THE CASE OF CORONAVIRUS AND HYDROXYCHLOROQUINE
TO TAKE OR NOT TO TAKE??
I BELIEVE THE ANSWER IS YES AND HERE IS WHY
In this matter, the opinions of President Trump, Surgeon General, Jerome Adams, Dr Stephen Fauci, Dr. Oz and The FDA are documented regarding the use of Hydroxychloroquine Sulfate ."Hydroxychloroquine" and reasonableness of their opinion given the rampant and significant threat to the health of our nation every day, the history and usage of the drug and the limited specific data related to COVID-19 were all factors I considered and I opined, YES, absolutely, take it- and Here is why:
For the purpose of not distracting from the specific topic of Hydroxychloroquine, and the development of my opinion, it should be noted the biographical and professional history of the noted Medical Professionals was researched in depth and my opinions did take that information into account.
However, for this paper, I felt it unnecessary to detail it due to importance of keeping this as short as possible but which contains specifically relevant and important information to help you make the decision for yourself .....which may be one of the most important decisions regarding your health you have or will ever make.
I take that seriously and so should you.***
1. AGREE AGREE AGREE: President Trump is not backing down that hydroxychloroquine, a drug used to treat lupus, “could be a game changer” in treating coronavirus.
2. AGREE AGREE AGREE Dr. Oz, Professor Columbia University, has stated Hydroxychloroquine shows real promise against coronavirus
3. DISAGREE DISAGREE DISAGREE Anesthesiologist MD Surgeon General, Jerome Michael Adams The Surgeon General has been outspoken about being adverse to using Hydroxychloroquine without clinical trials specific to Coronavirus,
"it's not practical to think that we're going to treat our way out of this problem with new drugs ... we need to lower demand for treatments with social distancing.
His most important method he keeps going back to: are his appeals to millennials and Generation Z celebrities for help in promoting self-quarantining.
"We need to lower demand, we need more people talking about staying at home, it's why I reached out to Kylie Jenner last week. It's why my kids say reach out to Loren Gray and Roman Atwood to help these millennials understand they are spreading the virus and the more they spread, the more we're going to need these drugs, the more we're going to need ventilators and masks."
His most important method he keeps going back to: are his appeals to millennials and Generation Z celebrities for help in promoting self-quarantining.
"We need to lower demand, we need more people talking about staying at home, it's why I reached out to Kylie Jenner last week. It's why my kids say reach out to Loren Gray and Roman Atwood to help these millennials understand they are spreading the virus and the more they spread, the more we're going to need these drugs, the more we're going to need ventilators and masks."
Really Mr. Surgeon General? Your answer to helping millions of people is not through a reasonable analysis of a drug used for the last 70 years which works by controlling the immune response and inability to control it from attacking itself essentially because it cannot recognize the COVID-19 virus and works too hard to the determent of our lives and instead, your saying that your recommendation is calling Kylie Jenner and have her tweet stay home? Of course it is vital to shelter at home, but shelter at home, is not saving the lives of those already sick. No offense to Ms Jenner, but she is not the answer to the life or death question of how to provide real help in real time right now, Mr Surgeon General.
4. DISAGREE DISAGREE DISAGREE : Dr. Stephen Fauci is an American physician and immunologist who has served as the director of the National Institute of Allergy and Infectious Diseases since suggested during his CBS interview that there was no evidence that hydroxychloroquine had any benefit against coronavirus.
"In
terms of science, I don't think we can definitively say it works," he
said.
“That there
was only anecdotal evidence that hydroxychloroquine works against the
coronavirus”.
“Researchers
have said studies out of France and China are inadequate because
they did not include control groups.
“much more
data is needed to prove that hydroxychloroquine is effective against the
coronavirus.”
It is apparent and reasonable given Dr Fauci's opinions, and his extensive and extraordinary experience in the field of infectious disease, that there is something else going on here and he clearly has a different agenda which has me asking, what is it ? You can be sure there is one, and it not saving lives. I praise President Trump for not backing down, because he is making this medication available to you if you want it, its not forced, but it's your choice. It is becoming more and more obvious even to him the medical professionals closest to him, are not interested in saving your life. The question of why must be examined further.
5. AGREE AGREE AGREE: As part of his role, Peter Navarro has been trying to source hydroxychloroquine from around the world. He's also been trying to ensure that there are enough domestic production capabilities inside the U.S.
that the studies that
he's seen regarding the treatment of COVID-19 with hydroxychloroquine, I believe they're mostly overseas,
show "clear therapeutic
efficacy."
-a source familiar with the conversation. "Those are the exact words out of his mouth."
The FDA made an Emergency Approval for the use of hydroxychloroquine for use specific to the treatment of COVID-19 as contained tn approval press resease:
"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate when used to treat COVID-19 outweigh the known and potential risks of such product "
The global Israeli company Teva Pharmaceutical Industries is donating more than 6 million doses of hydroxychloroquine sulfate tablets to hospitals across the United States to meet the urgent demand for the medicine as an investigational target to treat COVID-19 and had been scheduled to ship on March 31, 2020
What do you have to lose? Take it," the president said in a White House briefing on Saturday. "I really think they should take it. But it's their choice. And it's their doctor's choice or the doctors in the hospital. But hydroxychloroquine. Try it, if you'd like." AGREE AGREE AGREE
HYDROXYCHLOROQUINE
Hydroxychloroquine belongs to the family of medicines called “antimalarials” (AMs), which are also classified as disease-modifying anti-rheumatic drugs, or DMARDs.
Hydroxychloroquine was approved for medical use in the United States in 1955.
It is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system.
These drugs were initially used to prevent and to treat malaria but are no longer used for those purposes; more effective drugs have since been developed. Today’s AMs are hydroxychloroquine (Plaquenil®), chloroquine (Aralen®), and quinacrine (Atabrine®). (Quinacrine is no longer marketed in the U.S.; it can be dispensed by a compounding pharmacy, although insurance companies may not pay for it.)
The antimalarial quinine was first used to treat cutaneous lupus in 1834. Subsequent reports in 1928 and 1938 showed good results with another quinine-like drug in the treatment of both discoid and subacute cutaneous lupus. In 1941, discoid lupus patients were treated successfully with Atabrine, a compound developed in Germany in the 1920s. In the mid-1940s, both hydroxychloroquine (HCQ) and chloroquine (CQ) had been synthesized. In 1955 HCQ was shown to be effective for both systemic lupus and rheumatoid arthritis. (Wallace DJ, Hahn BH, eds. Dubois’ Lupus Erythematosus. 1997:1117.)
Hydroxychloroquine was previously prescribed only for people whose lupus disease activity was mild in its course; if the lupus became active, steroids or immunosuppressants would be prescribed instead. Today, however, HCQ is recommended for most individuals with lupus, whether mild, moderate, or severe, as well as during pregnancy and while breastfeeding.
Hydroxychloroquine has been proven to have many and varied beneficial effects as well as an excellent long-standing safety profile
The Immune System and a reaction known as a Cytokine Storm
A Cytokine Storm is an exaggerated immune system response to a highly pathogenic invader. When a cytokine storm occurs in the lungs, fluids and immune cells accumulate and eventually block off the airways, often resulting in death.
The key to the higher mortality rate for COVID-19 is the cytokine storm.
A cytokine storm is triggered when the body perceives that a viral attack is more than it can handle through a normal response.
This can happen in several different ways:
- A virus can be so virulent that its assault on the body is so great it triggers a cytokine storm as well as the fact your immune system cannot identify the virus.
- A normal immune system protects against invaders, but an immune system driven into over-active by an aggressive virus can not only damage the lungs but also other organs, including the kidneys, liver and heart
- A virus can be so new (unlike most flus or colds) that the body has no memory of it, or any virus like it. This means your immune system can't rely on its best, most trained defenders, the B-Cells and especially the T-Cells.
They are powerful; they are quick; and they are aggressive. But being untrained, their attack may not be so precise. In other words, they can cause collateral damage.
This is the pathway that can lead healthy and even young people into the critical stages of illness.
A virus by itself may not be strong enough to trigger a cytokine storm, but it may trigger a secondary infection (usually pneumonia) which, when combined with the initial infection, produces enough viral overload to trigger a cytokine storm.
Any respiratory virus, including flu, respiratory syncytial virus, human metapneumovirus, and now COVID-19 can lead to pneumonia. This is how seasonal flu kills over 600,000 people a year.
People don't die from the flu, they die from the storm unleashed by the pneumonia, which was brought on as a secondary infection.
No Matter how the storm is triggered, it causes your immune system to go crazy causing itself to become out of control in a frenetic response to the invading virus/viruses.
A biochemical cascade of immune cells and immune system bio-chemicals such as interferon, interleukin, and monokines - collectively known as cytokines - literally pours into the lungs bringing macrophages and dendritic cells along with them.
The subsequent damage to the lung tissue caused by these cells and biochemicals leads to Acute respiratory distress syndrome (ARDS) leads to:
- literally chewing up a person's lung tissue, causing fluid to pour into the lungs, ultimately causing the victim to suffocate as a result of their own disease-fighting chemistry.
- The patient literally drowns in their own body fluids.
- Most common flu's do not produce cytokine storms.
- Most flu's that kill people usually do so to those who have weak immune systems by eventually opening the door for pneumonia, which subsequently triggers a cytokine storm.
- That's why health authorities specify that the very old and very young and those with weak immune systems are prime candidates for annual flu vaccines (even though they don't work very well.
- Yes, they can follow the same path in seniors with weakened immune systems.
- But because they are so virulent, and because human immune systems have no memory of them, they don't need pneumonia to kill you.
- They can kill you by directly unleashing a cytokine storm, which means that it is your own, healthy immune system that kills you.
- And this means that the most vulnerable are not just the very old and the very young but also healthy adults and pregnant women, people who have very strong immune systems.
- To translate that into English, in a cytokine storm, the immune system overacts to the invasion of pathogens, and it's the immune system itself that damages the lungs, not the virus.
For example, researchers have found that both remdesivir (one of the drugs currently be used to combat Ebola in Africa) and chloroquine (a widely used and FDA approved anti-malarial and autoimmune disease drug) were both effective in stopping COVID-19 from replicating in a lab dish .( Wang, M., Cao, R., Zhang, L. et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res (2020). https://doi.org/10.1038/s41422-020-0282-0)
Also, both drugs were effective at low concentrations, and neither drug is considered particularly toxic to human cells.
Again, it's not about curing the disease.
All you need to do is support your body's ability to hold the viral load down low enough so that you never develop pneumonia, or your immune system never kicks into a cytokine storm followed by ARDS.
Into the Eye of the Storm
Hydroxychloroquine is an immunomodulatory drug that has been used for 60 years to treat malaria and autoimmune diseases such as systemic lupus erythematosus and inflammatory arthritis, and potential new uses and benefits continue to emergeHydroxychloroquine is especially important in its role in preventing a “cytokine storm,” which is when there are so many immune mediators being released at once to fight an infection that the host itself is overwhelmed and dies. Cytokine storms have been implicated in the death of SARS patients.
The most serious side effects of hydroxychloroquine are retinopathy, occurring in roughly 4% of patients treated for five or more years, other associated ophthalmic pathologies that may be reversible, and rare cases of cardiomyopathy.
Since antiviral therapy would be relatively short-term, these side effects would be rare. The rest of the side effects do not have a defined frequency and are the standard side effects one expects to see for any medication.
Prescribing hydroxychloroquine as first-line therapy might be our best option currently.
READ THE LETTER HERE:
FDA and Emergency Authorization for chloroquine-based drugs
The FDA has stepped in. In a letter released on Saturday, the FDA's Chief Scientist, Denise Hinton, responded positively to a request from the Department of Health and Human Services to provide an Emergency Use Authorization for chloroquine-based drugs.
According to the law that governs Emergency Use, authorizations can be made after the Secretary of Health and Human Services declares a public health emergency, which has already happened.
At that point, the judgement about whether an authorization should be granted is "based on the totality of scientific evidence available to the secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing" the cause of the emergency.
Obviously, "reasonable to believe" can mean different things to different people. Hinton specifically refers to what she terms the "limited" studies mentioned above and notes that a handful of other countries have recommended the use of chloroquine. For her, this constitutes "reasonable." For others, it almost certainly will not, ensuring that the decision will be controversial.
Given that we probably have weeks to months to go before properly controlled clinical-trial data allows us to make conclusions about any drug's effectiveness, it's likely that chloroquine will remain the standard treatment for the peak of several regional epidemics in the US. The one thing that this decision does ensure is that we'll have lots of anecdotal reports on its use to complicate the public's understanding of treatment options.
How is the United States getting Hydroxychloroquine and How Much is
it Costing?
The global Israeli company Teva Pharmaceutical Industries is donating more than 6 million doses of hydroxychloroquine sulfate tablets to hospitals across the United States to meet the urgent demand for the medicine as an investigational target to treat COVID-19.
YES, IT IS BEING DONATED. THE AMOUNT OF THE DRUG WHICH IS BEING DONATED eliminates claims that those whom it has been prescribed for such as lupus, will not be able to get it due to running out.
Donation of doses will be enough for everyone to has symptoms of the virus to ensure access for all.
Teva said in a statement that it will ship six million tablets of hydroxychloroquine sulfate, an FDA-approved drug for malaria, lupus erythematosus and rheumatoid arthritis, to hospitals across the country by March 31, and more than 10 million by next month.
“Immediately upon learning of the potential benefit of hydroxychloroquine, Teva began to assess supply and to urgently acquire additional ingredients to make more product while arranging for all of what we had to be distributed immediately,” said Brendan O’Grady, Teva Executive Vice President, North America Commercial.
“We are committed to helping to supply as many tablets as possible as demand for this treatment accelerates at no cost.”
O’Grady said that additional production of hydroxychloroquine sulfate tablets is also being assessed and subsequently ramped up with materials that are being sent to Teva from its ingredient supplier.
Teva will ship 6 million tablets through wholesalers to hospitals by March 31, and more than 10 million within a month.
The company is also reviewing supply of both hydroxychloroquine and chloroquine globally to determine whether there are additional supply and access opportunities for patients.
Teva is a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Teva provides more than 10% of the US drug supply, providing American patients with approximately 1 out of 7 prescriptions they take.
***It should be noted 9 years ago, when I first began experiencing life changing symptoms of autoimmune disease, after significant time spent trying to find a doctor which was trying to help me, help determine the causative factor, all I found were Dr's willing to prescribe a plethora of pharmaceuticals but not help me really get better and improve my quality of life. That was point I made the choice to stop taking any kind pharmaceutical medicine when it became clear I wasn't getting better and they did not care. I share this because, it's important to realize that I have never been one who turns to a pill to fix everything, quite the opposite, therefore my opinion that I am absolutely in favor of using hydroxychloroquine for the treatment of COVID-19 should carry greater impact because it goes against my typical inclination.