No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
How could a cheap, effective drug, FDA-approved and in use worldwide since 1955, suddenly be restricted for outpatient use by American physicians? On March 28, 2020, as physicians worldwide were seeing striking success using hydroxychloroquine to treat COVID-19, the FDA erected bureaucratic barriers.
Rick Bright, Ph.D., is a career bureaucrat, vaccine researcher, and political appointee, former head of BARDA (Biomedical Advance Research and Development Authority, a sub-agency of the FDA), who wielded the power and claimed credit for being the person imposing his will on all of us.
Rick Bright’s dictatorial decree restricts the use of chloroquine (CQ) and hydroxychloroquine (HCQ) from the National Strategic Stockpile in COVID-19 to hospitalized patients only. States are using Bright’s fiat to impose broad restrictions limiting the drugs’ availability for physicians to use for outpatients to help them recover without hospitalization.
In other countries, hydroxychloroquine in early use in outpatients is changing the life-and-death equation by reducing severity and spread of illness, greatly reducing the need for hospitalization and ventilators and markedly reducing deaths.
By his own admission, Rick Bright, who is not a physician, knowingly and unilaterally countermanded Secretary of Health and Human Services Alex Azar, Admiral Brett Giroir in charge of Public Health Service and the President of the United States, who had directed BARDA to establish a Nationwide Expanded Access Investigational New Drug (“IND”) protocol for chloroquine, which would provide significantly greater outpatient access for the drug than would an Emergency Use Authorization (EUA). Unlike an EUA, a Nationwide Expanded Access IND protocol would make the drug available for the treatment of COVID-19 outside a hospital setting at physicians’ medical discretion based on patients’ needs.
In an appalling admission, Bright said: “Specifically, and contrary to misguided directives, I limited the broad use of chloroquine and hydroxychloroquine, promoted by the administration as a panacea, but which clearly lack scientific merit.” Meanwhile, he promoted both remdesivir, a never-approved experimental antiviral in development by Gilead Sciences, and a vaccine for COVID-19. Early effective use of the older, safe, and available hydroxychloroquine, whose patents had expired decades ago, would decrease demand for these new products.
How does one non-physician bureaucrat have such power with impunity? How can one person brag about blocking physicians’ attempt to reduce hospitalization and deaths during a national emergency?
It is a falsehood to say that the administration promoted HCQ as a “panacea” or that this medicine “clearly lacks scientific merit.” Both statements are contradicted by video recordings of Presidential briefings, by NIH/CDC studies going back 15 years, and by U.S. and worldwide clinical outcomes studies in COVID-19.
It is unprecedented to restrict physicians from prescribing FDA-approved drugs for a newly discovered use—“off-label.” This is contrary to FDA regulations in place since World War II.
Basic science studies published in 2005 from our own CDC and NIH showed clearly that CQ and HCQ work early in SARS-CoV to block viral entry and multiplication, and suggested that they would not work as well in late-stage disease when the viral load had become huge. When SARS-CoV-1 waned and disappeared by late 2003, the drugs were not submitted for FDA-approval for this coronavirus.
In 2019, when Chinese doctors recognized the deadly impact of SARS-CoV-2, they began trying known and available anti-viral medicines, especially CQ and HCQ, based on 15-year-old studies. They shared information with South Korea, India, Turkey, Iran, and several other countries, who also began quickly and successfully using CQ and HCQ, alone or with azithromycin. Later, Brazil, Israel, Costa Rica, Australia, and others followed, with good results.
Based on these initial clinical reports, President Trump said, at an early press briefing, that CQ and HCQ “offered hope.”
More studies have replicated these findings. HCQ given within the first week of symptoms, especially with zinc, can prevent the virus from entering your body’s cells and taking over, much like people use locks and alarms to stop burglaries. Waiting until you are in the ICU is like installing home locks and alarm system after burglars have invaded, vandalized your home, and stolen all your valuables. The drugs cannot reliably undo the damage from the exaggerated immune response, or cytokine storm, triggered by COVID-19.
Examples from the world data on May 18, 2020, which is updated daily, show how Third-World countries are faring far better than the U.S., where entrenched bureaucrats, governors, and medical and pharmacy boards are interfering with physicians’ medical decisions.
|Country||# of cases||# of deaths||Deaths/million|
Use of HCQ
|India||101,261||3,164||2.0||Early and prophylactic|
|Costa Rica||866||10||2.0||Early and prophylactic|
|Australia||7,068||99||4.0||Early and prophylactic|
|South Korea||11,078||263||5.0||Early and prophylactic|
|Argentina||8,371||382||8.0||Early and prophylactic|
|Turkey||150,593||4171||50.0||Early and prophylactic|
|Israel||16,643||276||32.0||Early and prophylactic use|
|Brazil||255,368||16,853||79.0||Early, some prophylactic use|
|U.S.||1,550,294||91,981||278.0||Late, in hospitalized patients|
Instead of orchestrating a war on HCQ, the media should be asking key questions, such as:
Bright’s disastrous bureaucratic decision may well be remembered as one of the worst preventable medical tragedies in our time. Never again should one government employee be allowed unrestrained power without oversight, and allowed to make a sweeping order interfering with the prescribing authority of front-line physicians trying to save lives.
Disclaimer: The information contained in this website is for educational, general information, and entertainment purposes only and is never intended to constitute medical or legal advice or to replace the personalized care of a primary care practitioner or legal expert.
While we endeavor to keep this information up to date and correct, the information provided by America Out Loud, its website(s), and any properties (including its radio shows and podcasts) makes no representations, or warranties of any kind, expressed, or implied, about the completeness, accuracy, reliability, suitability, or availability with respect to its website(s) or the information, products, services or related graphics and images contained on the website(s) for any purpose.
The opinions expressed on the website(s), and the opinions expressed on the radio shows and podcasts, are the opinions of the show hosts and do not necessarily represent the opinions, beliefs, or policies of anyone or any entity we may endorse. Any reliance you place on such information is therefore strictly at your own risk.
At no time, nor in any event, will we be liable for any loss, or damage, including without limitation, indirect or consequential loss of data or profits arising out of, in an association of, or connection with the use of this website.
Through this website, users can link to other websites that may be listed. Those websites are not under the control of America Out Loud or its brands. We have no control over the nature, content, or availability of those sites. America Out Loud has no control over what the sites do with the information they collect. The inclusion of any links does not necessarily imply a recommendation, nor does it endorse the views expressed with or by them.
Every effort is made to keep the website up and running smoothly. However, America Out Loud takes no responsibility for, nor are we, and will not be liable for being temporarily unavailable due to technical difficulties beyond our control. America Out Loud does not sell, trade, nor market email addresses or other personal data.