Thursday, April 9, 2020

7 ANSWERS TO QUESTIONS ABOUT [HYDROXYCHLOROQUINE]




7 ANSWERS TO QUESTIONS ABOUT [HYDROXYCHLOROQUINE] THE Malaria Drug Trump Keeps Pushing 
By Denise Grady, Katie Thomas and Patrick J. Lyons    New York Times  • April 8, 2020


RED= Inappropriate anti-Trump or anti-hydroxychloroquine editorial comments  inserted by the New York Times in  a news story  AND  clarifying comments that the New York Times SHOULD  have presented to you  for your consideration


Here are the  some facts  and lots of negative anti-Trump editorial comments  on hydroxychloroquine, which the president has promoted despite little evidence that it works against the coronavirus. … .This NYT  statement is an example of the New York Times editorial pollution of what should be a straight forward recitation of information.

Hydroxychloroquine was approved decades ago to treat malaria, and it is also used to treat autoimmune diseases like rheumatoid arthritis and lupus.

There is no proof that any drug can cure or prevent infection with the coronavirus. True, but  more appropriate questions  are: can a medication significantly reduce the symptoms exhibited by a patient and/or the length of his/her illness and/ or improve the outcome and/or reduce the probability of death.  But in the face of an exploding pandemic with a frightening death toll, people are desperate for a bit of hope, a chance to believe there is something that will help.

The drug that has received the most attention is hydroxychloroquine, which President Trump has recommended repeatedly, despite warnings from his own health officials that there is little data to support its widespread use as a treatment against the virus.

Drug companies across the world have begun donating tens of millions of doses of hydroxychloroquine to the United States, and the president said on April 4 that 29 million doses had been added to the National Strategic Stockpile, a cache of medical supplies maintained by the government to respond to emergencies.

What is hydroxychloroquine?
Hydroxychloroquine is a prescription medicine that was approved decades ago to treat malaria. It is also used to treat autoimmune diseases like rheumatoid arthritis and lupus. It is sometimes referred to by its brand name, Plaquenil, and is closely related to chloroquine, which is also used to treat malaria.

Why has hydroxychloroquine even been considered as a possible treatment for the coronavirus?

There are several reasons. A promising laboratory study, with cultured cells, found that chloroquine could block the coronavirus from invading cells, which it must do to replicate and cause illness. However, drugs that conquer viruses in test tubes or petri dishes do not always work in the human body, and studies of hydroxychloroquine have found that it failed to prevent or treat influenza and other viral illnesses.


Reports from doctors in China and France have said that hydroxychloroquine, sometimes combined with the antibiotic azithromycin, seemed to help patients. But those studies were small and did not use proper control groups — patients carefully selected to match those in the experimental group but who are not given the drug being tested. Research involving few patients and no controls cannot determine whether a drug works. And the French study has since been discredited: The scientific group that oversees the journal where it was published said the study did not meet its standards.  

1.      ON THE OTHER HAND,   MORE THAN   2,304    PHYSICIANS WHO ARE CURRENTLY SUCCESSFULLY TREATING  PATIENTS INFECTED WITH THE COVID-19  REPORTED  THEIR  "ANECDOTAL EVIDENCE" OF THEIR  SUCCESS WITH THEIR PATIENTS UTILIZING HYDROXYCHLOROQUINE


"Hydroxychloroquine rated ‘most effective therapy’ by doctors for coronavirus” (by Valerie Richardson  Washington Tmes    4-2-20) 

An international poll of more than 6,000 doctors released Thursday found that the antimalarial drug hydroxychloroquine was the most highly rated treatment for the novel coronavirus.

The survey conducted by Sermo, a global health care polling company, of 6,227 physicians in 30 countries found that 37% of those treating COVID-19 patients rated hydroxychloroquine as the “most effective therapy” from a list of 15 options.

The U.S. Food and Drug Administration gave chloroquine and its next-generation derivative, hydroxychloroquine, emergency-use authorization Monday for treating the novel coronavirus, although the drug was already being used off-label by some doctors and hospitals for COVID-19 patients.

“Outside the U.S., hydroxychloroquine was equally used for diagnosed patients with mild to severe symptoms whereas in the U.S. it was most commonly used for high risk diagnosed patients,” the survey found.

The 30 nations surveyed included those in Europe, Asia, North America and South America, as well as Australia. No incentives were provided to participate in the poll, conducted March 25-27, according to Sermo.

Hydroxychloroquine usage was most widespread in Spain, where 72% of physicians surveyed said they had prescribed it, followed by Italy at 49%, and least popular in Japan, where 7% had used it to treat COVID-19.

The poll found 23% of U.S. medical professionals had prescribed the drug, which has been FDA-approved for malaria, lupus and rheumatoid arthritis.


Sermo CEO Peter Kirk: “ Physicians should have more of a voice in how we deal with this pandemic and be able to quickly share information with one another and the world,” he said. “With censorship of the media and the medical community in some countries, along with biased and poorly designed studies, solutions to the pandemic are being delayed.”


2.     AS AN EXAMPLE, a report from a  board-certified physician  with 30 years of experience in treating infectious diseases, including current Corona  virus cases:

AS A PHYSICIAN ON THE FRONT LINES OF THIS COVID PANDEMIC, I AM SHARING MY THOUGHTS ABOUT HOW TO IMMEDIATELY END THE EPIDEMIC AND THE QUARANTINE PROTOCOLS. 

I can confirm that the vast majority of patients infected with Covid19 have minimal, mild or modest cold and flu-like symptoms, requiring little to no medical intervention.  The planet is being systematically shut down because a very small percentage of those infected may have serious or grave reactions to the viral infection.  When these seriously ill patients contract the disease over a short period of time, the healthcare system can become overwhelmed as was the experience in China, Korea and Italy.

The Chinese have largely completed their Covid19 experience and some significant science has come from their doctors and researchers as to the virology, epidemiology and treatment of Covid19.  The most important of which is the recent study showing a 100% cure rate for Covid19 patients (n = 20) treated with the combination of chloroquine and azithromycin.

Now that a cure has been established (and is being confirmed in other areas hard hit with Covid19 — to my understanding), this new finding should be the antidote for public and political panic regarding any significant downside human costs (grave illness, casualties) of the pandemic.

As we no longer have the domestic capacity to manufacture these medications in the quantities needed on the timeline required, the Federal government should immediately work to re-tool US chemical factories that are capable of retrofitting to manufacture these two drugs.  The raw materials of these medicines can then be shipped directly to vitamin manufacturers who have the capacity to conservatively and collectively make 5 - 10 millions pills daily.  As a contract manufacturer of vitamins, I know first hand that these facilities follow strict FDA guidelines that are equivalent to the regulations of Big Pharma. Therefore, quality control will not be a concern.  Compound pharmacies are also capable of participating in this effort.

If this protocol were to be adopted, some 150M doses of these life-saving medications would be available in the next two weeks to treat all patients in need and any first responder/front line healthcare worker.

While not scientifically proven, it has also been anecdotally observed that chloroquine may offer significant prophylaxis so that those most at risk (the vulnerable patients and front-line healthcare workers) may never develop a primary infection during the epidemic.   This preventive intervention should be immediately offered to vulnerable populations and healthcare workers in an open-label, observational study.

With the cure in the hands of pharmacies, hospitals and first responders, the concern for the health and wellness of the vulnerable population (whose characteristics have been well described) can be assured. By treating these vulnerable patients in the early part of the 5 day prodrome (when mild symptoms begin), demands on hospital resources will be effectively countered.

Governmental authorities can then begin to immediately prepare the population for a systematic roll out of return-to-work orders while releasing the healthy, general public from quarantine.

It is my opinion, the vulnerable populations should remain quarantined for the next one month while the treatments are used and proven on a mass scale.

The concern of patients (and their providers) with an infectious disease is always the success and availability of the treatment for their condition.  Now that a treatment has been Now that a treatment has been identified and can be made widely available at minimal cost (but with considerable public-private coordination issues) the End Game for this pandemic is within our collective reach.


A recent study from China did include a control group, and suggested that hydroxychloroquine might help patients with mild cases of Covid-19, the disease caused by the coronavirus. But that study had limitations: It was also small, with a total of only 62 patients, and they were given various other drugs as well as hydroxychloroquine. The doctors evaluating the results knew which patients were being treated, and that information could have influenced their judgment. Even if the findings hold up, they will apply only to people who are mildly ill. And the researchers themselves said more studies were needed. All true…but meant to mislead.For example, if a physician had to wait for a FDA approved clinical trial, 99.5% of your clinical medical practice could not take place.

Another reason the drug has been considered for coronavirus patients is that it can rein in an overactive immune system, which is why it is used to treat lupus and rheumatoid arthritis. In some severe cases of Covid-19, the immune system seems to go into overdrive and cause inflammation that can damage the lungs and other organs. Doctors hope hydroxychloroquine might calm the condition, sometimes called a cytokine storm, but so far there is no proof that it has that effect. What has been proven is that in a large number of cases the  severity of the infection appears to be reduced. If  the medication slightly reduces the effects of the virus and  thus keeps a patient off a  ventilator this will substantially increase the survival rate.
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Can hydroxychloroquine protect you from catching the virus?


There is no evidence that hydroxychloroquine can prevent coronavirus infection. However, researchers at the University of Minnesota are testing the drug in people who live with coronavirus patients to see whether it can protect them.

Is hydroxychloroquine approved by the Food and Drug Administration?

Yes, but for malaria, lupus and rheumatoid arthritis, not for Covid-19. For decades, doctors have been legally allowed to prescribe it for any condition they think it might help, a practice called off-label use. Currently, physicians  prescribe thousands of drugs for “off label use “.  This is standard medical practice and there is nothing controversial  about physicians  doing this. However,  to raise this as an objection in the current epidemic situation is a political  device to delay  the rapid and widespread testing of hydroxychloroquine. Another objection, possible side effects, is also political since the attending physician knows his patients and their underlying conditions and thus carefully observe them alter treatments which might be also damaging to them

 However, because of hoarding and high demand for hydroxychloroquine, some states like New York have ordered pharmacists to fill prescriptions only for F.D.A.-approved uses of the drug or for people participating in clinical trials. Again, this action was   a misguided political hit  job.  A physician with extensive experience in producing medications and supplements states:"As we no longer have the domestic capacity to manufacture these medications in the quantities needed on the timeline required, the Federal government should immediately work to re-tool US chemical factories that are capable of retrofitting to manufacture these two drugs.  The raw materials of these medicines can then be shipped directly to vitamin manufacturers who have the capacity to conservatively and collectively make 5 - 10 millions pills daily.  As a contract manufacturer of vitamins, I know first hand that these facilities follow strict FDA guidelines that are equivalent to the regulations of Big Pharma. Therefore, quality control will not be a concern.  Compound pharmacies are also capable of participating in this effort."

In late March, the F.D.A. granted emergency approval to allow hospitals to use hydroxychloroquine from the national stockpile to treat patients who would not otherwise qualify for a clinical trial. Under the approval, patients and their families will receive information about the drug, and hospitals have to track information about the patients who received the drug, including their health condition and serious side effects. But that F.D.A.’s authorization for emergency use is not equivalent to meeting federal requirements, including scientific evidence through trials, that would deem hydroxychloroquine a proven treatment against the virus.

Is hydroxychloroquine being given to coronavirus patients now?

Yes. Many hospitals are giving it to patients because there is no proven treatment, and they hope it will help. Clinical trials with control groups have begun across the world. A nationwide trial began on April 2 in the United States; it is to enroll 510 patients at 44 medical centers. Had this medication  been offered to 5,000 patients this week is likely that a majority would have accepted the treatment and within three weeks we would have a definitive answer. The Centers for Disease Control is slow rolling our ability to find  immediately find a medication that  might reduce the severity  of the infection and the  length of time that the patient is suffering from the symptoms. Any mention of  a shortage of the  medication is hypocritical. There is plentiful stores  on hand  or available within a very short time period to  immediately  service 5,000 to 10,000 patients. Any  statements about money is also hypocritical. The medication is extremely inexpensive.

Researchers say those studies are essential to find out whether the drug works against the coronavirus. And thousands of patients , their families and  physicians in the field say that this  CDC  argument is irrelevant and dangerous academic nonsense 
since we have an inexpensive, very low risk way  to to evaluate hydroxychloroquine. And in three weeks we could definitely know whether hydroxychloroquine it is a improved treatment for any significant portion of the affected patients…  And  even very limited improvements in patient condition  and/or length of illness would  result in a substantial reduction in the burden on medical resources and on the death rate  resulting from Covid-19  infection.

See: "Dr.Anthony Fauci versus more than 2304 practicing physicians who are currently successfully treating their patients for the Covid-19 virus UTILIZING HYDROXYCHLOROQUINE”  http://ltgjcmilopsg3.blogspot.com/2020/04/dranthony-fauci-versus-more-than-2304.html

 If it does not, time and money can be redirected to other potential treatments. This statement  may sound reasonable to some, but it is profoundly stupid. …  Currently  Dr. Fauci’s  budget is between five and $6 billion annually.  An extensive test  of  possible effectiveness of utilizing hydroxychloroquine can be conducted in real time  at trivial financial cost.  The additional  pain  and  suffering of  the  patients and their families   resulting from delayed decisions is substantial.  Yet the CDC  approach, which  is endorsed by the New York Times,  is to perform a small  study which will lead to another study, which will then  lead to another study,  which will then result in a flood of academic papers.[ Dr Fauci is on the editorial boards of many scientific journals and is the  author,  or coauthor, or editor of more than 1,300 scientific publications, including several textbooks.]


Is there any danger in taking hydroxychloroquine?

Like every drug, it can have side effects. It is not safe for people who have abnormalities in their heart rhythms, eye problems involving the retina, or liver or kidney disease.   This is a false objection. The treating physician would balance the risks against the possible rewards prescribing this drug for each individual patient. Further, he would monitor and discontinue should such action be warranted.  This is a false objection.

Other possible side effects include nausea, diarrhea, mood changes and skin rashes.  BIG DEAL!!!

Overall, it is considered relatively safe for people who do not have underlying illnesses that the drug is known to worsen.

 But it is not known whether hydroxychloroquine is safe for severely ill Covid-19 patients, who may have organ damage from the virus. The hope is to reduce the severity and length of the symptoms so that organ damage is avoided.




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