitro, prophylaxis, clinical, safety, and large-scale epidemiologic studies (heterogenous populations in multiple different settings) BUT…
• Many of the trials thus far are methodologically flawed without enough information about baseline demographics, multiple primary outcomes, soft/subjective outcomes, convenience samples, and unclear definitions, just to name a few
• Additionally, a valid concern in evaluating the literature is that many of the trials have not yet passed the peer review process and are in pre-print format
• Although Ivermectin is cheap, readily available, with a fairly safe side effect profile, based on the evaluation of the literature above, at this time, Ivermectin should not be recommended outside of a clinical trial to ensure we get a true answer of effect
• Ivermectin is interesting, there is certainly signal to evaluate further, but in our desire to want a treatment option, let’s not continue to do the same thing over and over again, as we saw play out with Hydroxychloroquine

It is perhaps worth mentioning in closing. All across America, many frontline doctors and medical staff are currently using ivermectin as a prophylactic. Is it working? Well, again, we don’t know as it isn’t being studied properly in the U.S. 

The point is that this option if it does in fact prove efficacious against coronavirus, should be rolled out to the public. No one else is to blame here for the complete lack of action, other than the FDA and NIH and their hesitancy to encourage proper trials. The ball is firmly in their court.

An interesting footnote (Jan 11,2021)

India has extensive experience with both ivermectin and hydroxychloroquine in the treatment of covid. This mostly anecdotal report from Trialsitenews.com makes for fascinating reading and if anything, highlights the US’s lack of interest in pursuing any course, other than vaccines, in combating covid.

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He called it a blessing from God because he was able to get multiple treatments for COVID-19. He then went on to tout those treatments as a “cure” for the disease. The reality, however, is quite different. The treatments he received can hardly be characterized as “cures,” and here is the data behind each one.

Monoclonal Antibodies

The most high profile treatment President Trump received — under a “compassionate use” application — was monoclonal antibodies. These are proteins that are highly specific against SARS CoV-2, and they have the ability to latch on to the virus to prevent it from entering the cells.

The data behind using them is from a study of ambulatory patients, which means patients in a doctor’s office or clinic setting, not the hospital. Right off the bat, this tells me that those patients were not very sick, to begin with. If they were, they would have been hospitalized. The drug has not been studied in that patient population, as far as I know.

In that ambulatory setting, the greatest benefit was for those patients who did not have their own antibodies against the disease, so-called seronegative patients. Those who had antibodies already did not benefit as much. Furthermore, there is absolutely no evidence that this treatment will work in patients with severe disease requiring hospitalization or ICU care (such as patients whom I see).

What’s more, it seems that the highest dose of the antibodies — the same dose the President received — was not as effective as the lower dose. More of the patients receiving the highest dose had to seek medical attention, and it took them longer to achieve symptom alleviation. These findings, however, were not statistically significant.

So, really, this treatment is hardly a “cure” as the President claims. It is definitely promising, but we need to wait for more data to come out.

Remdesivir

President Trump also received remdesivir, an anti-viral drug that was originally developed for Ebola. Remdesivir may also be helpful in treating Covid-19. The final results were recently published in the New England Journal of Medicine.

All that remdesivir does is shorten the time to recovery from 15 days to 10 days compared to placebo. That’s it. I am not saying that this is not significant, but it is not a “cure.”

Now, there was a trend toward lower mortality in the patients who received the drug, but technically, it was not statistically significant. Thus, you can’t make this claim about Remdesivir, and the study authors did not make this claim in their study conclusions.

Dexamethasone

By far, the best data is for dexamethasone. In this randomized clinical trial, the number of days alive and free from mechanical ventilation during the first 28 days was significantly higher among patients treated with dexamethasone plus standard care when compared with standard care alone (6.6 days vs 4.0 days).

When they pooled all the data for steroids in a meta-analysis, the 28-day all-cause mortality was lower among patients who received corticosteroids compared with those who received usual care or placebo (summary odds ratio, 0.66). This odds ratio means that the group who got steroids had a 34% decreased risk of death.

Now, the President received other treatments such aspirin, famotidine, zinc, and vitamin D. The data for these treatments is even more sparse. That’s what makes it so frustrating with this disease: it such a horrific condition with few truly effective treatment options.

The treatments for seasonal influenza are also not blockbusters, but seasonal influenza is not nearly as deadly as COVID-19. So, at the end of the day, the studies behind the treatments that the president received were not blockbusters, and they showed some benefit. But, I would hardly characterize them as “cures.”

The post A Closer Look into the Treatments Trump Received for COVID-19 appeared first on Medika Life.

Clinicians the world over were trying to do all that they can to help their patients suffering from COVID-19 get better. From this deep desire to help came the push for treatments such as hydroxychloroquine and now convalescent plasma.

Just because we can do something, does not mean we should do it. If a treatment can cause more harm than good, then it should not be administered, even if it “makes sense” from a logical perspective.

Well-conducted, reliable randomized studies take time, and given the breathtaking speed this pandemic is affecting the world, it is hard to wait until good data comes out either in favor or against a particular treatment.

“These trial results from diverse clinical and geographic settings suggest that in the absence of compelling contraindications, a corticosteroid regimen should be a component of standard care for critically ill patients with COVID-19.” — JAMA

Well, finally, science has provided us with an answer as to what seems to work really well for COVID-19. On September 2, multiple studies were published in JAMA with respect to steroids and outcomes in COVID-19. The most important one was a meta-analysis, which is a study of multiple randomized trial data combined, showing a statistically significant improvement in mortality for steroids in COVID-19.

Finally, science has triumphed over hype.

While the meta-analysis studied three different steroids — hydrocortisone, methylprednisolone, and dexamethasone — the strongest data indicated that dexamethasone had a 36% reduced risk of death. This data is pretty robust and reliable, and as the authors wrote:

These trial results from diverse clinical and geographic settings suggest that in the absence of compelling contraindications, a corticosteroid regimen should be a component of standard care for critically ill patients with COVID-19.

In the beginning, I admit that I was more skeptical about using steroids in COVID-19. The initial expert consensus was not to use them, as they could be harmful. Again, I didn’t want to do more harm than good. Indeed, the data with steroids and influenza are actually not good.

But now, with this data, there should be no more hesitation. Unless there is a contraindication, steroids should be part of the standard treatment for COVID-19. It doesn’t mean that it is guaranteed to work. At the same time, we should do all that we can — without known harm — to help our patients suffering from COVID-19. And it seems steroids should be part of that plan.

The post The Data Are In: Steroids Should Be Standard Of Care For COVID-19 appeared first on Medika Life.

Convalescent plasma is the liquid portion of the blood of individuals who have recovered from COVID-19. In the plasma are hundreds of proteins, including the antibodies that are developed by the body after it has fought off the infection. It is assumed that the plasma of those who have recovered from COVID-19 will have antibodies against the SARS-CoV-2 virus.

The theory is that if we give the plasma of those who have recovered from COVID-19 to other people suffering from the disease, those antibodies will presumably help fight off the infection. Makes sense, right? The problem is, the studies conducted did not show that it worked.

The EUA was based on a number of studies, but there were only two of the gold standard: randomized, controlled trials. And those studies did not show a benefit for convalescent plasma.

In fact, in one study, there was a trend toward worse outcomes with plasma in patients with life-threatening COVID-19. I have spoken to colleagues who have seen that very outcome: their patients becoming worse — much worse — after getting plasma. Full disclosure, I have also had colleagues tell me that they have had patients get better with plasma as well.

And then there is the Mayo Clinic data. First of all, it is not even a controlled trial. And, if you read the fine print, the 7-day mortality rate was higher in those patients admitted to an intensive care unit vs not being in the ICU (10.5% vs 6.0%), and it was also higher in those patients on a ventilator compared to those not on a ventilator (12.1% vs 6.2%). So, how is this a “breakthrough”?

That’s why this move by the FDA — suddenly and curiously right before the Republican National Convention — is very concerning. They were right to be slow to authorize the emergency use of plasma because the data is not that great. This treatment can do some good, but it can also do a great deal of harm. We need better data, and I am very disappointed at the FDA for issuing this EUA. If they do this same move for an eventual COVID-19 vaccine, then count me out.

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