May 7, 2021

May 7, 2021

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Break the FDA Barriers! Make Hydroxychloroquine Over-The-Counter

by | May 29, 2020 |

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As a physician focused on saving lives, I am tired of people dying because of political games. I have extensively studied the history and medical data worldwide on hydroxychloroquine (HCQ). Until February/March 2020, it was considered one of the safest, most essential and effective medicines in the world. The experts who say otherwise now for political and financial agendas should be ashamed of themselves.
How can anyone with any common sense believe that a medicine that has been safe and effective in multiple conditions, called an “essential medicine” by the World Health Organization (WHO), and used in hundreds of millions of patients worldwide for 65 years, is suddenly so “dangerous” that doctors cannot prescribe 400 mg a day for 5 days for their COVID outpatients early in the disease, but we can at the same time continue to prescribe HCQ 400 mg a day for years for malaria or lupus or rheumatoid arthritis? It makes no medical sense whatsoever. 
Based on the same evidence the FDA cites in its March 28 Emergency Use Authorization (EUA) restricting HCQ to hospitalized patients, the CDC and NIH studies published in 2005 showed chloroquine (and HCQ) is a potent anti-viral if started at the earliest symptom onset in SARS-CoV virus to be most effective to (1) reduce severity of illness (and thereby keep people out of hospitals and off ventilators), and (2) reduce viral load/ multiplication, thereby decreasing duration of infectivity, which in turn reduces spread to other people.

In spite of this 15-year-old science showing how HCQ works and that the first two steps in establishing the viral infection are when it works best, the United States FDA and many state Governors restricted HCQ to hospitalized patients, preventing doctors from using HCQ in outpatients as soon as symptoms begin, when it is most effective. 

A Yale study of hydroxychloroquine plus azithromycin in more than 300,000 older adults, just published May 27, 2020 said: “Evidence about use of hydroxychloroquine alone, or of hydroxychloroquine+azithromycin in inpatients, is irrelevant concerning efficacy of the pair in early high-risk outpatient disease. Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy… These medications need to be widely available and promoted immediately for physicians.
Early treatment with HCQ, and widespread prophylactic use, are the critical factors that led to the dramatically lower death rates in countries such as India (2/million), Australia (4/million), South Korea (5/million), Argentina (8/million) as of May 18.
By delaying HCQ use until people are already critically ill in the hospital, the US now has a markedly higher death rate from COVID-19 (278/one million population as of May 18), even though we had adequate hospital beds, ventilators and other equipment. Data by countries on May 18, 2020, which is updated daily, shows the stunning differences:
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I sent my first letter to President Trump on April 10, with 1,304 other physicians, health care workers, and concerned patients signing the letter asking President Trump to exercise his full Presidential power under the Emergency Powers act to save lives: Issue an Executive Order expanding the FDA Emergency Use Authorization making hydroxychloroquine (HCQ) widely available outside of hospitals for primary care outpatients and nursing home patients in all 50 states. 
The FDA has continued to block changing their EUA to expand it to outpatient use, in spite of urging from the President, Secretary of Health and Human Services Azar, Admiral Giroir of the US Public Health Service, and physicians across America.

By May 25, with 75,000 more American deaths, we still had no action by the FDA to remove their restriction keeping HCQ for only hospitalized patients, which in effect prevented doctors in most states from prescribing HCQ off-label early to treat nursing home and outpatients. 

I decided drastic times called for drastic action. On Memorial Day, reflecting on all the additional lives lost, I sent another letter to President Trump. This time my pharmacist colleague and I prepared a well-documented proposal and supporting safety documentation from review of medical studies going back to the early FDA approval for HCQ. I was heartsick that so many more Americans had died, in the two months of waiting for FDA action, when I knew from studying other countries successes that many deaths could have been prevented with early treatment and making HCQ available to vulnerable  nursing home patients.
In this May 25 letter I said to President Trump:


“Please, Mr. President, I implore you: Use your full emergency powers NOW under the Defense Production Act. Order hydroxychloroquine to be made available over-the-counter during this National Emergency. Many of us physicians see this as your most important Executive Order of all, as we now surpass 100,000 deaths in the United States.
You have the Executive power to bypass the pontificating government experts and FDA bureaucrats as you did for the farmers and meat packers. Let WE THE PEOPLE decide whether to take HCQ to save our lives, just as you were able to do. Average Americans are blocked by Governors and the FDA from making the choice you made. What a POWERFUL message of HOPE you could give to the people of America!
You talk to us average Americans like adults. Now, let US make the decisions about how to take care of ourselves against this viral enemy. Let US decide how we want to use the medicines available. Restore to us our God-given freedom to preserve our own lives, our most fundamental liberty of all.
How many lives could have been saved if patients themselves, if families of nursing home patients, could have made the decision to use HCQ early? How can we in good conscience not provide an OTC option for HCQ to help save lives, when the FDA in 2006 approved Plan B high dose progestin abortifacient to be sold over-the-counter?
It is ONLY FOUR months to the beginning of early voting by mail in ballots. We simply have very little time left for you to exercise your authority under the Emergency Powers Act to show Americans you are responding to their frustration: (1) for access to medication they read online is saving lives overseas and in some U.S. states, and (2) for getting America OPEN for business and Americans back to work.”


We do not need more “nanny state” federal and state government officials deciding whether we are allowed to have hydroxychloroquine or not. If we can prevent pregnancy with over-the-counter Plan B, it should be our option to prevent COVID-19 and preserve our life with the choice to take HCQ.
How many times have you heard the pundits claim ‘HCQ can kill you!’? It’s important we look at how HCQ compares in safety with some common over-the-counter medicines (OTC). The common OTC pain and fever reliever, Tylenol (acetaminophen), has such liver toxicity that it is the number 1 cause of acute liver failure in the United States, ahead of hepatitis. Common pain relievers Aleve and Advil can cause acute kidney failure and life threatening gastrointestinal bleeding.
HCQ was FDA-approved in 1955 and used in hundreds of millions of prescriptions worldwide since then. If HCQ were actually killing people as media headlines and pundits claim, it would have been taken off the market decades ago. The FDA itself in the CDER data has only 62 cardiac deaths related to HCQ out of 50 MILLION prescriptions.

That is an actual risk of 1.2 per one million people for a life-threatening heart arrhythmia. Lower than deaths due to Tylenol, Aleve, Advil or Aspirin, and several other categories of existing over-the-counter medicines.

You have a TEN-fold greater risk (1/74,000) of dying in a fatal car accident on a 1000-mile road trip. Does the media tell you that?
What is happening across the United States with the media’s deliberate deceit, distortions, and outright lies about COVID-19 safe treatment options and the value, or lack thereof, and the outright damage of prolonged shutdowns, has been a dangerous partisan power struggle with hundreds of thousands of lives in the balance.
They are playing deadly games manipulating other peoples’ lives. People are dying every day.
People are dying from COVID-19. But people are dying in alarming numbers from the consequences of prolonged lockdowns:

  • suicidal despair losing their jobs and homes.
  • skyrocketing drug addiction and alcohol abuse
  • stress-induced heart attacks and strokes
  • diabetes and high blood pressure spiraling out of control as people turn to “comfort foods” and can’t get regular exercise with gyms, pools, and parks locked down for COVID

My allegiance is to patients, not government, insurance companies, politicians, or pharmaceutical companies. I went into medicine to help cure people and save lives. To help those suffering and support them in their decisions about treatment or no treatment. I did not go into medicine to play political games with peoples’ lives.
Yet that is exactly what is happening to physicians across this country whose legal prescribing authority has been usurped and overridden by politicians and bureaucrats in the most dangerous and unprecedented intrusion into the practice of medicine I have witnessed in my lifetime. Hydroxychloroquine has suddenly become the media’s “demon drug” that they claim can “kill you,” even when this is NOT based in the science evaluated by the FDA, CDC and NIH with over 65 years of global use of this medicine.
On top of distortions and deceptions assaulting us daily, Washington medical experts are constantly moving the goalposts in a game of political football⏤dragging out the lockdowns as long as possible in this Presidential election year. It makes your head spin when they contradict themselves so often. Average Americans just want their lives, their livelihoods, and their liberty back.
Americans are smart. Americans are decisive. Americans are creative. We know how to weigh pros and cons. We know how to evaluate the risks we are willing to take to save our own life.
It is time to GET OUT LOUD with legislators, Governors, the President and let them ALL hear from us. Light up the switchboards at the White House. Light up social media platforms with our OUT LOUD VOICES.
It is time to GET OUT LOUD with a new movement: Let Doctors be Doctors. Let Patients make their treatment choices. Get the politicians out of our decisions.
GET OUT LOUD to make HYDROXY ACCESS FOR ALL, not just the privileged. 
It is time to GET OUT LOUD for our medical freedom. Our body. Our life. Our CHOICE.

DrLee4America

DrLee4America has been a leader in patient-centered, individualized medical care. Since 1986, she has practiced medicine independently of insurance contracts that interfere with patient-physician relationships and decision-making. DrLee4America's focus is medical freedom and free-market approaches to healthcare.

DrLee4America is a 2014 Ellis Island Medal of Honor recipient for her national and international educational efforts in health, wellness, and endocrine aging in men and women, and she is recognized in the US as a motivational speaker in health and wellness and a powerful patient advocate, proponent of free-market approaches to lower healthcare costs. DrLee4America is the recipient of the Voice of Women Award from the Arizona Foundation for Women in recognition of her pioneering advocacy for the overlooked hormone connections in women’s health.

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Alexandra Stallings
Alexandra Stallings
11 months ago

Great Article!! I’ve been sharing about the benefits of HCQ when I first read about it early on! Tragic that certain political party is not allowing access to this medication! President Trump will do right by the American People!

Linda Batzek
Linda Batzek
10 months ago

People need access to this drug

Kristin Holochwost
Kristin Holochwost
Reply to  Linda Batzek
9 months ago

We the people of the United states of America, are asking for our RIGHT’S to be heard. Release the right to try order.PRESIDENT TRUMP APPROVED. My dr. Refused to prescribe to me. Knowledge of I took the flu shot,his nurse gave last year. And I have been suffering from R . A. For years. Will a dr please stand up and prescribe this medication to me please. It’s time for we the people who our for fathers built.This grand United States To have our voices heard. Iam 1 with millions

KAREM MCWHORTER
KAREM MCWHORTER
9 months ago

If, by executive order, POTUS supports HYDROXYCHLORIQUINE….there will be a judge that blocks it. They’ve blocked everything he’s tried to do. Can’t share this on Twitter and FB. They’re censoring anything beneficial to people.
So disappointed in our lawmakers and judicial (federal and circuit.

KAREM MCWHORTER
KAREM MCWHORTER
9 months ago

If, by executive order, POTUS supports HYDROXYCHLORIQUINE….there will be a judge that blocks it. They’ve blocked everything he’s tried to do. Can’t share this on Twitter and FB. They’re censoring anything beneficial to people.
So disappointed in our lawmakers and judicial (federal and circuit.
Thank you for standing up.

Debbie Bryant
Debbie Bryant
9 months ago

I have been taking this drug for lupus for years. It has to be closely monitored so I wouldn’t recommend OTC. It makes me sick as heck.
I don’t see a reason not to prescribe to patients.

Frank
Frank
9 months ago

If HCQ cannot be sold over the counter, the next best thing is to find one of the very few doctors that will prescribe it. This web page has a listing of those doctors.
At the top of the page is tele-health provider DocTalkGo.com. The only problem is that you will have to get a positive COVID test before they issue a prescription. I recommend bugging them to prescribe based on symptoms and risk categories (i.e., age and comorbidities) as Dr. Zelenko did.

Frank
Frank
Reply to  Frank
9 months ago
Margaret Smith
Margaret Smith
8 months ago

Please President Trump… make HCQ available to all in the USA. Thank you!

Rebecca Kidder
Rebecca Kidder
6 months ago

Save lives, make it OTC! I saw the person that said it makes them sick. Lots of OTC meds make ppl sick. Either don’t take it or call a physician.

Patti Kier
Patti Kier
4 months ago

Dear Mr. President, Please, come tot he AID of the American people, and make Hydroxychloriquin available OTC. I saw my Dr. yesterday, who “refused to give me a prescription for this preventative to the China Virus. ” Appreciate ALL you do for the GOOD of America,

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