AAPS: FDA DELAYS ON HYDROXYCHLOROQUINE OUTPATIENT APPROVAL ARE CAUSING DEATHS DAILY

SEE: https://www.technocracy.news/aaps-fda-delays-on-hcq-outpatient-approval-are-causing-deaths-daily/;

republished below in full unedited for informational, educational & research purposes:
The venerable Association of American Physicians and Surgeons is calling on the FDA to immediately release HCQ for outpatient treatment to save thousands of needless deaths from COVID-19. The FDA’s blatant hypocrisy in failing to do sos should outrage all Americans. ⁃ TN Editor

20,000 more Americans have died while the FDA has delayed since July 1 a new emergency use approval for outpatient use of hydroxychloroquine (HCQ) for COVID-19.

On July, 1 Henry Ford Hospital physicians and researchers in Detroit filed an urgent request to FDA Commissioner Dr. Stephen Hahn for a new outpatient Emergency Use Authorization (EUA) for FDA approval of HCQ to be used in early treatment for COVID-19. Baylor Scott & White Heart and Vascular Institute in Dallas, issued an urgent appeal supporting the Henry Ford EUA application, based on their clinical study of prophylactic use of HCQ in their own medical workers. Baylor cardiologists emphasized there were no adverse cardiac outcomes in their own or the Ford study.

Henry Ford’s new clinical trial found an impressive 51% reduction in deaths if HCQ was begun within 24 hours of admission to hospital. An outpatient primary care study by Dr. Vladimir Zelenko, using HCQ, azithromycin and zinc given within less than 7 days of COVID-19 symptoms, showed approximately 80% decrease in deaths, and less than 1% of his patients needed to be admitted to hospital. These U.S. early intervention studies extraordinary results show how many lives can be saved with early HCQ treatment.

If the FDA had acted quickly on the Henry Ford and Baylor approval request for HCQ, we can reasonably consider that 16,000 lives could have been saved since July 1.

EUA applications do not have to take long to approve, when well documented rationale and supporting research is presented as Henry Ford team and Baylor cardiologists did.

HCQ is already an FDA-approved drug, unlike remdesivir, which had almost an immediate compassionate use authorization granted that has now been expanded for early use despite severe side effects. The former director of the FDA subagency BARDA, Rick Bright, Ph.D., submitted an EUA for HCQ approval for hospital use at 11:30 pm on March 28, 2020. Dr. Hahn’s approval was granted a little after midnight, March 29, 2020. Approval in about 30 minutes.

We have been waiting almost 30 days for Dr. Hahn to issue approval of the Henry Ford EUA application for outpatient use. Dr. Hahn has stated that we need more data. Henry Ford and Baylor doctors have already provided research documentation stronger than in Rick Bright’s March application, and included current COVID-19 studies from the U.S. and other countries.What amount of “data” will ever satisfy Dr. Hahn?

Let THIS sink in: Laboratory studies published by the National Institutes of Health 15 years ago (2005) showed potent antiviral effects of chloroquine against SARS-CoV-1 to block the infection at the earliest stage. Anthony Fauci, who was working at NIH at that time, has to have known for the last 15-18 years that chloroquine and hydroxychloroquine are effective against SARS-Co-V-1, which shares 79% of the viral genome with SARS-CoV-2, the cause of COVID-19 disease.

It is appalling that so many more Americans have died, while the physician who is head of the FDA has dawdled on approving HCQ for an urgent new use in this pandemic. Dr. Hahn knows full well the 65-year track record of safety worldwide in patients of all ages, all ethnic groups, and even pregnant women and nursing mothers.

Doctors who are treating COVID-19 patients see lives being saved by cheap, safe, FDA-approved medicines—hydroxychloroquine, azithromycin, doxycycline.

It is crucial to start HCQ early, during days 1-7 of symptoms, for these key reasons:

  • Early treatment is when HCQ works best two ways: to stop viral entry into our cells, and block the virus from multiplying using the cell’s machinery.
  • The viral load explodes by day 6, and then can trigger an exaggerated inflammatory response called Cytokine Storm, which severely damages critical organs: lungs, kidneys, heart, brain, liver and intestines. This severe complication doesn’t occur in all COVID-19 patients, but often is fatal when it does.
  • Early treatment keeps infected people from spreading the virus to others.
  • Early treatment is crucial to keep people out of hospitals and off ventilators.
  • Availability of early treatment is urgently needed to safely re-open businesses, schools, and churches, and help relieve public anxiety and fear.

Front-line doctors have been pleading with the FDA and State officials since March to open access to early treatment with HCQ. The supply of HCQ has been ramped up to handle its use in early treatment of COVID. The Strategic National Stockpile has millions of doses deteriorating in government warehouses that are not being distributed because doctors are prevented from prescribing for outpatients with COVID-19. FDA’s misleading statements about HCQ have led to dangerous, unprecedented restrictions on physicians’ off-label prescribing rights imposed by state governors, medical boards and pharmacy boards.

Generic HCQ with azithromycin or doxycycline plus zinc is taken by mouth.Total treatment cost is about $25-$30 cash price for the 5-7 day course used in COVID-19.

Remdesivir must be given intravenously to patients in hospital, at a cost of about $3,500. Its serious side effects include respiratory failure, the very condition it is supposed to treat. It has shown limited success: it shortened hospital stays by only 4 days and has not been clearly shown to reduce deaths.

Baylor’s study showing prophylactic benefits for hospital workers is profoundly important, not only for front-line medical workers, but also for law enforcement officers, paramedics, clergy, dentists/dental hygienists, truck drivers, food-processing workers, teachers, behavioral health professionals, factory and grocery store workers, flight attendants, and many others.

HCQ is a safe, effective outpatient treatment we have NOW. Physicians and patients need freedom to use it. Delays waiting for the “magic bullet” of a vaccine inevitably mean more deaths. Even IF we have a vaccine that works, we still need therapeutics, such as HCQ.

Testing is inaccurate and often unavailable, and HCQ dispensing must not be limited to persons with a positive test. Such limits also prevent prophylactic use. Governors and other officials must not be allowed to arbitrarily restrict life-saving HCQ treatment.

Continued shutdowns of businesses, schools, churches, and mandatory mask edicts are not controlling the epidemic. Meanwhile, these orders have eroded our constitutional freedoms, and devastated our economic, psychological, physical, and spiritual well-being.

Dr. Hahn’s FDA is costing more lives with its delay in removing the obstructions it created to prescribing safe, effective early HCQ treatment: deaths directly from COVID-19 and indirectly by destroying livelihoods and distributions of foods, goods and services required to sustain our lives.

Dr. Hahn, America needs you to act NOW.

Read full story here…

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The Great Technocrat War Against Hydroxychloroquine

BY:  STEVEN HATFIL VIA REALCLEARPOLITICS

SEE: https://www.technocracy.news/the-great-technocrat-war-against-hydroxychloroquine/;

republished below in full unedited for informational, educational & research purposes:
It is Technocrats like Anthony Fauci who originally fomented the war against HCQ and they blocked its use at every turn. All testimony by MDs and scientists supporting HCQ is summarily ridiculed and dismissed.Tens of thousands of people have needlessly died because of these mean-spirited policies by Big Pharma to protect the deployment of their expensive drugs and vaccines. ⁃ TN Editor

On Friday, July 31, in a column ostensibly dealing with health care “misinformation,” Washington Post media critic Margaret Sullivan opened by lambasting “fringe doctors spouting dangerous falsehoods about hydroxychloroquine as a COVID-19 wonder cure.”

Actually, it was Sullivan who was spouting dangerous falsehoods about this drug, something the Washington Post and much of the rest of the media have been doing for months. On May 15, the Post offered a stark warning to any Americans who may have taken hope in a possible therapy for COVID-19. In the newspaper’s telling, there was nothing unambiguous about the science — or the politics — of hydroxychloroquine: “Drug promoted by Trump as coronavirus game-changer increasingly linked to deaths,” blared the headline. Written by three Post staff writers, the story asserted that the effectiveness of hydroxychloroquine in treating COVID-19 is scant and that the drug is inherently unsafe. This claim is nonsense.

Biased against the use of hydroxychloroquine for COVID-19 — and the Washington Post is hardly alone — the paper described an April 21, 2020, drug study on U.S. Veterans Affairs patients hospitalized with the illness. It found a high death rate in patients taking the drug hydroxychloroquine. But this was a flawed study with a small sample, the main flaw being that the drug was given to the sickest patients who were already dying because of their age and severe pre-existing conditions. This study was quickly debunked. It had been posted on a non-peer-reviewed medical archive that specifically warns that studies posted on its website should not be reported in the media as established information.

Yet, the Post and countless other news outlets did just the opposite, making repeated claims that hydroxychloroquine was ineffective and caused serious cardiac problems. Nowhere was there any mention of the fact that COVID-19 damages the heart during infection, sometimes causing irregular and sometimes fatal heart rhythms in patients not taking the drug.

To a media unrelentingly hostile to Donald Trump, this meant that the president could be portrayed as recklessly promoting the use of a “dangerous” drug. Ignoring the refutation of the VA study in its May 15 article, the Washington Post cited a Brazil study published on April 24 in which a COVID trial using chloroquine (a related but different drug than hydroxychloroquine) was stopped because 11 patients treated with it died. The reporters never mentioned another problem with that study: The Brazilian doctors were giving their patients lethal cumulative doses of the drug.

On and on it has gone since then, in a circle of self-reinforcing commentary. Following the news that Trump was taking the drug himself, opinion hosts on cable news channels launched continual attacks on both hydroxychloroquine and the president. “This will kill you!” Fox News Channel’s Neil Cavuto exclaimed. “The president of the United States just acknowledge that he is taking hydroxychloroquine, a drug that [was] meant really to treat malaria and lupus.”

Washington Post reporters Ariana Cha and Laurie McGinley were back again on May 22, with a new article shouting out the new supposed news: “Antimalarial drug touted by President Trump is linked to increased risk of death in coronavirus patients, study says.” The media uproar this time was based on a large study just published in the Lancet. There was just one problem. The Lancet paper was fraudulent and it was quickly retracted.

However, the damage from the biased media storm was done and it was long-lasting. Continuing patient enrollment needed for early-use clinical trials of hydroxychloroquine dried up within a week. Patients were afraid to take the drug, doctors became afraid to prescribe it, pharmacies refused to fill prescriptions, and in a rush of incompetent analysis and non-existent senior leadership, the FDA revoked its Emergency Use Authorization for the drug.

Read full story here…

 
 

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THE WAR ON HYDROXYCHLOROQUINE

BY DENNIS BEHREANDT

SEE: https://www.thenewamerican.com/print-magazine/item/36249-the-war-on-hydroxychloroquine;

republished below in full unedited for informational, educational & research purposes:

As strange as it may sound, a propaganda and demonization campaign is being waged against hydroxychloroquine so that globalism and U.S. socialism can make headway.

President Donald Trump several times has lauded the drug hydroxychloroquine (HCQ) as a potential cure for COVID-19, even saying that he was taking it himself to ward off the disease, and he ordered his administration to make it readily available. Recently, however, the U.S. Food and Drug Administration revoked its Emergency Use Authorization (EUA) for using hydroxychloroquine to fight COVID-19, saying, in essence, it doesn’t seem to treat COVID-19 and is dangerous. Doctors, though, can still prescribe it for off-label use.

Yet researchers writing a review of COVID-19 treatments for the Journal of the American Medical Association (JAMA) summarized the safety of chloroquine (CQ) treatment for COVID-19: “Chloroquine and hydroxychloroquine are relatively well tolerated as demonstrated by extensive experience in patients with SLE and malaria,” the researchers wrote, noting that in some cases there have been “rare and serious adverse effects.” Still, of the safety of the drugs in the context of COVID-19, they wrote: “No significant adverse effects have been reported for chloroquine at the doses and durations proposed for COVID-19. Use of chloroquine and hydroxychloroquine in pregnancy is generally considered safe. A review of 12 studies including 588 patients receiving chloroquine or hydroxychloroquine during pregnancy found no overt infant ocular toxicity.”

As well, peer-reviewed studies and anecdotal evidence show that the drug works to treat COVID-19.

So what is happening here? The answer: There is a war going on for your mind.

Prior to the election of Donald Trump, the war was somewhat hidden. Though a subset of Americans had noticed the gradual increase in statist, internationalist, and socialist propaganda over the years, most Americans remained unaware of the trend. The election of Donald Trump, however, was a wake-up call, and the statists, or “deep statists” if you will, began a concerted campaign to remove the president from office. Still, nasty as this was, for most Americans this was just political theater. 

The war broke furiously into the open with COVID-19, though, and has accelerated, and grown more vicious still, with the wave of violent terrorist riots that have struck the nation’s cities. With COVID-19, the nation’s petty tyrants in state government took the opportunity presented by the crisis to revoke the rights and freedoms of the American people and impose mass house arrest. The next phase of the war immediately followed in the form of the terrorist riots that have resulted in widespread property destruction and the sowing of intense fear among the law-abiding, who are increasingly left to their own devices in defending themselves against the tide of violence. In total, the entire campaign is aimed at forcibly limiting what Americans do, say, and even think — trying to make social controls “the new norm.”

As an integral part of this “new norm,” the elitists who desire total power have devised another strategem: institute a vaccine program — ostensibly to safeguard us against coronavirus — that will allow elites to track us at all times and control the lives and activities of people around the world. The scheme has been heavily promoted by Bill Gates and the controlled international menagerie of NGOs and world government bodies. (See the article “Bill Gates: Philanthropist or Scoundrel?”)

Anything that gets in the way of this effort is demonized by the leftist mainstream media. Case in point: Trump’s promotion of hydroxychloroquine to fight COVID-19. Why? Because if a simple and effective treatment for the pandemic disease exists and is readily available, the overarching need for a vaccine is diminished or eliminated.

Within this framework, the motivation behind the media and Democratic politicians’ unceasing attacks on hydroxychloroquine becomes understandable. Though the science is not yet settled and important studies are ongoing, some research and plenty of clinical anecdotal evidence continue to point to the drug as a useful treatment for COVID-19. If it is, then the need for a vaccine forced on the world’s population is diminished or even eliminated, and with that, the plan to track everyone via a digital vaccine ID has had a stake firmly planted in its heart.

Thus, we have an all-out campaign of demonization waged against the drug, convincing Americans to abandon hope of a non-vaccine treatment.

A Chorus of Lies and Calumnies

The Washington Post, one of the key organs of the statist propaganda machine, exemplifies the “coverage” given to HCQ by mainstream-media organs.

In a “Fact Checker” analysis, the paper first quoted President Trump, who said on March 19 about the drug that “it’s looking like it’s having some good results. That would be a phenomenal thing.” Then the newspaper criticized one of the French studies that had found potential value in HCQ. It said about the study by Didier Raoult, et al.: “Scientists have since discredited the trial, pointing to major flaws in the way it was conducted. The journal that published the study announced on April 3 that it did not meet its standards.”

The study was not retracted, and the journal in question did not call the paper’s findings into question; it merely cast aspersions on portions of how the study was conducted with regard to study participants. The study, the journal’s board said, did not meet the “expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.” Again, this was not a criticism of the results reported. Moreover, the journal said its peer-review process was followed. “Despite some suggestions online as to the reliability of the article’s peer review process, the process did adhere to the industry’s peer review rules,” the statement said.

But from the Post’s coverage, readers will get the impression that the entire study was dubious.

The online Daily Beast published a hit piece on Dr. Raoult calling him a “B.S. Artist,” along with attempting to shame him as a “climate denier” and a “coronavirus truther.” The Daily Beast even criticized him for having long hair and a beard, saying it made him look like “a latter day Wild Bill Hickok, albeit in a medical researcher’s white coat.” And he has bad taste too, they claimed: “He wears a biker ring and adorns the walls of his office with schlock paintings of, among others, an imposing Poseidon, god of the seas.”

According to the statists, you shouldn’t believe anything this man says because he is obviously a crackpot. Except this “crackpot” has many other scientific collaborators — he has 17 co-authors joining him on the paper criticized by the Post. This “B.S. Artist,” by the way, has authored or co-authored more than 3,000 peer-reviewed papers during his scientific career. He has collaborated on these with more than 6,000 other scientists, and his peer-reviewed papers have been cited more than 110,000 times by other scientists.

FDA Follies

Perhaps being persuaded by President Trump, or perhaps having actually taken the early results from hydroxychloroquine seriously, in March the Food and Drug Administration authorized emergency use of hydroxychloroquine to make it more available for study and use in the early days of the pandemic’s spread in the United States. The authorization made it possible for large donations of chloroquine and hydroxychloroquine from the companies Bayer and Novartis, respectively, “to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate.”

This earned positive commentary from Health and Human Services Secretary Alex Azar at the time. “President Trump is taking every possible step to protect Americans from the coronavirus and provide them with hope,” Secretary Azar said, according to an agency press release.

Since then, in the wake of ongoing demonization of the drugs, the FDA backtracked and revoked its EUA.

In a letter discussing the revocation of the EUA for the drugs, FDA chief scientist Denise Hinton said the agency no longer found the drugs likely to be effective in treating COVID-19. “We now believe that the suggested dosing regimens for CQ and HCQ as detailed in the Fact Sheets are unlikely to produce an antiviral effect,” Hinton said in the letter. “Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomized controlled trial assessing probability of negative conversion showed no difference between HCQ and standard of care alone,” she continued.

The agency concluded, Hinton wrote, that “it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”

Treatment Strategy Ignored

The claim that hydroxychloroquine use to fight COVID-19 infection lacks merit is a dubious assertion. Notably missing from the FDA’s statement pulling its Emergency Use Authorization is the fact that successful treatment protocols using the drug for COVID-19 have relied on hydroxychloroquine being part of a multi-drug treatment provided early in the course of a SARS-CoV-2 infection, not used alone and given in late stages of the disease.

One doctor who says he has had significant success with a combination treatment that includes hydroxychloroquine is Dr. Vladimir Zelenko.

Practicing in a community on the outskirts of New York City, the epicenter of the pandemic outbreak in the United States, Dr. Zelenko gained fame for his work in treating COVID-19 patients with a three-drug treatment consisting of hydroxychloroquine, azithromycin, and zinc. Heavily promoted early on by Trump, but panned by the mainstream media and politicized almost to extinction in the United States, the treatment as administered by Dr. Zelenko seems to have had noteworthy success.

In an interview with The New American’s Christian Gomez, Dr. Zelenko described how he decided on the course of treatment, as well as why and how he believes it has proven effective in saving lives. “I started studying the basic science of how this virus works,” Dr. Zelenko said in the video interview made available on YouTube.

“So it turns out that zinc, it’s well-known that it inhibits viral replication and specifically in the cytoplasm, in the inside of the cell there is an enzyme … and it’s used by the virus to make copies of its genetic material so that it makes more virus,” Zelenko said. “So this enzyme is essential to viral growth. Turns out that zinc inhibits that enzyme, it deactivates the enzyme and so it makes it very difficult if not impossible for the virus to grow. The problem that we have with zinc is that it doesn’t get into the cell…. So even though zinc is effective against the viral growth, it cannot get into the place where the virus is. So what does hydroxychloroquine do? In this case, it’s nothing more than opening a door, a channel, a zinc transport channel, it’s called a zinc ionophore, and it allows for zinc to go from outside the cell to the cytoplasm, to inside the cell. That’s all it does.”

Initially because of his claims of success in treating COVID-19, Zelenko was increasingly targeted by anti-Trump partisans eager to smear anyone who seemed to be providing evidence that supported the president’s contention that hydroxychloroquine might be useful in treating the disease.

Still, Dr. Zelenko pressed onward, seemingly eager to participate in a study that would clarify the usefulness of his course of treatment. Word of Zelenko’s work reached FDA commissioner Dr. Stephen Hahn, formerly the chief medical executive at the University of Texas MD Anderson Cancer Center, who reached out to Dr. Zelenko to offer insights into how to support the study.

This seems a completely innocent and understandable thing to do in the midst of a pandemic. Why wouldn’t a medical doctor and high-ranking federal official inquire into helping another medical doctor set up a study to investigate what seems a promising treatment? Failure to do so, if the opportunity existed, would seem a cold-hearted dereliction of duty. But the mainstream media, eager to create a controversy where none exists in order to harm Trump, presented the situation as a “gotcha, caught you red-handed” moment.

In a breathless report positioned as one intended to reveal a new administration “scandal,” Vanity Fair reported that it had obtained a series of text messages between Zelenko and Hahn. How scandalous!

Here’s what Vanity Fair said it had uncovered:

Two days after that first phone call, in a series of text messages obtained by Vanity Fair, Zelenko returned to Hahn for help setting up a clinical trial of some 750 outpatients at St. Francis Hospital in Roslyn, New York. “The Catholic Health System (St. Francis Hospital) / Dr Zelenko COVID-19 trial is ready to go,” Zelenko wrote to Hahn, copying one of the hospital’s doctors involved in the trial. “We need ASAP 1. Hydroxychloroquine 200mg. 10000 pills 2. Azithromycin 500mg 5000 pills 3. Zinc sulfate 220 mg 5000 pills. This treatment will be deployed in outpatient primary care.”

Hahn responded, “Not sure what the ask of FDA is.” To which Zelenko replied, “We need the medication to run the study.” Hahn then asked, “Do you have IRB approval?” This referred to an institutional review board that hospitals use to oversee clinical trials and research. The doctor answered, “Hopefully this week.”

“Congratulations,” Hahn offered. “Really well done.” He then advised the doctor to reach out to the Federal Emergency Management Agency (FEMA) to obtain hydroxychloroquine from the Strategic National Stockpile, a federal cache of emergency equipment and supplies managed by the Department of Health and Human Services (HHS). When the doctor expressed uncertainty over how to do that, Hahn offered, “I’ll send you the contact.”

That’s some smoking gun, right there. If anything it proves that there is at least one federal official who is willing to try to help people solve problems.

Subsequently, the left-wing establishment attacked the doctor. Yet, despite the bombast of Vanity Fair and the mainstream media in general, the study exists and is legitimate. Details about the study, entitled “Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting,” are available at ClinicalTrials.gov. 

The study is currently recruiting participants with a goal of enrolling 750 for the research. The study is expected to be completed by December 31.

The study is being led by Dr. Avni Thakore, a cardiologist, who said, according to WLNY, the CBS affiliate in New York, “What we know about the mechanism of action of the drugs suggests they could be helpful early in the course of a viral infection.” “We know zinc is an anti-viral. We know that hydroxychloroquine can help reduce an immune response that can get out of control.”

While we have to wait until the end of the year, at the earliest, to find out the results of this trial, a similar study has already reported results.

The study, conducted by researchers affiliated with the New York University School of Medicine and New York University Langone Health, has found that the combination of zinc with hydroxychloroquine may, in fact, prevent COVID-19 from progressing to serious illness. The researchers noted:

The main finding of this study is that after adjusting for the timing of zinc therapy, we found that the addition of zinc sulfate to hydroxychloroquine and azithromycin was found to associate with a decrease in mortality or transition to hospice among patients who did not require ICU level of care.

A Real Bogus Study

Promising findings such as this one and others are ignored by the mainstream media, but negative studies get loads of publicity. Their over-the-top propaganda campaign to discredit hydroxychloroquine reached a fever pitch with the publication in the prestigious medical journal The Lancet of a study that called the drug ineffective and unsafe.

The study, entitled “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis,” was led by Dr. Mandeep R. Mehra, a cardiologist and medical director of the Brigham and Women’s Hospital Heart and Vascular Center in Boston. 

Using data sourced from a small company called Surgisphere, the study’s authors, which also included Sapan Desai, the founder of Surgisphere, reached an alarming conclusion: “We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19.” “Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.”

The statist mainstream media latched onto this finding with all due haste and breathlessly reported its conclusions in most, if not all, mainstream outlets. The results were touted as the final straw that would end hydroxychloroquine once and for all. This gambit almost worked.

Shocked by the study’s conclusion, researchers conducting or contemplating clinical trials involving hydroxychloroquine began to reevaluate their efforts based on worries that patients included in such studies might be harmed. “The World Health Organization and a number of national governments have changed their Covid-19 policies and treatments on the basis” of the study, The Guardian newspaper reported. One of the studies halted was the COPCOV study, a very large international study from Oxford University in the U.K. That study has now been restarted, and its principal investigators have indicated that they are anxious to further understand the potential of HCQ in prevention and early treatment of COVID-19. (For full coverage of the restart of COPCOV, see TNA online here: www.thenewamerican.com/hcq-study)

But almost immediately after the Lancet study was published, other researchers began to notice disquieting elements in the work. So troubling were the flaws that no less than the left-wing mouthpiece New York Times was forced to report on the situation. “Critics were quick to point out anomalies … including implausible findings that should have been detected during the peer review process — like the … apparent inclusion of a large number of Covid-19 cases very early on in the pandemic, even in Africa, where few hospitals have electronic health records,” the Times reported.

The Times continued: “Many researchers were astonished to find out that such a database could exist, or that the gathering and analysis of tens of thousands of medical records on multiple continents could have been carried out so quickly.”

A key element of science in general and scientific studies in particular is the idea of reproducibility. In scientific writing, it is expected and required that researchers provide sufficient details in a “materials and methods” section or sections of a paper so that other researchers can reproduce the described experiment. Such reproduction allows other researchers to evaluate the methods and data described while allowing them to derive the conclusions — or not — for themselves. This is the central feedback loop in scientific publishing that prevents fraud and ensures accuracy of results.

This was a central failing of the studies (there were two in total) that were based on the Surgisphere data. After such concerns were raised, the authors of the paper who were not affiliated with Surgisphere arranged for an independent review of the data. That review could not be completed because Surgisphere “would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis,” a group of the study’s original authors pointed out.

Ultimately, The Lancet was forced to retract the study. Speaking to Tucker Carlson of Fox News, Dr. Marc Siegel said the study was simply political in nature. “Political,” he said, “we know this is a political hit job.”

More Work Remains

It seems fairly clear at this point, despite the controversy, that lives have been saved by the careful use of hydroxychloroquine and that continued investigation of the drug and continued use by physicians treating COVID-19 patients should not be stopped.

One example of a life likely saved is the story of Margaret Novins, 53, who tested positive for COVID-19 in March. “I couldn’t breathe,” she said of her fight with the disease, according to Forbes.

Very quickly her doctors prescribed hydroxychloroquine, and she experienced improvement in her condition in just one day, according to Forbes. She credited the drug, sold under the brand name Plaquenil, with her recovery. “From my notes it is clear that my fevers and horrible chills I fought hard from 3/8-3/18 turned the corner the day I started Plaquenil 3/19,” she said.

Others, including doctors, have said that they, a family member, or someone they know have used and needed hydroxychloroquine during the pandemic. The aforementioned Dr. Siegel is one of these.

Again speaking to Fox News host Tucker Carlson, Siegel shared a personal story. “Tucker, I want to tell you about a 96-year-old man in Florida who said one night, ‘I don’t think I’m going to make it. I feel very weak. The end is coming. I’m coughing, I’m short of breath, I can’t get up from the couch,’” Siegel said. “The next day he was on hydroxychloroquine and antibiotics, per his cardiologist, he got up the next day, he was fine.” That man was Siegel’s father.

Congressman Roger Marshall (R-Kan.), an obstetrician, commenting on President Trump’s use of HCQ, has said that his family, too, has taken hydroxychloroquine. According to Newsweek, Marshall said “that he, his siblings, his parents and his wife are taking the drug ‘prophylactically’” — to ward off the disease.

Even a Michigan Democratic lawmaker, Karen Whitsett (D-Mich.), told Fox host Laura Ingraham that the drug saved her when she was suffering from COVID-19. “I really want to say that you have to give this an opportunity,” she said. “For me, it saved my life.”

One expert who believes hydroxychloroquine should not be taken off the table is Harvey A. Risch, professor of epidemiology at the Yale School of Public Health and Yale School of Medicine. Risch argued in favor of early treatment of COVID-19 with a combination of hydroxychloroquine and azithromycin.

“Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy,” Risch observed in an article for the American Journal of Epidemiology. “Hydroxychloroquine+azithromycin has been used as standard-of-care in more than 300,000 older adults with multicomorbidities, with estimated proportion diagnosed with cardiac arrhythmias attributable to the medications 47/100,000 users, of which estimated mortality is <20%, 9/100,000 users, compared to the 10,000 Americans now dying each week. These medications need to be widely available and promoted immediately for physicians to prescribe.”

Clearly, despite bureaucratic resistance, the potential benefits of hydroxychloroquine seem significant enough to continue additional research, as well as to provide a foundation for doctors working with patients to continue, if they deem necessary, to utilize the drug, either alone or in combination with other drugs and supplements such as zinc.

Attempts by federal and state health agencies, bolstered by mainstream media propaganda, to restrict usage of hydroxychloroquine is, at its base, an effort to supplant individual physician expertise with blanket control of healthcare by government bureaucrats. It stands to reason that effective healthcare is delivered by skilled doctors and other healthcare staff working with patients directly, and that one-size-fits-all, politically motivated dictates from government bureaucrats put patients at significantly increased risk of poor outcomes.

The effort to discredit HCQ continues, but is on shaky ground because propaganda ultimately must fail when it is opposed by the truth.

Indeed, if COVID-19 is to be countered effectively, and lives are to be saved, then, as always, freedom is the cure. Government must get its nose out of the business of science and let researchers and doctors — the actual experts — conduct their life-saving research and work unencumbered by government regulation.

 

ALLERGY RISKS INCREASE AS FDA CHANGES FOOD LABELING REQUIREMENTS DURING COVID-19 PANDEMIC

BY CAROLYN HENDLER, J.D.

SEE: https://thevaccinereaction.org/2020/06/allergy-risks-increase-as-fda-changes-food-labeling-requirements-during-covid-19-pandemic/;

republished below in full unedited for informational, educational & research purposes:
Allergy Risks Increase as FDA Changes Food Labeling  Requirements During COVID-19 Pandemic

Opinion | On May 22, 2020, the U.S. Food and Drug Administration (FDA) issued a public comment providing new guidance that will relax the labeling requirements on packaged food to allow food companies more flexibility during the COVD-19 pandemic. Companies selling food are now allowed to make minor changes to the formulation of food products without being required to change the product label, raising the risks for serious food allergies.

FDA Made Change Without Public Comment

The FDA’s stated goal of changing food labeling requirements is to minimize the effects of food supply chain disruption and meet consumer demand.1 A departure from the standard practice of first taking public comment before issuing new guidance to companies selling products that carry health risks, this guidance by the FDA took effect immediately without public comment.2

The FDA is the oldest U.S. government consumer protection agency.3 The Federal Food, Drug, Cosmetic Act granted the FDA the authority to protect consumers from unsafe products by requiring that most prepared and packaged foods be accurately labeled by the manufacturer.4

The FDA states;

Consumers use the ingredient list to make purchasing decisions and determine whether a food contains an ingredient they want (e.g., whole grains) or ones they do not want (e.g., due to allergies). Without this ingredient information, consumers would not be able make nutrition-based food decisions, as well as avoid ingredients for health or other reasons.5

Protecting Food Company Profits But What About Safety?

However, during the coronavirus pandemic, it appears that the FDA has shifted its responsibility from protecting consumers to helping food companies protect their profits from any lost business stemming from potential disruption of the food supply chain.6

The guidelines provide that manufacturers may substitute a minor ingredient in a recipe without changing the label when the substituted ingredient:

  1. is not known to cause adverse health effects such as food allergens, gluten, sulfites;
  2. is generally less than 2 percent of the product weight;
  3. is not be a major product ingredient;
  4. is not a characterizing ingredient;
  5. does not affect the nutrient content or health claims on the product label; and does not have a significant impact on the finished product.7

A label does not need to be changed, for example, when certain oils that contain a similar type of fat have been substituted in a recipe, such as canola oil for sunflower oil, or when an oil is highly refined and does not pose a risk for an allergic reaction according to the FDA.8 However, many people have allergic reactions to highly refined products derived from one of the top eight allergens such as such as peanut oil or soy lecithin.9

The FDA guidance provides that minor formulation changes may be made as long as the substituted ingredient,

does not cause adverse health effect “(including food allergens, gluten, sulfites, or other foods known to cause sensitivities in some people, for example, glutamates).10

The FDA does not define what ingredients are considered to cause an “adverse health effect.”11 Food allergies are unique in that an individual may react to ingredients the FDA does not consider allergens. According to the Food Allergy Research and Education (FARE) more than 170 foods have been reported to cause allergic reactions.12

Cross Contamination A Safety Issue

The guidance states that food companies must continue to list the top 8 allergens including peanuts, tree nuts, milk, eggs, soy, wheat, fish, and crustacean shellfish on the package ingredient list. However, there is still cause for concern for those allergic to the top eight allergens even when other ingredients are substituted because of cross-contamination.

Take the example of a milk chocolate bar that carries the advisory statement: “Made on equipment that also processes almonds.” If the manufacturer decides to substitute peanut flour for almond flour in another product in the same line, that advisory statement may be rendered incorrect or incomplete.13

Manufacturers are not required to list the substituted ingredients of their food products on labels, or on their website or a central FDA website. The only way to find out if an ingredient was substituted and what it was substituted for is to call the manufacturers for every food product.14

32 Million Americans With Food Allergies

Approximately 32 million American live with a food allergy.15 In 2018, it was estimated that eight percent or one in 13 children and 1 in 10 adults had a food allergy.16 According to the CDC, food allergies increased 50 percent between 1997 to 2011. Between 1997 and 2008, peanut and tree nut allergies have tripled in children in the U.S.17

Food allergy reactions range from mild such as a few hives to life threatening anaphylactic reactions. In the U.S each year, allergic reactions to food send 200,000 people to seek emergency medical care.18

Allergic Reactions Are Life Threatening

Life threatening allergic reactions require the immediate use of an epi-pen within minutes of the start of symptoms of a reaction. Medical professionals instruct that anyone having an anaphylactic reaction immediately inject an epi-pen and then go to the hospital. While going to the hospital after an allergic reaction is always a cause for concern, it is an even more frightening experience during the COVID-19 crisis.

In order to protect their children from the risk of an allergic reaction, food allergy parents know exactly what packaged food their child can eat and what ingredients they need to stay away from. Many families have learned the hard way to have a list of safe snacks and not to vary their food choices. Even a small change in the type of spice or kind of oil used in a recipe could cause a child to react negatively or even go into anaphylactic shock.

Food Allergies of Special Concern in Autism Community

Food allergies are of special concern for parents of very young children or non-verbal children with autism, who may not be able to effectively communicate that they are having an allergic reaction.

These new guidelines will particularly affect the autism community. One in 54 children in the United States have autism. Studies have shown that children with autism are five times as likely as other children to have difficult eating habits such as only eating a narrow range of food items.19

Children with autism have an increased risk of food allergies.20 According to a study, 11.25 percent of children with autism had a food allergy compared to 4.25 percent of children without autism.21 22

Substituting ingredients in products without making corresponding changes to the label is especially concerning with nonverbal children on the autism spectrum, who may not be able to effectively communicate a reaction to foods they were once able to tolerate.

New Food Labeling Guidelines Could Remain in Effect Long Term

The FDA has stated that the new guidelines were issued in response to the COVD-19 pandemic. However, there is no set end date and these changes may be extended or renewed by the Secretary of Health and Human Services if food companies say they need additional time to restock supply chains.

Although the new guidelines went into effect immediately, without first taking public comments, public comments may be submitted at any time for FDA’s consideration.

The FDA provides,

… upon termination of the public health emergency, FDA intends to consider and publicly communicate regarding whether an extension, in whole or in part, is warranted, based on comments received to this guidance and our experience with its implementation.23

Submitting Written Comments to FDA on Food Labeling

You can submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket number FDA-2020-D-1139 and complete title of the guidance in the request.24

Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers.  The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.

References:

1 U.S. Food and Drug Administration. FDA Announces Temporary Flexibility Policy Regarding Certain Labeling Requirements for Foods for Humans During COVID-19 Pandemic. May 22, 2020.
2 FDA. Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency. March 2020.
3 FDA. The History of FDA’s Fight for Consumer Protection and Public Health. June 29, 2018.
4 FDA. FDA: Foods Must Contain What Label SaysFeb. 24, 2013.
5 FDA. Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines. May 2020.
6 FDA. FDA Fundamentals.
7 See Footnote 1.
8 Ibid.
9 Bloom D. The FDA Has Relaxed Labeling Requirements Under COVID-19. What it Means for the Food Allergy Community. SnackSafely.com May 4, 2020.
10 See Footnote 5.
11 Ibid.
12 Food Allergy Research & Research. The Food Allergy Epidemic. 2020.
13 See Footnote 9.
14 Ibid.
15 See Footnote 12.
16 U.S. Centers for Disease Control and Prevention. Healthy Schools Food Allergies. May 29, 2019.
17 See Footnote 12.
18 Asthma and Allergy Foundation of America. Allergy Facts & Figures. 2018.
19 Autism and Food Aversions: Seven Ways to Help a Picky EaterAutism Speaks Oct. 9, 2018.
20 TVR Staff. Autism Numbers Increase by 10 Percent in U.S.The Vaccine Reaction May 24, 2020.
21 Gordon S. Allergies More Common in Kids With AutismWebMD June 8, 2018.
22 MacReady N. ASD Tied to Excess Risk for Food AllergyMedscape June 8, 2018.
23 See Footnote 5.
24 See Footnote 2.

 
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